Injectable products that claim to lighten complexions, correct uneven skin tone, and clear up blemishes are potentially unsafe and ineffective, and might contain unknown harmful ingredients or contaminants, the US Food and Drug Administration (FDA) warns.
The FDA has not approved any 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, a pharmacist at FDA, in a news release.
Beyond the potential harm from the product itself, improper or unsafe injection practices may transmit disease, cause infection, and result in serious injury, the FDA warns.
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. “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,” Kim says.
The products contain ingredients that can include glutathione, vitamin C, collagen, and even human placenta.
In September 2014, US Marshals seized various unapproved and improperly labeled drug products sold and distributed by Flawless Beauty LLC at the request of FDA and the US Attorney’s Office for the District of New Jersey. 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. The seized products include Relumins Advanced Glutathione kits and Tatiomax Glutathione Collagen Whitening kits.
“In general, consumers should be cautious of any product marketed online with exaggerated claims on safety and effectiveness,” Kim says. “They also should consult their healthcare practitioner before deciding to use any new product.”
The FDA has also expressed safety concerns about noninjectable over-the-counter (OTC) skin-bleaching products containing ammoniated mercury.
Report an illness or injury potentially related to the use of these products by calling 1-800-FDA-1088 or visiting FDA online.