Department of Health and Human Services
Public Health Service
5100 Paint Branch Pkwy
August 13, 2002
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
1051 W. 7th, Ste 325
Fort Worth, TX 76102
Ref. No. CL-02-HFS-810-34
Dear Mr. Green:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address: http://www.dietsexercise.com and has determined that the products "Drinkables Liquid Joint Care and Repair," "Flax Seed Oil," "Acetyl-L-Carnitine," and "BHT" 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:
"Glucosamine is used extensively in Europe to treat osteoarthritis."
"Chondroitin sulfate is a constituent of shark cartilage, which helps to explain the beneficial effects that shark cartilage produces in arthritis patients… [R]esearch studies have provided much useful data on the safety and effectiveness of chondroitin sulfates in arthritis patients."
"Other benefits of consuming flax seed oil on a regular basis: Reverse eczema and psoriasis … Stop allergies and arthritis … Lower hypertension (high blood pressure) … Reverse cancer (including breast cancer) … Help eliminate depression and pain."
"Acetyl-L-carnitine is sold as a drug in Europe at outrageously high prices. Europeans often use acetyl-L-carnitine to treat age related neurological dysfunction and/or congestive heart failure."
"The authors of [a] study concluded that acetyl-L-carnitine may be an effective treatment for dementia."
"Several recognized tests for cognitive function were used and acetyl-L-carnitine consistently produced significant benefits, including... alleviation of depression."
"Several clinical studies have supported the efficacy of lysine supplementation for herpes therapy."
"Many people throughout the USA are using BHT to successfully keep the lesions dormant — no sores as long as they consume BHT regularly. Some people develop sores once every 3-4 months opposed to higher frequency when not using BHT. Those who use lysine coldstick, cream, or capsules regularly along with consuming 750-1,000 mg of BHT daily virtually keep the sores from ever occurring."
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 US 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 APope@CFSAN.FDA.GOV, or you may respond in writing to Angela F. Pope, Compliance Officer, Food and Drug Administration, Division of Compliance and Enforcement, 5100 Paint Branch Pkwy, College Park, MD 20740-3835. If you have any questions concerning any issue in this letter, please contact Ms Pope at 301-436-2375.
John B. Foret
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.