FDA will publish a proposed rule in the Federal Register on Tuesday, February 26, 2019, that, when finalized, would put into effect a final monograph for OTC sunscreen products, delineating the conditions under which these products would be considered generally recognized as safe and effective (GRASE) and not misbranded. The 2014 Sunscreen Innovation Act mandates that FDA publish the final monograph by November 26, 2019, and the Agency indicates it is on track to meet that deadline.
Importantly, FDA concludes in the proposal that of the 16 active ingredients originally designated as GRASE under the monograph FDA finalized in 1999 but stayed in 2002, only two sunscreen ingredients – zinc oxide and titanium dioxide – are now GRASE. The Agency also proposes that two ingredients – PABA and trolamine salicylate – are not GRASE due to safety issues. For the remaining 12 ingredients, FDA finds that, in light of changed conditions, including substantially increased sunscreen usage and exposure and evolving information about the potential risks associated with these products since they were originally evaluated, there are insufficient safety data to make a positive GRASE determination at this time. For these ingredients, FDA seeks additional evidence from clinical and non-clinical safety trials, as well as post-market safety data.
With respect to sunscreen dosage forms, FDA proposes that sprays, oils, lotions, creams, gels, butters, pastes, ointments and sticks are currently GRASE. However, the GRASE designation for sprays is “subject to testing necessary to minimize potential risks from unintended inhalation (particle size restrictions) and flammability (flammability and drying time testing), together with related labeling requirements.” In particular, FDA has proposed that for spray sunscreens: (a) 90 percent of the particles dispensed from the consumer container must be at least 10 µm or greater in order to limit exposure beyond the larynx and (b) the minimum particle size dispensed from the consumer container must be no less than 5 µm to prevent deposition in the deep lung.
FDA proposes that powder dosage forms are eligible to be considered for inclusion in the monograph. This is a major change, as FDA had previously stated that this dosage form was not eligible. This change occurred as a result of submissions to FDA of marketing data supporting the pre-1972 use of powder sunscreens. However, additional data will be needed to support a conclusion that powder sunscreens are GRASE and to support appropriate labeling. FDA provides a list of topics about which it would like to receive data for powder dosage forms. In addition, like sprays, powder sunscreens pose the potential for unintended inhalation, and for this reason, if admitted to the sunscreen monograph, the same limitations as to particle size proposed for sprays would be expected to apply.
Wipes, towelettes, body washes, shampoos and other dosage forms are not included in the monograph because FDA did not receive data that these forms were marketed before 1972. Thus, sunscreen products in those dosage forms would require new drug approval. Finally, sunscreen-insect repellent combination products are not GRASE because it is not possible to simultaneously comply with both FDA sunscreen requirements and Environmental Protection Agency insect repellent requirements.
FDA proposes that, based on variability in testing, sunscreen products be labeled with SPFs within certain blocked ranges, using the lowest result obtained in SPF testing. FDA additionally proposes to raise the maximum proposed SPF value on sunscreen labels from SPF 50+ to SPF 60+ and to require sunscreens with an SPF value of 15 or higher to also provide broad spectrum protection. For broad-spectrum products, as the SPF increases, the magnitude of protection against UVA radiation must also increase.
Finally, FDA proposes new sunscreen labeling requirements, including:
The proposed rule contains other information and should be reviewed in its entirety.
Comments on the proposed rule are due 90 days after the date of publication, which appears to be May 28 (but this date has not yet been officially published). However, FDA has indicated that if stakeholders request an extension to provide the requested data for a particular ingredient, the Agency may offer a deferral for that ingredient in the final rule. FDA has also noted that the proposed rule does not require any sunscreen products to be removed from the market at this time pending finalization of the monograph rulemaking.
We will continue to update our clients on any developments in this area and we are happy to answer any questions or assist in drafting comments.