‘Clear as mud’: Why the FDA has not approved new sunscreen ingredients
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Key takeaways:
- The FDA has not approved new sunscreen ingredients in decades due to sunscreen's classification as a non-prescription drug.
- New ingredients must be tested, which has delayed the arrival of new formulas.
The FDA has not approved a new sunscreen ingredient since the 1990s, leaving consumers and clinicians wondering why.
“Just know that at the end of this conversation you are going to be really confused, because I am really confused and I am very knowledgeable on this topic,” Heather D. Rogers, MD, FAAD, a dermatologist in Seattle, told Healio, echoing the sentiments of many physicians across the country regarding this long-standing question — what is keeping the U.S. from allowing better sunscreens?
While many consider the answer to be black and white, consisting of an opinion along the lines of “Europe has better sunscreens, so why shouldn’t we?” the reality is actually much more complicated.
At the root of the controversy is a 1938 U.S. law called the Federal Food, Drug, and Cosmetic Act that requires sunscreens to be classified as over-the-counter drugs rather than cosmetics.
In the U.S., products are classified as drugs if they are “intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease” or “affect the structure or functions of the human body.” On the other hand, a cosmetic is used to “cleanse, beautify, promote attractiveness or alter appearance.”
Since the daily application of sunscreen is recommended to prevent skin cancer and directly alters the way the skin responds to ultraviolet rays, it landed squarely in the FDA’s drug category. This stands in stark contrast to Europe and Asia, where sunscreens are considered cosmetics and are exempt from rigorous regulations.
While the public and media tend to vocalize a desire to emulate European policies, many dermatologists note the nuances of this issue.
“I think if we’re going to tell people that they need to use something on a regular basis to protect themselves from the sun, we need to know what the implications are of that,” Rogers said.
As someone who had to go through the FDA approval process himself for his sunscreen brand, Anthony Rossi, MD, FAAD, FACMS, assistant attending of dermatologic, Mohs, cosmetic and laser surgery at Memorial Sloan Kettering Cancer Center and founder of Dr. Rossi Derm MD Skincare, also believes the FDA’s process is ultimately beneficial.
“We want these ingredients to be safe,” he told Healio. “So, I think that the way we process sunscreens here is good. However, there are pros and cons.”
One such pro includes properly vetting ingredients to ensure they are safe. In 2019, the FDA issued a proposed rule stating that two of the 16 ingredients used in sunscreens — zinc oxide and titanium dioxide — are considered generally recognized as safe and effective (GRASE). These make up the active ingredients in mineral sunscreens.
Two other ingredients — aminobenzoic acid (PABA) and trolamine salicylate — which were used in chemical sunscreens, are now considered not GRASE due to risks for toxicity, allergic reactions, sensitization to other drugs and bleeding.
As for the remaining 12 ingredients, the FDA decided that more safety information was needed after determining that there was insufficient data proving their safety. For example, recent data showed that oxybenzone, one of the 12 ingredients, is absorbed through the skin more than previously thought and was present in human breast milk, amniotic fluid, urine and blood plasma.
Animal studies have also demonstrated that chemical sunscreens can disrupt the endocrine system; however, this has not been fully vetted in humans, according to Rossi. Furthermore, many clinicians have argued against the validity of those results, stating the sunscreen dose given to the animals was not equivalent to a quantity anyone would use in their lifetime, according to Rogers.
When asked about the validity behind these findings as well as the approval status for new sunscreen ingredients, the FDA did not respond to Healio’s request for comment.
Regardless, the FDA has shown an eagerness to “do its due diligence” in vetting the safety of products, Rossi explained positively. However, logistics have clouded these good intentions, and this is where the cons of the FDA’s process become glaring.
In the 2019 proposed order and a 2021 deemed final order, the FDA tasked sunscreen manufacturers with the job of testing the safety of the ingredients they are using.
“This is one of the reasons why we do not have more ingredients,” Rogers explained. “The FDA is requiring so much testing which costs millions and millions of dollars and companies do not want to do that work.”
Additionally, handing the responsibility of testing over to the manufacturers poses a risk for inherent bias, according to Rogers, which she deems as “concerning.” But above all, the largest hurdle that must be overcome to bring better sunscreens to the U.S. is animal testing.
“Because of the law that categorizes sunscreen as a drug, you have to go through rigorous testing, including animal testing, to get any new ingredient approved,” Rossi explained. “Most manufacturers are not testing on animals now, nor do most people want animal testing, so they are really not approving new sunscreen ingredients.”
After submitting requests for meetings nearly a decade or more ago to get popular European ingredients such as bemotrizinol and ecamsule approved, European companies BASF Corp. and L'Oréal received letters from the FDA stating that more data were needed to prove the ingredients were GRASE. However, because the EU has banned animal testing for cosmetics, including sunscreens, the companies face the risk for consumer backlash if they want their products approved in the U.S.
In a positive turn of events which occurred earlier this year, Congress introduced the FDA Modernization Act 3.0, proposing that the FDA establish a process that supports nonanimal testing methods for drug development. The act is currently being considered in the House and, if passed, could alter the landscape of sunscreen development in the U.S.
