The U.S. Food and Drug Administration said certain NJOY e-cigarettes can be legally marketed, while determining other vaping products made by the company need to be taken off the shelves.
The FDA said it had granted marketing orders to NJOY LLC for its Ace e-cigarette products, which are closed systems and come ready to vape. While the agency said the products can be legally marketed, it noted the order doesn’t mean they are safe or approved by the agency.
“All tobacco products are harmful and potentially addictive,” the FDA said. “Those who do not use tobacco products shouldn’t start.”
The FDA cleared the Ace device and the “classic tobacco” pods containing 2.4% and 5% nicotine, as well as the “rich tobacco” pod containing 5% nicotine. Two Ace pods flavored with menthol are still being reviewed by the agency.
The FDA added that NJOY had to show that marketing the products would “be appropriate for the protection of public health,” and that the company met this standard because chemical testing found the harmful or potentially harmful particle levels in the aerosol from the e-cigarettes was lower than those in traditional cigarettes.
The FDA had a court-ordered Sept. 9 deadline to review pre-market applications for vaping products. On that date, it rejected nearly 950,000 flavored vaping products on the grounds the data in their applications didn’t include sufficient evidence that the benefit to adult smokers outweighed the public health risk of youth use.
The court-ordered deadline resulted from a lawsuit brought by public health groups to speed up the FDA’s regulation of e-cigarettes under the Tobacco Control Act.
The FDA has yet to make a decision on industry giant Juul’s applications.
LAW360: https://www.law360.com/articles/1487560/fda-allows-njoy-e-cigs-to-stay-on-market