In a new document entitled, “Healthy Innovation, Safer Families: FDA’s 2018 Strategic Policy Roadmap,” the FDA lays out its goals for nicotine policy among other topics. On its face, it reads like good news for vaping. A deeper read, along with background knowledge about FDA policy and practice, suggests that this interpretation may be too optimistic.
The document states, “the Agency must also take a fresh look at products that can deliver satisfying levels of nicotine to adults who want access to it without burning tobacco.” It continues, “With appropriate product regulation, new technology, and product innovation – including new medicinal nicotine products and electronic nicotine delivery systems (ENDS) – could present an opportunity for more smokers to quit combustible tobacco and stay quit.”
That sounds good, apart from the hint that the FDA thinks of vapor products as basically being medicines. However, the FDA has been trying to sound good about low-risk alternatives to smoking since it gained authority over tobacco. But every policy decision has gone in the opposite direction. This includes denying multiple applications from smokeless tobacco manufacturers who wanted to tell consumers those products are less harmful than smoking, and banning new flavors of one smokeless product that were clearly aimed at smokers. There is also the deeming of e-cigarettes itself, which unnecessarily triggered a doomsday countdown for all products (now delayed from 2018 to 2022, but still counting).
The deeming already prohibits innovation and product upgrades in the vapor product market. The only new products allowed — and the only products allowed as of 2022 — will be standardized closed systems, mass produced on a scale that justifies the millions of dollars that new product approval costs. Thus, the “appropriate regulation” necessary to achieve “new technology and product innovation” must include ending these restrictions. The FDA’s document does not suggest they have any such intention.
Even apart from the Orwellian “safer families” (there is nothing about families in the document), the document is mistitled. It is not actually a roadmap — not unless you consider a page with a starting point and destination marked, but nothing but blank space in between, to be a roadmap. It is more of a wishlist.
There are a few vague points under the heading “Actions.” In the nicotine section, most of these are either busywork (“Initiate a public dialogue surrounding nicotine”), about the FDA’s main goal of forcing cigarette manufacturers to reduce nicotine content, or about increasing anti-vaping restrictions and propaganda (banning “kid appealing e-liquid flavors”; “expanding FDA’s public service programs aimed at reducing youth use of tobacco, including ENDS”).
There are two points about making regulations more conducive to the stated goal of encouraging smokers to switch, but they are exceptionally vague. The first reads:
Establish an appropriate regulatory framework for new product innovations that could serve as less harmful alternatives to combustible tobacco, for adults who want to get access to satisfying levels of nicotine. Create a framework to properly evaluate their safety and potential benefits.
This is the type of vague statement that an agency will write when first exploring whether to create regulations, not a few years in after the regulations are already hurting the market. It contains no information beyond the original wishlist statement. While it would be better to have such “frameworks” than to not have them, it is rather late and there is still no evidence of any movement in that direction. A “framework” created in 2018 means actual rules created in 2019 at best. Following that, applications will have to be submitted and the FDA will have to analyze each and make a decision, which will not even begin to happen for yet another year. Doing the research to evaluate safety and potential benefits — in the FDA-style of doing so — will take even longer.
The other relevant action point reads:
Develop a more efficient approach to the regulation of provisional applications and how sponsors establish substantial equivalence for new and currently marketed tobacco products.
This could actually be a game-changer, and it is something the FDA could actually just do, without the delay of presenting new regulations for public review and White House approval. The FDA has intentionally made the “substantial equivalence” application process onerous, confusing, uncertain and almost always unsuccessful. The process was intended to facilitate approval of minor changes — particularly improvements — to existing products, keeping this affordable to manufacturers and reasonably predictable. The FDA has chosen to do just the opposite, but it could choose to start doing substantial equivalence properly.
But will they really? Doing so would have been as simple as the “create a framework” clauses in the previous point are complicated. They could have just done it rather than making noise about developing a way to do it. Moreover, the FDA still suffers the disaster of trying to apply rules for the simple cigarette market to the complicated vapor product market. Even if they implemented “a more efficient approach” for the SE process, it seems unlikely to work for a market where, if it were free, there would be hundreds of SE-level changes to products every day.
Other aspects of the FDA’s document create further cause for concern. Low-nicotine cigarettes and vapor products were part of a section that also included the goal of cracking down on opioids. The tone of most of that section — particularly about both cigarettes and opioids, but some about vapor products — was pure drug-war rhetoric. It is all about supply, focusing on interdiction and basically treating the drugs as the actor and consumers as passive hapless victims. There is even talk of law-enforcement, though that role is mostly played by medical industry controls rather than police.
It is difficult to reconcile a few positive statements about consumer choice with the generally oppressive and controlling tones of their context. The positive statements seem forced. By contrast, the sections of the document on other topics read as straightforward statements of positive and practical goals. The “actions” statements on non-nicotine topics are not exactly clear roadmaps, but they are far more concrete and hint at specific work that is already underway. Those in the nicotine section read like the authors have no idea how they might actually be done.
It would be an enormous benefit to the vapor product market if the FDA really started allowing a proper SE process. At the very least it would be possible to use new and improved batteries and fix known problems, and (legally) keep selling a produce even if a component or ingredient supplier changed their product slightly. It would be better still if major regulatory changes were non-glacial and could head-off the 2022 doomsday. But it would seem a lot more promising if there were not such obvious enthusiasm about crackdowns and if the “plans” did not feel like they include the subtext of “yeah, we really ought to think about doing this one of these days.”
