FDA WARNING_LETTER - NVN Therapeutics

The FDA issued a Warning Letter to NVN Therapeutics after reviewing the label and website for their Glucorein™ PCOS product in December 2013. The product, marketed as a "medical food for dietary management of Polycystic Ovarian Syndrome (PCOS)," was found to be misbranded under 21 U.S.C. § 343(a)(1) and 21 C.F.R. 101.9(j)(8). It does not meet the statutory definition of a medical food because there are no distinctive nutritional requirements for PCOS that cannot be met by modifying a normal diet. Consequently, the therapeutic claims on the product label and website, such as reducing metabolic syndrome incidence and addressing insulin resistance, establish it as a drug under 21 U.S.C. § 321(g)(1)(B). Furthermore, the product is considered an unapproved "new drug" under 21 U.S.C. §321(p)(1) as it is not generally recognized as safe and effective for its intended uses. It is also misbranded as a drug under 21 U.S.C. § 352(f)(1) because it lacks adequate directions for use for a layperson, being intended for a condition not amenable to self-diagnosis. The introduction of an unapproved new drug and misbranded drug into interstate commerce violates the Act. NVN Therapeutics must take prompt corrective action and respond to the FDA within 15 working days, detailing steps taken to correct violations and prevent recurrence, or face potential legal action, including seizure and injunction.