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"What's Preventing the U.S. from Approving Better Sunscreens?"

Date: 5/7/2024

sunscreens

Sunscreen Regulation in the US: Blocking the Use of Better Sunscreens

  • Outdated Laws: The root of the problem stems from the Federal Food, Drug, and Cosmetic Act of 1938, which mandates sunscreens in the US are regulated as over-the-counter drugs. This necessitates extensive animal testing that companies, facing consumer backlash against such methods in Europe, are reluctant to undertake.


  • Foreign Innovation: Sunscreen manufacturers like BASF and L'Oréal, who produce newer, advanced sunscreen chemicals, argue this is unnecessary. They've already submitted safety data on these ingredients to European Union authorities decades ago.


  • Stalled Progress: Despite bipartisan support in Congress to streamline the process, companies are hesitant to invest in the FDA approval process due to its cost and potential for negative publicity.


Misinformation and Consumer Confusion:

  • "Chemical" vs. "Physical" Debate: A significant portion of misinformation about sunscreens centers around a false distinction. Some people promote "physical" or "mineral" sunscreens (like zinc oxide) as inherently safer than "chemical" sunscreens. However, all sunscreen ingredients are chemicals regardless of their source.


  • FDA's Contribution: This misconception was partly amplified by the FDA itself. Their studies finding trace amounts of sunscreen chemicals in bloodstreams fueled fears among sunscreen opponents, despite no evidence of harm at such levels.


The Push for Change:

  • Dermatologists' Perspective: Dermatologists like Dr. Adewole Adamson acknowledge the safety of existing sunscreens. But they emphasize the need for better UVA protection, which new ingredients could provide.


  • Skin Cancer Risk: Skin cancer is highly preventable with proper sun protection. Yet, it remains the most common and costly type of cancer in the US. The lack of access to more effective sunscreens is a significant public health issue.


  • Broader Support: Advocacy groups like the Environmental Working Group recognize the potential benefits of newer sunscreen ingredients and support giving the FDA the flexibility to allow their market entry.


A Potential Solution (with Delays):

  • Bemotrizinol: This ingredient, widely used in European and Asian sunscreens, is currently the only one undergoing the lengthy FDA approval process. While it could be a significant improvement in US sunscreen options, its potential approval isn't expected until 2025 at the earliest.


  • Consumer Frustration: Due to the slow regulatory process, many Americans resort to importing foreign sunscreens, even though it carries the risk of counterfeit products.


In Conclusion: The current situation highlights a complex issue where outdated regulations, public misconceptions about sunscreen, and a slow bureaucracy hinder innovation in a crucial area of public health – skin cancer prevention.


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