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Public Health Service
Food and Drug Administration

 

Center for Food Safety and Applied Nutrition
200 C St SW
Washington, DC 20204

May 7, 2002
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

L. Douglas Lioon
CEO,
Douglas Laboratories
600 Boyce Rd
Pittsburgh, PA 15205

Ref. No. CL-02-HFS-810-14

Dear Mr Lioon:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address: http://www.douglaslabs.com and has determined that the products "RheumaShield™" and "Resvera-Gold™" 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:

"Undenatured type II collagen from chicken has been shown to be effective in helping those with rheumatoid arthritis. Undernatured type II collagen from chicken works via a mechanism of oral tolerance in which the body's immune system is modified to make it less likely to attack its own tissue. This can result in a beneficial outcome for those with rheumatoid arthritis."

"Anti-inflammatory."

"A synergistic blend of herbs, including resveratrol, a derivative of grape vine shoots, designed to help fight inflammation. Many natural ingredients such as those found within this formula can naturally inhibit the activity of enzymes such as cylooxygenase-2 that contribute to inflammation and pain (often associated with 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 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 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, 5100 Paint Branch Pkwy, College Park, MD 20740-3835. 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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