E-cigarettes and vaping garnered a lot of attention in 2019, and the U.S. Department of Health and Human Services took notice. On Thursday, the agency announced a new enforcement policy that targets vape products especially enticing to young people, as the government takes steps to curb the prevalence of vaping among America's youth.
The policy is fairly specific when it comes to the types of e-cigarette products it will target. In the federal crosshairs are pod- or cartridge-based e-cigarettes, such as the popular Juul product, and vape flavors such as mint that are likely to appeal to children.
By May 12, manufacturers of e-cigarettes that remain on the market will have to apply for authorization from the Food and Drug Administration to keep their products on store shelves. Cartridge-based systems will only be allowed to offer tobacco and menthol flavors, as research shows these are the least popular flavors among youth.
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E-cigarettes that operate on an open tank system -- in which users add flavors manually -- have a little more breathing room under the new enforcement policy, although manufacturers of open tank e-cigarettes will still be required to apply for FDA clearance. Open tank products are generally larger and more cumbersome than the Juul, rendering them far less attractive to children, who tend to sneak vapes into school bathrooms.
The primary reason for the more relaxed enforcement of open tank systems is to keep products on the market that may allow adults to transition away from traditional, combustible cigarettes. While the administration's stated priority is to curb e-cigarette use among children and younger Americans, HHS Secretary Alex Azar said Thursday that research shows vaping is likely less harmful than smoking, and adults older than 21 should still have it as an option.
"We've developed a smart, targeted policy protecting our kids without causing unnecessary disruption," said Azar. "Vaping shouldn't be an on-ramp for children to become addicted, it should be an off-ramp for adults looking to break away from traditional cigarettes."
WHAT'S THE IMPACT
FDA Commissioner Dr. Stephen Hahn cited figures Thursday showing that about 3.6 million American children used vaping products in 2019, with 1.6 million using them frequently and for long durations. Overwhelmingly, youth prefer pod- or cartridge-based e-cigarettes such as Juul, and flavors such as mint and mango.
"Using e-cigarettes puts them at risk for nicotine addiction and other health consequences," said Hahn. "We're ready to take action against any unauthorized e-cigarette products. The FDA will take additional steps … if necessary."
According to Mitch Zeller, director of the FDA's Center for Tobacco Products, beginning 30 days from publication of the guidance in the federal register, the government will focus on products that don't have pre-market authorization, as well as flavored products that are not tobacco or menthol. Manufacturers will also be subject to FDA action if they fail to take appropriate steps to keep e-cigarettes away from children.
"Companies that do not comply with existing pre-market requirements and cease manufacture of cartridge-based e-cigarettes … risk FDA enforcement actions," said Zeller. "For all other products, the FDA will also prioritize enforcement where the manufacturers fail to take adequate measures to prevent children's use of these products," including the use of robust age verification technology on their websites.
Zeller said there would be a minimal impact on vape shops provided they sell non-cartridge-based products and adequately verify the ages of their customers.
Manufacturers submitting applications to the FDA can keep their products on the market for a 12-month period from the time the application is received. The products will be removed from the market after 12 months if they have not received FDA approval.
THE LARGER TREND
A rash of vaping-related lung injuries incited worry in 2019, as vaping-associated illnesses led to 40 deaths across the country. But according to the Centers for Disease Control and Prevention, Evali, the lung disease associated with vaping, has been linked to vitamin E acetate -- a solution most commonly found in black-market THC vaping cartridges, and rarely found in e-cigarette products. Though vitamin E acetate seems to be the most likely culprit, health officials caution it's too soon to rule out other causes.
The CDC has reported that 86% of the people who had become ill from vaping had used THC vaping products during the previous three months. THC, the psychoactive ingredient in cannabis, is illegal in most countries, perhaps explaining why Evali outbreaks have not been reported elsewhere. While THC does not cause Evali, unscrupulous manufacturers in states where cannabis is still illegal have sometimes mixed it with vitamin E acetate in cartridge-based vaping products.
The American Medical Association has called for thorough study of the use of pharmacologic and nonpharmacologic treatment strategies for tobacco use disorder and nicotine dependence resulting from the use of non-combustible and combustible tobacco products in people under 18. The agency has also signaled its intent to persuade retail pharmacies to cease sales of tobacco products, and is advocating for diagnostic codes for e-cigarette and vaping associated illnesses, including pulmonary toxicity.
ON THE RECORD
Dr. Patrice A. Harris, president of the American Medical Association said, "The Administration's new policy to address the youth e-cigarette epidemic by limiting flavors in some vaping products is a step in the right direction, but does not go far enough. The AMA is disappointed that menthol flavors – one of the most popular – will still be allowed, and that flavored e-liquids will remain on the market, leaving young people with easy access to alternative flavored e-cigarette products."