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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Triad 30-Mar-04

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3145


March 30, 2004


2004-DAL-WL-13

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Joel Blake Sawyer, Owner
Triad
101 Cristol Drive
Fredericksburg, Texas 78624

Dear Mr. Sawyer:

This letter is written in reference to your marketing of various products as part of “protocols” for disease treatment and prevention. Your labeling on your Internet websites at www.thehomeostasisprotocol.com, www.aototriad.com, www.triadforlife.com, www. homeostasisprotocol.org, www.thehomeostasisprotocol.org, www.thehomeostasisprotocol.net, www. homeostasisprotocolcom, www. homeostasisprotocol.net, and www.reversemultiplesclerosis.com promotes products used in your Homeostasis, Lupus, Multiple Sclerosis, Fibromyalgia, and Inflammatory Disease Protocols with claims that these products are intended for the cure, mitigation, treatment, or prevention of disease.

Under the Federal Food, Drug, and Cosmetic Act (the Act), articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man are drugs [Section 201 (g)(1)(B) of the Act.] Your website claims that your Homeostasis Protocol, including products taken by mouth as part of the protocol, are useful in the prevention and treatment of a wide variety of diseases. Examples of some of the claims observed on your websites include:

The Homeostasis Protocol:

“It does not matter what your disease is. Do you have: Cancer? High blood pressure? Chronic pain? Arthritis? Heart disease? Diabetes? Osteoporosis? Fibromyalgia? Obesity? Thyroid disease? Alzheimer’s? Depression? COPD?...Muscular Dystrophy?...Multiple Sclerosis?” “If you have a disease you think is incurable, think again. We have had people with all of the following diseases, as well as others, testify to slowing down, stopping, and/or reversing their condition! AIDS. Allergies. Alzheimer’s. Anorexia. Arthritis. Asthma. ADD.. . Cancer...Cerebral Palsy. . ..Cystic Fibrosis...Diabetes...Kidney Disease...Lupus...Multiple Sclerosis...Muscular Dystrophy...Obesity...Parkinson...Spinal Cord Injuries.”

On your websites, you also offer protocol packages that claim to cure or treat specific diseases, including multiple sclerosis, lupus, inflammatory diseases, gout, and fibromyalgia. Examples of some of the claims for products sold as part of these protocols include:

“The Multiple Sclerosis Starter Protocol Package: This Protocol Package has been created especially for people with Multiple Sclerosis or any demyelinating disease. The Starter Multiple Sclerosis Protocol Package supplies most of the different products needed to change your seven internal environments and begin the process to reverse MS.”

“The Lupus Advanced Protocol Package: This Protocol Package has been created especially for people with Lupus. The Advanced Protocol Package supplies all the different products needed to change your seven internal environments and begin the process to reverse lupus.” Additional examples of objectionable claims for the products used in your protocols include:

Royal Velvet:

“99.9% of the people who take Royal Velvet properly for 3 months report astonishing results. In fact, we have seen clinical trials, therapeutic use, or double-blind studies where near ‘miraculous’ recoveries have been reported for the following: obesity, diabetes, arthritis, osteoporosis, chronic pain syndromes, neuropathies, chronic renal/kidney problems, all cardiovascular diseases, Alzheimer’s, Multiple Sclerosis, Parkinson’s, Amyotrophic Lateral Sclerosis (Lou Gehrig’s), stroke, paralytic paraplegics, fibromyalgia, wound healing, nephropathy, retinopathy, artherosclerosis [sic], high blood pressure, depression..

Living Multi:

“Anyone suffering from ANY disease, illness, injury, chronic pain...MUST take nine caplets per day.”

FYI For Your Inflammation:

“if you have any of the following inflammatory conditions, FYI can be very helpful: . . . Fibromyalgia, Osteoarthritis, Rheumatoid Arthritis, . . . Scleroderma, Allergies, Lupus, Psoriasis, Crohns’ [sic] and Colitis”

OmegaZyme:

“For anyone with allergies...insomnia... or obesity; OmegaZyme is a MUST for you.”

Primal Defense:

“Primal Defense is the only way we have found to: . ..combat pathological molds,. . . bacteria, . ..parasites. and viruses. . ..”

“For those suffering from . . . yeast infections, Irritable Bowel Syndrome.. .take 6 to 12 per day for 90 days, followed by a maintenance level of 3 per day.”

RM-10:

“Those with a major illness (AIDS, cancer, MS, Diabetes, Lupus, viral infection, etc.) may want to do the advanced RM-10 protocol....”

Royal Chlorella:

“For: . . . high or low blood pressure, cardiovascular problems, . . . high cholesterol, obesity, . . . infections, . . . toxemia, . . . allergies.. .."

We also note that you promote the Homeostasis Protocol and product packages for the prevention of SARS and other diseases on your websites at www.resistsars.com and www.immunetosars.com. Examples of the claims you make include:

“[If you want to learn how to prevent SARS, AIDS, pneumonia, West Nile, Hantavirus, MRSA’s, or any other disease (diabetes, cancer, MS, MD, osteoporosis, arthritis, heart disease, etc.), then we recommend you: Go to the TRIAD site: www.thehomeostasisprotocol.com. . . . They have some great package deals . . . . The basic package is called The Foundation Package. We recommend you get it or The Super Seven Package..."

These claims cause your products to be drugs, as defined in section 201(g)(1)(B) of the Act. Because the products are not generally recognized as safe and effective when used as labeled, they are also new drugs as defined in section 201(p) of the Act. Under section 505 of the Act, a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA). These drugs are also misbranded within the meaning of section 502(a) of the Act because their labeling is false and misleading in that it suggests that these drugs are effective for the prevention and treatment of multiple diseases, when, in fact, these claims are not supported by reliable scientific evidence. These drugs are also misbranded within the meaning of section 502(f)(1) of the Act, in that the labeling for these drugs fails to bear adequate directions for use.

The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations.

The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products. You should take prompt action to correct the violations cited in this letter and prevent their future recurrence. Failure to do so may result in enforcement action without further notice.

Please advise this office, in writing and within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.

Your reply should be addressed to the Food and Drug Administration, Attention: Carolyn A. Pinney, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in the letter, please contact Carolyn A. Pinney at (214) 253-5312.

Sincerely,
/s/

Reynaldo R. Rodriguez Jr. for Michael A. Chappell

Dallas District Director