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We actually do have an example of a category that is regulated as “deny by default” in the US but not elsewhere! Sunscreen is regulated by the FDA unlike all o

We actually do have an example of a category that is regulated as “deny by default” in the US but not elsewhere! Sunscreen is regulated by the FDA unlike all other cosmetic products, and is considered a cosmetic in Korea, Japan, Canada and Asia. The end result is that there are a lot of new sunscreen formulations no one wants to put through the FDA process despite several attempts at simplification by the FDA and Congress; a new sunscreen chemical hasn’t been approved since the turn of the century. The problem is that the already approved 15 or so chemicals either have side effects of their own, or have bad cosmetic properties (bad texture, bad mixing, leaves white color on skin, etc.). We may actually be exposing people to more risk from skin cancer due to the lack of products that people actually want to apply to their skin daily.

Scoundreller 4y ago
I get the avoision factor, but what do we have to go on to know the safety of the other country’s products if they’re more loosely regulated? It’s not like the FDA requires studies to be done in USA, so it’s hard(er) to argue that this is a case of regulatory capture. It sounds like the evidence base for the non-FDA products isn’t there beyond “people in blank have used it and we can confirm they didn’t immediately die but otherwise we don’t really know”. Meanwhile, I can’t just import a European car and register it, even though it has met almost entirely overlapping safety standards.
- bobthepanda 4y ago
  The difference is that we certainly have approved new car safety features in the US in the last 22 years, not all of which were domestic in origin. How many regulatory categories can we speak of that have not allowed any new entries in that time frame? In that time frame some of these ingredients like bemotrizinol have been available to hundreds of millions of people. If there was a risk of something like thalidomide babies here, it would’ve been observable by now.
  - Scoundreller 4y ago
    Thalidomide was fairly straightforward because missing limbs are unusual and immediately obvious, among other issues with those exposed. History of usage doesn’t make something safer than the tested options. And a lot of potential issues aren’t immediately obvious.
autoexec 4y ago
> Sunscreen is regulated by the FDA unlike all other cosmetic products Sunscreen is not a cosmetic product, the intended effect of the product is not cosmetic. It makes perfect sense to regulate sunscreen as a drug. I'm really glad if they aren't letting people in the US lather up their faces with sunscreen lotions that can't demonstrate themselves to be "generally recognized as safe and effective". People are using sunscreen more than ever these days. If the products were so good that everyone would buy them over our tired old sunscreen formulas, and if they don't poison people or the planet, then someone will take the time and pay the money to meet that standard and they will make back their investment very quickly as they put every other sunscreen company in the US out of business. If no one has done that yet and you are so confident in these new sunscreens why not take a shot yourself?
- bobthepanda 4y ago
  > the intended effect of the product is not cosmetic I mean, what is the working definition of "cosmetic"? Toothpaste and moisturizer are considered cosmetic by the FDA even though they certainly have health applications. > they will make back their investment very quickly The key words here are very quickly. According to the GAO, the process is anything but: https://www.gao.gov/assets/gao-18-61-highlights.pdf https://www.gao.gov/assets/gao-18-61-highlights.pdf > Return on investment. The testing FDA requested is extensive, would cost millions of dollars, or take several years to conduct, according to sponsor representatives. Some stakeholders and sponsor representatives said that sponsors are currently working to develop newer sunscreen ingredients and are therefore reluctant to invest in the testing FDA requested for the older ingredients covered by the pending applications. So it's unclear that this process is worth it when the foreign cosmetics companies can just sell to the other 7.6B people not covered by these requirements, and the products might no longer be manufactured by the time they are approved for use in the US. Also, no ingredient has successfully made it through in the past 22 years, so it's not clear that spending all that money will actually result in actually being able to sell the ingredient. In addition, according to the same GAO report, the FDA requires animal testing. It is a really big movement right now in consumer cosmetics that the consumers who are paying for premium products also want cruelty-free products, so the required FDA testing may actually make the products unmarketable. > if they don't poison people or the planet To be clear, the approved ingredients don't necessarily do this either. Only two ingredients of the approved 16 are deemed to be GRASE (generally recognized as safe & effective) by the FDA. Two are just not safe, and the remaining 12 do not have enough data. https://www.fda.gov/drugs/understanding-over-counter-medicines/questions-and-answers-fda-posts-deemed-final-order-and-proposed-order-over-counter-sunscreen https://www.fda.gov/drugs/understanding-over-counter-medicin...

