Sunscreen Safety Update

In late February, the FDA proposed new regulations for over-the-counter (OTC) sunscreens marketed in the United States. The proposed rule, which is open for public comment through May 28, is a step toward developing a final monograph for OTC products, as required by the Sunscreen Innovation Act in 2014.¹ 

The proposal is an update to the FDA’s 2011 policy on sunscreen products, which, among other things, required that product labels provide consumers with information about the specific type of UV protection offered. The FDA’s goal is to ensure that OTC sunscreen products are safer and more effective, based on the most recent scientific data. The proposal touches on the safety of active ingredients, delivery systems, sun protection factor (SPF), broad-spectrum requirements, and labelling of products. 

The Dermatologist asked Bruce Brod, MD, a professor of dermatology at the University of Pennsylvania in Philadelphia, former chair of the American Academy of Dermatology’s Congressional Policy Committee, and current deputy chair of its Council on Government Affairs and Health Policy, about the proposed rule and its implications. 

Q: It’s been a few years since the FDA last looked at OTC sunscreen. What is the most significant proposed change in this new document? 

A: The most significant change is the request by the FDA for the sunscreen industry to provide additional safety data for 12 ingredients that have been in common use in the United States for awhile. 

Q: Do you feel that such a request is warranted? 

A: I respect the process. The FDA is responding to a legislative directive and their focus is on safety, which is of the upmost importance. But while I respect the process, I also think it’s important, since these are still only proposed regulations, to work with the FDA and other stakeholders to balance safety with the importance of having access to sunscreen. 

Chemical sunscreens in the United States generally have a long track record of safety with normal recommended use. In my experience, sunscreens used properly are very safe and effective, including these 12. But having improved safety data may ultimately encourage the use of sunscreen overall. The FDA is requiring additional safety testing for both existing sunscreens and a pathway for approval of additional sunscreens after safety testing. 

Q: What do you see as the biggest challenge in complying with the FDA’s request? 

A: When drugs come to market, there’s motivation for the industry to perform research because they have the patent. With these sunscreen ingredients, no one company stands to gain by investing in the research, so a collaborative approach is necessary. There needs to be real cooperation among multiple stakeholders. 

Q: What role do dermatologists play in all this? 

A: Dermatologists can play a vital role in facilitating those discussions. We should encourage industry to work closely with the FDA to ensure the mandate for safety is achieved while trying to mitigate any limitations on the access side. 

Q: What about from a patient perspective—what are the clinical implications, and what do dermatologists need to communicate about this issue? 

A: From my perspective, it’s about messaging the importance of all forms of sun safety to the public. We need to acknowledge that sunscreen is just one component of sun protection, an important one, but definitely not the only one. My approach to patient care is reframe the conversation so they’re not relying solely on sunscreen. Avoidance of the sun when the rays are strongest, seeking shade, and sun-protective clothing are also impactful. It’s important for dermatologists to be the arbiters of reframing this idea because there is a risk of a false sense of security. If people are outside with inadequate clothing at high-sun times of day, there is potential for them to rationalize that behavior by using sunscreen. Like everything we do in dermatology, sun protection needs to be about combination therapy. We need to get rid of the idea that there is one single solution and embrace a multimodal approach. If we think of photoaging as a disease, then as with any illness, you want to treat it with a combination of all these different therapies. 

Q: Could the proposed requirement that new delivery systems (wipes, towelettes, shampoos) go through the full FDA approval process be a deterrent to access? 

A: Some groups have expressed concern about how this might affect access, and whether or not that concern is founded remains to be seen. This is something that needs to be carefully considered in discussions about this proposal. If there was a period where currently used sunscreens and delivery systems were limited, which I feel is unlikely, that could impact the public. 

But the ultimate goal is to broaden the range of vehicles and formulations that are available after satisfying safety requirements. We’d all like to see more options, especially for broad-spectrum sun protection. The more we have, the better ultimately that is for the public. The bottom line is that choices are good, but it’s going to take a concerted effort on the part of industry and the regulators. It will be important for the FDA to partner with industry so that everyone can find common ground on meeting safety requirements in a timely fashion and Americans have access to a range of sunscreens. 

Q: The proposed regulations also make some updates to product labelling. What’s your take on that? 

A: It’s an additional piece of transparency for the public. I don’t think that’s ever a bad thing. Part of our role as dermatologists is to educate patients on what SPF means, the limitations, and to try to give them guidelines and ranges instead of absolutes. 

Q: Ultimately, what do you think the impact of these proposed rules will be? 

A: I’m definitely excited that at least there’s a dialog going on. It may be a wake-up call that we really need to work together to expand our array of sunscreen options and put forth an effort to make them more cosmetically elegant and even safer. Once those requirements are satisfied, that will only enhance the access and use of safe sunscreen. n 

Reference 

FDA advances new proposed regulation to make sure that sunscreens are safe and effective [press release]. Silver Spring, MD: FDA; February 21, 2019. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631736.htm. Accessed February 22, 2019.