Cosmetic drug companies scarred by misbranding

A district court enjoined two individuals and two New Jersey drug companies from distributing unapproved injectable skin whitening drugs. In addition to preventing Flawless Beauty LLC and RDG Imports LLC from distributing the unapproved and misbranded drugs, the injunction requires the companies to recall and destroy all of the unapproved and misbranded injectable skin whitening drugs. The companies and individuals agreed to settle the case and be bound by a permanent injunction.


According to the complaint, in addition to making skin whitening claims, the companies’ skin whitening drug products make other unsubstantiated therapeutic claims. For example, some of the products asserted that the drugs “contribute to good liver function” and “clinically treat degenerative brain & liver diseases including Parkinsons.” The complaint also identified public health risks associated with the companies purportedly sterile injectable skin whitening drugs—nerve or blood vessel damage, blood-borne infection, superficial skin infection, cellulitis, abscess formation, and toxic systemic reactions.

The complaint asserted that the products were misbranded because they contained false or misleading information, including the false implication of FDA approval. Other labeling issues identified in the complaint include improper directions for use and the absence of “Rx” on the label.

Injunction. Until the companies meet specific remedial measures, the injunction requires them to stop importing, receiving, manufacturing, preparing, processing, packing, labeling, holding, and/or distributing unapproved drugs. The companies have 20 days to meet the mandate to recall and destroy the unapproved drugs.