Why the US is Lagging Behind in Sunscreen Innovation
The State of Sunscreen in the US
After months of prompting, I have finally managed to help my husband form a daily sunscreen habit. Whenever I see traces of paper white cream in his dark beard, I think, We’re halfway there.
Hoping to avoid the white cast, heaviness and greasiness common in many sunscreen products available in U.S. drugstores, some Americans, including Representative Alexandria Ocasio-Cortez of New York, have taken matters into their own hands, opting for sunscreens manufactured abroad. In a recent interview, the congresswoman said she toggled between Bioré in the summer and Beauty of Joseon in the winter — two Asian brands that employ active ingredients not approved for use in the United States.
“The technology is very sophisticated,” Ms. Ocasio-Cortez said. “You don’t feel like you have a layer of sunscreen on, and it kind of just feels like you’re putting on a moisturizer in that sense, which makes it easier to use.”
The FDA’s Role in Sunscreen Regulation
While sunscreen is regulated as a cosmetic in major skin-care hubs like South Korea, Japan and the European Union, in the United States, it falls under the purview of the Food and Drug Administration. Any drug product marketed to American consumers must be approved by the F.D.A., and because sunscreen “makes a drug claim” — namely, that it can prevent sunburn, decrease the risk of skin cancer and mitigate early skin aging — the agency regulates it as an over-the-counter drug.
The last time the Food and Drug Administration approved new active ingredients for use in sunscreens was more than two decades ago, and at times it can feel as if the rest of the world has surpassed the United States in the development of new sunscreen formulations and protocols. Skin-care influencers on TikTok and Instagram are in a near-constant state of frenzy over exciting new products and innovations that are nowhere to be found on American shelves. Currently there are 14 sunscreen filters approved for use by the F.D.A. The European Union employs more than 30.
Frustrated by what seems to be a wealth of more exciting options for sun protection overseas, skin-care-conscious Americans have been quick to point the finger at the F.D.A. for the delay in approving new active ingredients. But according to Ms. Ocasio-Cortez, the agency is not to blame for the holdup, at least not entirely.
“I think the assessment here is that Americans need sunscreen, and they have sunscreen,” she said. “Are there other avenues that we can use in order to kind of break through this standstill? Yeah.”
Congress has begun a “preliminary, early process” of examining what a better approval procedure might look like, she said: a way that pushes the manufacturers of sunscreen filters to do the appropriate research and development to submit drug information to the F.D.A. for approval.
“I also think it’s very important that we maintain a level of rigor around safety,” Ms. Ocasio-Cortez said. “We want to make sure this is not about advocating for the deregulation of these filters.”
The Challenges of Sunscreen Innovation in the US
Many sunscreen ingredients that have appeared in foreign-made sunscreens for decades, favored by consumers for their ease of use, are still awaiting approval by the F.D.A. The ultraviolet-filtering compounds amiloxate, enzacamene and octyl triazone, for instance, have all been stuck in the F.D.A. regulatory pipeline since at least 2003.
In November 2014, President Barack Obama signed the Sunscreen Innovation Act into law. The legislation gave the F.D.A. five years to approve or deny the use of new sunscreen ingredients, including several that had been under review since 2002. In 2019, the F.D.A. reaffirmed the safety of titanium dioxide and zinc oxide in mineral sunscreens and asked manufacturers for more information on 12 other ingredients.
“They said you can continue to market products and utilize these but we want to see more data,” said Thomas F. Myers, executive vice president for legal and regulatory affairs at the Personal Care Products Council, a trade group representing companies that make cosmetics and personal care products. As long as the F.D.A. continues to defer a final decision on a product, Mr. Myers said, it remains eligible for use on the market.
In 2020, the CARES Act included a change in the approval process for over-the-counter drugs.
Under the new procedure, the F.D.A. asked for more information from manufacturers on new sunscreen filters, essentially kicking the can — or bottle — back over to them but not flat-out denying approval. The 14 chemicals moved up from 2019 to 2020 to satisfy the CARES Act are the chemicals allowed for use now.
In a statement, the F.D.A. said it was committed to helping “facilitate the marketing of sunscreen products that include additional over-the-counter sunscreen active ingredients.” It continued, “To do so, the F.D.A. relies on industry to submit the data needed to make safety and effectiveness determinations for these ingredients.”
The Importance of Sun Protection
Although skin cancer remains the most common type of cancer in the United States, the worrisome rates of the disease cannot be blamed on a lack of new sunscreen filters, according to Dr. Steven Q. Wang, chairman of the Skin Cancer Foundation’s photobiology committee.
The current rate of skin cancer in the United States is a result of the last 50 years, Dr. Wang said. Even today, new diagnoses are the legacy of the lack of awareness of sun damage in the 1950s, as well as the sun tanning and tanning bed culture of the 1980s and ’90s.
“Sunscreen is only a part of the overall protection,” said Dr. Wang, who is also a member of the Public Access to SunScreens Coalition. The other parts? Avoiding sunlight during the hours of most intense daylight, seeking out shade and wearing protective clothing.
U.S. sunscreen manufacturers, he added, have done “a pretty good job with the existing UV filters to make a superior, better sunscreen to protect Americans.”
The Path Forward
Although there are many potential solutions, the onus to provide the greatest possible sun protection to Americans is on Congress, Ms. Ocasio-Cortez said, adding that there had not been much attention on the matter since Mr. Obama signed the Sunscreen Innovation Act in 2014.
“It just doesn’t seem that this issue has risen to a level of awareness in Congress that creates the political momentum necessary to make things a priority,” Ms. Ocasio-Cortez said. “What I’m very excited about is that it does seem like there is a growing awareness among everyday people about this issue.”
Across her various platforms, she is trying to foster that political momentum. On Thursday, the congresswoman posted an Instagram video in which she told her 1.5 million followers that “U.S. sunscreens are far behind the rest of the world,” adding, “We deserve better here in the U.S.”
Online, influencers have been more outspoken about sunscreens, developing their own rules of thumb for use and creating videos of themselves trying one brand after another to determine which takes to the skin best. New, targeted brands like Black Girl Sunscreen populate the shelves at Target. Americans are branching out when it comes to the sunscreens they want to use.
“That, I think, is also creating a certain political and popular and cultural momentum that’s necessary for us to actually make changes around these things,” Ms. Ocasio-Cortez said.
“I don’t think this is a left or right flashpoint,” she added. “I think this is something that all people need.”