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June 10, 2022

NJOY Daily Is the First FDA-Authorized Disposable

The FDA has authorized sale of the NJOY Daily, the venerable disposable e-cigarette sold mostly in convenience stores and gas stations. A low-powered cigalike-style vape, the Daily is a popular beginner device, and is also widely used as a backup for experienced vapers.

The agency authorized two tobacco-flavored versions of the product: Rich Tobacco flavor (sold only with 4.5% nicotine) and Extra Rich Tobacco (6% nicotine only).

The Daily is the second NJOY product to earn FDA authorization, and the first disposable vape. In April the agency granted NJOY authorization for its Ace pod vape and three tobacco-flavored refill pods. The NJOY Ace is the first modern pod device given the go-ahead by the FDA.

No to watermelon; no decision on menthol

As with previously authorized vaping products, the FDA has made no decision on menthol-flavored NJOY Daily models, but issued Marketing Denial Orders (MDOs) for the Daily models containing flavors other than tobacco and menthol.

When the FDA announced in January 2020 that it would prioritize enforcement against pod- and cartridge-based vapes in flavors other than tobacco and menthol, the agency allowed otherwise-compliant manufacturers to continue selling flavored disposable products. However, NJOY at that time voluntarily removed its popular fruit-flavored Daily products from the market.

NJOY’s flavored vapes accounted for 70 percent of the company’s sales, according to the Wall Street Journal. Now the company has been denied the opportunity to sell them, unless it chooses to challenge the MDO in court.

Hundreds of vaping manufacturers have received MDOs for flavored products, all predicated on an evidence standard announced by the FDA nearly a year after the Sept. 9, 2020 Premarket Tobacco Application (PMTA) submission deadline.

About 40 small, independent vaping companies have challenged their MDOs in federal court, and others have filed administrative appeals with the FDA. Enforcement of some MDOs has been stayed by the courts, and the agency has been forced to rescind some others.

FDA promises more than 120 PMTA decisions before July

Although the FDA received millions of PMTAs, it has authorized just seven nicotine vaping products, including the NJOY Daily. The previous authorizations were for:

The FDA has been ordered by a federal judge to update the court on its progress reviewing pending PMTAs for the top 10 manufacturers (by market share). On May 13, the agency reported to the court it expects to make decisions on more than 120 products by the end of June (three weeks from now). The FDA is also reviewing PMTAs for non-vaping products, including popular nicotine pouches.

Smokers created vaping without any help from the tobacco industry or anti-smoking crusaders, and vapers have the right to keep innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I recently joined the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy
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