Skin Lightener Safety Warning Issued By FDA Over Unknown, Potentially Harmful Ingredients

Consumers are being urged not to use injectable skin lightening or skin whitening products, which have not been approved by the FDA and may pose serious health risks, since it has not been established that they are safe or effective. 

In a warning issued on September 2, the FDA noted that it has not approved any injections meant to whiten or lighten the skin.

The statement comes a year after U.S. Marshals seized shipments of a number of such products, including Relumins and Tatiomax, for being unadulterated drugs that were potentially harmful to the public.

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“These products pose a potentially significant safety risk to consumers,” said FDA pharmacist, In Kim, in the update. “You’re essentially injecting an unknown substance into your body — you don’t know what it contains or how it was made.”

The skin lighteners are promoted as having the ability to lighten or whiten one’s skin color, as well as fix uneven skin tomes and blemishes. Some of the products even claim to help treat liver disease and Parkinson’s disease. They are sold online, and through some retail stores and health spas, the FDA warns.

However, FDA investigators say some of the ingredients can cause serious harm. In addition, improper or unsafe injection practices can lead to infection, transmission of disease and serious injury. The FDA has also expressed concern about some non-injectable skin lightening or skin bleaching products that may contain mercury.

“In general, consumers should be cautions of any product marketed online with exaggerated claims on safety and effectiveness,” Kim said. “They also should consult their health care practitioner before deciding to use any new product.”

The FDA recommends that consumers who have used the injectable products and experienced an adverse event or side effects immediately contact their health care provider and report any illness or injury believed to be related to these products to the FDA MedWatch adverse event reporting program.


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