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After reviewing literature on the skin bleaching ingredient hydroquinone, the US Food and Drug Administration (FDA) announced additional safety studies are needed in order to rule out potential carcinogenic risk from topically applied hydroquinone in humans. In addition, research reportedly showed hydroquinone to cause disfiguring effects (ochronosis) after use of concentrations as low as 1-2%.
In light of this review, the FDA has proposed a new rule to establish that over-the-counter (OTC) skin bleaching drug products are not generally recognized as safe and effective (GRASE) and are misbranded. The FDA also withdrew the previous proposed rule on skin bleaching drug products for OTC human use, which was issued in the form of a tentative final monograph (TFM).
Further, upon issuance of a final rule, the FDA reports it intends to consider all skin bleaching drug products, whether currently marketed on a prescription or OTC basis, to be new drugs requiring an approved new drug application (NDA) for continued marketing.
The FDA tentatively concluded that the benefits of OTC skin bleaching drug products are insignificant when compared to the potential risks, and that this proposed rule would benefit society because it would eliminate a potentially unsafe drug product. The proposed rule would prohibit the continued marketing of hydroquinone as an OTC drug product and require a NDA under 21 CFR part 314 for marketing.
This proposed rule would have an impact on consumers who use OTC skin bleaching drug products containing hydroquinone to lighten limited areas of hyperpigmented skin as the would no longer be able to purchase these OTC drug products after current inventories are depleted. However, the FDA reported that the benefit of removing OTC skin bleaching drug products from the market will be a reduction in the number of cases of ochronosis that would otherwise occur each year.