12a - Public Comment

December 26, 2013
Via email [email protected]
Re:

Proposed Data Collections Submitted for Public Comment and Recommendations: List of
Ingredients Added to Tobacco in the Manufacture of Cigarette Products; Annual
Submission of the Ingredients Added to, and the Quantity of Nicotine Contained in,
Smokeless Tobacco Manufactured, Imported, or Packaged in the U.S., Request for
Comments (OMB Nos. 0920-0210, 0920-0338)

The Coalition of Independent Tobacco Manufacturers of America (CITMA) respectfully
submits these comments in response to the Centers for Disease Control and Prevention’s
(CDC’s) invitation to submit comments relating to the information collection for the following
proposed projects: (1) List of Ingredients Added to Tobacco in the Manufacture of Cigarette
Products (OMB No. 0920-0210, exp. 2/28/2014) and (2) Annual Submission of the Ingredients
Added to, and the Quantity of Nicotine Contained in, Smokeless Tobacco Manufactured,
Imported, or Packaged in the U.S. (OMB No. 0920-0338, exp. 2/28/2014). CITMA is a trade
coalition group that represents small tobacco product manufacturers (STPMs), defined in the
Federal Food, Drug, and Cosmetic Act (FFDCA) as domestic tobacco manufacturers and
importers that employ fewer than 350 people each. 21 U.S.C. § 387(16).
In particular, CDC requested comment on:
(a) Whether the proposed collection of information is necessary for the proper performance
of the functions of the agency, including whether the information shall have practical
utility;
(b) The accuracy of the agency’s estimate of the burden of the proposed collection of
information;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(d) Ways to minimize the burden of the collection of information on respondents, including
through the use of automated collection techniques or other forms of information
technology.
Each of the CDC’s information collections are duplicative of the Food and Drug
Administration’s (FDA’s) collection of tobacco product ingredient lists and reports on the

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quantities of harmful and potentially harmful constituents (HPHCs) in tobacco products. Both
CDC and FDA are part of the Department of Health and Human Services (HHS) and through a
formal inter-agency Memorandum of Understanding (MOU) could easily share this information
without requiring manufacturers and importers to submit the information multiple times. Thus,
the collection by CDC of information relating to ingredients in cigarettes and ingredients and
nicotine in smokeless tobacco is not necessary for the proper performance of the CDC’s
functions and will not have practical utility.
CDC’s Information Collection
The Comprehensive Smoking Education Act of 1984 (CSEA) requires each person who
manufactures, packages, or imports cigarettes to provide the Secretary of HHS with a general list
of ingredients added to tobacco in the manufacture of cigarettes. See 15 U.S.C. § 1335a(a).
HHS has delegated responsibility for implementing the CSEA’s ingredient reporting
requirements to CDC’s Office on Smoking and Health (OSH). CDC requires the ingredient
report to be submitted by chemical name and CAS number. Ingredient reports must be filed with
CDC annually.
The Comprehensive Smokeless Tobacco Health Education Act of 1986 (CSTHEA)
likewise requires each person who manufactures, packages, or imports smokeless tobacco
products to provide the Secretary of HHS with a general list of ingredients added to tobacco in
the manufacture of smokeless tobacco products. See 15 U.S.C. § 4403(a)(1)(A). The CSTHEA
further requires submission of the quantity of nicotine contained in each smokeless tobacco
product. See 15 U.S.C. § 4403(a)(1)(B). As with cigarettes, HHS has delegated responsibility
for implementing the required information collection to CDC’s OSH. Respondents are required
to meet reporting guidelines and to submit the ingredient report by chemical name and CAS
Registration Number. Ingredient reports must be filed annually.
FDA’s Information Collection
Ingredient Lists
Section 904(a)(1) of the FFDCA requires each tobacco product manufacturer or importer,
or agent thereof, to submit a listing of all ingredients, including tobacco, substances, compounds,
and additives that are added by the manufacturer to the tobacco, paper, filter, or other part of
each tobacco product, by brand and by quantity in each brand and subbrand. For tobacco
products on the market as of June 22, 2009, the list of ingredients was first required to be
submitted by December 22, 2009. For tobacco products not on the market as of June 22, 2009,
section 904(c)(1) requires that the list of ingredients be submitted at least 90 days prior to
delivery for introduction into interstate commerce. Section 904(c) also requires submission of
information whenever any additive, or the quantity of any additive, is changed.

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FDA has issued detailed guidance on the information that must be included in the list of
ingredients, as well as the level of detail required in the submission. See Guidance for Industry:
Listing of Ingredients in Tobacco Products (Nov. 2009) (attached). For example, ingredients that
are single chemical substances that may be purchased or prepared in-house and purified must be
identified by unique scientific name or code, such as the FDA Unique Ingredient Identifiers
(UNII) code, Chemical Abstract Service (CAS) number, or International Union of Pure and
Applied Chemistry (IUPAC) name. FDA also requires identification of the quality of the
ingredient, any internal identification number, and the expected function. FDA’s guidance
provides extensive advice on how manufacturers and importers should report required
information for leaf tobacco, complex purchased ingredients, and reaction products. FDA thus
collects information on cigarette and smokeless ingredients that it could easily share with CDC.
HPHC Reporting
Section 904(a)(3) of the FFDCA requires each tobacco product manufacturer or importer
to report to FDA “all constituents, including smoke constituents, identified by [FDA] as harmful
or potentially harmful to health in each tobacco product, and as applicable in the smoke of each
tobacco product.” For tobacco products that were not on the market on June 22, 2009, section
904(c)(1) requires that these reports be submitted to FDA at least 90 days before the product is
delivered for introduction into interstate commerce.
FDA issued a draft guidance document that expressed the agency’s intent to require
reporting of an abbreviated list of HPHCs, which includes nicotine levels for both cigarettes and
smokeless tobacco products. See Draft Guidance for Industry: Reporting Harmful and
Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under Section
904(a)(3) of the Federal Food, Drug, and Cosmetic Act (March 2012) (attached). FDA
recommends 20 replicates for the determination of quantities of nicotine in cigarette smoke and
seven replicates for the determination of nicotine in smokeless tobacco. FDA also specifically
recommends use of the CDC method to calculate nicotine levels in smokeless tobacco products
and therefore should receive nicotine content data that will satisfy CDC requirements. If FDA
and CDC coordinate, manufacturers and importers could provide to FDA the nicotine subset of
HPHC data in an electronic format that FDA may then convert for sharing with and appropriate
use by CDC, without the need for duplicative recordkeeping or regulatory submissions.
Recommendation
FDA’s collection of information under the FFDCA covers all of the information collected
by CDC under the CSEA and CSTHEA, but in substantially greater detail. Moreover, FDA
requires the submission of such information at least 90 days prior to delivery of a new tobacco
product into interstate commerce and each time any additive, or the quantity of any additive, is

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changed. In light of FDA’s active regulation of these tobacco products, in particular
enforcement of section 904 of the FFDCA, CDC’s proposed collection of information is
duplicative, lacks practical utility, and is a waste of government and industry resources. Thus, to
minimize the burden on respondents and the agencies, CITMA recommends that CDC enter into
an MOU with FDA with respect to these information collections. The agencies should work
together to ensure that FDA receives cigarette and smokeless ingredient and smokeless tobacco
nicotine content listings in a format that can be converted for sharing with and use by CDC
consistent with its statutory mandates.
Thank you for your consideration of the foregoing comments. Please do not hesitate to
contact me should you require additional information.
Respectfully Submitted,
Kevin Altman
Consultant, CITMA