Comment

1724 Massachusetts Avenue, NW
Washington, DC 20036
202-454-5555
www.LegacyForHealth.org

Lawrence G. Wasden, Chair
Attorney General of Idaho
Boise, ID

June 7, 2012

Susan Curry, Ph.D., Vice-Chair
Dean, College of Public Health
Distinguished Prof essor, Health Management and Policy
Univ ersity of Iowa
Iowa City , IA

VIA ELECTRONIC MAIL

Benjamin K. Chu, M.D., M.P.H., M.A.C.P.
Immediate Past Chair
President, Southern Calif ornia Region
Kaiser Foundation Health Plan and Hospitals
Pasadena, CA

Pamela Hyde
Administrator
Substance Abuse and Mental Health Services
Administration
ATTN: Summer King
Room 8-1099
One Choke Cherry Road
Rockville, MD 20857

Donald K. Boswell
President and CEO
Western New Y ork Public Broadcasting Association
Buf f alo, NY

RE: 2013 National Survey on Drug Use and Health (OMB
No. 0930-0110) – Revision

Jonathan E. Fielding, Treasurer
Director Health Of f icer,
Los Angeles County Department of Public Health
Prof essor of Health Serv ices and Pediatrics
Schools of Public Health and Medicine
Univ ersity of Calif ornia, Los Angeles
Los Angeles, CA

Gary R. Herbert
Gov ernor
State of Utah
Salt Lake City , UT
Tom Miller
Attorney General of Iowa
Des Moines, IA

Jeremiah W. (Jay) Nixon
Gov ernor
State of Missouri
Jef f erson City, MO
Charles K. Scott
Wy oming State Senator
Casper, WY
Leticia Van de Putte
Texas State Senator
San Antonio, TX

Cass Wheeler
Chief Executiv e Of ficer Emeritus
American Heart Association
Dallas, TX
Ritney Castine, Youth Board Liaison
Southern Univ ersity
Baton Rouge, LA
Lee Storrow, Youth Board Liaison
Univ ersity of North Carolina at Chapel Hill Alum
Chapel Hill, NC

Cheryl G. Healton, Dr. P.H. Ex-Officio
President and CEO
Legacy

Dear Administrator Hyde:
Legacy appreciates the opportunity to comment on the
2013 National Survey on Drug Use and Health (NSDUH)
Questionnaire. We submit the following comments that
focus on emerging tobacco products, cigar products and
smokeless tobacco products, that reflect similar
suggestions we have made in previous submissions
regarding various NSDUH surveys.
As we have stated previously, the tobacco product
landscape is changing and many novel tobacco products
have found their way to the market. In addition, products
that have been around for decades are undergoing
changes in order to take advantage of the new world where
cigarettes and smokeless tobacco are regulated for the first
time but, for now, other tobacco products are not. In order
for federal, state and local policy makers to develop
policies to protect the public health from the devastating toll
tobacco exacts, particularly on youth, national surveys
must monitor these new tobacco products and the trends in
their use. NSDUH is an important example of a national
study that garners critical information from a wide audience
of both youth and adults. While we have suggested similar
questions for other NSDUH surveys, we maintain that the

