FDA has ruled on 99% of e-cigarette PMTA applications, will soon decide the fate of popular brands
The FDA approved several tobacco-flavored ENDS products under the Logic Vapeleaf, Logic Power and Logic Pro brands, including devices, owned by Logic Technology Development LLC (Logic). The products were authorized after the agency's review of product applications concluded that the likely benefits to adult smokers who significantly reduced cigarette use (or changed completely and experienced cessation) outweighed the risks to adolescents, provided the company Follow post-marketing requirements to reduce teen exposure and exposure to their marketing. The FDA said that while today's action allows these specific 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 potentially addictive. Those who do not use tobacco products should not start. The agency also issued marketing denial orders to Logic for various other ENDS products. Any of these products currently on the market must be taken off the shelves or the FDA could take enforcement action. Retailers should contact Logic with any questions about products in stock. Applications for Logic's other products, including menthol, are still under FDA review. The FDA has taken action on approximately 99 percent of the nearly 6.7 million ENDS products submitted for premarket authorization, including marketing denial orders for more than 1 million ENDS products. The agency is about to make additional decisions on applications for popular ENDS products that make up a significant portion of the market. Continued marketing of these products has the potential to have a significant public health impact—both positive and negative—because they hold a huge market share and are used by so many people. "As a cardiologist, I have seen firsthand the devastating health effects of tobacco use, so I very much hope that the FDA will help reduce the death and disability caused by these products," said FDA Commissioner Robert M. Califf, MD. Knowing that adult smokers have a need to use vaping products to try and switch from more harmful burning cigarettes, millions of young people are using these products and addicted to nicotine. The agency's career scientists consider the balance of these issues when evaluating potential marketing of vaping products. They have come a long way, and I know they will 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 demonstrate to the agency that, among other things, the marketing of the new tobacco product will be suitable to protect public health. This statutory standard requires FDA to consider the risks and benefits to the entire population, including users and non-users of tobacco products. FDA must also consider the likely effects of products on people’s behavior—specifically, the likelihood that existing users will stop using such products and the likelihood that non-users of tobacco products will start using them. This is especially important for young people. Before products are authorized through the PMTA pathway, the agency reviews tobacco products for their ingredients, ingredients, additives, ingredients, and health risks, as well as how the products are manufactured.
← Older Post Newer Post →