Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide (Revised): Guidance for Industry

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

Contains Nonbinding Recommendations
Required Warnings for Cigarette
Packages and Advertisements
Small Entity Compliance Guide (Revised)*
Guidance for Industry
Comments may be submitted at any time for Agency consideration. Electronic comments may
be submitted to https://www.regulations.gov. Alternatively, submit written comments to the
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Room 1061, Rockville, MD 20852. All comments should be identified with the docket number
listed in the notice of availability that publishes in the Federal Register.
For questions regarding this guidance, contact the Center for Tobacco Products at (Tel) 1-
877-CTP-1373 (1-877-287-1373) Monday-Friday, 9 a.m. – 4 p.m. ET.
Additional copies are available online at https://www.fda.gov/tobacco-products/products-
guidance-regulations/rules-regulations-and-guidance. You may send an e-mail request to
SmallBiz.Tobacco@fda.hhs.gov to receive an electronic copy of this guidance. You may send a
request for hard copies to U.S. Food and Drug Administration, Center for Tobacco Products,
Attn: Office of Small Business Assistance, Document Control Center, Bldg. 71, Rm. G335,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Tobacco Products
September 2024
*This is a revision to the fourth edition of this final guidance, which issued in July 2021. A
summary of the revisions is at the end of the guidance.

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Table of Contents
I. 	INTRODUCTION……………………………………………………………………….1
II. 	BACKGROUND…………………………………………………………………………2
A. Definitions……………………………………………………………………………..3
III. 	QUESTIONS AND ANSWERS…………………………………………………………4
IV. 	DOCUMENT HISTORY………………………………………………………………15

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Required Warnings for Cigarette
Packages and Advertisements
Small Entity Compliance Guide (Revised)
Guidance for Industry1
This guidance represents the current thinking of the Food and Drug Administration (FDA or
Agency) on this topic. It does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff
responsible for this guidance as listed on the title page.
I. 	INTRODUCTION
FDA (Agency, we) is issuing this guidance to help small businesses understand and comply with
FDA’s final rule2, “Required Warnings for Cigarette Packages and Advertisements,” which
establishes new required cigarette health warnings for cigarette packages and advertisements.
The final rule implements a provision of the Family Smoking Prevention and Tobacco Control
Act (Tobacco Control Act) (Public Law 111-31) that requires FDA to issue regulations requiring
color graphics depicting the negative health consequences of smoking to accompany new textual
warning statements. The Tobacco Control Act amends the Federal Cigarette Labeling and
Advertising Act (FCLAA) (15 U.S.C. 1333) to require each cigarette package and advertisement
to bear one of the new required warnings. FDA has prepared this Small Entity Compliance Guide
in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act
(Public Law 104-121).
The contents of this document do not have the force and effect of law and are not meant to bind
the public in any way, unless specifically incorporated into a contract. This document is intended
only to provide clarity to the public regarding existing requirements under the law. FDA
guidance documents, including this guidance, should be viewed only as recommendations, unless
1 This guidance was prepared by the Office of Compliance and Enforcement, Office of Science, and Office of
Regulations in the Center for Tobacco Products at FDA.
2 For the purposes of this guidance, we refer to “rule” or “final rule” to refer to the final rule published in the
Federal Register of March 18, 2020, codified at 21 CFR 1141.

