As the end of the FDA's comment period approaches, CASAA (Consumer Advocates for Smoke-Free Alternatives) has issued its fourth “Call to Action”. Now is the time to take definitive action, says CASAA. The premier vaping advocacy group in the USA has issued three earlier calls to action, as well as “Calls to Prepare” and background documents for key congressional bodies and for members. However, until now the group has urged members to wait to submit their final comments, suggesting that comments submitted early might be glossed over, while well-crafted comments submitted as the comment period ends are likely to garner maximal attention and exert maximal impact.
Central to CASAA's argument is the observation that the proposed regulations seem likely to hand over the vaping supplies industry to Big Tobacco, the very group that is seen as the sinister author of a supposed plan to use e-cigs to hook (young) people on nicotine. This implicit view of Big Tobacco as the driving force behind the vaping movement can only be maintained by ignoring obvious facts, since Big Tobacco did not move to muscle in on the vaping industry until 2 years ago, two years after the courts ruled (in a lawsuit against INDEPENDENT e-cig companies) that the FDA could not regulate e-cigs as medicines. At that time Big Tobacco still viewed e-cigs with horror, as just one more drain on their revenues.
The way tight regulation will award the industry to Big Tobacco, according to CASAA, is by requiring vast amounts of expensive paperwork that are likely to sink the small and midsized, independent companies that provide a diverse array of personal vaporizers, vapor-tank systems, e-liquids, and mods – paperwork that the well-heeled cancer merchants of the tobacco industry can easily produce, taking the regulation in affluent stride. Several of the documents CASAA has supplied to Congress deal with the “paperwork reduction act”, but the job of reducing paperwork at an organization like the FDA would seem to be a hopeless “task of Sisyphus”.
The paperwork demand is worsened, says CASAA, since new products (defined as products introduced after 2007) must establish “substantial equivalence” with existing products or prove clear smoking-cessation benefit, both involving increased paperwork. The FDA has stacked the deck against demonstration of cessation benefit by resisting it in several ways: characterizing thousands of testimonials as “mere anecdotes” rather than as a statistic, declining to initiate studies of cessation benefit, ignoring persuasive studies out of Britain and France, and accepting blindly the flimsy allegations of e-cig opponents who deny cessation benefit.
CASAA maintains, with good reason, that the FDA and the Centers for Disease Control and Prevention (CDC) have presented a distorted picture of the scientific evidence on the alleged dangers of vaping, blindly accepting negative comment that has flimsy data, and ignoring persuasive studies of low harm levels. A persuasive study can persuade only if it is read by those responsible for taking action. An unread study, no matter how definitive, cannot be “persuasive”, lying there at the bottom of the trash bin.
Even more important than cherry picking and differential perusal and acceptance of studies, in CASAA's view, is SPIN. Positive evidence about low dangers of vaping, and cessation benefits, is qualified with phrases like “some sources argue” or “may be the case”, while negative allegations are spun with phrases like “doctors say” or “scientific studies indicate”.
Given all of the stacking of the deck against advocacy of vaping, only the most well-heeled companies can survive in the regulatory environment likely to emerge from the deeming regulations, says CASAA. The tobacco industry has lots of money from its decades of unregulated hawking of deadly smokes. Tobacco companies can handle the expenses of certifying e-cigarettes, but they are way behind on the diverse products experienced vapers prefer. CASAA argues that, unless the FDA can be persuaded to move in a different direction, Big Tobacco will be the winners, and smokers wishing to quit will be the losers. And the range of available products will shrink to a few “cigalike” e-cigs like those currently produced by Big Tobacco, closely imitating the smoking experience, but lacking the rich diversity of more satisfying products now available.
CASAA's “Fourth Call to Action” says the time is now to present well-reasoned, carefully crafted statements to the FDA. The comment period will close on August 8, and the CASAA website has invaluable guidelines for vapers wishing to craft their statements and submit them.
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