On January 31, Brian King, the director of the Center for Tobacco Products (CTP) at the US Food and Drug Administration (FDA), issued a public letter. In the letter, it was stated that significant progress was made in improving public health by the CTP in 2022 through proposing regulations, reviewing applications for new tobacco products prior to legal sales (PMTA), enforcing compliance, investigating and holding accountable companies that broke the law, and educating the public about the risks of tobacco products. Currently, preparations are underway for 2023.
So far, the FDA has received over 6.7 million applications for e-cigarette products, but has only approved 23 of them. Among them, 3 were approved in 2021 and 20 were approved in 2022, all of which were tobacco flavors.
According to a list, there are 9 products from R.J, a subsidiary of British American Tobacco (BAT), 8 products from Logic, a subsidiary of Japan Tobacco, and 6 products from NJOY LLC that are allowed to be sold on the market.
According to analysis, the primary considerations for FDA's PMTA review of e-cigarette products are the product's harm reduction and safety. Additionally, FDA favors closed and disposable e-cigarettes.
According to reports, NJOY is the third largest e-cigarette brand in the US and the only American e-cigarette company that has passed PMTA certification. Its ceramic chip is exclusively manufactured by SMIC. In July 2022, there were reports that Altria plans to acquire NJOY.
The PMTA has been approved for the following list:
List of products cleared by PMTA in 2021 | Image source: FDA official website
List of 2021 PMTA approvals | Image source: FDA official website
References:
1) Orders have been granted for premarket marketing of tobacco products.
As we reflect on the past year and anticipate the future, we examine the strides made by the FDA in regulating tobacco products in 2022.
Smoore, a leading vape manufacturer, has commented on the recent marketing orders issued by the US FDA. The company expressed flattery at being included in the targeted group for the orders. The FDA has ordered several companies to remove flavored vape products from the market due to concerns that they are targeting youth consumers. Smoore has stated that they will comply with the orders, but also voiced their desire to continue providing customers with quality products while ensuring the safety of all consumers.
E-cigarette maker NJOY is reportedly preparing for a possible sale.
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