“We are headed in a good direction,” Rossi said. “But like anything in the government, it’s not going to happen overnight.”
This waiting game comes as a blow to Americans who believe these European and Asian formulations are much better than those in the U.S.
“Those products are more cosmetically elegant, they are more photostable, you can reapply them less often and they provide broader spectrum protection,” Rogers affirmed. “So, in those regards, the EU sunscreens are better.”
While the sunscreen in the U.S. does provide good broad-spectrum protection, experts insist that there is room for improvement.
“Some countries, particularly those in the EU, follow higher standards for broad spectrum protection to ensure consumers get adequate protection from both UVA and UVB rays,” Emily Spilman, BE, program manager of the Environmental Working Group’s Healthy Living Science Program, told Healio. “Sunscreen manufacturers outside the U.S. also have access to many more ingredients that may be safer for our health and better at protecting against UV rays.”
However, according to Rogers and Rossi, more ingredients do not always mean safer ingredients.
“They are not necessarily safer,” Rossi said. “They do have good safety data, but they also haven’t gone through as rigorous testing as the FDA has mandated.”
Because sunscreen ingredients in the EU have not been tested the way ingredients in the U.S. have been, there is no data supporting the claim that the EU’s sunscreens are safer when absorbed in the skin, contrary to what many believe.
“I feel like there’s so many people out there saying the FDA is the worst and we would have better sunscreens if it weren’t for them and everything in Europe is perfect,” Rogers concurred. “But it’s not. It’s not perfect. This doesn’t mean that there aren’t some things we can learn and benefit from, but I think it would be great if the EU tested these ingredients a little bit more and the U.S. was a little less stringent.”
Ultimately, the real killer is not the chemicals in sunscreens but the increasing rates of skin cancer. According to the American Academy of Dermatology, nearly 20 Americans die from melanoma every day. In contrast, chemical sunscreens have been used for decades and researchers have not observed any real safety signals. As a result, dermatologists highly advise individuals to continue wearing sunscreens as the benefits greatly outweigh the little-to-no risks.
“We’d much rather you use chemical sunscreen than get cancer,” Rossi said. “But, if you’re worried, just use a mineral sunscreen. They do not get absorbed into the skin and they do a great job at blocking both UVA and UVB while remaining broad spectrum.”
So where does all this leave the U.S. in receiving new sunscreens? Waiting. The FDA’s deemed final order does not “take effect” until it is finalized, which could have occurred a year after the order’s most recent release in 2021 but has not.
“The FDA should finalize their proposed monograph and sunscreen chemical manufacturers need to do safety testing to ensure their ingredients are not causing long-term harm,” Spilman said.
According to Rossi, the delay could be attributed to the fact that the FDA is very “backlogged.” Regardless, the FDA’s actions — or lack thereof — may be villainized by the public and media, but the reality of the situation is much more complicated, or, as Rogers puts it, “clear as mud.”
References
- Cosmetics & U.S. law. https://www.fda.gov/cosmetics/cosmetics-laws-regulations/cosmetics-us-law#:~:text=Certain%20claims%20may%20cause%20a,varicose%20veins%2C%20or%20revitalize%20cells. Updated May 2, 2024. Accessed Aug. 27, 2024.
- Sunscreen drug products for over-the-counter human use. https://www.federalregister.gov/documents/2019/02/26/2019-03019/sunscreen-drug-products-for-over-the-counter-human-use. Published Feb. 2, 2019. Accessed Aug. 27, 2024.
- Questions and answers: FDA posts deemed final order and proposed order for over-the-counter sunscreen. https://www.fda.gov/drugs/understanding-over-counter-medicines/questions-and-answers-fda-posts-deemed-final-order-and-proposed-order-over-counter-sunscreen#:~:text=On%20September%2024%2C%202021%2C%20FDA,for%20marketing%20OTC%20sunscreen%20products. Updated Dec. 16, 2022. Accessed Aug. 27, 2024.
- Regulatory policy information | Sunscreen Innovation Act. https://www.fda.gov/drugs/guidance-compliance-regulatory-information/regulatory-policy-information-sunscreen-innovation-act. Updated Sept. 2, 2021. Accessed Aug. 27, 2024.
- Over-the-counter sunscreen drug products: Regulatory status of ecamsule. https://www.federalregister.gov/documents/2015/02/25/2015-03883/over-the-counter-sunscreen-drug-products-regulatory-status-of-ecamsule. Published Feb. 25, 2025. Accessed Aug. 27, 2024.
- H.R.7248 - FDA Modernization Act 3.0. https://www.congress.gov/bill/118th-congress/house-bill/7248. Published Feb. 9, 2024. Accessed Aug. 27, 2024.
- Skin cancer. https://www.aad.org/media/stats-skin-cancer. Updated June 4, 2024. Accessed Aug. 28, 2024.
For more information:
Heather D. Rogers, MD, FAAD, can be reached at drrogers@mdinseattle.com.
Anthony Rossi, MD, FAAD, FACMS, can be reached at Anthony@RossiDerm.com.
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