FDA WARNING_LETTER - 1 800 Get Thin LLC

The FDA issued a Warning Letter to 1-800-GET-THIN, LLC, on December 12, 2011, regarding the marketing of the LapBand gastric banding system. The LapBand is a restricted device, meaning its sale and distribution are limited to authorization by a licensed practitioner.

The FDA determined that 1-800-GET-THIN's advertising misbrands the LapBand under sections 502(q), 502(r), and 201(n) of the Federal Food, Drug, and Cosmetic Act. Violations include false or misleading advertising (502(q)), failure to reveal material facts (201(n)), and inadequate inclusion of intended uses, warnings, precautions, side effects, and contraindications in advertisements (502(r)).

Examples of misbranding cited include billboards and advertising inserts that promote weight loss with the LapBand, often using testimonials, without adequately disclosing risks, qualifying requirements (e.g., BMI), or the need for ongoing lifestyle changes. The letter notes that risk information, when present, is often in illegibly small font.

1-800-GET-THIN is required to immediately cease marketing the LapBand using violative advertising and take prompt corrective action. Failure to comply may result in regulatory actions such as seizure, injunction, and civil money penalties. The firm must respond in writing within fifteen working days