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Senate HELP Floats Draft For US Cosmetics Reform; Top Trade Groups Hustle To Respond

 
• By Ryan Nelson

Bundled within the draft FDA Safety and Landmark Enhancements Act are federal cosmetics reform provisions that would require facility registration and product listings with the US FDA, adverse event reporting and good manufacturing practices, while empowering the agency to order product recalls, access company records, and suspend dangerous operations.

A stack of legal books with "Regulations" on the spines.

A discussion draft bill released by the US Senate Health, Education, Labor and Pensions Committee on 17 May to reauthorize drug and medical device user fee programs also would modernize federal cosmetics oversight, reigniting movement in Congress that’s been underway for more than a decade.

The Personal Care Products Council and Independent Beauty Association said they are assessing the draft FDA Safety and Landmark...

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More from United States

Some Laid Off Employees Called Back At US FDA

 
• By Sarah Karlin-Smith

Some FDA employees who were recently laid off by the Trump Administration are being called back to work, multiple sources confirmed to the Pink Sheet.

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• By Malcolm Spicer

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Washington State TFCA Violators Likely To Face Conversation Before Penalties – DOE

 
• By Eileen Francis

The Washington State Department of Ecology will try to work with companies that violate the Toxic Free Cosmetics Act, rather than reflexively imposing the $5,000-per-violation fine for first-time offenders, says the law’s implementation planner. She noted financial assistance is available for small businesses, as well as incentives for companies adopting measures “beyond compliance.”

More from North America

Washington State TFCA Violators Likely To Face Conversation Before Penalties – DOE

 
• By Eileen Francis

The Washington State Department of Ecology will try to work with companies that violate the Toxic Free Cosmetics Act, rather than reflexively imposing the $5,000-per-violation fine for first-time offenders, says the law’s implementation planner. She noted financial assistance is available for small businesses, as well as incentives for companies adopting measures “beyond compliance.”

Adcomm Reform: Getting Needed Information More Important Than Vote Or Discussion

 
• By Derrick Gingery

US FDA Office of New Drugs Director Peter Stein says review divisions have made the case that a discussion-only meeting would solicit the necessary input.

US FDA’s Petition Procedures No Place For OTC Acetaminophen Pediatric Dosing Enforcement

 
• By Malcolm Spicer

Requests for “enforcement actions are not within the scope of FDA’s citizen petition procedures,” CDER says, rejecting petition dosing device firm Parenteral Technologies submitted as it prepares for workshop on Pediatric Research Equity Act requirements for OTC NDA sponsors.