On January 7, 2008, the FDA issued warning letters to several compounding pharmacies (example) advising them stop compounding hormone products contain estriol, an unapproved new drug. This activity has been going on since the mid-1990’s, popularized by the actress Suzanne Somer’s books. The general term used by this industry is bio-identical hormone replacement therapy – BHRT.
Oops, they went too far and made treatment claims (Village Compounding Pharmacy’s web site and product labeling – as of today (1/10), the web site claims have been removed). What separates drugs from so-called natural products, dietary supplements and a nutraceuticals is that only drugs may be labeled/promoted for treating a disease (the “treat, mitigate and prevent disease” requirement of a drug [21 USC 321(g)].
Predicatably, the targets of the warning letter are crying foul. They don’t like being singled out for enforcement action (true: hundreds of pharmacies are doing this but this is how FDA moves against all). They believe the FDA is acting now because of Wyeth’s citizen petition (docket for 2005P-0411). FDA actually denied the petition on technical grounds, but added that “we are issuing warning letters to cetain compounding pharmacies for violations relating to compounded BHRT drugs” (footnote 3 in the FDA response). Importantly, FDA agreed with Wyeth that estriol is a new drug. Thus, any pharmacy using this drug substance should remove it immediately. Clearly, the other action is to review all promotional material and labeling to remove claims.
FDA issued a Consumer Update entitled Bio-Identicals: Sorting Myths from Facts. FDA also issued a FAQ on Compounded Menopausal Hormone Therapy.