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specific regulatory or statutory requirements are cited. The use of the word should in FDA’s
guidances means that something is suggested or recommended, but not required.
II. 	BACKGROUND
The Tobacco Control Act was enacted on June 22, 2009, and granted FDA important new
authority to regulate the manufacture, marketing, and distribution of tobacco products. The
Tobacco Control Act also amended section 4 of the FCLAA to direct FDA to issue new cigarette
health warnings that would include a color graphic component depicting the negative health
consequences of smoking to accompany the new textual warnings (section 201 of the Tobacco
Control Act). In enacting this legislation, Congress also provided that FDA may adjust the
required warnings if FDA found that such a change would promote greater public understanding
of the risks associated with the use of tobacco products (section 202 of the Tobacco Control
Act). Additionally, as required under the FCLAA, the rule establishes marketing requirements
that include the random and equal display and distribution of the required warnings on cigarette
packages and quarterly rotations of the required warnings in cigarette advertisements.
Section 201(a) of the Tobacco Control Act requires manufacturers, distributors, and retailers of
cigarettes to submit plans for the random and equal display and distribution of required warnings
on cigarettes packages and the quarterly rotation of required warnings on cigarette
advertisements, and to obtain FDA approval of their plans before products required to bear such
warnings enter the market. The Tobacco Control Act also modified the FCLAA’s requirements
regarding the submission of plans for cigarette packages and advertisements and requires that
such plans be submitted to FDA (as delegated by the Secretary of Health and Human Services)
for review and approval, rather than to the Federal Trade Commission.
In the Federal Register of March 18, 2020, FDA published a final rule, codified at 21 CFR 1141,
that establishes new required warnings for cigarette packages and advertisements.3 Section
201(b) of the Tobacco Control Act provides that the required warnings are to become effective
15 months after the date the final rule publishes in the Federal Register. On April 3, 2020, the
final rule was challenged in the U.S. District Court for the Eastern District of Texas.4 Please see
FDA’s website at https://www.fda.gov/tobacco-products/labeling-and-warning-statements-
tobacco-products/cigarette-labeling-and-health-warning-requirements for updates regarding the
effective date of the rule and related timelines, including the recommended date for submitting
cigarette plans5 for FDA review.
3 In the Federal Register of August 16, 2019 (84 FR 42754), FDA issued a notice of proposed rulemaking (NPRM)
to amend 21 CFR 1141.
4 R.J. Reynolds Tobacco Co. et al., v. United States Food and Drug Administration et al., No. 6:20-cv-00176 (E.D.
Tex. filed April 3, 2020). On Dec. 7, 2022, the District Court issued an order vacating the rule. On March 21, 2024,
the U.S. Court of Appeals for the Fifth Circuit issued an opinion reversing the District Court and concluding that
FDA’s rule is consistent with the First Amendment. R.J. Reynolds Tobacco Co. et al., v. United States Food and
Drug Administration et al., No. 23-40076 (5th Cir. Mar. 21, 2024) (panel opinion), Doc. No. 140-1. A petition for
rehearing en banc was denied on May 21, 2024, and the court’s mandate issued on May 29, 2024. Accordingly, the
rule is no longer vacated.
5 For the purposes of this guidance, we refer to “cigarette plan” or “cigarette plans” to refer to the plan that provides
for the random and equal display and distribution of the required warnings on cigarette packaging and the quarterly
rotation of the required warnings in cigarette advertising, as described under section 4 of the FCLAA and 21 CFR
1141.

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A. Definitions
This guidance uses the following terms and definitions from the final rule published in the
Federal Register of March 18, 2020:
Cigarette. As defined in section 3(1) of the FCLAA, the term “cigarette” means (1) Any
roll of tobacco wrapped in paper or in any substance not containing tobacco; and (2) Any
roll of tobacco wrapped in any substance containing tobacco which, because of its
appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely
to be offered to, or purchased by, consumers as a cigarette described in subparagraph (1)
of this definition. (21 CFR 1141.3).
Commerce. As defined in section 3(2) of the FCLAA, “commerce” means --
(1) Commerce between any State, the District of Columbia, the Commonwealth
of Puerto Rico, Guam, the Virgin Islands, American Samoa, Wake Island,
Midway Islands, Kingman Reef, or Johnston Island and any place outside thereof;
(2) Commerce between points in any State, the District of Columbia, the
Commonwealth of Puerto Rico, Guam, the Virgin Islands, American Samoa,
Wake Island, Midway Islands, Kingman Reef, or Johnston Island, but through any
place outside thereof; or
(3) Commerce wholly within the District of Columbia, Guam, the Virgin Islands,
American Samoa, Wake Island, Midway Island, Kingman Reef, or Johnston
Island. (21 CFR 1141.3).
Distributor. Any person who furthers the distribution of cigarettes, whether domestic or
imported, at any point from the original place of manufacture to the person who sells or
distributes the product to individuals for personal consumption. Common carriers are not
considered distributors for the purposes of this proposed part. (21 CFR 1141.3)
Front panel and rear panel mean the two largest sides or surfaces of the package. (21
CFR 1141.3).
Manufacturer. Any person, including any repacker or relabeler, who manufactures,
fabricates, assembles, processes, or labels a finished cigarette product; or imports any
cigarette that is intended for sale or distribution to consumers in the United States. (21
CFR 1141.3).
Package or packaging. As defined in section 3(4) of the FCLAA, “package” means a
pack, box, carton, or container of any kind in which cigarettes are offered for sale, sold,
or otherwise distributed to consumers. (21 CFR 1141.3).
Person. As defined in section 3(5) of the FCLAA, “person” means an individual,
partnership, corporation, or any other business or legal entity. (21 CFR 1141.3).

