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FDA Publishes Opinion on Two Sunscreen TEAs and Is Urged for More Action by PASS

Posted: March 6, 2014
FDA Publishes Opinion on Two Sunscreen TEAs and Is Urged for More Action by PASS

The end of February was busy for the U.S. Food and Drug Administration (FDA), which published two letters on the Time and Extent Applications (TEAs) for diethylhexyl butamido triazone (Uvasorb HEB) and amiloxate (Neo Heliopan E 1000), finding insufficient scientific evidence to claim either as generally recognized as safe and effective (GRASE) and denying their addition to the OTC Sunscreen Monograph.

As the sunscreen industry is well aware, it took a long time for the FDA to respond to any of the TEAs pending its approval for the monograph. Some UV filter TEAs have been backlogged for over a decade, and there are many UV filter TEA's still waiting for a decision from the FDA.

In reponse, the sun care industry continues to urge action from the FDA. The Public Access to SunScreens (PASS) Coalition recently expressed prudent support for the FDA's March public meeting (March 25, 2014) to obtain input on the OTC Monograph Drug Review. However, the coalition hightlighted that while these efforts are necessary for revising the OTC monograph system in general, the FDA needs to do more to address the urgent public health need so that the American consumer has access to the latest, innovative sunscreen ingredients.

PASS notes that at a time when cases of skin cancer have reached epidemic levels in the United States, outnumbering the occurrence of all other cancers, and one American dies every hour from melanoma, it is imperative for Americans to have access to the latest safe and effective sunscreen products available.

The persistent delays in sunscreen approvals have caught the attention of Congress, and bipartisan legislation will be introduced to reform the sunscreen application process in the very near future. This legislation will ensure that Americans have access to the latest safe and effective sunscreen ingredients in a timely fashion. PASS strongly urges the FDA to work with Congress to clear the 10-year backlog in sunscreen applications and reform the review and approval process to help provide Americans with the tools they need to combat the sun's harmful UV rays and rising skin cancer rates.

Although the FDA has issued these two letters and finally started working through the pending TEAs for the OTC Sunscreen Monograph, sun care formulators and suppliers alike must be wondering if the remaining UV filters will succomb to the same fate. The FDA noted that although these two have not been considered GRASE, the industry may continue to submit scientific evidence in their support.