Thursday, 21 Mar 2019

American sunscreen isn’t good enough. Can new regulations help?

A new FDA proposal tries to address safety about current sunscreens but doesn’t make it easier for new ingredients to be approved.

Sunscreen has been in the news a lot lately. Both Hawaii and Key West, Florida, are trying to ban sunscreens containing certain ingredients, citing evidence that they might be contributing to the destruction of coral reefs. In the cosmetics community, thanks to the power of organizations like the Environmental Working Group, there’s a lot of chatter about whether certain ingredients like oxybenzone that have been used in sunscreen for decades might be hazardous to humans. The evidence is not clear, but it’s led to a lot of consumer concern and confusion.

Despite all this, no new sunscreen ingredients, also called filters, have been approved in the US since the 1990s. We are woefully behind Australia, Europe, Asia, and Canada, which all have more effective and more pleasant-to-use formulations than we do here, as Bloomberg explained in 2018. (The superficial aspect shouldn’t be ignored, because the ickier products are to use, the less likely people are to use them. They can be heavy, leave a white residue on skin, or feel greasy.)

But Thursday, Scott Gottlieb, the commissioner of the Food and Drug Administration, announced that his agency was proposing new regulations to improve American sunscreens and make them more “safe and effective.” The impetus for the proposals, according to the statement: “Since the initial evaluation of these products, we know much more about the effects of the sun and about sunscreen’s absorption through the skin. Sunscreen usage has changed, with more people using these products more frequently and in larger amounts.”

These are not official yet. They’re merely proposals, and the FDA will take public comments and other information into account before making them rules. This process can take months.

There are problems with the new proposals, though. While it’s great that questionable ingredients will get more scrutiny, there isn’t really a suggestion in this new proposal for how to get new filters approved more expeditiously. The cosmetics industry, which manufactures sunscreen, has balked at what it considers the FDA’s onerous testing requirements. The whole thing is a conundrum of how to balance different unknown and unknowable risks. As usual, consumers are caught in the middle.

A quick review of the current state of US sunscreens

In the US, sunscreen ingredients are treated like over-the-counter (OTC) drugs and are much more carefully regulated than, say, moisturizers, which are considered cosmetics and don’t undergo the same scrutiny. Currently, the FDA has approved 16 ingredients in its sunscreen monograph. Colloquially, the types of filters are referred to as either “physical” or “chemical.” Physical blockers are zinc oxide and titanium dioxide, and they generally deflect ultraviolet (UV) rays. Chemical ingredients include everything else, like oxybenzone, and they absorb and disperse UV rays.

There are two types of UV rays that we care about when it comes to skin: UVA and UVB. In the US, bottles are labeled with sun protection factor (SPF) ratings, which only refer to the level of UVB protection. (Please read Vox’s Julia Belluz for much more detail on the meanings and significance of these sunscreen concepts.) When you see the term “broad spectrum” on a bottle, that means you also get UVA protection.

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Dear #HydroBoost Sunscreen, you’re unlike any other. Your broad spectrum coverage. Your water-light feel. Your invisible finish. No other #SPF compares.

A post shared by Neutrogena (@neutrogena) on

We’ve learned relatively recently that in addition to aging the skin, UVA is linked to cancer. According to Dr. Henry W. Lim, the former president of the American Academy of Dermatology (AAD) and a practicing dermatologist at Henry Ford Hospital in Detroit, the standards for how we measure UVA are lower compared to Europe. (More on this later.)

It’s really hard to get new ingredients approved in the US

While zinc oxide and titanium dioxide protect against both UVA and UVB in higher concentrations, the only two chemical UVA filters approved in the US are avobenzone and oxybenzone. (There is also a filter called Mexoryl that is approved in just a few products here, but it includes avobenzone as one of its ingredients.)

Oxybenzone, in particular, has been a hot topic lately. It’s one of the ingredients that have been implicated in coral reef destruction and, as stated in the FDA report, there is evidence that it is easily absorbed through the skin. It has appeared in human breast milk, amniotic fluid, urine, and blood plasma. While the presence of something doesn’t mean it causes harm, there have been animal studies that suggest it may have endocrine activity in the body. There were many limitations in the studies and the results of animal studies can’t always be extrapolated to humans, but it raised red flags.

Somewhat ironically, Europe, which has been quick to ban cosmetic ingredients, is more lenient in its approval of sunscreen ingredients than the US is. As a result, there are more options for UVA blockers there.

In 2014, the Obama-era FDA passed the Sunscreen Innovation Act in the hopes that more companies would submit new filters for approval and to jump-start innovation here. Eight European ingredients were submitted and the FDA rejected them all, based on requirements that predated the SIA.

“It has been a logjam. The FDA was asking for more data, and several tests are quite laborious and quite long,” says Lim. “The industry has not been willing to do that.”

