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Gateways, “dual-manufacture”, and the FDA

The Food and Drug Administration has asked for suggestions, and one of the topics they'd like to hear about is behavior. ("We particularly request comment on behavioral data related to... the effects of e-cigarettes on the initiation and continuation of use of other tobacco products.") What do stakeholders in the vaping products industry – and that includes vapers – have to suggest about the way different product categories affect usage patterns.

[e-cig] Of course there's no data yet on usage patterns, aside from crude statistics on increases and decreases. The Centers for Disease Control went into a tizzy last Fall because e-cig use had gone up among teens, and the press obediently followed them into that tizzy. People wanted to believe that the data showed e-cigs to be a smoking gateway, even though other data emerging simultaneously suggested the opposite. So they went ahead and said it was a fact that vaping is a gateway to smoking, based on their fears and on their animus against a smoking lookalike.

There are no data yet about why more kids vaped. No proven correlations. The fact that fewer kids smoked while more vaped suggests a possible correlation – that vaping is an exit gate -- and it's certainly more plausible than its opposite, but it's not been proven. We simply have no proven behavioral correlations yet.

So what can we base our suggestions on, lacking data? What else do we have? We have logic, and I don't mean a brand.

The agency is open to the idea of a continuum of product danger. Some tobacco products are more dangerous, others less so. They have explicitly stated that there is a slight possibility that vaping nicotine might be just a teeny-weenie bit less dangerous than smoking nicotine, kind of like acknowledging the slight possibility that a light drizzle might be a teeny-weenie bit less dangerous than a tsunami. ("FDA realizes that there are distinctions in the hazards presented by various nicotine-delivering products. Some have advanced views that certain new tobacco products that are noncombustible [such as e-cigarettes] may be less hazardous than combustible products given the carcinogens in smoke and the dangers of secondhand smoke from combustible products. Accordingly, FDA is seeking comment in this proposed rule as to how e-cigarettes should be regulated based on the continuum of nicotine-delivering products. We welcome comment on how to implement the provisions in the FD&C Act with respect to e-cigarettes.") This "crack-in-the-door" implies the possibility that the agency might agree to regulate differently for products that display different levels of danger.

Their primary worry is about the gateway effect. So, thinking about it logically, since we still lack data, which product category would be more likely to become a smoking gateway, which one less? Let's take Hypothetical Teen 1 (HT1) and Hypothetical Teen 2 (HT2). HT1 vapes an e-cig made by a company that has never sold poison – they have never marketed a combustible, toxic cigarette. HT2 vapes an e-cig made by a Big Tobacco company that offers both a toxic, combustible product and an e-cig. Which teen is more likely to move from vaping on to smoking? Logically speaking, it would be HT2. Brand loyalty.

Some people are worried about "dual-use". Well, there are vaping product companies that "dual-manufacture".

The deeming proposals that are on the table open up a clear possibility of a product category distinction. ("FDA recognizes that there may be the potential for varying levels of harm and negative effects on public health for different categories of tobacco products. FDA is considering whether it might be appropriate for the protection of the public health to stagger the compliance dates for certain provisions for different categories of products. FDA seeks comment on this issue.") There is an impeccably logical rationale for ruling that different product categories represent different levels of "gateway-effect" danger, and therefore require different degrees of regulation. There are "dual-manufacture" companies (Big Tobacco) and there are independents ("clean hands" companies). Make it harder to get e-cigs from "dual-manufacture" companies, and the chance kids will go on to smoking will decrease.

If I were a stakeholder agency in the e-cig industry, that's the suggestion I'd send to the FDA.

Just sayin'....