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FDA warns makers of 'alternative hormones'

Sixteen companies that market "alternative hormone therapies" have been warned by the Food and Drug Administration because they appear to be selling unapproved drugs.
/ Source: The Associated Press

The Food and Drug Administration is warning 16 companies that market “alternative hormone therapies” that they appear to be selling unapproved drugs.

The FDA sent warning letters to the companies because they are making unproven claims about their products, which are often advertised as “natural” or “safer” than approved hormone therapies, the agency said Thursday.

“FDA takes seriously its responsibility to protect consumers from products promoted with unproven claims,” said Margaret O’K. Glavin, associate commissioner for regulatory affairs, in a statement. “It’s particularly troublesome when these claims provide false hope to patients with serious or life-threatening conditions.”

Some of the products claim to treat cancer, arthritis and osteoporosis-related bone loss, the FDA said. Those claims put them under the authority of the federal Food, Drug, and Cosmetic Act.

The companies have 15 days to respond.

The 16 companies are: All Natural Pain Relief Inc., Bio-Health,, CHS International Research Ltd., ComCore 21 Corp., Greatest Herbs on Earth, HMS Crown Inc., Healthworks 2000, Healthy Days Inc., Heba Laboratories LLC, Herbal Fields Supplements, Nutriteam Inc., One Life USA, Suzanne’s Natural Foods, The Way Up and Tip Top Vitamins.

The Federal Trade Commission also issued 34 warning letters to Web sites promoting products with similar claims, saying they may be making illegal marketing claims.