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March 21, 2018

The War on Flavors: FDA Fires the First Shot

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Jim McDonald

The FDA has issued a call for comments on regulation of flavored tobacco products, including e-liquids. As we reported previously, the wording of the FDA document betrays the agency’s intention to restrict supposedly “youth-appealing” flavors.

The advanced notice of proposed rulemaking (ANPRM) will be published today in the federal register. Today is the first day of a 90-day period during which interested parties can make comments.

In the weeks ahead, vaping organizations like CASAA, SFATA, VTA, and the American Vaping Association will offer suggestions and advice for vapers and vape vendors on the content of their submissions to the FDA. Vaping360 will try to consolidate these, and publish guidance for our readers to use.

Meanwhile, a great place to start formulating ideas for your comments is Clive Bates’ December blog post about the possibilities and pitfalls of regulating flavors.

FDA Commissioner Scott Gottlieb issued a press statement yesterday to accompany the rulemaking. In it, he seemed to give weight to supposed evidence that flavored e-cigarettes are addicting youth, while also referring to the stories of passionate adult vapers as anecdotes.

“ We must also consider how best to address flavors in non-combustible products like e-cigarettes – given both their clear appeal to youth but also the potential role certain flavors may play in helping some adult smokers transition to potentially less harmful tobacco products," said Gottlieb.

“I’ve talked to ex-smokers, who’ve told me that they quit cigarettes altogether and that they now vape," he added. "And they’ve also told me it was the flavors that helped them make that transition off combustible cigarettes. Now I know anecdotes aren’t the same as data. And the ANPRM specifically seeks data on this issue.”

This is the second ANPRM the FDA has issued in less than a week. Last Friday, the agency called for public comment on a proposal to reduce nicotine in cigarettes. Both proposals are part of the comprehensive approach to nicotine and tobacco regulation Gottlieb announced last July.

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Gottlieb, of course, is trying to please those on all sides of the issue. But the side most able to apply political pressure on him is the same one that opposes vaping at every turn. The Truth Initiative and the Campaign for Tobacco-Free Kids are leading an all-out war on the vaping industry, backed by all the major private health organizations and medical associations, like the American Heart Association and the American Academy of Pediatrics.

Those organizations have already begun the war on flavors, and they will only get louder and more aggressive in the coming weeks. The American independent vaping industry IS flavored e-liquid. If vapers and vaping advocates can’t mount an effective response, the independent vaping industry will slip away.

“We’ll continue to seek public input on a variety of significant topics as we advance our policy framework, which includes exploring clear and meaningful measures to make tobacco products less toxic, appealing and addictive,” said Gottlieb yesterday.

For most vapers, what could be less appealing than e-liquid without flavors?

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Jim McDonald

Vaping for: 13 years

Favorite products:

Favorite flavors: RY4-style tobaccos, fruits

Expertise in: Political and legal challenges, tobacco control haters, moral panics

Jim McDonald

Smokers created vaping without help from the tobacco industry or anti-smoking crusaders, and I believe vapers have the right to continue innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I’m a member of the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy

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