The Food and Drug Administration has effectively banned vaping company Juul’s products from the U.S. marketplace, issuing denial orders for all of its e-cigarette products that are currently available.
The company produces a vaping/e-cigarette device and four types of pods, which come in tobacco and menthol flavors and contain different levels of nicotine. The FDA requires all companies that produce “new tobacco products” to submit “Premarket Tobacco Product Applications” (PMTAs) in order to legally market the potential products in the U.S. and will either issue a “marketing granted order letter” or a “marketing denial order letter,” the latter of which was issued to Juul.
The agency said after reviewing the company’s PMTAs it determined Juul Labs’ study findings had “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.”
“As a result, the 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 in a press release on Thursday.
In 2020, the FDA banned fruit and mint-flavored vape cartridges. Juul also previously faced a class-action lawsuit for marketing their products – which a study found contained more of the addictive Nicotine than cigarettes – to young people.
“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products, in a press release. “As with all manufacturers, Juul had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”