FDA WARNING_LETTER - Derma Pen, LLC - July 22, 2014

An FDA inspection of Derma Pen, LLC, from July 16-22, 2014, revealed significant violations regarding their Derma Pen micro-needling device and associated "cosmeceutical" products. The Derma Pen, a Class I micro-needling skin dermabrasion device, was found to be adulterated under section 501(f)(1)(B) of the Act because the firm lacked an approved premarket approval (PMA) or investigational device exemption (IDE) application. It was also misbranded under section 502(o) for failure to submit a premarket notification (510(k)).

The FDA determined the Derma Pen, which creates puncture wounds with needles, uses a different fundamental scientific technology than Class I exempt powered dermabrasion brushes (21 CFR 878.4820) and thus is not exempt from premarket notification. Safety concerns regarding unknown needle lengths, penetration depths, and speeds were noted.

Additionally, several products marketed as "cosmeceuticals" (Derma Pen HA Boost, Photo-Boost, Scar Corrector, Stretch Mark Minimizer, Pigment Stabilizer) were deemed unapproved drugs based on their promotional claims (e.g., "heals the skin," "stimulates new collagen production," "reverses sun spots"). The FDA stated that "cosmeceutical" is not a recognized category