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Required warning means the combination of a textual warning label statement and its
accompanying color graphic required to be on cigarette packaging and in cigarette
advertising pursuant to section 4 of the FCLAA. (21 CFR 1141.10).
Retailer means any person who sells cigarettes to individuals for personal consumption,
or who operates a facility where vending machines or self-service displays of cigarettes
are permitted. This definition would include any person who sells cigarettes online (e.g.,
through a Web site or mobile phone application). (21 CFR 1141.3).
United States, when used in a geographical sense, includes the several States, the District
of Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin Islands, American
Samoa, Wake Island, Midway Islands, Kingman Reef, and Johnston Island. The term
“State” includes any political division of any State. (21 CFR 1141.3).
III. 	QUESTIONS AND ANSWERS
A. What is the purpose of this rule?
This rule establishes new required cigarette health warnings for cigarette packages and
advertisements. Section 201 of the Tobacco Control Act amends the FCLAA to require that each
cigarette package and advertisement bear one of the new required warnings. These new cigarette
health warnings consist of textual warning statements accompanied by concordant color
graphics, in the form of photorealistic images, depicting the negative health consequences of
cigarette smoking.
This rule also establishes marketing requirements that include the random display and equal
distribution of the required warnings on cigarette packages and quarterly rotations of the required
warnings in cigarette advertisements. Section 4(c) of the FCLAA and 21 CFR 1141.10(g). The
marketing requirements also require submission of a cigarette plan to FDA that provides for the
random and equal display and distribution of the required warnings on cigarette packaging and
quarterly rotation of the required warnings in cigarette advertising, as described under section 4
of the FCLAA.
B. What items are covered by this rule?
This rule covers cigarette packages and cigarette advertisements for any cigarette that is
manufactured, packaged, or imported for sale or distribution within the United States. All
cigarette packages and advertisements, regardless of type, must display the required warnings, in
accordance with an FDA approved cigarette plan. For print advertisements and other
advertisements with a visual component (including, for example, advertisements on signs, retail
displays, Internet Web pages, social media Web sites, digital platforms, mobile applications, and
email correspondence), the required warning must appear directly on the top area of the
advertisement. 21 CFR 1141.10(d)(1).

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C. Who is responsible and subject to enforcement?
1. 	Who must comply with this final rule?
This rule applies to any person who manufactures, packages, sells, offers to sell, distributes, or
imports for sale or distribution within the United States any cigarette, including small businesses.
Section 4 of the FCLAA and 21 CFR 1141.10(c).
2. 	Will FDA provide assistance for small businesses seeking additional
information about cigarette plans?
Yes. FDA’s Center for Tobacco Products (CTP) has established an Office of Small Business
Assistance in an effort to help small businesses access up-to-date information and comply with
the requirements of the Tobacco Control Act. CTP’s Office of Small Business Assistance can be
reached at SmallBiz.Tobacco@fda.hhs.gov or at 1-877-CTP-1373 (1-877-287-1373) Monday–
Friday, 9:00 a.m. – 4:00 p.m. EDT.
3. 	What are the consequences if a company is found out of compliance?
A cigarette will be deemed misbranded under section 903(a)(1) of the FD&C Act if its package
does not bear one of the required warnings in accordance with section 4 of the FCLAA and 21
CFR 1141. 21 CFR 1141.12(a). In addition, 21 CFR 1141.12(a) provides that a cigarette will be
deemed misbranded under section 903(a)(7)(A) of the FD&C Act if its advertising does not bear
one of the required warnings in accordance with section 4 of the FCLAA and 21 CFR 1141.
Under 21 CFR 1141.12(b), a cigarette advertisement and other descriptive printed matter issued
or caused to be issued by the manufacturer, packer, or distributor will be deemed to include a
brief statement of relevant warnings for the purposes of section 903(a)(8) of the FD&C Act if it
bears one of the required warnings in accordance with section 4 of the FCLAA and 21 CFR
1141. A cigarette distributed or offered for sale in any State shall be deemed to be misbranded
under section 903(a)(8) of the FD&C Act unless the manufacturer, packer, or distributor includes
in all advertisements and other descriptive printed matter issued or caused to be issued by the
manufacturer, packer, or distributor with respect to the cigarette one of the required warnings in
accordance with section 4 of the FCLAA and 21 CFR 1141.
Therefore, if a person is not in compliance with the final rule, it may be subject to actions and/or
penalties under the FD&C Act, such as warning letters, criminal and civil money penalties,
injunction, seizure, and no-tobacco-sale orders. Any adulterated and misbranded tobacco
products offered for import into the United States may be subject to detention and refusal of
admission.
4. 	Are retailers subject to enforcement actions?
Yes, retailers that violate the rule could be subject to enforcement actions. However, a retailer
would not be in violation of the requirements of section 4 of the FCLAA and 21 CFR 1141.10 as
long as the cigarette package:

