I was a co-author on a report for the American Enterprise Institute with Sally Satel (AEI), Don Kenkel (Cornell University), and Brad Rodu (University of Louisville).
Regulating the Tobacco and Nicotine Market in the American Public Interest: A Reform Agenda for the FDA [PDF – 26 pages]
The report’s primary objective is to make the case for non-marginal reform of the FDA’s PMTA process, arguing that the Chinese illegal market outcompetes the legal vape market because the FDA excessively constrains the latter, effectively promoting the former. About 86% of the market is either pure illicit or unauthorised, pending review (still illegal). As the regulator for the smoke-free products 25 million Americans use, the FDA is effectively missing in action.
Its main impact favours illicit products and cigarettes at the expense of lawfully marketed, safer alternatives to smoking. We see the US market as a three-corned contest between smoking products, illicit smoke-free products, and lawful, authorised and regulated smoke-free products. The FDA has erected massive barriers to entry to the lawful smoke-free category and, in doing so, has nurtured the illicit supply and protected the cigarette trade.
We assert that this imbalance will never be fixed solely by more enforcement (which is necessary but not sufficient), but only by allowing the legal market to meet the demand for the products adults wish to buy. An enforcement-driven approach is unlikely to be effective, but it would be highly damaging if it were to succeed.
We argue that authorization, not enforcement, should dominate the FDA’s response to the illicit Chinese market and the opportunity of tobacco harm reduction. We advocate radical reform that would allow authorization of at least 4,000 vaping and other safer products, meet the statutory 180-day requirement for complementing PMTA reviews, and lower barriers to entry by a factor of ten. We show that these are reasonable aims.
We make 15 practical recommendations for reform that would deliver that agenda without needing changes to the law. The most important change is to shift the assessment of population and behaviour change aspects of the “appropriate for the protection of public health” standard to post-market evaluation and corrective action. We think that the use of human subjects in evaluating these products is unnecessary, and the FDA could establish a wide range of norms through guidance that could be used to expedite reviews. The
The FDA also has no choice but to reform the PMTA process—it cannot continue to break the law and exceed its statutory obligation to complete product reviews within 180 days. Reviews have been taking ten times as long.
Thankfully, the FDA is now piloting an expedited review process for pouches. That is a step in the right direction, but reform needs to go much further in depth, scale and scope.