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	<title>Around the Crux</title>
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		<title>Around the Crux</title>
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		<title>New CC likely fraud</title>
		<link>http://atthecrux.wordpress.com/2009/08/22/new-cc-likely-fraud/</link>
		<comments>http://atthecrux.wordpress.com/2009/08/22/new-cc-likely-fraud/#comments</comments>
		<pubDate>Sun, 23 Aug 2009 02:54:45 +0000</pubDate>
		<dc:creator>atthecrux</dc:creator>
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		<description><![CDATA[Not that this&#8217;ll be interesting to most people, but posting it for the benefit of anyone searching for info in a similar situation.
I recently had a charge for $5.18 come through from DPOCOLLC.COM 423-4360167 TN on my Bank of America card. The odd thing is, they used a number that hasn&#8217;t been active for a [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=atthecrux.wordpress.com&blog=4074078&post=135&subd=atthecrux&ref=&feed=1" />]]></description>
			<content:encoded><![CDATA[<div class='snap_preview'><br /><p>Not that this&#8217;ll be interesting to most people, but posting it for the benefit of anyone searching for info in a similar situation.</p>
<p>I recently had a charge for $5.18 come through from DPOCOLLC.COM 423-4360167 TN on my Bank of America card. The odd thing is, they used a number that hasn&#8217;t been active for a number of years. (It&#8217;s a card I had with Fleet before they were merged into Bank of America.) I just called B of A and they said they&#8217;d credit me for the amount, and asked me to call the company and tell them never to charge me again. I&#8217;m not sure that they actually processed it as a fraud issue, but I guess it&#8217;s no skin off of my nose if they wait to call it &#8220;fraud&#8221; and more charges come through (though it does seem ridiculous that they&#8217;re still allowing charges through using the old number!).</p>
<p>Note that I&#8217;m not necessarily implicating DPOCOLLC.COM in anything; it&#8217;s entirely possible that a fraudster simply ran a test purchase (or real purchase of services) through them, if they&#8217;re a legitimate company. That said, however, I wouldn&#8217;t be anxious to do business with the company: their website was registered this year using GoDaddy&#8217;s &#8220;domain privacy&#8221; feature, the website has no names or physical addresses that I could see, and external references on the Internet are essentially nonexistent. Also, their &#8220;request full refund now&#8221; link on the Contact Us page reminds me of the bogus refund forms that IP-MYSTORE.COM, IP-ECOMMERCE.COM, and related scam sites used at one point. (See <a href="http://atthecrux.wordpress.com/2008/07/18/ip-mystorecom/">this post</a> for more info on that sorry saga.) I&#8217;ll reserve judgement, and let BofA sort it out.</p>
<p>Web searching revealed <a href="http://www.tngunowners.com/forums/general-off-topic/25462-strange-bank-charge-concealed-carry-2.html">another case</a> of CC fraud w/ some connections.</p>
<p><b>Update 8/24/2009 11:48:</b><br />
Per BoA&#8217;s request, I just called the number listed on the CC statement and on DPocoLLC.com&#8217;s Contact page, and got a &#8220;This mailbox is full.&#8221; message. My impression of the company&#8217;s legitimacy is not increasing. I&#8217;ll try sending an e-mail yet&#8230;</p>
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		<title>A Vote For The Kingdom?</title>
		<link>http://atthecrux.wordpress.com/2008/10/31/a-vote-for-the-kingdom/</link>
		<comments>http://atthecrux.wordpress.com/2008/10/31/a-vote-for-the-kingdom/#comments</comments>
		<pubDate>Fri, 31 Oct 2008 23:31:29 +0000</pubDate>
		<dc:creator>atthecrux</dc:creator>
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		<guid isPermaLink="false">http://atthecrux.wordpress.com/?p=130</guid>
		<description><![CDATA[I&#8217;ve been thinking recently about the subject of voting. Now, for many people voting isn&#8217;t a major issue. Much of my age group has, traditionally, been fairly unlikely to appear at the voting booth. My religious tradition, which I value, has emphasized the idea of the &#8220;Kingdom of Heaven&#8221;. Generally, the view of this tradition [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=atthecrux.wordpress.com&blog=4074078&post=130&subd=atthecrux&ref=&feed=1" />]]></description>
			<content:encoded><![CDATA[<div class='snap_preview'><br /><p>I&#8217;ve been thinking recently about the subject of voting. Now, for many people voting isn&#8217;t a major issue. Much of my age group has, traditionally, been fairly unlikely to appear at the voting booth. My religious tradition, which I value, has emphasized the idea of the &#8220;Kingdom of Heaven&#8221;. Generally, the view of this tradition has been that our primary allegiance is to Christ, whose kingdom operates under different rules (e.g., the forgoing of force). That being the case, the logic goes, we shouldn&#8217;t involve ourselves in earthly government&#8211;even to the extent of voting.</p>
<p>My thought on the topic has been evolving, and continues to evolve. Some of the things I&#8217;m chewing on (and some of which I simply need to research) include:</p>
<ul>
<li>What <em>is</em> the Kingdom of Heaven that Jesus came to establish? My current, general view (not original with me) is that His coming was &#8220;the beginning of the end&#8221; of a dark age, that He started the process of transforming our reality, of creating a new spiritual order with ethical and social ramifications.</li>
<li>How is a citizen of that Kingdom to interact with temporal kingdoms? My cultural-religious tradition has, through much of its history, tried to minimize interaction with governments. I&#8217;ve heard in recent days that Christians are ambassadors of God&#8217;s kingdom (agreed), and an ambassador doesn&#8217;t have the right to meddle in the affairs of the country to which he&#8217;s sent (is the analogy taken too far?). Another writer has <a href="http://www.sojo.net/blog/godspolitics/?p=3325">a different take</a> on our status as &#8220;ambassadors&#8221;:<br />
<blockquote><p>However, the call to liberate ourselves from the powers of this world is the foundation for a discipleship that re-engages these systems as prophetic agents of God’s kingdom.   We are equipped to do justice and named “ambassadors” of the Good News.  Ambassadors are sent to people with a foreign agenda, to engage at the highest levels of power.</p></blockquote>
</li>
<li>To what extent can one avoid responsibility for government in a democratic republic, and what responsibilities <em>should</em> one avoid? John Howard Yoder makes an effective argument (albeit one I haven&#8217;t studied sufficiently to effectively re-present) that Jesus <em>did</em> act &#8220;politically&#8221;, but according to the rules of the Kingdom of God. (E.g., he didn&#8217;t join the Zealots, a political movement of his day.) As Tim King <a href="http://www.sojo.net/blog/godspolitics/?p=3323">points out</a>, Jesus isn&#8217;t an Essene and he isn&#8217;t a Herodian; he neither withdrew to the desert nor &#8220;buddied up&#8221; with the political establishment, but he spoke to power in Jerusalem.</li>
<li>If one chooses to involve oneself in the political system, how can one effectively avoid  being pressed into a &#8220;worldly&#8221; thought pattern of using worldly politics as one&#8217;s primary tool?</li>
<li>I haven&#8217;t necessarily &#8220;swallowed&#8221; his conclusion, but Lawrence Temfwe <a href="http://www.sojo.net/blog/godspolitics/?p=3289">argues</a> that, like Israel in exile in a pagan nation (Jeremiah 29), we are to work to bless the nation where we are temporarily located. We are to be model citizens for Christ&#8217;s sake (see I Peter). And yet, is the kingdom against which &#8220;the gates of hell will not prevail&#8221; going to get there by its citizens playing defense?</li>
<li>Is it overly arrogant to weigh ills and goodness against each other in participating in politics? This argument has some resonance; who am I to decide that the evil of war outweighs the evil of abortion, or to decide that &#8220;Christian&#8221; national arrogance does more damage to God&#8217;s kingdom than does tolerance of immorality? And yet, Paul censures the Corinthians for not exercising their judgement (&#8220;Do you not know that we will judge angels?&#8221;), but bringing their cases for secular courts to decide. Is it arrogance to make a decision, or is it avoiding one&#8217;s duty not to do so?</li>
<li>How much, and how, does the difference between the political system of Jesus&#8217; situation and of our own make a difference?</li>
<li>I think voters and nonvoters agree on the primacy of Christ&#8217;s kingdom. Is it possible to accept, but subordinate, earthly civic responsibility?</li>
<li>Whether one concludes that one should vote or not, one&#8217;s responsibility to build Christ&#8217;s kingdom is still the same, as are the simple duties of citizenship in that kingdom. We&#8217;re to help the kingdom grow, and we&#8217;re to do that by telling people of it, equipping them to be productive citizens in it, and helping those&#8211;whether in the kingdom or outside it&#8211;who need us.</li>
</ul>
<p>So&#8230;can one vote for Christ&#8217;s kingdom? I&#8217;ll leave you to answer that question. I&#8217;m working on learning some answers, but am still journeying.</p>
<p>As you ponder, I think it&#8217;s worth reading a few articles from Sojourners. I don&#8217;t always agree with their writers, but think they do have a lot of good to contribute&#8211;some of which resonates closely with the faith tradition in which I grew up, and some of which differs substantially. I have no particular desire to either blindly cling to or blindly reject the values of my faith community. I don&#8217;t want to blindly accept, nor do I want to blindly reject, what these writers have to say. As a Christian trying to figure out how to live, interacting with other Christians in the same pursuit, I hope I, you, and others can be productive citizens of Christ&#8217;s kingdom.</p>
<p>Sojourners articles I&#8217;ve been thinking about:</p>
<ul>
<li><a href="http://www.sojo.net/blog/godspolitics/?p=3293">Voting as Damage Control</a></li>
<li><a href="http://www.sojo.net/blog/godspolitics/?p=3323">Jesus is not an Essene nor a Herodian</a></li>
<li><a href="http://www.sojo.net/blog/godspolitics/?p=3293">Advise Everyone&#8230;Endorse No One<br />
</a></li>
<li><a href="http://www.sojo.net/blog/godspolitics/?p=3325">Christian Voters Need to Reorient, not Disengage</a></li>
<li><a href="http://www.sojo.net/blog/godspolitics/?p=3342">Why I Believe Christians Should Vote</a></li>
<li><a href="http://www.sojo.net/blog/godspolitics/?p=3289">An International Challenge for Christians to Vote</a></li>
<li><a rel="nofollow" href="http://www.sojo.net/blog/godspolitics/?p=3166">My Personal &#8216;Faith Priorities&#8217; for this Election</a></li>
</ul>
<p>Oh, and definitely get a copy of John Howard Yoder&#8217;s <a href="http://www.amazon.com/Politics-Jesus-John-Howard-Yoder/dp/0802807348"><em>The Politics of Jesus</em></a>. I&#8217;ve read it only once and am far from having fully digested it&#8211;but it&#8217;s well worth reading.</p>
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		<title>America&#8217;s &#8220;damned institutions&#8221;</title>
		<link>http://atthecrux.wordpress.com/2008/10/09/americas-damned-institutions/</link>
		<comments>http://atthecrux.wordpress.com/2008/10/09/americas-damned-institutions/#comments</comments>
		<pubDate>Thu, 09 Oct 2008 18:09:32 +0000</pubDate>
		<dc:creator>atthecrux</dc:creator>
				<category><![CDATA[Politics]]></category>

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		<description><![CDATA[OK&#8230;I realize that this I&#8217;m simply passing on information learned from the blogosphere. But&#8230;if we&#8217;re talking anti-Americanism, would joining a group whose founder had this to say qualify?
I&#8217;m an [redacted], not an American. I&#8217;ve got no use for America or her damned institutions.
Replace the &#8220;[redacted]&#8221; above with the word &#8220;Alaskan&#8221;, and you have it. This [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=atthecrux.wordpress.com&blog=4074078&post=124&subd=atthecrux&ref=&feed=1" />]]></description>
			<content:encoded><![CDATA[<div class='snap_preview'><br /><p>OK&#8230;I realize that this I&#8217;m simply passing on information learned from the blogosphere. But&#8230;if we&#8217;re talking anti-Americanism, would joining a group whose founder had this to say qualify?</p>
<blockquote><p>I&#8217;m an [redacted], not an American. I&#8217;ve got no use for America or her damned institutions.</p></blockquote>
<p>Replace the &#8220;[redacted]&#8221; above with the word &#8220;Alaskan&#8221;, and you have it. This is a quote from the founder of the Alaskan Independence Party, off which Todd Palin <a href="http://en.wikipedia.org/wiki/Todd_Palin#Public_life">was a member from 1995-2002.</a> As I write, the quote can be found on the AIP&#8217;s <a href="http://www.akip.org/introduction.html">intro page</a> (also <a href="http://web.archive.org/web/20080116105845/http://www.akip.org/introduction.html">archived</a>).</p>
<p>I think &#8220;un-Americanism&#8221; is really a fairly worthless charge to throw; people can love the country and work for its best while strongly disagreeing with its policies. My primary identity is Christian; my identity as an American falls lower in priority, but I consider it my duty to be a &#8220;model citizen&#8221; as much as is possible. And so, I won&#8217;t demonize Mr. Palin for his historical affiliation. But, perhaps someone should remind Ms. Palin about the dangers of throwing stones from her vitreous mansion.</p>
<p>The full, attributed quote, as taken from the AIP&#8217;s website:</p>
<blockquote><p>&#8220;I&#8217;m an Alaskan, not an American. I&#8217;ve got no use for America or her damned institutions.&#8221;<br />
-Joe Vogler </p></blockquote>
<p>Gov. Palin&#8217;s claim, via a <a href="http://www.cnn.com/2008/POLITICS/10/04/palin.obama/index.html">CNN article</a>:</p>
<blockquote><p>&#8220;We see America as the greatest force for good in this world&#8230;Our opponent though, is someone who sees America, it seems, as being so imperfect that he&#8217;s palling around with terrorists who would target their own country.&#8221;</p></blockquote>
<p>If this is indeed her view, Gov. Palin and her husband should work on improving the lines of communication.</p>
<p><strong>Update:</strong> The article (of which I originally read excerpts) that got me thinking about this is <a href="http://www.salon.com/opinion/feature/2008/10/07/palins_unamerican/print.html">here</a>. It makes the links between Sarah Palin and the Alaska Independence Party more explicit, as well as providing more history of the AIP. According to quotes in that article (I haven&#8217;t dug deeper to date, besides the Wikipedia and AIP website reviews), Vogler supported armed resistance against the federal government, and &#8220;palled around&#8221; briefly with the Iranian government. He even, apparently, believed in &#8220;honor&#8221;&#8211;a concept that I once thought had meaning for Sen. McCain.</p>
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		<title>Follow-up on IHOP</title>
		<link>http://atthecrux.wordpress.com/2008/10/01/follow-up-on-ihop/</link>
		<comments>http://atthecrux.wordpress.com/2008/10/01/follow-up-on-ihop/#comments</comments>
		<pubDate>Wed, 01 Oct 2008 22:07:59 +0000</pubDate>
		<dc:creator>atthecrux</dc:creator>
				<category><![CDATA[Uncategorized]]></category>

		<guid isPermaLink="false">http://atthecrux.wordpress.com/?p=122</guid>
		<description><![CDATA[I&#8217;d written an earlier post about an unfortunate experience at IHOP. I&#8217;ve updated that post, but for the sake of RSS feeds thought I&#8217;d write a new post as well. From an initial problem, their follow-up is an example that any business would do well to follow.
       <img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=atthecrux.wordpress.com&blog=4074078&post=122&subd=atthecrux&ref=&feed=1" />]]></description>
			<content:encoded><![CDATA[<div class='snap_preview'><br /><p>I&#8217;d written <a href="http://atthecrux.wordpress.com/2008/09/27/ihop-woes/">an earlier post</a> about an unfortunate experience at IHOP. I&#8217;ve updated that post, but for the sake of RSS feeds thought I&#8217;d write a new post as well. From an initial problem, their follow-up is an example that any business would do well to follow.</p>
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		<title>Trick or Treatment</title>
		<link>http://atthecrux.wordpress.com/2008/09/30/trick-or-treatment/</link>
		<comments>http://atthecrux.wordpress.com/2008/09/30/trick-or-treatment/#comments</comments>
		<pubDate>Tue, 30 Sep 2008 14:52:18 +0000</pubDate>
		<dc:creator>atthecrux</dc:creator>
				<category><![CDATA[Books]]></category>
		<category><![CDATA[Health]]></category>
		<category><![CDATA[Quackery]]></category>

		<guid isPermaLink="false">http://atthecrux.wordpress.com/?p=117</guid>
		<description><![CDATA[There are, in fact, two things, science and opinion; the former begets knowledge, the latter ignorance.
