Bio-Identicals Under Scrutiny From the FDA

Related articles

The Food and Drug Administration has finally taken action against pharmacies that sell so-called bio-identical hormone therapy. Last week, letters from the FDA were sent to seven compounding pharmacies, instructing them to stop using false and misleading terminology such as "bio-identical" when selling their products. Furthermore, the FDA told the pharmacies to discontinue the use of estriol, a form of the hormone estrogen, which is essentially an unapproved drug. For years, compounding pharmacies have sold these therapies to women, under the unfounded premise that the menopause treatments thus concocted are safer and "more natural" than FDA-approved therapies.

At ACSH, we have always found it bewildering that women would trust an unapproved and unregulated therapy -- one therefore more likely to pose a risk of dangerous side-effects -- over those that have been approved by the FDA. Despite being totally unregulated and of unknown chemical composition, bio-identicals have become increasingly popular among menopausal women.

The boom in their popularity began in 2002, when a government study cast a shadow of doubt over traditional menopause hormone drugs. To make matters worse, the popular actress and American sweetheart Suzanne Somers publicly supported bio-identicals and even promoted their use in her books, increasing their popularity. Also, the marketing of bio-identicals as a more natural option for menopausal woman undoubtedly added to their appeal, as the public has become quick to assume that anything natural is better for their health. This is not true, especially when it comes to unregulated drugs.

Although traditional hormone therapy has been shown to be associated with some risks, consumers must realize the importance of weighing benefits and risks when choosing their medications -- as there is no such thing as absolute safety. Despite this fact, vulnerable consumers often fall victim to invalid health advice or remedies. Therefore, we at ACSH applaud the FDA for reining in the bio-identical industry -- which provides a dangerous mixture of false advertising and unregulated drugs.

Krystal Wilson is a research associate at the American Council on Science and Health (,