The United States government has been cracking down on cosmetics in recent years. With the Modernization of Cosmetics Regulation Act (MoCRA) taking effect in December 2023, cosmetics companies must now meet new regulatory requirements, including facility and product registration with the Food and Drug Administration (FDA). While beauty brands work to meet these new requirements, the FDA has simultaneously begun revising sunscreen regulations following their 2019 findings that certain ingredients can be absorbed through the skin into the body. These revisions now include requirements for animal testing of chemical sunscreen ingredients, despite years of existing human data supporting their safety.
“In the time since sunscreen ingredients were originally evaluated, new data have shown that many of them—which were previously thought to stay on the surface of the skin—are actually absorbed through the skin and into the body,” an FDA representative explained to BeautyMatter.
“This means that we need to know what these absorbed ingredients do when they are in the human body,” the representative continued. “The FDA routinely evaluates drugs that are absorbed into the body to ensure that the benefits of these products outweigh any potential risks that result from absorption. While many drugs do not show risks from systemic exposure, it is not possible to predict these potential risks under any scientifically valid and reliable method at this time aside from animal studies.”
Given the widespread and routine use of sunscreen by many people throughout the course of their lifetimes, the FDA representative emphasized the critical need to evaluate the potential risks associated with sunscreen exposure.
“In short, the current science does not allow for the replacement of all animal studies with nonanimal methods,” the representative continued. “This is because current nonanimal methods cannot reliably predict effects that may occur through complex interactions between the drug and the human body. Additional research is scientifically necessary before alternative methods can be used routinely for addressing such complex issues.”
How did these seemingly new sunscreen regulations sneak up on the industry so quickly, and what impact will these regulations have on the US sunscreen market? BeautyMatter spoke with advocacy organizations, ingredient suppliers, and beauty insiders to understand the implications of these upcoming regulatory hurdles.
The Complicated History of Sunscreen Regulation
Sunscreen requirements have been up in the air since they were first introduced in the 1970s, but the most sweeping changes occurred within the last few years. In 2019, the FDA proposed a rule to update sunscreen regulations, which included revisions to active ingredient requirements, maximum SPF levels, broad-spectrum requirements, dosage forms, and labeling standards. The intent behind these changes was to modernize sunscreens in accordance with the latest scientific findings, which include new research indicating that some sunscreen ingredients are absorbed into the body through the skin.
In 2020, the Coronavirus Aid, Relief, and Economic Security (CARES) Act was passed by Congress to provide economic relief to individuals and businesses, but the act also included provisions aimed at reforming some over-the-counter (OTC) drugs, including sunscreen. It’s important to note that OTC drugs are regulated by monographs, which are rule books that establish conditions for active ingredients, uses, doses, labeling, and testing. If an OTC drug meets these monograph conditions, it is "generally recognized as safe and effective" (GRASE) and can be marketed without FDA premarket approval.
The CARES Act mandated that the FDA issue a proposed order to amend and revise the deemed final order for sunscreens, which went into effect in March 2020 and established a baseline of current GRASE conditions for sunscreens. Notably, the deemed final order for sunscreens includes specific requirements about active ingredients pulled from a 1999 final monograph regulation for OTC sunscreen products that was never finalized. The 1999 final sunscreen monograph was stayed in 2001 before it could go into effect due to the emergence of new scientific evidence about UVA protection and testing methods.
Despite over two decades of scientific research and advancements, the FDA adopted the requirements for OTC sunscreen products that were outlined in the 1999 stayed final monograph, which was never put into effect. This means that the sunscreen regulations that are currently in effect are based on science from 1999.
The proposed order confirms that sunscreens containing the mineral ingredients zinc oxide and titanium dioxide are GRASE, which means they can continue to be sold on the American market as-is without any additional safety testing.
