Illinois-based Lifeway Foods received its warning letter on February 18 this year over immunity, allergy, anti-inflammatory and other claims made on the company website marketing its probiotic and antioxidant-containing products.
The FDA determined the claims contravened Section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) and gave Lifeway 15 days to correct the issues.
“The therapeutic claims on your web site establish that these products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease,” the FDA wrote in its letter to the company’s president and chief executive officer, Julie Smolyansky.
The claim breaches related to four antioxidant and fermented milk products: Lifeway Kefir, Lifeway ProBoost, BioKefir Blackberry and ProBugs Goo-Berry Pie.
Claims included the relief of the severity of celiac disease, Crohn’s disease, colitis and infantile colic; boosting the immune system; relief of allergic rhinitis; reduction in yeast infections; alleviation of irritable bowel syndrome; and anti-carcinogenic properties.
FDA wrote: “Under Section 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. The introduction into interstate commerce of unapproved new drugs without approved applications violates these provisions of the Act.”
“Furthermore, because your products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use the products safely for their intended uses.”
Too numerous to list
The FDA said its letter did not detail all violations on Lifeway’s website.
“The unlawful disease treatment and prevention claims on your website were too numerous to list in this letter. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.”
Lifeway was not available for comment at the time of publication due to its presence at the Expo West trade show in Anaheim, California.
The FDA also sent a letter on February 18 to Nevada-based Beneficial Solutions over virus-killing claims posted at this website for a product called NutraSilver.