New restrictions on flavors, more reports of health problems
As a new decade dawns, new federal regulations are cracking down on the e-cig industry with a targeted campaign to stem the tide of teen nicotine abuse through vaping.
On the heels of legislation changing the legal tobacco-buying age from 18 to 21, the U.S. Food and Drug Administration issued a policy prioritizing enforcement against unauthorized flavored e-cigarette products that appeal to kids.
Under the new policy, companies must “cease manufacture, distribution and sale of unauthorized flavored cartridge-based e-cigarettes (other than tobacco or menthol)” within 30 days of the policy’s filing, or risk legal enforcement.
The policy targets companies that do not take sufficient measure to ensure children do not have access to their products, or use potentially “kid-friendly” advertising or marketing like packages that resemble juice boxes or candy.
The policy specifically addresses cartridge-based, closed-system “electronic nicotine delivery systems” or ENDS like Juul, which have proven popular with teens.
The policy targets flavored products, with tobacco and menthol the only approved varieties.
Director of the FDA’s Center for Tobacco Products Mitch Zeller said agency is poised to spend “tens of millions” of taxpayer dollars for a hard-hitting multimedia campaign geared at informing teens that vaping is not risk-free.
“Survey after survey shows that kids think [e-cigarette products] are harmless,” Zeller said, adding that often, teen users aren’t aware of the nicotine in vaping products.
Effect on vaping businesses
Delaware Vapor operations manager Brendan Styles said he feels confident in speaking for vape shops across the country in support for the FDA’s decision.
“I say, we agree with these points and are happy to see sensible action from FDA on these issues,” he said.
However, Styles said the market is poised for “obliteration” this spring.
Last summer, Paul Grimm, U.S. District Court Judge for the District of Maryland, set a May 12 deadline for companies to submit premarket tobacco applications to the FDA.
According to Styles, the policy would require a PMTA application for every flavor produced and sold for both open and closed-system devices.
Open-style systems are refillable, in contrast to the use-and-dispose systems like Juul, where the user tosses the cartridge once it’s been depleted.
Styles noted that the application is identical for closed and open systems, with a price tag per application estimated to run between $800,000 and $1 million per flavor.
“While that might not sound unfair to the uninitiated, Juul only needs to provide test results for their e-liquid being used on their hardware,” Styles said. “For a small business that makes only e-liquid, it appears that they would need to provide testing data for all possible hardware, which is over-burdensome to the level of impossibility.”
While vaping is widely viewed a “healthy alternative” to combustible nicotine products, the nationwide rash of apparent vaping-related illnesses may challenge that.
The FDA’s policy on vaping, according to a Health and Human Services senior official, is that they should only be used by adults attempting to cease nicotine use entirely and are vaping as a means to that end.
A Dec. 20 release by the Centers for Disease Control noted that laboratory data showed that Vitamin E acetate, an additive in some THC-containing e-cigarette or vaping products, is closely associated with the e-cigarette or vaping product use-associated lung injury (EVALI) cases first seen in July.
The Centers for Disease Control reports that, as of Dec. 27, a total of 2,561 cases have been reported to the CDC from 50 states, the District of Columbia, Puerto Rico and the Virgin Islands.
Delaware has seen 11 suspected vaping illnesses, with one death confirmed in October. Of those cases, eight were in New Castle County, two in Kent, and one in Sussex, according to the Division of Public Health.
At the time, DPH Director Karyl Rattay noted that 10 of those patients reported using devices containing both nicotine and THC-based products.
She strongly recommended that no individuals should be vaping.
“At this point in time, no vaping is safe,” Rattay said.
If you need help quitting tobacco products, including e-cigarettes, call the Delaware Quitline at 1-866-409-1858.