FDA Releases Proposed Rule Regarding Sunscreens

Yesterday the Food and Drug Administration (FDA) released a proposed rule that would amend the final monograph for over-the-counter (OTC) sunscreen drug products as part of FDA’s ongoing review of OTC drug products. The proposed rule addresses formulation, labeling, and testing requirements for both ultraviolet B (UVB) and ultraviolet A (UVA) radiation protection, would introduce four-star rating system for the level of UVA protection, and would require a warning statement. FDA previously delayed regulations concerning UVA protection until reliable testing methodologies could be developed. The proposed rule specifically solicits comment on “the safety and effectiveness of sunscreen ingredients formulated in particle sizes as small as a few nanometers.”  Comments on the proposed avobenzone combinations will be due 60 days after publication of the Federal Register notice. Comments on all other parts of the proposed rule and on FDA’s economic impact determination will be due 90 days after publication in the Federal Register.

In the proposed rule, FDA states that it “recognizes that more sunscreens containing small particle size titanium dioxide and zinc oxide ingredients enter the market each year.” According to the proposed rule, FDA is interested in receiving comments and data about these sunscreen ingredients and products containing these ingredients, their safety and effectiveness, and how they should be regulated.  FDA notes that it received a citizen petition “shortly before publication of this document that, among other things, raises these issues.”  FDA is currently evaluating the citizen petition, which is filed as CP17 in Docket No. 1978N-0038.  FDA encourages other parties to submit additional data or information on the safety and effectiveness of sunscreen ingredients formulated in particle sizes as small as a few nanometers.