It is reported that the U.S. Food and Drug Administration announced today that it has authorized the sale of three new types of tobacco products, which marks that the first set of electronic nicotine delivery system (ends) products have been authorized by FDA through pre marketing tobacco product application (PMTA).
FDA issued a sales order to RJ Reynolds (RJR) vapor company for its VUSE solo closed e-cigarette equipment and accompanying tobacco flavored e-cigarette holder, including VUSE solo power unit, VUSE replacement cartridge original 4.8% G1 and VUSE replacement cartridge original 4.8% G2. Today’s authorization allows these products to be legally sold in the United States because the data submitted by RJR vapor to the FDA prove that the marketing of these products is suitable for protecting public health.
“Today’s authorization is an important step to ensure that all new tobacco products pass the FDA’s strong and scientific pre market evaluation. Manufacturers’ data show that their tobacco flavor products can benefit adult smokers who turn to these products by reducing their exposure to harmful chemicals, whether completely or significantly reducing cigarette consumption.” Mitch Zeller, director of the FDA tobacco center, said. “We must be vigilant against this authorization. We will monitor the marketing of products, including whether the company does not comply with any regulatory requirements, or whether there is reliable evidence that individuals (including teenagers) who have not previously used tobacco products use tobacco products in large quantities. We will take actions as appropriate.”
Under the PMTA approach, e-cigarette manufacturers must demonstrate to the agency that, inter Alia, the marketing of new tobacco products is suitable for protecting public health. These products were found to meet 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 components (HPHC) than users who burned cigarettes.
Based on the comparison of existing data and the results of non clinical studies, the toxicological evaluation also found that the toxicity of aerosol of authorized products was significantly lower than that of burning cigarettes. In addition, FDA considers the risks and benefits to the entire population, including users and non users of tobacco products. Importantly, this includes a review of available data on the likelihood of young people using the product. For these products, FDA determined that the potential benefits to smokers who completely or significantly reduce cigarette use would outweigh the risks to adolescents if the applicant followed post marketing requirements aimed at reducing adolescent exposure and exposure to products.
Today, the FDA also issued 10 marketing refusal orders (MDOs) for flavoring products submitted by RJR under the VUSE solo brand. Due to potential confidential business information issues, FDA will not publicly disclose specific flavoring products. These products subject to MDOs filed prior to marketing may not be introduced or delivered for introduction into interstate trade. If any of them are already in the market, they must be removed from the market or implemented. Retailers should contact RJR with any questions about their products in stock.
The agency is still evaluating the company’s application for VUSE solo branded Mint products.
FDA is aware that the 2021 National Youth Tobacco Survey (NYTS) found that about 10% of high school students who currently use e-cigarettes name VUSE their common brand. The agency attaches great importance to these data and considers the risks to adolescents when reviewing these products.
The evidence also shows that young people are less likely to start using tobacco flavored products and then turn to high-risk products, such as burning cigarettes, than users of non tobacco flavored e-cigarettes.
The data also show that most young people and young people who use e-cigarettes begin to use fruit, candy or mint instead of tobacco.
In addition, today’s authorization imposes strict marketing restrictions on the company, including digital advertising restrictions and radio and television advertising restrictions, so as to greatly reduce the possibility of teenagers’ exposure to tobacco advertising of these products.
RJR vapor company also needs to regularly report to FDA information about products on the market, including but not limited to ongoing and completed consumer research, advertising, marketing plans, sales data, current and new user information, manufacturing changes and adverse experiences.
If the FDA determines that the continued marketing of the product is no longer appropriate to protect public health, for example, if there is a significant increase in youth epidemics.
Although today’s action allows tobacco products to be sold in the United States, it does not mean that these products are safe or approved by the FDA. All tobacco products are harmful and addictive. People who do not use tobacco products should not start.
The FDA said it had taken action on more than 98% of applications submitted by the deadline. This includes issuing MDOs to more than 1 million flavored e-cigarette products, which lack sufficient evidence that adult smokers using the flavored product will overcome the public health problems caused by the product’s full record and considerable appeal to young people.
Recently, FDA released a sample summary of MDO decisions. This sample does not reflect the decision basis for each MDO action taken by FDA.
The agency will continue to issue decisions on applications as appropriate, and is committed to transforming the current market into a market where all electronic cigarette products available for sale prove that the marketing of the product is suitable for “protecting public health”.
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