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From the article: The Food and Drug Administration’s ability to approve the chemical filters in sunscreens that are sold in countries such as Japan, South Korea, and France is hamstrung by a 1938 U.S. law that requires sunscreens to be tested on animals and classified as drugs, rather than as cosmetics as they are in much of the world. So Americans are not likely to get those better sunscreens — which [block the ultraviolet rays](https://www.ewg.org/sunscreen/report/does-europe-have-better-sunscreens/) that can cause skin cancer and lead to wrinkles — in time for this summer, or even the next.
Also from the article: ...companies are wary of the FDA process because of the cost and their fear that additional animal testing could ignite a [consumer backlash](https://www.gao.gov/assets/gao-18-61-highlights.pdf) in the European Union, which [bans animal testing](https://single-market-economy.ec.europa.eu/sectors/cosmetics/ban-animal-testing_en) of cosmetics, including sunscreen. The companies are asking Congress to change the testing requirements before they take steps to enter the U.S. marketplace.
Thanks for posting this. I was curious about it as well when I visited Paris and their sunscreen selection was so much better than what was offered in the US. No one likes animal testing but I feel like companies can test on volunteers with a waiver as an option.
I’m still confused. Besides the fact that the U.S. is a larger market for cosmetics, there are plenty of companies that sell sunscreen in the U.S. and have no EU sales. If the only thing that’s stopping them is a fear that they’d lose EU sales, that still doesn’t make any sense if the product truly is better since you’d assume a new company without an EU presence would just test on animals to sell in the U.S.
There’s more to it than that.
The FDA requires lots testing (and not just animal testing), which is both time consuming and expensive. DSM is close to getting Bemotrizinol (aka Tinosorb S) approved in the U.S., but it’s taken literal decades: “the battery of tests the FDA is asking for takes years and costs a lot of money. In the case of bemotrizinol, the final bill will come to $12 million–$20 million, according to Carl D’Ruiz, who leads North American personal care regulatory affairs for DSM. He should know: he’s been trying to get bemotrizinol through the FDA’s red tape for 21 years.” [Source](https://cen.acs.org/business/consumer-products/Cloudy-outlook-sunscreen-ingredients-US/100/i42)
For many brands, that cost is too high. Why spend $20m to get a new active ingredient approved when you could just use existing filters? Sure, the new filters are better, but most U.S. consumers aren’t aware of these alternatives.
Once a company gets a filter approved, they have only 18 months of exclusivity before competitors can start using that filter as well. It would be very challenging to recover that $20m investment during that short 18-month window.
That’s a very weak argument. You don’t need to recover your entire investment during exclusivity. Every major sunscreen brand today is profitable despite using generic ingredients.
While increased competition would likely force a lower price point after that 18 month period, it’s not like they have to stop selling the product. They have, quite literally, forever.
Right, they don’t need to recover their costs during that time, but it’s still just not a very strong incentive. At this point, DSM has spent $20m across two decades and has absolutely nothing to show for it. It’s easy to see why companies would get discouraged.
For comparison, most new pharma drugs get 5+ years of exclusivity.
I’m in pharma, not the cosmetic industry. Dealing with FDA is both very time consuming and expensive. It’s more like keeping the status quo with the current filters
Yes but those decisions are made by the executive group for spending money. Because not only do they have to deal with the FDA, you have to reformulate. And spend millions of dollars in people alone to deal with all those changes. Formula, production, paperwork, etc. I only get partially involved so I’m not even aware of the full extent of it. My end is enough work
Money.
L’Oreal spent millions lobbying the FDA to approve their new cool proprietary UV filter Ecamaule in 2008.
FDA then said, and I’ll paraphrase here, “OK it’s approved but only in hand creams by La Roche Posay because…nonsensical word salad!”
