Many Companies Sent Warning Letters About Marketing Alternative HRT Still Selling Products, FTC Official Says

Main Category: Women's Health / Gynecology
Also Included In: Endocrinology;  Seniors / Aging
Article Date: 24 Apr 2007 - 21:00 PDT

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Many of the Web sites targeted by the Federal Trade Commission in 2005 for illegally claiming their alternative hormone replacement therapies were safer than prescription HRT still are selling the products, Eileen Harrington, deputy director of FTC's Bureau of Consumer Protection, said at a Senate Special Committee on Aging hearing on Thursday, CQ HealthBeat reports (Reichard, CQ HealthBeat, 4/19). FDA in November 2005 sent warning letters to 16 companies that market alternatives to approved HRT. FTC that same month also sent warning letters to 34 Web site operators marketing similar therapies, saying the sites make claims that "may be false or unsubstantiated and therefore may violate the law." The Web sites were identified during an FTC search of sites asserting that alternative HRT products -- including progesterone creams, sprays or dietary supplements -- could cure or prevent diseases. Some of the companies that received letters claim their products prevent cancer, osteoporosis-related bone deterioration or arthritis. Such claims would cause the products to fall under the auspices of FDA's Food, Drugs and Cosmetic Act. The companies were given 15 days to respond to FDA after receiving the letters (Kaiser Daily Women's Health Policy Report, 11/14/05).

Hearing
According to an unnamed FTC official, 19 of the 34 companies that received letters from the FTC are still selling the alternative HRT products, the AP/USA Today reports. Harrington said that many of the Web sites have modified or removed the unsupported claims that the treatments could cure or prevent diseases. Harrington added that the agency is following up the companies that have not made changes. Sen. Gordon Smith (R-Ore.), the committee's ranking Republican, said to reporters that FDA and FTC need to "step ... up" enforcement on the issue. Harrington said, "We could have moved faster here, and we should have" (Bridges, AP/USA Today, 4/19). The customized HRT alternatives are sold without warnings about the risks associated with the drugs, witnesses at the hearing said. According to CQ HealthBeat, Smith said that he plans to introduce legislation to strengthen regulation and that he hopes publicity about the issue will encourage FTC and FDA to better monitor sales of HRT alternatives. In addition, Smith at the hearing said he has requested a study by the Congressional Research Service to determine how well each state is regulating pharmacy compounding. Harrington said FTC would take further action against the companies but did not say when, CQ HealthBeat reports (CQ HealthBeat, 4/19).

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