-Hippocrates of Cos
I just finished reading a book by Dr. Edzard Ernst and Simon Singh. Dr. Ernst began his career practicing in a homeopathic hospital in Munich. He is the first professor of alternative medicine in the world, and the [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=atthecrux.wordpress.com&blog=4074078&post=117&subd=atthecrux&ref=&feed=1" />]]></description>
			<content:encoded><![CDATA[<div class='snap_preview'><br /><blockquote><p>There are, in fact, two things, science and opinion; the former begets knowledge, the latter ignorance.</p>
<p>-Hippocrates of Cos</p></blockquote>
<p>I just finished reading a book by Dr. Edzard Ernst and Simon Singh. Dr. Ernst began his career practicing in a homeopathic hospital in Munich. He is the first professor of alternative medicine in the world, and the only one in the UK. And, he chose to begin his book with this quote. The rest of the book continues in this spirit. Throughout the book, in (mostly) engaging prose, he examines various &#8220;alternative&#8221; approaches to health. He wishes to dismiss nothing out of hand, and sees value in some areas of alternative medicine. Repeatedly, however, he asks (and answers) several basic questions:</p>
<ul>
<li>How is an approach claimed to work?</li>
<li>What is the evidence for a therapy&#8217;s efficacy? What is the quality of the evidence?</li>
<li>What risks are involved in a therapy?</li>
</ul>
<p>Along the way and throughout the book, he provides numerous anecdotes to illustrate his point. He talks of James Lind, who conducted one of the first documented clinical trials and determined an effective cure for scurvy. He tells of various &#8220;mavericks&#8221; in medical history, such as the man who lost a libel case when he criticized bloodletting, a process which eminent doctor Benjamin Rush used freely. (He also notes that many mavericks were <em>not</em> &#8220;ahead of their time&#8221;, but simply wrong.) He describes the methods that exist for determining a treatment&#8217;s efficacy, leads his readers through the reasoning behind these methods, and examines numerous &#8220;complementary and alternative&#8221; therapies through the lens of evidence. Though it can get a little long, it&#8217;s written engagingly, and with an open-minded, inquiring, but thoroughly evidence-based approach. I enjoyed the book, and I&#8217;m guessing some of my acquaintances would enjoy it as well&#8211;even those who like alternative medicine much more than I.</p>
<p>From an initial chapter titled &#8220;How Do You Determine The Truth?&#8221;, the book proceeds through chapters on acupuncture, homeopathy, chiropractic therapy (the history of the field is fascinating!), and herbal medicine. A number of other therapies, including aromatherapy, &#8220;energy&#8221; treatments, and others, are treated much more concisely in an appendix. After finishing this book, you&#8217;ll be much better equipped than before to evaluate existing or new kinds of &#8220;alternative&#8221; medicine.</p>
<p>Highly recommended: <em>Trick or Treatment: The Undeniable Facts About Alternative Medicine</em>, by Simon Singh and Edzard Ernst. It&#8217;s available via Amazon or the alternate bookstore of your choice.</p>
<p>For further reading, see <a href="http://www.guardian.co.uk/science/2003/sep/25/scienceinterviews.health">this</a> article about Ernst.</p>
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		<title>Misleading Rules for Success?</title>
		<link>http://atthecrux.wordpress.com/2008/09/27/misleading-rules-for-success/</link>
		<comments>http://atthecrux.wordpress.com/2008/09/27/misleading-rules-for-success/#comments</comments>
		<pubDate>Sat, 27 Sep 2008 17:30:29 +0000</pubDate>
		<dc:creator>atthecrux</dc:creator>
				<category><![CDATA[Uncategorized]]></category>

		<guid isPermaLink="false">http://atthecrux.wordpress.com/?p=115</guid>
		<description><![CDATA[For the past week or two, a magazine&#8217;s been lying open in my bathroom. It&#8217;s open to a page about midway through, where a businesswoman gives her rule for success: &#8220;Assume Failure Is Impossible&#8221;. It just struck me: really, this could well be just an example of survivor bias. Warren Buffett gave another example in [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=atthecrux.wordpress.com&blog=4074078&post=115&subd=atthecrux&ref=&feed=1" />]]></description>
			<content:encoded><![CDATA[<div class='snap_preview'><br /><p>For the past week or two, a magazine&#8217;s been lying open in my bathroom. It&#8217;s open to a page about midway through, where a businesswoman gives her rule for success: &#8220;Assume Failure Is Impossible&#8221;. It just struck me: really, this could well be just an example of survivor bias. Warren Buffett gave another example in his <a href="http://www.valueinvesting.de/en/superinvestors.htm">The Superinvestors of Graham and Doddsville</a> speech, in which an &#8220;elite&#8221; group of coin-flippers mistakes random good fortune as an indicator of their great skill in calling coin tosses.</p>
<p>Assume failure is impossible. When creating your supersonic land vehicle, crashing and burning is impossible. When tapping out your HELOC to fund your online business selling Tahitian carved pepper shakers, assume failure is impossible. When&#8230;you get the idea. Maybe, assuming failure is impossible isn&#8217;t always the best approach?</p>
<p>&#8220;Assume failure is impossible&#8221; is one philosophy of decision-making. It&#8217;s a high-stakes one: either you&#8217;ll win big, or you&#8217;ll lose big. If you win big, you may be asked to offer &#8220;rules for success&#8221; to a national personal-finance magazine. If you lose big&#8230;well, I guess there aren&#8217;t a lot of lessons to learn from <em>your</em> business sense!</p>
<p>And thus, readers of this magazine learn a rule for success: assume failure is impossible.</p>
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		<title>IHOP woes&#8211;and excellent follow-up</title>
		<link>http://atthecrux.wordpress.com/2008/09/27/ihop-woes/</link>
		<comments>http://atthecrux.wordpress.com/2008/09/27/ihop-woes/#comments</comments>
		<pubDate>Sat, 27 Sep 2008 13:00:05 +0000</pubDate>
		<dc:creator>atthecrux</dc:creator>
				<category><![CDATA[Uncategorized]]></category>

		<guid isPermaLink="false">http://atthecrux.wordpress.com/?p=113</guid>
		<description><![CDATA[Update 2008-10-01: IHOP&#8217;s response was excellent. The Monday after I sent the complaint, I received this:
Dear atthecrux:
Thank you for taking the time to contact us concerning your experience at the IHOP in [city redacted]. While it is always disappointing to learn that we have not lived up to our guest&#8217;s expectations, it is invaluable to [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=atthecrux.wordpress.com&blog=4074078&post=113&subd=atthecrux&ref=&feed=1" />]]></description>
			<content:encoded><![CDATA[<div class='snap_preview'><br /><p><strong>Update 2008-10-01:</strong> IHOP&#8217;s response was excellent. The Monday after I sent the complaint, I received this:</p>
<blockquote><p>Dear atthecrux:</p>
<p>Thank you for taking the time to contact us concerning your experience at the IHOP in [city redacted]. While it is always disappointing to learn that we have not lived up to our guest&#8217;s expectations, it is invaluable to receive feedback so that we are able to continually improve our level of guest satisfaction.</p>
<p>We are sorry to learn of the service level you encountered at this franchised location. However, please be assured that the matter will be shared with the proper individuals to address your concerns.</p>
<p>I have forwarded your concerns to IHOP&#8217;s Franchise Business Consultant for the South region. They will contact the franchise owner regarding your recent dining experience in this restaurant. We are confident that the franchise owner or his representative will contact you shortly. It is our hope that you will once again allow us to earn your trust.</p>
<p>Thank you for keeping us informed.</p>
<p>Sincerely,</p>
<p>[name redacted]<br />
Guest Services Representative<br />
IHOP Restaurant Support Center
</p></blockquote>
<p>Today, I received a phone call from a lady at the company that manages IHOP. She apologized for the problems, invited the two of us back for a complimentary meal, said that my complaint&#8217;s been passed on to the local franchisee and they&#8217;re figuring out what went wrong (and mentioned that this location is recently under new management), and asked for feedback on the experience. </p>
<p>Separately, my girlfriend ate at the restaurant with a friend the next morning (possibly at the same time I was writing my complaint to HQ). A manager came by the table to ask how everything was, and she mentioned the previous night&#8211;asking whether people are supposed to seat themselves after a certain time, or what was up. He told her that no, we should have been seated. He was quite apologetic, and said he&#8217;d look into what was happening. He also mentioned that he&#8217;d been on the job for only three days.</p>
<p>IHOP messed up the evening we were there. Their follow-up, however, has been&#8211;thus far, at least&#8211;exemplary.</p>
<p><strong>Original Post:</strong><br />
When a company messes up, they <em>need</em> a bit of a public scourging. As of last night, IHOP qualified. I did them the favor of actually sending a comment to HQ, rather than <em>just</em> complaining to others&#8211;but I&#8217;ll do the latter as well. If they respond well, I&#8217;ll try to post that also&#8211;responding well to failures is an important corporate skill.</p>
<p>Here&#8217;s the message I sent HQ (along with specific location information):</p>
<blockquote><p>Last night, my girlfriend and I *almost* ate at IHOP. We walked in around 9:45, and noted a relatively-sparsely-filled restaurant: probably less then a third of the tables were occupied. We noted the &#8220;Please Wait To Be Seated&#8221; sign, and waited. After a bit, the couple ahead of us apparently decided to seat themselves. We waited a bit more, unsure of whether someone had simply failed to change the sign, but thought we&#8217;d comply with the request. Several waitstaff went by, apparently seeing us awkwardly standing there but not feeling any personal responsibility. One employee walked directly past us on his way out the door (for a break?), carefully ignoring us. Shortly afterward, my girlfriend and I decided to take IHOP&#8217;s message to heart, and enjoy a meal elsewhere.</p>
<p>I don&#8217;t know whether the problem here was due to corporate policies, to an error in changing the sign followed by apathetic (or policy-constrained staff), or what. I do know, however, that&#8211;based on this experience, and to a lesser degree on other experiences&#8211;service appears to be quite low on the priority list of this IHOP. Whether that&#8217;s from the top down or the bottom up, I don&#8217;t know&#8211;but it isn&#8217;t my problem, it&#8217;s IHOP&#8217;s to deal with. It has certainly affected my perception of IHOP.</p></blockquote>
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		<title>A Conservative for Obama</title>
		<link>http://atthecrux.wordpress.com/2008/09/21/a-conservative-for-obama/</link>
		<comments>http://atthecrux.wordpress.com/2008/09/21/a-conservative-for-obama/#comments</comments>
		<pubDate>Sun, 21 Sep 2008 22:09:55 +0000</pubDate>
		<dc:creator>atthecrux</dc:creator>
				<category><![CDATA[Politics]]></category>

		<guid isPermaLink="false">http://atthecrux.wordpress.com/?p=111</guid>
		<description><![CDATA[So&#8230;you&#8217;re probably going to see some politics on the blog for a while. I used to respect McCain&#8211;really, I did. And yet, he&#8217;s managed to slowly dismantle most of the positive impressions I had of him. Anyway&#8230;an interesting article by Wick Allison, former publisher of the National Review, is titled &#8220;A Conservative for Obama&#8220;.
  [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=atthecrux.wordpress.com&blog=4074078&post=111&subd=atthecrux&ref=&feed=1" />]]></description>
			<content:encoded><![CDATA[<div class='snap_preview'><br /><p>So&#8230;you&#8217;re probably going to see some politics on the blog for a while. I used to respect McCain&#8211;really, I did. And yet, he&#8217;s managed to slowly dismantle most of the positive impressions I had of him. Anyway&#8230;an interesting article by Wick Allison, former publisher of the <em>National Review</em>, is titled &#8220;<a href="http://www.dmagazine.com/ME2/dirmod.asp?nm=Core+Pages&amp;type=gen&amp;mod=Core+Pages&amp;tier=3&amp;gid=B33A5C6E2CF04C9596A3EF81822D9F8E">A Conservative for Obama</a>&#8220;.</p>
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		<title>Mortgage early payoff calculator spreadsheet posted</title>
		<link>http://atthecrux.wordpress.com/2008/09/17/mortgage-early-payoff-calculator-spreadsheet-posted/</link>
		<comments>http://atthecrux.wordpress.com/2008/09/17/mortgage-early-payoff-calculator-spreadsheet-posted/#comments</comments>
		<pubDate>Thu, 18 Sep 2008 04:57:29 +0000</pubDate>
		<dc:creator>atthecrux</dc:creator>
				<category><![CDATA[Uncategorized]]></category>

		<guid isPermaLink="false">http://atthecrux.wordpress.com/?p=106</guid>
		<description><![CDATA[I promised I&#8217;d post a calculator showing the effects of paying off your mortgage early&#8211;and why it might be a bad idea to do so. Though I added a note to that post, I thought I&#8217;d also add it here to make it available via RSS feeds:
Update 2008-09-17: Apparently, hosted WordPress doesn&#8217;t allow attaching Excel [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=atthecrux.wordpress.com&blog=4074078&post=106&subd=atthecrux&ref=&feed=1" />]]></description>
			<content:encoded><![CDATA[<div class='snap_preview'><br /><p>I <a href="http://atthecrux.wordpress.com/2008/09/09/paying-off-your-mortgage-early-a-calculator/">promised</a> I&#8217;d post a calculator showing the effects of paying off your mortgage early&#8211;and why it might be a bad idea to do so. Though I added a note to that post, I thought I&#8217;d also add it here to make it available via RSS feeds:</p>
<p><strong>Update 2008-09-17:</strong> Apparently, hosted WordPress doesn&#8217;t allow attaching Excel files. However, the <a href="http://www.mediafire.com/?ybmmxldxyyy">file</a> should be accessible through <a href="http://www.mediafire.com/">MediaFire</a>, a free (and ad-supported) file-hosting service that I&#8217;m now trying out for the first time.</p>
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		<title>Mannatech</title>
		<link>http://atthecrux.wordpress.com/2008/09/17/mannatech-2/</link>
		<comments>http://atthecrux.wordpress.com/2008/09/17/mannatech-2/#comments</comments>
		<pubDate>Thu, 18 Sep 2008 04:37:36 +0000</pubDate>
		<dc:creator>atthecrux</dc:creator>
				<category><![CDATA[Uncategorized]]></category>

		<guid isPermaLink="false">http://atthecrux.wordpress.com/?p=102</guid>
		<description><![CDATA[I&#8217;m hoping to come up with a well-researched list of my objections to Mannatech&#8230;once I have time.   In the meantime, I was just trying to get stuff freshly into my head when I came up with the following news bits regarding Mannatech&#8217;s relation with their auditors:
One article says that Mannatech fired their auditing [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=atthecrux.wordpress.com&blog=4074078&post=102&subd=atthecrux&ref=&feed=1" />]]></description>
			<content:encoded><![CDATA[<div class='snap_preview'><br /><p>I&#8217;m hoping to come up with a well-researched list of my objections to Mannatech&#8230;once I have time. <img src='http://s.wordpress.com/wp-includes/images/smilies/icon_sad.gif' alt=':(' class='wp-smiley' />  In the meantime, I was just trying to get stuff freshly into my head when I came up with the following news bits regarding Mannatech&#8217;s relation with their auditors:</p>
<p><a href="http://www.dallasnews.com/sharedcontent/dws/bus/stories/090608dnbusmannatech.1714922.html"></a><a href="http://www.dallasnews.com/sharedcontent/dws/bus/stories/DN-mannatech_19bus.ART.State.Edition1.8e9f88.html">One article</a> says that Mannatech fired their auditing firm after they demanded that Sam Caster be removed from all responsibilities, or Mannatech would need to find another auditor.</p>
<p><a href="http://www.dallasnews.com/sharedcontent/dws/bus/stories/090608dnbusmannatech.1714922.html">Another</a>, titled &#8220;Mannatech facing threat from SEC&#8221;, indicates that the SEC has some concerns about Mannatech&#8217;s behavior in that situation.</p>
<p>Also, I found that Oxford&#8217;s journal <em>Glycobiology</em> has a number of full-text articles relevant to Mannatech available in <a href="http://glycob.oxfordjournals.org/current.dtl">their current issue</a>, including &#8220;A &#8216;Glyconutrient Sham&#8217;&#8221;, a Mannatech (MTEX) response to that article, &#8220;Wielding the sword of professional ethics against misleading dietary supplement claims&#8221;, and a few other relevant articles.</p>
<p>Anyway&#8230;the main reason for the post is that I downloaded the PDF of the Texas Attorney General&#8217;s <a href="http://www.oag.state.tx.us/oagnews/release.php?id=2086">complaint of last year</a> (it&#8217;s one of the things I hope to look at, but far from the only thing) and ran it through OCR to make it searchable for my own use. Since I couldn&#8217;t find any online pure-text copies of the complaint, I decided to post the OCR results.  They&#8217;re obviously far from perfect, but might be helpful to someone. I&#8217;ve pasted the unedited results below; reference <a href="http://www.oag.state.tx.us/newspubs/releases/2007/070507mannatech.pdf">the original</a> to correct any errors in the OCR.  The first page or two is especially bad because of graphical and hand-written elements.</p>
<p>CAUSE NO.:r&gt;- \ &#8211; b ~ Oil ~ 00 13 &lt;8 (p<br />
STATE OF TEXAS,<br />
Plaintiff,<br />
vs.<br />
MANNATECH INCORPORATED;<br />
MANNA RELIEF MINISTRIES;<br />
THE FISHER INSTITUTE;<br />
SAMUEL 1. CASTER, Individually; and<br />
REGINALD McDANIEL, Individually,<br />
Defendants.<br />
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IN THE DISTRICT COURT OF<br />
TRAVIS COUNTY, T E X AS<br />
3S.3JUDICIAL DISTRICT<br />
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PLAINTIFF&#8217;S ORIGINAL PETITION<br />
TO THE HONORABLE JUDGE OF SAID COURT:<br />
