Healthy Habits, LLC. – FDA Warning Letter

On December 16, 2016, the FDA issued a Warning Letter to Healthy Habits, LLC, following an October 2016 review of their website, healthyhabits.com. The FDA determined that the products "Dermatox Ointment 1.7 oz" and "DermaTox? - 4 oz" are unapproved new drugs under sections 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B) and/or 21 U.S.C. § 321(g)(1)(C)].

The products are deemed drugs because website claims, including product descriptions, testimonials, and Q&A sections, indicate intended use for diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or function of the human body. Examples of claims include treating "red patches," "Diabetes related skin conditions," "pain and swelling around the scar," "neuropathy," "eczema," "diabetic sores," "skin tags," "infected cysts," "pain, wounds, cuts, bruises, sores, inflammation, blisters, abrasions," "shingles," "burns," and "staff infection."

Since these products are not generally