Thanks to TikTok and Alexandria Ocasio-Cortez we are currently going through yet another micro-frenzy about why awesome European sunscreens aren't approved for sale in the US. This happens roughly every summer, and as usual there's nothing new to report. The active ingredients at issue could probably be approved easily in the US if their makers conducted clinical tests and submitted safety results to the FDA. But they haven't so they aren't.
The options for getting more sunscreen options on the market are limited:
- Manufacturers could submit the required safety data and get FDA approval. But for the past two decades they've been unwilling to bother doing this.
- The FDA could reduce its testing requirements. But this is probably not legal.
- Congress could decree that sunscreen is not a drug and therefore not subject to the FDA's pre-market approval. But Congress has shown no stomach for this.
But wait! Maybe there's a fourth option. The holdup is that sunscreens make medical claims—namely, that they can prevent sunburn, decrease the risk of skin cancer and mitigate early skin aging—and this is what brings them under the FDA's drug-testing umbrella. So why not just jettison those claims? In fact, label the awesome Euro-sunscreens as specifically not for those things. It would be a wink-and-nod sort of affair since everyone would understand that the things being ostentatiously disavowed are, in fact, precisely what they are avowing.
Would that work? Or is the FDA too smart to allow such a ploy?
Medical claims? They should just claim that their sunscreens are nutritional supplements. As far as I can tell, truth in advertising is dead when it comes to nutritional supplements. As long as they put a disclaimer at the bottom of the screen that reads "These statements have not been evaluated by the FDA" then all is good. I see ads for nutritional supplements all the time that claim their product promotes healthy blood pressure. That sounds like a medical claim to me. And don't get me started on that crap that was originally discovered in jellyfish.
The strategy you mention reminds me of the large cans of malt extract that said something like "Warning! Do not add to 5 gallons water, 5 lbs sugar, stir to dissolve,and stir in yeast, then let ferment with an airlock for two weeks and decant and bottle."
My mom told me that story about the "grape juice" that my grandfather made during prohibition. It was a mail order kit with very specific step by step instructions on what not to do because if you did those things you would make wine and that was illegal. Grand Dad was sober too. He just made it to have on hand for visitors.
My maternal grandfather brewed beer during prohibition for home use and my paternal grandfather made wine in the bathtub.
Would these euro-screens be approved by Hawaii as being (iirc) coral-safe?
Thanks for trolling, now fck off. It would be nice to have some coral survive for future generations. If Hawaii’s efforts to protect it offend you in some way, you’re welcome to slather on whatever shitty sunscreen you like in Florida.
It would probably work.
Years ago I read something about a group that was looking into marketing microbes they isolated out of topsoil, on the notion that there must be some reason so many different animals like to roll in dirt.
And they had decided to market their product as a cosmetic because that would be much easier than claiming any sort of therapeutic value to it.
I have no idea where the project ended up.
If the US companies conducted the tests and proved them to be safe, they would simply open themselves up to competition and loss of revenue. Remember, our companies' mission is to earn money, and any product they offer is just a means to that end. Their products don't have to be good if they can keep better products off the market.
Isn't the EU generally a lot more strict about ingredients in products than the US?
Is there some reason sunscreen manufacturers specifically think they couldn't get FDA approval?
Presumably it’s because existing sunscreen in America is “good enough,” so there’s no incentive to go through FDA approval for others. It’s not that they don’t think euro sunscreens would sell in America, it’s that (1) they don’t want to diminish sales of American sunscreens in America and (2) they don’t want to pay for the approval tests. It’s the same reason why we have shittier versions of chocolate, cheese and other consumables compared to Europe.
They're the ones who outlawed oak moss and required perfumers to reformulate hundreds of classic scents so that they smell like cheap imitation scents sold to pre-teens. There was even talk of outlawing lavender which has only been used for a few thousand years.
In the US, sunscreen is a special case. Obama signed some kind of sunscreen law that was supposed to speed up approvals. I get the impression the FDA is in a bureaucratic paralysis and the manufacturers have given up. The last approval was in the 1990s, and there no applications since 2002 has gotten through the system.
It is quite obvious that the European makers don't see enough business in the US to spend the money on clinical trials.
Could they circumvent the FDA buy abandoning the health claims? I don't think so. They might have if they had done it from the outset. Now they are in FDA's bailiwick and the FDA won't let them escape without a fight.
What is the real scandal here is this: While EU sunscreen can not be sold here all sorts of supplements are allowed to make all sorts of medical claims (like making your mind "sharp") without proper clinical trials. That sunscreens that work and have no significant side-effects can not be sold while supplements making unproven and often obviously unbelievable claims can be sold freely and the FDA is only allowed to intervene if problems occur.
It is quite obvious that the European makers don't see enough business in the US to spend the money on clinical trials.
I think that's very far from obvious. The US is a larger market than the EU, with a GDP of about 25 trillion. Yes, clinical trials aren't cheap, but, large consumer goods companies are, uh, large. I think more likely is that there's considerable overlap between the makers of EU-approved sunscreens and the ones available for use in the US, so, we're talking about the same multinational firms producing both sets of products. IOW if the EU products were approved for use in the US, there'd be no net gain to the firms in question (they'd simply cannibalize their existing US sales). If you're Proctor and Gamble or Unilever or Johnson and Johnson, there's not sense in spending hundreds of millions in clinical trials to "accomplish" this.
I also wonder if they don't welcome the sunlight that would be shone on the efficacy and safety of their products.
Selling "sunscreens" with no active ingredients is the kind of thing Trump would do. Let's not enable that sort of behavior.
Label sunscreen a supplement; an unregulated market.
The issue isn't with the sunscreen companies, and even dropping any claims about benefits wouldn't do squat. The problem is that in the EU sunscreens are classified as cosmetics, while in the US they are classified as over the counter medications, which is why they fall under the purview of the FDA. That makes it extremely onerous and expensive for any sunscreen company to try to go through the drug regulatory process, especially given how fast the formulas for sunscreens can change to adapt to newer and more effective comounds. In the US these formulas haven't been updated in about 30 years, which is why their sunblocking efficacy is crap compared to their EU counterparts.
Follow the example of Q-Tips - explicitly say these are not to be inserted in the ear, when the reason 99% of buyers buy them is to insert into an ear to clean it. Seems to work there.