The document discusses tobacco harm reduction strategies proposed by a tobacco company. It summarizes research conducted or funded by the company suggesting lower-risk tobacco and nicotine products could reduce smoking-related diseases. It advocates introducing these products and allowing consumer choice while continuing strong warnings. Public health advocates argue reduced-risk products may delay quitting or increase dual use without actually reducing overall harm.

1. Can We Make Tobacco History
in our Life Time?
Gregory N. Connolly, D.M.D., M.P.H.
Harvard School of Public Health
November 29, 2012

2. Disclosure
I recently resigned my position at Harvard School of
Public Health to become a Senior Scientific Advisor to
a global consumer product manufacturer

3.  My decision was based on a growing realization
that a free market that maximizes individual free
choice with minimal government interference is
best able to benefit society and reward those
who contribute most.

4.  Just Ask the People What does Government
Best?
 Selling Power Ball Tickets?
 Regulating the Market Place?
 Reducing Poverty?

5. Steve Jobs sold products: Style, High Tech and Utility
It’s the Product Stupid
Apple, 1984 Apple, 2012

6. “Our company’s strategic priority is to develop,
assess and commercialize products that can
reduce the health risks of smoking on an
individual and population basis. These are New
Growth Products or “Safer Cigarettes”. These
products have the potential to be the greatest
innovation in the industry.”

7. Our new growth products efforts are guided by the
following key objectives:
“Our first objective has been to develop a series of
products that provide adult smokers the taste,
sensory experience and smoking ritual
characteristics that are as close as possible to those
currently provided by conventional cigarettes.”

8. Trends in Per Capita Consumption of Various
Tobacco Products – United States, 1880-2004 and
Linear Projection to 2035
16 Cigarettes Cigars Pipe/Roll your own Chewing Snuff
14
12
10
POUNDS
8
6
4
2
0
1880
1885
1890
1895
1900
1905
1910
1915
1920
1925
1930
1935
1940
1945
1950
1955
1960
1965
1970
1975
1980
1985
1990
1995
2000
2005
2010
2015
2020
2025
2030
2035
YEAR
Source: Giovino GA. Am J Prev Med 2007;33(6S):S318–S326.

9. Source: PM Investor Day, June 21, 2012

10. “We are very encouraged by the meeting (with the
Center for Tobacco Products with the Food and
Drug Administration) and although several details
still need to be discussed, we remain comfortable
with our current risk assessment approach.”

11. Trends in Per Capita Consumption of Various
Tobacco Products – United States, 1880-2004 and
Extremely Undesirable Projection to 2060
16
Cigarettes Cigars Pipe/Roll your own Chewing Snuff
14
12
10
POUNDS
8
6
4
2
0
1880
1885
1890
1895
1900
1905
1910
1915
1920
1925
1930
1935
1940
1945
1950
1955
1960
1965
1970
1975
1980
1985
1990
1995
2000
2005
2010
2015
2020
2025
2030
2035
2040
2045
2050
2055
2060
YEAR
Source: Giovino GA. Am J Prev Med 2007;33(6S):S318–S326.

12. “We are opting for one or two Greenfield facilities in Europe”
“…we envisage marketing our NGPs under our existing major
trademarks such as Marlboro.”
“…we expect the first factory to be ready in 2015 or 2016 final data
from clinical studies during the beginning of 2016 and a launch in
the first markets between 2016 and 2017.”
However we still must respect fundamental choice of individuals to
decide and let them choose and move the market to a safer one

13.  Until consumers accept an FDA approved
Modified Risk Product like our NGPs we have
as an interim Smokeless tobacco to let free
choice move the market to a safer one
 Some scientist who receive “independent”
grants from us see a 95% reduction. The
Swedish experience shows it can happened
 We now have Verve!!

14. Smokeless Tobacco as an Approved
FDA Modified Risk Product
 Data suggests Swedish Match has lower levels of lung
cancer among males where use rates are high and
smoking rates low
 Standards exist for lowering toxins in Swedish Snuss far
lower than its concentrations in moist snuff
 Hard core inadvertent adult smokers who cannot quit
should be given the choice for reducing harm
 Continuum of risk exists among tobacco products with
cigarettes highest, Moist Snuff middle and Snuss lowest.

