The U.S. Food and Drug Administration’s (FDA) plans to update sunscreen regulations could have a large impact on manufacturers.
The proposed regulations are aimed at nonprescription, over-the-counter (OTC) sunscreens that are marketed without FDA preapproval. According to the agency, the goal is to bring those OTC products “up to date with the latest science.”
A 90-day comment period on the proposed regulations is now open. FDA is under a congressional mandate to finalize the sunscreen regulations by November 26, 2019.
The proposal addresses sunscreen active ingredient safety, dosage forms and sun protection factor (SPF) and broad-spectrum requirements. It also would change how products are labeled in order to make it easier for consumers to identify key product information.
The U.S. has not approved any new photoprotective molecules since the Clinton administration, even though research since then has raised questions about the efficacy and safety of some ingredients and Europe has introduced new products. The proposal would re-evaluate the 16 ingredients currently approved by the FDA.
The FDA also is asking manufacturers to submit more data on new forms of sunscreens, like SPF powders. The agency is proposing removing wipes, towelettes, body washes and shampoos from the monograph, which would mean those products would no longer be acceptable under these regulations. Companies would need to submit a more rigorous premarket drug application for these types of sunscreens.
Among the other proposals:
- Raising the maximum proposed SPF value on sunscreen labels from SPF 50+ to SPF 60+
- Requiring sunscreens with an SPF value of 15 or higher to also provide broad spectrum protection and that, for broad-spectrum products, as SPF increases, the magnitude of protection against UVA radiation also increases
- Categorizing products that combine sunscreens with insect repellants as not GRASE, which will result in the elimination of this category of products.
The full FDA proposed regulation can be found here.