FDA clears e-cigarette products for sale, marking agency’s first-of-its-kind clearance

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Today, the United States Food and Drug Administration announced that it has cleared three new tobacco products, marking the first set of electronic nicotine delivery system (ENDS) products to be cleared. by the FDA through the Pre-Market Tobacco Product Application (PMTA) route. . The FDA has issued marketing orders to RJ Reynolds (RJR) Vapor Company for its Vuse Solo closed-end device and tobacco flavored e-liquid pods, specifically Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% G1 and Vuse Replacement Cartridge Initiale 4.8% G2. As the RJR Vapor Company has submitted data to the FDA demonstrating that the marketing of these products is appropriate for the protection of public health, today’s clearance allows these products to be legally sold in the United States. .

“Today’s approvals are an important step in ensuring that all new tobacco products undergo pre-market scientific evaluation by the FDA. The manufacturer’s data shows that 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, JD, Director of the FDA Center for Tobacco Products. “We must remain vigilant with this authorization and we will monitor the marketing of products, including if the company does not comply with regulatory requirements or if credible evidence emerges of significant use by people who have not previously used any tobacco product, including young people. . We will take appropriate action, including revoking the authorization. “

As part of the PMTA channel, manufacturers must demonstrate to the agency that, among other things, the marketing of the new tobacco product would be appropriate for the protection of public health. These products were found to comply with this standard because, among several key considerations, the agency determined that study participants who used only authorized products were exposed to fewer harmful and potentially harmful constituents (HPHCs) from aerosols by compared to users of burnt cigarettes. The toxicological evaluation also revealed that the aerosols of authorized products are significantly less toxic than burnt cigarettes based on the comparisons of available data and the results of non-clinical studies. Additionally, the FDA has looked at the risks and benefits for the general population, including users and non-users of tobacco products, and most importantly, young people. This included reviewing the available data on the likelihood of use of the product by young people. For these products, the FDA determined that the potential benefits to smokers who quit completely or drastically reduced their cigarette consumption would outweigh the risks to young people, provided the applicant meets post-market requirements to reduce the risk of smoking. exposure of young people and access to products.

Today, the FDA also issued 10 refusal to market (MDO) orders for flavored ENDS products submitted under the trademark Vuse Solo by RJR. Due to potential issues of confidential business information, the FDA does not publicly disclose specific flavored products. These products submitted to an MDO for a pre-market application cannot be introduced or delivered for introduction into interstate commerce. If any of them are already on the market, they must be taken off the market or risk law enforcement. Retailers should contact RJR with any questions regarding the products in their inventory. The agency is still assessing the company’s demand for menthol-flavored products under the Vuse Solo brand.

The FDA is aware that the 2021 National Youth Tobacco Survey (NYTS) found that about 10% of high school students currently use e-cigarettes named Vuse as their usual brand. The agency takes this data very seriously and has taken into account the risks to young people when reviewing these products. Evidence also indicated that, compared to users of non-tobacco-flavored ENDS products, young people are less likely to start using tobacco-flavored ENDS products and then switch to higher risk products, such as cigarettes. burned. The data also suggests that most youth and young adults who use ENDS start with flavors such as fruit, candy, or mint, and not with tobacco flavors. These data support the FDA’s decision to authorize tobacco flavored products as these products are less appealing to young people and authorization of these products may be beneficial for adult users of burnt cigarettes who switch completely to NDT or significantly reduce their cigarette consumption.

In addition, today’s authorization places strict marketing restrictions on the company, including digital advertising restrictions as well as radio and television advertising restrictions, to significantly reduce the potential for marketing. exposure of young people to tobacco advertising for these products. RJR Vapor Company is also required to regularly report to the FDA information regarding products in the market, including, but not limited to, ongoing and completed consumer studies, advertising, marketing plans, data. sales, information on current and new users, manufacturing changes and adverse experiences.

The FDA may suspend or withdraw a marketing order issued under the PMTA pathway for various reasons if the agency determines that the continued marketing of a product is no longer “appropriate for the protection of public health”, such as if there is an increase in the initiation of young people.

Although today’s action authorizes the sale of tobacco products in the United States, this does not mean that these products are safe or “FDA approved”. All tobacco products are harmful and addictive and those who do not use them should not start.

Applications for many ENDS and other well-known new tobacco products on the market as of August 8, 2016 were due to be submitted to the FDA by September 9, 2020. The agency took action on more than 98% of applications submitted before that date limit. . This includes the issuance of MDOs for over a million flavored ENDS products for which there was insufficient evidence that the benefits for adult smokers who used the flavoring products would overcome the public health problem posed by the well-documented attractiveness and considerable products for young people. Recently, the FDA released a sample MDO decision summary. This sample does not reflect the rationale for the decision of each MDO action taken by the FDA.

The agency will continue to make decisions on applications, where appropriate, and is committed to working on the transition from the current market to a market in which all ENDS products available for sale have demonstrated that the marketing of the product is ” appropriate for the protection of public health. . “

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The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biologicals for human and veterinary use, as well as medical devices. . The agency is also responsible for the safety and security of our country’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.


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