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Race, Skin-Lightening, Exogenous Ochronosis, and the Reclassification of Skin-lightening Cosmetics as Drugs by the FDA

Tue, August 11, 8:30 to 10:10am PDT (8:30 to 10:10am PDT), Hilton San Francisco Union Square, Floor: Ballroom Level, Franciscan A

Abstract

In 2006 the FDA issued a rule-making proposal to reclassify cosmetic skin-lightening products as drugs and prohibit their over-the-counter access. This policy proposal signaled a departure from the Agency’s previous rulings, which permitted skin-lightening products to be available for over-the-counter access. Among its justifications for a shift in policy, the Agency cited recent scientific evidence pointing to the toxicity and carcinogenicity of hydroquinone, the active ingredient in most skin-lightening products. Hydroquinone is also a known cause of exogenous ochronosis, a disfiguring skin condition that was also of concern to the Agency. This article examines the implications of this ruling and the Agency’s regulation of cosmetics skin lightening products, especially those containing hydroquinone. It draws from a 1968 California tort case Harris v. Belton, which involved a Black woman suffering from hydroquinone-induced exogenous ochronosis after utilizing the Artra skin-lightening cream. Aside from its significance in tort law, this case offers a critical examination of the multi-dimensional and intersectional nature of the practice of skin-lightening, particularly its socio-historical causes, the cosmeceutical industry’s capitalization on cosmetics biotechnology, and states’ regulatory capacity to protect the public health. Because skin-lightening is now an increasingly popular global practice, this timely proposal represents an encouraging policy shift, promising to protect those most vulnerable to toxic skin lightening cosmetics products—poor women of color.

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