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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

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.

Cloudy Tariff Conditions Expected To Linger In US

 
• By Malcolm Spicer

White House announces president extends deadline he set in April for other countries to make new tariff deals from July 9 to Aug. 1, when the administration will start sending letters warning other countries that higher tariffs could take effect.

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%.

More from Policy & Regulation

FDA Urged To Issue Formaldehyde Rule As California Finds Non-Compliance With State Ban

 
• By Lauren Nardella

Stakeholders are still waiting for the US FDA to issue its widely anticipated proposed rule to prohibit formaldehyde and formaldehyde releasers from hair smoothing or straightening products.

Cloudy Tariff Conditions Expected To Linger In US

 
• By Malcolm Spicer

White House announces president extends deadline he set in April for other countries to make new tariff deals from July 9 to Aug. 1, when the administration will start sending letters warning other countries that higher tariffs could take effect.

US FDA’s Tough Talk On Talc: Regulating In An Echo Chamber

 
• By Michael McCaughan

An FDA “expert roundtable” on talc produced a new talking point on a potential drug safety risk, but the basis of that claim is difficult to determine.