Presented by Richard B' Fien, M'D' F'A'C'C'

1
Regulation of Tobacco

• Presented by Richard B. Fien, M.D. F.A.C.C.

2
Cigarette Smoking

• 350,000 to 400,000 premature deaths annually
• The equivalent of two full jumbo jets crashing
  daily with no survivors
• More deaths annually than from AIDS, murder,
  suicide, cocaine, heroin, alcohol, fire, and car
  accidents combined
• More deaths than from any other preventable
  causes of premature death

3
Lung Cancer

• Incidence
• Diagnosed in about 99, 000 men and 78,000 women
  in the U.S. each year
• 86 of pts die within 5 years
• Leading cause of cancer deaths
• Accounts for 32 of all cancer deaths in men and
  25 in women
• Peak incidence occurs between ages 55 and 65
  years

4
Tobacco and Cancer

• Risk of developing lung cancer is 20 times higher
  in heavy cigarette smokers
• One of every three deaths from cancer
• Major risk factor for the development of
  COPD-Emphysema, and heart disease

5
Squamous Cell Ca Obstructing R. Bronchus

• This is a squamous cell carcinoma of the lung
  that is arising centrally in the lung
• It is obstructing the right main bronchus.

6
Large Squamous Cell CA of Lung

• Squamous cell carcinomas are one of the more
  common primary malignancies of lung and are most
  often seen in smokers.

7
Small Cell Anaplastic Carcinoma of the Lung

• Arising centrally in this lung and spreading
  extensively is a small cell anaplastic (oat cell)
  carcinoma.
• The tumor seen here has caused obstruction of the
  main bronchus to left lung so that the distal
  lung is collapsed.

8
The Problem

• Forty seven million persons continue to smoke in
  the United States
• 3000 children become regular smokers every day
• Estimated 1.2 billion people worldwide smoke
  cigarettes, cigars and pipes and expose billions
  more nonsmokers to the carcinogenic chemicals

9
Cigarette Manufacturers

• Do not have to
• Disclose the ingredients in each brand of
  cigarettes
• Tell anyone when they change the blend of
  tobacco, add new ingredients, or add ammonia to
  liberate nicotine in order to increase its effect

10
Cigarette Manufacturers

• Redesigned products and new ingredients do not
  have to be tested to determine the effects of the
  changes on the health of people who smoke.

11
Nicotine Content in Cigarettes
12
History of Tobacco Regulation in the United
States

• More than 100 years ago, the Tennessee Supreme
  Court upheld the conviction of a person for
  selling cigarettes, saying that cigarettes were
  "wholly noxious and deleterious to health
• Their use is always harmful, never beneficial.
  They possess no virtue, but are inherently bad,
  and bad only. They find no true commendation for
  merit or usefulness in any sphere."(Austin V.
  State)

13
At The Turn of the 20th Century

• 14 states outlawed the sale, the manufacture, or
  the possession of cigarettes
• 21 other states had considered such a ban
• 2 states had passed laws that declared cigarettes
  to be narcotics

14
At The Turn of the 20th Century

• Henry Ford and Thomas Edison condemned cigarettes
  and their users in a book entitled The Case
  against the Little White Slaver.
• In the book, Edison wrote that cigarettes produce
  "degeneration of the cells of the brain, which
  is quite rapid among boys
• Unlike most narcotics this degeneration is
  permanent and uncontrollable. I employ no person
  who smokes cigarettes."(Ford, 1914-1915)

15
At The Turn of the 20th Century

• As Cassandra Tate explains in her recent history
  of cigarette smoking and reform movements in
  America,
• "Early reformers described nicotine as both
  poisonous and enslaving.

16
Twentieth Century

• Tobacco Smoke
• Acrolein
• Carbon monoxide
• Arsenic
• Nitrogen dioxide
• Over 4000 other chemicals, more than 40 of which
  are known carcinogens

17
Twentieth Century

• Tobacco kills far more Americans than all the
  substances and products regulated by government
  combined.
• Yet, for nearly half a century after cigarettes
  were scientifically implicated as causing cancer,
  no agency responsible for health and safety ever
  attempted to regulate cigarettes.

18
Twentieth Century

• When a court told the Consumer Product Safety
  Commission to consider such regulation in the
  mid-1970s, Congress amended the relevant
  legislation to exclude tobacco and tobacco
  products.

19
Twentieth Century

• The Occupational Safety and Health Administration
  has consistently avoided regulating exposure to
  tobacco smoke in the workplace, while limiting
  exposure to at least two dozen hazardous airborne
  materials that are emitted in tobacco smoke.

20
Twentieth Century

• When Congress passed the Controlled Substances
  Act in 1970 to prevent the abuse of drugs,
  narcotics, and other addictive substances, the
  lawmakers specifically excluded the most deadly
  addictive substance, tobacco, from the purview of
  the act.

