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Stimulus Package Leaves Future of FDA Sunscreen Safety Testing Unclear

Buried in the bill is new legislation regarding the treatment and classification of sunscreen ingredients.

Confusion abounds when it comes to sunscreen and the federal stimulus bill. 

While sunscreen legislation was buried in the federal stimulus, beauty insiders and the FDA remain divided on exactly what that legislation means. Some say it puts a stop to the FDA’s review of sunscreen ingredient safety, reverting common active ingredients that were undergoing new safety testing back to a 20-year-old framework that classified them as safe for consumer use. Others say it’s meant to accelerate the approval of new sunscreen actives. 

On page 470 of the massive $2 trillion package, designed to provide immediate relief for businesses and tax-payers, is a measure requiring the FDA to further accelerate its approval process for new active sunscreen ingredients under the Sunscreen Innovation Act.

The measure has triggered conflicting reactions from the industry, lobbying groups and the FDA itself, which seem to have differing opinions as to what the new legislation means — not only for the future of safety testing for new sunscreen actives, but the ongoing safety review of actives currently being used in consumer sunscreen products.

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The measure regarding sunscreen ingredients in the stimulus package is part of the larger OTC Monograph Reform Bill, which was championed by industry lobbying groups, the Personal Care Products Council and Consumer Healthcare Products Association as well as makers of mass market sunscreens like Edgewell and Bayer Consumer Health. That bill was passed into law with the stimulus package, changing the approval process for makers of OTC drugs like Tylenol, owned by Bayer. Sunscreen ingredients were swept in as a small part of that bill. 

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Less clear is the future of the FDA’s ongoing safety review for the current sunscreen actives on the market, which was triggered by sunscreen regulation changes proposed by the FDA in 2019. At least one lobbying group is under the impression that the new legislation will stop the safety review. 

The FDA last year issued a call for updated safety data on 12 ingredients commonly used in consumer sunscreens, including oxybenzone and avobenzone.

In 1999, the FDA classified those 12 ingredients as GRASE — generally recognized as safe and effective for consumer use. But in the past two decades, new research suggesting these ingredients could be linked to health issues ranging from skin irritation to endocrine disruption led the FDA to reclassify them as Category III active ingredients — meaning more safety data is needed before they are reclassified as GRASE. 

The FDA has been conducting clinical testing on these ingredients over the past year, and since January has determined only that they are absorbed into the bloodstream after even just a single application and will require further testing to determine what that means for consumer health and safety.

Following the passing of the stimulus package on Friday, PCPC issued a statement commending the passage of the bill and specifically the measure involving sunscreen, commenting that language used in the legislation would push the sunscreen ingredient classifications back to their 1999 status, “which, among other things, confirms that active ingredients currently used in sunscreens on the market today are generally recognized as safe and effective (GRASE).”

But the FDA did not comment on whether the ongoing sunscreen ingredient safety testing would be halted or whether the active ingredients have been reclassified as GRASE. 

“The FDA is working to review all provisions of the CARES Act that apply to FDA. We look forward to providing regular updates as we move forward to implement the new law,” the FDA said in a statement to WWD.

For others in the industry who read the stimulus bill, the important takeaway from the language was that the FDA approval process for new sunscreen actives is now required by law to be on an accelerated track. 

Reports from a few online publications initially purported that the legislation on sunscreen innovation was connected to L’Oréal, which operates a manufacturing facility in Kentucky, Senate Majority Leader Mitch McConnell’s home state. In 2014, McConnell helped pass the Sunscreen Innovation Act, to establish a faster process for approval on new sunscreen ingredients. The press release from McConnell’s office announcing the law called out L’Oréal specifically for having “two sunscreen ingredients pending approval in FDA backlog.” 

A spokesperson for L’Oréal refuted any link between the new sunscreen legislation and the France-based beauty company, noting that L’Oréal does not manufacture sunscreen in its Kentucky plant. 

“L’Oréal did not advocate for the passage of OTC Monograph Reform nor did it seek, either directly or indirectly, its inclusion in the recently passed CARES Act. Recent news reports suggesting that we were involved in its passage are inaccurate.” 

It seems nothing ever happened with the “backlogged” sunscreen ingredients from L’Oréal, industry sources told WWD. 

What is clear about the sunscreen measure in the stimulus bill is that the updated legislation to the Sunscreen Innovation Act calls for a further expedited approval process for new sunscreen ingredients. 

While this could be a good thing for companies looking to launch innovation quickly, it could be bad for consumers, said Mia Davis, director of mission at Credo Beauty, the San Francisco-based natural beauty retailer. 

“It’s especially concerning [when it comes to sunscreen], because it’s nice to have cool new ingredients and innovation, but the risk analysis is totally different [than with an antiaging product] because it is potentially helping protect against skin cancer,” said Davis. “It’s imperative to have comprehensive testing to make sure it’s beneficial to humans and the environment in the long term.”