Food and Drug Administration ordered Juul to cease selling its electronic cigarette products. The FDA cited a lack of data and evidence for assessing their potential health hazards.
According to the FDA order, Juul is required to stop selling and distributing its e-cigarette devices and all four types of Juul pods in Virginia tobacco or menthol flavors. The FDA has ordered that all products on the shelves be removed from the market.
The FDA has found no evidence to date that e-cigarettes and pods are a health risk. The Agency stated that there were “insufficient and contradictory data” regarding the products’ toxicity and “potentially hazardous chemicals leaching out of the company’s proprietary E-liquid pods.”
In a statement, Michele Mital said that the FDA was responsible for ensuring that all tobacco products sold within the United States meet the legal standards.
She added that “Juul, like all other manufacturers, had the chance to show evidence that their marketing met these standards.” “However the company failed to provide this evidence, and instead left us asking significant questions.”
The FDA order doesn’t prevent consumers from using or possessing Juul products that they already own.
Joe Murillo said, “We respectfully differ with the FDA’s conclusions and decision. We continue to believe that we have provided enough information and data, based on high quality research, to address all the issues raised by the Agency.”
He said: “We are pursuing a stay, and we’re exploring all our options in accordance with the FDA regulations and law. This includes appealing the decision and engaging our regulator.”
The FDA’s decision is a major blow for Juul and Altria, the former Philip Morris company that owns 35% of Juul. This was the culmination of a two-year-long process where Juul requested FDA approval to continue selling their products.
The Agency will ban Juul’s fruit and mint flavors in 2020 to combat the vaping trend among teens. The company was criticized for its early marketing tactics, which critics claim targeted consumers younger than 21. Juul denies it intentionally tried to appeal to younger people.
The state of North Carolina received $40 million from the company as part of a settlement with a lawsuit filed in 2021 over allegations that they marketed their products to teenagers.
The American Lung Association responded to the FDA’s decision on Thursday by saying that Juul was largely responsible for youth vaping. It used the same tactics to exploit youth as major tobacco companies, such as appealing flavors, deep discounts, youth-focused campaigns, and high levels of nicotine to make them addicted.
According to survey results from the Centers for Disease Control and Prevention published in March, 11,3% of high-school students and 2,8% of middle-schoolers reported having used e-cigarettes within the past 30 days.
The FDA’s decision is in line with the Biden Administration’s efforts to implement regulations that will reduce disease and death caused by smoking. The administration announced on Tuesday that it will create a rule to limit the amount of nicotine in cigarettes. The FDA has also announced a proposal to ban menthol cigarettes.
Research has shown that e-cigarettes pose safety concerns beyond those associated with smoking. A 2021 Johns Hopkins study found thousands of unknown chemicals in vape products that manufacturers had not disclosed. According to the CDC, there were over 2,800 U.S. hospitalizations from March 31, 2019, to February 15, 2020, due to lung injuries caused by e-cigarettes and vaping.
The FDA has previously approved several vaping products, including those from Logic NJOY and Vuse (made by R.J. Reynolds Tobacco Co.).
