Federal Regulation of Tobacco: Legal Framework and Issues for the 116th Congress
September 30, 2019
Federal Regulation of Tobacco: Legal Framework and Issues
for the 116th Congress
The Family Smoking Prevention and Tobacco Control Act
Substantial Equivalence (SE): Nearly all new tobacco
(TCA), P.L. 111-31, establishes the central federal
products are marketed through the SE pathway. As a
regulatory regime for the manufacture, marketing, and
less rigorous alternative to a PMTA submission, FDA
distribution of tobacco products. The statute aims to
may permit a new tobacco product to be marketed based
balance competing interests in protecting the public’s health
on a demonstration that it is “substantially equivalent”
against the harmful effects of smoking and youth tobacco
to an existing product marketed as of February 15, 2007,
use, while preserving access to lawfully marketed tobacco
and complies with other federal tobacco-related
products for adult consumers. The TCA largely amends the
requirements. A tobacco product is substantially
Federal Food, Drug, and Cosmetic Act (FD&C Act) and
equivalent to its earlier counterpart if, in general, it has
grants the Food and Drug Administration (FDA) “primary
the same characteristics (e.g., ingredients, design,
Federal authority” over tobacco product regulation. This In
heating source, or other features) of the reference
Focus summarizes the TCA’s legal framework and
product or does not raise different public health
discusses key TCA-related issues in the 116th Congress.
questions. Additionally, certain new tobacco products
commercially marketed after February 15, 2007, but
Overview of the TCA
before March 22, 2011 (“provisional SE tobacco
The TCA regulates “tobacco products,” which generally are
products”), may be marketed unless FDA issues an
any products made or derived from tobacco and intended
order that the new product is not substantially
for human consumption, including the product’s
equivalent.
components, parts, or accessories. While the TCA explicitly
applies to cigarettes, cigarette tobacco, roll-your-own
Substantial Equivalence Exemption: FDA may exempt
tobacco, and smokeless tobacco, the statute also permits
certain new tobacco products with minor modifications
FDA to deem other tobacco products subject to the law.
from having to show substantial equivalence. Products
FDA has exercised this authority over additional tobacco
eligible for an exemption are those “modified by adding
products, including electronic nicotine delivery system
or deleting a tobacco additive, or by increasing or
(ENDS) products (e.g., e-cigarettes and vape pens) and
decreasing the quantity of an existing tobacco additive.”
cigars. Key components of tobacco product regulation
under the TCA include the following:
Manufacturer Requirements
The TCA creates several requirements that tobacco product
Premarket Review
manufacturers must meet to market a product. For example,
A marked change to federal tobacco regulation, the TCA
the act directs FDA to issue regulations related to tobacco
establishes a premarket review process for new tobacco
product manufacturing practices, to protect public health,
products (i.e., products not commercially marketed as of
and ensure that tobacco products are in compliance with
February 15, 2007, or products marketed after that date, but
federal law. FDA can grant exemptions and variances from
later modified). “Grandfathered products” on the market
such regulations under specified circumstances.
before February 15, 2007, may be sold without prior
authorization. In general, to market a particular new
The TCA also generally directs manufacturers to maintain
product, a manufacturer must submit a premarket tobacco
records, issue reports, and provide other information to
product application (PMTA) and receive a PMTA
FDA, as the agency may require by regulation. For
marketing order from FDA, unless the manufacturer can
instance, the TCA compels manufacturers to submit a
successfully show that the product is either substantially
report listing all product constituents, including smoke
equivalent to a predicate product or may be exempt from
constituents identified as harmful or potentially harmful by
this substantial equivalence demonstration.
FDA. The statute also authorizes FDA to conduct or require
testing and reporting of tobacco product constituents,
Premarket Tobacco Product Application: To receive a
ingredients, and additives that the agency determines need
marketing order from FDA, manufacturers must submit
testing to protect the public health.
a PMTA, which includes information on health risk
investigations; the composition, ingredients, and
Tobacco Product Standards
operation of the tobacco product; and the product’s
To reduce the allure of flavored tobacco products to minors,
manufacture, processing, and proposed product labeling.
the TCA bans flavors (other than tobacco and menthol) in
To issue a PMTA marketing order, FDA must determine
traditional cigarettes and components. The TCA also
whether, among other things, allowing the new tobacco
empowers FDA to adopt certain tobacco product standards
product to be on the market would be appropriate to
if the agency determines that a standard is appropriate to
protect public health.
