Nicotine as a Basis for Tobacco Regulation

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Nicotine as a Basis for Tobacco Regulation

• Neal L. Benowitz, MD
• August 28, 2009

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• Nicotine

• Addictive Tobacco Use

• 1/4 billion deaths

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Nicotine in cigarettes and smokeless tobacco is a
drug and these products are nicotine delivery
devices under the Federal Food, Drug, and
Cosmetic Act. U.S. Food and Drug
Administration Fed. Reg. Vol. 60, No. 155, Aug.
11, 1995
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FDA Regulation of Tobacco Product Characteristics

• Authority to promulgate tobacco product standards
  as appropriate to protection of public health.
• Authority to reduce nicotine yields of the
  product as long as it does not require total
  nicotine to be reduced to zero.

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Making Tobacco Products Less Addictive

• Nicotine is the addictive agent in tobacco
  products
• Tapering drug use is a common approach to
  treating addictions
• Reducing the nicotine content of
  cigarette-tobacco gradually over time proposed to
  lower the level of nicotine dependence

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A NICOTINE THRESHOLD FOR ADDICTION IMPLICATIONS
FOR TOBACCO REGULATIONBenowitz and Henningfield,
NEJM 331123, 1994

• Goal - To prevent nicotine addiction in youth.
• Threshold to establish and maintain addiction
• 5 mg/day.
• Assuming up to 30 cigarettes per day - absolute
  limit of 0.4-0.5 mg nicotine content per
  cigarette.
• Gradual reduction of nicotine content over 10-15
  years.

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Reducing the Addictiveness of Cigarettes
A Nicotine Reduction Strategy
Tobacco
Pharmaceutical Nicotine
NICOTINE AVAILABILITY
Addiction Threshold
0
10
15
20
5
YEARS
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• The extent of nicotine reduction across
  cigarette brands must be uniform

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Characteristics of Reduced Nicotine Content
Cigarettes
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RNC Study Cigarettes Per Day
                                              
         
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RNC Study Plasma Cotinine
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RNC Study Carboxyhemoglobin
                                                
       
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Fagerstrom Test of Nicotine Dependence
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Smoking Cessation4 Weeks after End of Yield
Reduction

• Self-reported 4 (20)
• Cotinine-confirmed 5 (25)

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Conclusions

• Regulation of the nicotine content of cigarettes
  and the use of a nicotine reduction strategy to
  prevent or reduce the level of nicotine addition
  appears to be safe and feasible, at least in the
  short term. Long-term studies are still needed.

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Simulation of the Population Health Impact of a
Proposal to Mandate Nicotine Reduction in
Cigarettes(Tsengs et al, Prev Med 2005, 40170)

• Policy makers would be hard-pressed to identify
  another domestic public health intervention,
  short of historical sanitation efforts, that has
  offered this magnitude of benefit to the
  population.

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Recommendations for the FDA

• FDA should give priority to exploring the
  potential effectiveness of a long-term strategy
  for reducing the amount of nicotine in cigarettes
  and should commence the studies needed to assess
  the feasibility of implementing such an agenda.
• If such a strategy appears feasible, the agency
  should develop a long-term plan for
  implementation of the strategy as part of a
  comprehensive plan for reducing tobacco use.
• (IOM 2007)