The war between FDA chief Scott Gottlieb and the e-cig industry continues to escalate with Gottlieb last week threatening to just say “Fuck it” and completely take e-cigs off the market.
To wit, the Food and Drug Administration has come out harshly against the e-cig industry beginning about six months ago because of the skyrocketing increase in teen vaping rates.
So, the FDA came out with a series of rules regarding e-cigs, including some restrictions on fruity flavours and the requirement that e-cig products only be sold in areas open to adults. The FDA didn’t get into marketing of e-cig products.
These rules weren’t as strong as what *I* had hoped for, at the very least, I liked an idea that was floated to restrict e-cig sales strictly to tobacco shops, but that got dropped, likely because of pressure from the industry.
Anyway, Gottlieb said he has met with industry representatives and he remains unimpressed with their response so far.
This is a quote from a Gottlieb tweet:
I still believe e-cigarettes present an opportunity for adult smokers to transition off cigarettes and onto nicotine delivery products that may not have the same level of risks. However, if the youth use continues to rise, the entire category will face an existential threat
Also, from an NBC News article:
“I’ll tell you this. If the youth use continues to rise, and we see significant increases in use in 2019, on top of the dramatic rise in 2018, the entire category will face an existential threat,” Gottlieb told a meeting.
“It will be game over for these products until they can successfully traverse the regulatory process.”
Gottlieb said he has met repeatedly with the vape industry. “I find myself debating with tobacco makers and retailers the merits of selling fruity flavors in ways that remain easily accessible to kids,” he said.
Last November, Gottlieb said he was starting the process to limit sales of flavored e-cigarettes, as well as to ban menthol in combustible cigarettes.
“I have questions about whether they are living up to the very modest promises that they made,” he said. “It matters if the e-cig makers can’t honor even modest, voluntary commitments that they made to the FDA.”
I’m curious if the industry is taking these threats seriously? Juul very quickly shut down its social media presence, but it might be too little, too late to slow down teen vaping use … or to satisfy the FDA.
Gottlieb said the dramatic rise in e-cigs is sabotaging the success public health advocates have had in cutting the teen smoking rate.
“This progress is being undercut — even eclipsed — by the recent, dramatic rise in youth vaping. A few years ago, it would have been incredible to me that we’d be here, discussing the potential for drug therapy to help addicted youth vapers quit nicotine,” he said Friday.
Gottlieb cited statistics about the large use of e-cigarettes by young people, saying that between 2017 and 2018 there was a 78 percent increase in e-cigarette use in high school students, and a 48 percent increase among middle schoolers. That means the total number of middle- and high-school students using e-cigarettes rose to 3.6 million — 1.5 million more than used the product the previous year. He added that more than a quarter (27.7 percent) of high-school-age e-cigarette users use the product regularly, and more than two-thirds (67.8 percent) are using flavored e-cigarettes.
“Youth use of e-cigarettes has become an epidemic,” Gottlieb said, adding, “It could be ‘game over’ for some [of] these products until they can successfully traverse the regulatory process. I think the stakes are that high.” Gottlieb also noted that e-cigarettes can be a helpful tool for adults trying to quit smoking traditional cigarettes, and said he hopes to avoid removing e-cigarettes from the market because of the good they can serve in that regard.
Stay tuned. Gonna be a rocky year on this issue likely.