GliSODin Skin Nutrients – FDA Warning Letter

On May 18, 2018, the FDA issued a Warning Letter to GliSODin Skin Nutrients, specifically addressing their "Advanced Skin Brightening Formula." The FDA reviewed the company's website (https://www.glisodinskin.com/) in March 2018 and purchased the product, subsequently reviewing its label and labeling.

The FDA determined that the product is an unapproved new drug under sections 201(g)(1)(B) and 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 321(g)(1)(B), 321(p)]. This classification is based on claims made on the website and product brochure, which indicate the product's intended use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Examples of such claims include: "Are you aware that skin cancer is the most common form of cancer diagnosed in North America? ... The good news is there is a simple and natural way to strengthen your skin?s defenses against ultraviolet radiation in the form of a daily supplement designed to improve skin health," "The Advanced Skin Brightening Formula contains ingredients that reduce oxidative stress (one of the harmful effects of UV light)," and "Enhances photoprotection."

Introducing or delivering this product into interstate commerce for these uses without prior FDA approval violates sections 3