Lifeway Foods Attracts FDA Attention

MORTON GROVE, Ill.Lifeway Foods received a warning letter from FDA, after the agency determined claims made on the Lifeway website and in labeling for certain kefir offerings position the products as unapproved new drugs. The Feb. 18 warning letter, issued by FDAs Chicago office, specifically called out therapeutic claims for Lifeway Kefir, Lifeway ProBoost, BioKefir Blackberry and ProBugs Goo-Berry Pie. The claims related to the ability of the products to stimulate the production of immune cells" and control intestinal inflammatory diseases," such as celiac disease and irritable bowel syndrome, and to ward off carcinogens" or exert anti-bacterial effects. In fact, FDA stated the unlawful disease treatment and prevention claims on your website were too numerous to list in this letter."

As the products have not been approved for the cited purposes, they are new drugs" under federal regulations, and are also misbranded as the labeling does not carry adequate directions for use. Lifeway was advised to take prompt action to correct the cited violations, as failure to do so could result in enforcement action, including product seizure and injunctions against the company and its distributors.