FDA WARNING_LETTER - Pharmagel International - March 31, 2015

The FDA issued a Warning Letter to Pharmagel International after reviewing their website, http://www.pharmagel.net/, in March 2015. The FDA determined that five products—Beta-C, Bio-A Concentrate, Eye Firm, Pharma Clear Medicated Moisturizer, and Slender Shaper—are promoted with claims that cause them to be unapproved new drugs and/or misbranded drugs under the Federal Food, Drug, and Cosmetic Act (the Act).

The products are deemed drugs because their website claims indicate they are intended for the cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or function of the human body. Examples of drug claims include "helps erase and repair the ravages of sun damage," "stimulates collagen production," "speeds healing," "helps control acne by reducing inflammation and bacteria production," "reduces that red inflamed appearance associated with Rosacea and acne," "increases fat metabolism," and "cellulite starts to disappear."

Since these products are not generally recognized as safe and effective for their claimed uses, they are considered "new drugs" under section 201(p) of the Act and require an approved New Drug Application (NDA) before interstate commerce introduction, which they lack, violating section 301(d).

Furthermore, "Bio-A Concentrate" and "Pharma Clear Medicated Moisturizer" are misbranded under section 502(f)(1