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Should Consumers Beware of Injectable Skin Lighteners?

The FDA has issued a consumer advisory warning the public about the dangers of using injectable skin lighteners. According to the advisory, there are no FDA approved injectable skin lighteners on the market, yet there are products sold and marketed online that purport to lighten the skin, correct uneven skin tone, and clear up blemishes. Some products even claim to treat conditions, such as liver disorders and Parkinson’s disease. These products, which require injection into a vein or muscle or under the skin, can also be found in some retail outlets and health spas.

In September 2014, U.S. Marshals seized various unapproved and improperly labeled drug products sold and distributed by Flawless Beauty. This followed a voluntary recall by the same company of multiple unapproved drugs. The seized products included Relumins Advanced Glutathione kits and Tatiomax Glutathione Collagen Whitening kits. The FDA is also concerned about unapproved topical treatments that include ammoniated mercury. Skin bleaching products containing this ingredient have not yet been through the FDA-approval process.

The FDA warns that though consumers may not realize these are unapproved new drugs. In Kim, a pharmacist at FDA, states that, “You’re essentially injecting an unknown substance into your body—you don’t know what it contains or how it was made. We have noticed a number of online companies marketing injectable products for skin whitening and are concerned that these products and their ingredients may cause serious harm to consumers.”

The advisory notes that there are FDA-approved topical drug products to treat certain skin conditions, such as hyperpigmentation and melasma. These FDA-approved drugs have been determined to be safe and effective for their intended use and the facilities where they are made are subject to FDA-inspection and must comply with FDA regulations and good manufacturing practices.

Byline: Martha L. Sikes, MS, RPh, PA-C and Wendy Meltzer, MPH

Source: FDA

Adapted from the original press release.

[image by Stephen Depolo]

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