However, sunscreens containing aminobenzoic acid (PABA), trolamine salicylate, cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone—all of which are considered chemical sunscreen filters—are not classified as GRASE by the FDA due to “safety concerns.” The regulatory body claims that additional data is needed to demonstrate the safety and effectiveness of these sunscreen ingredients.
What Does This Mean for the Beauty Industry?
The beauty industry has accumulated extensive clinical data on human subjects through decades of product use in the market. Companies have shared this data in response to updated regulations and the FDA's safety testing requirements. Sources tell BeautyMatter that the FDA has maintained its outdated approaches to certain types of safety testing, particularly regarding reproductive toxicity and carcinogenicity assessment, despite the availability of this real-world data. According to industry sources, the FDA has privately informed companies seeking approval for products containing non-GRASE sunscreen ingredients that animal studies will be required to demonstrate safety. These studies are not only time-consuming and costly but also frequently yield complex results that don’t always lead to a straightforward conclusion.
Since becoming aware of these concerning regulatory updates, advocacy groups like PETA have been pressuring the FDA to update its outdated safety testing methods. Currently, PETA is only issuing cruelty-free seals for brands that develop sunscreens using the two mineral sunscreen active ingredients that the FDA deemed GRASE. The organization has frozen approvals for brands that develop products containing non-GRASE sunscreen ingredients.
To obtain PETA's cruelty-free certification, companies must verify that neither their ingredient suppliers nor their suppliers' suppliers have conducted animal testing.
“Most companies right now don't really want to go that far back, because as soon as we know that some supplier has started this animal testing, then it ends new cruelty-free designations for everyone [who has relationships with that supplier], and it would result in the ones that are out there being revoked,” Jeffrey Brown, a Senior Scientist at PETA tells BeautyMatter. “So at the moment, we're in this limbo.”
Brown states that several chemical suppliers have committed to testing based on FDA interactions, but he is unsure if any have actually begun. Due to the recent change in administration, which includes a new head of the Department of Health and Human Services and an FDA commissioner who have yet to be confirmed, companies were likely waiting to approach the agency again, hoping for a change of heart.
“This is a political problem, and political problems have political solutions,” says Brown. “It's very difficult to conduct some of these studies, and they cost so much money that no one wants to actually start them until everything is right, and all of the I’s have been dotted and T's have been crossed, so I think it's still quite likely that none of this testing has begun, and that's an optimistic reading of the scenario.”
“But even if it's begun, it doesn't have to finish,” he continues. “All of this testing can stop tomorrow, if the FDA will just listen to reason and modernize.”
BeautyMatter reached out to over a dozen cruelty-free beauty brands to find out what steps they’re taking to prepare for these major regulatory changes but none were willing to comment publicly on the issue.
“Cosmetic companies are probably not trying to publicize it yet, because the backlash would be tremendous,” Tamar Kamen, a beauty product developer, tells BeautyMatter.
Kamen first learned about these potential regulatory issues when she attempted to acquire PETA's cruelty-free seal for a chemical sunscreen she was developing. Today, most “clean” beauty brands actively seek out these certifications to substantiate their animal testing claims, which have become a baseline expectation among conscious consumers.
“For the first time, we can't get a PETA seal on it,” she says. Kamen expects that this will result in a broad consumer backlash for all brands that develop chemical sunscreens and therefore are now ineligible to receive PETA’s cruelty-free seal.
“Unless there's a huge education campaign, it'll [lead to] negative backlash for the brand and not the party that's responsible, and the party that's responsible is the FDA.”
Kamen notes that many beauty brands specifically avoid entering the Chinese market because of the country’s premarket animal testing requirements. Beauty brands would rather avoid the lucrative market altogether than compromise their cruelty-free status.
The new sunscreen requirements will affect certain groups of people more than others. While Kamen acknowledges that the American market is shifting towards mineral sunscreen, many formulations still leave a white cast on the skin, which means that people with lighter skintones can use mineral sunscreen more easily than people of color. “This is setting us back decades,” she says.
