LAPBANDVIP.com – FDA Warning Letter, Jun 25, 2012

The FDA issued a Warning Letter to Hooman Shabatian, M.D., of Lap-Band VIP, on June 25, 2012, for misbranding the LapBand gastric banding system. The LapBand is a restricted device, meaning its sale and distribution are limited to prescription authorization.

The FDA found that Lap-Band VIP's advertising violated sections 502(q), 502(r), and 201(n) of the Federal Food, Drug, and Cosmetic Act. Specifically, two television commercials and two billboards were cited. These advertisements were deemed misleading under section 201(n) and misbranded under section 502(q) because they failed to disclose material facts, including relevant risk information, age and qualifying requirements, and the necessity of ongoing dietary modifications, as stipulated in the approved LapBand labeling. Furthermore, the advertisements did not include the required brief statement of intended uses, warnings, precautions, side effects, and contraindications, thus misbranding the device under section 502(r).

The FDA requested that Lap-Band VIP immediately cease marketing the LapBand with violative advertising and take prompt corrective action. Failure to comply could result in regulatory actions such as seizure, injunction, and civil money penalties. Lap-Band VIP was required to respond in writing within fifteen working days, detailing corrective steps and preventative measures.