Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration

 

200 C St SW
Washington, DC 20204

January 28, 2002
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

David Wheeler
President,
Light Resources Unlimited, Inc
PO Box 177
Gladstone, OR 97027

Ref. No. CL-02-HFS-810-06

Dear Dr Wheeler:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.0disease.com and has determined that the products Oat Beta Glucan 1000™, Immune Power Herbal Formula™, Primordial M Water, MPS-GOLD™, Celtic Trace Minerals™, Immune Revitalizer™, Flaxseed Oil, Pure Crystalline CoQ10™, Supreme 7 Oils™, Marine Matrix®, Immune Power Herbal and Allergy Relief Herbal Formula™ being offered are promoted for conditions that cause the products to be drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 321(g)(1)]. The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The continued marketing of these products with these claims violates the Act and may subject you or the products to regulatory action without further notice.

Examples of some of the claims observed on your website include:

"For all the new chronic infectious disease, such as AIDS, hepatitis and others, these supplements will give the body a chance to completely conquer an invading organism."

"[I]n Dr. Wheeler's system of alternative cancer treatment, he has included natural supplements that provide cofactor nutrients that are responsible for linking up all the chemical pathways of the body to function correctly and for nutrients from food to be used to be used properly for energy and metabolism so that the immune system can carry on a continuous fight against cancer and leukemia cells in the body."

"[N]ot only to reverse malignant cells and their growth (metastasis as well) but to prevent caner and leukemia…"

"There are a vast number of Auto Immune diseases. … Rheumatoid Arthritis, Multiple Sclerosis, Ulcerative Colitis, Crohn's Disease, Lupus, Diabetes and Shogrun's Disease. … The fundamental mistake made with Auto Immune Diseases is that the immune system cells recognize self as non-self. … To stop the attack on non-self and lower inflammation, natural immune system modulators Dr. Wheeler has developed should be taken."

"For a true allergy, or for asthma, people should 1) take a complete combination of Dr. Wheeler's natural supplements for the immune system … and 2) take a special herbal tea developed by a Canadian Medical Researcher, Immune Power Herbal and Allergy Relief Herbal Formula™."

"The active ingredients in MPS-GOLD and Beta Glucan 1000 have been studied for their effects on reversing many different components of heart disease in the body. A full range of Dr. Wheeler's natural supplements should also be taken to fully engage the immune system in reversing gum disease and heart disease."

"MPS-GOLD™ … is the most effective natural supplement available today for gut diseases of all kinds, whether it is due to chronic infections of bacterial or parasites, auto-immune disease or other inflammatory disease."

"Mainstream medical research has already discovered that Vitamin E is the best way to slow down the progression as well as for the prevention of Alzheimer's Disease. It makes sense, based on the mainstream research to use Dr. Wheeler's specialized natural supplements for the immune system to further deal with the breakdown that occurs in the central nervous system causing Alzheimers Disease."

Furthermore, FDA has no information that your products are generally recognized as safe and effective for the above referenced conditions and therefore, the products may also be new drugs under section 201(p) of the Act [21 USC 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505 (a) of the Act [21 USC 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

FDA is aware that Internet distributors may not know that the products they offer are regulated as drugs or that these drugs are not in compliance with the law. Many of these products may be legally marketed as dietary supplements or as cosmetics if therapeutic claims are removed from the promotional materials and the products otherwise comply with all applicable provisions of the Act and FDA regulations.

Under the Act, as amended by the Dietary Supplement Health and Education Act (DSHEA), dietary supplements may be legally marketed with truthful and non-misleading claims to affect the structure or function of the body (structure/function claims), if certain conditions are met. However, claims that dietary supplements are intended to prevent, diagnose, mitigate, treat, or cure disease (disease claims), excepting health claims authorized for use by FDA, cause the products to be drugs. The intended use of a product may be established through product labels and labeling, catalogs, brochures, audio and videotapes, Internet sites, or other circumstances surrounding the distribution of the product. FDA has published a final rule intended to clarify the distinction between structure/function claims and disease claims. This document is available on the Internet at http://vm.cfsan.fda.gov/~lrd/fr000106.html (codified at 21 CFR 101.93(g)).

In addition, only products that are intended for ingestion may be lawfully marketed as dietary supplements. Topical products and products intended to enter into the body directly through the skin or mucosal tissues, such as transdermal or sublingual products, are not dietary supplements. For these products, both disease and structure/function claims may cause them to be new drugs.

Certain over-the-counter drugs are not new drugs and may be legally marketed without prior approval from FDA. Additional information is available in Title 21 of the Code of Federal Regulations (21 CFR) Parts 310 and 330-358, which contain FDA's regulations on over-the-counter drugs.

This letter is not intended to be an all-inclusive review of your website and products your firm may market. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations.

If you need additional information or have questions concerning any products distributed through your website, please contact FDA. You may reach FDA electronically (e-mail) at APaeng@CFSAN.FDA.GOV, or you may respond in writing to Andrew H. Paeng, Compliance Officer, Food and Drug Administration, Division of Compliance and Enforcement, ONPLDS, 200 C St SW, Washington, DC 20204. If you have any questions concerning any issue in this letter, please contact Mr Paeng at 301-436-2375 for Food Safety and Applied Nutrition.

Sincerely yours,
/s/
John B. Foret
Director,
Division of Compliance and Enforcement
Office of Nutritional Products, Labeling and Dietary Supplements
Center for Food Safety and Applied Nutrition

This page was posted on May 4, 2006.

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