It’s not clear that the new FDA proposed guidelines will alleviate this logjam. In fact, they might leave us with fewer options here in the US.

The new FDA-proposed regulations

Arguably, the most important item in the proposal is that the FDA wants to evaluate 12 of the 16 currently approved ingredients for safety; it feels there is not enough evidence to deem them “GRASE” or “generally recognized as safe and effective,” even though some have been in use since the late ’70s. Zinc oxide and titanium dioxide are considered GRASE. PABA and trolamine salicylate are considered non-GRASE and can’t be used in sunscreens.

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#SmellsLikeSummer We were busy hangin’ with friends and fam yesterday & forgot to wish an extra happy 4th of July to our fish friends, Hawaii’s governor signed the legislation banning two UV filter ingredients (Oxybenzone and Octinoxate) Recent studies show these ingredients could be contributing factors to the bad health of our reefs. We are very proud that none of our sunscreen products throughout the U.S. contain oxybenzone and all meet the requirements of this new regulation (pictured in this post), with the exception of a few products that are being reformulated now to remove octinoxate. Thanks for stepping up Hawaii!!! We’ve got you covered, SB #reeffriendly #savethereefs

A post shared by Sun Bum (@sunbum) on

The FDA is asking companies to submit whatever data and studies they have to support the safety of the remaining 12, including oxybenzone. The agency clarified, “We emphasize that this proposed rule does not represent a conclusion by FDA that the sunscreen active ingredients … are unsafe for use in sunscreens. We are requesting additional information on these ingredients so that we can evaluate their GRASE status in light of changed conditions. …” It will also consider whether newer formulations like SPF powders and wipes are GRASE.

The FDA also wants to do away with combined sunscreen and insect repellent products, which are not as effective together as they are when used separately. Lim says dermatologists support this.

Next, the agency wants to address labeling issues, allowing 60+ to be the maximum SPF, up from 50+. The labels also will need to clearly state the active ingredients (i.e., “zinc oxide”) on the front of the package.

Significantly, these new regulations would also require that all sunscreens with SPF 15 or higher be broad-spectrum, which is not the case now. That definition of broad spectrum will also now be more closely aligned with the superior European standards:

The body of scientific evidence linking UVA exposure to skin cancers and other harms has grown significantly. This evidence raises concerns about the potential for inadequate UVA protection in marketed sunscreen products — particularly in high SPF sunscreen products that either do not pass the current broad spectrum test or (though they pass our current broad spectrum test) have inadequate uniformity in their UVA protection.

But don’t give up on your sunscreen until all this new data gets hashed out. The American Academy of Dermatology Association released the following statement, in part:

Because sunscreen is an important tool in the fight against skin cancer, the AADA supports any and all regulations to ensure that the public has access to safe and effective sunscreens. … The AAD’s sun protection recommendations are based on the existing body of scientific evidence and current FDA regulations; these recommendations will continue to evolve as the science develops and the FDA issues new regulations. In the meantime, however, it’s important to understand that the proposed rule does not conclude that the sunscreens currently on the market are unsafe.

The limitations of the new FDA proposal

So this all sounds great, right? Get more safety data on currently used ingredients and get rid of the ones that are questionable. It’s not quite that simple.

Let’s say there is enough data to determine that oxybenzone isn’t GRASE and needs to be removed from the market.

“The challenge for US manufacturers is that it’s very difficult to take oxybenzone out because we don’t have additional filters that could function to cover the UVA portion,” says Lim.

Avobenzone is a UVA filter, but it isn’t as stable and covers a different wavelength than oxybenzone. We could all just use zinc oxide, but it’s heavy and often leaves a ghostly white cast on skin.

It ultimately comes down to money, of course. Lim calls the tests the FDA requires “onerous, expensive, and time-consuming.” Cosmetics companies like L’Oréal are the prime manufacturers of these products. While sunscreen is arguably good for humanity, it’s ultimately a product to be sold, and it has to be worth it for companies. Lim says when he was the AAD president, he tried to facilitate discussions between the AAD and industry, but there’s clearly more to be done.

Is there a middle ground that ensures these tests for safety are accurate but are also economically feasible and don’t discourage companies from innovating? While not explicitly discussed in the proposals, Gottlieb seems to be working on it behind the scenes.

“The proposal we’ve put forward would improve quality, safety, and efficacy of the sunscreens Americans use every day. We will continue to work with industry, consumers and public health stakeholders to ensure that we’re striking the right balance,” Gottlieb writes. “To further advance these goals, we’re also working toward comprehensive OTC reform, which will help foster OTC product innovation as well as facilitate changes necessary for the FDA to keep pace with evolving science and new safety data.”

In the meantime, think about loading up on sunscreen when you’re overseas.

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