The FDA issued an announcement saying that it had authorized NJOY to market NJOY Daily, an ancient disposable electronic cigarette, sold in convenience stores and gas stations in the U.S. market.

The NJOY Daily is a low-power e-cigarette that is a popular beginner device and is also widely used as a backup device for experienced e-cigarette users.

The agency licensed two tobacco-flavored versions of the product: strong tobacco (4.5 percent nicotine only) and extra strong (6 percent nicotine only).

NJOY Daily is the second FDA-authorized NJOY product and the first single-use e-cigarette.

In April, the agency granted NJOY authorization for its Ace line and three tobacco-flavored refills. The NJOY Ace is the first FDA-cleared modern reloading device.

As with previously authorized vaping products, the FDA made no determinations on the menthol-flavored NJOY Daily model, but issued a Marketing Denial Order (MDO) for the Daily model containing flavors other than tobacco and menthol.

When the FDA announced in January 2020 that it would prioritize enforcement of pod-based e-cigarettes in flavors other than tobacco and menthol, the agency allowed other compliant manufacturers to continue selling flavored, single-use products. However, NJOY at the time took the initiative to take its popular fruit-flavored products off the shelves.

According to The Wall Street Journal, NJOY's flavored e-cigarettes account for 70% of the company's sales. Now the company is denied the opportunity to sell them unless it chooses to challenge MDO in court.

Hundreds of e-cigarette manufacturers have received MDOs for flavored products, all based on standards of evidence announced by the FDA nearly a year after the September 9, 2020, premarket tobacco application (PMTA) submission deadline.

About 40 small independent e-cigarette companies have challenged their MDOs in federal court, and others have filed administrative appeals with the FDA. The enforcement of some MDOs has been put on hold by the courts, and the agency has been forced to rescind others.

Although the FDA has received millions of PMTAs, it has authorized only seven nicotine vaping products, including NJOY Daily. The previous authorization was:

Vuse Solo – October 12, 2021

Logic Pro and Logic Power – March 24, 2022

NJOY Ace – April 26, 2022

Vuse Ciro and Vuse Vibe – May 13, 2022

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

The FDA said this authorization allows these products to be legally sold in the U.S. While this action allows these specific products to be sold in the U.S., it does not mean that these products are safe, nor that they are FDA-approved. All tobacco products are harmful and potentially addictive. Those who do not use tobacco products should not start.

Under the PMTA pathway, applicants must demonstrate to the agency that, among other things, the marketing of new tobacco products will be appropriate to protect public health. Authorized NJOY products meet this criterion because, among several key considerations, the overall toxicological risk to users of new products is lower compared to burning cigarette smoke due to significantly reduced aerosol harmful and potentially harmful Ingredients (HPHC). In addition, estimates of full switch from cigarettes to new products in current adult smokers are higher than estimates in the literature for full switch to electronic nicotine delivery systems (ENDS).

Importantly, FDA considers the risks and benefits of the entire population, including users and non-users of tobacco products, including adolescents. This includes reviewing existing data on the likelihood of young people using the product. For the authorized product, the FDA determined that the potential benefits for adult smokers who completely or significantly reduce cigarette use will outweigh the risks to adolescents—provided the company follows postmarketing requirements to reduce adolescent exposure and exposure to tobacco.

As shown in the 2021 National Youth Tobacco Survey (NYTS), among teens who currently use e-cigarettes, the most commonly used type of vaping device is single-use. When reviewing applications for these products, the agency takes this data very seriously and strongly considers the risks to teens. While the NYTS shows that single-use e-cigarettes are relatively popular among teens, it also shows that the flavor type most commonly used by teens who use any type of e-cigarette today are flavors such as fruit, candy, or mint, rather than tobacco flavors. These data inform the FDA's decision to authorize tobacco-flavored products because these products are less attractive to young adults, and authorizing these products may be beneficial for current adult smokers who switch entirely to e-cigarettes or significantly reduce their cigarette consumption.

In addition, the authorization imposes strict marketing restrictions on companies to greatly reduce the likelihood of youth exposure to tobacco advertising for these products. FDA will closely monitor how these products are marketed and will take necessary action if companies fail to comply with any applicable legal or regulatory requirements, or if there is a significant increase in the number of non-smokers, including adolescents, using these products.

Prev : Korea Electronic Cigarette News

Next : Canada plans to put warnings on every cigarette

Email:sales@mlifevapor.com

WhatsApp:+86 13871529372

Email:sales@mlifevapor.com

WhatsApp:+86 13871529372

Tel：+86 13871529372

Add：6 / F, block B, building 2, Fuyong Tongtai times center, Bao'an District, Shenzhen

Language：简体中文 | >

Tel：+86 13871529372

Add：6 / F, block B, building 2, Fuyong Tongtai times center, Bao'an District, Shenzhen Website