Spencer Forrest, Inc. – FDA Warning Letter, Dec 9, 2011

The FDA issued a Warning Letter to Spencer Forrest, Inc. on December 9, 2011, after reviewing their website, www.spencerforrest.com, and identifying that the firm is marketing the X5 HairLaser in the United States without the necessary marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act. The X5 HairLaser is deemed adulterated under section 501(f)(1)(B) of the Act because the firm lacks an approved premarket approval (PMA) application or an investigational device exemption (IDE). Additionally, the device is misbranded under section 502(o) due to the firm's failure to submit a 510(k) notification before introducing the device into commercial distribution. The letter also cited the firm for not fulfilling its annual establishment registration and device listing requirements for 2011, as mandated by section 510(p). Consequently, all of the firm’s devices are considered misbranded under section 502(o) because they were processed in an unregistered establishment and were not included in the required device list under section 510(j). Spencer Forrest, Inc. must respond in writing within fifteen business days, detailing specific corrective actions, preventative measures, and a timetable for implementation, along with supporting documentation, to address these significant compliance issues.