Is the FDA banning chemical sunscreen?
In short, it's one of the many possibilities for American sunscreen, including all chemical filters undergoing animal testing. Sunscreen is the *spiciest* category in skincare.
If you want a visual of the past few decades of sunscreen regulation in the United States, close your eyes, take a deep breath, and imagine setting a dumpster on fire. It’s a case study in how making no decision can be a disastrous decision. For well over 20 years, the FDA has dragged its regulatory feet regarding sunscreen.
The inaction has created the perfect storm for misinformation, panic, fear and grifting. Before we dive into the FDA potentially banning all chemical sunscreen (to be clear, this is unlikely to happen but is a possibility) and the unfortunate realities of animal testing, let’s address common sunscreen myths.
Note: comments are on for everyone!
Myth: sunscreen is a carcinogen and causes cancer:
Truth: The sun is a known carcinogen and is proven to cause cancer. Sunscreen has been shown to reduce these effects. Sunscreen does this by using different active ingredients that absorb and scatter light. However, sunscreen isn't a panacea; practicing safe sun is crucial. Considerations like clothing, shade, time of day, and your skin tone are all important in avoiding cancer caused by sun exposure.
Myth: chemical sunscreens bleach coral reefs.
Truth: they all do when you put them at high doses near delicate reefs. Zinc ions have been shown to bleach reefs at high enough doses. This includes nano zinc and zinc. A reminder that zinc is considered eco-toxic in Europe. This isn’t to say that zinc is worse than any other filter, just that selling anything as “reef safe” is a marketing gimmick that is playing to your better intentions.
Myth: Chemical filters absorb UV radiation, mineral sunscreen reflects it
Truth: Michelle Wong, a PhD in Chemistry with one of the best blogs & resources on skin science (and SPF) has debunked this endlessly. May this myth die in 2024. For her, for all of us. Please.
Myth: Chemical filters cause cancer because they absorb into your skin and cause cancer. The FDA said so!
Truth: yes, some filters do absorb into the skin. This does not mean they cause cancer. What the FDA asked for is more information. Asking for more information is not a declaration of danger, if the FDA thought sunscreen was truly dangerous, they would have pulled it from the market in 2019.
Now that we’ve gotten some of the myths out of the way, let’s dive into why sunscreen might go through a seismic change this Valentine’s Day.
Why is sunscreen so complicated?
Sunscreen is a drug in the United States. This means any new ingredient has to go through drug testing to make it onto the market. Look at the back of any sunscreen bottle, you’ll see this. Sunscreen is not a cosmetic, it is a drug in America.
The US isn’t alone here. Australia, the skin cancer capital of the world, sunscreen is designated as a therapeutic good. In Canada, it’s also a drug, the difference though is Canada has allowed a few of the newer sunscreen actives that are available, for example in Europe, onto the market.
Some things to remember that are uniquely American when it comes to sunscreen:
No new sunscreen actives (aka filters like zinc or avobenzone) have entered the US market since 1999.
Innovation internationally has outpaced the U.S. with newer and more innovative filters being introduced to the market.
These new filters are more stable, less irritating to the skin and eyes, cosmetically elegant and some are much better at broad spectrum protection.
Sunscreen actives like Uvinul A Plus, Uvinul T 150, BEMT and Tinosorb M are commonplace internationally. In the United States, they’re prohibited from being marketed or sold as a sunscreen active (therefore, “banned”).
The U.S. has a growing secondary market when it comes to sunscreen. You can buy international sunscreen from Amazon, TikTok, Walmart… this also means counterfeit SPF is commonplace.
What’s the new drama with sunscreen filters?
As previously mentioned, in 2019, the FDA asked that all chemical sunscreen filters undergo safety testing for human use. This is due to a study the FDA conducted where chemical filters were shown to absorb into the bloodstream. It’s important to note that this does not mean the sunscreens are unsafe, just that small amounts are absorbed, therefore the FDA wants more testing.
This includes ocinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone. Now, for the drama. Animal testing is required. And the cost to test each filter?
$18,000,000.00. So, a total of up to 216 million dollars.
If that seems exorbitant, remember that this is for sunscreens that are already on the market. Sunscreens that people largely complain about. Sunscreens that have been demonized to no end by influencers and media. No exclusivity, no award, just sinking hundreds of millions of dollars into old technology that’s been in use since the 70s. Siri, please play America Has a Problem.
According to the article on Happi and the FDA, if no one steps up, this could lead to chemical filters being pulled from the market. Someone has to test them if we want to keep them.
