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Refrigerators, automobiles, and vaporizers

The “Vaping on My Mind” conference hosted by Wells Fargo November 20 also featured a 2-session panel for discussion of refulatory issues. The moderator was law professor David Sweanor of the University of Ottawa, who focused the first panel on the role of innovation. Taking the example of stomach cancer, the believe-it-or-not leading cause of cancer death a mere 70 years ago, Sweanor noted that refrigeration changed diets, which rendered the disease a rare one in a short period of time. The analogy to e-cigarettes is clear.

Saul Schiffman, a “health psychologist” at the University of Pittsburgh, stressed the idea that harm reduction theory is based on an understanding of the difference between absolute safety and relative safety. “The question is not whether they are absolutely safe,” he argued, “but whether they are materially safer.” He noted the plummeting cancer rate in snu-using Sweden. The low-nitrosamine chaw may not be mother's milk, but it has saved many lives.

“If you have a kid who's already smoking, or you have a kid who has a choice of taking up combustible cigarettes or e-cigarettes, . . . you're better off with that kid taking up e-cigarettes," Schiffman opines.

Schiffman also lamented the fact that current laws prevent companies from communicating clearly and honestly with customers about health benefits and dangers.

Dave Dobbins of the American Legacy Foundation (a think tank funded by Master Settlement Agreement), turned out to be the stand-up comic of the show. Here's a line from his routine: “The horse hasn't only left the barn on the e-cigarette; it's living in the master bedroom and getting ready to run off with their wife. I don't think you can do anything about it.” Good one, Dave.

Dobbins drew his example of regulatory successes, not from refrigerators but from automobiles. The Model T was a relatively dangerous machine, he noted, citing a then-era magazine cartoon. A hunter and a motorist exchange dialog where the road enters the forest. “Have you killed anything,” queries the driver. “No,” retorts the hunter. “Have you?”

But through well-designed regulation, this dangerous product evolved into something relatively safe, effective, and consumer-driven. (Pun intended?) There has been an adversarial duel between business and workers, and between both and regulators, which Dobbins sees as a norm for such a market. “But they've both come to a pretty good place. This product is much, much better than the 1970s-era Dodge Omni was crawling all over when was a kid.”

Pathways linking new products with modified risk need to be used, and will produce “a tremendous consumer advantage,” argues Dobbins.

Dobbins also notes that according to the 2014 Surgeon General's report, cigarette company technologies have managed “to increase its addictiveness profile, and as a result the morbidity and mortality from cigarettes.” That line wasn't so funny, Dave. Try this one: How many morticians does it take to change a light-bulb.... Or: How many vape-bashing journalists does it take to safely recharge an e-cig battery?

Deborah Arnott of Britain's Action on Smoking and Health (ASH) puts forward the probability that teenage e-cig experimenters are much less likely to become regular users than their peers trying smoking, 40% of whom will become smokers.

The second panel, also moderated by Sweanor, began with another Brit, the feisty Clive Bates (who preceded Arnott at ASH). “My starting point,” says Bates, “is that just about every idea for regulation so far conceived, whether it's the FDA, European Union, Australia, Canada, World Health Organization, UK will actually make things worse for health for the marketplace than make it better. The proposals on the table, so far, are worse than doing nothing.” He believes there is little to be gained by changing anything, with great potential for “unintended consequences”.

Gal Cohen, a neuroscientist who works for Ploom Vaporizers, lauds the FDA for recognizing a “continuum of risk”. He notes that they are considering “an expedited premarket review pathway, based on this principle of the sliding scale of relative risk, so meaning the less risk you have, the less regulation you need to meet in order to get to market.” Commentators like Bates may not share Cohen's enthusiasm for the FDA, but certainly an expedited pathway for lower-risk products is good news for all.

David Graham, who heads the office for regulatory matters at NJOY, explains the expected pathway: “Initially, six months after the deeming rule goes into effect, you have to provide an ingredients list submission. FDA is going to know what's in the product. You're going to provide an establishment and product registration. FDA is going to know who's making what where. Product lists, labeling, samples of advertising; FDA is going to know what's in the market and how it's being promoted.”

Graham claims

ideological common ground with independents and with the vaping community, because we're both passionate about obsoleting tobacco.

He wants to partner with other independent (non-Big Tobacco) companies to make sure that vapers have a “vibrant choice”.

Joe Gitchell of the nicotine consultancy, Pinney, says he is encouraged by current FDA moves, arguing that Mitch Zeller's Center for Tobacco Products at that agency offers “a comprehensive approach to nicotine product regulation that is clear, and extends beyond just the Center for Tobacco Products...." 

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