17. Our Response to Infant Poisoning 45
“For instance, in 2007 the total number of
reported pediatric exposures for cosmetics was
172,541 compared with only 6,724 pediatric
exposures for tobacco.”
(Source: RJRT Submission on Impact of Dissolvable Tobacco Use
on Public Health to TPSAC, Food and Drug Administration, September 2010)
G.R. Krautter, & M.H. Abdelhameed, Clinical and Pharmacokinetic (PK) Characteristics of an
Orally Ingested Tobacco Pellet (2007)

19. VERVE: Our “Much” Safer New Nicotine Chewing Gum
Verve is a nicotine chewing gum we are test marketing in Richmond
with very low levels of toxins thus greatly reducing the risk of
many smoking related diseases
Although the amount and type of nicotine is a trade secret , we
have provided our consumers with very strong warnings:
“This product is addictive, can harm your baby if you are pregnant
and can increase your risk to heat disease, aggravate diabetes, etc.”
Verve has child proof packaging to prevent poisoning !!!!!

20.  WE Designed Verve “Voluntarily” to Make It
the Package Safe from Child Poisoning
 Let Me Show You

22. You Can be Part of the Solution!
You can help us! Together we can eliminate tobacco disease with
NGPs and “safer” SMOKELESS
Stop Fighting over Menthol and Give Freedom to the Black Smoker
to Decide
Provide funds to support research and attempts not to have
cigarettes sold to children or help tobacco users quit
Our power is too great not to accept this offer!

23. Multinationals Profits vs National GDPs
25,000
$19,817 $19,870
20,000
Millions of Dollars
15,000
32 of the
lowest income 4 TTTCs
10,000
nations
5,000 $3,890
Total Budget
0
Total GDP Profits WHO Budget
Total GDP is inclusive of 32 nations: Tuvalu, Montserrat, Nauru, Kiribati, Marshall Islands, Anguilla, Sao Tome and Principe, Palau, Cook Islands,
Micronesia (Federated States of), Tonga, Dominica, Comoros, Saint Kitts and Nevis, Samoa, Solomon Islands, United Republic of Tanzania: Zanzibar,
Saint Vincent and the Grenadines, Vanuatu, Grenada, Timor-Leste, Guinea-Bissau, Liberia, Micronesia, British Virgin Islands, Seychelles, Gambia, Somalia,
Antigua and Barbuda, Djibouti, Saint Lucia, and Turks and Caicos Islands.

24. For Countries Who Are Not
Ready For Safer Cigarettes
 We are an international Company competing
with the Japanese, British and now the
CHINESE!!!!! Your best bet is America!!!
 We need to make a profit for our Shareholders
State Pension Funds, Colleges, Health Insurance
Companies. All of You will be affected.
 We sell the superior America Marlboro with
more taste and pleasure and their Light!!!
 They’ll smoke anyways why not ours???

25. Female Smokers
“The number of Indian female smokers eclipsed those of
China by 2007, growing by 31% between 2006-2011.”
The kinds of innovations in place to cater to this growing
consumer base include super slims – longer, thinner
cigarettes… often with a charcoal filter for a smoother smoke,
and packaged in so-called “purse packs”…sometimes in
colors…coordinate with outfits or mood.”
Source: Euromonitor June 2012

26. Filter and Menthol Innovation
Role Filter Innovation
Much of the “added value” NPD activity centers around the filter, as it is here that
the flavour and any reduced chemical load or odour and enhanced product taste are
manifest.
Source: Euromonitor June 2012

27. Marlboro Filter
Flavor Plus

29. Our Response to FDA
“
’Our company is” opposed to regulations
that are extreme in nature and are not
evidenced based. These include plain
packaging, health warnings covering most
of the pack, display bans and bans on the
use of all ingredients.”
Remarks from our CEO

32. Smokeless Tobacco Warning
Labels in the US
-Must cover 30% of the two principle sides of package
-4 rotating warnings