While it’s unlikely that brands and those making the sunscreens will let this happen, there is a risk. If no one submits a work plan to study the filters and commits to paying for said testing… then yes, all chemical sunscreens could be pulled from the market leaving America with only zinc and titanium dioxide. This would be incredibly limiting. Not everyone tolerates mineral sunscreen, it’s drying, it leaves a cast and people with deeper skin tones would be left with largely casket-ready options.
Another complication? The FDA is requiring that brands test on animals to prove safety.
So, all chemical filters will be animal tested?
Cruelty free is a misnomer, most ingredients were tested on animals at some point or another. Even in regions like Europe, where animal testing on cosmetics has been banned, the situation is not so cut and dry. In a recent EU court decision, two sunscreen filters from the German company Symrise were mandated to undergo animal testing.
This means that, increasingly, you are likely to see more animal testing for sunscreens, particularly in the United States. In the U.S., such testing is commonly done on rats. Since sunscreen is regulated as a drug and not a cosmetic, the FDA has shown no signs of budging or making allowances, citing safety purposes. However, many scientists believe animal testing is not only cruel but also outdated. At a sunscreen symposium in Washington D.C., I had the opportunity to hear Emily Anderson, M.S., a representative for the Physicians Committee for Responsible Medicine, speak about New Approach Methodologies (NAMs) for testing. These methods require no animals and are considered more accurate.
Unfortunately, the FDA has rejected NAMs as an option for safety testing. They are insisting on animal testing (rats). So, reading the tea leaves, it looks like all chemical filters including new ones will be animal tested.
Does this mean chemical filters aren’t safe?
No, as much as the internet loves to make you panic and scared, this is directly from the FDA:
“The findings in these studies do not mean that the FDA has concluded that any of the ingredients tested are unsafe for use in sunscreens, nor does the FDA seeking further information indicate such. The agency’s proposed rule requested additional safety studies to fill in the current data gaps for these ingredients. The rule also proposed that two active ingredients (zinc oxide and titanium dioxide) are generally recognized as safe and effective for use in sunscreens, and additional data was not requested for them.”
So, to every internet grifter selling you a seed-oil-free diet to ditch the sunscreen, please, I implore you, stop.
How long do companies have to figure this out?
Currently, the FDA has set mid-February as the deadline for receiving commitments from anyone willing to invest hundreds of millions of dollars in testing old sunscreen filters. This comes with no exclusivity or direct benefit to the company. Having observed the workings of capitalism for 36 years, I’m curious to see who will step up. The current players are:
Companies that make the sunscreen filters. Reminder, they have no incentive to do this as they’re doing testing for the entire market. They will lose millions to help other companies stay on the market.
Brands like L’Oreal who have a massive share of the sunscreen market. Reminder here, this is a European company that has made commitments to animal testing, not sure how they’d be able to participate as consumers don’t seem to care this is a drug, not a cosmetic.
Consortiums like PCPC that will use member funds to get sunscreens approved. This seems the most likely but… we’ll see.
What about newer filters?
This is the part where there is good news. DSM-Firmenich has done the work to get PARSOL Shield (brand name of Bemotrizinol or BEMT) approved. They did the animal testing, they did the work, and it looks like by this year we will have a new filter on the market. If you’re wondering what popular brands have BEMT in the formula… here are a few (yes, these are some of my favorites):
For all my friends who want to buy cruelty-free products, I feel the same. Humans are not rats, and I don’t believe that subjecting animals to testing makes us more safe; it's also cruel. However, is it fair for a company to invest tens of millions of dollars and years of research, only for another company to step in later and claim 'cruelty-free' status? I don’t think so. We know it’s going to happen, and I’m already irritated by the marketing campaigns.
What can I do?
Right now, it seems like all you can do is call your representatives to raise awareness on the issue. From my Instagram post in August and a loose script:
“Hi Representative X my name is X,
I’m in your district (give your address to prove you’re a constituent).
I’m calling as a concerned constituent, the FDA has spent 50 years trying to figure out a regulatory process for sunscreen and we have no progress. The U.S. is behind on sunscreen and instead of approving new filters for more safe sunscreen, the FDA is could further restrict sunscreen. This is unsafe, and we need action now on sensible sunscreen regulation.
The United States is behind and as a member of Congress I’m asking that you break through some of the regulatory barriers at the FDA and fund public research. I also ask that you urge the FDA to reconsider how we test sunscreen, particularly on animal testing and approve new filters that have been available internationally for 20 years. We need you to act now.”
US Capitol Switchboard: 202-224-3121.
And say a prayer for that February deadline.