The FDA hasn’t approved a new sunscreen ingredient since 1999, but recently, there’s been talk about a new sunscreen filter that the FDA is supposedly approving soon. Because these new sunscreen requirements apply to both new and existing sunscreen ingredients, any new ingredient will also be subject to these additional safety testing measures until it is officially classified as GRASE by the FDA.
Beauty brands and consumers have been begging for sunscreen ingredient innovation for years, but will they still want this buzzy new ingredient if they know it’s been tested on animals? Kamen isn’t so sure. She was hoping to use the new ingredient in an upcoming sunscreen formulation but has since put those plans on hold.
Ingredient suppliers are also pausing their efforts to bring new ingredients to the US due on this new required testing. BASF Care Chemicals, a beauty ingredient supplier headquartered in Germany, offers an extensive array of UV filters and other sunscreen products. The company has been actively involved in developing, validating, and advocating for animal-free testing methods for decades. Previously, BASF submitted various UV filters for registration in the US.
“Due to extraordinarily high additional requirements set by the U.S. FDA, which included further animal studies despite the proven safety of the ingredients, and unclear regulatory outcomes, BASF decided not to proceed with the registration,” a representative confirmed to BeautyMatter.
Presperse, a beauty ingredient supplier, does not manufacture sunscreens directly. However, the ingredient supplier is already preparing for the regulatory shift's industry-wide impact.
“These proposed regulations, if not modified, could limit the number of available sunscreen filters, due to consumer nonacceptance of ingredients that underwent animal testing,” Dr. Daphne Benderly, Director of Research & Development at Presperse, tells BeautyMatter. “In that case, innovation will be focused on sunscreen formats and textures when using mineral sunscreen filters.”
Benderly notes that Presperse's scientific team is currently researching cosmetic powders already used in the industry as "SPF boosters,” an approach that could help cosmetic companies achieve higher SPF ratings with mineral filters.
What Happens Next
Aside from the change in government, one reason why companies have held off on planning these animal studies is that the FDA has intentionally not set a deadline for when safety testing will be required. It could be tomorrow, or it could be never, Brown says. The FDA hasn’t given a clear reason for why they’re insisting on animal studies when companies already have years of human data that they’re willing to share with the FDA that prove safety.
“They're not willing to say the FDA is requiring all this new animal testing,” he says. “They're just hoping that companies will give into the pressure … It's not what you expect of a very important regulator; you expect them to be very clear about why they're making decisions.”
PETA has initiated a request for a meeting with the new FDA commissioner to hopefully get some answers. A group of sunscreen companies has presented a modernized plan for evaluating human safety risks, already in use in many other parts of the world, to the FDA. The FDA has an obligation to respond to public sentiment, which is why Brown is encouraging both companies and citizens who are against animal testing to voice their concerns.
“This new administration does seem to have a renewed focus on improving government efficiency, so it would be a wise step for companies to re-approach the FDA and make the case again that they believe that their science is much better, and the route that the previous FDA has recommended is excessively expensive and is not going to improve human safety,” says Brown.
The FDA's requirement for animal testing sends an implicit message to consumers across the globe about the safety of these sunscreen active ingredients, despite their long history of use. Unless the FDA knows something that beauty brands and other major regulatory agencies around the world don’t, this requirement appears to conflict with decades of real-world evidence and international scientific consensus. Organizations around the world and here in the states believe in the safety of chemical sunscreen ingredients.
“The sunscreen ingredients currently FDA-approved have been used in the US for many years, and there is no evidence that these ingredients are harmful to humans,” Steven Q. Wang, MD, Chair of The Skin Cancer Foundation’s Photobiology Committee, tells BeautyMatter. “The Skin Cancer Foundation encourages further research on the 12 sunscreen ingredients that have not yet been deemed GRASE, in hopes that additional data can help the FDA come to a conclusion about the safety of these UV filters. We also hope the FDA will take action in approving new sunscreen ingredients that could help diversify consumer choices.”
