FDA Wants More Sunscreen Regulations, but Would Consumers Get Burned?


Although many consumers and dermatologists are satisfied with the quality and safety of current sunscreens, sweeping changes may soon be coming.

The Food and Drug Administration recently proposed a variety of new heavy-handed regulations for over-the-counter sunscreen. The regulations getting the most media attention involve sixteen ingredients common in sunscreen products. According to the new guidelines, many of these ingredients have “insufficient data to decide on safety,” requiring manufacturers to undertake additional tests and submit their products for FDA approval. The proposal is currently under discussion and taking comments from the public.

By requiring sunscreen to undergo additional tests and earn FDA approval, the agency hopes to incorporate current scientific knowledge into supposedly outdated standards. As FDA Commissioner Scott Gottlieb stated in a news release, the agency’s proposal “is an important step in the FDA’s ongoing efforts to take into account modern science to ensure the safety and effectiveness of sunscreens.”

He continued:

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.

But in its attempt to find “the right balance,” the FDA is more likely to throw the sunscreen market wildly out of balance.

The costs of undergoing safety testing and obtaining FDA approval would raise the cost of over-the-counter sunscreen, making it less affordable for consumers needing stronger protection from ultra-violet rays. The proposed regulations are estimated to cost sunscreen producers over $3.5 billion, most of which would be passed on to consumers. With melanoma and other skin cancer rates steadily increasing since 1999, policies making sunscreen less accessible may cause considerable harm.

As a secondary consequence, other products using these ingredients would also face FDA scrutiny. For example, para-aminobenzoic acid (PABA) and trolamine salicylate, both ingredients in question, are found in numerous skin creams, towelettes,  body washes, and shampoos. If the proposed regulations are approved, these products will also require FDA approval.

Perhaps most troubling frustrating about the FDA’s proposal is that calling these ingredients into question is hardly “incorporating current scientific knowledge.” Many of them are already approved by regulators in Europe. Several ingredients have been under investigation by the FDA for over ten years. And with previous regulations implemented by the FDA in 2011, 2014, and 2016 aimed to reform sunscreen regulation, there is little reason to suspect that current efforts will provide noticeable benefits.

Let’s hope the FDA learns from its previous failures and retracts its proposal. If not, we’ll be the ones who get burned.