Michael Scaturro

Thanks for having me.

I think the main reason is that it's expensive to bring a new drug through the FDA because in the United States, sunscreen chemicals are considered over-the-counter drugs.

In France or in Korea or in many places around the world, sunscreens and sunscreen chemicals are considered cosmetics.

And so they don't really have to be subjected to animal tests.

But in the US, the FDA defines sunscreen as an OTC, an over-the-counter drug, which is kind of like aspirin or cough syrup or anything that you might buy, like a Walgreens or a CVS.

And those are things that have to go through, traditionally, an animal testing process.

So DSM, the company that manufactures this chemical, had to submit that data.

And so that's hard, right?

Because it's very expensive.

It costs them about $18 million to bring this product.

new chemical through the FDA.

And Congress has tried in like two laws now to sort of nudge the FDA in the direction of alternative testing methods.

And they're not quite convinced because for this new-ish, right, this new for us in the U.S.

but widely used globally, this EMT was still subjected to animal tests.

That's a good question.

I think it's because the FDA is concerned about the potential toxicity of a product that people use every day.

People are putting a lot of this on their bodies, and I think their position would be that they have to really be certain that some of these drugs don't cause reproductive harm or that they have a low level of toxicity in the body.

Well, so in writing about this over the last two years, I kept hearing that the FDA is very proud of its record in the 1960s of having been one of the only regulators globally to have prevented thalidomide from being sold in the US.

That's the drug that caused egregious harm to fetuses in many countries and led to people being born with birth defects.

And so they have always been very, very overcautious