FDA Blocks Better Sunblocks

July 4^th is just around the corner on my calendar, but summer has already arrived in Texas. After a rainy spring, the sun has finally burned off the cloud cover and has begun to fry my grass. 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. American sunscreens suck. By contrast 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. They are superior at all the attributes that make slathering on American sunscreens unpleasant.

Thanks in part to the U.S. Food and Drug Administration (FDA) we not allowed to have the new sunscreens available elsewhere. The only ingredients allowed in over-the-counter personal care products in the United States are those that are generally recognized as safe and effective (GRASE) by the FDA. 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, 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.

Here is the problem: the FDA considers 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 a cosmetic, thus it does not require clinical testing to manufacture. By contrast sunblock in the U.S. 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. 2) the data proving the ingredients for the GRASE List are safe would also 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 they would not recoup the cost. It is not that the FDA believes newer sunscreen ingredients are unsafe; it is 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 be added to the GRASE List.

This summer millions of Americans will head outdoors. They will hit the beach, hit local lakes or do outdoor activities like hiking, biking, baseball, picnics, cookouts and pool parties with friends. Many will slather on a greasy sunblock before heading outdoors for activities in the sun, while others will skip it. Many will forget to reapply sunscreen after a few hours and still get burned. More people would likely use sunscreen if better, more pleasant products were available at your local drugstore.