FDA/FTC Join Regulatory Efforts against Hormone-Related Product Claims

(Silver Spring, MD, November 11, 2005) --- The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) announced actions against a number of companies marketing unapproved “alternative hormone therapies,” targeting unproven disease claims. In a press release dated November 10, FDA said it has sent Warning Letters to 16 dietary supplement and hormone cream marketers; FTC is issuing letters that notify 34 websites that include unsubstantiated claims.

“While the internet has created new avenues for commerce,” said Michael McGuffin, president of the American Herbal Products Association (AHPA), “It has also created another arena for potential regulatory enforcement, for those companies that are not prudent in their marketing.”

AHPA has recognized the need for particular caution in internet advertising of dietary supplements; this past July, AHPA recommended that websites offering dietary supplements or dietary ingredients provide contact information for the company and the nutrition labeling information that is required on dietary supplement labels, or alternately, provide a statement to the effect that this information is available upon request. The guidance also urges that any website that makes a structure/function claim include the standard FDA disclaimer. Under the Dietary Supplements Health and Education Act of 1994 (DSHEA), all statements of nutritional support for dietary supplements must be accompanied by a two-part disclaimer on the product label: that the statement has not been evaluated by FDA and that the product is not intended to “diagnose, treat, cure or prevent any disease.” The full language of the guidance policy is on AHPA’s website: www.ahpa.org/guidelines.htm.

AHPA also has been developing another of its educational tele-seminars, Claim Substantiation and Advertising, to be held early next year.

FDA’s press release is posted on the agency’s website: www.fda.gov/bbs/topics/news/2005/NEW01260.html. FTC’s Notice is posted at: www.ftc.gov/opa/2005/11/HRTlettermodel.pdf


The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal products industry, the only trade association devoted solely to herbal issues. AHPA is the recognized leader in representing the responsible center of the botanical trade, and is comprised of the finest growers, processors, manufacturers and marketers of herbal products. AHPA’s mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of responsibility with respect to the way herbs are manufactured, labeled and sold. Website: www.ahpa.org

Karen Robin, Director of Communications
Telephone: (301) 588-1171, x-107
Email: [email protected]
Website: www.ahpa.org

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