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• 	contains a warning;
• 	is supplied to the retailer by a license- or permit-holding tobacco product manufacturer
or distributor; and
• 	is not altered by the retailer in a way that is material to the requirements of section 4 of
the FCLAA or 21 CFR 1141.6 21 CFR 1141.1(c).
The requirements under 21 CFR 1141.10 only apply to a cigarette retailer if that retailer is
responsible for or directs the warnings for advertising. 21 CFR 1141.1(d). However, this does not
relieve a retailer of liability if the retailer displays, in a location open to the public, an
advertisement that does not contain a warning or has been altered by the retailer in a way that is
material to the requirements of section 4 of the FCLAA or 21 CFR 1141. 21 CFR 1141.1(d).
5. 	In cases where a retailer would not be held liable for a violation, can FDA still
take enforcement actions against other entities for violations under 21 CFR 1141?
Yes. If a cigarette package and/or advertisement is not in compliance with the rule, and the
retailer is not in violation of the rule because of the retailer exception in 21 CFR 1141.1(c), FDA
may take enforcement action against the responsible party (e.g., the manufacturer, packer, or
distributor).
D. What is the timeframe for implementing this rule?
1. 	When does the new rule become effective?
Please see FDA’s website at https://www.fda.gov/tobacco-products/labeling-and-warning-
statements-tobacco-products/cigarette-labeling-and-health-warning-requirements for updates
regarding the effective date of the rule and related timelines, including the recommended date for
submitting cigarette plans for FDA review. Section 201(a) of the Tobacco Control Act requires
manufacturers, distributors, and retailers of cigarettes to submit plans for the random and equal
display and distribution of required warnings on cigarettes packages and the quarterly rotation of
required warnings on cigarette advertisements, and to obtain FDA approval of their plans before
products required to bear such warnings enter the market.
Therefore, FDA strongly encourages entities to submit their cigarette plans as soon as possible
after publication of the final rule to ensure timely FDA review before the effective date of the
required warnings.
2. 	When are the new cigarette health warnings required to be included on
cigarette packages and advertisements?
6 For example, this would require that a retailer ensure that all cigarette packages it displays or sells contain a
warning that is unobscured by stickers, sleeves, or other materials on the packages.

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Pursuant to section 201(b) of the Tobacco Control Act, cigarette packages and advertisements
must bear the required warnings once the final rule goes into effect.7 Once the final rule goes
into effect, cigarette packages that do not comply with the requirements of the final rule must not
be manufactured for sale or distribution in the United States. In addition, beginning 30 days after
the effective date, a manufacturer must not introduce into domestic commerce of the United
States any product, irrespective of the date of manufacture, that does not conform with the final
rule.
In addition, as of the effective date,8 no manufacturer, distributor, or retailer of cigarettes may
advertise or cause to be advertised within the United States any cigarette product unless the
advertising complies with the final rule. Section 201(b) of the Tobacco Control Act.
3. 	After the effective date for the required warnings, can manufacturers continue
to sell and distribute their remaining stock of cigarettes if the packaging does not comply with
the final rule?
In the final rule, if a cigarette product was manufactured prior to the effective date of the final
rule and its package does not contain the required warning, the product may be introduced into
commerce in the United States within 30 days from the effective date of the final rule. After the
30-day period, manufacturers would not be permitted to introduce into domestic commerce any
cigarette packages, irrespective of the date of manufacture, that does not conform with the
requirements under 21 CFR 1141. While the limitation applies to only manufacturers, FDA
believes that under the final rule, keeping products without the required warnings on the market
for an extended period would not be in the interest of the public health.
4. 	After the effective date of the final rule, may distributors and/or retailers sell-off
their remaining stock of cigarette products if the packaging does not comply with the final
rule?
Yes. Distributors and retailers may continue to sell and distribute the cigarette product after the
effective date of the final rule, but only if the product was manufactured before the effective
date, and introduced into domestic commerce by the manufacturer within 30 days from the
effective date of the rule.
E. What are the new textual warning label statements?
Under 21 CFR 1141.10(a), a required warning must include (1) a textual warning label
statement; and (2) a color graphic to accompany the textual warning label statement.
The textual warning label statements are as follows:
7 Please see FDA’s website at https://www.fda.gov/tobacco-products/labeling-and-warning-statements-tobacco-
products/cigarette-labeling-and-health-warning-requirements for updates regarding the effective date of the rule and
related timelines, including the recommended date for submitting cigarette plans for FDA review.
8 Please see FDA’s website at https://www.fda.gov/tobacco-products/labeling-and-warning-statements-tobacco-
products/cigarette-labeling-and-health-warning-requirements for updates regarding the effective date of the rule and
related timelines, including the recommended date for submitting cigarette plans for FDA review.

