FDA WARNING_LETTER - Atlantic Trading Co. LLC - June 01, 2014

The FDA issued a Warning Letter to Atlantic Trading Co., Inc. for violations related to their Atlantic Salmon Boneless Skinless Center Cut Fillets product. An examination of the product label in January 2014 and the website www.cwirthy.com in June 2014 revealed that the product is promoted with therapeutic claims, causing it to be an unapproved new drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). Examples of drug claims include "Omega-3s lower triglycerides, reduce abnormal heart rhythms, reduce blood pressure" and "Omega-3s have also shown promise in the prevention and treatment of certain cancers and inflammatory conditions."

The product is considered a "new drug" under section 201(p) of the Act because it is not generally recognized as safe and effective for these uses and lacks FDA approval, violating section 505(a) and 301(d). Furthermore, it is misbranded under section 502(f)(1) as it lacks adequate directions for use for conditions not amenable to self-diagnosis.

Even if not an unapproved drug, the product is a misbranded food under section 403 of the Act. It bears unauthorized health claims, such as "Fish high in Omega-3 reduce the risk of heart disease and lower blood pressure," violating section 403(r