After being criticised for the insurmountable PMTA process for years, the FDA recently relaxed enforcement on some unauthorised vaping products and approved the first non-tobacco-flavoured vape devices through the same process. This marks a notable change in U.S. nicotine regulation and could signal a more practical harm-reduction approach. Even more interesting, though, are the events surrounding former FDA Commissioner Marty Makary’s resignation. His departure highlighted a bigger problem: a widening gap between current nicotine science, regulatory actions, and the stories that shape public opinion.
Drama vs science
Sadly, the real scientific discussion about the benefits of flavours, which should have been front and centre, never made it to the headlines.
When Makary resigned, the media jumped on a pretty straightforward tale: one which alleged that Donald Trump had a sit-down with tobacco and vaping execs at a golf club, who were there to push for approvals on flavoured products. Makary wasn’t having it, Trump dug in his heels, and before long, Makary found himself out of a job. It all sounds like a scene from some political drama—golf carts zipping around, clouds of cigar smoke in the air, hush-hush deals happening, and a regulator trying to stand firm against corruption. This version of events spread through major news outlets like wildfire. Sadly, the real scientific discussion about the benefits of flavours, which should have been front and centre, never made it to the headlines.
Discussing this pathetic state of affairs,
Roger Bate reiterated that, meanwhile, official data from the CDC and FDA have clearly indicated that vaping rates in the U.S. have dropped significantly in recent years. Youth cigarette smoking has also fallen during the rise of vaping. In fact, federal agencies note that youth e-cigarette use is now at its lowest level in a decade. “In other words, the dominant narrative was political. The scientific dispute itself was largely sidelined. This matters because one can simultaneously believe two things: first, that political influence from industry or the White House is undesirable; and second, that Makary’s policy position may nevertheless have been scientifically flawed,” explained Bate.
Is the FDA finally listening?
In fact, a group of tobacco harm experts, including Clive Bates, Brad Sweanor and Brad Rodu, recently wrote
a critique in response to flavour restrictions proposed by the FDA prior to its recently released guidance. The experts criticised the agency for missing the point about what actual consumers are up to. They emphasised that the FDA’s overlooking things like the rise of illicit trade and the needs of adults who are trying to quit smoking, warning that overly harsh rules might end up causing more problems than they solve.
The authors highlighted that the FDA tends to treat vaping as if quitting nicotine altogether is the only way forward. But if everyone were honest, it is a known fact that people often bounce between different products. If smokers can’t get their hands on safer options, many of them just stick with cigarettes or end up looking for illegal alternatives. That switch matters since cigarettes are still the deadliest way to get nicotine.
More importantly, there is strong scientific support for harm reduction. Cochrane Reviews show with high certainty that vaping helps people quit smoking more effectively than traditional nicotine replacement therapies. That said, it’s not a clear-cut situation. Of course, all stakeholders agree that the market should be sensibly regulated. Sadly, the PMTA process is anything but sensible.
The PMTA: A faulty filtering system
In fact, this situation highlights another issue with nicotine regulation in the U.S.: there’s a growing divide between the big multinational companies that can navigate these ever-changing rules and the smaller, independent businesses that are just trying to stay afloat. Some small vape companies are facing years of PMTA requirements. These businesses spend millions on legal teams and compliance, often waiting five years or more for a decision. Some receive marketing denial orders after all that effort, while others go out of business before getting any answers. For these smaller companies, this situation feels increasingly unfair.
Whether intentionally impossible or not, this process leads to scepticism that size and political influence matter as much as scientific evidence. The FDA’s shifting position adds more uncertainty. Thankfully, the agency recently announced it would not prioritise enforcement against some pending PMTAs, a move criticised by former FDA tobacco chief Mitch Zeller, who called it a “get-out-of-jail-free card.”
In contrast, critics of Zeller’s and Makary’s viewpoints highlight that being overly strict is counterproductive. The black market for vapes is already a huge player in U.S. sales, with unauthorised flavoured products accounting for the majority of consumer purchases, so broad bans feel all the more out of touch. Australia offers a cautionary example. Strict restrictions down under led to one of the largest illicit vape markets in the world, with organised crime and unregulated imports. Thankfully, the U.S. now appears cautious about repeating these mistakes.
Bate made another interesting point: Many remain uneasy about the links between regulators (in this case, the FDA) and advocacy groups, which, of course, adds to the distrust around discussions on nicotine policy. There are several examples of professionals hopping back and forth between the FDA and organisations like the Truth Initiative or Tobacco Free Kids. And while these could be indicative of regulatory capture, what is more worrying is that science and real-world data indicating what actually works remain, in most cases, unacknowledged, let alone followed.
Putting it into context
Politics will always play a role in regulation, but problems arise when only some influences are criticised while others are accepted as objective expertise without question. One needs to be able to look beneath their political convictions and preferences (even though political figures make that hard at times – very hard), and scrutinise individual issues objectively.
Ultimately, smoking rates are reaching record lows as a result of millions switching to smoke-free nicotine options from traditional cigarettes. Policies that focus solely on prohibition refuse to acknowledge this reality and, as a result, are outdated and ineffective. The FDA’s recent actions suggest the agency may finally be recognising these realities.
