FDA WARNING_LETTER - Skin 2 Spirit

The FDA issued a Warning Letter to Skin 2 Spirit, LLC, following a review of their website (http://www.skin2spirit.com/) in April 2017. The FDA determined that products sold, including Shea Body Butter Creme, Magnesium Oil, Organic Caffeine Eye Whip, Advanced Hyaluronic Acid Antiaging Serum, Organic Bioclear Pink Grapefruit Acne Face Wash, Organic Bioclear Pink Grapefruit Face Toner, and Organic Coconut Rose Face Whip, are unapproved new drugs.

The products are deemed 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 321(g)(1)(C)] due to claims on the website indicating their intended use in the cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or function of the human body. Examples of such claims include Magnesium Oil for "reducing muscle aches, pains, cramps & spasms" and "improving sleep quality," Organic Caffeine Eye Whip for "increasing circulation," Advanced Hyaluronic Acid Antiaging Serum referencing FDA-approved injectable materials, and various "Bioclear" products for treating acne, reducing inflammation, and destroying bacteria.

Since these products are not generally recognized as safe and