EFFECTIVE TOBACCO PREVENTION FOR TENNESSEE

1
FDA Regulation of Tobacco Why It Is
Necessary What It Will Mean
Kevin OFlahertyDirector of Advocacy, Northeast
RegionCampaign for Tobacco-Free KidsBuffalo,
New YorkApril 22, 2009
2
Mary Kevin Marina Cay, British Virgin
Islands March 28, 2009
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The Problem
4
Tobaccos Toll in U.S.

• Tobacco is the leading preventable cause of
  death, killing more than 400,000 each year
• Tobacco kills more people than from AIDS,
  alcohol, car accidents, murders, suicides, and
  fires combined
• Tobacco results in 96.7 billion in annual health
  care costs
• Nearly 90 of lung cancer cases, 1/3 of total
  cancer deaths, and 1 in 5 deaths from heart
  disease are tobacco related

5
Tobaccos Toll in U.S.

• 4,000 kids try their first cigarette every day
• Another 1,000 kids become regular daily smokers
  every day one-third will die from
  smoking-related diseases
• 23 of high school students smoke, according to
  CDC
• 28.4 used some tobacco product in the last month

6
The Good Guys
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The Mission of Tobacco Control

• Mission Reduce Tobacco Use Its Toll on Health
  by
• Preventing youth from starting to smoke, dip,
  chew
• Helping tobacco users quit
• Protecting everyone from secondhand smoke
• Reducing harm, if possible, to those who are
  unable to quit

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The Tools of CTFK

• State-Based Initiatives
• Tobacco Taxes
• Smoke-free Laws
• Comprehensive Prevention Cessation Programs
• Coverage for Smoking Cessation Services
• Media Advocacy and Counter-marketing
• Community-based Agents of Change

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Cigarette Tax Rates(cents per pack)State Avg.
is 1.24 Per Pack
WASHINGTON 202.5
MONTANA 170
MAINE 200
NORTH DAKOTA 44
VT199
MINNESOTA 150.4
OREGON 118
VT
IDAHO 57
NH 108
NH
WISCONSIN 177
SOUTH DAKOTA 153
NEW YORK 275
MA
MA251
WYOMING 60
MICHIGAN 200
CT
RI346
CT200
IOWA 136
PENNSYLVANIA 135
NJ2575
NEBRASKA 64
NEVADA 80
OHIO 125
DELAWARE115
UTAH 69.5
IN 99.5
ILLINOIS 98
WV 55
30 VIRGINIA
MARYLAND200
COLORADO 84
KANSAS 79
MISSOURI 17
DC200
87
KENTUCKY 60
CALIFORNIA
NORTH CAROLINA 35
TENNESSEE 62
OKLAHOMA 103
ARKANSAS 115
ARIZONA 200
NEW MEXICO 91
SOUTH CAROLINA 7
GEORGIA 37
ALABAMA 42.5
MS 18
TEXAS 141
36 LOUISIANA
ALASKA 200
HAWAII 260
FLORIDA 33.9
States that have not passed tax increases since
1999
States that have recently passed or implemented a
cigarette tax increase (since 1999)
April 2008
HIs increase to 2.60 per pack will go into
effect on 7/1/2009..
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State Smoke-Free Restaurant and Bar Laws
Restaurants Bars
Restaurants
The Montana and Utah laws extend to bars in 2009.

February 2007
12
Percent of Population Covered By Smoke-Free Laws
(Including Bars)

2009 54
1998 12 CA Law in effect
Includes laws passed by March 2009
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Funding for Tobacco Prevention
States that have funded tobacco prevention
programs at a level that meets the CDCs minimum
recommendation. States that have committed
substantial funding for tobacco prevention
programs (more than 50 of CDC minimum). States
that have committed modest amounts for tobacco
prevention programs (25 - 50 of CDC minimum).
States that have committed minimal amounts for
tobacco prevention programs (less than 25 of CDC
minimum). States that have committed no tobacco
settlement or tobacco tax money for tobacco
prevention programs.
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December 12, 2007
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Tobacco Revenue and Prevention Spending FY
2000-FY 2008
Some totals based on TFK estimates
15
FY 2009 Tobacco Money for Tobacco Prevention
24.6 Billion
8.0 Billion Estimated Tobacco Settlement Revenues
16.6 Billion Estimated Tobacco Tax Revenues
3.7 Billion
670.9 Million
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Recent Trends
17
Adult Smoking Trends1992 - 2004
Adult Smoking Rate
N/A
Year
Data are from the National Health Interview
Survey
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Youth Smoking Trends 1991 - 2005
36.4
34.8
34.8
Youth Smoking Rate
30.5
28.5
27.5
23.0
21.9
19 decline
34 decline
37 decline
Year
Data are from the Youth Risk Behavior
Surveillance Survey (1991-2005)
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Why have declines stalled?

