You may wonder how in the world an act crafted to financially help and support Americans during the COVID-19 crisis relates to sunscreen overhaul, but by now, you’re also probably used to the government working in very mysterious ways.
It is true, though. This year’s earlier Coronavirus Aid, Relief and Economic Security Act (CARES) includes a sunscreen bill. You may be wondering just how in the world a sunscreen bill included in CARES affects you (or why it’s there in the first place), and you’d be in good company.
Considering a recent FDA study of six very popular sunscreen ingredients found that the accumulation of the protective chemicals in one’s blood exceeded the Food and Drug Administration’s (FDA) safety threshold, you’d think the inclusion would mean a lot toward improving sunscreen safety on all fronts. Emphasis on think.
Implications of the CARES Act on Sunscreen Ingredients
The biggest implication of the CARES Act on Sunscreen will be that the Act will replace the FDA’s OTC drug monograph process with more of an administrative process that is theoretically more efficient. What does that mean?
It means that guidelines that were introduced in the late ’80s and early ’90s will be looked at, and hopefully scrutinized now in light of research we have on many of those chemical ingredients. Except….that already sort of happened…last year…when several popular sunscreen ingredients were deemed as having too little research to declare them safe.
Another implication will be to clarify the jargon of several OTC products that have been marked as generally recognized as safe and effective (GRASE). With the new provisions, they’d be able to move past two current categories–GRASE or newly submitted drugs with new drug applications (NDA)
Additionally, the Act would introduce two unique aspects to the OTC drug review process. Typically, user fees have been part of the approval process, but will now be imposed on the facilities that are manufacturing the OTC drugs/ingredients and on those who are requesting an OTC monograph administrative order. The Act also would create a new 18-month exclusivity period for newly approved OTC drugs. Experts wonder how THAT would work in practice and how inactive ingredients that currently have no FDA determination of GRASE stats would fare.
And just how in the world did a sunscreen act get included in a stimulus package anyway?
In an article with the Houston Chronicle, Nneka Leiba said that it’s very odd that it would be included, particularly a few months after the new monograph (that essentially deemed only zinc oxide and titanium dioxide as safe) was propositioned to be finalized last year. Leiba is the vice president of the EWG’shealthy living science department. She says that the FDA had a draft monograph published that strengthened UVA standards in sunscreens.
The CARES Act mandated that sunscreen relations stay status quo, and Leiba says this is essentially them saying that those chemical ingredients they found to need more research for last year are safe and protective. Last year ended, though, and the monograph never passed. Now, the inclusion of this sunscreen bill would have you still believing the ingredients that last year didn’t have enough information to be declared safe and effective actually are.
The research hasn’t changed. The suspect ingredients still exceed safety thresholds, and the FDA says that under the CARES Act, they have to propose a revised sunscreen order by September 27, 2021.
No matter what, we’ve always advised our mamas to read labels and ingredients and pay attention to the research that guides what is safe and what is not safe for our children. Earlier this summer, we shared our top pics for sunscreens that were safe and scored no lower than 1 on the EWG’s safety scale.
When it comes to sunscreen (and other OTC or beauty products), check the ingredients first!