FDA Takes Action On Injectable Skin Lighteners

Posted By American Med Spa Association, Monday, October 2, 2017

According to the complaint for permanent injunction, the company sold unapproved and improperly labeled (misbranded) drugs which present serious public health risks, particularly purportedly sterile injectable skin whitening drug products. In a recently updated notice for consumers, the FDA warns that it has not approved any injectable drugs for skin whitening or lightening and that intravenous and intramuscular administration of these unapproved drugs, for which sterility cannot be assured, could result in serious health risks. Some of the products sold by Flawless Beauty also implied FDA approval or endorsement, which the company did not have.
“Despite repeated warnings, Flawless Beauty continued to put patients at risk by selling potentially dangerous and unproven treatments to consumers,” said Donald D. Ashley, J.D., director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research. “We urge consumers to beware of these and other unproven drug products that use deceptive marketing tactics to sell their unsafe products.”
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