COMES NOW THE STATE OF TEXAS, acting by and through Attorney General Greg<br />
Abbott (&#8220;State&#8221;), and files Plaintiff s Original Petition, complaining ofand againstMANNATECH<br />
INCORPORATED, MANNARELIEF MINISTRIES, THEFISHERINSTITUTE, SAMCASTER,<br />
Individually, and REGINALD McDANIEL, Individually, (&#8220;Defendants&#8221;), and would respectfully<br />
show the court the following:<br />
AUTHORITY<br />
1. This action is brought by Attorney General Greg Abbott, through his Consumer<br />
Protection and Public Health Division, in the name of the STATE OF TEXAS and in the public<br />
interest under the authority granted him by §431.060, §431.047, and §431.0585 ofthe Texas Food,<br />
Drug and Cosmetic Act, TEX. HEALTH&amp; SAFETY CODEANN. §431.001 et seq. (&#8220;TFDCA&#8221;). Section<br />
431.060 ofthe TFDCA specifically provides that the Attorney General, to whom the Commissioner<br />
Plaintiff&#8217;s Original Petition page 1<br />
of the Texas Department of State Health Services (&#8220;TDSHS&#8221;) reports a violation of the TFDCA,<br />
shall initiate and prosecute appropriate proceedings. In addition, §431.047 authorizes the Attorney<br />
General to seek injunctive reliefunder certain circumstances and recover any costs and attorney fees<br />
incurred in obtaining that relief. This action is also brought pursuant to §431.0585, which authorizes<br />
the Commissioner of Health to refer matters to the Attorney General to seek civil penalties in favor<br />
of the State for violation of §431.021 of the TFDCA and regulations pursuant to that Act.<br />
2. This action is also brought under the authority granted to the Attorney General by<br />
§17.47 ofthe Texas Deceptive Trade Practices &#8211; Consumer Protection Act, TEx. Bus. &amp; COM. CODE<br />
ANN. §17.41 et seq. (&#8220;DTPA&#8221;), upon the grounds that Defendants have engaged in false, misleading,<br />
or deceptive acts or practices in the course of trade and commerce as. defined in, and declared<br />
unlawful by, §§17.40(a) and (b) of the DTPA.<br />
PARTY DEFENDANTS<br />
3. DefendantMANNATECHINCORPORATED (&#8220;Mannatech&#8221;), a Texas corporation,<br />
is doing business in Texas at 445 S. Royal Lane, Suites 200 and 800, Coppell, Texas, 75019, and<br />
may be served with process through its registered agent, Corporation Service Company, 701 Brazos<br />
St., Ste. 1050, Austin, Texas, 78701.<br />
4. DefendantMANNARELIEF MINISTRIES (&#8220;MannaRelief&#8217;), is a Texas corporation<br />
doing business at 3017 Red HawkDr., Grand Prairie, Texas, and may be served with process through<br />
its registered agent, George Reninger, at 530 South Carrier Parkway, Grand Prairie, Texas, 75051.<br />
5. Defendant THE FISHER INSTITUTE, is a Texas corporation doing business at 580<br />
Decker Dr., Irving, Texas, and may be served with process through its registered agent, John W.<br />
McCuistion, at 580 Decker Dr., Ste 100, Irving, Texas, 75062.<br />
Plaintiff&#8217;s Original Petition page 2<br />
6. Defendant SAMUEL L. CASTER (&#8220;Caster&#8221;), is Chairman and Chief Executive<br />
Officer of Defendant MANNATECH INCORPORATED, and works at 445 S. Royal Lane, Suite<br />
800, Coppell, Texas, 75019, and may be served with process at that address.<br />
7. Defendant REGINALD McDANIEL (&#8220;McDaniel&#8221;), was formerly the &#8220;Medical<br />
Director&#8221; of Defendant MANNATECH INCORPORATED, and currently holds a similar position<br />
with Defendant MANNA RELIEF MINISTRIES. On information and belief, Defendant<br />
McDANIEL also generally controls the operations of Defendant THE FISHER INSTITUTE.<br />
Defendant McDANIELresides at 4 Woodland Dr., Mansfield, Texas,76063, and may be served with<br />
process at this address.<br />
VENUE<br />
8. Venue ofthis action lies in Travis Countypursuantto §431.047(c) and §431.0585(d)<br />
of the TFDCA by virtue of the fact that Defendants are engaged in the business of manufacturing,<br />
offering to sell, and selling unapproved new drugs and/or misbranded or adulterated foods in Texas.<br />
PUBLIC INTEREST<br />
9. Because Plaintiff STATE OF TEXAS has reason to believe that Defendants<br />
MANNATECHINCORPORATED, MANNARELIEF MINISTRIES, THEFISHERINSTITUTE,<br />
SAM CASTER, Individually, and REGINALD McDANIEL, Individually, have engaged in, and will<br />
continue to engage in, the unlawful practices set forth below, Plaintiff STATE OF TEXAS has<br />
reason to believe that Defendants have caused and will continue to cause injury, loss, and damage<br />
to the STATE OF TEXAS, and its citizens, and will also cause adverse effects to legitimate business<br />
enterprises which conduct their trade and commerce in a lawful manner in this State. Therefore, the<br />
Attorney General of the STATE OF TEXAS believes and is of the opinion that these proceedings<br />
Plaintiff&#8217;s Original Petition page 3<br />
are in the public interest.<br />
ACTS OF AGENTS<br />
10. Whenever in this petition it is alleged that Defendants MANNATECH<br />
INCORPORATED, MANNARELIEF MINISTRIES, THEFISHERINSTITUTE, SAMCASTER,<br />
Individually, or REGINALD McDANIEL, Individually, did any act or thing, it is meant that<br />
Defendants performed or participated in such act or thing or that such act was performed by agents<br />
or employees ofDefendants and in each instance, the agents or employees ofDefendants were then<br />
authorized to and did in fact act on behalfof Defendants or otherwise acted under the guidance and<br />
direction of Defendants.<br />
TRADE AND COMMERCE<br />
11. Defendants MANNATECH INCORPORATED, MANNA RELIEF MINISTRIES,<br />
THE FISHER INSTITUTE, SAM CASTER, Individually, and REGINALD McDANIEL,<br />
Individually, have, at all times described below, engaged in conduct which constitutes &#8220;trade&#8221; and<br />
&#8220;commerce&#8221; as those terms are defined by §17.45(6) of the DTPA.<br />
NATURE OF DEFENDANTS&#8217; CONDUCT<br />
12. Defendants MANNATECH INCORPORATED, MANNA RELIEF MINISTRIES,<br />
THE FISHER INSTITUTE, SAM CASTER, and REGINALD McDANIEL operate an elaborate<br />
scheme designed to promote the sales ofMannatech&#8217;s dietary supplements. Defendants market and<br />
sell such dietary supplements as a way to cure, mitigate, treat, or prevent diseases, illnesses, or<br />
serious conditions, despite Defendant Caster&#8217;s admission that the products do not cure any disease,<br />
and despite the fact that this marketing violates both federal and state food and drug laws, as well<br />
as the Texas Deceptive Trade Practice &#8211; Consumer Protection Act. Defendants are aware that such<br />
Plaintiff&#8217;s Original Petition page 4<br />
marketing techniques are illegal, and try to distance themselves from responsibility for these illegal<br />
disease claims for their dietary supplements in numerous ways, including: substituting the word<br />
&#8220;glyconutrients&#8221; for the name ofMannatech&#8217;s products; setting up alternate websites; claiming that<br />
third parties who they have no control over are making the illegal claims in books, videos, and other<br />
marketing materials; using testimonials to make claims that Defendants&#8217; products cure, mitigate,<br />
treat, or prevent diseases; and employing the facade of a disciplinary policy for associates making<br />
illegal disease claims, all the while enabling the system under which the claims are made.<br />
13. Defendants&#8217; products are dietary supplements under federal law and are regulated as<br />
foods in Texas pursuant to Chapter 431 of the Health and Safety Code, known as the Texas Food,<br />
Drug, and Cosmetic Act (&#8220;TFDCA&#8221;). By law, claims cannot be made that dietary supplements are<br />
intended to cure, ~itigate, treat, or prevent disease. Only drugs approved by the Federal Food and<br />
Drug Administration (&#8220;FDA&#8221;) can be represented to have intended uses to cure, mitigate, treat, or<br />
prevent disease.<br />
14. The FDA, by affidavit, states that it has not approved any new drug applications for<br />
Defendant Mannatech. Moreover, the FDA further states that it has not approved any new drug<br />
application for the products! marketed by Mannatech or its affiliates or for Manapol or<br />
glyconutrients. Therefore, Defendants cannot legally market any of their products as drugs by<br />
making claims that these products can cure, treat, mitigate, or prevent disease. (See Exhibit 1<br />
attached).<br />
!Ambrotose, Glycentials, Phytomatrix, CardioBalance, GI-Pro, GI-Zyme,<br />
ImmunoSTART, Man-Aloe Classic, MannaCLEANSE, Ambrostart, Manna-C,<br />
Mannatonin,Glyco-Bears, Manna-Bears<br />
Plaintiff&#8217;s Original Petition pageS<br />
15. Defendants know that their products are not approved as drugs and know that it is<br />
illegal for them to make claims that these products are intended to cure, mitigate, treat, or prevent<br />
disease. Nevertheless, they continue to employ their deceptive scheme for monetary gain, earning<br />
in excess of $400 million in 2006. In particular, to further their sales, Defendants make disease<br />
claims, directly or indirectly, at corporate events, on corporate or affiliated websites, and through<br />
marketing material, websites, and sales presentations of Defendants&#8217; associates.2<br />
Corporate Events<br />
16. Defendants host at least four corporate conventions each year &#8211; the event in Texas is<br />
called &#8220;MannaFest&#8221; &#8211; to promote their products. One essential element of each of the events is a<br />
time set aside for testimonials, often referred to by Mannatech as &#8220;Life Experiences.&#8221; These<br />
testimonials, which are generally made by Mannatech&#8217;s associates and their families and friends,<br />
make numerous claims that Mannatech products have cured, mitigated, treated, or prevented<br />
diseases. The whole purpose ofthe testimonials is to create a frenzy and motivate associates to sell<br />
even more products, in large part through the relaying of deceptive claims set forth in the<br />
testimonials. Moreover, as explained below, the testimonials are recorded on video so that<br />
associates may later use them to assist in the sale of Mannatech&#8217;s products. The following<br />
testimonials are just a few examples ofthe type ofillegal disease claims about Defendants&#8217; products<br />
that are made at these corporate events:<br />
A. Testimonial 1: A woman testified that her four year old son was initially<br />
2In addition to selling directly through its website, Mannatech also sells its products<br />
through a Multi-Level Marketing structure, which utilizes thousands of affiliates &#8211; or associates around<br />
the country to sell Mannatech&#8217;s products.<br />
Plaintiff&#8217;s Original Petition page 6<br />
developing normally according to all the markers, but eighteen months after<br />
his well-child check, he started presenting bizarre behavior. He soon lost<br />
basically all language ability and all ability to make eye contact. In October,<br />
2004, he was diagnosed with autism. In March, 2005, the woman testified<br />
that he started on &#8220;the product&#8221; (i.e. Mannatech products). In three days he<br />
started talking. Today, according to the woman, he has normal eye contact,<br />
social skills, and dramatically improved language. Now he has no sensory<br />
issues, he eats well, and sleeps well.<br />
B. Testimonial 2: A man testified that he was diagnosed with Non-Hodgkin&#8217;s<br />
B-cell Lymphoma a little over one year ago. The oncologist told him cancer<br />
had spread to eight places in his body and that they could not cure it, but with<br />
treatment could give him as many years as he could. He started doing<br />
research and a dear friend and chiropractor gave him some information about<br />
&#8220;glyconutritionals&#8221; (i.e., Mannatech products), which he started taking. He<br />
testified that after five months, his lab work started looking better. .He<br />
continued to improve, and in June the doctor told him that maybe he didn&#8217;t<br />
have lymphoma after all. The last lab work indicated seven spots were<br />
cancer-free, and the one remaining spot (originally the size of a racquetball)<br />
was now size of a pea.<br />
C. Testimonial 3:A woman shared a story about a friend ofhers who had severe<br />
chest pain at home and passed out and was rushed to the hospital. The<br />
doctors told the family that she had to be put into a comatose state or she<br />
Plaintiff&#8217;s Original Petition page 7<br />
would die from a stroke or massive heart attack. They put her into a<br />
comatose state and sedated her heavily. She got pneumonia and then<br />
deve~oped staph in her lungs. After one week, the doctors told the family that<br />
she wasn&#8217;t going to make it and took her off the medications. A friend of<br />
hers that is a Mannatech associate finally got the doctors to give her &#8220;the<br />
product.&#8221; She started on products at 5:00 Wednesday night. By 5:00 on<br />
Thursday morning she was making facial motions. At 8:00 that morning the<br />
nurse called two of her sons in and they couldn&#8217;t believe what was going on<br />
- she was blinking her eyes and she did it on command. On Friday she<br />
started speaking a few words. In total, she was in ICU for one week, was in<br />
the hospital on a regular floor for another week, and spent two weeks in<br />
rehabilitation. She&#8217;s now back to work, she has her life back, and her family<br />
and children have their mom back.<br />
17. In addition to the testimonials, at each of Defendants&#8217; corporate conventions,<br />
Defendants dedicate a large area of the convention facility to vendors and other persons to sell<br />
promotional materials designed to help Mannatech&#8217;s associates promote Defendants&#8217; products.<br />
Defendants, who obtain a financial benefit from these vendors, know or have reason to know that<br />
many of the marketing materials that are sold make illegal claims that Defendants&#8217; products cure,<br />
mitigate, treat, or prevent disease; A few examples of the illegal disease claims for Defendants&#8217;<br />
products made in materials sold at Defendants&#8217; MannaFest and similar conventions include the<br />
following:<br />
A. Defendants facilitated the offering for sale of a CD titled &#8220;Back from the<br />
Plaintiff&#8217;s Original Petition pageS<br />
Brink&#8221; by Michael Schlachter, M.D. This CD provides example after<br />
example ofhow &#8220;glyconutrients&#8221; (i.e. Mannatech&#8217;s products) cured, treated,<br />
or mitigated diseases, including but not limited to toxic shock syndrome,<br />
heart failure, asthma, arthritis, Lou Gehrig&#8217;s Disease, Attention Deficit<br />
Disorder, and lung inflammation. Examples of these claims include:<br />
1. &#8220;We administered 25g ofthis glyconutrient at 9PM that third night. The<br />
same amount was repeated four hours later. By eight o&#8217;clock the next<br />
morning, without any change whatsoever in therapy except for the<br />
addition of the special glyconutrient formula, Greg&#8217;s pulses returned.<br />
Greg&#8217;s legs and arms were now warm. Only hours before, they were icecold.<br />
By morning, the severe&#8217;metabolic acidosis, which indicated dying<br />
cells, had all but reversed. I had never seen anything like this. A few<br />
hours earlier, Greg was at the point ofdeath. Now, Greg was at the point<br />
, ofrecovery. This formula had reversed what we had been told in medical<br />
school would be an irreversible process.&#8221;<br />
2. &#8220;My first introduction to this glyconutrient formula came from a<br />
physician friend, Dr. Blaine Purcell, who had been telling me ofsome of<br />
his patients with asthma, who no longer needed steroids for therapy.<br />
These patients had been on lifelong steroids. Now, in my experience,<br />
being a pulmonary specialist, when a personwith asthma requires lifelong<br />
steroids, they can&#8217;t function without them. They practically suffocate<br />
without them. Dr. Purcell went on to say that his asthma patients were<br />
eliminating the steroids largely due to this glyconutrient.&#8221;<br />
3. &#8220;My second case was a gentleman who suffered from heart failure,<br />
arthritis, and asthma. Scripps Clinic gave him the prognosis that he<br />
would have to live with his illness and get ready to die. &#8230; I put him on<br />
a solid program of glyconutrients and scheduled an appointment to see<br />
him in six weeks. Five and a half weeks later, this man practically burst<br />
into my office to tell me he was feeling great and that he did not need to<br />
see me. He proceeded to do a knee bend, and proclaimed that if he had<br />
tried that six weeks ago, he would have fallen to the ground and not been<br />
able to get up. A few weeks later when I rechecked his heart function, it<br />
had improved from one-third normal to ,entirely normal. To add to this,<br />
his asthma symptoms were also resolved.&#8221;<br />
4. The Brink CD concludes with:<br />
Plaintiff&#8217;s Original Petition page 9<br />
&#8220;Thank you for listening to the &#8220;Back from the Brink&#8221; audio program.<br />
This information you just heard could dramatically affect the quality of<br />
your life as well as the lives of your loved ones. Since research shows<br />
that these biological sugars are very likely missing from your diet, they<br />
are now available to everyone through nutritional supplementation. You<br />
maybe wondering howto order this special glyconutrient formula for you<br />
and your family. The same formula that Dr. Schlachter used and<br />
continues to use with his patients. Since this formula has been patented,<br />
it&#8217;s available through only one company only. To order, please get back<br />
with the person who shared this important health breakthrough with you.<br />
And remember, glyconutrients are for everyone, whether you feel great<br />
and want to enhance your health even more, or whether you&#8217;re struggling<br />
with a health condition. Your body depends on these glyconutrients.&#8221;<br />
B. Defendants further endorse the making of a disease claim to cure, treat, or<br />
mitigate Down syndrome for their products through a book offered at their<br />
conventions titled, A Gift Called Michelle, which includes a forward by<br />
