In the US, products that protect the skin against sunburns are classified as OTC drugs (standing for “over-the-counter drugs”). One of the consequences of this classification is that the approval of new active ingredients (in this case new UV filters) for these products is subject to a process initially designed for the approval of new drugs. Over the years, the acceptance of new sunscreens has proved much more complex and long in the United States than in Europe or Asia, where sunscreens are generally considered as cosmetic products.
“The last over-the-counter (OTC) sunscreen ingredient to be approved by FDA was in the 1990s. Since 2002, eight new sunscreen applications have been filed and are still awaiting review 12 years later,” said the Public Access to SunScreens (PASS) Coalition, which members include the Skin Cancer Foundation, Prevent Cancer Foundation, Melanoma Research Foundation, Dr. Fallick, Dr. Henry Lim, Dr. Nadim Shaath, Dr. Steven Wang, Dr. Warwick Morison, Beiersdorf, L’Oréal USA Products, Ashland Inc., BASF Corporation, DeWolf Chemical, Fitz Chem Corporation, and McCullough & Associates.
The new law:
Requires the FDA to reduce the existing regulatory backlog of sunscreen applications and ensure an improved, reliable approval pathway for future sunscreen applications while maintaining the existing safety and effectiveness requirements for sunscreens;
Requires the FDA to provide expedited approval pathways for pending sunscreen ingredients;
Requires the FDA to regularly report to Congress on its efforts to reduce the backlog of existing applications and review of new ingredients;
Requires independent reporting by the Government Accountability Office (GAO) on the regulatory pathway for sunscreen products and other OTC products;
Requires the FDA to finalize its regulations related to all OTC sunscreens.
“We are confident that the new law will enable Americans to have greater choice when it comes to protecting their skin from the sun’s harmful UVA and UVB rays,” said Michael Werner, PASS Coalition Policy Advisor.
Read the new Public Law No: 113-195 here below: