FDA Tobacco Regulation: Opportunity or Diversion for the Next Decade

1
FDA Tobacco RegulationOpportunity or Diversion
for the Next Decade

• Michael Siegel, MD, MPH, Boston Univ. School of
  Public Health
• William T. Godshall, MPH, Smokefree Pennsylvania
• K. Michael Cummings, PhD, Roswell Park Cancer
  Institute
• Alan Blum, MD, University of Alabama

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Detailed Analysis of FDA Tobacco LegislationAn
Accounting of Benefits and Costs

• Michael Siegel, MD, MPH
• Professor
• Boston University School of Public Health

3
Benefit 1

• Stronger Warning Labels

4
Counterargument to Benefit 1

• NONE

5
Benefit 2

• Curtailing of Tobacco Advertising and Marketing,
  Especially Directed at Youths

6
Counterargument to Benefit 2

• THE FIRST AMENDMENT TO THE UNITED STATES
  CONSTITUTION

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Benefit 3

• Disclosure of Tobacco and Smoke Ingredients,
  Additives, and Constituents
• Performance Standards

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Counterargument to Benefit 3

• THE BASIC LAWS OF SCIENCE AND COMMON SENSE

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• LIST A
• Acetaldehyde, Acetic Acid, Acetone, Acetylene,
  Acrolein, Aluminum, Aminobiphenyl, Ammonia,
  Anabasine, Anatabine, Aniline, Argon,
  Benz(a)anthracene, Benzene, Benzo(a)pyrene,
  Benzo(j)fluoranthene, Butadiene, Butane, Cadmium,
  Campesterol, Carbon, onoxide, Carbon Sulfide,
  Catechol, Chromium, Chrysene, Copper, Cyclotenes,
  DDT/Dieldrin, Dibenz(a,h)acridine,
  Dibenz(a,h)anthracene, Dibenz(a,j)acridine,
  Dibenzo(a,l)pyrene, Dibenzo(c,g)carbazole,
  Dimenthylhydrazine, Ethanol, Ethylcarbamate,
  Fluoranthenes, Fluorenes, Glycerol, Hexamine,
  Hydrazine, Hydrogen cyanide, Hydrogen sulfide,
  Indole, Isoprene, Lead, Limonine, Linoleic Acid,
  Linolenic Acid, Magnesium, Mercury, Methane,
  Methanol, Methyl formate, Methylpyrrolidine,
  Naphthalene, Naphthylamine, Neophytadienes,
  Nicotine, Nitric Oxide, Nitrobenzene,
  Nitropropane, Nitrosonomicotine, Nitrous oxide
  phenols, Nomicotine, Palmitic acid,
  Phenanthrenes, Phenol, Picolines, Polonium-210,
  Propionic acid, Pyrenes, Pyrrolidine, Quinoline,
  Quinones, Scopoletin, Sitosterol, Skatole,
  Solanesol, Stearic acid, Stigmasterol, Styrene,
  Titanium, Urethane, Vinyl Chloride, Vinylpyridine

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• LIST B
• Acetaldehyde, Acetic Acid, Acetone, Acetylene,
  Acrolein, Acrylonitrile, Aluminum, Aminobiphenyl,
  Ammonia, Anabasine, Anatabine, Aniline,
  Anthracenes, Argon, Arsenic, Benz(a)anthracene,
  Benzene, Benzo(a)pyrene, Benzo(j)fluoranthene,
  Butadiene, Butane, Cadmium, Campesterol, Carbon,
  onoxide, Carbon Sulfide, Catechol, Chromium,
  Chrysene, Copper, Crotonaldehyde, Cyclotenes,
  DDT/Dieldrin, Dibenz(a,h)acridine,
  Dibenz(a,h)anthracene, Dibenz(a,j)acridine,
  Dibenzo(a,l)pyrene, Dibenzo(c,g)carbazole,
  Dimenthylhydrazine, Ethanol, Ethylcarbamate,
  Fluoranthenes, Fluorenes, Formic Acid, Furan,
  Glycerol, Hexamine, Hydrazine, Hydrogen cyanide,
  Hydrogen sulfide, Indeno(1,2,3-c,d)pyrene,
  Indole, Isoprene, Lead, Limonine, Linoleic Acid,
  Linolenic Acid, Magnesium, Mercury, Methane,
  Methanol, Methyl formate, Methylamineethylchrysene
  , Methylamine, Methylnitrosamino,
  Methylpyrrolidine, Naphthalene, Naphthylamine,
  Neophytadienes, Nickel, Nicotine, Nitric Oxide,
  Nitrobenzene, Nitropropane, n-Nitrosodiethanolamin
  e , n-Nitrosodiethylamine, n-nitrosodimethylamine,
  n-Nitrosoethyl methylamine, Nitrosonomicotine,
  Nitrous oxide phenols, Nomicotine, Palmitic acid,
  Phenanthrenes, Phenol, Picolines, Polonium-210,
  Propionic acid, Pyrenes, Pyrrolidine, Quinoline,
  Quinones, Scopoletin, Sitosterol, Skatole,
  Solanesol, Stearic acid, Stigmasterol, Styrene,
  Titanium, Urethane, Vinyl Chloride, Vinylpyridine