protect the public health. Such standards may relate to
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Federal Regulation of Tobacco: Legal Framework and Issues for the 116th Congress
reducing nicotine levels, harmful components of a product,
Enforcement
or other features, such as further restrictions on the sale of
Persons who violate tobacco-related provisions of the
flavored products. That said, the TCA prevents FDA from
FD&C Act, as amended by the TCA, may be subject to
banning all cigarettes and other specified types of tobacco
sanctions, including civil monetary penalties. Retailers that
products, and the agency cannot compel nicotine yields to
violate FDA regulations on selling tobacco products to
be zero in certain products.
minors (as well as other FDA regulations) may be liable for
a special civil monetary penalty. FDA may impose a No-
Labeling Requirements and Marketing Restrictions
Tobacco-Sale Order (NTSO) against retailers that have five
A complex legal landscape governs the labeling, promotion,
or more repeated violations of these FDA regulations within
and other marketing of tobacco products. As a central part
36 months. NTSOs prohibit retailers from selling tobacco
of this landscape, the TCA altered and expanded upon
products for a specified time.
existing federal restrictions relating to labeling, advertising,
and other marketing of cigarettes and other tobacco
Current Legal Considerations
products. Among other things, the act instructs FDA to
Issues related to the TCA and its implementation have been
largely reissue a 1996 rule containing several restrictions on
of interest to the 116th Congress. These issues include the
the sale, distribution, and advertisement of tobacco products
following:
(in 2000, the Supreme Court invalidated the rule on grounds
that at that time, Congress had not authorized FDA to
Age Restrictions: While the TCA generally permits
regulate tobacco products). The TCA also permits FDA to
FDA to issue regulations creating a federal minimum
impose additional marketing restrictions based on a
age for the sale tobacco products, the agency lacks
determination that such restrictions are appropriate to
authority to establish an age restriction beyond age 18.
protect the public health. Current TCA-related statutory and
As noted above, the TCA allows states and localities to
regulatory requirements include the following:
establish stricter age requirements. To help curb
adolescent tobacco use, some Members of Congress
Health Warnings: Mandatory warnings on cigarette
have expressed support for federal legislation that would
packages and advertisements must be a specific size and
alter FDA’s existing authority and prohibit the sale of
format and bear graphic images that portray the negative
tobacco products to individuals under the age of 21.
consequences of cigarette use, under FDA regulations.
Other types of tobacco products must include warning
Graphic Warnings: Several of TCA’s labeling and
statements, and statements vary based on product.
marketing restrictions have been challenged in court on
First Amendment grounds. For example, in 2012, a
Advertising and Promotion Restrictions: FDA
federal appeals court vacated FDA’s mandatory health
regulations limit manufacturers of cigarettes and
warnings rule because aspects of the rule violated free
smokeless tobacco from sponsoring athletic, musical,
speech protections of the First Amendment. FDA
artistic, and other events in the tobacco brand’s name.
recently reissued a proposed rule on these warnings, and
These entities may not offer gifts or items in
it remains to be seen whether the rule will be subject to
consideration of a tobacco purchase, and there are limits
further litigation.
on advertising in certain audio and video formats.
Flavored ENDS Products and Enforcement: Some
Sales and Distribution Limitations: FDA regulations
Members of Congress have raised concerns about the
prohibit the sale of tobacco products to persons under
popularity of ENDS products with minors, particularly
age 18 (the TCA limits the agency’s ability to establish
flavored products. Newly regulated ENDS products are
a higher age), and retailers must verify a purchaser’s age
subject to premarket review, but FDA has delayed
using photographic identification for persons younger
enforcement of these requirements, providing
than age 27. Subject to exceptions, regulations also ban
manufacturers more time to prepare for the review
distribution of free samples of tobacco products and the
process. In September 2019, FDA announced plans to
sale of products through vending machines and self-
prioritize enforcement of the premarket authorization
service displays.
requirements for some flavored e-cigarettes and other
flavored ENDS products. Accordingly, while it appears
Preservation of State, Local, and Tribal Authority
that FDA does not seek to “ban” these products,
Under the TCA, states, localities, and tribal governments
manufacturers may soon need to obtain a PMTA or
retain authority to regulate tobacco products in certain
other FDA authorization to remain on the market, or risk
ways. For example, the TCA states that these governmental
enforcement action.
entities may generally maintain additional (or more
stringent) requirements on the sale or distribution of
For information on the TCA and policy considerations, see
tobacco products. Under this language, states may, for
CRS Report R45867, FDA Regulation of Tobacco
instance, enact their own minimum age restrictions for the
Products, by Victoria R. Green.
purchase of tobacco products. Yet, the TCA limits state and
local governments from adopting, among other things, their
Jennifer A. Staman, Legislative Attorney
own tobacco product standards, requirements for premarket
review, or manufacturing practices.
IF11321
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Federal Regulation of Tobacco: Legal Framework and Issues for the 116th Congress
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