33. Federal Tax Rates on Tobacco Products (2009)
Previous Tax SCHIP 2009 (New Tax) Tax Increase % Increase % of the Tax on a Cigarette Pack
Cigarettes (20) $0.39/pack $1.01/pack $0.62/pack 158% 100%
Small Cigars (20) $0.04/pack $1.01/pack $0.97/pack 2653% 100%
RYO Tobacco (20) $0.04/pack $0.80/pack $0.76/pack 2159% 79.21%
Snuff (1.2 oz.) $0.04/tin $0.11/tin $0.07/tin 158% 10.89%
Chewing Tobacco (2.5 oz.) $0.03/pouch $0.08/pouch $0.05/pouch 158% 7.92%
Source: United States Department of Treasury, Alcohol and Tobacco Tax and Trade Bureau. http://www.ttb.gov/main_pages/schip-summary.shtml -
December 14, 2009
Note: 20 RYO Cigarettes = 14.5g of Tobacco (0.51 oz)

34. Current Use of Flavored Smokeless by Users of Smokeless
Tobacco Products - 2010
Maryland Public High School Youth
100%
90%
80%
68.9%
70%
61.1%
60%
50%
40%
30%
20%
10%
0%
High School Middle School
Source: Maryland Department of Health and Mental Hygiene, Youth Tobacco Survey – Fall 2010. Current smokeless tobacco use is any use of any smokeless tobacco
product during the 30 days prior to the survey.

35. 32
“The Government has proven that the
Enterprise [Tobacco Industry] knowingly
and intentionally engaged in a scheme to
defraud smokers and potential smokers,
for purposes of financial gain, by making
false and fraudulent statements,
representations, and promises.”
United States District Court For the District of Columbia. United States of
America et al, v. Philip Morris USA Inc., et al. Final Opinion: August 17, 2006. Civil
Action No. 99-2496 (GK).

36.  But What Do You Tell the Kids!!
 Read What the FDA Scientific Advisory
Committee has to Say about US
 We Would Like to Thank our Non Voting
Members for their Collegial Scientific Input into
Our Menthol Report!!!

37. A Jeffersonian View of a Citizens Role in
Governance
A
My typical day at work on tobacco control

38. 31
 Over the past few years, the cigarette
industry has acquired the smokeless
tobacco industry dramatically changing the
incentives for product design and use;
Combined use? Maintenance of smoking?
Initiation?

39. Smokeless Tobacco is a Very
Serious Public Health Problem
Smokeless Tobacco Causes
 Periodontal disease
 Oral Mucosal lesions
 Oral and pancreatic cancer
 Low birth weight
 CHD
 Addiction
 Extremely high levels of heavy metals may contribute
to unknown systemic diseases

40. 34
Industry Intent on Use
 “RJRT designed Camel dissolvable tobacco products to
complement its current product offerings for adult
tobacco consumers who may have an interest in using,
or switching to, new smokeless tobacco product.
(Source: RJRT Submission on Impact of Dissolvable Tobacco Use on Public Health to TPSAC, Food and Drug
Administration, September 2010)
 RJR: Oral tobacco is an expansion of choice
 PM USA: Oral tobacco is an adjacency product

41. Snus Free Nicotine (mg/g)
6.00
5.00
4.00
3.00
2.00
1.00
0.00
Taboka Camel Camel Camel Marlboro Marlboro Marlboro Marlboro Marlboro
Snus Snus Snus Snus Snus Snus Snus Moist
Original (OH) (WVa) Spice Rich Mild Mint Snuff
(TX/OR)

42. 35
Use of Snus -Sweden-
 Has not reduced current occasional smoking
 Among adolescents reporting current use of oral snuff,
71% also smoked (same as US)
 20% of male current smokers also used moist snuff
 Overall rate of cigarettes in Sweden is 25%
 higher than Canada, US or Australia
 has fallen by less over the last decade
Swedish Tobacco Control 2006. Progress & Challenges- both are greater than ever. Swedish Network for
Tobacco Prevention
WHO IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Vol.89:Smokeless
Tobacco and Some Tobacco-specific N-Nitrosamines. 2007. IARC Monographs Vol. 89. ISBN 978
92 832 1289 8

43. 36
Oral Tobacco -Norway-
 Males 16-24
 Prevalence of daily or occasional snuff use
 1985: 9%
 2004/5: 33%
 Prevalence of daily smoking
 1983: 28%
 2001: 32%
 Increase in snuff not accompanied by less smoking
WHO IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Vol.89:Smokeless Tobacco and
Some Tobacco-specific N-Nitrosamines. 2007. IARC Monographs Vol. 89. ISBN 978 92 832 1289