Defendant Reginald McDaniel, who at the time the forward was written was<br />
the Medical Director ofMannatech. At MannaFest 2006, Michelle, a Down<br />
syndrome girl who is the subject of the book, was in attendance signing<br />
copies ofthe above book. The book also includes &#8220;before and after&#8221; pictures<br />
ofMichelle, including an &#8220;after&#8221; picture ofMichelle with Defendant Caster.<br />
1. The McDaniel forward makes the following claims:<br />
&#8220;I requested to hear from other parents with significant improvements in<br />
children with Down syndrome which resulted in over 50 positive<br />
responses with the addition of micronutrients to the diet&#8230;Each child&#8217;s<br />
genes know what to do with elements and nutrients, if the right and<br />
sufficient nutrients are added back into the diet. The same results were<br />
reported from parents with children having: cerebral palsy,<br />
leukodystrophy, fragile-X syndrome, autism, and a wide range of gene<br />
caused malfunction and development based alterations in cellular<br />
synthesis, physical damage to the brain and the neuromuscular system,<br />
other organs that include types of muscular dystrophy and other rarer<br />
enzyme or glycoprotein gene defects that include hemophilia.&#8221;<br />
Plaintiff&#8217;s Original Petition page 10<br />
2. Excerpts from the book, which has been endorsed by both Defendants<br />
McDaniel and Caster, include:<br />
a. p. 9. &#8221; &#8230;we were introduced to glyconutritionals through a friend.<br />
Almost immediately Michelle was transformed from a chronically<br />
sick child to a well, asthma and ADHD-free child&#8230; .In 2001 Las<br />
Vegas Magazine ran a feature article called &#8220;Beating the Odds in<br />
Vegas,&#8221; about a man who had a near-death experience from<br />
streptococcal toxic-shock syndrome but who returned to health from<br />
giving him aggressive amounts of glyconutitionals &#8230;.Suddenly it<br />
became evident that these supplements were changing more than<br />
health. They were changing the features ofa chromosomal disorder!&#8221;<br />
b. p.20. &#8220;When essential sugars are missing from our diets it weakens<br />
our immune system and opens it up to cancer, diabetes, heard dIsease,<br />
AIDS, allergies, asthma, hepatitis-C, fibromyalgia, ADHD, and<br />
eighty-five other autoimmune diseases.&#8221;<br />
c. p.25. &#8220;I have witnessed first hand the body&#8217;s healing powers when<br />
glyconutritionals were taken for someone who suffered from lupus,<br />
cancer, autism and ofcourse asthma and seizures&#8230;.The person with<br />
lupus had suffered for years with the disease. She was in the final<br />
stages of the disease when someone introduced her to the product.<br />
She has been symptom free now for years. The person with cancer<br />
was diagnosed with an inoperable form of cancer. After taking the<br />
product he shocked his doctors when the tumor shrank and<br />
disappeared. Within two weeks oftaking the product, the young man<br />
with autism stopped his screaming, and started to engage in social<br />
conversations.&#8221;<br />
d. p. 26. &#8220;Michelle&#8217;s facial features had indisputably changed since<br />
taking the supplement. The features associated withDown Syndrome<br />
had dramatically softened and the folds on her lids had nearly<br />
disappeared&#8230; .In short, her appearance changed as much as her<br />
health.&#8221;<br />
3. In addition to the forward by Defendant McDaniel, Defendant Caster has<br />
also endorsed the book. In a September 10, 2006 Fort Worth StarTelegram<br />
article, Defendant Caster is quoted as saying that he has read<br />
the book and has no problem with its assertions because, &#8220;ifyou read the<br />
document &#8230; what [the mother] basically quantifies is all the quality-oflife<br />
improvements that have come as a result of the intervention of<br />
Plaintiff&#8217;s Original Petition page 11<br />
glyconutrients.&#8221;<br />
C. Another CD offered at Defendants&#8217; convention was titled &#8220;The Road to<br />
Recovery &#8211; A Cancer Survivor&#8217;s Story,&#8221; which tells Dr. Michael Currieri&#8217;s<br />
story about his recovery from tongue cancer thanks to Mannatech&#8217;s products.<br />
Excerpts from the CD include:<br />
1. &#8220;1 took home the material that they had offered me, some brochures and<br />
some scientific data, some audio tapes&#8230;and read through the material,<br />
listened to the tapes, decided to attend a meeting that a doctor was<br />
hosting, a meeting about glyconutritional products&#8230;! went to a meeting,<br />
found out how1could obtain the products, and began taking the products,<br />
a fairly high dosage of it. 1 talked to the doctor who had hosted that<br />
meeting, told him my situation, and he recommended the dosage that 1<br />
should take&#8230;About ten days after 1 started taking these products&#8230; 1 felt<br />
a shift in my body.. .! continued taking the products and the following<br />
month, when 1got my new lab results in, came a wonderful surprise: that<br />
the T-cells and B-cells were both in the mid-20&#8217;s, which prior to that, they<br />
had been around 1, and my natural killer cells, which had been around<br />
300-500, were now above 56,000.&#8221;<br />
2. &#8220;1 recommend it to everyone&#8230;had 1known abut a product like this and<br />
been on it, 1would not have had to go through this in the first place. So,<br />
preventative maintenance, it&#8217;s a whole lot better to prevent in the first<br />
place than to try to cure it afterward, and 1would hightly recommend this<br />
for everyone to protect yourself, protect your loved ones. It&#8217;s proven<br />
science, I&#8217;m living proof of that.&#8221;<br />
3. The CD concludes with<br />
&#8220;Okay, after hearing that, ifyou&#8217;d like to have additional information on<br />
the glyconutritionals, the phytochemicals, the plant steroids or anything,<br />
get with the person who gave you this tape. Thank you very much for<br />
listening.&#8221;<br />
&#8220;Glyconutrient&#8221; Sham<br />
18. The above testimonials and promotional materials also demonstrate another shamthat<br />
Defendants continuously employ in an attempt to avoid liability. Defendants instruct their associates<br />
not to refer to Mannatech&#8217;s products by name when making certain claims, but instead to refer to<br />
Plaintiff&#8217;s Original Petition page 12<br />
them·generically as &#8220;glyconutrients.&#8221; The associates are taught that once they have peaked the<br />
interest of potential customers with these illegal health claims, they can direct the customer to the<br />
&#8220;only company that makes these patented glyconutrients&#8221; &#8211; Mannatech. Defendants created and<br />
perpetuate this &#8220;glyconutrient&#8221; sham in the hopes ofavoiding liability because Defendants know that<br />
the disease claims that are being made for their dietary supplements are illegal and that such claims<br />
make their products unapproved new drugs or misbranded foods.<br />
Corporate Websites<br />
19. Defendants also use multiple websites to further market their dietary supplements as<br />
drugs in violation offederal and state law. For example, Mannatech maintains its corporate website<br />
at www.mannatech.com. At this website, you can find information about Mannatech&#8217;s products and<br />
can order the products. For the most part, the portion ofwww.mannatech.com that is accessibleto<br />
the general public avoids making illegal health claims. But this website includes a password<br />
protected area, accessible only to Mannatech associates, that includes other information that enables<br />
and assists associates in promoting Mannatech&#8217;s products by making illegal disease claims. For<br />
example, the www.mannatech.com backpages include links to videos of the testimonials that are<br />
given at Mannatech&#8217;s corporate conventions, like those described above. Defendant Mannatech, at<br />
the insistence of Defendant Caster, has even indexed the testimonials and made them sortable by<br />
disease, making it as easy as possible for its associates to use the illegal testimonials to peddle<br />
Mannatech&#8217;s products.<br />
20. Mannatech maintains another website at www.glycoscience.com which purports to<br />
&#8220;provide information on nutritional saccharides &#8211; glyconutritionals &#8211; that form the scientific<br />
underpinnings for Mannatech&#8217;s product line&#8230;&#8221; This website is accessible to the general public as<br />
Plaintiff&#8217;s Original Petition page 13<br />
well as to Mannatech associates, and contains a number of &#8220;scientific studies&#8221; and papers that<br />
Defendants use to try to support their claim that &#8220;glyconutrients&#8221; (Le. Mannatech&#8217;s products) can<br />
cure, treat, mitigate, or prevent diseases. Defendants and their affiliates heavily rely on these studies<br />
to give Mannatech&#8217;s products an air oflegitimacy and to support the sale oftheir products. The vast<br />
majority of these studies and papers were prepared by Mannatech employees or affiliates, are not<br />
peer reviewed, have not been published or are published by Mannatech or entities closely affiliated<br />
with Mannatech, and have little, if any, scientific value. Some of the studies referenced on the<br />
glycoscience.com website are legitimate studies that have been published in recognized journals.<br />
Those studies, however, are generic studies that have been done in the field of glycobiology and<br />
provide no support for the claims being made by Defendants. Many doctors in the field of<br />
glycobiology have strenuously objected to Defendants using their work to mislead consumers into<br />
believing Mannatech&#8217;s products can cure diseases. Nevertheless, Defendants continue to encourage<br />
associates to use the studies in order to convince their non-medical and unsophisticated customers<br />
that Mannatech&#8217;s products have these incredible curative properties.<br />
21. Even if all of the studies were scientifically valid studies and supported the<br />
proposition that Defendants&#8217; products could cure diseases, Defendants still.cannot rely upon these<br />
studies to support their claims that their products cure, mitigate, treat, or prevent any diseases<br />
because their products are dietary supplements and not drugs. IfDefendants want to rely on any of<br />
these studies to make disease claims for their products, Defendants must apply to the FDA for<br />
approval of any drug prior to it being marketed for that intended use. Defendants have not done so.<br />
Nevertheless, Defendants continue to promote and heavily rely on &#8220;studies&#8221; with titles like:<br />
A. Glyconutritionals: Implications in Cancer;<br />
Plaintiff&#8217;s Original Petition page 14<br />
B. Glyconutritionals: Implications in Rheumatoid Arthritis; and<br />
C. Glyconutritionals: Implications in Asthma.<br />
Defendant&#8217;s Patent<br />
22. Defendants&#8217; patent for its products, obtained in 2005, clearly demonstrates that<br />
Defendants&#8217; intended use for their products are to cure, mitigate, treat, or prevent diseases. The<br />
patent identifies many diseases that Mannatech claims its products cure, mitigate, treat, or prevent.<br />
Attached as Exhibit 2 is an excerpt from Defendants&#8217; patent, which is a list of more than fifty<br />
diseases or conditions that Defendants assert can be cured, mitigated, treated, or prevented by<br />
Defendants&#8217; products. These are generally the same diseases that Defendants and their associates<br />
promote the use oftheir dietary supplements to cure, mitigate, treat, or prevent in violation offederal<br />
and state law. The patent protection obtained by Mannatech is for products with intended uses that<br />
would make the products drugs, and therefore have to be approved by FDA. Again, FDA has not<br />
approved any drugs for marketing by Mannatech or any Defendant. Mannatech and its associates<br />
heavily rely on its Mannatech&#8217;s patent for credibility and validation.<br />
23. Defendants purport to have a policy that prohibits associates from using the patent<br />
in the marketing and promotion of Mannatech&#8217;s products. But Defendants are well aware that<br />
associates continue to use the patent to support their illegal disease claims, yet Defendants refuse to<br />
take any reasonable action to prevent such conduct.<br />
Associate Websites<br />
24. Defendants also promote their products as drugs that can cure, treat, mitigate, or<br />
prevent numerous diseases in violation offederal and state law by allowing Defendants&#8217; associates<br />
to make such claims at sales presentations and on their websites. Defendants, including Defendant<br />
Plaintiff&#8217;s Original Petition page 15<br />
Caster, are fully aware that associates are making illegal claims, yet they refuse to take any<br />
reasonable enforcement action against the associates to get the associates to stop making such<br />
claims. A couple of examples of illegal marketing claims made by Mannetech associates that has<br />
gone unchecked include the following:<br />
A. The website www.glycohealthservice.com. which belongs to a Mannatech<br />
associate, and is used to promote Defendants&#8217; products, includes:<br />
1. A transcript of &#8220;Back from the Brink&#8221; (which, as discussed above<br />
contains multiple illegal claims) and<br />
2. An Open Letter by Dr. Rayburne W. Goen (a prominent Mannatech<br />
Associate). Excerpts of the letter include:<br />
a. &#8220;Amazing to me was the dramatic response of Lupus by restoring<br />
these glyconutrients. Lupus is a disease from an overactive immune<br />
system, when the immune system actually attacks its &#8220;own&#8221; body<br />
cells. (&#8220;mis-communication&#8221;) On the other hand, I have seen reports<br />
that taking glyconutrients dramatically increases low immune<br />
function as in AIDS or Cancer.&#8221;<br />
b. &#8220;A few of the disorders which have been shown (in reports or<br />
published articles in Medical and Scientific journals) to be benefitted<br />
or restored to normal health, (without interfering with appropriate<br />
drug therapy as indicated ) are: Asthma, Rheumatoid Arthritis,<br />
Osteoarthritis, Systemic Lupus, Fibromyalgia, Chronic Fatigue<br />
Syndrome, Multiple Sclerosis, Peripheral Neuropathies, Attention<br />
Deficit-Hyperactivity Disorder, DownSyndrome, Diabetes, Muscular<br />
Dystrophy, Cancer, Ulcerative Colitis, Crohn&#8217;s, Alzheimer&#8217;s,<br />
Parkinsonism, Hepatitis C, and AIDS, as well as a whole host of<br />
others.&#8221;<br />
c. &#8220;Check it out. [This Company] is the only source of an oral form of<br />
these eight monosaccharides, any combination of which is<br />
&#8216;composition patented or patent-pending&#8217; worldwide.. [The<br />
Company's] Science and Research labs are second to none in the field<br />
of pharmaceutical grade nutrients (nutraceuticals).&#8221;<br />
Plaintiff&#8217;s Original Petition page 16<br />
B. Another Mannatech associate website used to promote Defendants&#8217; products,<br />
www.livingsugars.com. includes:<br />
1. Numerous testimonials with pictures and descriptions, including Down<br />
syndrome, subglottic hemangioma, skin rash, severe burns, birthmarks,<br />
cerebral palsy, severe allergies, anorexia, MS, and skin cancer. These<br />
same pictures and testimonials are found on numerous other websites.<br />
2. Statements that imply that the last four Nobel Prizes have been won in<br />
connection with the study of glyconutrients, including the 1999 Nobel<br />
Prize which went to Dr. Gunter BIobel. Dr. BIobel has previously sent<br />
a cease and desist letter to Mannatech in 2004 to get the Defendants to<br />
stop using his name and research in the promotion of Defendants<br />
products. Dr. Blobel, along with two other Nobel laureates, Dr. Paul<br />
Greengard and Dr. Paul Nurse, filed a complaint with the New York<br />
Attorney General&#8217;s Office over the use of their names by Mannatech.<br />
C. The website of another associate, www.healthtestimonies.com. includes an<br />
audio recording of four different marketing products which feature various<br />
doctors. These recordings, all ofwhich include multiple illegal testimonials,<br />
are listed under a page titled &#8220;Dr Reports.&#8221; Combined, the four presentations,<br />
each of which is approximately 30 minutes, are represented to contain<br />
testimonials for a total of 24 conditions which are identified on the website<br />
as: Arthritis, Asthma, Attention Deficit Disorder, Brain Aneurysm, Brest<br />
Plaintifrs Original Petition page 17<br />
Cancer, Cancer, Cataract, Cerebral Palsy, Diabetes, Diabetic Blind,<br />
Fibromyalgia, Golf Ball Brain Tumor, Heart Failure, Lou Gehrig&#8217;s Disease,<br />
Low Back Pain, Micro Valve Prolapse, Muscular Dystrophy, Osteoarthritis,<br />
Peripheral Neuropathy, Progeria, Prostate Cancer, Retinopathy, Rotor Cuff<br />
Pain, Streptococcal Toxic-Shock Syndrome. The website has another page<br />
titled &#8220;Products&#8221; which specifically includes the names and marketing<br />
materials for Mannatech&#8217;s products.<br />
Third Party Marketing Materials<br />
25. As noted throughout, there are many individuals and companies who have produced<br />
and sell promotional materials to be used as an aid to selling Mannatech&#8217;s products. Many of these<br />
promotional materials can be found on associate websites, can be purchased at Mannatech corporate<br />
events, and can be purchased from vendors over the Internet. For example, www.glycotools.com<br />
is a website that is exclusively dedicated to selling Mannatech sales aids, including dozens of CDs,<br />
DVDs, brochures, and other promotional materials. This website is owned and operated by Dupli-<br />
Pack, which is also a prominent vendor at Mannatech&#8217;s corporate events. The same products that<br />
are available over the Internet are generally available at Mannatech&#8217;s conventions. Many of the<br />
products sold on the website include very specific and illegal disease claims. Some of the<br />
promotional materials even include descriptions or titles which in and ofthemselves consist ofillegal<br />
