Th The P Pot otenti tial I Impact of ct of Nicoti otine R - - PowerPoint PPT Presentation

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Th The P Pot otenti tial I Impact of ct of Nicoti otine R - - PowerPoint PPT Presentation

Dec 30, 2023 180 likes •319 views

Th The P Pot otenti tial I Impact of ct of Nicoti otine R Reducti ction Eric C. Donny, Ph.D. Professor, Departments of Physiology and Pharmacology & Social Science and Health Policy Director, Tobacco Control Center of Excellence

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SLIDE 1

Th The P Pot

  • tenti

tial I Impact of ct of Nicoti

  • tine R

Reducti ction

Eric C. Donny, Ph.D. Professor, Departments of Physiology and Pharmacology & Social Science and Health Policy Director, Tobacco Control Center of Excellence Wake Forest School of Medicine

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SLIDE 2

Disclosure

  • This work was supported by the National Institute on Drug Abuse and

Food and Drug Administration Center for Tobacco Products (U54 DA031659). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or the Food and Drug Administration.

  • I have received honoraria from the World Health Organization, Food

and Drug Administration, Campaign for Tobacco Free Kids, Truth Initiative, and various universities for work on the potential impact of nicotine product standards.

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SLIDE 3

Family Smoking Prevention and Tobacco Control Act

  • 2009 amendment to the Food, Drug and Cosmetic Act
  • Creating new center to regulate tobacco products (CTP)
  • Public health standard
  • Must consider the risks and benefits to the population as a whole including

users and nonusers

  • Section 907 – Product Standards
  • Can limit nicotine
  • Cannot require reducing nicotine to zero
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SLIDE 4

10 years later…

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SLIDE 5

Let’s dive in…

Top

  • p 6

6 question

  • ns abou
  • ut n

nicot

  • tine reduction

Addressed in 30 seconds each!

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SLIDE 6

How low do you have to go to reduce smoking?

* * *

5.2 and above ↑ 2.4 and below ↓

*indicates significant (p<.0125) difference compared to 15.8 mg/g (controlling for BL)

*

N=839

Donny et al. NEJM. 2015

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SLIDE 7

Should FDA reduce nicotine gradually or rapidly?

5 10 15 20 25 Baseline Weeks 1-4 Weeks 4-8 Weeks 8-12 Weeks 12-16 Weeks 16-20 Total CPD Gradual Immediate Control Hatsukami et al. JAMA. 2017

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SLIDE 8

Could people be exposed to more toxicants because they smoke more intensely?

Hatsukami et al. JAMA. 2017

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SLIDE 9

Will it make it easier for smokers to quit?

Hatsukami et al. JAMA. 2017

Immediate reduction increased

  • dds of abstinence

at Week 20 (OR: 3.22)

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SLIDE 10

Will it reduce the likelihood that kids smoke?

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Won’t this just lead to a massive illicit market?

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SLIDE 12