Attachement 10 FCLAA-FDA-CDC OMB packages latest version 5-10-11

An Overview of Current Tobacco Industry Reporting and Data Collection:
Differences in Tobacco Reporting Programs Authorized Under the Federal Cigarette Labeling and
Advertising Act (FCLAA), the Comprehensive Smokeless Tobacco Health Education Act (CSTHEA) and
the Family Smoking Prevention and Tobacco Control Act (FSPTCA)

Purpose:
• To identify the differences in tobacco industry reporting programs to the Department of
Health and Human Services (HHS), with the idea of reducing any duplication, if it exists,
and potentially open the ability to coordinate information sharing between HHS agencies.
Background:
• The Center for Disease Control and Prevention’s (CDC) Office on Smoking and Health
(OSH) and the Food and Drug Administration’s (FDA) Center for Tobacco Products
(CTP) have engaged in discussions over their tobacco manufacturer reporting programs,
determining that while similarities exist in the nature of information collected, there are
key distinctions that make their program reporting non-duplicative.
Key Distinctions:
Product Data:
• FDA’s regulatory authority requires
data collection of ingredient content for
cigarettes and smokeless tobacco,
including paper, filter, & other
components of these tobacco products.
FDA regulations will detail information
collection specifically regarding
nicotine content.
o

•

Data includes/will include quantity of
ingredients, and brand- and sub-brandspecific information.

CDC’s program requires data collection
of ingredient components for cigarettes
and smokeless tobacco. Nicotine data is
collected for smokeless tobacco
products only.
o

Timeline of Collection:
• FDA’s regulatory authority allows for a
baseline collection of product
information at least 90 days prior to
market introduction (or 6 months after
FSPTCA enactment for existing
products already on the market) and
again upon any changes in product
formulation.

Data does not include the quantity of
ingredients, or brand- or sub-brandspecific information. Such data is
collected for smokeless tobacco nicotine
content only.

o

•

There is no periodic data collection.

CDC’s program allows for annual data
reporting, regardless of changes to
product formulation.

Summary Conclusions & Recommendations:
• While similarities exist in the nature of the information collected, key differences in the
scope and detail of the information make these collections non-duplicative.
• Aligning the programmatic collection and sharing of information will improve the overall
utility of data collected. This will allow the agencies to verify the reliability and accuracy
of the data, given CDC’s year-by-year program and ability to serve as an annual quality
assurance check for FDA monitoring of tobacco product changes by manufacturers.
• The HHS agencies would benefit from the ability to share information received under the
FCLAA, CSTHEA, and FSPTCA legislation.
Appendix:
Additional Information about FCLAA, CSTHEA, and FSPTCA:
• The Federal Cigarette Labeling and Advertising Act (FCLAA), 15 U.S.C. 1335a, requires
each person who manufactures, packages, or imports cigarettes to submit to the
Department of Health and Human Services (HHS) a list of ingredients added to tobacco
in the manufacture of cigarettes. The Centers for Disease Control and Prevention’s
(CDC) Office on Smoking and Health (OSH) has the primary responsibility for this
aspect of HHS’ tobacco and health program.
•

The Comprehensive Smokeless Tobacco Health Education Act (CSTHEA), 15 U.S.C.
4403, requires each person who manufactures, packages, or imports smokeless tobacco
products to report to the HHS a list of ingredients added to tobacco in the manufacture of
smokeless tobacco products and the quantity of nicotine in each smokeless tobacco
product. CDC/OSH is also responsible for administering this aspect of HHS’ program.

•

The Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 11131, establishes the authority of the Food and Drug Administration (FDA) to regulate the
manufacture, marketing, and distribution of tobacco products. 21 U.S.C. 387, et. seq. As
part of this authorization, section 904(a) (21 U.S.C. 387d(a)) requires tobacco product
manufacturers or importers to submit to FDA a listing of the identity and quantity 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. In
addition, once FDA promulgates regulations, manufacturers and importers will be
required to submit to FDA information on the content, form, and delivery of nicotine in
each tobacco product, measured in milligrams of nicotine. 21 U.S.C. 387d(a)(2). It
should be noted that at the current time, FDA has jurisdiction over cigarettes, cigarette
tobacco, roll-your-own tobacco, and smokeless tobacco. 21 U.S.C. 387a(b).

Reporting Program Comparison:

FCLAA/CSTHEA (1969/1986)

FSPTCA (2009)

HHS Program Administration

CDC

FDA

Reference Section of US Code

15 U.S.C. 1335a / 15 U.S.C.
4403

21 U.S.C. 387

Cigarette Data Collected: Ingredients

Yes, no quantities, brands &
sub-brands not specified

Yes, quantities, brands & subbrands specified

Cigarette Data Collected: Nicotine

Not collected

Yes, after FDA promulgates
regulations; quantities, brands
& sub-brands specified

Smokeless Tobacco Data Collected:
Ingredients

Yes, no quantities, brands &
sub-brands not specified

Yes, quantities, brands & subbrands specified

Smokeless Tobacco Data Collected:
Nicotine

Yes, quantities, contained in
each product

Yes, after FDA promulgates
regulations; quantities, brands
& sub-brands specified

Annual

Baseline collection, with
additional collection upon any
changes to product

Information submitted is
considered trade secret and
confidential. Disclosures
permitted only as authorized
by legislation.

Information submitted is
considered trade secret and
confidential. Mandate to
establish list of harmful or
potentially harmful
constituents. Other disclosures
as permitted by legislation.

Timeline of Collection

Confidentiality Provisions &
Information Sharing