On June 23, the FDA denied the marketing applications for Juul, which would pull one of the most popular e-cigarettes off the US market. (The Wall Street Journal first reported the impending decision.)
The Food and Drug Administration (FDA) stated that there was “insufficient evidence to asses the potential toxicological risks of using Juul products,” yet there was no “clinical information to suggest an immediate hazard.”
“After reviewing the company’s premarket tobacco product applications (PMTAs), the 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,” an FDA press release reads.
“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.”
Alex Norcia – Filter – 2022-06-22.
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