The Food and Drug Administration approved a new sunscreen ingredient this week for U.S. markets. That shouldn’t be remarkable. Yet this is the first time the agency has done so since 1999, thanks to an 88-year-old law.
The active ingredient, bemotrizinol, was first authorized by European regulators in 1999 and has been a staple in products there ever since, as well as in countries such as Japan and South Korea.
The reason for this disconnect is a 1938 law that classified sunscreen products as drugs to be regulated by the FDA. That has required time-consuming animal testing and clinical trials to prove that they every new variety is safe to be sold over the counter.
Other countries treat sunscreen products as cosmetics, making it much easier for them to hit the shelves. There is no evidence that such an approach has resulted in any safety issues.
It’s allowed Europe to approve twice the number of ingredients as the U.S. that can be used as filters for ultraviolet rays, giving their shoppers more options to prevent skin damage from the sun.
Skin cancer is the most common cancer globally, and while it is treatable, it will kill more than 8,500 Americans this year and cost billions of dollars.
Applying sunscreen is a simple way for people to reduce that risk, yet regulations have blocked more effective products and choked off competition, resulting in higher prices, which causes people to use less of it.
The sunscreen approved on Tuesday was first submitted for FDA review more than 20 years ago, and the byzantine process cost its manufacturer roughly $20 million. No startup could absorb such a waste of time and money to get their product to market.
Congress has twice attempted to fix this problem. In 2014, a law required the FDA to respond to its large backlog of sunscreen applications. It did so by by rejecting all of them and demanding more data.
In 2020, another law streamlined the agency’s rulemaking process. Bemotrizinol is the first active ingredient to reach approval under those reforms. It shouldn’t have taken six years.
Consumers don’t typically understand what the government doesn’t allow them to have. Imagine how many other products have been stifled by similarly unnecessary bureaucracy.
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