FDA Restricts Flavored E-Cigarettes, But Not the Real Killers. Huh?
A version of this article first appeared in BU Today.
On November 15, 2018, the Food and Drug Administration announced the strictest regulation of nicotine-containing product sales in decades, banning the sale of most electronic cigarettes, or e-cigarettes, at most gas stations and convenience stores. Sales will still be allowed in adult-only stores as well as in sections of stores that are adults only. However, just putting up a curtain or divider will not be sufficient—it basically has to be a completely separate room. For most gas stations and small convenience stores, this is going to be impossible. And although tobacco, mint, and menthol flavors will still be allowed, the majority of adult vapers are not using those products.
So while it’s true that the regulation is technically not as stringent as an outright ban, for all intents and purposes, it is going to be impossible for the majority of gas stations and convenience stores to sell e-cigarettes and related products.
The FDA said it was forced to take this drastic action because it has evidence that “a new generation is being addicted to nicotine, and we can’t tolerate that.”
Yet, convenience stores and gas stations can continue to sell traditional cigarettes as usual, which are addicting a new generation to nicotine despite lower smoking rates. According to the Centers for Disease Control and Prevention, every day more than 3,200 youth smoke their first cigarette. It has been estimated that it takes only four to five cigarettes for a youth to become addicted to smoking. One out of every two long-term addicted smokers will die prematurely, primarily from lung cancer, lung disease, heart disease, stroke, or other cancers.
Somehow, we have completely lost all sense of public health perspective. Every argument that the FDA is making in justifying a ban on the sale of e-cigarettes in convenience stores and gas stations applies even more strongly for tobacco cigarettes: you know, the ones that kill hundreds of thousands of Americans each year. Something is terribly wrong with our sense of perspective when we take the e-cigarettes off the shelf but allow the old-fashioned ones to remain.
Tobacco companies intentionally make cigarettes addictive by adding ammonia to the product, which enhances nicotine absorption. Cigarettes are the most effective known product to deliver nicotine in a pattern that is capable of quickly initiating and then sustaining addiction. Similarly, we need to recognize that the problem of youth addiction to e-cigarettes is not a broad problem; it is a very specific and narrow problem of youth becoming addicted to Juul, which provides blood nicotine levels as high as cigarettes. It is one specific product that is causing the problem.
Other than Juul, all other closed system e-cigarettes do not have high-addiction potential because they are actually quite poor at delivering nicotine. Specifically, there is no nicotine spike in the blood, and the nicotine level drops off quite slowly. In contrast, Juul uses a specially formulated nicotine salt that is absorbed much more rapidly into the bloodstream, and the pattern of blood nicotine levels from vaping a Juul e-cigarette mimics that of smoking a cigarette. Youth are becoming addicted to nicotine not because they are vaping generally, but because there is an epidemic of Juul use occurring in middle schools and high schools across the nation.
However, on November 13, 2018, Juul announced that it would voluntarily stop selling flavored Juul products in all convenience stores and gas stations. In fact, Juul has agreed to stop selling flavored Juul products in any brick-and-mortar establishment. These products will only be available online and with strict age verification procedures.
As a result, the recent sweeping action by the FDA is not necessary. It will not result in the elimination of flavored Juul sales from convenience stores because that is already occurring. Youth will not be able to purchase flavored Juul products from stores, but that was also going to happen anyway.
The rest of the story is that the FDA’s action will make it much more difficult for adults who have quit smoking to continue to stay smoke-free using their favorite brands of e-cigarettes, which will be taken off the shelves. The other e-cigarettes that are being sold at these stores (i.e., products other than Juul) have low nicotine addiction potential. It makes no sense to take them off the shelves, but to allow cigarettes, which have extremely high addiction potential, to remain available for sale and distribution to the thousands of youth who try these products every day.
I believe the FDA’s action will have a net negative impact on public health because it will almost certainly result in many ex-smokers returning to smoking as these flavored products disappear from convenience store shelves.
What the FDA should have done is to deal directly with Juul and demand that they voluntarily remove their flavored products from the shelf and bolster their age verification procedures for online purchases. But since Juul has already agreed to this, there is no need for this drastic regulation, especially because cigarette sales are being left unencumbered.
One might argue that the reason that Juul agreed to remove their flavored products from the shelf is that they anticipated this FDA regulation. If that is the case, then perhaps the threat of regulation was successful in achieving this result. But now that Juul has agreed to take most of their products off the shelves, the FDA should not have proceeded with the regulation, unless it is sincerely concerned about youth becoming addicted to nicotine—in which case it should restrict the sale of all cigarettes in brick-and-mortar establishments.
Michael Siegel is professor of community health sciences.