The Food and Drug Administration (FDA) approved bemotrizinol, a sunscreen ingredient widely used in Europe, on June 9 to provide consumers with safer, lighter sunscreen options and help restore confidence in sun protection products in the United States, officials and advocates said.
What Happened
On June 9, the FDA granted its “generally recognized as safe and effective” (GRASE) status to bemotrizinol (also called BEMT), a chemical sunscreen filter that has been used in Europe for decades but awaited U.S. approval for nearly twenty years. The decision follows a lengthy review process, allowing U.S. sunscreen makers to reformulate products and introduce formulations resembling popular international brands by autumn 2024.
Key Facts
- Bemotrizinol joins zinc oxide and titanium dioxide on the FDA’s GRASE list for sunscreen ingredients.
- The approval followed comprehensive testing, including irritation, allergy sensitization, carcinogenicity in animal studies, and reproductive health assessments.
- Approximately 3.3 million Americans are diagnosed annually with basal and squamous cell carcinomas, the most common forms of skin cancer.
- The FDA regulates new sunscreen ingredients as over-the-counter drugs, requiring more stringent testing compared to cosmetic regulation in Europe or Japan.
- In 2019, the FDA found insufficient safety data for 12 commonly used sunscreen chemicals; four—avobenzone, homosalate, octisalate, and octinoxate—remain approved but with some safety concerns noted internationally.
Why It Matters
The approval of bemotrizinol offers American consumers access to sunscreens that are lighter on the skin and provide broader ultraviolet (UV) protection, potentially increasing user compliance and protection against skin cancer and premature skin aging. This ingredient’s acceptance could rebuild consumer trust shaken by prior concerns over unknown chemical safety and reduce reliance on ingredients linked to allergic reactions or environmental harm.
Background
The FDA’s cautious and lengthy review is due to its classification of sunscreen ingredients as over-the-counter drugs, demanding animal testing and extensive safety data, unlike the European Union or Japan. Bemotrizinol has been available in Europe and other regions for nearly 20 years, but U.S. regulatory standards delayed its domestic approval. Previously, several common UV filters were flagged by the FDA for insufficient safety data, contributing to public skepticism.
Analysis
Health and Human Services Secretary Robert F. Kennedy Jr. highlighted the ingredient’s long history of safe use in Europe and its potential to increase competition and consumer confidence in the U.S. “People will talk more positively about sunscreens,” said Carl D’Ruiz, senior manager at DSM-Firmenich, the chemical’s manufacturer. Alexa Friedman, environmental epidemiologist at the Environmental Working Group, noted the robust safety data package submitted to the FDA. Pediatrician Mark Mitchnick described bemotrizinol as an effective UVA blocker that allows sunscreen formulations to avoid chemicals like avobenzone, which have more safety concerns.
Who Is Affected
American consumers seeking effective and cosmetically appealing sunscreens will benefit from the new ingredient’s approval. The skin care industry gains the ability to innovate and compete with international brands. Public health initiatives focused on reducing skin cancer incidence also stand to gain from safer, more acceptable sunscreen options.
What Remains Unclear
This approval does not address the safety of other commonly used sunscreen chemicals lacking GRASE status. The FDA has not yet banned these ingredients, some of which have raised concerns internationally regarding endocrine disruption and environmental effects. How bemotrizinol’s availability will affect long-term sunscreen adherence and skin cancer rates remains to be seen.
What Comes Next
Sunscreen manufacturers are expected to launch reformulated products containing bemotrizinol and mineral filters like zinc oxide in the U.S. by autumn 2024. The FDA will continue evaluating other sunscreen ingredients’ safety data and adjust regulatory decisions accordingly.
Sources
This article is based on reporting and publicly available information from the following source:
Read more Health & Public Health stories on Goka World News.