FDA WARNING_LETTER - Jian Peng Zhou

The FDA issued a Warning Letter to Jian Peng Zhou of Luxing Jlning, China, on May 29, 2015, regarding the marketing of unapproved hyaluronic acid gel dermal fillers, including "Dermafil," for wrinkle treatment, lip augmentation, and other dermal filler products for buttocks and breast augmentation. These products are considered devices under the Federal Food, Drug, and Cosmetic Act.

The FDA determined, through a review of the website www.beautycosmeticstore.com, that these Hyaluronic Acid Gel Products are being marketed in the U.S. without the required marketing clearance or approval. This constitutes a violation of the Act.

Specifically, the products are adulterated under section 501(f)(1)(B) because the firm lacks approved Premarket Approval (PMA) applications or Investigational Device Exemption (IDE) applications. They are also misbranded under section 502(o) because the firm failed to notify the FDA of its intent to introduce these devices into commercial distribution, as required by section 510(k).

Due to these serious violations, the Hyaluronic Acid Gel Products are subject to refusal of admission into the U.S. under section 801(a), leading to "detention without physical examination." To resolve this, the firm must provide a written response within fifteen business days detailing specific corrective actions, including documentation and a timetable for implementation if corrections will take longer. The