FDA Announces Plans for Proposed Rule to Reduce Addictiveness of Cigarettes and Other Combusted Tobacco Products

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The Biden-Harris Administration published plans for future potential regulatory actions on Tuesday, including the Food and Drug Administration’s plans to develop a proposed product standard establishing a maximum nicotine level to reduce the addictiveness of cigarettes and certain other combusted tobacco products. The possible purpose of the rule would be to minimize teenage usage, addiction, and mortality.

Every year, 480,000 individuals die prematurely as a result of a smoking-related disease, making tobacco use the biggest avoidable cause of disease and death in the United States. Tobacco usage also costs about $300 billion each year in direct health care and lost productivity.

While nicotine itself does not make smoking cigarettes so harmful, it is the substance that makes it so difficult to stop. The primary cause of continued use of these goods is an addiction to the nicotine included in combusted products. In reality, more than half of adult smokers make a genuine attempt to stop each year (giving up cigarettes for at least a day), yet most of them fail because cigarettes are so addicting. If such a product standard were to be developed, followed by a careful review procedure, it would render such items either marginally or completely non-addictive.

“Nicotine is powerfully addictive. Making cigarettes and other combusted tobacco products minimally addictive or non-addictive would help save lives. The U.S. Surgeon General has reported that 87 percent of adult smokers start smoking before age 18, and about two-thirds of adult daily smokers began smoking daily by 18 years of age. Lowering nicotine levels to minimally addictive or non-addictive levels would decrease the likelihood that future generations of young people become addicted to cigarettes and help more currently addicted smokers to quit,”

said FDA Commissioner Robert M. Califf, M.D.

According to a paper by the FDA that was published in the New England Journal of Medicine in 2018, a potential nicotine product standard could prevent more than 33 million people from starting to smoke regularly, reduce the smoking rate to just 1.4 percent, and prevent more than 8 million deaths from tobacco-related illnesses. 12.5 percent of people currently smoke.

The Spring 2022 Unified Agenda of Regulatory and Deregulatory Actions, released today, offers a report on the actions administrative agencies are contemplating releasing in the short and long term, and presently contains numerous anticipated prospective regulatory actions pertaining to tobacco products. The dates in the Unified Agenda are not meant to represent an exact estimate of the time required to finish work on a proposed rule or a determination of whether a rule will be adopted.

The FDA continues to concentrate on its regulatory monitoring of electronic cigarettes and other nicotine delivery devices (ENDS). Nearly 6.7 million goods had applications submitted by the deadline of September 9, 2020, and as of now, FDA has acted on nearly 99 percent of those, including issuing marketing denial orders for more than 1 million ENDS devices. Manufacturers and sellers of ENDS products that continue to promote and sell unlawful goods have also received warning letters from the FDA.

The organization is concentrated on swiftly finishing the evaluation of the remaining applications we obtained before the deadline of September 9, with a focus on those goods with a significant market share. Additionally, the FDA has invested significantly in a multimedia e-cigarette public education program that highlights information about the possible harms of e-cigarette use and is targeted at the almost 10.7 million kids aged 12 to 17 who have ever used or are open to trying them.


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