Scoundreller 4y ago

I get the avoision factor, but what do we have to go on to know the safety of the other country’s products if they’re more loosely regulated? It’s not like the FDA requires studies to be done in USA, so it’s hard(er) to argue that this is a case of regulatory capture. It sounds like the evidence base for the non-FDA products isn’t there beyond “people in blank have used it and we can confirm they didn’t immediately die but otherwise we don’t really know”. Meanwhile, I can’t just import a European car and register it, even though it has met almost entirely overlapping safety standards.

bobthepanda 4y ago
The difference is that we certainly have approved new car safety features in the US in the last 22 years, not all of which were domestic in origin. How many regulatory categories can we speak of that have not allowed any new entries in that time frame? In that time frame some of these ingredients like bemotrizinol have been available to hundreds of millions of people. If there was a risk of something like thalidomide babies here, it would’ve been observable by now.
- Scoundreller 4y ago
  Thalidomide was fairly straightforward because missing limbs are unusual and immediately obvious, among other issues with those exposed. History of usage doesn’t make something safer than the tested options. And a lot of potential issues aren’t immediately obvious.

autoexec 4y ago

> Sunscreen is regulated by the FDA unlike all other cosmetic products Sunscreen is not a cosmetic product, the intended effect of the product is not cosmetic. It makes perfect sense to regulate sunscreen as a drug. I'm really glad if they aren't letting people in the US lather up their faces with sunscreen lotions that can't demonstrate themselves to be "generally recognized as safe and effective". People are using sunscreen more than ever these days. If the products were so good that everyone would buy them over our tired old sunscreen formulas, and if they don't poison people or the planet, then someone will take the time and pay the money to meet that standard and they will make back their investment very quickly as they put every other sunscreen company in the US out of business. If no one has done that yet and you are so confident in these new sunscreens why not take a shot yourself?

bobthepanda 4y ago
> the intended effect of the product is not cosmetic I mean, what is the working definition of "cosmetic"? Toothpaste and moisturizer are considered cosmetic by the FDA even though they certainly have health applications. > they will make back their investment very quickly The key words here are very quickly. According to the GAO, the process is anything but: https://www.gao.gov/assets/gao-18-61-highlights.pdf https://www.gao.gov/assets/gao-18-61-highlights.pdf > Return on investment. The testing FDA requested is extensive, would cost millions of dollars, or take several years to conduct, according to sponsor representatives. Some stakeholders and sponsor representatives said that sponsors are currently working to develop newer sunscreen ingredients and are therefore reluctant to invest in the testing FDA requested for the older ingredients covered by the pending applications. So it's unclear that this process is worth it when the foreign cosmetics companies can just sell to the other 7.6B people not covered by these requirements, and the products might no longer be manufactured by the time they are approved for use in the US. Also, no ingredient has successfully made it through in the past 22 years, so it's not clear that spending all that money will actually result in actually being able to sell the ingredient. In addition, according to the same GAO report, the FDA requires animal testing. It is a really big movement right now in consumer cosmetics that the consumers who are paying for premium products also want cruelty-free products, so the required FDA testing may actually make the products unmarketable. > if they don't poison people or the planet To be clear, the approved ingredients don't necessarily do this either. Only two ingredients of the approved 16 are deemed to be GRASE (generally recognized as safe & effective) by the FDA. Two are just not safe, and the remaining 12 do not have enough data. https://www.fda.gov/drugs/understanding-over-counter-medicines/questions-and-answers-fda-posts-deemed-final-order-and-proposed-order-over-counter-sunscreen https://www.fda.gov/drugs/understanding-over-counter-medicin...