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. “And that goes to the ability of the public to have trust and faith in institutions like FDA.”
