On Feb. 21, 2019, The US Food and Drug Administration (FDA) issued a proposed rule (tentative final monograph) that would update regulatory requirements for most sunscreen products in the United States. This government pronouncement has led to consumers uncertainty around sunscreen safety.
Per the FDA press release issued earlier this year on this matter, this action is aimed at bringing nonprescription, over-the-counter (OTC) sunscreens “up to date with the latest science to better ensure consumers have access to safe and effective preventative sun care options.” This announced triggered a flurry of concern in the consumer sphere with media headlines such as The New York Times “How Safe is Sunscreen?” and Allure Magazine warning consumers that it’s “time to double-check the ingredient list on your favorite SPF.”
In the proposed rule, of the 16 currently approved OTC active ingredients for sunscreens, only two – zinc oxide and titanium oxide, will be recognized by the FDA as “Generally Regarded as Safe and Effective” (GRASE) as of November 2019. The others will be required to have further data generated to attain GRASE status or will be eliminated from use in the US market.
While the desire from the industry is that the most widely used UV-filters attain GRASE status, the timeline to complete the current testing proposed by the FDA will take years to complete. Furthermore, despite the FDA stating that most of these sunscreens will continue to be allowed for use in consumer products during the testing period, consumers have unfortunately equated the additional testing required as proof that if an ingredient is not GRASE, it is not safe. DSM suggests an alternative, accelerated approach to UV-filters and sunscreen products safety assessment and presented its finding to FDA with the example of its avobenzone UVA filter (Parsol 1789).
“Skin cancer is a significant and largely preventable public health concern, and every day that consumers are actively avoiding sunscreens due to misplaced concerns regarding their safety puts them further at risk,” stated Carl D’Ruiz, senior regulatory manager for DSM’s Personal Care’s North American division and 20 year veteran of the sunscreen industry.
In the company’s comments to the FDA submitted last month, D’Ruiz stated “...FDA should not discount other potential categories of valid scientific and global epidemiological evidence, including real world evidence and post-market surveillance data. Use of such information would meaningfully reduce the time that it will take for the agency to issue a final rule on the sunscreen ingredients... and provide more certainty to the public around safe sun practices.”