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E-Cigarettes Spark Evolution Of FDA’s Nicotine-Containing Medical Product Regulation

 
• By Malcolm Spicer

FDA’s tobacco, drug and medical device centers are discussing “some sort of jurisdictional policy” to “determine how to evolve the regulation of therapeutic nicotine products,” including OTC drugs, says tobacco program head Mitch Zeller.

Electronic cigarettes are the “poster child” for FDA considering new nicotine-delivery products as treatments to help smokers quit using combustible tobacco, says Center for Tobacco Products Director Mitch Zeller.

CTP is working with FDA’s drug and medical device centers on “some sort of jurisdictional policy” to “determine how to evolve the regulation of therapeutic nicotine products, whether they are prescription drugs, over-the-counter drugs,

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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.