FDA WARNING_LETTER - Reed's Compounding Pharmacy

The FDA issued a Warning Letter to Reed's Compounding Pharmacy on January 7, 2008, following a review of their website, www.reedsrx.com. The letter identified several violations related to their compounded hormone therapy drugs.

Firstly, the pharmacy's website contained false and misleading claims, causing their compounded hormone therapy drugs to be misbranded under Section 502(a) of the FDCA. These unsubstantiated claims included efficacy claims such as "Better maintenance of muscle mass and strength," "Improved sleep and better mood, concentration, and memory," and "May prevent senility and Alzheimer's disease." The FDA stated it was unaware of substantial evidence to support these claims. Additionally, the website made unsubstantiated superiority claims, suggesting "Many fewer unwanted side effects than with synthetic hormones" and "very few side effects of natural hormone replacement therapy of progesterone," which the FDA found unsupported by substantial evidence. Unsubstantiated "bio-identical" claims, implying the drugs are natural or identical to body hormones, were also cited as false and misleading.

Secondly, the firm was found to be compounding a hormone therapy drug containing estriol without an FDA-approved new drug application or an FDA-sanctioned investigational new drug application, violating Section 505 of the FDCA. The FDA classified these estriol products as unapproved new drugs because they are not generally recognized as safe and effective for their labeled uses and lack