FDA WARNING_LETTER - PC Tan

The FDA issued a Warning Letter to PC Tan on October 10, 2012, for marketing KBL brand devices (Mon Amie, Optima, and pureCollagen) without marketing clearance or approval. These products are classified as devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).

The violations stem from claims on PC Tan's website, http://www.pctan.com/eguipment.php, indicating that Mon Amie and Optima are "Tanning & Red Light Lamp Combination" devices, and pureCollagen offers "body forming, health training or target muscle formation." The addition of red LED light to UV tanning booths, which are typically exempt under 21 CFR 878.4635 when used with only UV light, constitutes a new technology requiring a premarket submission. Furthermore, the pureCollagen device's claims for body forming, health training, or target muscle formation have not been proven safe and effective.

Consequently, these devices are adulterated under section 501(f)(1)(B) of the Act because PC Tan lacks an approved premarket approval (PMA) or investigational device exemption (IDE). They are also misbranded under section 502(o) of the Act for failure to provide a 510(k) premarket notification.

Additionally, PC Tan failed to fulfill annual