FDA Staff Were Blindsided by Their Own Agency’s Vaping Policy Change — AP Exclusive
Senior officials at the FDA’s Center for Tobacco Products were not consulted on a policy change that allows companies to launch nicotine products without full agency vetting, according to an Associated Press investigation. Staffers only learned of the six-page memo the night before publication.
The guidelines, posted days before former FDA Commissioner Marty Makary resigned, will allow companies to bring certain nicotine-based products to market before receiving full premarket authorization. The policy bypassed the federally required public comment period and was published as finalized hours after reports surfaced that President Trump had approved Makary’s dismissal.
What the Policy Changes
The memo breaks with longstanding FDA policy that required scientific verification of health benefits for smokers before any new nicotine products could be introduced. Under the new framework, companies can launch products without proving they help smokers quit.
The policy covers both electronic nicotine delivery systems (ENDS) and nicotine pouches. The FDA’s own staff tasked with enforcing vaping regulations were excluded from drafting the document, creating what one staffer described to AP as “internal confusion about how the policy came about and who authorized it.”
Mitch Zeller, who retired as FDA tobacco director in 2022, told AP: “It begs the question of whether the true subject matter experts may have actually opposed this policy and were ordered to do it anyway. That goes to the ability of the public to have trust and faith in institutions like FDA.”
What This Means for Vapers
In the short term, the policy change could accelerate the availability of new vape products and nicotine pouches on the US market without the typical multi-year PMTA review process. This is good news for consumers looking for more options, but it raises questions about product safety oversight.
For vape shop owners: expect a flood of new products hitting the market that lack FDA authorization. Verify your suppliers’ compliance status carefully. Products that enter the market under this policy could face retroactive enforcement if the policy is reversed by a future administration.
For consumers: more products on shelves does not mean they are FDA-authorized. Stick to brands with established PMTA submissions and check the FDA’s authorized products list when in doubt.
Reactions and Fallout
The AP report has triggered bipartisan concern on Capitol Hill. The policy bypassed standard FDA procedure including the Administrative Procedure Act’s notice-and-comment requirements, which could make it vulnerable to legal challenge.
FDA officials have convened hours-long meetings since the memo’s release grappling with implementation, according to the AP sources. The agency has not issued a public statement explaining the rationale for the policy change or why staff were excluded from the process.
Senate health committee staff are reportedly reviewing the policy for potential oversight hearings, though no hearings have been scheduled yet.
Action Advice
For vape businesses: document your compliance status now. If this policy is reversed or challenged in court, products brought to market under it could face expedited enforcement. Maintain records of any PMTA submissions or marketing orders.
For consumers: this policy change means the line between authorized and unauthorized products just got blurrier. Continue buying from reputable retailers who can verify their supply chain. The FDA’s enforcement priorities remain focused on products marketed to youth and those making unsubstantiated health claims.
Keep Reading
- FDA Vape Enforcement Policy 2026: Which Products Face Action
- US Vape Seize and Destroy Law 2026: Federal Enforcement Explained
- Vape Industry Weekly: July Week 1
- Best Nicotine Pouches of 2026
Kevin Li — Founder & Editor, VapeObservation.com Kevin reviews vape products hands-on, prioritizing real-world performance over manufacturer claims. His goal: honest, practical advice that helps everyday vapers make informed choices. Before launching VapeObservation, he was a longtime vaper frustrated by promotional content disguised as reviews. Every article on the site reflects his commitment to data-driven, reader-first testing.