testimonials or disease claims. For example, the following promotional materials and descriptions<br />
are available on the website:<br />
A. How I Conquered Cancer &#8211; &#8220;After taking the nutrients for a short period of<br />
time, his tumor started to shrink and it eventually disappeared altogether.&#8221;<br />
Plain~iff&#8217;s Original Petition page 18<br />
B. The Spectrum of Autism &amp; Glyconutrients &#8211; &#8220;These 2-CDs contain<br />
interviews with 11 experts. It also contains stories of children who have<br />
recovered / are recovering, and the parent&#8217;s journey utilizing<br />
Glyconutritionals.&#8221;<br />
C. Pass It On &#8211; &#8220;It mentions over 30 major illnesses and catastrophic maladies.<br />
It also contains 8 powerful testimonies, four of which have never been seen<br />
before.&#8221;<br />
Defendants are well aware that these websites exist and are aware that they are selling marketing<br />
materials that are illegal for Mannatech associates to use. This is evident by the fact that the<br />
glycotools.com website includes a link to mannarelief.org and the mannarelief.org website (as<br />
described below) includes a link to glycotools.com. Moreover, Defendant McDaniel is featured on<br />
a number ofthe promotional materials sold on these websites, including as a speaker on several CDs<br />
or DVDs (including the &#8220;Pass It On&#8221; DVD) and has written forwards or introductions for written<br />
materials. Despite their knowledge, Defendants have failed to take reasonable steps to prevent the<br />
sale or use ofthese materials, and even encourage their use by allowing these companies to sell their<br />
products at Mannatech sponsored conventions.<br />
Defendant&#8217;s Compliance and Training Policies<br />
26. Defendants represent that they maintain strict training and compliance procedures to<br />
ensure that no ill~gal claims are made about Mannatech&#8217;s products. For example, Mannatech has<br />
written&#8221;Associate Policies and Procedures,&#8221; a copy ofwhich Mannatech claims to give to each new<br />
associate. The Associate Policies and Procedures include the following provisions:<br />
A. Advertising (paragraphs 2.1.1-2.1.2) &#8211; The policies state that an associate may<br />
only advertise on the Internet using the &#8220;MannaPage&#8221; which are provided by<br />
Mannatech and may only utilize Mannatech-produced sales materials.<br />
Plaintiff&#8217;s Original Petition page 19<br />
B. Advertising (paragraph 2.7) &#8211; Associates are strictly prohibited from creating,<br />
selling or distributing sales aids that are not Company-approved materials for<br />
use in the U.S.<br />
C. Generic Materials (paragraph 2.1 0) &#8211; Associate mayuse generic materials that<br />
do not mention or directly allude to Mannatech or its products.<br />
D. Use Educational Materials (paragraphs 2.11.1- 2.11.3) &#8211; The policies provide<br />
that educational material (Le. published scientific and peer-reviewed articles<br />
or papers ·approved by Mannatech) are strictly prohibited from being<br />
mentioned, unless the American Nutraceutical Association or equivalent has<br />
certified the presenting associate. The papers may NOT be discussed, but<br />
only mentioned ifthe specific disease condition is asked about or commented<br />
on during the meeting and may be displayed if they are physically separate<br />
from the dietary supplements.<br />
E. Testimonials at Meetings (paragraph 2.12) &#8211; At opportunity meetings, the<br />
host may allow attendees to make public statements concerning improved<br />
health they have personally been witness to after use of Company products,<br />
if certain written or spoken disclaimers are made. At educational meetings,<br />
the policies provide that a testimonial segment is not allowed, but then allows<br />
the &#8220;communicating&#8221; of only personal first-hand knowledge of health<br />
improvement.<br />
F. Product Claims and Misrepresentations (paragraphs 2.25, 2.25.5, 2.25.6) An<br />
Associate is prohibited from 1) making or alluding to any medical or other<br />
Plaintiff&#8217;s Original Petition page 20<br />
prohibited claims regarding the prevention, treatment, cure or mitigation of<br />
any disease from the use of Company products; 2) using disease-specific<br />
names or written testimonials in promotion of the Company or its products;<br />
3) audio, video and written testimonials cannot be used when discussing the<br />
opportunity or the products.<br />
27. Mannatech also represents that it has a disciplinary process that includes a<br />
Compliance Committee that meets on a regular basis to decide cases of reported policy violations.<br />
Mannatech reports that associates that are found to have violated one or more of Mannatech&#8217;s<br />
Associate Policies and Procedures may be required to complete additional compliance training or<br />
may be subject to probation, fines, suspension, or termination of their associate agreements.<br />
28. While Mannatech tries to create the appearance that it strictly prohibits illegal drug<br />
claims through its written policies and procedures, Defendants&#8217; conduct clearly tells a different story.<br />
First, Mannatech&#8217;s policies and procedures outlined above specifically allow conduct that is<br />
prohibited by the TFDCA. For example, Mannatech&#8217;s policies allow at least limited personal<br />
testimonials at both opportunity meetings (i.e. meetings to sign up new associates) and educational<br />
meetings (i.e. meetings designed to sell products). Such personal testimonials, even with a<br />
disclaimer, constitute false advertising and are prohibited by the TFDCA.<br />
29. Mannatech&#8217;s policies and procedures on the use of &#8220;educational materials&#8221; and<br />
&#8220;generic materials&#8221; also directly facilitate and perpetuate the &#8220;glyconutrient&#8221; scam discussed above.<br />
While Mannatech Associates are &#8220;prohibited from making or alluding to any medical or other<br />
prohibited claims regarding the prevention, treatment; cure or mitigation ofany disease from the use<br />
ofCompany products,&#8221; this policy, like the policy on testimonials, provides the &#8220;stamp ofapproval&#8221;<br />
Plaintiff&#8217;s Original Petition page 21<br />
for associates to advertise and market Mannatech&#8217;s products using disease claims. For example, the<br />
policies and procedures allow the &#8220;mention&#8221; and display of scientific papers with claims regarding<br />
the treatment or cure of diseases, if the specific disease condition is asked about or commented on<br />
during the meeting. The policies also allow all generic materials to be used, regardless ofthe claims,<br />
as long as the name of the product or company is not mentioned (i.e. if &#8220;glyconutrients&#8221; is<br />
supplemented for Mannatech&#8217;s product). But such representations, both orally and on display,<br />
constitute false advertising under Texas law because the representations are being used to advertise<br />
and sell Mannatech&#8217;s products.<br />
30. Moreover, regardless ofits written policies and procedures, Defendants&#8217; conduct actually<br />
encourages associates to make illegal drug claims, rather than deterring illegal claims. For example,<br />
many ofthe people brought in by Mannatech to &#8220;train&#8221; associates regarding Defendants policies and<br />
procedures are the very same Mannatech associates that are known to make some of the most<br />
egregious disease claims. Rather than training associates on how to comply with the law, the trainers<br />
often train new associates on how to try to avoid the law.<br />
31. Defendants&#8217; compliance program is also ineffective, in part, because rather than<br />
actively monitoring associates, Defendants rely on &#8220;self-regulation&#8221; (i.e. the reporting ofviolations<br />
by other associates or consumers). Moreover, even when a complaint is reported, Defendants fail<br />
to take any reasonable action to discipline violating associates, especially if the associates are high<br />
ranking associates who make a lot of money for Defendants. On occasion, Defendants take<br />
&#8220;disciplinary action&#8221; against Mannatech associates in the form ofa written or verbal warning to stop<br />
making illegal disease claims. But such disciplinary action is only illusory, intended to create. the<br />
impression that Defendants take real enforcement action. In fact, Defendants fail to follow up on<br />
Plaintiff&#8217;s Original Petition page 22<br />
such warnings to ensure that the associate has stopped making illegal claims, or take any further<br />
action to deter associates from making illegal health claims. Some associates have received multiple<br />
warning letters from Mannatech, but continue to make illegal claims without repercussion.<br />
32. Moreover, Defendant Caster refuses to allow any more serious enforcement action<br />
to be taken against high ranking associates. For example, on at least two occasions, Defendants&#8217;<br />
Compliance Committee has met and made a recommendation to terminate and/or suspend for a<br />
significant period of time a high ranking associate because of egregious illegal disease claims. In<br />
each case, however, because the associate was a highly productive associate, Defendant Caster has<br />
overruled the Compliance Committee&#8217;s recommended punishment and instead given the associate<br />
a slap-on-the-wrist.<br />
Defendant MannaRelief<br />
33. In order to further perpetuate Mannatech&#8217;s illegal scheme, Defendant Caster and his<br />
wife, Linda, also started a nonprofit organization in 1999, Defendant Manna Relief Ministries, that<br />
purports to distribute Mannatech&#8217;sproducts to &#8220;health challenged children&#8221; around the world. While<br />
Defendant MannaRelief may in fact distribute Mannatech&#8217;s products to people around the world,<br />
Defendants and their affiliates largely use MannaRelief as a marketing tool and use its website<br />
www.mannarelief.orgtopromote Mannatech&#8217;s products as method to cure, mitigate, treat, or prevent<br />
diseases. For example, the www.mannarelief.org website contains the following claims:<br />
A. &#8220;We brought to completion the year long survey of 30 children and a few<br />
adults with HIV/AIDS. A couple of adults commented that they didn&#8217;t<br />
believe they would be alive this year had it not been for these products.&#8221;<br />
B. &#8220;One experience in particular had a profound effect on his decision to launch<br />
Plaintiff&#8217;s Original Petition page 23<br />
the organization. In 1999 Caster began sending Mannatech&#8217;s glyconutritional<br />
products to orphans in Romania, where the harsh winters had a debilitating<br />
effect on the children. The orphanage staff said the first year the children<br />
were on the nutritional products, the incidence of disease dropped<br />
dramatically.&#8221;<br />
C. Although they have now been removed from the website,<br />
www.mannarelief.org formerly included a number oftestimonials, including<br />
testimonials for all of the following diseases: ADHD, ADD, Asperger&#8217;s<br />
Syndrome, anaplastic astrocytoma, autism, blood disorder, blindness/partial,<br />
Burkitt&#8217;s lymphoma, cancer, cerebral palsy, coma, cystic fibrosis, Down<br />
syndrome, dyslexia, dysgraphia, Diamond Blackfan Anemia, eye tick,<br />
hydrocephalus, improved coordination, metastatic osteosarcoma,<br />
neurofibromatosis, quadriplegia, and retinoblastoma.<br />
D. The website continues to have a link to Glycotools.com, which as explained<br />
above, sells promotional materials for Mannatech products, many of which<br />
contain specific disease claims.<br />
34. Moreover, Mannatech associates will often promote a charitable event for<br />
MannaRelief as a hook to get people to attend meetings. The meetings will then tum into a sales<br />
presentation for Mannatech products and the Mannatech business opportunity.<br />
35. In addition to furthering Defendant Mannatech&#8217;s illegal scheme, Defendant<br />
MannaRelief has independently violated federal and state law by making illegal disease claims,<br />
because even when products are given away for free, state and federal law prohibit claims that the<br />
Plaintiff&#8217;s Original Petition page 24<br />
product can cure, treat, mitigate, or prevent diseases.<br />
Defendant Fisher Institute<br />
36. Defendant Fisher Institute, which is a nonprofit corporation, represents itself as an<br />
independent medical research organization whose &#8220;primary objective is to explore the extent, if any,<br />
to which nutraceuticals, glyconutritionals, phytonutritionals, functional foods, and/or other natural<br />
substances may provide integrative and complementary health and wellness support.&#8221; In fact, upon<br />
information and belief, Defendant Fisher Institute serves no legitimate charitable purpose, but instead<br />
is run and controlled by Defendant McDaniel and his wife Candace for the benefit ofMannatech and<br />
its associates. As a result, Defendant Fisher Institute is little more than a sham charity3 with the sole<br />
purpose of providing &#8220;scientific&#8221; support to the illegal health claims made about Mannatech&#8217;s<br />
products. Virtually all of Defendant Fisher Institute&#8217;s revenue comes from selling publications to<br />
Mannatech associates. In particular, Defendant Fisher Institute publishes and sells its own&#8221;journal,&#8221;<br />
titled the &#8220;Proceedings ofthe Fisher Institute for Medical Research.&#8221; Upon information and belief,<br />
almost all of the articles published in the &#8220;journal&#8221; are written by Defendant McDaniel or other<br />
3Even the method by which Defendant McDaniel gained control of the Fisher Institute<br />
was fraudulent. The Fisher Institute was incorporated in 1977 by Sherrill Edwards, Phil Gramm,<br />
and Henry Gilchrist, with the purpose of studying and promoting free market economic theories.<br />
In 1991, Edwards, who at the time was the only person still involved in the corporation, died of<br />
cancer. At the time of his death, the Fisher Institute had no assets, and Edwards widow and<br />
executrix, Virginia; filed the proper paperwork to dissolve the corporation. Shortly thereafter she<br />
was contacted by Defendant McDaniel, who had apparently been treating Edwards&#8217; cancer with<br />
alternative remedies, and Defendant McDaniel expressed an interest in continuing to operate the<br />
institute. Virginia died shortly thereafter without acting on Defendant McDaniel&#8217;s request.<br />
Approximately a year after her death, Virginia&#8217;s son-in-law Thomas Corboy was contacted<br />
regarding reinstating the corporation. Mr. Corboy, who was lead to believe the corporation<br />
would continue with the same mission and purpose, agreed to a friendly lawsuit to reinstate the<br />
charter. A lawsuit was filed, without the notice required by law to be sent to the Attorney<br />
General, and the corporate charter was reinstated.<br />
Plaintiff&#8217;s Original Petition page 25<br />
persons affiliated with Defendant Mannatech, usually with no disclosure of the connection. And<br />
very few, if any, of the articles or studies are scientifically valid, randomized, double-blind, peerreviewed<br />
studies. In addition to being sold on Defendant Fisher Institute&#8217;s own website, copies of<br />
the &#8220;journal&#8221; are also available for sale on www.glycotools.com and other websites that sell<br />
promotional material to Mannatech associates.<br />
Defendant McDaniel<br />
37. Defendant McDaniel is one of the original developer&#8217;s of Mannatech&#8217;s original<br />
product, Ambrotose. Although Defendant McDaniel is no longer an employee ofMannatech, he has<br />
been involved with Mannatech since its inception and continues to playa prominent role with<br />
Mannatech. Defendant McDaniel served as the &#8220;Medical Director&#8221; for Mannatech until mid-2002.<br />
At that time, he was forced to resign from Mannatech because ofpressure from the FDA. Even so,<br />
rather than sever ties with Defendant McDaniel, Defendant Caster gave Defendant McDaniel a<br />
similar position with MannaRelief. Defendant McDaniel also has a similar position with Defendant<br />
Fisher Institute. Moreover, Defendant McDaniel continued to receive compensation from<br />
Mannatech, in the amount of $25,000 per month, for several years following his resignation.<br />
Defendant McDaniel is also the fifth largest shareholder of Mannatech.<br />
38. Today, through his position with MannaRelief and the Fisher Institute, Defendant<br />
McDaniel is still a prominent player in Mannatech&#8217;s illegal scheme through his presence at corporate<br />
events, his contributions to third party marketing materials, and his almost constant speaking circuit<br />
at events and meetings hosted by Mannatech associates. As demonstrated by his removal from<br />
Mannatech, Defendant McDaniel has a long history of making illegal health claims. Defendant<br />
McDaniel continues to makes such illegal claims in his speaking tour. Defendant McDaniel goes<br />
Plaintiff&#8217;s. Original Petition page 26<br />
so far as to prescribe certain dosages of Mannatech products for certain diseases.<br />
Defendant Caster<br />
39. DefendantCaster is one ofthe original founders ofDefendant Mannatech and is still<br />
one of the largest shareholders. Except for a brief period in 2001, Defendant Caster has been<br />
intimately involved with Mannatech since its founding, serving in various roles, including President,<br />
CEO, and Chairman ofthe Board. Currently Defendant Caster serves as CEO and Chairman ofthe<br />
Board for Mannatech.<br />
40. Defendant Caster is also one ofthe founders ofMannaReliefand has been intimately<br />
involved in MannaRelief since its inception. Defendant Caster currently serves as the Chairman of<br />
the Board for MannaRelief.<br />
41. Defendant Caster is very involved in the day-to-day operations of both Mannatech<br />
and MannaRelief. He has knowledge of all aspects of Mannatech&#8217;s and MannaReliefs business<br />
practices, including all ofthose detailed above. Despite Defendant Caster&#8217;s knowledge ofthe illegal<br />
