Yes. No. Yes. Well, sort of.
That’s the position President Trump has taken over banning flavored electronic cigarette pods ever since he came out in favor of their prohibition several months ago. While he quickly backed away from that stance after an industry uproar, his Food and Drug Administration decided to ban e-cig flavors anyway, but with exceptions:
- Menthol and tobacco flavors will still be permitted.
- The ban only affects so-called closed systems in which the e-liquid pods are sealed at the manufacturer. Open systems, in which users can refill the pods with e-liquids of their choosing, are still permitted to offer flavors.
While that seems like an arbitrary line to establish, the FDA’s dual policy might be its way of targeting Juul Labs, the e-cig maker in which Altria (NYSE:MO) has a hefty ownership stake, because its JUUL device is the one preferred by teenagers.
Going after the industry leader?
In announcing the new enforcement policy, Health and Human Services Secretary Alex Azar said, “By prioritizing enforcement against the products that are most widely used by children, our action today seeks to strike the right public health balance by maintaining e-cigarettes as a potential off-ramp for adults using combustible tobacco while ensuring these products don’t provide an on-ramp to nicotine addiction for our youth.”
While that sounds admirable, in practice it still makes no sense, since Juul voluntarily stopped manufacturing flavored pods for its device last year, and teens can just migrate to the open systems if they really want flavor.
Maybe the FDA will crack down on those devices in the future — indeed, the statement goes on to say the agency will monitor teen usage of those devices and “will take additional steps … if necessary” — but only banning flavored pods on closed systems now suggests that the FDA may be really just targeting Juul Labs and Altria with this new action.
The ENDS is nigh
It’s likely the regulation will only need to be in effect for a few months anyway. By May 12, e-cig manufacturers and vape shops that mix their own e-liquids to sell to the public are required to submit to the FDA premarket tobacco product applications (PMTA) demonstrating their product “is appropriate for the protection of the public health,” according to the FDA’s press release.
The FDA’s announcement ominously points out that the agency has not authorized a single electronic nicotine delivery system (ENDS), meaning all devices and e-liquids on the market “are considered illegally marketed and are subject to enforcement, at any time, in the FDA’s discretion.”
Moreover, the FDA promises to come after any company that continues to sell an ENDS product after the deadline without submitting a PMTA. Because most manufacturers and vape shops probably do not have the financial resources to comply with the law, virtually all devices and e-liquids will have to be removed from the market.
Few and far between
To date, only tobacco giants Philip Morris International (NYSE:PM) and British American Tobacco (NYSE:BTI) have been able to afford the lengthy and labyrinthine process of submitting a PMTA.
It took Philip Morris more than 1 million pages of documentation and three years to get its IQOS heated-tobacco device approved for sale, and it is still awaiting FDA action on its application to have it declared a reduced-risk product. Undoubtedly because the IQOS is merely heating real tobacco and not an e-liquid to create a vapor, it is not considered an ENDS product. British American submitted its PMTA last year with several hundred thousand pages of documentation to support its Vuse e-cig.
Although Juul Labs has said it is committed to submitting a PMTA, the former commissioner of the FDA has said he does not believe the application will be successful because of the device’s popularity with teens.
Tobacco companies win again
The FDA’s position on flavored e-cigs says it is trying to strike a balance between adult needs and teen abuse, but the outcome is likely to be the same regardless. Fewer people will end up using electronic cigarettes, though they are widely seen as a safer alternative to smoking traditional cigarettes.
The agency’s broadsides against the industry during an outbreak of lung illnesses and deaths related to illicit pods bought on the internet caused a decrease in e-cig use and an uptick in smoking. We may be about to see a similar result as the impact of this new regulation is felt.