2013 survey should contain questions that are on the cutting edge of tobacco control.
First, as the Food and Drug Administration (FDA) implements the Family Smoking
Prevention and Tobacco Control Act (Tobacco Control Act), it is critical that all studies,
whether funded or conducted by FDA or other agencies, be harmonized, so that
information can be compared across studies. In the response we received from the
Substance Abuse and Mental Health Services Administration (SAMHSA) regarding our
previously submitted comments, you indicated that SAMHSA was “in communication with”
FDA. While communication is an important first step, we hope that SAMHSA will go
beyond that and work in concert with FDA in developing the NSDUH questionnaire. We
believe NSDUH should ask questions that better reflect the new tobacco product
marketplace. While we understand the need to maintain trends in surveys, if a survey does
not ask about products that youth and adults are actually using, its utility diminishes.
Considering the immense impact that tobacco has on the nation’s health, we hope that you
will seriously consider asking more detailed questions about tobacco products, particularly
with regard to new tobacco products that have entered the market.
To that end, Legacy suggests the following regarding questions concerning specific
tobacco products.
Cigarettes: The2013 NSDUH questionnaire contains several questions regarding the time
respondents first smoked a cigarette, including age and date of respondents’ first cigarette.
Legacy respectfully suggests that a question be added regarding whether or not a
respondent’s first cigarette was mentholated, a regular flavor cigarette, or if it contained
some other flavor. Research suggests that menthol cigarettes are a starter product among
youth. For example, studies, including previous NSDUH data, show that among smokers,
a disproportionate number of youth and other vulnerable populations smoke menthol
cigarettes.1,2 In addition, a CDC analysis of the 2004 and 2006 National Youth Tobacco
Survey concluded that among established, middle and high school smokers, Newport, a
solely menthol brand at that time, was the second most preferred brand. 3 A study of earlier
NYTS data suggests that menthol cigarettes are a starter product that may be associated
with smoking uptake by youth.4 However, there are few national studies that ask
specifically if the first cigarette used was a mentholated cigarette. Because FDA is
currently reviewing the TPSAC report regarding menthol cigarettes, knowing whether
respondents started smoking with menthol or other flavored cigarettes is of critical
importance, and may be useful to FDA, as well as state and local authorities, in making its
policy determinations regarding menthol and other flavored tobacco products. Similarly, in
the section asking questions about becoming an everyday smoker, it would be helpful to
know if respondents were using mentholated, regular or other flavored cigarettes when they
started smoking every day. We suggest asking such questions for each category of
tobacco product.
Smokeless tobacco: Smokeless products in particular are on the forefront of the
changing landscape of tobacco products. For example, snus is a relatively new smokeless

tobacco product in the United States. In addition, products known as dissolvable tobacco
products may be considered smokeless tobacco by FDA.5 As newcomers to the U.S.
tobacco market, there is a paucity of information on these products. Therefore, it is critical
that national surveys include questions regarding these products in order to get a better
picture of what respondents are actually using. This will also aid FDA as well as state and
local policy makers in making prudent public health policy decisions regarding these
products. We understand from your response to our previously submitted comments that
you want to maintain trend data. This is understandable, but if questions about new
products are not asked, we will not know the extent to which they have infiltrated the
marketplace.
With regard to smokeless products, we suggest adding questions about additional types of
smokeless tobacco, such as dissolvable tobacco or snus. Snus, moist snuff in tea bag-like
packets, may also be addressed in the snuff category. While the 2013 NSDUH does ask
about snuff separately as we advocate, it does not ask about snus products, and no snus
brand names are included in the questions on snuff brand names. SAMHSA should either
add snus and snus brand names to the snuff questions or ask about snus separately from
snuff products.
Additionally, it may be helpful to add brand name prompts into the initial questions
regarding smokeless tobacco products. This can help ensure that respondents understand
which products they are being asked about, and may be particularly helpful with newer
products, such as snus. At the same time, Legacy suggests adding questions about brand
names of other smokeless products, such as snus or dissolvable tobacco.
Finally, Legacy recommends that questions regarding flavors of smokeless products be
added. As we suggested in the cigarette section, it would be valuable to add a question
about the first time respondents used a smokeless tobacco product and whether or not that
product was flavored. In addition, we suggest that a question or questions be added
regarding whether or not the products respondents are currently using are flavored. It may
be helpful to include a list of potential flavors and allow respondents to choose which they
use currently or have used in the past.
Cigars: Legacy has submitted suggestions for changes to NSDUH questions in several
previous submissions to SAMHSA. We reiterate those here. First, because the users and
the usage patterns appear to vary across the different types of cigars, Legacy encourages
SAMHSA to ask questions in the NSDUH about typical large cigars, sometimes referred to
as “stogies,” separately from the questions about little cigars or cigarillos. Research
suggests large cigar users and little cigar and cigarillo users have different demographic
profiles and may have different patterns of multiple product use, with little cigars and
cigarillos being more popular among young adults, males, African-Americans, individuals
with lower education and those reporting current cigarette, marijuana and blunt use. 6,7,8
Furthermore, since the 2009 federal excise tax that increased the tax on little cigars to
equal that of cigarettes, some little cigar manufacturers have slightly increased the weight

