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US FDA Warning Letter Salvo: No Such Thing As Approved OTC Skin-Lightening Product

Executive Summary

The FDA issued warning letters to a dozen companies about marketing OTC skin-lightening products containing hydroquinone. While the agency’s stance was friendlier toward such products when it launched the OTC drug review program 40 years ago, the program has changed, and so have the FDA’s views on hydroquinone.

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