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FDA To Try Its Hand At Sunscreen Absorption Study, A MUsT For TEA Sponsors

 
• By Ryan Nelson

Agency may be teaming with an outside party to conduct a maximal usage trial on sunscreen formulations. FDA guidance advises MUsTs to assess systemic exposure to sunscreen drug ingredients, but ingredient sponsors have been loath to invest in such tests due to questions about cost and viability.

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FDA is in the process of contracting a study to assess systemic exposure to sunscreen formulations, an undertaking that could serve public health interests and those of sunscreen ingredient firms seeking agency approval of their formulations as generally recognized as safe and effective.

"Most sunscreen active ingredients are organic chemicals and some have been shown to be absorbed through human skin with detectable...

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More from Regulation

ECHA Adds Two Cosmetic/Personal Care Silicones To REACH Candidate List

 
• By Eileen Francis

ECHA has added two silicone ingredients used in cosmetics and personal care products to the REACH Candidate List as they are persistent and have bioaccumulative properties, requiring companies to notify customers and update safety data sheets if concentrations exceed 0.1%.

MoCRA Implementation Delay Creates More Legal Exposure For Stakeholders – Attorney

 
• By Eileen Francis

The delay in implementation of MoCRA is seen by many companies as a temporary reprieve, but it does create more legal uncertainty, says attorney Marissa Alkhazov of law firm Buchalter.

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By Sue Sutter

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

Animal Studies Would Not Provide ‘Meaningful Insights’ Into UV Filter Safety - Study

 
• By Lauren Nardella

A new study on the safety of sunscreen filters relies on an alternative assessment methodology and concludes that six sunscreen UV filters are unlikely to be carcinogenic.

More from Policy & Regulation

California Legislators Advance Bill To Ban Plastic Glitter, Abrasive Microbeads In Personal Care

 
• By Lauren Nardella

Lawmakers in California heeded calls from industry to change proposed legislation to avoid a wider ban on microplastics in personal care products.

EPR Alert! Unregistered Producers In Colorado No Longer Permitted To Sell 1 July

 
• By Eileen Francis

Packaging producers subject to Colorado’s Extended Producer Responsibility program that have not registered with the organization running the program will no longer be able to sell in the state starting 1 July.

House Bill Aims to ‘Modernize’ US FDA’s Review Process For Sunscreens

 
• By Eileen Francis

Four co-chairs of the House of Representatives’ Skin Cancer Caucus have introduced the Safe Sunscreen Standards Act to direct FDA to establish clearer, ‘more flexible’ standards for evaluating sunscreen ingredients.