The FDA has officially pulled Juul e-cigarettes from shelves after the brand’s parent company, Altria, failed to submit sufficient safety data, according to a recent statement.
“[T]he company must stop selling and distributing these products. In addition, those currently on the U.S. market must be removed, or risk enforcement action,” the FDA said.
About 6% of U.S. adults — around 15 million people — use e-cigarettes, according to a 2021 Gallup poll.
The FDA said the decision was made to address product safety rather than the subject of illegal underage use.
“[T]he FDA determined that the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health,” the agency said.
“In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data – including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods – that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications.”
Juul’s chief regulatory officer, Joe Murillo, said in a statement that the company had “appropriately characterized the toxicological profile of Juul products,” and added that it believes its e-cigarettes meet federal health and safety standards.
“We intend to seek a stay and are exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator,” he said in the statement.
“We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide.”
Gregory Conley, president of the American Vaping Association advocacy group, spoke against the FDA decision.
Conley told The New York Post that it was “the latest in a series of missteps from the FDA that signal something is seriously wrong within the agency.
“From turning a blind eye to the opioid crisis to having no plans to combat a baby formula shortage, the FDA keeps coming up short on issues of vital importance to Americans,” Conley said.