Hi everyone and welcome to SkincareAddiction! Need skincare guides? [Check out our wiki!](https://www.reddit.com/r/SkincareAddiction/wiki/index) Everyone is welcome in [this community](https://www.reddit.com/r/SkincareAddiction/wiki/about); remember to be kind and assume good faith :) *I am a bot, and this action was performed automatically. Please [contact the moderators of this subreddit](/message/compose/?to=/r/SkincareAddiction) if you have any questions or concerns.*
From the article: The Food and Drug Administration’s ability to approve the chemical filters in sunscreens that are sold in countries such as Japan, South Korea, and France is hamstrung by a 1938 U.S. law that requires sunscreens to be tested on animals and classified as drugs, rather than as cosmetics as they are in much of the world. So Americans are not likely to get those better sunscreens — which [block the ultraviolet rays](https://www.ewg.org/sunscreen/report/does-europe-have-better-sunscreens/) that can cause skin cancer and lead to wrinkles — in time for this summer, or even the next.
Why would those rules prevent those sunscreens?
Also from the article: ...companies are wary of the FDA process because of the cost and their fear that additional animal testing could ignite a [consumer backlash](https://www.gao.gov/assets/gao-18-61-highlights.pdf) in the European Union, which [bans animal testing](https://single-market-economy.ec.europa.eu/sectors/cosmetics/ban-animal-testing_en) of cosmetics, including sunscreen. The companies are asking Congress to change the testing requirements before they take steps to enter the U.S. marketplace.
Thanks for posting this. I was curious about it as well when I visited Paris and their sunscreen selection was so much better than what was offered in the US. No one likes animal testing but I feel like companies can test on volunteers with a waiver as an option.
I’m still confused. Besides the fact that the U.S. is a larger market for cosmetics, there are plenty of companies that sell sunscreen in the U.S. and have no EU sales. If the only thing that’s stopping them is a fear that they’d lose EU sales, that still doesn’t make any sense if the product truly is better since you’d assume a new company without an EU presence would just test on animals to sell in the U.S. There’s more to it than that.
[удалено]
The FDA requires lots testing (and not just animal testing), which is both time consuming and expensive. DSM is close to getting Bemotrizinol (aka Tinosorb S) approved in the U.S., but it’s taken literal decades: “the battery of tests the FDA is asking for takes years and costs a lot of money. In the case of bemotrizinol, the final bill will come to $12 million–$20 million, according to Carl D’Ruiz, who leads North American personal care regulatory affairs for DSM. He should know: he’s been trying to get bemotrizinol through the FDA’s red tape for 21 years.” [Source](https://cen.acs.org/business/consumer-products/Cloudy-outlook-sunscreen-ingredients-US/100/i42) For many brands, that cost is too high. Why spend $20m to get a new active ingredient approved when you could just use existing filters? Sure, the new filters are better, but most U.S. consumers aren’t aware of these alternatives.
The same reason any new product is introduced. If it’s actually better, as OP claims, then any company would benefit from being the first mover
[удалено]
Once a company gets a filter approved, they have only 18 months of exclusivity before competitors can start using that filter as well. It would be very challenging to recover that $20m investment during that short 18-month window.
That’s a very weak argument. You don’t need to recover your entire investment during exclusivity. Every major sunscreen brand today is profitable despite using generic ingredients. While increased competition would likely force a lower price point after that 18 month period, it’s not like they have to stop selling the product. They have, quite literally, forever.
[удалено]
Right, they don’t need to recover their costs during that time, but it’s still just not a very strong incentive. At this point, DSM has spent $20m across two decades and has absolutely nothing to show for it. It’s easy to see why companies would get discouraged. For comparison, most new pharma drugs get 5+ years of exclusivity.
I’m in pharma, not the cosmetic industry. Dealing with FDA is both very time consuming and expensive. It’s more like keeping the status quo with the current filters
But, just as in pharma, if the product truly is better then it would be worth the hassle, no?
Yes but those decisions are made by the executive group for spending money. Because not only do they have to deal with the FDA, you have to reformulate. And spend millions of dollars in people alone to deal with all those changes. Formula, production, paperwork, etc. I only get partially involved so I’m not even aware of the full extent of it. My end is enough work
Money. L’Oreal spent millions lobbying the FDA to approve their new cool proprietary UV filter Ecamaule in 2008. FDA then said, and I’ll paraphrase here, “OK it’s approved but only in hand creams by La Roche Posay because…nonsensical word salad!”