FDA WARNING_LETTER - Dr. Bronner's Magic Soaps - January 31, 2014

The FDA issued a Warning Letter to Dr. Bronner’s Magic Soaps in January 2014, following a review of the label for their product, Dr. Bronner’s Magic “All-One!” Fresh-Pressed Virgin Coconut Oil.

The FDA determined 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). The therapeutic claim, "Clinical research confirms that the saturated medium chain fatty acids (MCT’s) in [Virgin Coconut Oil], such as lauric acid, actually improve blood cholesterol by increasing the ratio of HDL to LDL cholesterol," indicates intent for use in mitigating, treating, or preventing coronary heart disease. The product is not generally recognized as safe and effective for these uses, making it a "new drug" under section 201(p)(1) of the Act, requiring prior FDA approval. Furthermore, it is misbranded under section 502(f)(1) because it lacks adequate directions for use by a layperson for conditions not amenable to self-diagnosis.

Even if not an unapproved new drug, the product is a misbranded food under section 403 of the Act. Specifically, it violates section 403(q) because the label fails to include a declaration of trans fat as required by 21 CFR 101.