Cosmetic or Drug? The FDA's Classification of Sunscreen Limits Which Products Hit US Shelves

As stifling rays of sunshine beat down across the United States, it’s the time of year citizens flock to the store to load up on sun protection.

It’s also the time of year consumers and media raise the annual question of why Europe is able to market sunscreen that contains more potentially effective ingredients, but the U.S. isn’t.

The answer is not related to sunscreen or its ingredients, but rather how the country’s regulatory body – The Food and Drug Administration (FDA) – legally operates.

“In order for the FDA to legally regulate products, those products are given classifying labels,” said Ana Santos Rutschman, a professor of law at Villanova University who studies health law. “A toothbrush, for instance, is labeled a medical device. That’s because it has to fit in one of the sources of authority of the FDA and the FDA, per the law, regulates drugs or medical devices.”

Here is where it gets tricky. The FDA does not have to approve cosmetics, aside from certain color additives, before those products go to market. In the European Union’s European Medicines Agency (EMA), sunscreen is labeled as a cosmetic. Many other countries also classify it as such. In the U.S., however, sunscreen is labeled a drug because it has a therapeutic effect, and thus falls under the authority of the FDA.

To make the classification system even more convoluted, some items are labeled as both a cosmetic and drug by the FDA. Shampoo, for instance, is inherently cosmetic.

“But if it’s anti-dandruff shampoo, then it’s also a pharmaceutical,” said Santos Rutschman. “It’s super common for this to happen with a lot of products that you and I would not think are classified as drugs. It’s very natural under the regulatory regime that we have, but then it is very hard to bring anything to market – harder than other countries.”

Case in point, sunscreen used in the EU that contains ingredients which may be more effective against certain types of ultraviolet rays cannot simply just come to market in the U.S.

“If sunscreen fits the definition of a drug, then it must meet drug requirements,” said Santos Rutschman. “If you want a new drug to enter the U.S., you have to show efficacy and safety. But in order to do that, there must be clinical trials, and if those trials happened elsewhere, they would not conform to our domestic protocols.

“Even if another country performed their own clinical trials, the odds the FDA would utilize the data are not incredibly high. If you think another country recognizes something we should, based on their data, then immediately this is going to raise questions of why we are deferring to a foreign regulator.”

The FDA could go through the process of approving ingredients in question – and has indicated it will do so – but it’s a complicated process, and there is “also a matter of risk,” according to Santos Rutschman.

“The FDA has always been less risk averse than its counterparts in Europe. I understand the market concerns, but this seems about right from a regulatory perspective… We aren’t talking about a specific drug that people need and cannot access. Sunscreen is available for the average American to purchase.”

Barring an overhaul to the regulatory system in the U.S. to include an agency for cosmetics – an idea some argue has merit, but Santos Rutschman described as “not feasible” with the available funding – the only way Europe’s sunscreen would be available for Americans to purchase is if the FDA moved forward in regulating the ingredients. And that will continue to take time.

“The FDA has never moved quickly on anything,” said Santos Rutschman. “It just can't.”