FDA WARNING_LETTER - Refine, USA, LLC

On April 18, 2011, the FDA issued a Warning Letter to Refine USA, LLC, regarding its VeinGogh Ohmic Thermolysis System. The FDA's Office of Compliance reviewed the firm's website and determined the device, initially listed as an exempt needle-type epilator (21 CFR 878.5350), was being marketed for unapproved uses. Promotional claims for treating conditions like telangiectasia, spider veins, angiomas, and rosacea represent a major change in intended use, requiring premarket notification under 21 CFR 807.81(a)(3)(ii). Consequently, the device is being marketed without marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act. Specifically, it is adulterated under Section 501(f)(1)(B) (21 U.S.C. 351(f)(1)(B)) due to the absence of an approved PMA (Section 515(a)) or IDE (Section 520(g)). Furthermore, the device is misbranded under Section 502(o) (21 U.S.C. 352(o)) because the firm failed to provide premarket notification (Section 510(k)). Refine USA, LLC is required to immediately cease disseminating the described promotional materials and submit a written response within 15 working days outlining its corrective actions and plan for discontinuing such materials. Failure to comply may result in regulatory actions including seizure, injunction, or civil money penalties.