The Food and Drug Administration issued a much-anticipated policy on Wednesday designed to restrict how and where flavored e-cigarettes are sold – an effort to combat what the agency’s commissioner has called “an epidemic” of underage vaping.
The initiative, a signature effort of departing FDA commissioner Scott Gottlieb, reflects a major departure in how the agency regulates vaping products. It limits sales of fruity and kid-friendly vaping products to stores that bar minors or have separate adult-only sections. And it says online sellers must tighten age verification and restrict the quantities they sell.
The agency said that companies that violate those conditions would be subject to FDA enforcement actions – including having their products ordered off the market.
Gottlieb also moved up by one year the deadline for flavored e-cigarettes to get agency approval — to August 2021. The sales restrictions and new deadline would apply to a vast array of e-cigarette products, including those offered in flavors such as cherry and bubblegum.
They would not apply to mint, menthol and tobacco flavors unless those products were being sold in a way that targeted minors because the agency says those products are most often used by adult smokers trying to quit.
The policy was issued as a draft guidance and is similar to the plan Gottlieb outlined in November to combat youth vaping. Its issuance disproves rumors that the White House was thwarting his efforts to crack down on vaping.
The guidance also bans flavored cigars that were on the market as of 2016 — although that is a small subset of the total number of flavored cigars on the market.
The latest vaping effort represents a much tougher stance than the lenient one Gottlieb adopted soon after becoming commissioner nearly two years ago.
It is sure to be criticized by vaping enthusiasts, who say e-cigarettes can be powerful tools in helping addicted adult smokers quit more dangerous conventional cigarettes. They argue that sales restrictions could make it harder for adults to get the products. Tobacco-control advocates, meanwhile, are likely to be unhappy the new policy largely exempts mint, menthol and tobacco flavors, saying those products are used be a large percentage of teen vapers.
The policy, which is expected to be finalized after a 30-day public comment period, changes the FDA’s enforcement policy on the products. Currently, e-cigarettes are on the market under a policy called “enforcement discretion” – meaning the products have not been approved but the agency is not moving against them.
Under the new guidelines, the FDA is revoking that discretion for all e-cigarettes products, but saying it will prioritize enforcement actions for those sold in ways that allow minors to get access to them. The draft guidelines are not legally binding but companies are expected to adhere to them to avoid getting in trouble with the FDA. However, the companies and other retail interests could challenge them in court.
The dominant player in the youth vaping market, Juul Labs, adopted measures to reduce youth vaping in November.