FDA Regulation of Menthol in Tobacco
Products
Patricia Kovacevic
Director, Regulatory Affairs & Associate General Counsel
Lorillard Tobacco Company
Presentation before FDLI September 11, 2013 webinar audience
Nothing in this presentation should be construed as forward-looking statements for investment purposes
1
Where are we now?
• Smoking in the U.S. is declining
– The number of cigarettes distributed to wholesalers and
retailers in the U.S. is declining:
• 2008 - 322.6 billion
• 2009 - 290.3 billion
• 2010 - 282.0 billion (1)
• Menthol is safe
– Recognized as a GRAS (Generally Recognized As Safe) ingredient
for use in food and also as a direct food additive by the FDA
– Used in numerous consumer products and drugs: chewing gum,
mouthwashes, nicotine inhalers, etc.
(1) FTC Cigarette Report for 2009 and 2010
2
There is No Correlation Between Menthol Share and
Youth Smoking in the U.S., at the State Level
%
%
30
25
70
Youth prevalence
smoking (LHS)
Menthol share of
market (RHS)
60
50
20
40
15
30
10
20
10
0
0
Hawaii
DC
Maryland
Delaware
Pennsylvania
Mississippi
South Carolina
New York
New Jersey
Michigan
Rhode Island
Virginia
Connecticut
Wisconsin
North Carolina
Georgia
Illinois
Louisiana
Alabama
Florida
Massachusetts
Ohio
Indiana
Tennessee
Arkansas
Missouri
Texas
Nebraska
Nevada
Kansas
Iowa
Minnesota
West Virginia
Arizona
California
Kentucky
Colorado
Washington
South Dakota
New Hampshire
Oklahoma
New Mexico
Alaska
Utah
North Dakota
Vermont
Wyoming
Maine
Oregon
Idaho
Montana
5
Source:
YRBS,
see footnote
2,(YRBS)
and Lorillard
Tobacco
In 2011. Source: Youth
Risk Behavior
Surveillance
System
and Lorillard
TobaccoCompany,
Company shipment volume from wholesale to retail.
shipment
volume
from
wholesale
to
retail
The 2009 YRBS was used for Missouri, Nevada and Pennsylvania. Data for Minnesota were taken from the Minnesota Youth Tobacco and
Asthma Survey 2011; data for California from the County and Statewide Archive of Tobacco Statistics 2010; data for Oregon from Oregon
Healthy Teens 2011; and data for Washington from Washington State Healthy Youth Survey 2010
3
And yet FDA is considering restrictions on menthol
• TPSAC report published March 23, 2011
• FDA issued an Advanced Notice of Proposed Rule
Making (“ANPRM”) on July 24, 2013
– seeking comments on possible product standards and
sale/distribution, marketing/promotion, and other
possible restrictions
– seeking comments on whether restrictions should apply
to other tobacco products beyond cigarettes
• FDA also published its Preliminary Scientific
Evaluation of the Possible Public Health Effects of
Menthol v. Nonmenthol Cigarettes
• 60-day comment period –due Sept. 23, 2013
4
If FDA seeks to establish a product standard . . .
• Must issue Proposed Rule
– Must fairly consider all of the issues required by
Section 907 of the FDCA
– Comment period: at least 60 days
• To promulgate a Final Rule, agency must:
– Consider and respond to comments submitted
– Comply with all other requirements for
promulgating a rule (federalism, environmental
impact, economic impact statement)
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. . . and can only issue the standard based on
“scientific evidence” . . .
• In order to promulgate a product standard on
menthol, FDA must consider “scientific
evidence” concerning:
– Risks and benefits to the population as a whole (users
+ nonusers)
– Likelihood that existing users will stop using such
products;
– Likelihood that new users will initiate using such
products.
• FDA’s Draft Guidance on MRTP applications
establishes standards for the scientific evidence
required to support FDA decision-making
6
. . . and if the standard is appropriate for the
protection of public health
• FDA may adopt a product standard if it
“would be appropriate for the protection of
the public health”
• FDA’s draft guidances on premarket tobacco
product applications (PMTAs) and MRTP
applications provide guidance on the rigorous
studies necessary to meet this standard
7
Currently, science does not support restricting
menthol . . .
“This review of the scientific
evidence, which includes
epidemiology studies, as well as
those of biomarkers of exposure and
harm, smoking topography,
toxicology and chemistry, clearly
demonstrates that smokers of
menthol cigarettes are at no greater
risk of developing smoking-related
diseases than are non-menthol
smokers.”
No Difference
• Epidemiology