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• 	WARNING: Tobacco smoke can harm your children.
• 	WARNING: Tobacco smoke causes fatal lung disease in nonsmokers.
• 	WARNING: Smoking causes type 2 diabetes, which raises blood sugar.
• 	WARNING: Smoking reduces blood flow to the limbs, which can require amputation.
• 	WARNING: Smoking causes cataracts, which can lead to blindness.
• 	WARNING: Smoking causes bladder cancer, which can lead to bloody urine.
• 	WARNING: Smoking reduces blood flow, which can cause erectile dysfunction.
• 	WARNING: Smoking causes head and neck cancer.
• 	WARNING: Smoking can cause heart disease and strokes by clogging arteries.
• 	WARNING: Smoking during pregnancy stunts fetal growth.
• 	WARNING: Smoking causes COPD, a lung disease that can be fatal.
21 CFR 1141.10(a)(1).
Under 21 CFR 1141.10(b), each required warning, comprising a combination of a textual
warning label statement and its accompanying color graphic, must be accurately reproduced as
shown in the materials contained in “Required Cigarette Health Warnings, 2020,” which is
incorporated by reference at 21 CFR 1141.5.
F. How do I obtain the electronic files for the required warnings?
The rule identifies the material that FDA incorporates by reference, entitled “Required Cigarette
Health Warnings, 2020.” 21 CFR 1141.5. You may obtain a free copy of the material from
FDA's web site, located at https://www.fda.gov/cigarette-warning-files; the Docket at
https://www.regulations.gov; or from the Food and Drug Administration, Center for Tobacco
Products, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002, email: cigarettewarningfiles@fda.hhs.gov.
The material incorporated by reference, entitled “Required Cigarette Health Warnings, 2020,”
includes the required warnings (comprising a textual warning label statement, as specified in 21
CFR 1141.10(a), and its accompanying color graphic) in different layouts based on the size and
aspect ratio of the display area where the required warning must appear (i.e., on cigarette
packages, in cigarette advertisements). The rule includes an electronic portable document format
(.pdf) file containing all the required warnings as a reference in the docket for the final rule (Ref.
Required Cigarette Warnings, 2020). FDA is also making this material available on its web site
at https://www.fda.gov/cigarette-warning-files.
As discussed in the final rule, FDA recognizes that adaptations to the required warnings may be
needed to avoid technical implementation issues due to the varying features, formats, and sizes
of cigarette packages and advertisements. FDA has created electronic, layered design files, built
as Encapsulated PostScript (.eps) files,9 in different formats and aspect ratios designed to fit
9 The United States government owns all rights in the required warnings, which may not be used, reproduced,
displayed, modified or distributed except for purposes of displaying them on cigarette packages (including cartons)

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packaging and advertising of various shapes and sizes. The final rule does not require the use of
these .eps files, but we are providing the files as a resource to assist regulated entities implement
21 CFR part 1141 and section 4 of the FCLAA, 15 U.S.C. 1333.
G. How must the required warnings appear on cigarette packages?
• 	Size and location – The required warning must comprise at least the top 50 percent of
the front and rear panels of the cigarette package (i.e., the two largest sides or surfaces of
the package). 21 CFR 1141.10(c)(2). For cigarette cartons, the required warnings must be
located on the left side of the front and rear panels of the carton and must comprise at
least the left 50 percent of these panels. 21 CFR 1141.10(c)(2). The required warning
must appear directly on the package and must be clearly visible underneath any
cellophane or other clear wrapping. 21 CFR 1141.10(c)(1).
• 	Orientation – The required warning must be positioned so that the text of the required
warning and the other information on that panel of the package have the same orientation.
21 CFR 1141.10(c)(3). For example, if the front panel of a cigarette package contains
information, such as the brand name of the cigarette, in a left to right orientation, the
required warning, including the textual warning statement, must also appear in a left to
right orientation.
• 	Random and equal display and distribution – All 11 required warnings for packages
must be randomly displayed in each 12-month period, in as equal a number of times as is
possible on each brand of the product and must be randomly distributed in all areas of the
United States in which the product is marketed, in accordance with an FDA-approved
cigarette plan. Section 4(c) of the FCLAA and 21 CFR 1141.10(g)(1).
• 	Irremovable or permanent warnings – Required warnings must be indelibly printed on
or permanently affixed to the cigarette package. 21 CFR 1141.10(e). For example, these
required warnings must not be printed or placed on a label affixed to a clear outer
wrapper that is likely to be removed to access the product within the package. 21 CFR
1141.10(e).
H. How must the required warnings appear in cigarette advertisements?
• 	Size and location – For print advertisements and other advertisements with a visual
component (including, for example, advertisements on signs, retail displays, Internet Web
pages, social media Web pages, digital platforms, mobile applications, and email
correspondence), the required warning must appear directly on the advertisement. 21
CFR 1141.10(d)(1). Additionally, required warnings must comprise at least 20 percent of
the area of the advertisement in a conspicuous and prominent format and location at the
top of each advertisement within the trim area, if any. Section 4(b) of the FCLAA and 21
CFR 1141.10(d)(2).
and in cigarette advertising as required by 21 CFR part 1141, or with the express written permission of FDA, or as
permitted under the Copyright Act.

