FDA's tobacco center just drafted new rules to let ecigs, pouches onto market, but staffers didn't write them | Fortune

Guidelines issued by the FDA allow companies to launch certain nicotine-based products before regulators fully vet them. Some enforcement officials were not consulted and learned about the changes only the night before publication, leading to internal confusion about how the policy was created and who authorized it. Agency officials held long meetings to determine how to implement the six-page memo, which departs from longstanding FDA policy requiring scientific verification of health benefits for smokers before new products are introduced. The guidelines were published as finalized without the federally required public comment and revision period. The timing followed media reports about presidential approval of a plan to fire former FDA Commissioner Marty Makary, who resigned after months of industry complaints. A spokesperson said the approach strengthens protections against youth nicotine addiction while supporting evidence-based alternatives for adult smokers.

"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. 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 earlier this month, according to two staffers who spoke to the AP on condition of anonymity to discuss confidential agency matters. The document's sudden appearance sparked internal confusion about how the policy came about and who authorized it, the staffers said."

"In recent days, agency officials have convened hourslong meetings grappling with how to implement the six-page memo, which breaks with longstanding FDA policy requiring scientific verification of health benefits for smokers before any new products are introduced. It's highly unusual for the FDA to draft new policies without input from the staffers who oversee them. "It begs the question of whether the true subject matter experts may have actually opposed this policy and were ordered to do it anyway," said Mitch Zeller, who retired as the FDA's tobacco director in 2022."

"The vaping guidelines bypassed a federally required period that allows for public comment and revisions. Instead, the FDA published them as a finalized policy hours after media reports surfaced that President Donald Trump had approved a plan to fire Makary. He resigned from the FDA last week following months of complaints from industry lobbyists close to the White House. A Health and Human Services spokesperson did not address the origins of the guidance in a written statement."

""This approach strengthens protections against youth nicotine addiction while supporting evidence-based alternatives for adult smokers seeking to move away from combustible tobacco products,""

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