21
Twentieth Century

• Similarly, in 1976, Congress exempted tobacco and
  tobacco products from the definition of "chemical
  substance" in the Toxic Substances Control Act,
  which was intended to "regulate chemical
  substances and mixtures which present an
  unreasonable risk of injury to health."

22
California Tobacco Tax and Health Promotion Act
of 1988

• Approved by voters in 1988
• Increased the tax on cigarettes by 25 cents per
  package and allocated 5 cents of the new tax for
  an anti-tobacco educational campaign
• Resulted in the creation of the largest
  tobacco-control program ever undertaken
• Administered by the California department of
  health services

23
California Tobacco Tax and Health Promotion Act
of 1988

• Aggressive media campaign
• Taxation
• Enforcement of age-restricted sales, and legal
  actions
• Community-based programs which promoted clean
  indoor air and policies designed to foster a
  smoke-free society

24
California Tobacco Tax and Health Promotion Act
of 1988

• Accelerated the downward trend of tobacco
  consumption
• Even among the young, consumption of tobacco
  products has declined, demonstrating the
  effectiveness of all-encompassing tobacco
  control.

25
The California Tobacco Control Program

• Led to significantly larger decreases in the
  prevalence of smoking and in the rate of per
  capita cigarette consumption in California than
  in the rest of the United States

26
Per Capita Cigarette Consumption(USA vs.
California)
27
The California Tobacco Control Program Heart
Disease

• Mortality from heart disease decreased
  significantly more in California than in the rest
  of the USA
• Changes in mortality from heart disease mirrored
  the changes in per capita cigarette consumption
  over time
• Why?

28
The California Tobacco Control Program Heart
Disease

• Associated with 33,300 fewer deaths from heart
  disease between 1989 and 1997 than the number
  that would have been expected if the earlier
  trend in mortality from heart disease in
  California relative to the rest of the United
  States had continued.

29
Age Adjusted Mortality from Heart Disease USA vs.
California
30
FDA Under David Kessler and Tobacco Control
31
1996

• FDA announced that the agency had jurisdiction
  over tobacco and would regulate cigarettes as
  "drug-delivery devices
• Under the federal Food, drug and Cosmetic
  Act(1938) the FDA would have authority to
  regulate tobacco products if they were properly
  classified as articles(except for food) intended
  to affect the structure or any function of the
  body

32
1996

• On August 23, 1996 FDA issued a regulation
  restricting the sale and distribution of
  cigarettes and smokeless tobacco to children and
  adolescents
• This regulation, known as a rule, is considered
  by some as the most far-reaching measure ever
  instituted to reduce the use of tobacco by young
  people.

33
Restricting Access to Tobacco to Minors

• 1.Prohibits the sale of tobacco products to
  anyone under 18 years old
• 2. Requires retailers to check photographic
  identification, such as a driver's license, for
  everyone 26 or under
• 3.Prohibit tobacco vending machines and
  self-service displays, except in facilities, such
  as certain nightclubs, where the management
  ensures that no one under 18 will be present at
  any time

34
Restricting Access to Tobacco to Minors

• 4.Prohibits free samples, kiddie packs, and most
  sales of single cigarettes
• 5.And while permitting mail-order sales, it
  prohibits coupons for cigarettes or smokeless
  tobacco from being redeemed through the mail

35
Reducing the Appeal of Advertising

• 1.Limits tobacco advertising in the media to a
  black-and-white, text-only format
• 2.Advertising in publications read primarily by
  adults or that appears in places frequented only
  by adults is exempt from restrictions
• 3.Outdoor advertising within 1000 feet of schools
  or playgrounds is prohibited

36
Reducing the Appeal of Advertising

• 4.Tobacco companies are not be permitted to sell
  or distribute promotional items, such as
  T-shirts, caps, and sporting goods, that carry
  the brand name or logo of a tobacco product
• 5.Tobacco companies that sponsor sporting or
  other events, race cars, athletic teams, or the
  like will be restricted to using their corporate
  names only.

37
Tobaccos Companies Suit

• The tobacco companies objected and sued the FDA,
  arguing that Congress had not given the FDA
  jurisdiction over their product.
• The industry noted that the FDA had been in
  existence for decades and had never before
  concluded that its authority extended to tobacco

38
Tobaccos Companies Suit

• The industry claimed that Congress could never
  have intended the FDA to have jurisdiction over
  tobacco products because tobacco products are
  inherently dangerous and thus could never meet
  the agencys basic safety standards
• The manufacturers actually claimed that if it had
  the authority, the FDA would legally have to ban
  tobacco products because they are so dangerous

