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FDA issues update on Sunscreen Innovation Act

The FDA has issued additional information on the agency’s review of sunscreen ingredients and the Sunscreen Innovation Act.

Congress enacted the Sunscreen Innovation Act (SIA) on Nov. 26, 2014, which President Obama then signed into law Nov. 29, providing a new process for the review of safety and effectiveness of active ingredients in nonprescription sunscreen and a timeline for FDA review, according to the FDA Voice blog.

There were eight Time and Extent Applications for sunscreen ingredients submitted to the FDA prior to the SIA going into effect, according to the blog post by Theresa M. Michele, MD, director of the Division of Nonprescription Drug Products in the FDA’s Center for Drug Evaluation and Research’s Office of New Drugs.

On Jan. 7, the FDA announced that six of the ingredients were not generally recognized as safe and effective (GRASE) for use as sunscreen because the agency needed more manufacturer data to determine the products’ safety and effectiveness, according to the blog post.

The FDA met with stakeholders on Feb. 4 to discuss plans for implementation of the SIA, according to guidance, compliance and regulatory information on the agency’s website.

On Feb. 24, the agency determined it needed more data to determine whether the final two pending ingredients, ecamsule and enzacamene, could be classified as GRASE for use in over-the-counter sunscreen products, according to the blog post.

Other clarifications made in the post regarding the SIA included:

• To assist in meeting the requirements in the legislation, the FDA is requesting funds for implementation of the SIA as part of President Obama’s fiscal year 2016 budget.
• There is not a specified timeframe when products with additional sunscreen ingredients will be on the market.

“We cannot achieve success in bringing additional sunscreens to market on our own,” Michele wrote in the blog post. “FDA … will be transparent in our process and progress. Successful implementation of the SIA will require a cooperative effort with industry and other stakeholders.” – by Bruce Thiel

References: www.fda.gov, blogs.fda.gov.