FDA WARNING_LETTER - Fioravanti Custom Products - April 24, 2014

The FDA issued a Warning Letter to Essential Wholesale following an inspection of their Portland, Oregon manufacturing facility from April 7 to April 24, 2014, and a review of their website, www.essentialwholesale.com. The letter states that the firm's response to the Inspectional Observations (Form FDA 483) was inadequate, specifically regarding unaddressed labeling discrepancies.

The FDA determined that numerous products, including Tamanu Butter, Neem Butter, Blue Green Algae Antibacterial Toner, Leave-In Conditioner & Detangler, Zinc Oxide, Salicylic Acid Powder, Rooibos Tincture, and Tea Tree & Vinegar Facial Toner, are marketed with claims that classify them as unapproved new drugs under sections 201(g)(1)(B) and/or 201(g)(1)(C) and 201(p) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. §§ 321(g)(1)(B), 321(g)(1)(C), 321(p)]. These products are presented as cosmetics but their labeling and website claims indicate intended uses for diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the human body.

Examples of violative claims include: Tamanu Butter for treating burns, psoriasis, acne, and promoting healthy tissue;