Image Source: NY Times
Juul Labs Inc., one of the top e-cigarette manufacturers in the US, has had all of its products banned from sale in the US.
FDA stated that it lacked sufficient information to determine if marketing the company’s products were “appropriate for the protection of public health.” Juul declared that it would contest the action.
It follows other recent anti-smoking initiatives by the FDA, such as proposals to lower the permissible level of addictive nicotine in cigarettes. The agency had already prohibited the fruity flavors that had helped Juul become a teenage phenomenon a few years prior.
FDA commissioner Robert M. Califf stated in a statement that “today’s action is additional progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products presently being marketed to consumers fulfill our public health requirements.”
Juul Labs Inc., has marketed its vaping pods as a healthier alternative to conventional tobacco cigarettes since it was created in California in 2015 by a couple of ex-smokers. However, as teen usage of the devices, which have high nicotine contents, skyrocketed, a federal poll found that in 2019, more than a quarter of high school students were smoking e-cigarettes.
The FDA said that in 2020, businesses would have to submit their e-cigarette goods for approval. Since then, it has given some of them the go-ahead. The FDA claimed in its statement that it had not been provided with any information indicating an “immediate hazard.” But it also acknowledged Juul’s continued industry dominance, given that the products under consideration contained between 3 and 5 percent of nicotine.
“We acknowledge that these make up a sizeable number of the goods on the market and that many of them have contributed disproportionately to the surge in juvenile vaping,” Mr. Califf said.
In order to continue selling while considering its options, including an appeal, Juul said it would ask for a stay of the decision.
Joe Murillo, the company’s chief regulatory officer, said in a statement: “We respectfully disagree with the FDA’s conclusions and determination and continue to feel we have provided adequate information and evidence-based on high-quality research to address the problems identified by the agency.”
“We plan to request a stay and investigate all of our legal and regulatory options, including appealing the judgment and speaking with our regulator.
“We are committed to doing all in our power to continue servicing the millions of adult smokers in the United States who have successfully switched to our products from combustible cigarettes, which are still sold on store shelves across the country,” he added.
Regulators have already taken action against Juul Labs, looking into its tactics for marketing to teenagers and tightening restrictions on the flavors that might be offered. International constraints have also constrained its growth outside of the US.
Altria Group, which paid more than $12 billion for a 35 percent stake in the business in 2018, has had to write off a significant portion of the value of its investment. Following news of the suspension from the Wall Street Journal, the company’s shares fell 9 percent on Wednesday.
Opinions expressed by California Gazette contributors are their own.
