FDA WARNING_LETTER - Juve International, LLC - March 31, 2013

The FDA issued a Warning Letter to Juve International LLC following a review of their websites, www.juve-international.com and www.juvejuice.com, in February and March 2013. The review found serious violations of the Federal Food, Drug, and Cosmetic Act. The JUVE Juice product is promoted with therapeutic claims, such as reducing blood pressure, lowering cholesterol, fighting arthritis, inhibiting E. coli, preventing strokes, and aiding in the fight against cancer and diabetes, which cause it to be classified as a drug under section 201(g)(1)(B) of the Act. As it is not generally recognized as safe and effective for these uses, it is an unapproved "new drug" under section 201(p) of the Act, requiring prior FDA approval per section 505(a). Additionally, the product is misbranded under section 502(f)(1) because adequate directions for use cannot be written for laypersons, as the conditions it addresses are not amenable to self-diagnosis and treatment. The introduction of this misbranded drug into interstate commerce violates section 301(a) of the Act. Juve International LLC must take prompt action to correct these violations and notify the FDA in writing within fifteen working days, detailing corrective steps and providing documentation, or face potential regulatory actions like seizure and injunction.