Carl V. Phillips | Contributor
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.