Thursday, January 02, 2020

Vape Shops Saved for Now: Dodged One Bullet, But Now Must Dodge Another One

I am expecting the FDA to announce this afternoon that it plans to enforce a ban on the sale of all flavored e-cigarette pods and cartridges for closed vaping systems, with the exception of tobacco and menthol flavors, but that it is exempting e-liquids and vape juices sold for open systems. This means that the restriction will primarily affect the vaping products sold by convenience stores, but not all of the products sold by vape shops.

The decision of the FDA not to ban all flavored e-cigarettes is a huge victory for public health. By allowing vape shops to continue selling flavored vape liquids, the FDA is preventing hundreds of thousands of ex-smokers from being forced to return to smoking. It also ensures that this important off-ramp from smoking remains available to adult smokers.

However, the battle is not yet over because if the FDA implements the PMTA deadline in May of this year, it will wipe out most of the vaping industry, handing it over to the tobacco companies. The results would be devastating to the public’s health, as many ex-smokers would return to smoking and many more would turn to a new black market for these products.

Hopefully, the FDA will re-think its overall approach to tobacco product regulation and announce a more sensible policy—one that regulates products based on their level of risk. Such a policy would remove the addictive nicotine from combustible cigarettes and restrict their sale to tobacco shops open only to adults. It would also directly regulate e-cigarette safety by issuing standards, including a maximum nicotine level for e-liquids that use nicotine salts, battery safety, and temperature regulation.

This proposal is unlikely to curb the rise in underage vaping because teens who use JUUL can simply switch over to the menthol or tobacco flavors. Since the proposal does not restrict the nicotine level in these products—something I have been calling for since my Congressional testimony last fall—JUUL can continue to sell pods with more than 50 mg/mL of nicotine, a ridiculously high level that is contributing to youth addiction to this product.

The FDA needs to stop focusing on the flavorings and for once, focus on the nicotine, which is the problem. The epidemic we have is not one of youth flavor use, but of youth addiction to the JUUL device, and that is occurring not because JUUL is flavored but because JUUL has more than 50 mg/mL of nicotine salts, compared to less than 25 mg/mL in most other products on the market, which use freebase nicotine rather than nicotine salts.

All of the recent restrictions we have seen on the sale of flavored e-cigarettes are about politics rather than protecting the health of Americans. If policy makers were interested in protecting the health of Americans, the first thing they would do is to get the nicotine out of combustible cigarettes and restrict their sale to tobacco shops that are only open to adults. And the second thing they would do is limit the level of nicotine salts in electronic cigarettes, especially JUUL, because it’s the high levels of nicotine salts--not the flavors--that is causing the problem of youth addiction to vaping.

All in all, the announced policy is a huge victory for the public’s health, compared to what would have happened had the FDA banned all flavored e-cigarettes. Now, attention must turn to the problem of the May 2020 PMTA deadline, which will decimate the vape shops, severely constrict the vaping market, and result in devastating health effects for hundreds of thousands of ex-smokers who will either be forced to return to smoking or forced to buy products from--ironically--a completely unregulated black market.

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