of their little cigars (though not so much as to look very different to the average consumer)
and they now qualify as large cigars and get a more preferable tax treatment. 9,10,11 This
conflation of cigar products creates a need to be more specific in survey questions
regarding cigar products.
In addition, we recommend that SAMHSA amend and re-structure questions in the 2013
NSDUH about brand use for little cigars and cigarillos. Research indicates that little cigar
and cigarillo users may not recognize these products as cigars or even as tobacco
products.12,13 Studies demonstrate that little cigar and cigarillo users do not self-report as
cigar users despite reporting that they smoke a little cigar or cigarillo when asked
specifically about brands like Swisher Sweets or Black & Mild.14,15 Little cigar and cigarillo
brands may be more reliably reported than cigar type (i.e., little cigar or cigarillo),
particularly among at-risk groups such as younger and African-American users.16,17,18
Asking only about little cigar or cigarillo use without specific brand item prompts may lead
to underestimates of prevalence.19
Currently in the NSDUH, only respondents who report past 30 day cigar use are asked
brand-specific questions. Those who do not report smoking cigars at least once in their
lifetime and those who report smoking cigars at least once in their lifetime but not in the
past 30 days are not subsequently asked about brand use. To improve the precision of
prevalence estimates, we recommend that the NSDUH include brand-specific prompts,
particularly of little cigar and cigarillo brands, for questions regarding cigar ever and current
use for all respondents.
The lack of significant data regarding the different types of cigar products is illustrated in a
recent analysis using 2002-2008 NSDUH data. That analysis showed that the top 5 cigar
brands smoked by respondents (Black & Mild, Swisher Sweets, Phillies, White Owl, and
Garcia y Vega) include large cigars, cigarillos and little cigar products. Yet, the authors
were unable to determine whether respondents were smoking large cigars as opposed to
little cigars or cigarillos due to the grouping together of cigar products in the questions. 20
As we have suggested for other tobacco products, SAMSHA should include questions
regarding the use of flavored and non-flavored cigars for little cigars and cigarillos in the
NSDUH. This is especially important for cigar products given the fact that flavored
cigarettes, except for menthol, were banned by the Family Smoking Prevention and
Tobacco Control Act. Furthermore, there is evidence that some brands of flavored
cigarettes simply changed their products to flavored cigars.21
Finally, we suggest adding a question regarding the number of cigar products smoked per
day for those who report usage in the past 30 days, as well as questions that ascertain
concurrent use of cigars with other tobacco products. These types of questions regarding
usage patterns are critical in understanding how and when respondents are using cigar
products.

Electronic Cigarettes: Electronic cigarettes are also new products that have been
deemed by the courts to be a tobacco product.22 While not yet subject to FDA regulation,
FDA has given indications that they intend to regulate these products.23,24 There are
currently no questions in the 2013 NSDUH regarding electronic cigarettes. Questions in
national surveys about these products would be very helpful to FDA, as well as state and
local entities, in making public policy decisions regarding electronic cigarettes. We suggest
adding questions regarding ever use and past 30 day use of electronic cigarettes to the
2013 NSDUH.
Legacy appreciates SAMHSA taking these comments into account as it develops the 2013
NSDUH. It is critical that we have the appropriate information about tobacco products in
order to best determine how to protect the public health from the deadly effects of tobacco,
especially as the breadth and variety of tobacco products continues to change. If you have
questions or need further information, please contact Diane Canova, Vice President of
Government Affairs at [email protected] or 202-454-5559.
Sincerely,