39
Supreme Court Decision

• The Supreme Court, in a five-to-four opinion
  issued in March 2000, agreed with the tobacco
  companies. (FDA v Brown Williamson Tobacco,
  2000)
• Court acknowledged that tobacco products appear
  to fit the statutory definition of the terms
  drug and drug-delivery devices in the federal
  Food, Drug, and Cosmetic Act
• Nonetheless, the Court focused on the years of
  inaction by the agency and the inconsistency of
  allowing an agency charged with protecting the
  public health to regulate a product that is
  inherently dangerous

40
Master Settlement Agreement

• Signed with the tobacco industry in November 1998
• 46 states settled lawsuits in which they sought
  to recover tobacco-related health costs and to
  hold the tobacco companies accountable for
  decades of wrongdoing
• The industry agreed to pay the states 206
  billion over a 25-year period(four other states
  settled their lawsuits separately for a total of
  40 billion)

41
Master Settlement Agreement

• Broad Goals
• 1. Reduce the exposure of young people to tobacco
  marketing by respecting certain limits on tobacco
  advertising
• 2. To generate comprehensive smoking-prevention
  efforts in every state by funding a nationwide
  campaign of public education
• 3. Counteract the effect on children of marketing
  by by the industry

42
Has the Settlement Lived Up to its Promise ?

• In 1999, the year after the agreement was signed,
  the marketing expenditures of the cigarette
  companies actually rose 22 percent to a record
  8.24 billion
• Use of in-store promotions, discounts on
  cigarette brands favored by children, and free
  gifts that appeal to young people skyrocketed
• Advertising in youth-oriented magazines and
  advertising outside retail stores also increased

43
Has the Settlement Lived Up to its Promise

• States have not used the money from the tobacco
  settlement as was intended
• As of June 2001, only five states-Arizona, Maine,
  Massachusetts, Minnesota, and Mississippi were
  funding prevention and cessation programs at the
  minimal level recommended by the CDC
• 14 states are spending less than 25
• Some states, such as Montana, have actually cut
  spending on these programs for fiscal year 2002

44
New Legislation Proposals

• Congress would need to grant the FDA
  comprehensive regulatory authority over tobacco
  that is similar to its authority over other
  regulated products
• New legislation must give the FDA flexibility to
  shift its approach as scientific knowledge and
  experience accumulate and do best to protect the
  public health
• This would be a more appropriate standard for
  tobacco than the standard used for approval of
  drugs and medical devices, which is a reasonable
  assurance that a product is safe and effective

45
New Legislation Proposals

• Broad Goals
• Reduce tobacco use by young persons
• To encourage and help adults to quit smoking
• Reduce the harm caused by the products that
  remain on the market
• Encourage the development of products that reduce
  the health risks for consumers and to determine
  whether these new products are actually less
  harmful than existing products

46
References

• Fee E, Kreiger N Thinking and rethinking AIDS
  Implication for health policy. Int J Health Serv
  1993 23323
• Glantz Leonard, Annas George Tobacco, the Food
  and Drug Administration, and Congress. New
  England Journal of Medicine December 14, 2000
  Volume 343 1802-1806
• Myers, Matthew Protecting the Public Health by
  Strengthening the Food and Drug Administrations
  Authority over Tobacco products. New England
  Journal of Medicine December 14, 2000 Volume
  3431806-1809

47
 References

• Fichtenberg, C, Glantz, Stanton Association of
  the California Tobacco Control Program with
  Declines in Cigarette Consumption and Mortality
  from Heart Disease. New England Journal of
  Medicine December 14, 2000 Volume 3431772-1777
• Austin v. State, 101 Tenn. 563(1898)
• Idem. Cigarette wars, the triumph of the little
  white slaver. New YorkOxford University press,
  1999

48
 References

• Ford H. The case against the little white slaver
  volumes I, II, and III. Detroit Henry Ford,
  1914-5
• Tate C. In the 1800s anti-smoking was a burning
  issue. Smithsonian 1989 20 107-17
• Warner, K. Book Reviews A Question of Intent A
  great American Battle with a Deadly Industry by
  David Kessler. 492 pp. New York, Public Affairs,
  2001

49
References

• Action on Smoking and health v. Harris, 655 F. 2d
  236(DC Cir. 1980)
• Kessler DA, Witt AM, Barnett PS, et al. The Food
  and Drug Administration's regulation of tobacco
  products. N Engl J Med 1996 335988-994

50
References

• Food and Drug Administration et al. v. Brown and
  Williamson Tobacco Corporation et al., no.
  98-1152, 529 U.S. 120 (March 21, 2000).
• Department of Health and Human Services, Office
  on Smoking and Health. The health consequences of
  smoking nicotine addiction a report of the
  Surgeon General. Washington, D.C. Government
  Printing Office, 19887-8. (DHHS publication no.
  (CDC) 88-8406.)

51
References

• Department of Health and Human Services.
  Regulations restricting the sale and distribution
  of cigarettes and smokeless tobacco products to
  protect children and adolescents. Fed Regist
  1996 6144396-44618.