FDA WARNING_LETTER - Tan Extreme Inc - July 27, 2012

On July 27, 2012, an FDA inspection of Tan Extreme, Inc. and L.A. Tan, Inc. at 3775 West Arthur Ave., Lincolnwood, IL, revealed the firm marketed and distributed seven imported sun tanning devices, specifically "42 Collagen BodyWave" units, also labeled "VANITY SUN + SLIM 180W 240W 3PHASE 60HZ ATTRACTION." These devices were promoted for anti-aging, anti-cellulite, slimming, toning, and skin rejuvenation.

The FDA determined these products are devices under Section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act). The firm failed to obtain premarket clearance or approval, rendering the devices adulterated under Section 501(f)(1)(B) of the Act because no approved Premarket Approval (PMA) or Investigational Device Exemption (IDE) was in effect. Additionally, the devices are misbranded under Section 502(o) of the Act for failure to provide notification of intent to introduce them into commercial distribution, as required by Section 510(k).

During an October 2, 2012 meeting, the firm was informed of the need to remove the devices from the market and apply for PMA, but as of the letter's date, the devices had not been removed.