conduct described herein, and despite his authority to prevent such illegal conduct, he has taken no<br />
steps to prevent the illegal conduct. To the contrary, Defendant Caster has orchestrated the illegal<br />
scheme being perpetrated by Defendants, and has hindered the efforts of any person attempting to<br />
rein in the practices of Mannatech and its associates.<br />
Regulation by Texas Department of State Health Services<br />
42. Defendant Mannatech has been licensed as a food manufacturer since 1996 by the<br />
Texas Department of State Health Services (or its predecessor, the Texas Department of Health).<br />
Defendants are responsible for knowing both the federal and state laws that regulate the dietary<br />
supplements that they manufacture and distribute. Defendants&#8217; regulatory history clearly<br />
Plaintiff&#8217;s Original Petition page 27<br />
demonstrates that Defendants are well-aware that it is illegal to make any claims that dietary<br />
supplements can cure, treat, mitigate, or prevent diseases. In fact, as detailed below, Defendants<br />
have been notified by TDSHS that the conduct outlined above contravenes state and federal law.<br />
Despite these warnings, Defendants have continued to allow and encourage the illegal conduct.<br />
TDSHS 2006 Inspection and Warning Letter:<br />
43. TDSHS issued a warning letter to Mannatech Incorporated on September 21, 2006,<br />
to inform Mannatech of the adverse conditions found during a physical inspection ofMannatech&#8217;s<br />
facilities conducted on July 13 and 17,2006. The letter also detailed numerous unapproved disease<br />
claims for dietary supplements TDSHS discovered in a review of websites, advertising and<br />
promotional materials, scientific literature, and other information used by Mannatech Associates to<br />
advertise, offer for sale, and sell Mannatech&#8217;s glyconutrient products. TDSHS determined that these<br />
adverse conditions and the unapproved disease claims made for Mannatech&#8217;s glyconutrient products<br />
violate Chapter 431 of the Texas Health and Safety Code (TFDCA). The adverse conditions and<br />
unapproved disease claims result in violations of the prohibited acts listed in §431.021 of the<br />
TFDCA.<br />
44. In addition, TDSHS also re-stated in the letter its oral and written request from July<br />
17,2006 for the distribution records for Mannatech&#8217;s glyconutrient products which is authorized<br />
under §431.044 of the TFDCA. Mannatech has continued to refuse to produce these distribution<br />
records, in violation of §431.021 (g) of the TFDCA.<br />
45. In particular, the September, 2006 letter summarized the following violations found<br />
byTDSHS:<br />
A. TDSHS determined that the &#8220;Back From the Brink&#8221; audio CD described<br />
Plaintiff&#8217;s Original Petition page 28<br />
above makes numerous illegal drug Claims, including claims regarding Toxic<br />
Shock Syndrome, ADD/ADHD, asthma, pneumonia, and ALS.<br />
B. TDSHS determined that the &#8220;Conspiracy Against Our Children,&#8221; audio CD<br />
described above makes illegal drug claims regarding the ability ofDefendants<br />
products to treat, cure, or mitigate ADD/ADHD.<br />
C. TDSHS determined that the audio CD, &#8220;The Road to Recovery, A Cancer<br />
Survivor&#8217;s Story,&#8221; which is described above, makes illegal drug claims,<br />
including specific dosages used, regarding cancer.<br />
D. TDSHS concluded that a promotional DVD titled &#8220;Pass It On,&#8221; which<br />
features Defendant McDaniel, makes claims that 30 illnesses were improved<br />
or cured by Defendants&#8217; products, including sarcomacancer, severe allergies,<br />
PMS, arthritis, Sturge-Weber syndrome, and diabetes.<br />
E. TDSHS determined that a pamphlet, &#8220;Restore Your Cells, Restore Your<br />
Health,&#8221; was used to promote and sell Mannetech&#8217;s glyconutrients. The<br />
pamphlet includes illegal disease claims in the form of testimonials and<br />
&#8220;before and after&#8221; pictures which purport to show&#8221;ill, handicapped&#8221; children<br />
being turned into &#8220;healthy children.&#8221; The pamphlet includes claims<br />
representing that the products can cure cystic fibrosis, anemia, seizures, brain<br />
damage, cognitive dysfunction, cancer, endometriosis, bladder infections,<br />
degenerative joint disease, depression, fibromyalgia, irritable bowel<br />
syndrome, multiple sclerosis, severe psoriasis, lupus, polycythemia vera, and<br />
autoimmune disease.<br />
Plaintiff&#8217;s Original Petition page 29<br />
F. TDSHS found that the book, &#8220;A Gift Called Michelle&#8221; described above,<br />
including the forward written by Defendant McDaniel, makes numerous<br />
illegal disease claims regarding Down Syndrome, cerebral palsy,<br />
leukodystrophy, Fragile-X Syndrome, autism, muscular dystrophy, and<br />
hemophilia from taking Mannatech&#8217;s glyconutrient products.<br />
G. TDSHS also concluded that a book written by Defendant Caster&#8217;s wife,<br />
Linda, Undeniable Destiny, promotes Mannatech&#8217;s glyconutrient products to<br />
treat or cure various health problems. For example, the book includes a<br />
passage, &#8220;[a]t Mannatech National Events the testimonies of people&#8217;s<br />
miraculous recoveries from various health problems became overwhelming<br />
both in number and in substance. We would sit literally for hours and listen<br />
to one story after another of life-changing experiences.&#8221;<br />
H. TDSHS reviewed DefendantMannaReliefs website, www.mannarelief.org,<br />
and concluded that it included unapproved disease claims that promote<br />
Mannatech products to treat or cure diseases. Unapproved disease claims<br />
cannot be made for Mannatech&#8217;s glyconutritient products without violating<br />
the TFDCA, even ifthe products are given away. TDSHS also noted that the<br />
MannaReliefwebsite has a direct link to www.glycotools.com which offers<br />
for sale &#8220;Dr. Reg&#8217;s Famous Cancer Lecture&#8221; on video by Defendant<br />
McDaniel, which also makes unapproved disease claims for Mannatech&#8217;s<br />
glyconutrient products.<br />
I. TDSHS further noted that the website www.glycotools.com also markets<br />
Plaintiff&#8217;s Original Petition page 30<br />
many other promotional materials that are used by Mannatech associates that<br />
contain Mannatech glyconutrient product testimonies on a variety of health<br />
issues, including cancer, fibromyalgia, depression, ADD, ADHD, AIDS,<br />
cystic fibrosis, weight loss, and many additional diseases.<br />
J. TDSHS also reviewed the website wWw.mannapharmacists.com and<br />
determined that it also makes unapproved disease claims for Mannatech&#8217;s<br />
glyconutrient products by claiming that the &#8220;blood pressure drugs no longer<br />
will be needed&#8221; when taking Mannatech&#8217;s glyconutrient products.<br />
K. TDSHS also reviewed the following website of Mannatech Associates, Hal<br />
and Shirley Mesler of Michigan, www.glycohealthservice.com.as<br />
representative ofMannatech associates&#8217; websites and the illegal claims that<br />
are made. TDSHS determined that the Mannatech associates&#8217; website made<br />
unapproved disease claims that Mannatech&#8217;s glyconutrient products could<br />
treat or cure Toxic Shock Syndrome, asthma, Lou Gehrig&#8217;s disease, heart<br />
failure, arthritis, and fibromyalgia.<br />
The September, 2006 warning letter detailed how all of the above materials made illegal disease<br />
claims, and how such claims made Mannatech&#8217;s glyconutrient products unapproved new drugs or<br />
misbranded foods.<br />
46. In addition to the illegal disease claims noted above, the September, 2006 warning<br />
letter also detailed other violations of the TFDCA. For example, TDSHS&#8217;s inspection of<br />
Mannatech&#8217;s warehouse revealed a pallet of cases and bottles labeled &#8220;Mannatech Distribution<br />
Center&#8230;Sugars for Asthma Study&#8230;Study #HS0307C&#8230;Phytaloe.&#8221; TDSHS was informed that this<br />
Plaintiff&#8217;s Original Petition page 31<br />
product was used in a study conducted by the Research and Development department and this was<br />
left over product from the study. TDSHS requested this study on July 13,2006, but Mannatech<br />
refused to provide the study. Mannatech has no approval from FDA to manufacture or test any drug<br />
to treat asthma and Mannatech&#8217;s dietary supplements cannot make any claims to prevent, treat,<br />
mitigate, or cure asthma.<br />
47. TDSHS&#8217; inspection ofMannatech also revealed numerous observed violations ofthe<br />
TFDCA on the labels and in labeling and advertising by Mannatech. Those observed violations were<br />
detailed in a report that was provided to Mannatech as part of the September, 2006 letter.<br />
TDSHS Inspection December 14, 2005:<br />
48. TDSHS, in a December 22, 2005 letter, provided Mannatech with a copy of a<br />
complaint from a customer who had been misled to believe that Mannatech&#8217;s products would help<br />
him to feel better during his chemotherapy treatment for cancer. Mannatech responded to the<br />
complaint by providing a detailed explanation of its &#8220;self-regulation&#8221; compliance and training<br />
policies.<br />
TDSHS Complaint Investigation Aug. 1,2002:<br />
49. On February 6, 2002, the Smithville police called TDSHS to refer a complaint about<br />
Max Brache, a Mannatech associate. The complainant had cancer and had surgery to remove a<br />
tumor on her leg. She was also receiving chemotherapy, but the Mannatech distributor had her stop<br />
taking her chemotherapy and purchase $1,100.00 worth ofMannatech products to give her body the<br />
tools it needed to heal itself from the cancer.<br />
50. TDSHS sent a letter, dated June 5, 2002, to the President ofMannatech to notify him<br />
ofthe complaint against Mannatech. TDSHS stated that a distributor promoted various Mannatech<br />
Plaintiff&#8217;s Original Petition page 32<br />
products for the treatment ofcancer, encouraged the complainant to cease current chemotherapy and<br />
only take Mannatech products, and promoted a dosage far in excess ofthe dosing instructions on the<br />
product label. TDSHS indicated that these representations constituted false advertising under the<br />
TFDCA. Such false advertising also misbrands the Mannatech products which results in additional<br />
violations of the TFDCA.<br />
TDSHS Complaint Investigation June 24, 2002:<br />
51. On April 24, 2002, TDSHS received a complaint from a consumer stating that she<br />
had received an unsolicited e-mFlil, dated February 1,2002, from Mannatech associates, Steve and<br />
Sylvia McCuistion. The e-mail&#8217;s subject stated &#8220;Scientific Am News!! AMBROTOSE BEATS<br />
Cancer!&#8221; and indicated that the &#8220;Scientific American news article FURTHER VALIDATING<br />
Mannatech&#8217;s proprietary patent granted/pending Glyconutrient Complex AMBROTOSE!&#8221; The email<br />
then stated that this Mannatech product changes cancer cells and can inhibit tumor growth.<br />
52. The e-mail from these Mannatech associates was sent to an unknown number of<br />
&#8220;undisclosed-recipients&#8221; and begins by making another disease claim by thanking Dee Hergenreter,<br />
a Mannatech leader, who has helped &#8220;save 1000s of lives by helping Dr. Tim Hollingshead&#8217;s<br />
daughter&#8230;rid herself of the many perils ofDOWN SYNDROME!!!&#8221;.<br />
53. On June 6, 2002, TDSHS sent a letter to the President of Mannatech regarding the<br />
complaint about an e-mail from Mannatech associates that made claims for the treatment and cure<br />
ofcancer and Down Syndrome. TDSHS indicated that these unapproved disease claims constituted<br />
false advertising under the TFDCA. Such false advertising also misbrands the Mannatech products<br />
which results in additional violations of the TFDCA.<br />
Plaintiff&#8217;s Original Petition page 33<br />
TDSHS Letter Notifying Adverse Conditions, dated September 21, 2001:<br />
54. TDSHS issued a letter to Mannatech on September 20,2001, to inform Mannatech<br />
of the adverse conditions found during the August 13, 2001, and August 15, 2001, detention of<br />
misbranded dietary supplements, MVP with Ambrose Complex and GlycoLean Accelerator. The<br />
letter indicated that the adverse conditions found misbranded Mannatech&#8217;s glyconutrient products<br />
by failing to include required information on labels, by making unapproved disease claims for dietary<br />
supplements in Mannatech&#8217;s website, and in advertising and promotional materials used by<br />
Mannatech. TDSHS determined that these adverse conditions, including the unapproved disease<br />
claims, made for Mannatech&#8217;s glyconutrient products violate Chapter 431 of the Texas Health and<br />
Safety Code (TFDCA). The adverse conditions, including the unapproved disease claims, resuit in<br />
violations of the prohibited acts listed in §431.021 of the TFDCA.<br />
55. Additional violations observed byTDSHS were detailed in a report that was provided<br />
to Mannatech as an attachment to the September, 2001 letter, and included but were not limited to:<br />
A. Product literature and Mannatech&#8217;s website www.mannatech.com made<br />
claims, both direct and implied, that these products may be used to treat<br />
diseases and/or symptoms ofdiseases, including a product brochure entitled,<br />
&#8220;What Do I Take For&#8230;&#8221;, subtitle, &#8220;Guidelines for Use of Mannatech<br />
Products&#8221; that states that the product, Ambrotose Complex, may be a<br />
treatment for &#8220;viruses,&#8221; &#8220;people who are ill,&#8221; &#8220;genetic errors ofmetabolism,&#8221;<br />
and &#8220;diabetics.&#8221; The brochure also stated, &#8220;Those who have health challenges<br />
may discern improvement in specific signs and symptoms;&#8221;<br />
B. The product description for Phyt-Aloe Complex associated the product with<br />
Plaintifrs Original Petition page 34<br />
a disease by referring to &#8220;The National Cancer Institute&#8221; and &#8220;persons<br />
undergoing radiation therapy or chemotherapy;&#8221; and<br />
C. Mannatech&#8217;s website www.mannatech.com. under the page heading<br />
&#8220;Introduction&#8221; stated that its products may be used to treat &#8220;persons with<br />
compromised health, maybe even with a specific disease condition.&#8221;<br />
FDA&#8217;s Findings of Claims to Treat, Prevent, Cure, or Mitigate a Disease<br />
56. The FDA, like the TDSHS, has notified Mannatech on multiple occasions that its<br />
marketing materials make illegal drug claims. For example, on December 27,2000, FDA sent a<br />
letter to Mannatech to respond to a submission pursuant to 21 U.S.C. 343(r)(6), Section 403(r)(6)<br />
of the Federal Food, Drug, and Cosmetic Act for the product ImmunoStart. FDA determined that<br />
numerous claims by Mannatech suggest that ImmunoStart is intended to treat, prevent, cure, or<br />
mitigate diseases, including a claim that it will &#8220;fight infection and disease.&#8221;<br />
FDA concluded that these claims to treat, cure, prevent, or mitigate disease cannot be made for<br />
products under 21 U.S.C. 343(r)(6), dietary supplements. FDA determined that such claims make<br />
these products drugs and drugs require approval by FDA pursuant to 21 U.S.C. 321(g)(l)(B).<br />
57. Again, on February 28, 2001, FDA sent a letter to Mannatech to respond to<br />
submissions pursuant to 21 U.S.C. 343(r)(6), Section 403(r)(6) of the Federal Food, Drug, and<br />
Cosmetic Act for the products Ambrotose Powder, Ambrotose Capsules, and Ambrotose Capsules<br />
with Lecithin; Manna-C Capsules; MannaCleanse Capsules; and AmbroStart Drink Mix. Again the<br />
FDA determined that certain claims made by Mannatech suggest that these products are intended to<br />
treat, prevent, cure, or mitigate diseases. For example, Mannatech&#8217;s marketing material claimed that:<br />
A. Ambrotose Powder, Capsules, and Capsules with Lecithin to &#8220;&#8230;delay the<br />
Plaintiffs Original Petition page 35<br />
onset of various degenerative conditions&#8221;;<br />
B. AmbroStart Drink Mix &#8220;Helps lower serum cholesterol levels in individuals<br />
with elevated cholesterol;&#8221; &#8220;Aids in control of diabetes. Insulin-requiring<br />
diabetics often need lower amounts ofinsulin when they consume a diet high<br />
in soluble fiber,&#8221; and &#8220;&#8230;prevent the growth of disease-producing<br />
bacteria&#8230;help alleviate lactose intolerance.&#8221;<br />
FDA concluded that these claims to treat, cure, prevent, or mitigate disease cannot be made for<br />
products under 21 U.S.C. 343(r)(6), dietary supplements. FDA determined that such claims make<br />
these products drugs and drugs require approval by FDA pursuant to 21 U.S.C. 321(g)(I)(B).<br />
VIOLATIONS OF THE TEXAS FOOD, DRUG AND COSMETIC ACT<br />
58. Based on the findings in paragraphs 1 through 57, incorporated by reference herein,<br />
Defendants have manufactured and/or introduced into commerce or caused the introduction into<br />
commerce unapproved new drugs and/or misbranded foods; have misbranded drugs and/or foods in<br />
commerce or caused the misbranding of drugs and/or foods in commerce; falsely advertised these<br />
foods and/or unapproved new drugs or caused the false advertising ofthese foods and/or unapproved<br />
new drugs; and failed to produce distribution records in violation of the Texas Food, Drug and<br />
Cosmetic Act.<br />
59. .Defendants manufacture and sell products that are drugs within the meaning of<br />
§431.002(14) ofthe TFDCA because these products are intended to cure, mitigate, treat, or prevent<br />
disease although Mannatech labels these glyconutrients as dietary supplements. Mannatech is<br />
licensed as a food manufacturer by TDSHS and is not licensed to manufacture or distribute drugs.<br />
60. Defendants&#8217; products are additionally classified as &#8220;new drugs&#8221; within the meaning<br />
Plaintiff&#8217;s Original Petition page 36<br />
of §431.002(25) of the TFDCA because TDSHS is unaware of any evidence that establishes that<br />
these drugs are generally recognized as safe and effective for their intended uses. New drugs must<br />
be approved by FDA before they may be marketed. The FDA, by affidavit, states that it has not·<br />
