FDA Cracks Down on Compounded Hormone Products

On January 9, the FDA warned seven compounding pharmacies to cease marketing estrogen/progestin products containing estriol. The FDA also warned the pharmacies to stop making claims that the compounded products could be used to treat Alzheimer’s disease, breast cancer, depression, and colon cancer. The FDA also demanded that the pharmacies stop using the non-scientific term “bio-identical”, which the FDA concluded made the products “misbranded” drugs.

The seven pharmacies were targeted after an FDA review of their websites revealed that they were marketing products with estriol. Estriol is an estrogen produced during pregnancy that has not been FDA approved for clinical use. The FDA review identified what it considered to be “patently false” claims. The FDA also questioned the manner in which the products were marketed to suggest to the consumer that the products were “natural” and therefore safer than FDA approved hormone replacements.

Source: FDAhttp://www.fda.gov/bbs/topics/NEWS/2007/NEW01766.html