FDA WARNING_LETTER - Zarbee's, Inc. - May 31, 2014

The FDA issued a Warning Letter to Zarbee's, Inc. following a May 2014 review of their website and social media pages. The agency determined that several Zarbee's Naturals products, including various cough syrups, seasonal relief, and sleep aids, are promoted for conditions that cause them to be unapproved new drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Therapeutic claims and personal testimonials on the website, Twitter, and Facebook establish the products' intended use for disease cure, mitigation, treatment, or prevention, classifying them as drugs under section 201(g)(1)(B). As these products are not generally recognized as safe and effective for their claimed uses, they are considered "new drugs" under section 201(p) and cannot be legally introduced into interstate commerce without prior FDA approval, violating sections 505(a) and 301(d). Furthermore, specific children's products are intended for conditions not amenable to self-diagnosis, meaning adequate directions for layperson use cannot be provided. This renders them misbranded under section 502(f)(1) for failing to bear adequate directions for use, and their introduction into interstate commerce violates section 301(a). Zarbee's, Inc. must take prompt action to correct these violations and notify the FDA in writing within fifteen working days, detailing corrective steps and timelines, to avoid potential legal action including seizure and/or injunction.