FDA Issues Warning Against Skin Lightening Injectables

The U.S. Food and Drug Administration (FDA) has warned consumers that injectable products marketed to whiten or lighten the complexion are potentially unsafe and ineffective, and may contain unknown harmful ingredients or contaminants. There are currently no FDA-approved injectable drugs for skin whitening or lightening. “These products pose a potentially significant safety risk to consumers. You’re essentially injecting an unknown substance into your body—you don’t know what it contains or how it was made,” says In Kim, pharmacist with the FDA. “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.”

Last September, U.S. Marshals seized unapproved and improperly labeled drug products sold and distributed By Flawless Beauty after a recall. Such products may contain ingredients including as glutathione, vitamin C, collagen, and human placenta. The FDA also warns that improper or unsafe injection practices may transmit disease, cause infection and result in serious injury.

The FDA has also expressed safety concerns about non-injectable over-the-counter skin bleaching products. Skin bleaching drug products containing ammoniated mercury are new drugs, and are therefore required to go through the FDA-approval process for new drugs. “In general, consumers should be cautious of any product marketed online with exaggerated claims on safety and effectiveness,” says Kim. “They also should consult their health care practitioner before deciding to use any new product.”

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