Is Skin 2 Spirit Safe? FDA Warning Letter Review (2017)

Detailed Analysis

False Claims and Regulatory Violations

This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.skin2spirit.com/ in April 2017 and has determined that you take orders there for the products 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. The claims on your website establish that the products are drugs under section 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)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are intended to affect t

Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:

Organic Bioclear Pink Grapefruit Acne Face Wash• "Addition of CLOVE [(an ingredient in your product)], an antiseptic, and CAYENNE [(an ingredient in your product)], an anti-inflammatory ingredient that helps soothe redness, fade dark spots and promotes healing of Acne scars."• "Also includes WILLOW BARK [(an ingredient in your product)], a 100% pure and natural way to help stop Acne in its tracks! Willow Bark, or Salicin, is a derivative of Salicylic Acid, the key additive in many skin-care products for the treatment of acne."• "WILLOW BARK [(an ingredient in your product)] ... reduce inflammation, soothes pain."• "PINK GRAPEFRUIT ESSENTIAL OILS [(an ingredient in your product)] ... reduce oil production."• "CLOVE [(an ingredient in your product)] ... Has antibacterial properties, and some

Potential Health Risks

Advanced Hyaluronic Acid Antiaging Serum• "Hyaluronic Acid has recently been used to create Hylaform Gel, an FDA Approved injectable material that aestheticians and plastic surgeons predict will replace collagen injections because the risk of reaction is lower (most collagen being of bovine origin) and Hylaform Gel is more effective, and the results last longer than those of collagen injections."

Regulatory Context

Organic Caffeine Eye Whip• "Caffeine Extract, known for increasing circulation ... "• "ROSE HIP SEED OIL [(an ingredient in your product)]: Supports the keratin migration cycle that is responsible for the natural regeneration of skin cells and can increase renewed cells in the epidermis."• "CUCUMBER PEEL EXTRACT [(an ingredient in your product)]: ... has antiinflammatory ... properties."

Organic Coconut Rose Face Whip• "LICORICE ROOT [(an ingredient in your product)], which has excellent antiinflammatory properties ... "• "ROSE HIP SEED OIL [(an ingredient in your product)] ... Supports the keratin migration cycle that is responsible for the natural regeneration of skin cells and can increase renewed cells in the epidermis."• "VITAMIN C [(an ingredient in your product)] ... skin whitening agent ... "• "Licorice extract [(an ingredient in your product)] can inhibit the melanogenesis and is thus used also as skin whitening agent."

Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are "new drugs" under section 201(p) of the Act [21 U.S.C. § 321 (p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. § § 331 (d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.