David Dobbins, JD
Chief Operating Officer

1

Caraballo R. Menthol and Demographics. Presentation to Food and Drug Administration Tobacco
Products Scientific Advisory Committee. March 30, 2010.
2
Substance Abuse and Mental Health Services Administration (SAMHSA). The NSDUH Report: The Use
of Menthol Cigarettes. Rockville, MD: Substance Abuse and Mental Health Services Administration,
Office of Applied Studies. November 19, 2009
3
Centers for Disease Control Cigarette Brand Preference Among Middle and High School Students Who
Are Established Smok ers – United States, 2004 and 2006. February 13, 2009 MMWR 58(05);112-115
4
Hersey et al, Are menthol cigarettes a starter product for youth? Nicotine and Tobacco Research. 2006;
8(3): 403-13.
5
FDA statement Clarification About Dissolvable Products
http://www.fda.gov/ TobaccoProducts/NewsE vents/ucm248801.htm . Accessed 04-24-12.
6
Cullen J, Mowery P, Delnevo C, et al. Seven Year Patterns in U.S Cigar Use Epidemiology among
Young Adults aged 18-25: A Focus on Race/Ethnicity and Brand American Journal of Public Health. 2011
7
Borawski E, Brooks, A., Colabianchi, N., Trapl, ES, Przepyszny , KA., Shaw, N., Danosky, L. Adult use of
cigars, little cigars, and cigarillos in Cuyahoga County, Ohio: A cross -sectional study. Nicotine and
Tobacco Research. 2010;12(6):669-673.
8
Richardson A et al. “Primary and Dual Users of Cigars and Cigarettes: Profiles, Tobacco Use Patterns
and Relevance to Policy.” Nicotine and Tobacco Research, January 17, 2012
9
Kesmodal, D. Close and It Is a Cigar: Tobacco Manufacturers Are Accused of Exploiting a Tax Loophole
to Boost Sales. The Wall Street Journal. September 23, 2010.
http://online.wsj.com/article/SB10001424052748703399404575505670223138144.html . Accessed 4-2512.
10
Government Accountability Office. Illicit Tobacco: Various Schemes Are Used to Evade Taxes and
Fees. GAO-11-313. March 2011. http://www.gao.gov/new.items/d11313.pdf. Accessed 4-25-12.
11
Government Accountability Office. Large Disparities in Rates for Smoking Products Trigger Significant
Market Shifts to Avoid Higher Taxes. GAO-12-475. April 2012.
http://www.gao.gov/assets/600/590192.pdf Accessed 4-25-12.
12
Page JB, Evans, S. Cigars, Cigarillos, and Youth: Emergent Patterns in Subcultural Complexes.
Journal of Ethnicity in Substance Abuse. 2003;2(4):63-76.
13
Yerger VP, C., Malone, M.E. When is a cigar not a cigar? African American youths' understanding of
cigar use. American Journal of Public Health. 2001;91(2):316-317.
14
Terchek J, Larkin, EMG., Male, ML., Frank, SH. Measuring cigar use in adolescents: Inclusion of a
brand-specific item. Nicotine and Tobacco Research. 2009;11(7):842-846.
15
Borawski E, Brooks, A., Colabianchi, N., Trapl, ES, Przepyszny, KA., Shaw, N., Danosky, L. Adult use
of cigars, little cigars, and cigarillos in Cuyahoga County, Ohio: A cross -sectional study. Nicotine and
Tobacco Research. 2010;12(6):669-673.
16
Terchek J, Larkin, EMG., Male, ML., Frank, SH. Measuring cigar use in adolescents: Inclusion of a
brand-specific item. Nicotine and Tobacco Research. 2009;11(7):842-846.
17
Borawski E, Brooks, A., Colabianchi, N., Trapl, ES, Przepyszny, KA., Shaw, N., Danosky, L. Adult use
of cigars, little cigars, and cigarillos in Cuyahoga County, Ohio: A cross-sectional study. Nicotine and
Tobacco Research. 2010;12(6):669-673.
18
Trapl ES, Terchek JJ, Danosky L, Cofie L, Brooks-Russell A, Frank SH. Complexity of measuring "cigar
use" in adolescents: results from a split sample experiment. Nicotine and Tobacco Research. Apr
2011;13(4):291-295.
19
Cullen J, Mowery P, Delnevo C, et al. Seven Year Patterns in U.S Cigar Use Epidemiology among
Young Adults aged 18-25: A Focus on Race/Ethnicity and Brand American Journal of Public Health.
2011.
20
Cullen J, Mowery P, Delnevo C, et al. Seven Year Patterns in U.S Cigar Use Epidemiology among
Young Adults aged 18-25: A Focus on Race/Ethnicity and Brand American Journal of Public Health.
2011.

21

Letter from Rep. Henry Waxman to FDA Commissioner Margaret Hamburg. March 28, 2011. Available
at : http://democrats.energycommerce.house.gov/index.php?q= news/rep -waxman-urges -fda-to-banclove-flavored-cigars Accessed 4-23-12.
22
Sottera, Inc. v. Food and Drug Administration, 627 F.3d 891 (D.C. Cir. 2010)
23
Food and Drug Administration letter to industry stakeholders April 2011. Available at:
http://www.fda.gov/NewsE vents/PublicHealthFocus/ucm252360.htm . Accessed 4-25-12.
24
Health and Human Services Semiannual Regulatory Agenda “Tobacco Products Subject to the Federal
Food, Drug and Cosmetic Act as Amended by the Family Smoking Prevention and Tobacco Control Act.”
RIN 0910-AG38. Published in the Federal Register July 7, 2011,at 40061-40062; and February 13, 2012,
at 7952. Available respectively at:
http://www.fda.gov/downloads/TobaccoProducts/Guidanc eComplianceRegulatoryInformation/ UCM 26381
9.pdf (accessed 4-25-12) and http://www.gpo.gov/fdsys/pkg/FR-2012-02-13/pdf/2012-1647.pdf
(accessed 4-25-12).