Recently, according to media, the U.S. government ushered in a new wave of regulation with the Modernization of Cosmetics Regulation Act (MoCRA), mandating stricter oversight of cosmetics, including facility and product registration with the Food and Drug Administration (FDA). As beauty brands scramble to comply with these changes, another significant regulatory shift is unfolding—one that directly impacts the sunscreen market.
The FDA, which has been revising its sunscreen regulations since 2019, now requires animal testing of chemical sunscreen ingredients. This revision stems from new findings that certain sunscreen ingredients, previously thought to remain on the skin’s surface, are absorbed into the body. As a result, the FDA has determined that it must better understand the potential risks posed by these absorbed ingredients, especially given the routine, long-term use of sunscreen by millions of Americans.
An FDA representative emphasized that, while the safety of these ingredients was previously supported by human data, new data demonstrating systemic absorption raised critical questions about their long-term effects. “The FDA routinely evaluates drugs that are absorbed into the body to ensure their benefits outweigh any risks,” the representative said in a media interview. “However, given the complexity of interactions between these ingredients and the human body, animal testing remains the only scientifically valid method to assess potential risks at this time.”
This shift has generated significant concern, particularly among advocacy groups and beauty industry insiders. While there is mounting pressure for non-animal testing alternatives, the FDA has made it clear that current non-animal testing methods are not sufficiently reliable to predict the complex interactions that could arise from the systemic absorption of sunscreen ingredients. As a result, animal studies are deemed essential for evaluating potential risks associated with these products.
