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FDA News Release
Today, the U.S. Food and Drug Administration took additional actions as part of the agency’s work to ensure any electronic nicotine delivery system (ENDS) products available for sale have demonstrated that marketing of the products is appropriate for the protection of the public health.
What You Need to Know
“As a cardiologist, I’ve personally seen the devastating health effects of tobacco use, so I’m highly motivated for the FDA to help reduce death and disability caused by these products,” said FDA Commissioner Robert M. Califf, M.D. “We know that there is a demand among adult smokers to use e-cigarette products to try to switch from more harmful combusted cigarettes, but millions of youth are using these products and getting addicted to nicotine. The balance of these issues was considered by the agency’s career scientists when evaluating the potential marketing of e-cigarette products. They have made great progress and I know they will use the best available evidence with the most robust methods to ensure that products that continue to be marketed are appropriate for the protection of the public health.”
Under the Premarket Tobacco Product Application (PMTA) pathway, manufacturers or importers must demonstrate to the agency, among other things, that marketing of a new tobacco product would be appropriate for the protection of the public health. That statutory standard requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products. The FDA must also consider the likely impact of the products on people’s behavior—specifically, the likelihood that existing users will stop using such products and the likelihood that those who do not use tobacco products will start using such products. This is especially important for youth. Before a product is authorized under the PMTA pathway, the agency reviews a tobacco product’s components, ingredients, additives, constituents and health risks, as well as how the product is manufactured, packaged and labeled.
“Ensuring new tobacco products undergo premarket evaluation by the FDA is a critical part of our work to reduce tobacco-related disease and death,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “For the authorized products, the manufacturer demonstrated that possible benefits to adult smokers outweigh the risk of youth possibly initiating. We are making progress in our review of flavored ENDS, and we will continue to deny marketing of products where the applicant hasn’t provided enough evidence to show that the potential benefit to adult smokers outweighs the considerable risk to youth. We are committed to continuing to take the appropriate actions to protect our nation’s youth from the dangers of all tobacco products, including e-cigarettes, which remain the most commonly used tobacco product by youth in the United States.”
The FDA’s review of the applications for the products authorized today determined that the marketing of the tobacco-flavored products and associated components is appropriate for the protection of the public health. The FDA authorized these tobacco-flavored ENDS products because, among several key considerations, the data submitted by the company and the available evidence show that marketing these products may help addicted adult smokers transition away from combusted cigarettes and reduce their risk of exposure to harmful and potentially harmful toxins compared to combusted cigarettes. At the same time, the data showed there was low risk for non-users, including youth, to use the products. The risk was also low for non-users, including youth, to progress to regular use of the products.
Specifically, available data showed that current tobacco users who used these tobacco-flavored products were more likely to significantly decrease their use of combusted cigarettes and that those who don’t smoke are unlikely to start using these products. Most study subjects decreased the number of combusted cigarettes they smoked each day by greater than 80%, from an average of 13-16 cigarettes per day at screening to 1-2 by day 59. The data also showed that the products produce fewer or lower levels of some toxins, like carbon monoxide, than combustible cigarettes and the products’ abuse liability, or their ability to encourage continued tobacco use, addiction or dependence, was lower than combusted cigarettes.
Additionally, today’s authorization imposes strict marketing restrictions on the company to greatly reduce the potential for youth exposure to tobacco advertising for these products. The FDA will closely monitor how these ENDS products are marketed and will act as necessary if the company fails to comply with any applicable statutory or regulatory requirements, or if there is a notable increase in the number of non-smokers—including youth—using these products.
As evidenced through data collected via the National Youth Tobacco Survey, compared to users of non-tobacco-flavored ENDS products, young people are less likely to start using tobacco-flavored ENDS products. The data also suggest that most youth and young adults who use ENDS begin with flavors such as fruit, candy or mint, and not tobacco flavors. These data reinforce the FDA’s decision today, consistent with past decisions, to authorize the marketing of the tobacco-flavored ENDS products in part because they are not significantly appealing to youth and authorizing these products may be beneficial for individual adult combusted cigarette users who completely switch to ENDS or significantly reduce their cigarette consumption.
The FDA may suspend or withdraw a marketing order issued under the PMTA pathway for a variety of reasons, including if the agency determines the continued marketing of a product is no longer “appropriate for the protection of the public health,” such as if there is a notable increase in youth initiation.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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