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The Food and Drug Administration (FDA) recently said they are banning the sale of JUUL e-cigarettes. In addition, they have issued a marketing denial order (MDOs) to the company JUUL Labs Inc.
It means JUUL has to stop the distribution and selling of e-cigarette products, as well, as anything on the market has to be removed, or there will face prosecution types of action.
The banned products include the JUUL device along with their four types of JUULpods: Virginia tobacco flavoured pods at nicotine concentrations of 3.0% and 5.0%, and menthol-flavoured pods with nicotine concentrations of 3.0% and 5.0%.
Robert M. Califf, M.D., The FDA Commissioner, said, “The action today is progress on the FDA’s pledge to guarantee that all e-cigarettes’ products are currently being marketed to people that meet our public health standards.”
Why did this happen?
After looking over JUUL’s premarket tobacco product applications (PMTAs), the FDA determined that these applications did not show sufficient enough evidence about the products’ toxicological profiles. Consequently, the company couldn’t prove that marketing its products would be suitable for the protection of public health.
There was additional concern about the findings of JUUL Labs inc. studies caused doubts because of conflicting and insufficient data – particularly concerning the possibly harmful chemicals that leach from their e-liquid pods and the genotoxicity possibility.
The FDA claimed that they didn’t receive any clinical information to prove that there is an immediate hazard if people use these devices and pods. Although, the MDOs issued by FDA can’t determine the toxicological risk potential of using the JUUL products.
The FDA couldn’t find the risks of using other e-liquid pods with JUUL devices or vice versa.
The FDA recommends that people who use JUUL products with any surprising product and health problems report them to the FDA immediately through the Safety Reporting Portal and get the necessary medical attention.