In November 2015, the FDA released a draft guidance entitled “Over-the-Counter Sunscreens: Safety and Effectiveness Data.” The draft guidance was published for comment purposes only, and shared the Agency’s “current thinking about the safety and effectiveness data needed to determine whether a nonprescription (also referred to as over-the-counter (OTC)) sunscreen active ingredient or combination of active ingredients evaluated under the Sunscreen Innovation Act (SIA) is generally recognized as safe and effective (GRASE) and not misbranded when used under specified conditions.”
What is the Sunscreen Innovation Act?
The Sunscreen Innovation Act (SIA) was passed in 2014 and “amends the Federal Food, Drug, and Cosmetic Act to establish a process for the review and approval of over-the-counter (OTC) sunscreen active ingredients.” Among others, the SIA creates timelines for FDA to review sunscreen active ingredients and allows any sunscreen active ingredient that has been determined to be safe and effective, to be used in OTC sunscreen products.
Draft Guidance
The draft guidance was published “in partial implementation of SIA.” FDA’s recommendations are intended to help sponsors identify and obtain the safety and effectiveness data that is needed to prove sunscreen active ingredients are GRASE for use in nonprescription sunscreens. The draft guidance states that:
“The recommendations in this guidance are designed to ensure that FDA’s GRASE determinations for OTC sunscreen active ingredients under the SIA are consistent, up to date, and appropriately reflect current scientific knowledge and patterns of nonprescription sunscreen use by consumers. The recommendations reflect FDA’s scientific expertise, existing technical guidance, experience from reviewing safety and efficacy data submitted for GRASE review of sunscreen active ingredients under current OTC drug regulations, and input from and concurrence by outside scientific experts. This guidance also addresses FDA’s current thinking about an approach to safety-related final formulation testing that it anticipates adopting in the future.”
The document touches on a number of topics related to OTC sunscreen active ingredients, including:
- Pharmaceutical Quality/Manufacturing Data
- Safety Data Needed to Establish that an OTC Sunscreen Active Ingredient is GRASE
- Effectiveness Testing
- Anticipated Final Formulation Testing
The document was published on November 23, 2015, and the FDA announced that it would be accepting comments on the proposed regulation until January 22, 2016. However, on January 8, 2016, the Agency announced that it would be extending the comment period for 30 days, giving interested persons until February 22, 2016 to submit any comments, questions, or concerns regarding the draft guidance.
Comments are being accepted via electronic and paper submission. Submit comments electronically here.
Do you have an OTC sunscreen product that is subject to FDA regulation? We can help ensure compliance and work with you to achieve a successful outcome with FDA. To learn more about our services and how we can help you, please contact us.
