FDA Warns Injectable Drugs for Skin Lightening are Unapproved, Potentially Unsafe

FDA Warns Injectable Drugs for Skin Lightening are Unapproved, Potentially Unsafe
September 2, 2015

Injectable products marketed to whiten or lighten skin complexion are potentially unsafe and ineffective, warns the Food and Drug Administration (FDA).

The FDA has not approved any injectable drugs for skin whitening or lightening, but products continue to be sold for this purpose.

"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," FDA pharmacist In Kim said in a statement.

Along with being ineffective, the drugs may contain harmful ingredients or contaminates. Improper or unsafe injection practices may transmit disease, cause injection and result in serious injury.

The FDA says that injectable skin whitening products often promise 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 are marketed for injection into a vein or muscle or under the skin, and are sold online and in some retail outlets and health spas. Although the average consumer may not assume so, these products are unapproved new drugs.

The products contain ingredients that can include glutathione, vitamin C, collagen and even human placenta.

In September 2014, at the request of the FDA and the U.S. Attorney's Office in New Jersey, U.S. Marshals seized various unapproved and improperly labeled drug products sold and distributed by Flawless Beauty LLC. Earlier that year, Flawless Beauty LLC voluntarily recalled multiple unapproved drugs. Despite a recall, the company continued marketing and distributing unapproved drugs, which prompted federal authorities to seek further enforcement action.

"In general, consumers should be cautious 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."

FDA has also expressed safety concerns about non-injectable over-the-counter (OTC) 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.