In an exclusive interview with BeautyMatter earlier this week, a representative for the Food and Drug Administration (FDA) confirmed that the federal agency has revised its stance on sunscreen safety, requiring extensive testing of chemical sunscreen ingredients.
This decision has sparked controversy, particularly because it mandates animal testing, despite years of human-based data supporting the safety of these ingredients.
In 2019, following research which found that certain sunscreen chemicals are absorbed into the body, the FDA proposed updated rules to address active ingredient requirements, SPF limits, and labelling standards.
The FDA asserts that additional studies are needed to determine the potential health risks of these absorbed ingredients. However, the agency insists that animal testing remains the only scientifically valid method available for assessing these risks. “In short, the current science does not allow for the replacement of all animal studies with nonanimal methods,” the representative stated.
Despite decades of real-world use, the FDA has flagged chemical ingredients – including oxybenzone, octinoxate and avobenzone – for additional testing. The only two ingredients that are cleared from this additional safety evaluation are zine oxide and titanium dioxide, both of which are mineral filters. These two ingredients are still deemed safe for use in sunscreens as they are certified ‘generally recognised as safe and effective’ (GRASE) by the FDA.
The representative continued, “The FDA routinely evaluates drugs that are absorbed into the body to ensure that the benefits of these products outweigh any potential risks that result from absorption. While many drugs do not show risks from systemic exposure, it is not possible to predict these potential risks under any scientifically valid and reliable method at this time aside from animal studies.”
The article notes that with the regulatory uncertainty surrounding chemical sunscreens, many beauty brands are adopting a wait-and-see approach, whilst it also refers to the reduced diversity of suncare this additional testing will leave on the US market. Mineral sunscreens, which leave a noticeable white cast on darker skin tones, may not be a viable alternative for all consumers. Beauty product developer Tamar Kamen told BeautyMatter that “This is setting us back decades,”.
The FDA has yet to provide a clear deadline for the required animal studies, leaving brands and ingredient suppliers in limbo. As the debate continues, industry leaders hope the FDA will consider alternative testing methods to maintain both safety and ethical standards in sunscreen regulation.
You can read the full BeautyMatter article here.
