The future of sunscreens in the US and the ongoing debate about the safety and efficacy of organic UV filters.
Introduction: Is the FDA going to ban ‘chemical’ UV filters in the US?
Understanding ‘Chemical’ UV filters
The FDA’s Regulatory Concerns
The FDA’s Stance and Proposed Regulations
The Sunscreen Industry’s Response
Misconceptions and Industry PR Campaigns
A New UV Filter to Be Approved in the US
Conclusions
Introduction:
The FDA has proposed February 15, 2024 as the deadline for submitting safety data for 7 UV filters. Considering this deadline but even with all of the general controversy surrounding sunscreens, many consumers and industry insiders have been wondering about the future for US sunscreen. Will the FDA remove from the shelves, i.e. ‘ban’, all ‘chemical’ UV filters? Will mineral sunscreens be the only options for US consumers. In this article, we delve into the complexities of this issue to provide a comprehensive understanding of the current landscape and potential outcomes, including some important clarifications of commonly misunderstood terms and the history of US sunscreen regulation in comparison to the EU’s regulation.
Understanding Chemical Sunscreens:
Consumers and even many experts continue to refer to non-mineral sunscreens as ‘chemical’ sunscreens. There is a popular misconception that mineral sunscreens sit on the surface of the skin and ‘block’ or reflect light and thus they are ‘physical’ filters. Meanwhile, ‘chemical’ UV filters like oxybenzone, avobenzone, octisalate, and octocrylene to absorb UV radiation and prevent it from penetrating the skin. The truth is that both ‘physical’ and ‘chemical’ sunscreens mostly work by absorption of UV light and converting it to heat. Mineral sunscreens do some amount of light scattering. Importantly, zinc oxide does some light scattering in the crucial long wave UVA and visible part of the light spectrum giving it excellent protection against skin aging, pigmentation and specific forms of skin cancer but some other ‘chemical’ filters like Tinosorb M also do this.
We have found that the more important distinction for UV filters when it comes to examining their potential safety and efficacy relates to whether they are large particulate grade filters that are insoluble, i.e. can’t be dissolved and must be dispersed in a formula, vs. ones that are soluble (i.e. dissolve like sugar in water), that incredibly small in size (lower than 500 Daltons in molecular weight).
Many of the current safety issues with soluble UV filters relate to their tiny size. People often think that nano sized zinc oxide or titanium dioxide are tiny at potential sizes of less than 100 nm. However, they do not realize that UV filters like oxybenzone and octinoxate are much smaller at .5nm in size. Their small size means they do absorb into the body and bloodstream through the skin and those pose significant concerns about their potential to act as endocrine disruptors (impact our hormonal health).
The FDA's Regulatory Concerns:
The FDA in 2019 surprised many in the industry when they proposed an update to the sunscreen monograph that deemed only two UV filters, zinc oxide and titanium dioxide, met the threshold of being considered Generally Regarded as Safe and Effective (GRASE). Two UV filters were deemed not safe at all and to be removed from the monograph. The remaining UV filters, all of them ‘chemical’, were moved to Category III and would only be moved to Category I and deemed GRASE if substantial safety data was provided. Specifically, the FDA highlighted concerns that these filters absorbed into human bodies at much higher levels than anticipated. They showed potential adverse effects as endocrine disruptors. They have shown potential issues to the environment especially aquatic systems. The FDA also noted they had concerns that many US sunscreens did not have adequate protection against UVA light, compromising the health of those who used them to protect against skin cancer.
FDA's Stance and Proposed Regulations:
Since this 2019 proposal, the FDA has clarified that all UV filters other than zinc oxide and titanium dioxide must provide safety data, otherwise they will no longer be permitted to be used in the US. They created protocols for testing on humans called Maximal Usage Safety Trials (MUsT) in order to show how much of any one filter actually can be detected a person’s bloodstream after repeated and extensive application. They are also calling for toxicology and carcinogenicity tests to be performed on animals to show at what doses these UV filters might cause human adverse effects.
The Sunscreen Industry’s response:
Needless to say, the sunscreen industry has not been happy with the proposed rule. The first response was to form a coalition between several companies that supply ingredients under the umbrella of the lobbyist group Personal Care Product Council, called the PCPC Sunscreen Consortium. Their main task has been to ‘defend UV filters’ under the FDA monograph and they have indicated to the FDA that they will be working to support the continued use of 7 of the ‘chemical’ UV filters.
However, this support has mostly consisted to date of complaining about the cost and breadth of the tests that the FDA is requiring of them. As of the publication date of this post, February 8 2024, no MUsT trials or other required tests have been completed and submitted to the FDA for their review. This means that the February 15, 2024 could be the date that the FDA enforces their earlier position that all ‘chemical’ UV filters and the finished sunscreen products that contain them be removed from the US market. However, it’s important to note that this is not the first proposed deadline, it’s been proposed and delayed several times in the past few years.
