Jeffrey A. Singer
With summer upon us, many American consumers are purchasing sunscreens to protect themselves from the ultraviolet rays that can cause skin cancer. Unfortunately, government regulations limit consumers’ choices to decades-old formulations that offer less comprehensive protection than the options available to people in other countries.
The Food and Drug Administration last approved a sunscreen product in 1999. Many dermatologists recommend sunscreens available in Australia, the European Union, South Korea, Japan, and other countries, but the FDA restricts these options for American consumers. These sunscreens offer significantly better protection against ultraviolet rays (UV‑A and UV‑B) than their US counterparts. Many dermatologists inform their patients about the superior protection provided by these international products. Several of these products are also less likely to cause allergic reactions. Many Americans stock up on sunscreens from Australia, Europe, or South Korea when traveling abroad. However, not every American can afford to travel the world.
Australian, Asian, and European sunscreens generally contain newer UVA filters (like bemotrizinol) that offer stronger and broader UVA protection. In contrast, US sunscreens often focus on UVB protection (which prevents sunburn) but usually provide less effective UVA coverage, which is responsible for deeper skin damage and aging.
The FDA approval process causes the US to lag behind Europe and other developed countries in sunscreen availability. Under the Food, Drug, and Cosmetic Act of 1938, the FDA regulates sunscreens as over-the-counter drugs, requiring them to undergo lengthy clinical safety and efficacy trials. Most other countries regulate sunscreens as cosmetic products.
The FDA does not require premarket approval for cosmetics, except for color additives. Manufacturers are responsible for ensuring product safety, but they do not need to submit data before marketing. The FDA mandates that cosmetics manufacturers label their products truthfully and avoid making claims that cross into drug territory (e.g., “treats acne” or “heals sunburn”), as such claims would classify the product as a drug. The agency permits a wide range of ingredients in cosmetics and bans only a few, such as mercury and certain color additives.
The EU approved bemotrizinol, an effective UVA and UVB filter, as a sunscreen ingredient in 2000, and Australia followed suit in 2004. Health Canada, which regulates some sunscreen products as over-the-counter drugs, approved bemotrizinol (marketed as Tinosorb S) in 2023, allowing Canadians to access the product. Axios reports that the FDA has been evaluating data provided by the Swiss chemical manufacturer of bemotrizinol, DSM-Firmenich, raising hopes that it may soon eliminate barriers for American consumers seeking to purchase sunscreens that contain this sunblocker. DSM-Firmenich has spent more than 20 years and 18 million dollars seeking FDA approval thus far.
But even if the FDA eventually unblocks American consumers’ access to bemotrizinol, there are several other sun filters that it will prevent them from obtaining, which consumers in other advanced countries currently access. Examples include Tinosorb M (bisoctrizole), Mexoryl SX, Mexoryl XL, and Uvinal A Plus.
In Your Body, Your Health Care, I discuss what health economists refer to as “drug lag”:
Drug lag refers to the additional time that the FDA’s proof‐of‐efficacy requirement forces consumers to wait before they may access a drug. Every day that the FDA adds to the drug development and approval process is a day that the agency denies consumers their right to self‐medicate with that drug. Drug lag is cruelest to terminally ill patients, to whom it denies the right to try to save their lives by using drugs that have already been proven safe but are awaiting efficacy approval. Many seriously ill Americans die waiting for the FDA to approve drugs that regulators in other countries have already approved.
While I propose alternatives to the government monopoly on the drug approval process in the book, I also suggest a more politically feasible interim reform that policymakers refer to as international drug reciprocity.
Economists write about “the seen and the unseen.” As the 19th-century French economic polemicist Frederic Bastiat put it:
There is only one difference between a bad economist and a good one: the bad economist confines himself to the visible effect; the good economist takes into account both the effects that can be seen and those effects that must be foreseen.
How many cases of skin cancer could have been prevented if the FDA eliminated barriers to Americans using the best sunscreens available? We’ll never know—but the delay is indefensible.