Blue Hole New Consumer Reported, March 25 news, according to foreign news reports, the US FDA has authorized the sale of two electronic cigarette devices and tobacco flavor refills produced by Logic Technology Development LLC, the e-cigarette products division of Japan Tobacco International (JTI). These are the only e-cigarette products authorized by the agency since Vuse Solo became the first e-cigarette product in October 2021 (more than five months ago).
Logic is an American e-cigarette manufacturer that was acquired by Nichiren International in April 2015.
These products include Logic Vapeleaf, Logic Power, and Logic Pro, including hardware devices. The agency also issued marketing rejection orders to Logic for a variety of other electronic nicotine delivery system (ENDS) products.
Logic submitted PMTA in 2019 for Power and Pro devices and Smoke Bombs. They were one of the earliest submissions — more than a year before the September 9, 2020 PMTA submission deadline.
The FDA authorizes the sale of Logic Vapeleaf heated tobacco products (HTP) and odorless tobacco-filled capsules for use in this device. Vapeleaf is the only FDA-authorized HTP other than Philip Morris International's IQOS, which is not currently sold in the United States due to a patent dispute.
Vapeleaf is sold in other countries under JTI's PLOOM TECH brand. PLOOM is based on technology that JTI purchased from what is now called PAX Labs, which spun off from Juul Labs in 2017. The original PAX products were also sold under the name Ploom.
Logic Power is a rechargeable cigar-like device with a traditional screw-in nebulizer refill.
Logic Pro is an e-cigarette with an embedded sealed capsule that holds 1.5 ml of e-liquid.
According to the FDA, any of these products currently on the market must be removed or the FDA may take enforcement action.
The agency said the products were authorized after its review of product applications came to a conclusion, provided the company complied with post-marketing requirements to reduce opportunities for teens to reach exposure and exposure to its marketing.
While today's action allows these specific products to be sold in the United States, this does not mean that these products are safe or "FDA approved."
"If a retailer has any questions about a product in stock, please contact Logic. Applications for Logic's other products, including menthol, are still under FDA review." A statement released by the FDA said. "Of the nearly 6.7 million ENDS products submitted for premarket authorization, FDA has taken action against approximately 99 percent of products, including marketing rejection orders for more than 1 million ENDS products."
The agency is about to make an additional decision on the application for popular ENDS products, which make up a large portion of the market. The continued marketing of these products has the potential to have significant public health implications – both positive and negative – because they have huge market share and are used by many people.
"As a cardiologist, I've seen first-hand the devastating health effects of tobacco use, so I'm very keen for the FDA to help reduce the deaths and disabilities caused by these products." FDA Commissioner Robert M. Califf said. "We know that adult smokers need to use e-cigarette products to try to switch from more harmful burning cigarettes, but millions of young people are using these products and are addicted to nicotine. The agency's career scientists considered the balance of these issues when evaluating the potential marketing of e-cigarette products. They've come a long way, and I know they're going to use the best evidence and the strongest methods available to ensure that the products they continue to sell are fit to protect public health."
Under the Premarket Tobacco Product Application (PMTA) pathway, the manufacturer or importer must certify to the agency that, inter alia, the marketing of the new tobacco product will be suitable for the protection of public health. The statutory standard requires the FDA to consider the risks and benefits to the entire population, including users and non-users of tobacco products. FDA must also consider the possible impact of products on people's behavior—in particular the likelihood that existing users will stop using such products and that people who do not use tobacco products may start using such products.
This is especially important for young people. Before a product is authorized through the PMTA route, the agency reviews the composition, ingredients, additives, ingredients and health risks of tobacco products, as well as how the products are manufactured, packaged and labeled.
"Ensuring that new tobacco products are subject to FDA premarket assessments is a key part of our efforts to reduce tobacco-related illness and death." Mitch Zeller, director of the FDA's Center for Tobacco Products, said. "For authorized products, manufacturers demonstrate that the possible benefits for adult smokers outweigh the risks that adolescents may start smoking. We are making progress in our review of flavored ENDS and will continue to refuse to sell products if the applicant does not provide sufficient evidence that the potential benefits for adult smokers outweigh the considerable risks to adolescents. We are committed to continuing to take appropriate action to protect our nation's youth from all tobacco products, including e-cigarettes, which remain the most commonly used tobacco products among american teenagers."
Logic is the second company to receive FDA approval to sell e-cigarette products. In October 2021, the agency authorized RJ Reynolds (RJR) Vapor Company to provide marketing licenses for three obsolete steam products for its Vuse Solo equipment and two tobacco-flavored cartridges.
The agency also denied that Vuse PMTA was used in flavored products other than tobacco.
It's worth noting that neither the Logic products and Vuse Solo licensed today have a significant share of the U.S. e-cigarette market. The most popular mass-market e-cigarette products, such as JUUL and Vuse Alto, are still subject to FDA review.