Marketing Approval for 2 Tobacco NJoy Daily Vapes


The U.S. Food and Drug Administration has approved the premarket tobacco product applications (PMTA) for NJOY’s Daily Rich Tobacco 4.5% and NJOY Daily Extra Rich Tobacco 6%.

“It should be noted that our determination that the marketing of these products is APPH [appropriate for the protection of public health] is based in part on the submitted microbial stability data,” the agency wrote in its marketing granted order (MGO).

The designation does not mean the products are safe and they are not “FDA approved,” the agency said, but the MGOs allows the NJOY to legally market the authorized products in the United States.

While approving NJOY’s Daily Rich Tobacco 4.5% and NJOY Daily Extra Rich Tobacco 6%, the FDA denied authorization for multiple other Daily e-cigarette products. These are presumed for products with nontobacco flavors. Any of those products that remain on the market must be removed or risk FDA enforcement, the agency said. Applications for two menthol-flavored Daily products remain under FDA review.

Additionally, the authorization imposes marketing restrictions on the company to greatly reduce the potential for youth exposure to advertising for these products. The FDA said it will closely monitor how these products are marketed and will act as necessary if the company fails to comply with any applicable statutory or regulatory requirements, or if there is a notable increase in the number of non-smokers—including youth—using these products.

On April 26, the FDA authorized four NJOY Ace products through the PMTA pathway.

Read full article here.

Tobacco Reporter – 2022-06-10.

Want More Investigative Content?

Curate RegWatch
Curate RegWatch
In addition to our original coverage, RegWatch curates top stories on issues and impacts arising from the regulation of economic, social and environmental activity in Canada and the U.S.


Please enter your comment!
Please enter your name here


Health Canada says heroin is now a ‘new’ treatment option in...

Health Canada says it has legalized heroin as a treatment option for people with "severe opioid use disorder." But local advocates in Vancouver say the barriers to...

Vaping Coverage Get it NOW!

Sign Up for Incisive Content!

RegWatch original video is designed to move opinion. Get our videos first and be the first to share.

Your Information will never be shared with any third party