August 1, 2022
The US Food and Drug Administration (FDA) announced plans to develop a product standard that would set a maximum nicotine level in cigarettes and associated products to reduce their overall addictiveness and concomitant youth use. According to the release, “Such a product standard, if proposed and then finalized after a thorough process, would make those products minimally or non-addictive.”
“Making cigarettes and other combusted tobacco products minimally addictive or non-addictive would help save lives,” Robert Califf, MD, FDA Commissioner, said. “The US Surgeon General has reported that 87% 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.”
A 2018 FDA paper published in the New England Journal of Medicine projected that a maximum nicotine standard could result in more than 33 million people not becoming regular smokers, a smoking rate of only 1.4%, and more than 8 million fewer people dying from tobacco-related illnesses.
Read the full FDA press release.
Smoking is an independent risk factor for complications ranging from lung function to wound healing to cardiovascular events such as heart attack.
As part of its Strong for Surgery program, which helps prepare surgical patients to experience optimal postoperative outcomes by following evidence-based guidelines and checklists, the American College of Surgeons recommends that patients quit smoking before surgery and during recovery. The reduction of nicotine levels in cigarettes would help patients who smoke quit with less difficulty and lead to fewer smokers overall—a net benefit for overall surgical outcomes.
Also in June, the FDA issued marketing denial orders to JUUL Labs, Inc., for all of its products sold in the US, which effectively bars their commercial sale. In reviewing the company’s tobacco profile in product applications, the FDA determined that the business “lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.” Contemporary studies have suggested that use of JUUL and other e-cigarette devices, which are popular with the youth market, is associated with increased risk of smoking cigarettes and have their own inherent health risks.
However, shortly thereafter, the US Court of Appeals for the DC Circuit entered a temporary administrative stay of the marketing denial order for JUUL Labs, Inc., noting the purpose of this administrative stay is to give the court sufficient opportunity to consider the petitioner’s forthcoming emergency motion for stay pending court review and should not be construed in any way as a ruling on the merits of that motion.
In response, the FDA stayed the marketing denial order in July, determining that there are scientific issues unique to JUUL that warrant additional review. This administrative stay suspends the marketing denial order during the additional review but does not rescind it. However, according to the updated press release, “The stay and the agency’s review does not constitute authorization to market, sell, or ship JUUL products.”
The health effects of e-cigarettes such as JUUL are still under investigation, and there is emerging evidence that rather than acting as an aid to quitting cigarette smoking, these products instead may transition young users to engaging with traditional cigarette smoking. Preventing use of JUUL and other potential products that predict future smoking may be an important addition to a surgical care team’s smoking cessation toolkit.