FDA staff blindsided by move allowing more e-cigarettes and nicotine pouches onto US market
The policy lets some nicotine products launch before full review and shifts enforcement away from products already sold widely in stores.
- Earlier this month, the Food and Drug Administration released new guidance allowing companies to launch certain nicotine-based products before full regulatory vetting, blindsiding senior officials in the agency's tobacco center.
- The policy followed months of complaints about former FDA Commissioner Marty Makary from industry lobbyists. President Donald Trump came to power last year after vowing to "save" the vaping industry.
- Under the guidance, the FDA will publish a list of products subject to "enforcement discretion," allowing sales without regulatory removal. The memo bypassed federally required public comment periods.
- Juul and other major companies see an opportunity to compete with disposable Chinese vapes, which by some estimates account for 80% of U.S. sales. Currently, unauthorized vapes containing various flavors are already widely available.
- Former FDA tobacco director Mitch Zeller questioned whether "true subject matter experts may have actually opposed this policy and were ordered to do it anyway." Brian King of the Campaign for Tobacco-Free Kids noted a broader opening to flavored products.
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68 Articles
FDA's tobacco center just drafted new rules to let ecigs, pouches onto market, but staffers didn't write them
Senior officials in the Food and Drug Administration’s tobacco center were blindsided by a recent decision that opens the door to allowing more unauthorized electronic cigarettes and nicotine pouches onto the U.S. market, The Associated Press has learned. The guidelines, posted days before former FDA Commissioner Marty Makary resigned, will allow companies to launch certain nicotine-based products before they’ve been fully vetted by regulators. …
FDA allowing more e-cigarettes and nicotine pouches onto US market
Senior officials in the Food and Drug Administration’s tobacco center were blindsided by a recent decision that opens the door to allowing more unauthorized electronic cigarettes and nicotine pouches onto the U.S. market, The Associated Press has learned.
FDA move allowing more e-cigarettes and nicotine pouches into U.S. blindsides officials
Senior officials in the Food and Drug Administration's tobacco center were blindsided by a recent decision that opens the door to allowing more unauthorized electronic cigarettes and nicotine pouches onto the U.S. market, The Associated Press has learned.
FDA staff blindsided by move allowing more e-cigarettes and nicotine pouches onto US market - The Boston Globe
Some FDA officials tasked with enforcing vaping regulations were not consulted on the changes and only learned of them the night before the document was published.
FDA staff blindsided by move allowing more e-cigarettes and nicotine pouches onto US market
The Associated Press has learned that officials at the Food and Drug Administration were blindsided by a recent policy change allowing more electronic cigarettes and nicotine pouches to hit the U.S. market.
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