Today, the U.S. government unveiled plans for potential future regulatory action, including plans by the U.S. Food and Drug Administration to develop a proposed product standard that would determine maximum nicotine levels to reduce cigarette smoke. and the addictive properties of certain other burned tobacco products. The goal of the potential rule is to reduce teen use, addiction and death.
480,000 people die each year from diseases caused by smoking, making tobacco the leading cause of preventable disease and death in the United States. In addition, tobacco use causes nearly $300 billion in direct medical costs and lost productivity each year.
While nicotine isn't what makes smoking toxic, it is an ingredient that makes quitting very difficult, the FDA said. Addiction to the nicotine in burning products is a major driver of continued use of these products. In fact, more than half of adult smokers make serious attempts to quit smoking (for at least one day) each year, but most are unsuccessful because of the addictive nature of cigarettes. Such a product standard, if proposed and then finalized through a thorough process, would make these products minimal or non-addictive.
"Nicotine is highly addictive," said U.S. Food and Drug Administration Commissioner Robert M. Califf. "Minimizing or not adding cigarettes and other burnt tobacco products will help save lives. U.S. Surgeon General's report says , 87% of adult smokers started smoking before age 18, and about two-thirds of adult smokers started daily smoking before age 18. Reducing nicotine levels to minimum addictive or non-addictive levels will reduce the likelihood of smoking in the future Generations of young people will become addicted to cigarettes and help more currently addicted smokers quit.”
In 2018, a U.S. Food and Drug Administration (FDA) article published in the New England Journal of MedicineExternal Link predicted that potential nicotine product standards could lead to more than 33 million people by 2100 Stop being a regular smoker, with a smoking rate of just 1.4% and more than 8 million fewer deaths from tobacco-related diseases. The current smoking rate is 12.5%.
The Consolidated Agenda for Spring 2022 Regulatory and Deregulatory Actions, released today, provides a report on actions that the Administration has recently and long-term consideration for issuing, and currently lists potential regulatory actions in several plans related to tobacco products; however, The dates in the unification agenda are not intended to be an accurate estimate of when the work required to complete the proposed rule will be completed, nor is it a final decision on whether to propose a rule.
The FDA is also focusing on the regulation of e-cigarettes and other nicotine electronic delivery systems (ENDS). To date, the FDA has taken action on approximately 99 percent of the nearly 6.7 million products that received applications by the September 9, 2020 deadline, including issuing marketing denial orders for more than 1 million end-products. The FDA also issued warning letters to end-product manufacturers and retailers who continue to market illegal products.