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FDA Fallout

Huge condemnation for Scott Gottlieb and the FDA’s announcement about JUUL and banning eliquid flavours has built up over the last 24 hours.

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The last 24 hours has seen a flood of criticism for the anti-vape move by Scott Gottlieb and the Food and Drug Administration (FDA). The letters giving 60-day notice for firms to notify it of how they intend to comply and ensure teens can’t buy their products saw a massive leap in the value of tobacco company shares as the markets saw this as a huge attack on the tobacco-harm reduction technology.

Matt Braynard, who worked as a campaign strategist on the Trump election team, is quoted as saying that Scott Gottlieb has “lost his mind”.

“What the FDA chief is proposing here is not to, say, limit teenagers from being able to buy this, it’s not educating people it might be harmful but to banning it entirely for everybody including adults, which seems to me that he has lost his mind. There’s great risk reduction in allowing these vaping products on the market.”

Clive Bates used the same terminology, saying that the FDA has “lost its mind and gone all in against vaping.” He wondered why it has not issued similar letters about sale of cigarettes and youth smoking.

Bates says: “Leading experts in nicotine have advised Scott Gottlieb that low-risk alternatives - vaping products - are essential for the policy of reducing nicotine in cigarettes. The FDA needs to get back on track and embrace risk-proportionate regulation.”

Bates points to the letter written to the FDA by Iowa Attorney General Thomas Miller in July, that states: “Both adult and youth smoking prevalence have fallen sharply over the period in which e-cigarettes have risen in popularity. The evidence as summarised by Abrams et al is positive about the potential for alternative nicotine delivery systems to displace smoking with a significant benefit to public health.”

Cynthia Cabrera, a consultant to the vapour industry, has stated she believes that the FDA has gone “rogue”. She says the FDA’s demands equate to asking the industry to prove negatives and that they remove flavours and stop selling online while they try to get the answers, and that this is a ridiculous proposition.

Dr Konstantinos Farsalinos writes: “[The] FDA has declared an epidemic of e-cigarette use by adolescents that none else has seen yet. This is a very important development with multiple serious potential implications.”

Farsalinos believes the FDA has totally failed to find the correct balance when weighing the benefits and adverse effects of any intervention: “You cannot simply ignore the benefits and take action only based on the adverse effects. This is public health harm. The FDA officials certainly know that.”

He goes on to offer up a comparison, using a snus study: “The authors reported that in the US in 2005 among men aged 35 years or over, there were a total of 104,737 deaths from seven cancers were attributed to smoking. If none of the smoked but the whole population (including never smokers) were using snus, there would have been 2,081 deaths (instead of 104,737 deaths).”

It highlights the importance of factoring in the benefits of embracing harm reduction rather than vilifying it. Farsalinos goes on to write that there is a minimal risk posed by the use of nicotine when not part of smoking tobacco cigarettes, and talks about evidence that “has never been refuted but is simply ignored and hidden from the public.”

The (mis)use of the term “epidemic” by Gottlieb troubles Farsalinos: “Published data SHOULD include frequency of use and smoking status of e-cigarette users. Everyone knows that ever e-cigarette use is simply meaningless. Current e-cigarette use is also for the most part meaningless because (until now) most of never-smoking current e-cigarette users use them for 1-2 days of the past 30 days.”

“This is certainly not an epidemic. Even if e-cigarettes are causally linked to subsequent smoking (which has not been proven to be the case, the common liability phenomenon is a much more plausible explanation), the contribution of e-cigarettes to smoking prevalence is minimal.”

The situation is redolent of Clive Bates’ recent letter to the World Health Organisation (WHO) where it was stated that “hostility to tobacco harm reduction” is “misplaced”. The letter’s authors called on the WHO and call on it to change its approach and put “the health goal first”. There is only one way to do this, they argued, and that is to make regulations reflect the risk posed by electronic cigarettes and the other related products.

Carl Phillips, an independent researcher and consultant, and Scientific Director of CASAA, has written an excellent article (All people like better products. Teenagers are people. Therefore…), addressing how advocates need to respond – and it’s not by tackling Gottlieb’s assertions head-on: “Advocates need to do a better job of backing a few steps up the prohibitionists’ chain of reasoning, rather than being tricked into conceding so much ground.”

“Every argument should begin with the observation, ‘this policy is about intentionally harming people (vapers, smokers, other product users).’ This should always be pointed out, because in itself that is a radical use of government power that should not pass without comment. It should be followed with a demand for an answer to, ‘by what right do you harm me/adult consumers/your citizens, even if it is true that this harms others more and harming them is a good thing because it changes their behaviour’?”

While advocates and consumer organisations plan their next steps, the companies in receipt of the letters have no other option than complying. If push comes to shove, the FDA is able to force them to remove products from the market and roll out more stringent regulation on the whole vape industry.

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Dave Cross avatar

Dave Cross

Journalist at POTV
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Dave is a freelance writer; with articles on music, motorbikes, football, pop-science, vaping and tobacco harm reduction in Sounds, Melody Maker, UBG, AWoL, Bike, When Saturday Comes, Vape News Magazine, and syndicated across the Johnston Press group. He was published in an anthology of “Greatest Football Writing”, but still believes this was a mistake. Dave contributes sketches to comedy shows and used to co-host a radio sketch show. He’s worked with numerous vape companies to develop content for their websites.

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