Earlier this year, Drs. Ribisl, Hatsukami, Huang, Williams, and Donny authored an important article published last month in the American Journal of Public Health (AJPH) that provides lawmakers and public health officials with strategies to minimize the impact of “illicit markets” that may form when the U.S. Food and Drug Administration (FDA) mandates that all cigarettes sold in the U.S. contain only “minimally or non-addictive” levels of nicotine. In a companion piece, Eric Lindblom, Director of Tobacco Control and Food & Drug Law at the O’Neill Institute at the Georgetown University Law Center in Washington, D.C., characterizes the risk of an illicit market forming as “too small and too weak to justify any further delay in the FDA’s implementation of a strong nicotine-minimizing rule.”
Mr. Lindblom explains that a potential illicit market for nonconforming cigarettes would not seriously interfere with the substantial public health gains from implementing the FDA’s nicotine reduction strategy. Mr. Lindblom asserts: “No other FDA action could do as much to reduce tobacco harms and costs more quickly.” Mr. Lindblom’s comments reaffirm previous research by Benjamin J. Apelberg, Ph.D, et al. as reported in the May 2018 issue of the New England Journal of Medicine, which projected that a reduced nicotine product standard could result in an additional 5 million smokers quitting in the first year alone and up to 13 million smokers quitting within 5 years. The model also forecasts that by the end of the century, 33 million people – mostly youth and young adults – would avoid becoming regular smokers and 8 million fewer smoking-related deaths would occur.
Drs. Ribisl, et al. explain the many reasons why current tobacco control efforts are well-positioned to regulate the reduced-nicotine market planned by the FDA:
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- “… decades of experience in regulating the sales, taxation, and marketing of tobacco products can inform strategies to minimize an illicit market and increase the likelihood of a successful implementation of a reduced-nicotine product standard;”
- “Implementation of a reduced-nicotine standard would be a catalyst creating large economic incentives for manufacturers of e-cigarettes, other non-combusted products, and nicotine replacement therapies to promote their products to eager smokers looking for alternative products;” and
- “strong governance, effective administration, strong control of illicit trade, and strong enforcement and penalties will reduce the likelihood that an illicit market could occur after a reduced-nicotine standard is implemented.”
- “Research on factors that affect both the supply and demand of illicit combusted tobacco products offers valuable lessons for the FDA and other regulators outside the United States considering lowering the nicotine content of combusted tobacco products.”
22nd Century’s proprietary Very Low Nicotine Content (VLNC) tobacco cigarettes contain 95% less nicotine than conventional cigarettes and make feasible the FDA’s nicotine strategy. Since 2011, 22nd Century has supplied millions of VLNC SPECTRUM® research cigarettes to the National Institute of Health for use in numerous independent scientific studies. Collectively, these studies show that smokers who use 22nd Century’s VLNC cigarettes (i) reduce their nicotine exposure and dependence, (ii) smoke fewer cigarettes per day, (iii) experience reduced withdrawal symptoms, (iv) increase their number of smoke-free days, and (v) double their quit attempts.
Following a review of public responses to the FDA’s proposed nicotine reduction rule, the FDA is now preparing a Notice of Proposed Rulemaking (NPRM) with a release scheduled for October 2019. In the NPRM, the FDA will spell out the proposed product specifications and the details for how the FDA will implement its new nicotine reduction rule, including a timetable for national implementation throughout the United States.
The FDA’s actions to minimize the powerful addictive properties of combustible cigarettes are urgently needed. Every year, tobacco use in the United States alone causes more than 480,000 deaths and costs nearly $300 billon in direct health care and lost productivity costs.
“In examining the risks of illicit trade and correctly dismissing them as insignificant in light of the public health benefits represented by VLNC cigarettes, researchers have quashed one of Big Tobacco’s favorite excuses for opposing the FDA’s planned reduced nicotine mandate. We encourage the FDA, public health advocates, and responsible members of industry to move forward with all haste to implement a nicotine reduction strategy that will improve the lives of millions of Americans who smoke, while protecting future generations from the perils of smoking addiction.”
– John Pritchard, Vice President of Regulatory Science for 22nd Century Group.