• Still Marketing to Kids Targeting Young Adults
• Still Lying About Their Products
• and Introducing New Ones
• Still Opposing Real Policy Change
• Still Attacking Real Prevention Programs and
  Promoting Phony Ones

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The Big, Bad Industry
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The Tools of Tobacco Companies The 4 Ps of
Marketing

• Price
• Placement
• Promotion
• Product

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Price
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Domestic Cigarette Advertising and Promotional
Expenditures 1998 - 2003(thousands of dollars)
15.15 Billion
12.47 Billion
11.22 Billion
9.59 Billion
8.24 Billion
6.73 Billion
Includes 10.8 Bill. in price discounts
Source Federal Trade Commission Cigarette Report
for 2003
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Impact of Price Discounts

• From 1997 to 2002, the average retail pack price
  of cigarettes increased by nearly 91 percent, and
  youth smoking rates declined by 26.8 percent
  among twelfth graders and 44.8 percent among
  eighth graders.
• From 2002 to 2004, the avg retail pack price
  barely increased at all (only two cents, or .5
  percent) despite a 28 percent increase in state
  cigarette taxes, and youth smoking declines
  slowed markedly - the decline was only 6.4
  percent among twelfth graders and 14 percent
  among eighth graders.

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Price Discounting Minorities
Cigarette prices for premium brands like Marlboro
and Newport are LOWER in low-income communities
and in communities with higher percentages of
African-Americans. While some of this is
clearly attributable to differences in state
tobacco taxes, these differences do not explain
all of the variation.
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Pricing
Recent SCHIP Example
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Placement
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Promotion
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Point of Sale Marketing

• Three-fourths of teenagers visit convenience
  stores weekly
• Point of purchase promotions have increased in
  recent years. Virtually all retail outlets have
  some form of tobacco promotions, and the amount
  of marketing materials per store has increased
  over time.
• There is more interior and exterior tobacco
  advertising in retail outlets in low-income
  communities and communities with larger
  African-American populations.
• Tobacco advertising inside and outside retail
  outlets is greater in states with comprehensive
  tobacco prevention programs. This suggests
  efforts by the industry to counter the
  effectiveness of these programs.

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Who, us????

• The industry continues to claim that they only
  market their product to adult consumers, not
  youth

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Washington DC, April 2006
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Rolling Stone, May 18-June 1, 2006. Courtesy of
trinketsandtrash.org
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InStyle, Cosmopolitan, Elle, Marie Claire, Vogue,
January 2007 Lucky, February 2007.
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Tin of Cherry Skoal (2007)
A former UST sales representative revealed that,
Cherry Skoal is for somebody who likes the
taste of candy, if you know what Im saying.
Juiced Up How a Tobacco Giant Doctors Snuff
Brands to Boost Their Kick, The Wall Street
Journal, 26 October 1994.
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Product
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The Product is Critical

• Manipulated from its rawest form through the
  entire manufacturing process all the way to the
  packaging
• Much more than just tobacco leaves rolled in
  paper, put in pouches, etc.
• Highly engineered and finely tuned Nicotine
  Delivery Devices
• Every aspect thoroughly researched and controlled
  by the tobacco companies, with no government
  oversight or even disclosure
• Products designed to appeal to targets, sustain
  addiction, assuage health concerns, create an
  image
• Design decisions ultimately and exclusively based
  on tobacco company bottom line

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Compounds released from filter pellet of Camel
Twist

• Tetradecane
• Caryophyllene
• Dodecanal
• ß-Cubebene
• ç-Elemene
• a-Caryophyllene
• ?-Muurolene
• Valencene
• a-Candinene
• Pentadecane
• ß-Candinene
• Hedycaryol
• Caryophyllene oxide
• Hexadecane
• 1,4-Methanobenzocyclodecene, 1,2,3,4,4a,5,8,9,12,1
  2a-decahydro-
• Octadecane
• 3,7,11,15-Tetramethyl-2-hexadecen-1-ol
• Eicosane

