Representative Alexandria Ocasio-Cortez (AOC as she’s often called) and I agree on one thing. I know it’s hard to imagine but it’s true. We both think the United States deserves better sunscreens and the FDA needs to get off its collective derrière and approve them.
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.”
“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.”
AOC was not just waxing philosophic. She is referring to the two-decade battle to allow Americans to buy superior sunscreen products already sold around the world. Most people probably do not recall the Sunscreen Innovation Act (SIA) of 2014. That’s when Congress got so tired of the U.S. Food and Drug Administration (FDA) dragging its feet on approving new sunscreen ingredients that Congress passed a bill and then President Obama signed it into law. The SIA was supposed to prod the FDA into approving new sunscreen ingredients, but it didn’t work.
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 FDA approved a new sunscreen ingredient was two dozen years ago.
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.
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.
On this AOC and I will have to agree to disagree. The FDA basically told the manufacturers of new ingredients used in Europe and Asia they needed to conduct studies and provide data on the safety of use. Millions of people living in Europe and Asia using the new, more advanced sunscreens are anecdotes, not data. The FDA wanted studies but no one company had an incentive to conduct costly studies, since approval would benefit not just them but also numerous other companies. AOC seems to suggest Congress needs to find a way to streamline getting the companies to comply with FDA’s request, not get the FDA to streamline their bureaucracy. The FDA is so duty bound by regulations and adherence to bureaucracy it probably does not know who to move forward.
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.”
Go figure! The biggest case study in the world is everyone else in the world using better sunscreens, but that’s not good enough for the FDA. The issue is ingredients used in OTC products need to be on the so-called GRAS list. This is an FDA listing of ingredients generally recognized as safe (GRAS). It is difficult to prove a negative. That is, it is easier to identify the presence of danger than the absence of danger. The FDA seemingly has no procedures (nor desire) to change their system and use 20 years of anecdotal data to add 14 sunscreen ingredients to the GRAS list.