approved any new drug applications for Mannatech or Mannatech, Inc. FDA also finds that there<br />
is no valid new drug application on file for any of the following products: Ambrotose, Glycentials,<br />
Phytomatrix, CardioBALANCE, GI-Pro, GI-Zyme, ImmunoSTART, Man-Aloe Classic,<br />
MannaCLEANSE, Ambrostart, Manna-C, Mannatonin, Glyco-Bears, Manna-Bears, Manapol, and<br />
glyconutrients. (See Exhibit 1 attached).<br />
61. Defendants&#8217; drugs are also misbranded under the terms of the TFDCA. Section<br />
431.112(e)(l) ofthe TFDCA states that a drug is deemed to be misbranded unless its labeling bears<br />
adequate directions for use, unless the drug has been exempted from those requirements by<br />
regulations adopted by the Secretary ofthe United States Department ofHealthand Human Services.<br />
62. By federal regulation, 21 CFR § 201.5 &#8220;adequate directions for use means directions<br />
under which the layman can use a drug safely and for the purposes for which it is intended.&#8221;<br />
Defendants advertise and sell drugs that fail to bear adequate directions for their intended uses since<br />
adequate directions for use by a layperson cannot be written for an unapproved drug under the terms<br />
of §431.112(e)(1) of the TFDCA.<br />
63. Accordingly, the sale, delivery, offering for sale, holding for sale, or giving away of<br />
any new drugs by Defendants without an FDA approved new drug application violates<br />
§431.114(a)(1) of the TFDCA. The introduction or delivery for introduction into commerce or<br />
causing the introduction or delivery for introduction into commerce of any article in violation of<br />
§431.114 of the TFDCA is prohibited, under §431.021(e) of the TFDCA.<br />
Plaintiff&#8217;s Original Petition page 37<br />
64. Section 431.021(a) of the TFDCA prohibits the introduction or delivery for<br />
introduction into commerce or causing the introduction or delivery for introduction into commerce<br />
within the State ofTexas ofany misbranded drug, such as Defendants&#8217; products which are intended<br />
to cure, mitigate, treat, or prevent disease and/or whose label and/or labeling is not in conformance<br />
with state and federal standards, and the misbranding or causing the misbranding of any drug in<br />
commerce. Since Defendants&#8217; drugs are misbranded under Texas law, Defendants are in violation<br />
of §431.021(a) and/or (b) of the TFDCA.<br />
65. Defendants&#8217; advertising of unapproved new drugs is false within the meaning of<br />
§431.182 of the TFDCA because such advertising is misleading in numerous particulars asset out<br />
above. In addition, because FDA has not approved these drugs, they are illegal to market and any<br />
advertising is therefore false.<br />
66. Such representationsfor unapproved new drugs by Defendants constitute advertising<br />
within the definition set out in §431.002(l) of the TFDCA since they are intended to induce<br />
consumers to purchase Defendants&#8217; drugs. Section 431.005 ofthe TFDCA provides that the selling<br />
ofdrugs or foods includes &#8220;manufacture&#8230;offer, possession, and holding ofany such article for sale;<br />
and the sale, dispensing, and giving of any such article&#8230;&#8221;<br />
67. .In the alternative, Defendants manufacture, advertise, offer for sale, and sell products<br />
that are foods (includes dietary supplements) within the meaning of §431.002(l6) of the TFDCA.<br />
Defendants&#8217; foods are misbranded under the terms of the TFDCA based upon the disease claims<br />
made for these food products and the lack oflabels and labeling that comply with §431.082(a), (t),<br />
and (g) of the TFDCA. Defendants&#8217; foods are deemed misbranded because the labeling is false or<br />
misleading and fails to prominently display information and statements required by regulations in<br />
Plaintiff&#8217;s Original Petition page 38<br />
such a manner to render it likely to be read and understood by the ordinary individual under<br />
customary conditions of purchase and use.<br />
68. Defendants&#8217; advertising offoods is also false within the meaning of §431.182 ofthe<br />
TFDCA because it is misleading in numerous particulars, as set out above, and because disease<br />
claims cannot be made for foods, and it is illegal to market these foods with such claims.<br />
69. Mannatech and Sam Caster have also failed to produce for copying distribution<br />
records as requested in the July, 2006 inspection pursuant to §§431.042-431.044 ofthe TFDCA, in<br />
violation of §431.021 (g) of the TFDCA.<br />
PROHIBITED ACTS UNDER THE TEXAS FOOD, DRUG AND COSMETIC ACT<br />
70. Based on the conduct alleged above in paragraphs 1 through 69, Defendants have<br />
committed or caused to be committed the following acts prohibited and declared to be unlawful by<br />
§431.001 et seq. of the TFDCA:<br />
A. Introducing into commerce or causing the introduction into commerce a<br />
misbranded drug in violation of §431.021(a) of the TFDCA;<br />
B. Introducing into commerce or causing the introduction into commerce of an<br />
unapproved new drug in violation of §431.021(e) of the TFDCA;<br />
C. Misbranding or causing the misbranding of a drug in commerce, in violation<br />
of §431.021 (b) of the TFDCA;<br />
D. Falsely advertising or causing the false advertising of drugs in Texas in<br />
violation of §431.021(f) of the TFDCA;<br />
E. Manufacturing within this state food that is misbranded in violation of<br />
§431.021(h) of the TFDCA;<br />
Plaintiff&#8217;s Original Petition page 39<br />
F. Distributing in commerce or causing the .distribution into commerce of a<br />
consumer commodity that has a label that does not conform to the provisions<br />
of this chapter and of rules adopted under the authority of this chapter, in<br />
violation of §431.021(d) of the TFDCA;<br />
G. Introducing into commerce or causing the introduction into commerce a food<br />
that is misbranded, in violation of §431.021(a) of the TFDCA;<br />
H. Misbranding or causing the misbranding ofa food in commerce in violation<br />
of §431.021(b) of the TFDCA;<br />
I. Falsely advertising or causing the false advertising of foods in Texas in<br />
violation of §431.021(f) of the TFDCA, and<br />
J. Failing to produce distribution records in violation of §431.021(g) of the<br />
TFDCA.<br />
VIOLATIONS OF THE TEXAS DECEPTIVE TRADE PRACTICES ACT<br />
71. Defendants as alleged above in paragraphs 1 through 70, have in the course oftrade<br />
and commerce engaged in false, misleading and deceptive acts and practices declared unlawful in<br />
§17.46(a) ofthe DTPA. Additionally, Defendants have violated §17.46(b) ofthe DTPA as follows:<br />
A. Causing confusion or misunderstanding as to the approval of the dietary<br />
supplements and/or drugs manufactured, advertised, offered for sale, and sold<br />
by Defendants, in violation of §17.46(b)(2) of the DTPA;<br />
B. Causing confusion or misunderstanding as to the affiliation or connection<br />
between Mannatech and the Fisher Institute;<br />
C. Representing that Defendants&#8217; dietary supplements have benefits which they<br />
Plaintiff&#8217;s Original Petition page 40<br />
do not have, in violation of §17.46(b)(5) of the DTPA;<br />
D. Representing that Defendants&#8217; dietary supplements are drugs and have<br />
benefits which they do not have, in violation of §17.46(b)(5) of the DTPA;<br />
E. Representing that Defendants&#8217; dietary supplements are of a particular<br />
standard, quality, or grade, if they are of another, by, in violation of<br />
§17.46(b)(7) of the DTPA;<br />
F. Representing that Defendants&#8217; drugs are of a particular standard, quality, or<br />
grade, if they are of another, in violation of §17.46(b)(7) of the DTPA; and<br />
G. Failing to disclose that Defendants dietary supplements are not approved by<br />
FDA as drugs, when such failure to disclose such information was intended<br />
to induce the consumer into a transaction into which the consumer would not<br />
have entered had the information been disclosed, in violation of<br />
§17.46(b)(24) of the DTPA.<br />
INJURY TO CONSUMERS<br />
72. By means of the foregoing unlawful acts and practices, Defendants have acquired<br />
money or other property from identifiable persons to whom such money or property should be<br />
restored, or who in the alternative are entitled to an award of damages.<br />
TEMPORARY AND PERMANENT INJUNCTION<br />
73. The State alleges that by reason ofthe foregoing, Defendants should not continue to<br />
operate a food manufacturing establishment, advertise, offer to sale, and sell its products in violation<br />
of the laws of Texas. The interests of the State of Texas require a temporary injunction and a<br />
permanent injunction to prohibit Defendants from continuing to operate a food manufacturing<br />
Plaintiffs Original Petition page 41<br />
establishment and to advertise, offer for sale, and sell their products if they refuse or are unable to<br />
comply with standards required by the TDSHS pursuant to their authority granted by the TFDCA.<br />
The interests of the State of Texas also require a temporary injunction and a permanent injunction<br />
to prohibit Defendants from advertising and selling their products, unless Defendants are in<br />
compliance with the DTPA.<br />
74. Unless injunctive reliefis granted, Defendants will continue to violate the laws ofthe<br />
State of Texas to irreparable injury of the State of Texas and to the general public.<br />
PRAYER<br />
75. WHEREFORE, Plaintiff prays that Defendants be cited according to law to appear<br />
and answer herein; that after due notice and hearing a TEMPORARY INJUNCTION be issued; and<br />
upon final hearing a PERMANENT INJUNCTION be issued, restraining and enjoining Defendants<br />
their successors, assigns, officers, associates, members, distributors, agents, servants, employees, and<br />
any other person in active concert or participation with Defendants from engaging in the following<br />
acts or practices:<br />
A. Selling, marketing, promoting, distributing, advertising or assisting or<br />
allowing others to sell, market, promote, distribute, or advertise, the sale of<br />
any Mannatech dietary supplement by representing, expressly or by<br />
implication, that the product can cure, treat, mitigate, or prevent any disease;<br />
B. Selling, distributing, sending, mailing, printing, giving, disseminating,<br />
advertising, referencing, or assisting or allowing any other person, entity or<br />
business affiliated with Defendants or subject to their control, directly or<br />
indirectly, to sell, distribute, send, give, mail, print, advertise, reference, or<br />
Plaintiff&#8217;s Original Petition page 42<br />
disseminate, any materials that in any manner represent, expressly or by<br />
implication, that Mannatech&#8217;s dietary supplements can cure, treat, mitigate,<br />
or prevent any disease;<br />
C. Failing to completely remove all claims and testimonials that Mannatech&#8217;s<br />
dietary supplements can cure, treat, mitigate, or prevent any disease from all<br />
of Defendants&#8217; websites, promotional materials, and advertisements;<br />
D. Shipping products or promotional materials to any other associates, sellers,<br />
distributors, or buyers of Defendants&#8217; dietary supplements who fail to<br />
completely remove all claims and testimonials that Mannatech products can<br />
cure, treat, mitigate, or prevent any disease from all of such person&#8217;s<br />
websites, promotional materials, and advertisements;<br />
E. Causing confusion or misunderstanding as to the approval of dietary<br />
supplements manufactured and sold by Defendants;<br />
F. Causing confusion or misunderstanding as to the approval of drugs<br />
manufactured and sold by Defendants;<br />
G. Representing that Defendants&#8217; dietary supplements have benefits which they<br />
do not have;<br />
H. Representing that Defendants&#8217; dietary supplements have any benefits or<br />
characteristics unless Defendants have in their possession at the time such<br />
representation is made scientific substantiation for such representation;<br />
1. Representing that Defendants&#8217; dietary supplements are drugs and have<br />
benefits which they do not have;<br />
Plaintiff&#8217;s Original Petition page 43<br />
J. Representing that Defendants&#8217; dietary supplements are of a particular<br />
standard, quality, or grade, if they are of another;<br />
K. Representing that Defendants&#8217; dietary supplements are drugs that are of a<br />
particular standard, quality, or grade, if they are of another;<br />
L. Failing to disclose that Defendants&#8217; dietary supplements are not approved by<br />
FDA to cure, treat, mitigate, or prevent disease;<br />
M. Failing to disclose that FDA has not determined that Defendants&#8217; dietary<br />
supplements are safe and effective to cure, treat, mitigate, or prevent disease<br />
and that such claims are illegal to make for dietary supplements;<br />
N. Introducing into commerce or causing the introduction into commerce of a<br />
new drug not approved by the FDA;<br />
O. Advertising or causing the advertising of new drugs because FDA has not<br />
approved them as safe·and effective;<br />
P. Introducing into commerce or causing the introduction into commerce a<br />
misbranded drug;<br />
Q. Misbranding or causing the misbranding of a drug in commerce;<br />
R. Falsely advertising or causing the false advertising of drugs in Texas;<br />
S. Manufacturing within this state food that is misbranded;<br />
T. Distributing in commerce or causing the distribution into commerce of a<br />
consumer commodity that has a label that does not conform to state law;<br />
U. Introducing into commerce or causing the introduction into commerce a food<br />
that is misbranded;<br />
Plaintiff&#8217;s Original Petition page 44<br />
V. Misbranding or causing the misbranding of a food in commerce;<br />
W. Falsely advertising or causing the false advertising of foods in Texas;<br />
X. Failing to produce distribution records requested by the Texas Department of<br />
State Health Services;<br />
Y. Failing to develop and implement a plan for monitoring and regulating<br />
Defendants&#8217; websites and the websites of their associates, sellers, or<br />
distributors and all advertising and promotional materials to insure that<br />
claims to treat, cure, mitigate, or prevent diseases and serious illnesses are not<br />
included;<br />
Z. Failing to revise Defendants&#8217; policies and procedures for associates, sellers,<br />
or distributors to reflect compliance with state and federal laws regarding<br />
claims;<br />
AA. Using MannaReliefor any nonprofit entity to further the profits ofMannatech<br />
through the promotion and marketing ofMannatech&#8217;s dietary supplements to<br />
cure, treat, mitigate, or prevent diseases or, serious conditions;<br />
BB. Advertising, offering for sale, selling or giving away any Mannatech dietary<br />
supplement or glyconutrient for the treatment, cure, mitigation or prevention<br />
of diseases or serious conditions;<br />
CC. Using The Fisher Institute to conduct and publish scientific research on<br />
glyconutrients unless the studies are double-blinded, randomized, and peerreviewed;<br />
DD. Using MannaRelief, the Fisher Institute, any nonprofit or charitable<br />
Plaintiff&#8217;s Original Petition page 45<br />
corporation, or any other third party to make claims about Defendants&#8217;<br />
dietary supplements that Defendants could not make themselves;<br />
EE. Using research studies on the use of glyconutrients or any of Mannatech&#8217;s<br />
products to support the use ofMannatech&#8217; s dietary supplements to cure, treat,<br />
mitigate, or prevent disease or serious conditions;<br />
FF. Misrepresenting that the Fisher Institute is an independent scientific research<br />
entity;<br />
GG. Failing to disclose the relationship between the Fisher Institute and<br />
Mannatech; and<br />
HH. Using testimonials to make claims about Defendants&#8217; dietary supplements<br />
that Defendants could not make themselves.<br />
76. Plaintiff further prays that this court upon final hearing order each Defendant to pay<br />
civil penalties in favor ofthe STATE OF TEXAS in the amount of$25,000.00 per day per violation<br />
of §431.021 of the TFDCA.<br />
77. Plaintiff further prays that upon final hearing this Court will order each Defendant<br />
to pay civil penalties in favor ofthe STATE OF TEXAS in the amount of$20,000.00 per violation<br />
of the DTPA.<br />
78. Plaintiff further prays that upon final hearing that his Court order Defendants to<br />
restore all money or other property taken from persons by means of unlawful acts or practices, or,<br />
in the alternative, award judgment for damages to compensate for such losses.<br />
79. Plaintifffurther prays that upon final hearing that this Court order Defendants to pay<br />
to the STATE OF TEXAS attorney fees and costs of court pursuant to the TEX. GOVT. CODE<br />
Plaintiff&#8217;s Original Petition page 46<br />
§402.006(c).<br />
80. Plaintiff further prays that upon final hearing that this court order Defendants to pay<br />
to the Office of the Attorney General and to the Texas Commissioner of Health their reasonable<br />
expenses incurred in obtaining injunctive relief under §431.047 of the TFDCA, including<br />
investigative costs, court costs, reasonable attorneys&#8217; fees, witness fees, and deposition expenses<br />
pursuant to §431.047(d) of the TFDCA.<br />
81. Plaintiff further prays that upon final hearing that this Court grant all other relief to<br />
which the STATE OF TEXAS may show itself entitled.<br />
Respectfully submitted,<br />
Plaintiff State of Texas<br />
GREG ABBOTT<br />
Attorney General of Texas<br />
KENT C. SULLIVAN<br />
First Assistant Attorney General<br />
JEFF L. ROSE<br />
Deputy First Assistant Attorney General<br />
Plaintiff&#8217;s Original Petition page 47<br />
PAUL D. CARMONA<br />
Assistant Attorney General<br />
Chief, Consumer Protect&#8217;0 and Public Health Division<br />
B DSCHU KE<br />
Assistant Attorney General<br />
Consumer Protection and Public Health Division<br />
State Bar No. 24008000<br />
300 W. 15th Street<br />
Austin, Texas 78701<br />