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Benefit 4

• Reduced Risk Products on the Market will Save
  Lives Because They Will Be Documented to Do So
• Prevent Reduced Risk Products from the Market
  Without Substantiation of Health Claims

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Counterargument to Benefit 4

• THE LANGAUGE OF THE BILL ITSELF

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Requirements for Approval Modified Risk
Tobacco Products

• MODIFIED RISK PRODUCTS
• The product will significantly reduce harm and
  the risk of tobacco-related disease to individual
  tobacco users and
• The product will benefit the health of the
  population as a whole taking into account both
  users of tobacco products and persons who do not
  currently use tobacco products.

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Requirements for Approval Modified Risk
Tobacco Products

• REDUCED EXPOSURE PRODUCTS
• Scientific evidence is not available, and, using
  the best available scientific methods, cannot be
  made available without conducting long-term
  epidemiological studies and
• The scientific evidence that is available without
  conducting long-term epidemiological studies
  demonstrates that a measurable and substantial
  reduction in morbidity or mortality among
  individual tobacco users is anticipated in
  subsequent studies.

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Detrimental Effects of Any FDA Legislation

• FDA Stamp of Approval Effect

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Detrimental Effects of Any FDA Legislation

• End of the Problem Effect

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Detrimental Effects of Any FDA Legislation

• End of Meaningful Litigation Effect

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Detrimental Effects of Any FDA Legislation

• Tobacco Company Goodwill Effect

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Detrimental Effects of Any FDA Legislation

• FDA Stamp of Approval Effect
• End of the Problem Effect
• End of Meaningful Litigation Effect
• Tobacco Company Goodwill Effect

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Limitations of FDA Authority in Currently
Proposed FDA Legislation

• Section 907(b)(3) Because of the importance of
  a decision of the Secretary to issue a regulation
  establishing a tobacco product standard banning
  all cigarettes, all smokeless tobacco products,
  all little cigars, all cigars other than little
  cigars, all pipe tobacco, or all roll your own
  tobacco products, Congress expressly reserves to
  itself such power.

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Limitations of FDA Authority in Currently
Proposed FDA Legislation

• Section 907(b)(3) Because of the importance of
  a decision of the Secretary to issue a regulation
  establishing a tobacco product standard requiring
  the reduction of nicotine yields of a tobacco
  product to zero, Congress expressly reserves to
  itself such power.

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Limitations of FDA Authority in Currently
Proposed FDA Legislation

• Section 906(d)(3)(A) No restrictions under
  paragraph (1) may prohibit the sale of any
  tobacco product in face-to-face transactions by a
  specific category of retail outlets.

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Limitations of FDA Authority in Currently
Proposed FDA Legislation

• Section 906(d)(3)(A) No restrictions under
  paragraph (1) may establish a minimum age of sale
  of tobacco products to any person older than 18
  years of age.

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Limitations of FDA Authority in Currently
Proposed FDA Legislation

• Section 906(d)(1) No such regulation may
  require that the sale or distribution of a
  tobacco product be limited to the written or oral
  authorization of a practitioner licensed by law
  to prescribe medical products.

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Limitations of FDA Authority in Currently
Proposed FDA Legislation

• Section 915 In accordance with section 801 of
  title 5, United States Code, Congress shall
  review, and may disapprove, any rule under this
  chapter that is subject to section 801.