Lifeway Foods, Inc. – FDA Warning Letter, Feb 18, 2011

The FDA issued a Warning Letter to Lifeway Foods, Inc. following a review of their website (lifeway.net) and product labels. The FDA determined that products including “Lifeway Kefir,” “Lifeway ProBoost™,” “BioKefir Blackberry,” and “ProBugs Goo-Berry Pie” are promoted with therapeutic claims, causing them to be classified as drugs under Section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act). Examples of these claims include alleviating symptoms for Celiac Disease, Crohn’s and Colitis, Immune Deficiency, Infantile Colic, Seasonal Allergies, Yeast Infections, Irritable Bowel Syndrome, and fighting cancer. These products are considered "new drugs" under Section 201(p) because they are not generally recognized as safe and effective for their claimed uses. Their introduction into interstate commerce without FDA-approved applications violates Sections 301(d) and 505(a) of the Act. Furthermore, the products are misbranded under Section 502(f)(1) because adequate directions for use by a layman cannot be written for conditions not amenable to self-diagnosis. The introduction of misbranded drugs into interstate commerce violates Section 301(a). Lifeway Foods, Inc. is required to take prompt action to correct these violations and prevent future recurrence, notifying the FDA within fifteen working days with documentation of corrective steps. Failure to comply may lead to enforcement actions, including product seizure and injunctions.