FDA Issues Marketing Decisions on NJOY Daily E-cigarette Products

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FDA Issues Marketing Decisions on NJOY Daily E-cigarette Products

On June 10, 2022, the U.S. Food and Drug Administration (FDA) issued marketing decisions on NJOY Daily e-cigarette products. These decisions included the authorization of two new tobacco products that went through the Premarket Tobacco Product Application (PMTA) process.

These new authorizations issued to NJOY, LLC for its tobacco-flavored Daily disposable e-cigarettes–the NJOY Daily Rich Tobacco 4.5% and NJOY Daily Extra Rich Tobacco 6%. With these new authorizations, NJOY can now legally market these products in the U.S. The FDA reiterates the point that these authorizations do not mean these products are safe nor are they “FDA approved.”

In addition to these authorizations, the FDA also issued marketing denial orders to NJOY for several of its Daily e-cigarette products, though it did not specify which ones. The FDA is encouraging retailers to contact NJOY with any questions about these products that may be in their inventory. The FDA has yet to decide on two applications for menthol-flavored Daily products from NJOY.

Here’s what the FDA said about its review of NJOY’s PMTAs and its authorization decision:

“Under the PMTA pathway, the applicant must demonstrate to the agency, among other things, that marketing of the new tobacco product would be appropriate for the protection of the public health. The authorized NJOY products were found to meet this standard because, among several key considerations, the overall toxicological risk to the users of the new products is lower compared to combusted cigarette smoke due to significant reductions in aerosol harmful and potentially harmful constituents (HPHCs) from the new products compared to cigarettes.

“Additionally, estimates of complete switching from cigarettes to the new products for current adult smokers was at a level higher than what is typically seen in the literature for estimates of complete switching to electronic nicotine delivery systems (ENDS). Therefore, the applicant has demonstrated that some current adult smokers are interested in the new products to assist in decreasing or quitting their cigarette use, and these products have the potential to benefit that group.”

To view the entire press release regarding the FDA’s authorization of NJOY Daily, click here.

For all the latest news from the U.S. Food and Drug Administration, visit FDA.gov.