The scare tactics seem to have worked on FDA commissioner Scott Gottlieb.
The constant, shrill refrain of "we have to save the kids" from anti-vaping advocates, "scientists", journalists and politicians put enough pressure on the agency to not only backtrack on the pre-market tobacco application policy but also state at banning flavored vape juice all together is on the table.
We have covered really bad science that seeks to scare people away from e-cigarettes and have discussed legislation that also seeks to ban flavored vape juice in the United States recently, so perhaps we shouldn't have been that surprised.
When Scott Gottlieb began making changes to the draconian way the FDA approached vaping during the Obama administration, everyone thought e-cigarettes would finally get recognized as a life changing innovation.
Commissioner Gottlieb even said that he believed the FDA should approach e-cigarettes as part of a "continuum of risk" where combustible tobacco represents the highest risk (smoke and tar being the killers) and ENDS (electronic nicotine delivery systems) being a lower risk alternative for adult smokers looking for satisfying levels of nicotine. This was a huge policy reversal that seems to have just been double reversed.
In a speech delivered today at the agency headquarters, Commissioner Gottlieb, signaled his intent to focus on "youth" addiction to nicotine at the expense of adult smokers.
But in enabling a path for e-cigarettes to offer a potentially lower risk alternative for adult smokers, we won’t allow the current trends in youth access and use to continue, even if it means putting limits in place that reduce adult uptake of these products.
That was the last line of his delivered remarks in a press release from the FDA today and foreshadows what vapers and smokers can expect in the future. Vape product bans incoming! Don't worry though, cigarettes will still be available.
If you are an adult, your health outcomes from cigarette smoking really don't matter if teenagers can buy JUUL pods on the black market.
The FDA has given the top 5 manufacturers 60 days to prove that minors can't access their products, which seems fairly impossible to prove and is quite strange. The "Youth" are already banned from purchasing or possessing nicotine products and devices in the United States.
This "prove people can't access your product illegally" approach isn't taken for products that are seemingly more dangerous than nicotine such as alcohol or even prescription opiates. The approach to regulation seems fairly unheard of and quite radical.
Is the FDA going to ask pharmaceutical companies to prove people aren't abusing oxycodone otherwise they get shutdown?
Is the FDA going to ask Budweiser to prove teens aren't having keg parties when their parents are out of town?
From the New York Times:
“They say they’ve changed from the days of Joe Camel,” Dr. Gottlieb said. “But look at what’s happening right now, on our watch and on their watch. They must demonstrate that they’re truly committed to keeping these new products out of the hands of kids.”
Dr. Gottlieb has said many times he believes that e-cigarettes and similar products known as electronic nicotine delivery systems may be effective options for adults who want to stop smoking but still crave nicotine. But he said teenage vaping has become so concerning that regulators may have to curb the availability of the devices to keep them out of the hands of youths.
“Inevitably what we are going to have to contemplate are actions that may narrow the off-ramp for adults who see e-cigarettes as a viable alternative to combustible tobacco in order to close the on ramp for kids,” Dr. Gottlieb said. “It’s an unfortunate trade-off.”
At least he recognizes that it isn't a good trade, adults continuing to smoke and die instead of teens illegally buying JUUL pods on the street.
There was an estimated 480,000 smoking related deaths in the United States last year by the way.
Is it weird that teens vaping in the bathroom at high school get more attention than the 70,000 drug overdoses last year?
Further down in the NY Times article:
“It’s nice they want to do something but realistically, what are they going to accomplish this way when they could be so much more effective by following the regulatory plan that had been ready to put into place and that the commissioner postponed?” said Diana Zuckerman, president of the National Center for Health Research, a nonprofit health policy group.
She also pointed to the popularity of vaping among young adults. Researchers generally believe that the adolescent brain continues to develop through age 26. “It’s a big epidemic among people ages 18 to 30, too,” she said.
"Great! Now that the FDA capitulated on the youth, time to move on to keeping vapes out of the hands of people under 30."
What is the old parable? Give them an inch and they take a mile?
Advocates want society to be move towards a state of perpetual childhood, where you have to be protected from yourself until you die and it seems like they are winning. It actually seems like some tobacco control advocates would rather you die than vape.
The Times article points out how JUUL has taken steps to try and comply with the threat from the government by not using models under the age of 35 any more as well as raising the age to purchase its products to 21, despite the national age to purchase the products being 18, and even removing around 5,000 questionable social media posts.
Dr. Gottlieb said he was not impressed by the measures Juul and the other companies have taken.
“It didn’t have the intended impact or I wouldn’t be viewing the statistics I’m now seeing,” he said
Things aren't looking too good.
What does the Wall Street Journal have to say?
Juul has captured 72% of the estimated $2.3 billion annual U.S. e-cigarette market, according to a Wells Fargo analysis of Nielsen sales data. That figure doesn’t include internet sales. The startup recently raised $650 million in a financing round that valued the company at about $15 billion.
Shares of tobacco companies advanced on the news, which fanned investor hopes that the U.S. regulator might crack down on a startup that has been taking market share. Marlboro maker Altria and Camel maker BAT gained 6% apiece in early Wednesday trading.
Altria, BAT and the other tobacco companies didn’t immediately respond to requests for comment. Imperial Tobacco Group PLC’s Blu and Japan Tobacco Inc.’s Logic hold the fourth and fifth spots in the U.S. market, respectively.
The agency is attempting to thread “a public-health needle, which is trying to sustain the market” for products adults could use as smoking-cessation tools while protecting children from becoming addicted to nicotine, Dr. Gottlieb said. He added that if he hadn’t extended the grace period, manufacturers would still have been able to keep their products on store shelves until next year.
“I think we’re going to have to step into this market,” Dr. Gottlieb said. “I am willing to narrow the off-ramp for adults to close the on-ramp for kids.”
Narrow the off-ramp for adults translates into adults continuing to smoke cigarettes.
Big money investors think that people are more likely to start buying more cigarettes in the future to have a 6% pop, which is huge.
Cigarette company executives are probably drinking champagne, eating steak and doing some back slapping right now.
Wall street thinks the new policy is going to prop up cigarette sales, so maybe someone at FDA headquarters will reconsider.
If the goal is to get people to quit smoking cigarettes, this is a big failure.