• a-linalool
• p-menth-1-en-8-ol
• Dodecane
• Decanal
• a-citronellol
• citral
• 1-Decanol
• p-Mentha-1(7),8(10)-dien-9-ol
• Tridecane
• Undecanal
• a-Cubebene
• Limonenediol
• diacetin
• Copaene
• ß-elemen
• Tetradecanal
• Dodecanoic acid, 1-methylethyl ester
• Heptadecane
• Nonadecane

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Select Cigarette Design Features and Intended
Effect
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For Decades, Defendants Have Recognized that
Controlling Nicotine Delivery, in Order to Create
and Sustain Smokers Addiction, Was Necessary to
Ensure Commercial Success
Defendants Researched, Developed, and Utilized
Various Designs and Methods of Nicotine Control
to Ensure that All Cigarettes Delivered Doses of
Nicotine Adequate to Create and Sustain Addiction
Excerpts from U.S. v. Philip Morris USA, Inc., et
al., (Final Opinion) (August 17, 2006)
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RJR document Identified the Specific
Characteristics to Be Used in Developing "New
Brands Tailored to the Youth Market."

• Nicotine level of 1.0- 1.3 mg/cigarette
• Nicotine absorption minimized by holding pH
  down
• Tar content of 12-14 mg/cigarette to achieve
  desired taste and "visible" smoke

• Bland smoke to address low
• tolerance for smoke irritation
• of beginning smokers and inhalers
• Suggests 100 mm "to facilitate
• lighting
• Reasonably firm" rod

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Particle Size Determinant of Tar Nicotine Lung
Penetration
Too Large
.5 - 2 microns
Too Small
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Philip Morris (1950s)

• Paraphrase Insofar as particle size is a
  determinant of lung absorption of smoke, we
  should explore this as a way to reduce lung
  cancer risk
• History shows they did the opposite to
  increase efficiency of nicotine absorption as the
  priority concern over potentially increased lung
  cancer

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It will not kill them as quick or as much
as other brands, Bennett LeBow, CEO, Vector,
Manufacturer of new Omni cigarettes. -- USA
Today 1/11/02
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Keeping Up The Fight
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Ending the Tobacco ProblemA Blueprint for the
Nation
Institute of Medicine, May 2007

• The committee concludes that product regulation
  by the FDA will advance tobacco control efforts
  in the United States and around the world. The
  proposed Tobacco Control legislation embodies
  the principles that should govern the regulation
  of tobacco products in the coming years.

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Presidents Cancer Panel Report
August 2007

• The Panel recommends foremost that the
  influence of the tobacco industry particularly
  on Americas children be weakened through
  strict Federal regulation of tobacco products
  sales and marketing.

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The Need for FDA Regulation

• States can impact price through tax increases,
  minimum pricing laws, etc. and can affect
  placement through regulation of the sale and
  distribution of tobacco products, BUT
• The product that kills the most is regulated the
  least. Food, cosmetics, drugs, and even dog food
  are regulated, but not tobacco
• Tobacco companies are free to manipulate the
  product at will without regard to health and
  without disclosing changes
• Health claims are virtually unregulated as
  evidenced by recent spate of reduced risk
  products
• States are currently preempted by FCLA from
  regulating the time, place, and manner of tobacco
  advertising, so they cannot act
• States have the authority to regulate the tobacco
  product, but few if any have the resources or
  scientific capabilities it would take to oversee
  regulation of tobacco products

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Key Components of FDA Regulation

• Regulates the manufacture of tobacco products
• Regulates the marketing of tobacco products
• Using a Public Health standard, which takes
  into account not just the impact on the
  individual smoker but on encouraging initiation
  and discouraging cessation

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Product Regulation

• For the first time, gives FDA authority to
  regulate tobacco products like it does other
  consumer products
• Does not use safe and effective standard
  because tobacco products are inherently unsafe
• Makes some changes immediately (e.g., bans use of
  terms like light and low-tar) but gives agency
  the authority to react flexibly based on the best
  scientific evidence
• Puts the onus on tobacco companies to prove that
  product changes do not have a negative impact on
  the public health -- taking into account the
  impact on encouraging initiation and discouraging
  cessation
• States will no longer have this authority

