FDA orders Juul Labs to remove products from US market


“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 on Thursday.

Juul gadgets and 4 kinds of pods — tobacco and menthol-flavored — can’t be bought or distributed, the FDA mentioned.

The company mentioned it reviewed the corporate’s premarket tobacco product purposes and decided tJuul Labs’ research 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.”

“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,” mentioned Michele Mital, appearing director of the FDA’s Center for Tobacco Products, within the information launch. “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.”

The FDA motion focuses on importation, distribution and gross sales, not particular person use, and it “cannot and will not enforce against individual consumer possession or use of JUUL products or any other tobacco products.”

NCS has contacted Juul for remark however didn’t instantly hear again.



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