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

Public Health Service
Food and Drug Administration

 

College Park, Maryland 20740

November 3, 2004
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Michael Charron
Health Sites, Inc.
653 West 23rd Street #287
Panama City, Florida 32405

Ref. No. CL-04-HFS-810-99

Dear Mr. Charron:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet addresses www.nutritionupdate.info www.glucobetic.com www.flourishwellness.com and and has determined that the products "Glucobetic," "Oxi-Antioxidant Formula," "MSM-1000," "Super-Flex," and "Natural E-400" are promoted for conditions that causes the product 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 web site establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.

Examples of some of the claims observed on your web site include:

Glucobetic

"STOP the Ravages of Diabetes with GLUCOBETIC!"

"Helps Normalize Blood Sugar"

"Enhances Cells [sic] Response to Insulin"

"Designed with Herbs, Minerals and Botanicals that improve glucose tolerance, aid blood sugar control, and enhance insulin sensitivity. . . . Glucobetic was designed specifically for both Type I and Type II diabetes. . . ."

Oxi — Antioxidant Formula

"Your ammunition is the antioxidant nutrients that you hear so much about for their usefulness in warding off cancer, heart disease, arthritis, and neurological diseases."

MSM — 1000

"MSM has powerful anti-inflammatory effects that are beneficial for arthritis, fibromyalgia, carpal tunnel syndrome . . ."

"Relieve Muscle and Joint Pain"

"A clinical study at the University of California Medical School found that patients who took MSM daily for six weeks reported an 80% reduction in arthritis symptoms."

Natural E — 400

"[G]et heart disease-fighting, cancer-fighting, . . . doses of Vitamin E . . ."

Super-Flex

"Reduce the Pain and Inflammation of Arthritis"

"Arthritis Relief — Naturally"

Your websites also include disease claims in the form of personal testimonials about the use of Glucobetic for diabetes and the use of Super Flex for arthritis.

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 if claims about diagnosis, cure, mitigation, treatment, or prevention of disease 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, 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 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.

If you need additional information or have questions concerning any products distributed through your web site, please contact FDA. You may reach FDA electronically (e-mail) at Linda.Webb@FDA.gov, or you may respond in writing to Linda J. Webb, Compliance Officer, Food and Drug Administration, Division of Dietary Supplement Programs, 5100 Paint Branch Parkway, College Park, Maryland 20740-3835. If you have any questions concerning this letter, please contact Ms. Webb at (301) 436-2375.

Sincerely yours,
/s/
Susan J. Walker, MD
Director,
Division of Dietary Supplement Programs
Office of Nutritional Products, Labeling and Dietary Supplements
Center for Food Safety and Applied Nutrition

This page was posted on January 27, 2005.

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