FDA Warns Consumers About Skin-Whitening Injectables
This article was originally published in The Rose Sheet
A growing number of injectable skin-whitening products are available to consumers through online retailers and other channels, FDA says in an update cautioning the public that such products could pose "significant" safety risks. The agency singles out Flawless Beauty, LLC, which has been subject to recent enforcement activity, including product seizure by U.S. Marshals, but continues to market questionable skin-whitening products with aggressive claims.
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"We didn't want to fight this any further because of the legal fees," said Jack Gindi, owner of the firm. Four months after it agreed to within 20 days recall all lots of 19 products that FDA said were injectable or that contained human placenta, supplement and cosmetic firm Flawless Beauty on Jan. 23 announced the recall.
Ocean Township, N.J.-based Flawless Beauty has been on FDA's radar since 2013, targeted with two facility inspections and a previous complaint that triggered product seizures by US Marshals. Unapproved skin-whitening injectables sold by the company pose potential serious health risks, according to a New Jersey District Court consent decree of permanent injunction against the company and its owners.
Yet another skin-care marketer, Skin Authority, has been served with an FDA warning letter for excessive product claims that identify its offerings as drugs. The agency cites statements touting the firm’s ingredient benefits, including collagen production, improved circulation, inflammation relief and hyperpigmentation treatment, consistent with other warnings issued to cosmetics firms in recent months.