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Fda Brand Strategy Smoking

Juul ‘disagrees’ with FDA findings in aftermath of sales ban

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By Kendra Barnett, Associate Editor

June 23, 2022 | 4 min read

Following an FDA order requiring Juul to stop selling its e-cigarettes in the US, the popular vape brand snaps back.

Hand holding Juul

Juul is displeased with the FDA's order that the company stop selling its e-cigs in the US market / Fallon Michael

The US Food and Drug Administration (FDA) ordered Juul to stop selling its e-cigarettes in the US on Thursday. In its decision, the FDA argued that the company provided conflicting and insufficient data on the chemicals that may seep out of its e-cigarette liquid pods. The agency cited health and safety concerns.

FDA commissioner Dr. Robert M. Califf said in a statement that the decision furthers the agency’s “commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards.”

Califf also noted that the FDA remains concerned about and focused on curbing the teen vaping crisis. “The agency has dedicated significant resources to review products from the companies that account for most of the US market. We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping,” he said.

The order follows a string of controversies involving Juul. The e-cigarette company has been at the heart of social and regulatory debate concerning the problem of e-cigarette use among young people. Data from Truth Initiative indicates that from 2011 to 2019, e-cigarette use among middle and high school students rose 1,800% — much of this increase has been blamed on product and marketing tactics employed by companies like Juul that appeared to be targeted toward young people. Last July, Juul coughed up $40m in a settlement with the North Carolina Attorney General’s office for allegedly marketing to teens.

Juul, however, disputes the FDA’s claims that its data on the chemicals of its liquid pods was insufficient evidence for keeping the brand’s devices on the market. “We respectfully disagree with the FDA’s findings and decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency,” Joe Murillo, the company’s chief regulatory officer, said in a statement.

Murillo argues that the company’s FDA applications, submitted more than two years ago, “appropriately characterized the toxicological profile of Juul products, including comparisons to combustible cigarettes and other vapor products.” He says that “the totality of the evidence” should fulfill the statutory requirement for being dubbed “appropriate for the protection of the public health.”

The company plans to examine other options under the FDA and federal law — “including appealing the decision,” per Murillo — to try to keep its e-cigarettes on the US market.

The FDA decision follows a Tuesday announcement in which the agency said it plans to reduce nicotine levels in regular cigarettes as well. Both decisions are part of a larger agenda to update federal regulations concerning tobacco and nicotine products in the US.

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