FDA denies marketing authorization to Juul products and orders all existing ones to be removed from U.S. market

The U.S. Food and Drug Administration said Thursday it has issued marketing denial orders to Juul Labs Inc. for all of its products that are currently marketed in the U.S., and ordered the company to remove all or risk enforcement action. The products in question comprise the Juul device and four types of pods; Virginia tobacco flavored pods at nicotine concentrations of 5.0% and 3.0% and menthol flavored pods at nicotine concentrations of 5.0% and 3.0%. The action was expected after a Wall Street Journal report from Wednesday. “Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” FDA Commissioner Dr. Robert M. Califf said in a statement. Juul has been under regulatory scrutiny since its fruity flavors and marketing were blamed for a spike in teenage vaping about four years ago. The FDA has already banned it from selling flavors such as creme brulee, that proved highly popular with underage smokers. The news is viewed as a negative for Altria , which paid $12.8 billion in 2018 to acquire a 35% stake in Juul that valued the company at about $35 billion. Since then, Altria has written down the value of the stake to $1.6 billion as of March 31. Altria shares were up 1.2% Thursday, but are down 11% in the year to date, while the Dow Jones Industrial Average has fallen 16% and the S&P 500 has fallen 21%.

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