As there is “insufficient information to assess the possible toxicological hazards” of using the goods, the U.S. Food and Drug Administration ordered Juul Labs Inc. to stop selling its vape products on Thursday. FDA Commissioner Robert Califf said in a statement announcing the action that “today’s action represents additional progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system devices presently being marketed to consumers fulfil our public health requirements. “He stated, “The agency has committed considerable resources to reviewing goods from the corporations that account for the majority of the U.S. market. “
We acknowledge that they make up a sizeable share of the items on the market and that many of them have contributed disproportionately to the surge in juvenile vaping.”The FDA stated that although it “has not received clinical information to suggest an immediate hazard associated” with the use of Juul devices or pods, the agency issued its marketing denial orders (MDOs) against the company because “there is insufficient evidence to assess the potential toxicological risks” associated with doing so. In a statement, Juul refuted the FDA’s assertions and stated that it will be appealing the agency’s ruling.
Juul chief regulatory officer, Joe Murillo, said in a statement: “We respectfully disagree with the FDA’s conclusions and determination and continue to think we have given adequate information and evidence based on high-quality research to address all problems identified by the agency.”
According to the FDA’s rules and the legislation, “we expect to seek a stay and are investigating all of our options, including appealing the judgement and speaking with our regulator,” Murillo added. “We are dedicated to doing all in our power to continue servicing the millions of American adults who have successfully switched to our products from combustible cigarettes, which are still sold on store shelves across the country,” the company stated.
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