44. 37
Percentage of US High School Students, by Sex, Who Reported
Current Smokeless Tobacco Use,* 1995-2009
25 Total Male Female
19.7
20
15.8
14.8 15
14.2 13.6
15 13.4
Percent
11.4 11
9.3 8.9
10 7.8 8.2 8 7.9
6.7
5
2.4 1.9 2.2 2.2 2.3 2.2
1.5 1.3
0
1995 1997 1999 2001 2003 2005 2007 2009
Year
Source: National Youth Risk Behavior Surveillance Surveys, 1995 – 2009
* Used chewing tobacco, snuff, or dip on  1 of the 30 days preceding the survey

45. Percentages of Cigarette Use among Past Month
38
Smokeless Tobacco Users, by Age Group:
2002 to 2009 –USA-
Source: SAMSHA, 2002-2009
NSDUHs

46. 40
Dissolvables Health Effects
•Infant Child poisoning
•Youth Initiation
•CHD (Heavy Metal, Nicotine)
•Cancer (TSNAs, Heavy Metals, PAHs)

47. Using the “Smokeless” Argument to Invent
New Nicotine Drug Delivery System
(.6 – 3.3 mg/unit)

48. Lethal Nicotine Poisoning 43
Dosages
Toxicology
Estimated lethal pediatric dose of nicotine is 1.0 mg - 1.4 mg / kg body
weight
Average body weight of an infant one year old is 22.7 pounds, or 10.3 kg.*
Lethal dose for an infant one year old, of average body weight, is 10.3 – 14.4
mg.
Novel Dissolvable Tobacco Product Estimated Lethal Dose
Camel Orbs (1 mg nicotine per pellet)* 10 – 15 pellets
Camel Sticks (3.1 mg nicotine per 3 - 5 sticks
stick)*
Camel Strips (0.6 mg nicotine per 17 – 24 strips
strip)*
*conservatively high estimate
* Per manufacturer’s promotional literature

49. FDA Tobacco Product Authority
-Standard setting for existing or substantially equivalent
tobacco products. Burden is on FDA to make a finding
with likely legal challenge (menthol)
-New tobacco products introduced after 2/15/2007 with
no substantially equivalent predicate tobacco product;
burden on industry to demonstrate
-Modified risk tobacco products that make a claim the
burden is on industry to show risk reduction

50. SLT: Population Impact
 Initiation: Graduation strategy to promote youth
addiction and only male adolescents have shown
a significant increase in use paritcularly flavored
products
 Maintenance: Industry is actively promoting
Snuss as a way to arrest the decline in cigarette
sales through dual use
 There is science to support Swedisn Toxin level
reduce risk

51. US Tobacco’s Dose-Controlled
“Graduation Strategy”
COPENHAGEN
SKOAL SKOAL/KEY
WINTERGREEN NATURAL
GRADUATION PROCESS
GRADUATION PROCESS
SKOAL SKOAL SKOAL SKOAL
LONG CUT LONG CUT LONG CUT LONG CUT
WINTERGREEN MINT MINT NATURAL
HAPPY DAYS MINT HAPPY DAYS HAPPY DAYS
LONG CUT SWEET NATURAL
LONG CUT LONG CUT
SKOAL SKOAL SKOAL SKOAL
BANDITS BANDITS BANDITS BANDITS
WINTERGREEN MINT SWEET NATURAL
Source: Marsee vs. UST. UST Document No. 12017104. Court Exhibit No. 100.

