BREAKING: Federal Court Places Hold On Juul Ban

The U.S. Court of Appeals for the D.C. Circuit reportedly approved a halt on a U.S. Food and Drug Administration (FDA) order banning sales of Juul e-cigarette products.

The company said in its filing that the FDA “cannot credibly argue that there is a critical and urgent public interest” in removing its products from the market right now, “rather than after this Court reviews FDA’s action,” according to Axios. The company characterized the FDA’s move as “extraordinary and unlawful.”

FDA Commissioner Robert Califf said on Thursday that the action represented 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.”

“The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market,” he added. “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.”

Juul — which markets itself as an alternative to cigarettes for adult smokers — sells nicotine capsules smoked through a small device. Sales surged nearly 800% between 2017 and 2018, causing Juul to gain a 68% market share in the e-cigarette category. The Wall Street Journal first broke news on the FDA’s ban of the product earlier this week.

“The marketing denial order would follow a nearly two-year review of data presented by the vaping company, which sought authorization for its tobacco- and menthol-flavored products to stay on the U.S. market,” the outlet explained.

Over the past four years, the FDA has been seeking ways to regulate e-cigarettes — especially for young consumers.

“We see clear signs that youth use of electronic cigarettes has reached an epidemic proportion, and we must adjust certain aspects of our comprehensive strategy to stem this clear and present danger,” then FDA Commissioner Scott Gottlieb said in 2018. “While we remain committed to advancing policies that promote the potential of e-cigarettes to help adult smokers move away from combustible cigarettes, that work can’t come at the expense of kids. We cannot allow a whole new generation to become addicted to nicotine.”

The Thursday order is reflective of the “FDA’s determination that there is insufficient evidence to assess the potential toxicological risks of using the JUUL products. There is also no way to know the potential harms from using other authorized or unauthorized third-party e-liquid pods with the JUUL device or using JUULpods with a non-JUUL device.”

Michele Mital, acting director of the FDA’s Center for Tobacco Products, said on Thursday that 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.”

Mital claims that Juul failed to supply the necessary information to meet the FDA’s standards.

“As with all manufacturers, JUUL had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards,” she continued. “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.”

Tim Meads contributed to this report.


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