Federal judge orders U.S. company to stop distributing unapproved drugs

FDA has reported that the federal judge ordered a New Jersey company that sold injectable skin whitening and other beauty products to stop selling and recall some of its products because they are unapproved new drugs that may be unsafe, putting consumers at risk.

U.S. District Judge Peter G. Sheridan entered a consent decree of permanent injunction today between the United States and Flawless Beauty LLC of Ocean Township and Asbury Park, New Jersey, the company’s co-owners, Jack H. Gindi and Susana B. Boleche, and an affiliated company owned by Mr. Gindi, RDG Imports LLC.

According to the complaint for permanent injunction, which the U.S. Department of Justice filed on the FDA’s behalf, Flawless Beauty sold unapproved and improperly labeled (misbranded) drugs which present serious public health risks, particularly purportedly sterile injectable skin whitening drug products. Intravenous and intramuscular administration of these unapproved drugs, for which sterility cannot be assured, could result in serious health risks. These risks include nerve or blood vessel damage, infection or toxic systemic reactions. The company also sold several products that are labeled to contain human placenta, which can result in serious illness, FDA said.

Also, some of the products sold by Flawless Beauty implied FDA approval or endorsement, which the company did not have.