Thanks in part to the U.S. Food and Drug Administration (FDA), Americans do not have access to all sunscreens
The United States is in the full throes of summer. After a rainy spring, summer arrived in my home state of Texas a couple of months ago. The sun has burned off the cloud cover, and my grass has begun to fry. Hello, big water bills!
The grass is not the only thing the sun fries in Texas (and elsewhere). It also fries Americans’ skin.
Skin cancer is the most common form of cancer in the United States. One in five Americans will develop skin cancer within their lifetimes. In the past few decades, Americans have become increasingly aware of the danger of skin cancer and the need to wear sunscreen.
Improvements Stalled
American sunscreens suck. The newer sunscreens sold in Asia and Europe are far better. By “better,” I mean they work better, they feel better, they go on smoother, and they are less greasy. The sunscreens sold in other countries are superior in all the attributes that make slathering on American sunscreens unpleasant.
Thanks in part to the U.S. Food and Drug Administration (FDA), Americans do not have access to these sunscreens. The only ingredients allowed in over-the-counter personal care products in the U.S. are those that are “generally recognized as safe and effective (GRASE).”
The GRASE List may sound benign, but it is not. If an ingredient is not on the GRASE List, it’s not allowed in products sold over the counter. The FDA currently allows 17 UV filters in American sunscreens. Of those, only eight are typically used, because the others have undesirable side effects, have textures that don’t lend themselves to skin care products, or are difficult to manufacture.
The FDA has not approved a new sunscreen ingredient since 1999, which means the sunscreens Americans have access to have not changed in decades. A 2014 law, called the Sunscreen Innovation Act, was an attempt to force the FDA to fast-track approvals of more advanced sunscreen ingredients. It did not work. Congress tried again in 2020, and the jury is still out on whether that will work.
Clinical Testing Roadblock
Here is the problem: the FDA considers the evidence for the newer UV-blocking ingredients, safely used by hundreds of millions of people for more than a decade, as anecdotal. Anecdotes are not data. The Europeans and Asians who have safely used newer sunblock were not part of any clinical study. In Europe, for example, sunblock is categorized as a cosmetic and thus does not require clinical testing to obtain the government’s permission to manufacture.
In the United States, by contrast, sunblock is regulated by the FDA. The FDA invited manufacturers to submit costly clinical studies on safety and efficacy. That is a tough sell because (1) clinical trials are expensive, and (2) the data proving the ingredients for the GRASE List are safe would allow competitors to produce a competing sunscreen.
In other words, no company has an incentive to be the first and bear the cost of clinical trials, because it would not recoup the cost.
It is not that the FDA believes newer sunscreen ingredients are unsafe. It happens because bureaucrats want the process to comply with how they believe the process should work. They want a costly paperwork exercise so they can file it away as evidence that newer UV blockers are safe enough to be added to the GRASE List.
Unnecessary Bother
As a result, when millions of Americans head outdoors this summer and hit the beach, visit local lakes, or do other outdoor activities such as hiking, biking, baseball, picnics, cookouts, and pool parties with friends, they will have less protection from the sun than their European counterparts.
Many Americans will slather on a greasy type of sunblock before heading outdoors for activities in the sun, and others will skip it. Many will forget to reapply sunscreen after a few hours, and they will get burned. More people would probably use sunscreen if better, more pleasant products were available at the local drugstore.
They would be available if the federal government would get out of the way.
Devin Herrick, Ph.D. (devonherrick@sbcglobal.net) is a health care economist. An earlier version of this article was published on the Goodman Institute Health Blog. Reprinted with permission.
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