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Proposed FDA sunscreen rule could save lives, reduce confusion
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The FDA has proposed a rule that it says would update regulatory requirements for most sunscreen products sold in the United States.
These proposals, if enacted, could have a positive impact on the health of patients and eliminate confusion surrounding these products, several dermatologists told Healio Primary Care Today.
Proposed rule
The proposed rule was added to the Federal Register in February and was termed “a significant action” by the FDA. By some accounts, this would be the first major overhaul of the sunscreen industry in almost a decade.
“[This] is an important step in the FDA’s ongoing efforts to take into account modern science to ensure the safety and effectiveness of sunscreens,” Scott Gottlieb, MD, and FDA commissioner said in the release.
According to the release, the proposal has several components:
- brings nonprescription, over-the-counter sunscreens that are marketed without FDA-approved applications up to date with the latest science;
- ensures consumers have access to safe and effective preventative sun care options;
- discusses sunscreen active ingredient safety, dosage forms, and sun protection factor and broad-spectrum requirements; and
- suggests updates to how products are labeled to make it easier for consumers to identify critical product information.
“The proposal we’ve put forward would improve quality, safety and efficacy of the sunscreens Americans use every day,” Gottlieb added.
Dermatologists review rule
Data presented at the American Academy of Dermatology earlier this year suggest that only 8.7% of patients correctly answered all three questions on a survey related to sunscreen labeling terminology.
Given this lack of awareness and the position of the AAD and the American Cancer Society on the role of sunscreen in preventing skin cancer, dermatologists supported the FDA’s action.
“Proper use of sunscreen can prevent skin cancer and premature aging, so I am encouraged by any new regulations that enhance consumer knowledge,” Joshua Zeichner, MD, and director of cosmetic and clinical research within the department of dermatology at The Mount Sinai Hospital in New York City said in an interview.
Seemal R. Desai, MD, FAAD, of Innovative Dermatology in Plano, Texas, told Healio Primary Care Today that some of the ingredients used to make some of the most carcinogen-protective sunscreens are currently not available in the United States, but that could change with the proposed rule.
“There are some new ingredients out there that have really good data on UVA coverage, but right now those ingredients can only be studied in Europe. As dermatologists, we want to be able to advocate for the science behind those new ingredients, be allowed to study their use in the United States and allow the manufacturers of these products to sell them here,” he said.
Bruce A. Brod, MD, the co-director of the Occupational and Contact Dermatitis Program at Penn Medicine, agreed that the proposal could open the U.S. market for more broad spectrum sunscreens.
“Other countries outside of the United States have sunscreens that aren’t yet approved here,” he said in an interview. “My hope is that the personal care products industry in the United States can work in partnership with the FDA so that in the future we have even more choices beyond what we currently have now for commercial sunscreen products in the United States.”
The experts also discussed specifics on how the FDA proposal could set into motion the first such change to FDA labels since 2012. At that time, labels clarified the definition of broad spectrum, allowed consumers to understand the risks of using an SPF of less than 15, and explained more precisely how long the SPF can retain its protection.
“The newly announced proposal calls for raising the maximum SPF value labels from 50 plus to 60 plus. The FDA also wants public comment on SPF sunscreens that are 15 and below to see if there is a need for such products, since lower numbers haven’t really shown much anti-skin cancer or anti-aging for safe benefit,” Desai said.
“The FDA will also take a look at simplifying labels so the public has a better understanding and doesn’t get as confused and overwhelmed when they go to the store,” Desai added.
Brod and Zeichner said the proposed label changes will go beyond the SPF levels visible on the front of sunscreen products.
“The FDA proposal classifies two sunscreens as safe and effective — titanium dioxide and zinc oxide — although these tend to be white and opaque on the skin. In addition, the proposal classifies two ingredients as not being generally regarded as safe and effective (GRASE) and these ingredients are PABA and trolamine salicylate. If the FDA did move forward with the proposal, the companies responsible for the testing would be able to file for a delay so that they have more time to comply with the safety testing,” Brod said.
“Currently, the SPF value listed on sunscreen bottles only identify protection against UVB rays. The proposed new rule calls for sunscreen with SPF 15 or higher also be labeled as broad spectrum to provide adequate protection against UVA rays as well. These are the rays that penetrate deeper into the skin and are responsible for the development of skin cancers and early wrinkling,” Zeichner added.
Suzanne M. Olbricht, MD, FAAD, president of the American Academy of Dermatology Association said in a statement that her society looked forward to working with the FDA as it finalized the rule.
She also provided important takeaways from the FDA announcement that clinicians should remember as the rule goes through the review process.
“It’s important to understand that the proposed rule does not conclude that the sunscreens currently on the market are unsafe,” Olbright said. “As the proposed rule is finalized, we encourage the public to continue protecting themselves from the sun’s harmful ultraviolet rays.”
How PCPs can comment
The public can comment on the proposed rule until 11:59 p.m. EST on May 28, 2019. Instructions on how to do so can be found at: https://www.federalregister.gov/documents/2019/02/26/2019-03019/sunscreen-drug-products-for-over-the-counter-human-use. – by Janel Miller
References:
American Academy of Dermatology. “Sunscreen FAQs.” https://www.aad.org/media/stats/prevention-and-care/sunscreen-faqs. Accessed March 5, 2019.
American Cancer Society. “Choosing the right sunscreen.” https://www.cancer.org/latest-news/choose-the-right-sunscreen.html. Accessed March 5, 2019.
Prado, G. “Patient knowledge of FDA-mandated sunscreen labelling terminology.” Presented at AAD Annual Meeting, March 1-5 2019, Washington D.C.
Wilson BD, et al. J Clin Aesthet Dermatol. 2012 Sep; 5(9): 18–23.
Disclosures: Desai reports serving as a consultant for several companies that make sunscreen and being a member of an FDA committee, but adds these responsibilities do not interfere with his comments. Olbricht is president of the American Academy of Dermatology Association. Zeichner reports no relevant financial disclosures. Healio Primary Care Today was unable to determine Brod’s financial disclosures prior to publication.