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