Senior officials at the Food and Drug Administration’s tobacco center were blindsided by a sudden policy shift that will allow more unauthorized electronic cigarettes and nicotine pouches onto the U.S. market, two agency staffers told The Associated Press. The new guidelines, which permit certain nicotine-based products to launch before regulators complete a full safety review, were posted online in early May 2026—days before FDA Commissioner Marty Makary resigned—without consultation of the enforcement staff tasked with overseeing the vaping market.
The staffers, who spoke on condition of anonymity because they were not authorized to discuss internal deliberations, said they and their colleagues were informed of the document only the night before it appeared on the FDA’s website. “We were told it was coming, but we had no input on its content,” one of the staffers said. The other said the sudden appearance of the policy “created confusion about who authorized it and why the normal review process was circumvented.”
The guidance, described in a document titled “Enforcement Priorities for Electronic Nicotine Delivery Systems,” instructs FDA field agents to prioritize enforcement against products that are clearly marketed to minors or that make unsubstantiated health claims. For everything else—including new e‑cigarette devices and nicotine pouches that have not gone through the agency’s pre‑market authorization process—the policy effectively gives companies a green light to sell, provided they do not violate the few remaining hard lines. Public health advocates argue that this undercuts the 2009 Tobacco Control Act, which gave the FDA the authority to regulate new tobacco products and required pre‑market safety reviews.
The vaping industry welcomed the shift. Tony Abboud, executive director of the Vapor Technology Association, described the guidelines as “a common‑sense regulatory framework that preserves adult access to harm‑reduction products while keeping them out of the hands of kids.” Yet critics warned of a return to the years before the FDA gained authority over e‑cigarettes, when companies freely marketed flavored products that fueled an epidemic of youth vaping. Matthew Myers, president of the Campaign for Tobacco‑Free Kids, said the policy “amounts to a gift to the tobacco industry at the expense of children’s health.”
The timing immediately before Makary’s departure added to the turmoil. Makary, a Johns Hopkins surgeon and author, had been confirmed as commissioner in early 2025 amid promises to speed up drug and device reviews. His tenure was marked by a series of deregulatory moves favored by the Trump administration, including a push to permit more vaping products. He announced his resignation on May 13, and the White House named Kyle Diamantas, a former pharmaceutical executive, as acting commissioner.
For longtime FDA staff, the episode is the latest in a string of internal upheavals. The agency has weathered leadership churn, a contentious drug‑voucher program, and repeated interventions by political appointees that career scientists say have eroded the agency’s independence. Brian King, director of the FDA’s Center for Tobacco Products, said in a statement that the agency “remains committed to protecting public health and preventing youth initiation,” but he did not address how the new policy was developed.
The guidelines remain in effect while the FDA’s acting leadership settles in. Public health groups have vowed to challenge the policy in court, arguing that the agency cannot bypass the pre‑market authorization process without formal rulemaking.