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

Disclosure

I recently resigned my position at Harvard School of

Public Health to become a Senior Scientific Advisor to

a global consumer product manufacturer

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.

Just Ask the People What does Government

Best?

Selling Power Ball Tickets?

Regulating the Market Place?

Reducing Poverty?

Steve Jobs sold products: Style, High Tech and Utility

It’s the Product Stupid

Apple, 1984 Apple, 2012

“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.”

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.”

Trends in Per Capita Consumption of Various

Tobacco Products – United States, 1880-2004 and

Linear Projection to 2035

0

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YEAR

PO

UN

DS

Cigarettes Cigars Pipe/Roll your own Chewing Snuff

Source: Giovino GA. Am J Prev Med 2007;33(6S):S318–S326.

Source: PM Investor Day, June 21, 2012

“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.”

Trends in Per Capita Consumption of Various

Tobacco Products – United States, 1880-2004 and

Extremely Undesirable Projection to 2060

0

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YEAR

PO

UN

DS

Cigarettes Cigars Pipe/Roll your own Chewing Snuff

Source: Giovino GA. Am J Prev Med 2007;33(6S):S318–S326.

“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

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!!

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.

“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)

Our Response to Infant Poisoning 45

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 !!!!!

WE Designed Verve “Voluntarily” to Make It the Package Safe from Child Poisoning

Let Me Show You

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!

Multinationals Profits vs National GDPs

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.

$19,817 $19,870

$3,890

0

5,000

10,000

15,000

20,000

25,000

Total GDP Profits WHO Budget

Millio

ns

of

Do

lla

rs

32 of the

lowest income

nations

4 TTTCs

Total Budget

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???

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

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.

Filter and Menthol Innovation

Role Filter Innovation

Source: Euromonitor June 2012

Marlboro Filter

Flavor Plus

“

’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

Our Response to FDA

Smokeless Tobacco Warning Labels in the US

-Must cover 30% of the two principle sides of package -4 rotating warnings

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)

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%

Current Use of Flavored Smokeless by Users of Smokeless

Tobacco Products - 2010 Maryland Public High School Youth

68.9%

61.1%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

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.

“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).

32

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!!!

A

My typical day at work on tobacco control

A Jeffersonian View of a Citizens Role in

Governance

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?

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

“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

Industry Intent on Use 34

Snus Free Nicotine (mg/g)

0.00

1.00

2.00

3.00

4.00

5.00

6.00

Taboka Camel

Snus

Original

(TX/OR)

Camel

Snus

(OH)

Camel

Snus

(WVa)

Marlboro

Snus

Spice

Marlboro

Snus

Rich

Marlboro

Snus

Mild

Marlboro

Snus

Mint

Marlboro

Moist

Snuff

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

35

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

36

Percentage of US High School Students, by Sex, Who Reported

Current Smokeless Tobacco Use,* 1995-2009

Source: National Youth Risk Behavior Surveillance Surveys, 1995 – 2009 * Used chewing tobacco, snuff, or dip on 1 of the 30 days preceding the survey

11.4

9.37.8 8.2

6.78 7.9

8.9

19.7

15.814.2 14.8

11

13.6 13.415

2.41.5 1.3 1.9 2.2 2.2 2.3 2.2

0

5

10

15

20

25

1995 1997 1999 2001 2003 2005 2007 2009

Total Male Female

Perc

en

t

Year

37

Percentages of Cigarette Use among Past Month

Smokeless Tobacco Users, by Age Group:

2002 to 2009 –USA-

Source: SAMSHA, 2002-2009

NSDUHs

38

Dissolvables Health Effects

•Infant Child poisoning

•Youth Initiation

•CHD (Heavy Metal, Nicotine)

•Cancer (TSNAs, Heavy Metals, PAHs)

40

Using the “Smokeless” Argument to Invent

New Nicotine Drug Delivery System

(.6 – 3.3 mg/unit)

Lethal Nicotine Poisoning

Dosages

Novel Dissolvable Tobacco Product Estimated Lethal Dose

Camel Orbs (1 mg nicotine per pellet)* 10 – 15 pellets

Camel Sticks (3.1 mg nicotine per

stick)*

3 - 5 sticks

Camel Strips (0.6 mg nicotine per

strip)*

17 – 24 strips

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.

* Per manufacturer’s promotional literature

*conservatively high estimate

43

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

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

US Tobacco’s Dose-Controlled

“Graduation Strategy” COPENHAGEN

SKOAL WINTERGREEN

SKOAL/KEY NATURAL

SKOAL LONG CUT

WINTERGREEN

SKOAL LONG CUT

MINT

SKOAL LONG CUT

MINT

SKOAL LONG CUT NATURAL

HAPPY DAYS MINT LONG CUT

SKOAL BANDITS

WINTERGREEN

SKOAL BANDITS

MINT

SKOAL BANDITS SWEET

SKOAL BANDITS NATURAL

HAPPY DAYS SWEET

LONG CUT

HAPPY DAYS NATURAL LONG CUT

GR

AD

UA

TIO

N P

RO

CE

SS

GR

AD

UA

TIO

N P

RO

CE

SS

Source: Marsee vs. UST. UST Document No. 12017104. Court Exhibit No. 100.

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]

0

2000

4000

6000

8000

10000

12000

14000

16000

18000

Taboka PM Camel Snus

(Texas)

Marlboro

SNUS Rich

Marlboro

SNUS Mild

Marlboro

SNUS Spice

Marlboro

SNUS Mint

Marlboro

Fine Cut

Original

Marlboro

Long Cut

Original

Marlboro

Fine Cut

Wintergreen

Marlboro

Long Cut

Wintergreen

TSNAs: Snus vs. Moist Snuff (ng/g)

Mg/g

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

Facebook

“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.”

Does Baking Soda Give You a Buzz?

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.”

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.

Snus & NRT Annual Dollar Sales

(2003-2007)

2003 2004 2005 2006 2007

FDA-

Approved

NRT

$437,482,997 $444,561,898 $477,086,467 $496,640,220 $501,806,178

Snus $0 $15,239 $14,300 $34,349 $32,773

FDA Authority

•Directive-Controls behavior of

manufacturing

•Gatekeepers-Defines debate, agenda while

keeping he gate closed

•Conceptual-Ability to shape concepts and

standards

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

Camel 1917 Camels 2010

Submissions to the FDA for Substantially Equivalent (SE),

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

Products 0

MRTP Products 16

Source: Food and Drug Administration, June 2011

33

Substantially Equivalent to What?

-Section 905(j)

Predicate Product or Predicate Product

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 ????

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

-

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

“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

"They can crush a few flowers, but they cannot hold back the springtime."

Sister Pat Farrell, Leadership Conference of Women Religious August 2012