So, where do brands go from here? Sources say it’s a bit of a waiting game until the FDA either changes its stance on animal testing or provides a timeline on when they want these studies to be done. Until then, ingredient suppliers and brands are at a standstill. They can continue to develop chemical sunscreens, knowing that it's a possibility that they might have to test the ingredients on animals to meet the new sunscreen requirements. Organizations like PETA will continue their work with the FDA to convince them that science already exists to prove human safety.
In recent years, politicians have made attempts to bring the issue of sunscreen regulations to light both in Washington and in the greater public consciousness. U.S. Senator Cory Booker of New Jersey sent a letter to the FDA Commissioner speaking out against the proposed animal studies in December. In it, Senator Booker requested clarity on whether the FDA will explicitly require manufacturers and/or ingredient suppliers to test existing and novel sunscreen ingredients on animals and whether the FDA plans to remove sunscreens from the market if they are not tested on animals, among other questions. In 2023, U.S. House Representative Alexandria Ocasio-Cortez took to Instagram to speak out about the poor quality of sunscreens in the US compared to other countries and asked her 1.5 million followers to contact their congresspeople to advocate for a change in federal sunscreen regulations.
The FDA intends to issue a final order regarding the GRASE status of any chemical sunscreen ingredient once sufficient evidence is available to determine whether sunscreens containing that ingredient are considered GRASE. Additionally, the FDA could consider deferring further action to allow additional time for data to be developed and submitted. If these studies will, in fact, be required, the costs will inevitably be passed down to consumers.
“The FDA is committed to working with interested parties to help reduce reliance on animal-based studies to the extent possible but recognizes there are still many areas where animal studies are necessary to answer important safety questions,” a representative told BeautyMatter. “The FDA continues to encourage industry to submit such alternative methods for validation so we can continue to reduce reliance on animal studies.”
Beauty brands are seemingly already responding to the FDA’s increased regulatory sunscreen scrutiny. Beauty of Joseon recently announced they will be pulling the Korean versions of some the brand’s most viral sunscreens from their site because the products contain ingredients that are not approved by the FDA.
While Korean brands like Beauty of Joseon may have gotten away with selling their products online through platforms like Stylevana and Olive Young in the states in the past, it is still considered illegal to sell anything with a sunscreen claim and ingredients that aren’t approved. In light of these new regulatory and administration changes, Korean brands that want to do business in the states are being extremely cautious to avoid getting in trouble with the FDA. Korean sunscreens are popular with American consumers because they contain innovative chemical sunscreen ingredients that aren’t available in the states. European sunscreens are popular for the same reason, but these products will likely become harder to come by as the FDA intensifies its oversight of chemical sunscreen ingredients.
“The ultimate fate of UV filters in the US has the potential to catalyze significant change to the sunscreen choices available to the US consumer, as well as beauty businesses offering sunscreen products,” says Meredith Petillo, Vice President of Technical and Regulatory Affairs at the Independent Beauty Association. “The testing requirements for existing UV filters could have an impact on new brands entering this product space or limit innovation. It seems likely that this will challenge brands to really delve into understanding the complexities of the regulatory space governing this product category and make informed decisions about how to best understand their customers, and what communication on this topic will need to look like.”
These ongoing regulatory hurdles provide a chance for brands to have transparent and open conversations with their consumers who are already reeling from the sudden removal of popular Korean sunscreens from the market.
“Consumers expect transparency and are increasingly interested in understanding the nuance and complexity of this fascinating industry,” says Petillo. “Communication on complex subjects like global regulatory requirements for animal testing for cosmetics and how those regulations can overlap and sometimes conflict with other regulated product categories is not easily distilled into a quick soundbite. Indie brands wishing to communicate and educate their customers in this space should build a strong cross-functional team that may include colleagues from regulatory, legal, formulation, and product development, in addition to marketing and communications.”
