Understanding Nicotine Reduction Strategies for Tobacco Regulation
This information discusses the importance of reducing nicotine content in tobacco products to lower addiction levels and overall harm. It emphasizes the FDA's comprehensive plan for tobacco and nicotine regulation, aiming to shift users to less harmful alternatives. Immediate reduction in nicotine has shown benefits in reducing cigarettes smoked and dependence, leading to increased quit attempts without compensatory smoking. However, concerns exist regarding withdrawal symptoms and non-compliance.
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Nicotine Reduction Strategy Dorothy Hatsukami, PhDi Professor of Psychiatry and Behavioral Sciences Associate Director, Masonic Caner Center University of Minnesota
Disclosures Funding from NIDA, NCI and FDA None of my comments reflect the opinion of these agencies
FDAs Nicotine Strategy FDA Announcement: Comprehensive Plan for Tobacco and Nicotine Regulation (July 28, 2017) Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources .
Continuum of Risk There is a continuum risk for nicotine-containing products where combusted products are the most toxic Nicotine maintains addiction but other constituents kill people Ultimate goal is abstinence from all nicotine products But for people unable or unwilling to quit, the goal is to shift them to lower risk products COMBUSTIBLES NRT NON-COMBUSTED PRODUCTS Reduce appeal and addictiveness Push
Reducing Addictiveness of Cigarette Immediate reduction in nicotine is the best approach et al., JAMA, 2018 Dose to reduce addictiveness is < 0.4 mg/g tobacco Reduced cigarettes smoked Reduced dependence and urges Increased quit attempts Resulted in no compensatory smoking Reduced CPD, smoke exposure and/or dependence in vulnerable populations, youth and non-daily smokers. Higgins et al.,, 2020; Cassidy et al., 2018; Tidey et al., NTR, 2019; Shiffman et al., 2018 Hatsukami Donny et al., 2015; WHO, 2019 12.00 10.00 Immedia te Gradual Days Abstinent 8.00 6.00 4.00 2.00 0.00 Week 20
Concerns about Immediate Nicotine Reduction Immediate nicotine reduction is associated with: 10 MNWS total score, Mean 8 6 Greater withdrawal symptoms Gradual Immediate 4 Control Higher drop-out rates 2 Higher non-compliance with using only study cigarettes 0 -91 0 1 2 3 4 8 10 12 14 16 18 20 Week 6 Some smokers will seek other nicotine sources
Continuum of Risk There is a continuum risk for nicotine-containing products Nicotine maintains addiction but other constituents kill people Ultimate goal is abstinence from all nicotine products But for people unable or unwilling to quit, the goal is to shift them to lower risk products COMBUSTIBLES NRT NON-COMBUSTED PRODUCTS
Reduced Nicotine Content vs. Normal Nicotine Content Cigarette plus ANDS Greatest uptake of ANDS in the VLNC group. Greater uptake of non-combusted products was significantly (p< 0.001) associated with: Greater reductions in combusted product use Greater number of days abstinent from combusted products Lower carcinogen exposure Hatsukami et al., Addiction, 2016
Continuum of Risk There is a continuum risk for nicotine-containing products Nicotine maintains addiction but other constituents kill people Ultimate goal is abstinence from all nicotine products But for people unable or unwilling to quit, the goal is to shift them to lower risk products COMBUSTIBLES NRT NON-COMBUSTED PRODUCTS Regulate
Supporters Harm Elevating Uptake among youth Effects on the developing brain Gateway to combusted product use Dual use is common Harmful to health Harm Reducing Disruptive technology shifting smokers away from cigarettes Regulations to promote shift
Opposers Harm Elevating Uptake among youth Effects on the developing brain Gateway to combusted product use Dual use is common Harmful to health Harm Reducing Reduced toxicant exposure Cessation of combusted Products Emerging evidence of efficacy
Evaluation of ENDS After Devaluing Cigarettes to Promote Switching but Prevent Uptake among Non-users Toxicity: Minimize toxicity Appeal: flavors (only tobacco and menthol); Addictiveness: cap on nicotine Communication: Relative risk of the product
Continuum of Risk There is a continuum risk for nicotine-containing products Nicotine maintains addiction but other constituents kill people Ultimate goal is abstinence from all nicotine products But for people unable or unwilling to quit, the goal is to shift them to lower risk products COMBUSTIBLE S NRT NON-COMBUSTED PRODUCTS Innovate March 2, 2016 | SRNT Pre-Conference Mitch Zeller (Modified)
Continuum of Risk There is a continuum risk for nicotine-containing products Nicotine maintains addiction but other constituents kill people Ultimate goal is abstinence from all nicotine products But for people unable or unwilling to quit, the goal is to shift them to lower risk products COMBUSTIBLE S NRT NON-COMBUSTED PRODUCTS Reduce addictiveness Regulate Innovate Rapid elimination of combusted products Reduce gateway effect and dual use Reduce uptake among youth; promote uptake in smokers Assure non-combusted products are reduced risk Provide smokers with NRT that are more effective
Controversies Smacks of prohibition Not banning cigarettes Other less harmful nicotine containing products are available Limiting continued use of a highly toxic product Shifting smokers could occur without a draconian measure Shifting will occur faster, preventing many more lives lost (i.e., herd immunity vs. vaccine) Non-supporters of e-cigarettes are going to come to their senses with increasing evidence of less harm Reassurance that we are not creating another generation of nicotine addicted individuals
8.5 million tobacco related deaths would be averted by 2100 if a nicotine product standard was implemented in the U.S. alone. Apelberg et al., NEJM, 201
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