Sellers of Alternative Hormone Replacement Therapy Products Settle with FTC for Failing to Substantiate Health Claims

The Federal Trade Commission today announced a consent agreement with online sellers of alternative hormone replacement therapy (HRT) products that settles charges that they made health claims for their products without supporting scientific evidence.

The Commission’s administrative complaint, filed in September 2007, alleged that Herbs Nutrition Corporation and its principal, Syed M. Jafry, claimed that their natural progesterone creams are effective in preventing, treating, or curing osteoporosis; are effective in preventing or reducing the risk of estrogen-induced endometrial (uterine) cancer; and do not increase the user’s risk of developing breast cancer and/or are effective in preventing or reducing the user’s risk of developing breast cancer. The complaint alleged that they did not have substantiation for these claims and, in some cases, misrepresented that clinical testing proved that the products, Eternal Woman Progesterone Cream and Pro-Gest Body Cream, were effective.

Under the terms of the order, the respondents are required to have competent and reliable scientific evidence substantiating claims about the health benefits, performance, efficacy, safety, or side effects of any dietary supplement, food, drug, device, or health-related service or program, including claims that progesterone products are effective in mitigating, treating, preventing, or curing any disease. The order also prevents the respondents from misrepresenting the existence, contents, validity, results, conclusions, or interpretations of any test, study, or research. In addition, the order contains record-keeping and notification provisions designed to ensure that the respondents comply with the terms of the order, which will expire in 20 years.

The FTC staff identified the respondents during an Internet search of Web sites advertising products as natural alternatives to HRT. The FTC staff found that many of these marketers, including the respondents, were making disease cure and prevention claims, and sent them warning letters advising them to revise or delete any false, misleading, or unsubstantiated claims. The U.S. Food and Drug Administration also sent letters to other alternative HRT sellers, warning them that their business practices could be in violation of FDA law.

The FTC staff followed up with online advertisers who received letters, and all but seven modified the claims on their Web sites. In October 2007, the FTC announced that it had settled charges against six of the marketers that failed to modify their advertising, and issued a complaint against Herbs Nutrition Corporation and Jafry.

The vote authorizing the filing of the consent order and an analysis to aid public comment was 5-0. The consent order will be subject to public comment for 30 days, beginning today and continuing through February 19, 2008, after which the Commission will consider whether to make it final. Comments should be send to: FTC Office of the Secretary, 600 Pennsylvania Ave., N.W., Washington, DC 20580.

Copies of the order are available from the FTC’s Web site at http://www.ftc.gov and the FTC’s Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580. The FTC works for the consumer to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them. To file a complaint in English or Spanish, click http://www.ftc.gov/ftc/complaint.shtm or call 1-877-382-4357. The FTC enters Internet, telemarketing, identity theft, and other fraud-related complaints into Consumer Sentinel, a secure, online database available to more than 1,600 civil and criminal law enforcement agencies in the U.S. and abroad. For free information on a variety of consumer topics, click http://ftc.gov/bcp/consumer.shtm.