NPA Calls for Added Clarification Of FDA Sunscreen Evaluation

The Natural Products Association (NPA), in a recent public filing with the Food and Drug Administration (FDA), encouraged the adoption of standardized equivalent active ingredient controls across OTC sunscreen clinical trials, clarification of “non-diseased” skin, further guidance on submitting Maximum Usage Protocols, and conscious efforts by FDA to reduce the number of animals used in clinical testing submitted to FDA.

“Giving consumers access to more safe and effective sunscreen products and supporting the goal of reducing skin cancer in the United States is something NPA will always promote. The safety and effectiveness of sunscreen products containing nanoparticles should not be taken lightly. Advocating for reductions in the number of animals used to support studies of safety and effectiveness for OTC sunscreens is also a fundamental guiding principle of NPA’s natural standard,” said Dr. Daniel Fabricant, CEO and executive director of NPA.

While the NPA supports aspects of the current draft guidance, “Over-the-Counter Sunscreens: Safety and Effectiveness Data,” and the implementation of the Sunscreen Innovation Act, NPA is urging FDA to consider all points made for the draft guidance.