FDA WARNING_LETTER - Naprodis, Inc. - November 22, 2011

The FDA issued a Warning Letter to NAPRODIS, Inc. following an inspection from November 8-22, 2011, and a subsequent review of product labeling and websites (naprodis.com, aromune.com) in March 2012. The FDA determined that the firm's Phybiosis Aromune, Kinarome Oregano Oil, and Kinarome PMS & Menopause Synergy products are promoted with claims that cause them to be unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act. Specifically, the products are deemed drugs under section 201(g)(1)(B) [21 U.S.C. § 321(g)(1)] due to claims of cure, mitigation, treatment, or prevention of disease, such as "anti-infectious properties" and "for bacterial, viral, fungal, and parasitic infections." These products are also considered "new drugs" under section 201(p) [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their intended uses and lack prior FDA approval as required by section 505(a) [21 U.S.C. § 355(a)]. Furthermore, they are misbranded under section 502(f)(1) [21 U.S.C. § 352(f)(1)] because they are intended for conditions not amenable to self-diagnosis, and adequate directions for use cannot be provided for a layman. The introduction of these misbranded drugs into interstate commerce violates section 301(a) [21 U.S.C. § 331(a)]. NAPRODIS, Inc. is required to take prompt corrective action and notify the FDA in writing within 15 working days, detailing steps taken and providing a timetable for any outstanding corrections. Failure to comply may result in regulatory actions, including product seizure or injunction. The letter also notes that if products are marketed as dietary supplements, they must comply with 21 CFR Part 111 CGMPs, but the therapeutic claims render them drugs.