U.S. Warns Sellers of "Alternative" Hormone Treatments

Last Updated: 2005-11-10 16:22:17 -0400 (Reuters Health) WASHINGTON (Reuters) - U.S. regulators said on Thursday they had issued warnings to dozens of companies that are promoting unproven "alternative" hormone therapies for women.

The government sent letters to about 50 firms and Web sites that market supplements and creams as alternatives to hormone replacement therapy, warning them against making baseless claims that the treatments can help with serious diseases such as cancer, heart disease and osteoporosis.

"It's particularly troublesome when these claims provide false hope to patients with serious or life-threatening conditions," Margaret Glavin, the Food and Drug Administration's associate commissioner for regulatory affairs, said in a statement.

Hormone Replacement Therapy (HRT) aims to replace hormones diminished by menopause and is prescribed to women to relieve menopause symptoms such as hot flushes, night sweats and mood swings.

However, millions of women have stopped taking the therapy and sought alternatives after learning in recent years that HRT can raise the risk of heart attack, stroke, breast cancer and other serious conditions.

The FDA said it sent 16 letters to companies marketing alternative therapies, telling them that it considers the products unapproved new drugs, which require FDA approval before they can be sold.

Many of the alternatives claim to be either natural progesterone creams or dietary supplements that contain plant-based hormones.

Among the unproven claims cited in the warning letters, the FDA said, are that the therapies can reverse osteoporosis-related bone loss and increase bone density; reduce or arrest the growth of cancer cells; protect against fibroids, ovarian, and endometrial cancers; and treat various forms of arthritis.

The Federal Trade Commission, meanwhile, said it sent warning letters to 34 Web site operators making similar kinds of claims.

The FTC, which enforces U.S. consumer protection laws, warned in its letters that some claims made on the Web sites "may be false or unsubstantiated and therefore may violate the law."

The agency said it "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."