In its August 29, 2006, proposed rule, the FDA reversed its long-held position on OTC skin bleaching drug products containing hydroquinone. The Agency withdrew the TFM for such products, which it had issued on September 3, 1982. In that TFM, the FDA proposed that 1.5 percent to 2.0 percent hydroquinone be considered GRAS/E as an active ingredient in OTC skin bleaching drug products. Hydroquinone was the only active ingredient proposed for inclusion in the skin bleaching TFM.

If finalized as proposed, the rule would establish that OTC skin bleaching drug products, including those containing hydroquinone, are not GRAS/E and are misbranded. FDA based its proposal on “significant new data on the safety of hydroquinone.” Specifically, the FDA cites National Toxicology Program (NTP) toxicology and carcinogenesis studies on orally administered hydroquinone. The NTP studies, according to the proposed rule, indicate “some evidence” of carcinogenicity in animals. Based on this evidence, the FDA states that it cannot rule out the potential carcinogenic risk to humans from topically applied hydroquinone. The FDA also cites studies that have shown a possible effect on fertility and ochronosis (a condition that causes darkening and thickening of skin).

In light of this “significant new data,” the FDA has reassessed its position regarding the risk-to-benefit ratio for the use of hydroquinone in skin bleaching drug products. Although the FDA concedes that the risk to humans has not been fully determined because the sole intended benefit of skin bleaching products is to improve the user’s skin appearance, it declares that the use of hydroquinone in OTC skin bleaching drug products cannot be justified. “For OTC skin bleaching drug products, FDA tentatively concludes that there is no benefit to physical health that would justify the continued marketing of these products.”

Finally, the scope of this proposed rule extends to prescription skin bleaching drug products. The FDA also announced that it intends, upon issuance of the final rule, 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.”

Skin bleaching drug products containing hydroquinone are widely used and marketed, both on an OTC and prescription basis. The FDA estimates that there are at least 200 products containing hydroquinone currently marketed in the United States by approximately 65 different manufacturers. We encourage these companies and consumers, as well as any other interested parties, to submit comments on the proposed rule by the FDA’s deadline of December 27, 2006. Once finalized, the rule will become effective 30 days after its publication in the Federal Register.

The proposed rule can be accessed at: http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-14263.pdf.

Marsha Wertzberger
202.857.6122
wertzberger.marsha@arentfox.com

Julia Tierney
202.828.3427
tierney.julia@arentfox.com

Sarah Beck
202.857.6036
beck.sarah@arentfox.com