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• 	Rotation – The 11 required warnings must be rotated quarterly, in alternating sequence,
in advertisements for each brand of cigarettes, in accordance with an FDA-approved
cigarette plan. Section 4(c) of the FCLAA and 21 CFR 1141.10(g)(2).
• 	Irremovable or permanent warnings – Required warnings must be indelibly printed on
or permanently affixed to a cigarette advertisement. 21 CFR 1141.10(e).
I. How do I implement the required warnings on different sized and shaped cigarette
packages and advertisements?
FDA recognizes that adaptations to the required warnings may be needed to avoid technical
implementation issues due to the varying features, formats, and sizes of cigarette packages and
advertisements. FDA has created electronic, layered design files, built as Encapsulated
PostScript (.eps) files, in different formats and aspect ratios designed to fit packaging and
advertising of various shapes and sizes. The final rule does not require the use of these .eps files,
but we are providing the files as a resource to assist regulated entities implement 21 CFR 1141.
In addition to the material incorporated by reference and the .eps files, FDA is making available
technical specifications (i.e., instructions) document that includes information on how to access,
select, use, and adapt the .eps files based on the size and aspect ratio of the display area where
the required warning must appear. These .eps files and technical specifications are also available
on FDA's web site at https://www.fda.gov/cigarette-warning-files.
J. How do I incorporate the required warnings on packs with hinged lids?
To ensure that the required warning is clear and legible on a hinged lid package, FDA is allowing
for minor variations in how the required warnings appear. Manufacturers can separate two lines
of text within the textual warning statement such that the line at the location where the lid is to
open cuts across the background space between two lines rather than through a line of text. This
will help ensure that the textual warning statement is not severed when the package is opened
and is clear, conspicuous, and legible in accordance with section 4 of the FCLAA.
K. How do I incorporate the required warnings on “soft pack” style packaging?
As described in the final rule, to incorporate the required warnings without obstructing any of the
elements of the warning (i.e., the image and the textual warning statement), a company may
adapt the warnings on "soft pack" style packaging by moving the warning below the closure.
Because of the importance of maintaining the integrity of the required warning (e.g., not
distorting the image or text), an adaptation of 0.375 inches may be acceptable only when it is not
technologically feasible to incorporate the required warnings on "soft pack" style packaging
without the need to adapt the required warning and when the required warning after the
adaptation is still accurately reproduced (e.g., the required warning is not distorted). Anything in
excess of 0.375 inches may begin to distort the required warning and likely would not be in
compliance with the requirements of section 4 of the FCLAA and 21 CFR 1141. FDA strongly
encourages manufacturers to reach out to us to discuss these issues and any related questions.

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As illustrated in the preamble of the final rule, companies using "soft pack" style packaging
could move only the upper boundary of the display area of the warning so that it runs along a
line that is parallel to and not more than 0.375 inches from the top edge of the package. The
companies may compress the vertical size of the required warning and then shift it down (so that
it stays within the top 50 percent of the package), but companies who do this must ensure that, to
the extent the required warning is adapted to fit the dimensions of the warning area below the
closure, the proportions of the required warning are maintained. In addition, the closure and the
portion of the packaging that appears between the top edge of the package and the upper
boundary of the display area of the required warning must be either solid black or solid white.
This will allow companies to continue to produce "soft pack" style packaging with closures at
the top center of the pack without obstructing the required warning. However, if FDA determines
that it would be technologically feasible to incorporate the required warnings on "soft pack" style
packaging without the need to adapt the warning in this way, we plan to notify the regulated
companies and the public of this conclusion and give regulated companies a reasonable amount
of time to modify their packaging before any regulatory action is taken under this rule.
L. How do I determine if I should use the required warnings with the white background or
the black background?
As required by section 4 of the FCLAA, the text of the cigarette health warnings on
packages must be black on a white background, or white on a black background, in a manner that
contrasts, by typography, layout, or color, with all other printed material on the package.
Therefore, companies must determine which text and background color option contrasts with the
other printed materials. In addition, the required warnings will be provided in the final rule, and
companies must select the appropriate warnings and must ensure the required warnings are
accurately reproduced across various sizes and shapes of cigarette packages and cigarette
advertisements.
M. How do I ensure that the required warnings are “indelibly printed on” or
“permanently affixed to” digital advertisements?
To ensure that the required warnings are indelibly printed on or permanently affixed to digital
advertisements, the required warning must remain on the advertisement at all times and be clear,
conspicuous, and legible as required in section 4 of the FCLAA. FDA invites manufacturers to
raise any specific implementation issue they have as part of the submission of the cigarette plans
under 21 CFR 1141.10(g) to facilitate a solution that reflects the requirements and is also
technically feasible for the manufacturer or other responsible entity.
N. How do I implement the required warnings in “small” advertisements?
It is the advertiser’s responsibility to ensure that the required warning is clear, conspicuous, and
legible as required by section 4 of the FCLAA. FDA invites manufacturers to raise the specific
implementation issue they have as part of the submission of the plan under 21 CFR 1141.10(g) to
facilitate a solution that reflects the requirements and is also technically feasible for the
manufacturer or other responsible entity.