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Product Regulation

• Bans fruit or candy flavored cigarettes by
  banning flavors other than menthol that are the
  characterizing flavor
• Gives the agency the authority to ban menthol
• Bans on labels or in advertising terms such as
  light, mild, or low
• Requires stronger, larger warning labels more
  specific warnings covering 30 of the front and
  rear panels of the package and 20 of
  advertisements.
• Gives the agency the authority to revise labels
  including graphic pictures, without going back to
  Congress

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Product RegulationDisclosure

• Requires detailed disclosure to the FDA of all
  ingredients in existing tobacco products
  including product and smoke constituents
• Requires companies to inform FDA of changes to
  the product
• Must provide all industry documents related to
  health, behavioral, or physiological effects
• FDA will publish brand specific lists of harmful
  and potentially harmful ingredients

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Product RegulationPerformance Standards

• FDA can require changes in current and future
  tobacco products to protect public health such
  as the reduction or elimination of harmful
  ingredients , additives, or smoke constituents
• FDA can reduce nicotine levels to any level other
  than zero (only Congress can do that) if it
  determines that this is in the interest of public
  health.

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Product RegulationReduced Harm Products

• Requires FDA approval before the introduction of
  any so-called reduced harm product
• Prohibits explicit or implicit health claims
  unless it can be proven that
• -- the product as actually used by consumers
  will significant reduce disease risk, AND
• -- the product as marketed will benefit the
  health of the population as a whole, taking into
  account any effect on encouraging initiation or
  discouraging cessation
• Requires tobacco companies to conduct post-market
  surveillance on the actual usage of the product
  and report to FDA
• THE BALANCE Prohibit products that do not
  actually reduce harm and claims that result in
  overall harm to public health without serving as
  a bar to the development of products that may
  genuinely reduce harm

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Marketing Regulations

• Puts in place the marketing restrictions in the
  1996 FDA Rule
• Even more important, gives the FDA ongoing
  authority and flexibility to regulate tobacco
  marketing
• And removes FCLA preemption of state marketing
  restrictions, allowing states to regulate the
  time, place, and manner of tobacco marketing
• States retain authority to regulate sale,
  distribution, etc. regardless of age

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Key Elements of FDA Rule

• Requires that the FDAs 1996 Rule, which
  restricted tobacco marketing and sales to youth,
  be republished within one month and take effect
  within one year of enactment of the legislation.
  These rules include
• No outdoor tobacco advertising within 1,000
  feet of schools and playgrounds
• No tobacco brand sponsorships of sports and
  entertainment events
• No free giveaways of any non-tobacco items with
  the purchase of a tobacco product or in exchange
  for coupons or proof of purchase
• No free samples or sales of cigarettes in
  packages that contain fewer than 20 cigarettes
• Limits any outdoor and all point-of-sale
  tobacco advertising to black-and- white text only
• Limit advertising in publications with
  significant teen readership to black-and- white
  text only
• Restrict vending machines and self-service
  displays to adult-only facilities
• Require retailers to verify age for
  over-the-counter sales and provide for federal
  enforcement and penalties against retailers who
  sell to minors.

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Status of Legislation

• House bill (HR 1256) has passed full House,
  awaits action in the Senate.
• Senator Ted Kennedy plans to reintroduce Senate
  version in the next week or two.
• Senate President Harry Reid has placed HR 1256 on
  the Senate Calendar this week.
• This means Senate bill will likely not be heard
  in HELP Committee, action will most likely move
  straight to Senate floor, probably within the
  next 30 days.

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Why Should I Care?

• If you are working on prevention
• New marketing restrictions and new flexible
  authority to limit marketing that appeals to kids
  or deceives consumers
• Bans flavored cigarettes, which we know are more
  popular with young smokers
• Allows oversight of product changes and health
  claims that encourage initiation
• Bans free sampling increasing used to appeal to
  young adults

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Why Should I Care?

• If you are working on cessation
• Bans terms like light, low, and mild that
  we know have discouraged smokers from quitting
• Provides oversight over deceptive claims
• Requires FDA approval of reduced harm products
  with a public health standard, including impact
  on cessation

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Why Should I Care?

• If you are working in policy advocacy
• States have expanded power to regulate tobacco
  marketing
• States retain authority to regulate sale and
  distribution, regardless of age
• States are in no way restricted from continuing
  to pursue policies that are proving successful
  tobacco taxes, smoke-free laws, etc.

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Kevin OFlahertyDirector of Advocacy, Northeast
RegionCampaign for Tobacco-Free Kids
kevin_at_tfk.org 646-919-0469