(512) 463-2185<br />
J INILIYA<br />
AssIstant Attorney General<br />
Consumer Protection and Public Health Division<br />
State Bar No. 00784319<br />
Attorneys for the State<br />
Plaintifrs Original Petition page 48<br />
Declaration of Michael M. Levy<br />
I, Michael M. Levy, declare as follows:<br />
1. I am the Director of the Division of New Drugs and Labeling<br />
Compliance, Office of Compliance, Center for Drug Evaluation and<br />
Research (COER), United States Food and Drug Administration<br />
(FDA).<br />
2. The responsibilities of my position require that I be familiar with and<br />
knowledgeable aboutthe legal requirements of the Federal Food,<br />
Drug, and Cosmetic Act (Act), 21 U.S.C. §§ 301-97, and the FDA&#8217;s<br />
enforcement policies pertaining to &#8220;drugs&#8221; and &#8220;new drugs.&#8221;<br />
3. 21 U.S.C. § 321 (g) defines the term &#8220;drug&#8221; in relevant part as U(A)<br />
articles recognized in the official United States Pharmacopoeia,<br />
official Homeopathic Pharmacopoeia of the United States, or official<br />
National Formulary, or any supplement to any of them; and (8)<br />
articles intended for use in the diagnosis, cure, mitigation, treatment,<br />
or prevention of disease in man or other animals; and (C) articles<br />
(other than food) intended to affect the structure or any function of the<br />
body of man or other animals; and (D) articles intended for use as a<br />
component of any articles specified in clause (A), (8), or (C) &#8230;.&#8221;<br />
4. 21 U.S.C. § 321(p) defines the term &#8220;new drug&#8221; in relevant part as:<br />
a. Any drug &#8230; the composition of which is such that such drug is not<br />
generally recognized, among experts qualified by scientific training<br />
and experience to evaluate the safety and effectiveness of drugs,<br />
as safe and effective for use under the conditions prescribed,<br />
recommended, or suggested in the labeling thereof &#8230; or<br />
b. Any drug &#8230; the composition of which is such that such drug, as a<br />
result of investigations to determine its safety and effectiveness for<br />
use under such conditions, has become so recognized, but which<br />
has not, otherwise than in such investigations, been used to a<br />
material extent orfor a material time under such conditions.<br />
5. In order to be generally recognized as safe and effective (GRAS/E)<br />
within the meaning of 21 U.S.C. § 321(p), a drug must satisfy three<br />
criteria. First, the drug must have been subjected to adequate and<br />
well-controlled studies that establish that the drug is safe and<br />
. effective. See 21 C.F.R. § 314.126. Second, those studies must<br />
have been published in the scientific literature, so that they are<br />
,&#8217;available to qualified experts. Third, experts must generally agree,<br />
EXHIBIT 1<br />
based on those published studies, that the drug is safe and effective<br />
for its intended use.<br />
6. Even if an active ingredient has been previously approved as safe<br />
and effective in another drug product, a drug is considered a new<br />
drug if its particular formulation of active and inactive ingredients has<br />
not been previously approved or has not been found to be GRAS/E.<br />
7. The FDA is charged with the regulation of drugs for human use.<br />
Drugs that are &#8220;new drugs&#8221; within the meaning of 21 U.S.C. 321 (p)<br />
must be approved by FDA before they may be marketed. For new<br />
drugs, FDA&#8217;s approval is granted in the form of an approved New<br />
Drug Application (NDA) or an approved Abbreviated New Drug<br />
Application (ANDA). Among other information, an NDA must contain<br />
data from scientific studies conducted both in animals (&#8220;preclinical<br />
data&#8221;) and man (&#8220;clinical data&#8221;) that establish that the drug is safe and<br />
effective for its intended uses.<br />
8. Under sections 301 (d) and 505(a) of the Act, 21 U.S.C. §§ 331 (d) and<br />
355(a), a new drug may not be introduced or delivered for introduction<br />
into interstate commerce unless an FDA-approved application is in<br />
effect for it; except that 21 U.S.C. 355(i) permits, subject to<br />
regulations, the introduction or delivery for introduction into interstate<br />
commerce of unapproved new drugs solely for investigational use by<br />
experts qualified by scientific training and experience to investigate<br />
the safety and effectiveness of drugs. The regulations providing for<br />
such investigational exemptions are contained in 21 CFR 312.<br />
9. I have access to all New Drug Applications (NDAs) filed pursuant to<br />
21 U.S.C. § 355(b), all Abbreviated New Drug Applications (ANDAs)<br />
filed pursuant to 21 U.S.C. § 355(j), and all Investigational New Drug<br />
Applications (INDs) filed pursuant to 21 U.S.C. § 355(i), as well as<br />
related records.<br />
10.When a sponsor submits to FDA an NDA, ANDA, or IND for any<br />
intended use of a new drug, the existence of that submission is<br />
reflected in various records that FDA regularly makes and preserves<br />
in the normal course of its regulatory affairs. , have caused a diligent<br />
search of the official FDA records referred to in paragraphs 9. Those<br />
searches revealed that there is not on file a valid IND, NDA or ANDA<br />
for any of the following products: Ambrotose, Glycentials,<br />
Phytomatrix, CardioBALANCE, GI-Pro,GI-Zyme, ImmunoSTART,<br />
Man-Aloe Classic, MannaCLEANSE, Ambrostart, Manna-C,<br />
Mannatonin, Glyco-Bears, Manna-Bears, Manapol and glyconutrients.<br />
Nor does Mannatech or Mannatech, Inc., hold an approved NDA,<br />
ANDA, or IND for any drug product regulated by FDA.<br />
o<br />
Pursuant to 28 U.S.C. § 1746, I declare under penalty of perjury that the<br />
foregoing is true and correct to the best of my knowledge and belief.<br />
Executed on June 5, 2007<br />
United States Patent: 6,929,807 Page 26 of31<br />
Glyco-1 capsules used in this study were prepared according to Example 6. The purpose of this study<br />
was to evaluate the effectiveness of dietary glyconutritiona1 supplementation on the mood states and<br />
craving for alcohol in alcoholics. The study was conducted as follows.<br />
Two groups of subjects were recruited from a local alcoholic support group in Little Rock, Ark.: three<br />
recovering alcoholics and two practicing alcoholics. Each met the Diagnostic and Statistical Manual 4th<br />
Ed. (DSM-IV) criteria for alcohol dependency. In the recovering group, abstinence varied from 2.5 years<br />
to six years and 11 months. For both groups, year=of alcohol abuse ranged from 15 to 30 years and ages<br />
ranged from 33 to 62.<br />
Assessment tools consisted of a self-rating scale of craving for alcohol which was scored from 0 to 9 and<br />
the Profile of Mood States (POMS). The POMS 65 items were divided into five scales: Cognitive,<br />
Depression, Energy, Anger/Temper, and Positive Outlook. These assessments were completed prior to<br />
taking glyconutritionals and again at the end of the five-week study.<br />
Glyconutritionals were added to each subject&#8217;s diet: 1 capsule per 10 pounds of body weight for the first<br />
day and thereafter 1 capsule per 20 pounds of body weight for the duration of the trial. No other<br />
interventions were introduced.<br />
Results indicated that the mean initial alcohol craving of the five subjects had decreased in a statistically<br />
significant manner. Likewise, the results also indicated statistically significant improvements in the all<br />
of the measured mood states.<br />
EXAMPLE 8<br />
Treatment of Various Disorders with Glyconutrients<br />
The following table summarizes the results obtained when patients were administered Glyco-1 either<br />
alone or in combination with one or more ofPhyto-1, Glyco-1 with dioscorea and PROFILETM. Each<br />
patient was administered an initial dose Glyco-1 and anyone or more of the respective supplements in<br />
the dosages indicated as follows:<br />
SUPPLEMENT DOSAGE<br />
Glyco-1 (A) 2 capsules, 4x/day<br />
Phyto-1 (B) 1 caplet, 4x/day<br />
Glyco-1 with dioscorea complex (C) 1 caplet, 4x/day<br />
PROFILE™ (D) 1 tablet, 3x/day<br />
• &#8220;E&#8221; indicates a topical hydrogel formulation comprising glyconutritionals<br />
• &#8220;F&#8221; indicates an oral dietary supplement comprising glyconutritionals and herbal extracts.<br />
• &#8220;E&#8221; indicates a topical hydrogel formulation comprising glyconutritionals<br />
• &#8220;F&#8221; indicates an oral dietary supplement comprising glyconutritionals and herbal extracts.<br />
During each study, patient progress and nutritional or overall health response to administration of a<br />
given dietary supplement regimen was monitored For those patients not responding well to initial doses,<br />
their dosing regimen was altered and their progress monitored again. It should be noted that in each of<br />
the cases, the Glyco-1 at an appropriate dose provided nutritionally effective amounts of the essential<br />
saccharide(s) necessary to promote good overall health in a given patient That is, the glyconutrientcontaining<br />
dietary supplement of the invention is not intended or professed to cure any of the disorders<br />
listed below. Rather, the dietary supplement provides a patient the necessary glyconutrients to permit a<br />
EXHIBIT 2<br />
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United States Patent: 6,929,807<br />
patient&#8217;s own body to heal itself.<br />
TABLE 4<br />
Disorders treated by administration of glyconutrients alone or in<br />
combination with one or more ofphytonutrients, dioscorea complex<br />
and vitamins and minerals.<br />
Page 27 of31<br />
NUTRITIONAL<br />
PRODUCTS<br />
DISORDER ADMINISTERED TREATMENT RESULTS<br />
aging process or A,B,C,D decreased body fat;<br />
optimal health plan increased muscle mass and<br />
bone density; serum biochemistry<br />
altered to more<br />
healthy values<br />
old stable strokes A,B,C restored sensory and<br />
muscular control<br />
multiple sclerosis A,B,C restored sensory and<br />
muscular control<br />
amyotrophic lateral A,B,C restored sensory and<br />
sclerosis muscular control<br />
muscular dystrophy A,B,C restored· sensory and<br />
muscular control<br />
cerebral palsy A,B,C restored sensory and<br />
muscular control<br />
macular degeneration A,B,C sight restorations<br />
seizures A,B,C reduction or elimination of<br />
allergies and infections;<br />
coordination, learning,<br />
memory and appearance<br />
improvements<br />
Down&#8217;s Syndrome A,B,C reduction or elimination of<br />
allergies &amp; infections;<br />
coordination, learning,<br />
memory and appearance<br />
improvements<br />
systemic combined A,B,C antibody and T-cell<br />
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United States Patent: 6,929,807 Page 28 of31<br />
immune deficiency function restoration<br />
syndrome<br />
Tay..Sachs A,B,C restoration of lost functions<br />
retinitis pigmentosis A,B,C sight restoration<br />
color blindness A,B,C can see color<br />
Huntington&#8217;s chorea A,B,C restoration or improvement<br />
of lost functions<br />
Alzheimer&#8217;s A,B,C restoration orimprovement<br />
of losl functions<br />
Parkinson&#8217;s A,B,C restoration or improvement<br />
of lost functions<br />
inflammatory A,B,C restoration or improvement<br />
polyneuropathy of lost functions<br />
Closed head traumatic A,B,C restoration or improvement<br />
syndromes of lost functions<br />
spinal cord injury A,B,C restoration or improvement<br />
of lost functions<br />
ulcerative colitis A,B,C healed ulcers<br />
Crohn&#8217;s disease A,B,C healed ulcers<br />
schizophrenia A,B,C improvements in functions<br />
depression A,B,C improvements in functions<br />
anxiety reactions A,B,C improvements in functions<br />
compulsive disorders A,B,C improvements in functions<br />
nervous tics A,B,C improvements in functions&#8217;<br />
restless leg syndrome A,B,C improvements in functions<br />
Tourette&#8217;s syndrome A,B,C improvements in functions<br />
autism A,B,C improvements in functions<br />
Wegener&#8217;s A,B,C restoration of tissue<br />
granulomatosis<br />
Lupus E. A,B healing of lesions<br />
Rheumatoid arthritis A,B relief of symptoms<br />
thyroiditis A,B normalization of antinuclear<br />
antibodies<br />
myesthenia gravis A,B normalization of antinuclear<br />
antibodies<br />
diabetes mellitus A,B normalization of glucose<br />
and Hgb AlC; restoration of<br />
renal functions; healing of<br />
ulcers, elimination of infection;<br />
elevated lipids normalize;<br />
reduced insulin and<br />
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glycomeds<br />
osteoporosis A,B reduced pain increased<br />
bone density<br />
alcoholism A reduction in craving<br />
cocaine A reduction in craving<br />
atherosclerosis A,B reduced total cholesterol,<br />
LDL, and triglycerides and<br />
increased HDL; improved<br />
patency of vessels and<br />
arrhythmia<br />
idiopathic myocarditis A,B increased ejection function;<br />
(presumed viral origin) restoration of heart size;<br />
increased Coxsackievirus<br />
antibody levels; and<br />
reversal of heart failure<br />
rheumatoid arthritis A,B elimination of pain, stiffness,<br />
fever, and swelling;<br />
restoration of scope of<br />
motion, strength and<br />
endurance<br />
degenerative arthritis A,B elimination of pain, stiffness,<br />
fever, and swelling;<br />
restoration of scope of<br />
motion, strength and<br />
endurance<br />
traumatic arthritis A,B elimination ofpain, stiffness,<br />
fever, and swelling;<br />
restoration of scope of<br />
motion, strength and<br />
endurance<br />
juvenile arthritis A,B elimination ofpain, stiffness,<br />
fever, and swelling;<br />
restoration of scope of<br />
motion, strength and<br />
endurance<br />
asthma A elimination of shortness of<br />
breath and wheezing and<br />
improvement of pulmonary<br />
function<br />
allergy &#8211; nasal, eyes, A elimination of itching,<br />
hay fever swelling, rash discomfort<br />
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silicon breast implant A,B,C reduction or elimination of<br />
symptoms<br />
environmental toxin A,B,C reduction or elimination of<br />
syndrome symptoms<br />
agent orange A,B,C reduction or elimination of<br />
symptoms<br />
Gulf War syndrome A,B,C reduction or elimination of<br />
symptoms<br />
Hepatitis B &amp; C A,C,D normalization of liver<br />
enzymes and symptoms<br />
influenza virus A,C,D prevention or amelioration;<br />
improvement of symptoms<br />
common cold A,C,D prevention or amelioration;<br />
improvement of symptoms<br />
AIDS A,C,D elimination of symptoms;<br />
m-RNA ofHIV-1 is undetected;<br />
restored immune<br />
function<br />
herpes A,C,D elimination of infestations<br />
warts A,C,D elimination of infestations<br />
human papillovirus A,C,D elimination of infestations<br />
otitis media (chronic A,C,D elimination of symptoms<br />
or persistent) and need for antibiotics<br />
leukemia A,B,C,D correction of altered<br />
chromosomes<br />
lymphomas A,B,C,D normalization of tissue<br />
biopsies<br />
sarcomas A,B,C,D normalization of tissue<br />
(astrocytomas) biopsies<br />
adenocarcinomas such A,B,C,D elimination of metastasis<br />
as breast, prostate, and shrinkage of mass to<br />
ovarian, gastrointes- undetectable level<br />
tinal and lung<br />
profound introversion A,B,C,D restoration of psychological<br />
and female impotence interest and physiological<br />
sexual function in the<br />
elderly<br />
pain, ulcers and A,C,E restoration to intact, paincoldness<br />
of extremities less extremity and microin<br />
diabetes, raynauds, vascular circulation<br />
frost-bite, snake-bite<br />
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United States Patent: 6,929,807<br />
and atherosclerosis<br />
sun damaged skin, age<br />
damaged skin, and<br />
radiation damaged skin<br />
athletic performance<br />
A,C,E<br />
C,F<br />
lessening of pigmentation,<br />
wrinkles, and lost elasticity<br />
and restoration of dermis<br />
and epidermis<br />
increased strength and<br />
endurance, delayed fatigue,<br />
facilitation of recovery in<br />
young and aging athletes<br />
Page 31 of31<br />
In summary, this invention pertains to the field of dietary supplements and nutritional support for<br />
promotion and maintenance of optimal good health. More specifically, the invention relates to<br />
compositions of carbohydrates as dietary supplements that are essential for the production of correctly<br />
structured and, therefore, properly functioning glycoproteins.<br />
Science has recently shown that glycoproteins playa key role in all cellular communication. Many of<br />
the cytokines, i.e. cellular &#8220;words,&#8221; do not function properly without an attached glycosyl moiety. The<br />
body hydrolyzes complex polysaccharides such as plant carbohydrates into various monosugars and<br />
restructures them into oligosaccharides that are then used by the body to build the glycoproteins required<br />
by cytokines for cellular communication and, thus, for good health.<br />
This invention will correct the problem caused by modem diets consisting of highly refined foods, from<br />
which many essential ingredients have been eliminated during processing, specifically sugars needed for<br />
correctly structured and properly functioning glycoproteins.<br />
The above is a detailed description of particular embodiments of the invention. Those of skill in the art<br />
should, in light of the preset disclosure, appreciate that obvious modifications of the embodiments<br />
disclosed herein can be made without departing from the spirit and scope of the invention. All of the<br />
embodiments disclosed herein can be made and executed without undue experimentation in light of the<br />
present disclosure. The full scope of the invention is set out in the disclosure and equivalent<br />
embodiments thereof. The specification should not be l:onstrued to unduly narrow the full scope of<br />
protection to whic~ the present invention is entitled.<br />
As used herein and unless otherwise indicated, the terms &#8220;a&#8221; and &#8220;an&#8221; are taken to mean &#8220;one&#8221;, &#8220;at least<br />
one&#8221; or &#8220;one or more&#8221;.<br />
*****<br />
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