FDA WARNING_LETTER - Orgen Nutraceuticals - July 16, 2015

The FDA inspected Orgen Nutraceuticals, Inc. from July 8-16, 2015, and subsequently reviewed its website in August 2015. The review revealed that the firm's dietary supplement products, including "Orgen Lipichol," "Orgen Diabcont," "Orgen Muc-O-Lite," "Progen," "Orgen Flax Seed Oil," "Vedagara," and "Orgen Melatonin," are promoted with therapeutic claims that cause them to be unapproved new drugs under sections 201(g)(1)(B) and 201(p) of the FD&C Act. Examples of such claims include lowering blood pressure and cholesterol, regulating blood sugar, preventing hair loss, and treating insomnia or erectile dysfunction. Introducing these unapproved new drugs into interstate commerce violates sections 505(a) and 301(d) of the Act. Furthermore, several products are deemed misbranded under section 502(f)(1) of the Act because they are intended for conditions not amenable to self-diagnosis and treatment, thus lacking adequate directions for layperson use. The introduction of misbranded drugs into interstate commerce is a violation of section 301(a). Although the firm responded to the FDA-483 with a SOP and stated it would cease certain operations, its website continued to promote the products as drugs, indicating insufficient corrective action. Orgen Nutraceuticals must promptly correct these violations and notify the FDA within 15 working days, providing documentation of corrective steps, to avoid potential legal actions like seizure or injunction.