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FDA Cracks Down on Skin Lighteners

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Public health won this round—on Sept. 26, 2017, on behalf of the U.S. Food & Drug Administration (FDA), a federal judge ordered Flawless Beauty to cease selling and to recall a number of its skin whitening products due to their unsafe nature. 

Wayward Whitening

Skin whitening products are popular with Asian consumers for cosmetic purposes, while in western countries they are utilized more often to treat pigmentation issues. The products run the risk of crossing into drug or cosmeceutical classifications, especially in injectable formulations such as Flawless Beauty's.

The FDA cites the risk of unsafe injection practices and potentially harmful ingredients or contaminants in injectable products as cause for concern over the products, and has not approved any such injectable drugs in this category. Consumers risk nerve or blood vessel damage, toxic systemic reactions or infection from potentially unsterile injections.

In addition, commonly used ingredients such as mercury and hydroquinine, which, while effective in whitening the skin, pose health risks and are banned in North American and European cosmetic whiteners. The key ingredient in Flawless Beauty's banned products is glutathione, an antioxidant that whitens as a side-effect.

On the Rise

Despite controversy over the implications of unsafe skin whiteners, the global skin lightening market is on the rise, and is projected to reach US $31.2 billion by 2024. Such products are moving fastest in the Asia-Pacific region, where consumers face prevalent colorism and have increased spending power in the middle class.

While topical and injectable applications are common skin whitening products, ingestible whiteners such as candies, tablets and beverages have also been formulated; many are available only through the black market.

Flawless Beauty

The company's injectable skin whitening products came under fire in 2014. It continued marketing and distributing unapproved and improperly labeled injectable whitening products after having stock seized by U.S. Marshals in September of that year. The company also implied FDA approval for a number of the products sold.

Per the consent decree, Flawless Beauty, along with an affiliated company RDG Imports and its owners, have 20 days to recall the offending products, along with undergoing an expert review of their drug products and a halt on distribution until written permission is granted from the FDA.

"Despite repeated warnings, Flawless Beauty continued to put patients at risk by selling potentially dangerous and unproven treatments to consumers. We urge consumers to be aware of these and other unproven drug products that use deceptive marketing tactics to sell their unsafe products," said Donald D. Ashley, J.D., director of the FDA's Center for Drug Evaluation and Research Office of Compliance.

Taken together, this isolated tale of indiscretion is not only a win for public safety; it's a cautionary reminder for skin-whitening product developers to know the rules and follow them.

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