53. Dual Users are a Big Driver of
Current MST Growth
 “Based on our research, we believe the bulk of
smoker migration into MST is coming from dual
users (consumers that dip and smoke). We
estimate that about 30% of dippers also smoke.
The proliferation of smoking bans has
effectively increased the number of dipping
occasions.
Source: UBS Research, 2007, Nat’l Tobacco Incidence Study [UST]

54. TSNAs: Snus vs. Moist Snuff (ng/g)
18000
16000
14000
12000
10000
8000
6000
4000
2000
0
Taboka PM Camel Snus Marlboro Marlboro Marlboro Marlboro Marlboro Marlboro Marlboro Marlboro
(Texas) SNUS Rich SNUS Mild SNUS Spice SNUS Mint Fine Cut Long Cut Fine Cut Long Cut
Original Original Wintergreen Wintergreen
Mg/g

55. Olalekan Ayo-Yusuf, B.D.S., M.Sc., D.H.S.M .

57. Facebook
Does Baking Soda Give You a Buzz?
 “Baking Soda is basic and it opens up the pores in ur lip and
gum allowing for more nicotine if u want a buzz tha’s an easy
way.”
Does one cut the webbing in their foot so you can
still get the satisfaction during school?
 “All u gotta do is cut urself between your big and second toe,
then pack it like u would ur lip, throw a sock on and u have
descreet enjoyable dippin.”

58. The Bottom Line for Health or
Public Health Professionals
“To recommend use of a cancer causing, addictive product in lieu
of smoking while safe approved cessation medications exist raises
professional, ethical and liability questions and may violate the
oath to do no harm.”

59. Snus & NRT Annual Dollar Sales
(2003-2007)
2003 2004 2005 2006 2007
FDA- $437,482,997 $444,561,898 $477,086,467 $496,640,220 $501,806,178
Approved
NRT
Snus $0 $15,239 $14,300 $34,349 $32,773
Source: AC Nielsen ScanTrak, including sales in US food stores with at least $2 million in annual sales, US
drug stores with at least $1 million in annual sales and all US mass merchandisers, with the exception of
WalMart.

60. FDA Authority
•Directive-Controls behavior of
manufacturing
•Gatekeepers-Defines debate, agenda while
keeping he gate closed
•Conceptual-Ability to shape concepts and
standards

61. FSTCPA Challenge
Freezing Innovations?
 No new products should be allowed into the
market unless they reduce public health impact .
Exempt are Substantially Equivalent products
with a predicate (like) product in market as of
2/15/07.
 The key to is success is an FDA restrictive not
permissive definition of substantially equivalent
that can survive a legal challenge

62. Camel 1917 Camels 2010

64. Submissions to the FDA for Substantially Equivalent (SE), 33
New and Modified Risk Products (MRTPs)
(up to April 2011) (A Clear Definition of Dissolvables is Needed)
Application 4/11
SUBSTANTIALLY
EQUIVALENT
3,661
NEW
0
Products
MRTP Products
16
Source: Food and Drug Administration, June 2011

65. Substantially Equivalent to What?
-Section 905(j)
Predicate Product or Predicate Product

66. The Family Smoking Prevention and
Tobacco Control Act
The states gave the federal government authority due to
the lack of state resources of expertise to regulate
tobacco products
Highly centralized, non-transparent rule making body
A body that must maintain strict neutrality as would a
court of law while subject to political realities of an
administrative agency
CAN WE WAIT FOUR MORE YEARS ????

68. Local Tobacco Control Must
Remain as Locus of Tobacco
Reduction in America
-The environment has changed and we must use our local authority
wisely and courageously and to set moral limits on the tobacco
market. Demand Federal and FDA accountability and involve our
federally elected officials to do so!
--Stick to our strengths! Level the playing field between cigarettes and
SLT: Taxes, Prohibiting public use of all tobacco products, local
public education, well funded program
Avoid issues of federal preemption in the FSTCPA and issues of
restricting speech

70. Like SHS We Need a New
Effective Local Interventions
 Licensing of Retail Outlets (Constitutional)
 Limit the Number of Licenses as with Alcohol
 Limit Location (schools), Density as Retailers
Close, Age of Entry(adults only) and Products
Sold
 Products: No Flavored Products, Require Child
Proof Packaging (2015), 18 years after
enactment (2030) allow sale of non initiating
prodcuts

72. “A Tiny Ripple of Hope”
“Each Time a Man Stands up for and Ideal
or acts to improve the lot of others or strike
out at injustice, he sends forth a tiny ripple
of hope, and crossing each other from
a different centers of energy builds
a current that can sweep down
the mightiest”
Robert Kennedy 1986 South Africa

73. "They can crush a few flowers, but they cannot hold back the springtime."
Sister Pat Farrell, Leadership Conference of Women Religious August 2012