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O. In what language must the required warnings appear on cigarette packages and in
cigarette advertisements?
The rule requires that the text of the required warning be in English, except in the following
cases:
(1) If an advertisement appears in a medium (e.g., newspaper, social media Web
site, Internet Web pages) where the predominant language is not English, the
text in the required warning must appear in the predominant language of the
medium, whether or not the advertisement is in English. The predominant
language is the primary language used in the non-sponsored content in the
publication (e.g., stories or articles featured in or on newspapers, social media
Web sites, Internet Web pages).
• 	For example, if the predominant language of the medium is French,
but the advertisement is in English, the text of the required warning
would be required to be in French.
(2) If the advertisement appears in a medium (e.g., newspaper, social media Web
site, Internet Web page) where the predominant language is English but the
advertisement itself is not in English, then the text of the required warning
should not appear in English. In this case, the text in the required warning
must appear in the predominant language used in the advertisement.
• 	For example, if the predominant language of the medium is English,
but the advertisement is in Spanish, the text in the required warning
would have to appear in Spanish, which is the language predominantly
used in the advertisement.
21 CFR 1141.10(d)(3).
P. Can I obtain the required warnings with textual statements in languages other than
English?
English-language and Spanish-language warnings are contained in “Required Cigarette Health
Warnings, 2020,” which is incorporated by reference at 21 CFR 1141.5. FDA is also making
available electronic, layered design files, built as .eps files for all the required warnings
contained in “Required Cigarette Health Warnings, 2020,” including the Spanish-language
textual warning label statements for advertisements. The technical specifications document
includes instructions for selecting either the English-language or Spanish-language text layer
within the .eps files. See the response to question I, above, for more information on the .eps files
and accompanying technical specifications document.
For non-English warnings, other than Spanish-language warnings, each required warning must
be accurately reproduced as shown in the materials contained in “Required Cigarette Health
Warnings, 2020,” which is incorporated by reference at 21 CFR 1141.5, including the
substitution and insertion of a true and accurate translation of the textual warning label statement

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in place of the English-language version. The inserted textual warning label statement must
comply with the requirements of section 4 of the FCLAA, including area and other formatting
requirements. 21 CFR 1141.10(d)(5). The manufacturer, distributor, or retailer is required to
accurately and appropriately translate the textual warning label statement into the appropriate
non-English language, or the advertisement is in violation of the FCLAA and 21 CFR 1141. The
translated required warning also needs to meet the area, format, and other requirements of
section 4 of the FCLAA and 21 CFR 1141.
Q. What if my advertisement only contains text without images? Do I still have to use the
textual warning label statement and a color graphic, or can I only use the textual
warning label statement?
The advertisement must bear a required warning, which includes the combination of a textual
warning label statement and its accompanying color graphic. 21 CFR 1141.10.
R. Who can I contact for technical assistance if I need help accessing, selecting, using, or
adapting the electronic files for the required warnings?
For assistance accessing and using the electronic, layered design files (i.e., .eps files) for the required
warnings, contact CTP at cigarettewarningfiles@fda.hhs.gov. For questions regarding the technical
specifications document, contact CTP at ASKCTPRegulations@fda.hhs.gov.
S. How can I obtain Printer’s Proofs of the required warnings?
FDA intends to provide Printer's Proofs upon request. Regulated entities can request a set of
SWOP or GRACoL Printer's Proofs for the required cigarette health warnings (each set will
contain a total of 22 proofs: the 11 warnings with black text on white backgrounds and the 11
warnings with white text on black backgrounds). Requests can be submitted by email
(cigarettewarningfiles@fda.hhs.gov), phone (1-877-CTP-1373) or regular mail (Food and Drug
Administration, Center for Tobacco Products, Document Control Center, Building 71, Room
G335, ATTN: Office of Health Communication and Education, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002).
T. When do I have to submit a cigarette plan for cigarette packages and advertisements?
Section 201(a) of the Tobacco Control Act requires manufacturers, distributors, and retailers of
cigarettes to submit plans for the random and equal display and distribution of required warnings
on cigarettes packages and the quarterly rotation of required warnings on cigarette
advertisements, and to obtain FDA approval of their plans before products required to bear such
warnings enter the market. To ensure timely FDA review prior to the effective date of the
required warnings, FDA strongly encourages entities to submit their cigarette plans as soon as
possible after publication of the final rule. Doing so will benefit regulated industry, as firms may
need to work with printers to implement the required warnings as outlined in their approved
plans. Early submission will facilitate timely FDA review prior to the effective date of the
required warnings, encourage dialogue with entities regarding any implementation concerns, and
provide the Agency with the ability to consider proposals by entities in a timely manner. For the
recommended date for submitting cigarette plans for FDA review, please see FDA’s website at

