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American sunscreen isn’t good enough. Can new regulations help?
VOX Feb 22, 2019 (excerpts)
Sunscreen has been in the news a lot lately. Both Hawaii and Key West, Florida, are trying to ban sunscreens containing certain ingredients, citing evidence that they might be contributing to the destruction of coral reefs. In the cosmetics community, thanks to the power of organizations like the Environmental Working Group, there’s a lot of chatter about whether certain ingredients like oxybenzone that have been used in sunscreen for decades might be hazardous to humans. The evidence is not clear, but it’s led to a lot of consumer concern and confusion.
Despite all this, no new sunscreen ingredients, also called filters, have been approved in the US since the 1990s. We are woefully behind Australia, Europe, Asia, and Canada, which all have more effective and more pleasant-to-use formulations than we do here, as Bloomberg explained in 2018. (The superficial aspect shouldn’t be ignored, because the ickier products are to use, the less likely people are to use them. They can be heavy, leave a white residue on skin, or feel greasy.)
But Thursday, Scott Gottlieb, the commissioner of the Food and Drug Administration, announced that his agency was proposing new regulations to improve American sunscreens and make them more “safe and effective.” The impetus for the proposals, according to the statement: “Since the initial evaluation of these products, we know much more about the effects of the sun and about sunscreen’s absorption through the skin. Sunscreen usage has changed, with more people using these products more frequently and in larger amounts.”
These are not official yet. They’re merely proposals, and the FDA will take public comments and other information into account before making them rules. This process can take months.
There are problems with the new proposals, though. While it’s great that questionable ingredients will get more scrutiny, there isn’t really a suggestion in this new proposal for how to get new filters approved more expeditiously. The cosmetics industry, which manufactures sunscreen, has balked at what it considers the FDA’s onerous testing requirements.….
Somewhat ironically, Europe, which has been quick to ban cosmetic ingredients, is more lenient in its approval of sunscreen ingredients than the US is. As a result, there are more options for UVA blockers there.
In 2014, the Obama-era FDA passed the Sunscreen Innovation Act in the hopes that more companies would submit new filters for approval and to jump-start innovation here. Eight European ingredients were submitted and the FDA rejected them all, based on requirements that predated the SIA.
“It has been a logjam. The FDA was asking for more data, and several tests are quite laborious and quite long,” says Lim. “The industry has not been willing to do that.”
It’s not clear that the new FDA proposed guidelines will alleviate this logjam. In fact, they might leave us with fewer options here in the US.
The new FDA-proposed regulations
Arguably, the most important item in the proposal is that the FDA wants to evaluate 12 of the 16 currently approved ingredients for safety; it feels there is not enough evidence to deem them “GRASE” or “generally recognized as safe and effective,” even though some have been in use since the late ’70s. Zinc oxide and titanium dioxide are considered GRASE. PABA and trolamine salicylate are considered non-GRASE and can’t be used in sunscreens….
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