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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

UK Org ‘Snapshot’ Sampling: Most Third-Party Beauty On Four Ecommerce Sites ‘Likely’ Counterfeit

 
• By Eileen Francis

UK consumer advocacy organization finds more than two-thirds of 34 skin care and makeup products it purchased from third party sellers on major ecommerce sites are likely fake.

EU Green Claims Directive: Commission Says It ‘Has Not Withdrawn’ From Negotiations

 
• By David Ridley

What's going on with the EU Green Claims Directive? HBW Insight speaks to the European Commission, Parliament and Council to find out why trilogue negotiations seem to have stalled.

US FDA: No Replacement Yet For Animal Methods In Testing Systemic Effects Of Sunscreens

 
• By Lauren Nardella

While FDA fully supports the recent roadmap to reduce and eliminate animal testing, animal tests are still necessary for assessing systemic effects, says Jacqueline Corrigan-Curay, acting director for CDER, during a House Energy and Commerce Health Subcommittee hearing.

EU Proposal To Simplify Hazardous Chemical Rules For Cosmetics ‘Step In Right Direction’ - Industry

 
• By Eileen Francis

The European Commission’s Simplification Omnibus published July 8 is ‘step in right direction’ for streamlining processes and providing more legal certainty and predictability for regulations addressing cosmetics, says Cosmetics Europe.

More from Policy & Regulation

Senate HELP Committee Adds Sunscreen Regulation Overhaul To OMUFA Reauthorization

 
• By Lauren Nardella

OMUFA reauthorization bill including amendment with sunscreen regulation provisions passed by Senate committee, which also approved other provisions not included in House OMUFA bill.

Sunscreen Regulation Reforms Still Could Hitch Ride On Senate OMUFA Reauthorization Bill

As stakeholders and lawmakers pin their hopes on OMUFA reauthorization as a vehicle for enacting sunscreen regulatory changes, Senate version of the bill could be the ticket after a sunscreen-specific amendment withdrawn in the House.

Unanimous Support Across House Energy And Commerce To Reauthorize FDA’s OMUFA Program

 
• By Malcolm Spicer

Committee voted 51-0 to approve five-year authorization of FDA program user fee program needed to support regulatory pathway for large majority of nonprescription drugs available in the US with amendment to expand stakeholder engagement with FDA.