FDA WARNING_LETTER - Carrington - August 01, 2014

The FDA issued a Warning Letter to Carrington Farms in April/August 2014 after reviewing their Coconut Oil product label and website. The FDA determined that the product is promoted for conditions that classify it as an unapproved new drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). Examples of therapeutic claims include treating infections (salmonella, ringworm, candidiasis, gastroenteritis), exhibiting anti-viral/microbial/fungal properties, easing acid reflux, lowering hemorrhoid incidence, soothing earaches, reducing inflammation, and preventing osteoporosis. Since the product is not generally recognized as safe and effective for these uses, it is an unapproved new drug under section 201(p) and its introduction into interstate commerce violates section 301(d). Furthermore, the product is misbranded under section 502(f)(1) because it lacks adequate directions for layperson use.

Even if not an unapproved drug, the product is a misbranded food under section 403(r)(1) due to unauthorized nutrient content claims. Claims like "Healthy Foods," "The healthiest oil on earth," and "Perfect for healthy...cooking" are used despite the product exceeding saturated fat limits and lacking sufficient vitamins/minerals to qualify as "healthy" per 21 CFR 101.65(d). The claim "low in calories" is