FDA WARNING_LETTER - CocoKefir LLC

The FDA and FTC issued a Warning Letter to CocoKefir LLC in July 2011, following a review of their website, www.cocokefir.com.

The FDA determined that CocoKefir products are promoted for conditions that classify them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)], due to therapeutic claims for diagnosis, cure, mitigation, treatment, or prevention of disease. Examples of claims cited include reversing disease symptoms in people with sensitive neurological systems (e.g., autism), healing the gut for autism recovery, and alleviating colds, flu, cold sores, ear infections, acid reflux, and UTIs. Testimonials also claimed benefits for Ulcerative Colitis and Crohn's disease.

These products are considered "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for these uses, and thus require prior FDA approval under section 505(a) [21 U.S.C. § 355(a)]. Furthermore, the products are misbranded under section 502(f)(1) [21 U.S.C. §