FDA first approved atomized electronic cigarette PMTA: VUSE three products are allowed to be sold legally
The world’s first e-cigarette brand through American PMTA has been born, that is, the three e-cigarette products of RJ Reynolds, a subsidiary of British American tobacco. Synthetic Nicotine.
The U.S. Food and Drug Administration (FDA) said on Tuesday that it authorized the legal sale of e-cigarettes in the U.S. market for the first time, allowing RJ Reynolds to sell its three VUSE e-cigarettes. “Although today’s action allows e-cigarette products to be sold in the United States, it does not mean that these products are safe or FDA approved. All tobacco products are harmful and addictive, and those who do not use tobacco products should not start,” the FDA said in a statement.
The FDA said it rejected the company’s license to sell 10 flavoring products, but did not say what they were. All three licensed products are tobacco flavored. The FDA said they are unlikely to attract children and adolescents, and are more likely to be used by smokers to reduce their risk of injury.
“Today’s authorization is an important step to ensure that all new tobacco products pass the FDA’s strong and scientific pre market evaluation,” Mitch Zeller, head of the FDA’s tobacco products center, said in a statement.
“The data of e-cigarette manufacturers show that by reducing exposure to harmful chemicals, their tobacco flavor products can benefit addicted adult smokers who switch to these products and can completely or significantly reduce cigarette consumption,” Zeller added.
“Although the FDA rejected the application for 10 flavors of VUSE e-cigarettes, which is a positive step, it is worrying that a product with nicotine concentration three times that allowed by Canadian, British and European laws has been approved. VUSE product nicotine with this level puts young people in our country at risk of excessive addiction.” Matthew miles, President of the tobacco free children’s movement, said in a statement. At least one congressman also expressed concern.
“The FDA has approved a high nicotine e-cigarette, abandoning public health. Many countries in the world have limited the allowable nicotine content in e-cigarettes, which enables them to avoid the prevalence of e-cigarettes among teenagers,” Raja krishnamoorthi, chairman of the economic and consumer policy Subcommittee of the House Oversight Committee, said in a statement.
“Over the years, I have been trying to reduce nicotine levels in the United States. The FDA ignored these data and missed another opportunity to solve the adolescent e-cigarette epidemic,” he said.
FDA said it would pay close attention to the marketing of products.
“We must be vigilant against this authorization. We will monitor the marketing of products, including whether the company fails to 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, including withdrawing the authorization.” Synthetic Nicotine .
The FDA said its action would limit digital, radio and television advertising of e-cigarette products.
“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 ingredients than users who burned cigarettes,” the FDA said. “FDA knows that the 2021 national youth tobacco survey found that about 10% of high school students who currently use e-cigarettes use VUSE as their common brand. The agency attaches great importance to these data and considers the risks to teenagers when reviewing these products,” it added.
“The data also show that most young people and young people who use e-cigarettes begin to use flavors such as fruit, candy or mint rather than tobacco. These data strengthen the FDA’s decision to approve tobacco flavor products because they are less attractive to consumers. Authorizing these products may be beneficial to adult burning cigarette users who completely switch to e-cigarettes or significantly reduce cigarette consumption Beneficial. ”
Electronic cigarette products have been allowed to be sold on the market for many years, although so far FDA has not officially approved electronic cigarette products.
According to previous FDA rules, e-cigarette manufacturers must submit an application before September 9 last year to obtain the agency’s authorization to continue to stay on the market.
The FDA said in September that it needed more time to decide on applications.
The largest players in the e-cigarette market, including Juul, have not yet been determined.
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