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FTC Warns Hormone Replacement Therapy Promoters

November 10, 2005

Hormone Replacement Therapy • Risks of Long-Term Hormone Therapy Continue to Outweigh Benefits • FDA Warns Makers of 'Bio-Identical' Hormone Replacement Therapy • HRT May Prevent Heart Attacks In Some Women • FTC Warns Hormone Replacement Therapy Promoters

The Federal Trade Commission staff has sent warning letters to 34 Web site operators making claims that products advertised as natural alternatives to hormone replacement therapy will prevent or treat diseases, such as cancer, heart disease, or osteoporosis.

The warning letters advise these sellers that their marketing claims may be illegal.

The letters, sent to Web sites identified through an FTC Internet surf, warn that any health-related claims must be supported by competent and reliable scientific evidence. Another 16 sellers will receive letters from the U.S. Food and Drug Administration, warning them that their business practices may violate FDA law.

“False or unsubstantiated claims about disease cure and prevention are of particular concern because of their potential harm. Our action today reminds marketers that they must have scientific support for such marketing claims before making them,” said Lydia Parnes, Director of the FTC's Bureau of Consumer Protection.

The Web sites were identified during an FTC Internet surf of sites making claims that their hormone replacement therapy alternative products – for example, progesterone creams, sprays or dietary supplements containing plant-based hormones – could cure diseases or prevent them.

The letters note that the FTC staff is not aware of any competent and reliable scientific evidence to support claims that the types of products advertised could prevent, treat, or cure cancer, heart disease, or other diseases, prevent osteoporosis, or increase bone density. They also emphasize that according to FTC case law, all health claims – including claims about the safety of natural hormones – must be supported by reliable scientific evidence.

FTC staff strongly advised the marketers to review their advertising and promotional materials, and to revise or delete any false, misleading, or unsubstantiated product claims.

The FDA letters were sent to 16 Web sites, warning them about possible violations of the federal Food, Drug, and Cosmetic Act. The letters list the suspect claims, note the possible law violations, and state the consequences of noncompliance.

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