FDA Approves Two New Tobacco Products by NJOY

On June 10th, the FDA announced its decision regarding the NJOY Daily e-cigarette products, which includes granting authorization for two new tobacco products - NJOY Daily Rich Tobacco 4.5% and NJOY Daily Extra Rich Tobacco 6% - through the premarket tobacco product application (PMTA) process.

This authorization allows these products to be legally sold in the United States. While the authorization permits the sale of these specific products in the U.S., it does not mean they are safe or FDA-approved. All tobacco products are harmful and carry the risk of addiction. Those who have not used tobacco products should not try them.

The US Food and Drug Administration (FDA) has issued a ban on several NJOY Daily products, and all current products on the market must be removed, or the FDA may take enforcement action. Retailers should contact NJOY with any inventory concerns. Two mint-flavored NJOY Daily products are still under review by the FDA.

According to PMTA requirements, applicants must demonstrate to the agency that, among other things, the marketing of new tobacco products is compatible with protecting public health. NJOY's authorized products meet this standard, as the aerosol from the new product has significantly lower levels of harmful and potentially harmful constituents (HPHCs) than cigarette smoke in several key considerations, therefore users of the new product have an overall lower toxicity risk than traditional cigarette smoke.

Furthermore, estimates suggest that the number of current adult smokers who would completely switch from cigarettes to new products is higher than the estimates found in literature for switching to electronic nicotine delivery systems (ENDS). Therefore, the applicant has demonstrated that there is interest among current adult smokers in new products that could help them reduce cigarette use, and these products may hold potential benefits for this group.

The FDA has considered the risks and benefits of tobacco products for the entire population, including both users and non-users, including adolescents. This includes reviewing existing data on the possibility of young people using this product. For authorized products, the FDA has determined that the potential benefits for adult smokers who completely quit or significantly reduce cigarette use will outweigh the risks to adolescents – as long as the company complies with post-market requirements to reduce access for young people.

According to the 2021 National Youth Tobacco Survey (NYTS), the most commonly used type of electronic cigarette device among current teenage users is disposable. This data is of great concern to the agency, as they heavily consider the risks to youth when reviewing applications for these products. Although the NYTS shows that disposable ENDS are relatively popular among teens, it also indicates that the most commonly used flavor types by teens currently using any type of electronic cigarette are fruit, candy, or mint flavors, instead of tobacco flavors. This data provides a basis for the FDA's decision to authorize tobacco-flavored products, as these products are less attractive to youths and authorizing them may benefit current adult smokers who have completely switched to ENDS or significantly reduced their cigarette consumption.

In addition, the authorization imposes strict marketing restrictions on the company in order to significantly reduce the likelihood of tobacco advertising for these products reaching underage individuals. The U.S. Food and Drug Administration will closely monitor the marketing practices of these products, and if the company fails to comply with any applicable legal or regulatory requirements or if the number of non-smokers (including youth) using these products increases significantly, necessary action will be taken.

If the FDA determines that a product is no longer "appropriate for protecting public health", for example if there is a significant increase in the number of teenagers who start smoking, the FDA can suspend or revoke the sales authorization issued under the PMTA pathway for various reasons.

Before providing the public with marketing clearance decision documents, the FDA must edit commercial secrets and confidential commercial information (CCI) and ensure that the documents published on the FDA website are available for everyone to view. For these reasons, the complete summary of the marketing authorization decision may not be published on the webpage granting the order for tobacco products to be placed on the market until after the order is issued. During this time, to provide as much information as possible when the order is issued, the FDA is providing an edited letter of marketing authorization and summary of the decision in the "executive summary" section to broadly explain the public health reasons for authorizing these products.

Source: U.S. Food and Drug Administration (FDA)