WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) today released new policy and restrictions on flavored e-cigarettes that amounts to a ban of such products, with the exception of tobacco and menthol flavors.
“Companies that do not cease manufacture, distribution, and sale of unauthorized flavored cartridge-based e-cigarettes (other than tobacco or menthol) within thirty days risk FDA enforcement actions,” said the FDA’s press release.
“The United States has never seen an epidemic of substance use arise as quickly as our current epidemic of youth use of e-cigarettes. HHS [Health and Human Services] is taking a comprehensive, aggressive approach to enforcing the law passed by Congress, under which no e-cigarettes are currently on the market legally,” said HHS Secretary Alex Azar, in the release.
“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,” Azar added. “We will not stand idly by as this crisis among America’s youth grows and evolves, and we will continue monitoring the situation and take further actions as necessary.”
FDA also cited the 2019 National Youth Tobacco Survey (NYTS), released in early November and published in the Journal of the American Medical Association (JAMA), in which results showed levels of self-reported, current e-cigarette use among high schoolers at 27.5 percent, and at 10.5 percent for middle school students.
The new restrictions apply to unauthorized electronic nicotine delivery systems (ENDS), which includes e-cigarette products manufactured by companies that have not submitted product applications to the FDA.
According to the FDA release, thirty days after “publication of the notice of availability of this guidance in the Federal Register, the FDA intends to prioritize enforcement against these illegally marketed ENDS products by focusing on the following groups of products that do not have premarket authorization:
- Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product);
- All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and
- Any ENDS product that is targeted to minors or likely to promote use of ENDS by minors.”
Pre-filled e-juice cartridges and pods are primarily targeted by the new policies. A significant exception to restrictions allows retailers to continue selling vaporizers with tanks that are filled with e-juice by the user. The FDA reasoned that adults more commonly used self-filled vaporizers.
The FDA also promised to step up enforcement on vape manufacturers and retailers by increasing requirements for age verification technology to prevent underage users access to vape product websites, as well as product sales to minors online.
Emphasizing that the new policy was not an outright ban of flavored vape products, the FDA pointed out that they have “already accepted and begun review of several premarket applications for flavored ENDS products through the pathway that Congress established in the Tobacco Control Act.
“Manufacturers that wish to market any ENDS product—including flavored e-cigarettes or e-liquids—are required by law to submit an application to the FDA that demonstrates that the product meets the applicable standard in the law, such as whether the product is appropriate for the protection of the public health,” they said.
The new policy followed comments from President Donald J. Trump, who addressed the press on New Year’s Eve from an event held at the Miralago resort, in Florida. “We’re going to protect our families, we’re going to protect our children, and we’re going to protect the industry,” media reports quoted President Trump as saying. “People have died from this.”
On December 20, the President signed legislation that raised the age to purchase tobacco products to 21-and-over.
Two days before Christmas, the FDA in cooperation with the Drug Enforcement Agency (DEA) shuttered forty-four websites offering illicit THC-infused vape products. “The action, which is part of Operation Vapor Lock, reflects ongoing work by federal, state, and local authorities to investigate the supply chain of vaping products associated with recent lung injuries,” mgRetailer reported at the time.
Tobacco vaping advocate organization American Vaping Association (AVA) had not issued comment on today’s events at the time of this post; but in September, when President Trump first announced intentions for his administration to issue policy restrictions on flavored tobacco products, the nonprofit did comment, and said:
“In the history of the United States, prohibition has never worked. It didn’t work with alcohol. It hasn’t worked with marijuana. It won’t work with e-cigarettes. The President should meet with just one of the millions of American voters who have used flavors to quit smoking before moving forward on this draconian approach to regulation and public policy.
“Destroying thousands of small businesses and sending ex-smokers back to smoking will do nothing to stop drug dealers from selling contaminated THC cartridges. A flavor ban will only lead to the creation of yet another multi-billion-dollar black market that will operate with zero safety controls,” AVA President Gregory Conley said.
Tobacco vaping advocates, as well as public health experts and third-party testing laboratories have held illegally produced vape products, especially those containing cannabis extract, responsible for the recent outbreak of EVALI, the vaping-related respiratory condition that spread to all fifty states, and two U.S. territories.
Though numbers seem to have leveled off, since December 27, there have been 2,561 patients hospitalized with EVALI, and fifty-five deaths attributed to the condition, according to the Centers for Disease Control.