Department of Health and Human Services
Public Health Service
Office of Nutritional Products, Labeling and Dietary Supplementsv
Division of Dietary Supplement Programs
May 8, 2006
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
145 Wilton St.
New Hyde Park, NY 11040
Ref. No. CL-06-HFS-810-215
Dear Ms. Hogan:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.healthsupportyou.com and has determined that the products "Coconut Oil Diet Gourmet Style," "Coconut Oil Diet," and "Beautiful You" 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 and in other promotional material 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 website include:
- Coconut Oil Diet Gourmet Style
- "ANTI-VIRAL, ANTI-BACTERIAL"
- Coconut Oil Diet
- "Helps To Decrease Cholesterol Levels"
- Beautiful You
"White Tea Extract reveals anti-cancer … properties"
"Scientists at University Hospitals of Cleveland and Case Western Reserve University have proven that ingredients in white tea are effective in boosting the immune function of skin cells and protecting them against the damaging effects of the sun, this ads [sic] another important element in the battle against skin cancer."
"The western cosmetic industry has already discovered the beneficial properties of White Tea, including … it's [sic] anti-skin cancer properties.…"
In addition to reviewing your website, FDA picked up promotional material for "Coconut Oil Diet Gourmet Style" (also referred to in one flyer as "Organic Extra Virgin Coconut Oil") and "Coconut Oil Diet" at the Natural Products Expo East trade show that was held on September 15 through 18, 2005 at the Washington DC Convention Center. Claims in this material also promote the products for use in the cure, mitigation, treatment, or prevention of disease. Examples of such claims in your promotional material for "Coconut Oil Diet Gourmet Style" and "Coconut Oil Diet" include:
Furthermore, your products are not generally recognized as safe and effective for the above referenced conditions and therefore, the products are also "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 if claims about diagnosis, cure, mitigation, treatment, or prevention 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 requirements 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 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 markets. It is your responsibility to ensure that all products marketed by your firm comply 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 respond in writing to Linda J. Webb, Compliance Officer, Food and Drug Administration, Division of Dietary Supplement Programs, 5100 Paint Branch Pkwy, College Park, MD 20740-3835. If you have any questions concerning this letter, please contact Ms Webb at 301-436-2375.
Susan J. Walker, MD
This page was posted on February 12, 2008.