Misconceptions and Industry PR Campaigns:
The PCPC Sunscreen Consortium have made a push to bring the US consumer on their side and rally against the FDA and their proposed updates. The have made the animal testing requirement a cornerstone of their argument as to why these tests should not be required by the FDA. The head of their Strategic Advisory team, Carlos D’Ruiz of DSM wrote this article in the industry publication Happi, “Is a US Sunscreen Public Health Crisis Brewing?” arguing that American consumers will be and should be incensed that the FDA is requiring animal testing especially when “compared to other countries that utilize more efficient and modern toxicological, safety and risk assessment methods for reviewing and approving new sunscreen actives, this approval process seems to be extremely inefficient and burdensome.”
However, it’s incredibly misleading to make it sound like all other regulatory jurisdictions approve UV filters without the safety data of animal testing. The clear intention is to portray the FDA as being obstinate and out of touch when other regulatory bodies like the EU are more open to more ‘innovative’ testing methodologies. The fact remains that even in the EU where animal testing has been prohibited since 2009 on cosmetics and their ingredients, including UV filters- they have struggled to validate alternative testing replacements for animal testing. They have ongoing and concerted efforts like the recent 6-year contract to a consortium of research institutes to develop and validate alternative methods that would reduce the burden of testing all new substances on animals. However, no UV filter, even ones that were approved after the 2009 prohibition have used alternative testing data to for their approval. Instead, any UV filter that has been approved in the EU since 2009 has made use of testing data using animal testing that occurred before the 2009 cut-off date. This is a rapidly closing loophole that newer proposed UV filters will not be able to take advantage of. The question of animal testing is going to be one that plagues all regulatory bodies around the world, not just the FDA and their current requirements.
It should also be noted that the PCPC Sunscreen Consortium has not completed the other non-animal tests like the MUsT trials that are performed on humans for the 7 UV filters in question. It’s not a matter of animal testing being the dealbreaker while all other tests and requirements have been completed. Instead, the PCPC Sunscreen Consortium is also complaining about the costs of completing all the requirements which they have estimated to be $10-$12 million upwards to $18 million per filter.
A New UV Filter to Be Approved in the US:
While the PCPC Sunscreen Consortium has shared their ‘‘ire’’ at the cost and requirements for the testing of the 7 existing UV filters, the company DSM has completed and submitted all the requirements to the FDA for a new UV filter called Bemotrizinol (BEMT), sometimes referred to by the DSM brand name Tinosorb S.
Why has one company managed to complete something that the PCPC Sunscreen Consortium has struggled to do for the other 7 existing UV filters? Did they undertake new animal testing and complete the MUsT trials? How much did this cost? Is it close to the figures provided by the PCPC of $10-$18 million dollars? Why did one company undertake the expenditure for one single UV filter where the PCPC has struggled to pool the cost across its members for any of the other UV filters?
The confusing part is the head of the strategic council Carlos D’Ruiz on the PCPC Sunscreen Consortium is part of the same company, DSM, that managed to complete the requirements for BEMT. Why create a public awareness campaign under the auspices of the PCPC Sunscreen Consortium about the impossibility of completing the required tasks by the FDA and create public fear about the potential ‘public health crisis brewing’, while also being part of the same company that quietly completed the tests and submitted them for another UV filter?
In short, if it can be done for one UV filter, why can’t it be done for all? Is it possible that concerns of animal testing and the costs are misdirection, and the real concern is that these 7 UV filters might not pass the safety testing?
Conclusions:
Is the FDA being unreasonable in their requests for the existing seven ‘chemical’ UV filters? The PCPC Sunscreen Consortium and others in the industry would have consumers believe that proposed updates by the FDA endanger the American public and reduce their options for preventing skin cancer. We’ve heard echoes across social media on TikTok, originating from the PCPC Happi article, that these ingredients have been used “many of which have been used for nearly 50 years without any significant or notable safety issues.” However, let’s recognize how nonsensical that statement is. Many human practices including smoking and slavery, were done for 50 years or more before humanity recognized them for being dangerous or inhumane. Longevity of use is not and has never been a valid argument for something’s continued use. It’s also pure fabrication to say that there has been no evidence of any safety issues with these 7 UV filters in question. The considerable evidence of their potential harm is what prompted the FDA, Health Canada, the EU and the Therapeutics Good Administration in Australia to review the safety of these ingredients.
If you are reading this before February 15, 2024, then almost no one in the industry is 100% clear as to what the FDA might do in the absence of any provided date for these 7 UV filters. If you are reading this after the deadline, then whatever the FDA decided to do, recall all ‘chemical’ sunscreens or delay further, it’s worth questioning why a single company could provide the required data for a single UV filter when the Consortium failed to for any one of the 7 UV filters.
Meanwhile, here at The Sunscreen Company , we make beautiful and easy to wear all-mineral sunscreens with 25% zinc oxide. The fate of our company and our sunscreen products is not in danger or in question. We use the maximum concentration of a UV filter that is considered GRASE by the FDA and imparts excellent UVA and UVB protection. Zinc oxide as an ingredient does not require any animal testing to validate its continued use. While we would also prefer the validation of newer alternative non-animal modes of testing, we think the 7 proposed UV filters need to substantiate their safety. However with the combined 150 years of our research team in the medical and scientific field, we know that these filters will most likely not ever be able to.
