FDA Approves First ENDS Product for Marketing

R.J. Reynold’s Vuse and tobacco-favored pods OK’d for marketing, but 10 other flavored products were denied.

October 13, 2021

Vuse Vaping Product

ALEXANDRIA, Va.—The U.S. Food and Drug Administration authorized the marketing of R.J. Reynolds’ Vuse vape product, which includes the Vuse Solo closed electronic nicotine delivery system (ENDS) device and accompanying tobacco-flavored e-liquid pods (Vuse Replacement Cartridge Original 4.8% G1 and Vuse Replacement Cartridge Original 4.8% G2).

This is the first set of ENDS products to be authorized by the FDA through its Premarket Tobacco Product Application (PMTA) pathway. In order to receive approval by the FDA to sell these products, R.J. Reynolds had to submit data proving that the marketing of these products is appropriate for the protection of public health.

The data that R.J. Reynolds provided showed the FDA that participants in a study who used only the authorized products were exposed to fewer harmful and potentially harmful constituents from aerosols compared to users of combusted cigarettes, and the products’ aerosols are significantly less toxic than combusted cigarettes based on available data comparisons and results of nonclinical studies.

“Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation. The manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products—either completely or with a significant reduction in cigarette consumption—by reducing their exposure to harmful chemicals,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products.

Additionally, the FDA issued marketing denial orders (MDOs) for 10 flavored ENDS products submitted under R.J. Reynold’s Vuse Solo brand, but the agency refuses to release the specific names of the flavored products, claiming confidential commercial information issues. The FDA states that the products are not allowed to be released into the market, and if there are any for sale, they must be removed from shelves. The FDA encourages retailers to contact RJR with questions about specific products in their inventory.

To date, the FDA has focused its enforcement efforts on manufacturers for marketing products whose PMTAs were denied. Last Thursday, the FDA issued warning letters to 20 manufacturers for continuing to unlawfully market ENDS products that are the subject of MDOs. The FDA also issued warning letters for the unlawful marketing of tobacco products to one manufacturer that received refuse to file (RTF) determinations on its PMTA, one manufacturer that received RTF and MDO determinations on its PMTA, and six manufacturers that did not submit any premarket applications. Collectively, these 28 manufacturers have listed a combined total of more than 600,000 products with the FDA.

As of Sept. 23, the FDA issued a total of 323 MDOs, accounting for more than 1,167,000 flavored ENDS products.

Last month, NACS called on the FDA to release a public list of ENDS products for which the agency issued MDOs.

“Without this list, our retail members, who make every effort to comply with the law, do not know which products must be removed from shelves,” NACS stated in a letter to the FDA.“As the agency takes action on PMTAs, it is imperative that there is continued transparency in the process and that stakeholders across the tobacco trade know all of the products that have had PMTAs rejected as well as all of the products that have had marketing orders granted.”

The FDA said it has taken action on 98% of applications for more than six million ENDS products that were submitted by the Sept. 9, 2020, deadline.