FDA WARNING_LETTER - Sunset Natural Products Inc. - September 11, 2012

On March 19, 2013, the FDA issued a Warning Letter to Sunset Natural Products Inc. following an inspection from August 31 to September 11, 2012. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering their products adulterated.

Additionally, the FDA determined that several products, including "Hongofin Anti-Fungus Spray w/Aloe Vera," "Melatonin," and "Sugar Burner," are promoted with therapeutic claims on labels and the company website (www.sunsetnaturallab.com), causing them to be unapproved new drugs under the Federal Food, Drug and Cosmetic Act. These products are not generally recognized as safe and effective for their claimed uses and lack FDA approval. Furthermore, many of these drug products are misbranded because they lack adequate directions for lay use.

Specific CGMP violations include: * Failure to conduct identity testing for dietary ingredients (e.g., Goldenseal Powder, Milk Thistle). * Failure to qualify suppliers by confirming the reliability of their Certificates of Analysis (COAs) for numerous components (e.g., Zinc oxide, Echinacea, DHEA). * Failure to prepare and follow written Master Manufacturing Records (MMRs) for various dietary supplement batches (e.g., Fungus Control, Hepasil B-Complex, DHEA).