• Biomarkers

• Toxicology

• Chemistry

• Smoking
Topography

The Industry Menthol Report, Chapter 3.
8
For example, FDA and even TPSAC Agreed that Additional
Research on the Topic of Initiation is Needed
Overall, there is a paucity of data on this topic... A lack of
data prevents further conclusions on the role of menthol
cigarettes in the initiation of smoking.
- “Menthol and Initiation of Smoking”
FDA draft white paper, published May 23, 2011 in Tobacco
Induced Diseases
In the course of reviewing the evidence related to its charge, TPSAC noted gaps in
understanding of menthol cigarettes and public health that should be addressed with
further research.
…..
Cohort studies of adolescents and young adults should be carried out that follow
participants from experimentation to initiation to dependence. These studies would
provide an improved understanding of the risk for moving across this sequence that is
associated with menthol cigarette availability.
- TPSAC Menthol Report, March 2011
9
. . . and FDA must consider the countervailing effects of
disproportionate menthol regulation
• FDA must also consider “technical achievability” and “countervailing
effects,” including contraband
72% of Current Menthol Sales Would Be
Sold On Black Market
Black Market will be
significant
Estimate from Compass Lexecon Report
Increased youth access
Counterfeit cigarettes
with unknown
ingredients
• TPSAC devoted only 3 out of 231 pages and stated: “FDA would need to assess the
potential for contraband menthol cigarettes as required by the Act”
• To date, FDA has not published evaluations of the countervailing effects of
removing menthol cigarettes from the market
10
FDA Must Consider Many Major Government Bodies that Have
Warned about Contraband Risks
Further, the illicit [tobacco] trade has been linked to
organized crime and violent crime, and poses a serious
risk to our national security.”
- Department of Treasury Report to Congress,
2/4/2010
Law enforcement intelligence reports have indicated that
gangs and other organized crime rings have increasingly
begun to focus their efforts on cigarette trafficking as a
source of revenue. The profit margins on black market
cigarettes are now greater than for cocaine, heroin or
illegal firearms.”
- Report of the Virginia State Crime Commission (SJR 21, 2010)
Banning all cigarettes – or any type of cigarette favored by a large
portion of U.S. smokers – could significantly increase the existing black
market for cigarettes and all the attendant contraband trafficking and
other illegal activity. There is already a sizeable black market for
cigarettes in the United States.”
- United States Trade Representative report to WTO, 11/16/2010
11
Also FDA must consider and study alternatives
before banning menthol
• ANPRM sets forth other possible regulatory actions:
– Sales and distribution restrictions
– Marketing and promotion restrictions
– Limiting/banning other additives that produce a menthol
flavor
– “Stepped approach”
– Other, unspecified actions that may be proposed
• But there is little scientific evidence evaluating any of
these actions
– The scientific record should be developed for such
alternatives before any action is taken
12
In conclusion, Lorillard appreciates that FDA is
pursuing additional research
• FDA must conduct rigorous, prospectivelydesigned, well-controlled studies
• FDA-NIH funded PATH Studies may provide
additional information on menthol over the next
several years
“As a regulatory agency, we can go only as far as the regulatory science
will take us.”
“The bottom line is, we need more information.”
Mitch Zeller, CTP Center Director,
quoted in NYT on July 23, 2013
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