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https://www.fda.gov/tobacco-products/labeling-and-warning-statements-tobacco-
products/cigarette-labeling-and-health-warning-requirements.
Given the initial high volume of original submissions FDA may receive and based on our
experience with review of plans for required warnings on other tobacco products, our best
estimate is that it will take up to 6 months for the Agency to review those original submissions.
FDA will ensure that its review of cigarette plans will be completed no later than 6 months after
receipt of an adequate plan from persons who work in good faith with FDA to complete its
review (e.g., persons should work diligently with FDA and be responsive by submitting any
requested information in a timely manner). If there is a higher volume of submissions received
than currently expected, for those entities who submit an adequate plan as soon as possible after
publication of the final rule, and in any event by the recommended date for submitting cigarette
plans for FDA review,10 and who work in good faith with FDA to complete its review, FDA
intends to ensure that entities are not delayed or prevented from distributing cigarette packages
or advertising their products due to the Agency’s not having approved their plans by the effective
date of the final rule.
In reviewing the cigarette plans, FDA will apply the criteria specified in section 4(c)(3) of the
FCLAA and in 21 CFR 1141.10(g). For FDA to approve a cigarette plan for cigarette packaging,
the plan must provide for the required random and equal display and distribution of required
warnings on cigarette packaging and must assure that all of the required warnings will be
displayed by the manufacturer, distributor, or retailer at the same time. Section 4(c)(3) of the
FCLAA and 21 CFR 1141.10(g)(3). For FDA to approve a cigarette plan for cigarette
advertising, the plan must provide that all of the required warnings are rotated quarterly, in
alternating sequence, in advertisements for each brand of cigarettes. Section 4(c)(2) of the
FCLAA and 21 CFR 1141.10(g)(3). Although we acknowledge that there may be some
challenges as industry moves to implement these requirements, FDA intends to assist
manufacturers, distributors, and retailers, as applicable, with specific questions and concerns
regarding these requirements. Manufacturers with concerns about complying with this
requirement for their products should reach out to FDA to discuss their approach and proposal
for reasonably achieving the random and equal display and distribution of the required warnings,
in as equal a number of times as is possible, and any other specific concerns or circumstances
regarding compliance with the final rule.
In general, we recommend that for efficiency of review and to the extent possible, each
manufacturer, distributor, or retailer submit a single cigarette plan under proposed 21 CFR
1141.10(g) that covers both packaging and advertising, rather than submitting each plan
separately, when applicable.
U. Where can I find information on the submission of cigarette plans for cigarette
packages and advertisements?
10 Please see FDA’s website at https://www.fda.gov/tobacco-products/labeling-and-warning-statements-tobacco-
products/cigarette-labeling-and-health-warning-requirements for updates regarding the effective date of the rule and
related timelines, including the recommended date for submitting cigarette plans for FDA review.

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FDA intends to issue a final guidance document with additional information and
recommendations that may be helpful in preparing these plans, which, when issued, may be
found at https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance.
IV. 	DOCUMENT HISTORY
March 2020 – First edition of guidance issued.
May 2020 – Guidance is revised to reflect the court order granting a joint motion in the case of
R.J. Reynolds Tobacco Co. et al. v. United States Food and Drug Administration et al., No. 6:20-
cv-00176 (E.D. Tex. May 8, 2020), to govern proceedings in that case and postpone the effective
date of FDA’s final rule on required warnings for cigarette packages and advertisements by 120
days (until October 16, 2021), in light of the COVID-19 pandemic. Specific revisions include the
following:
• 	Section II – Added reference to order postponing the effective date of the final rule by
120 days.
• 	Section II (and throughout) – Changed effective date of the final rule to October 16,
2021.
• 	Section II (and throughout) – Changed language stating that FDA strongly encourages
entities to submit cigarette plans to FDA as soon as possible after publication of the final
rule, and in any event within “5 months after the publication of the final rule” (i.e.,
August 18, 2020) to “5 months and 120 days after the publication of the final rule” (i.e.,
December 16, 2020).
February 2021 – Guidance is revised to reflect the court order that granted a motion by the
plaintiffs in the case of R.J. Reynolds Tobacco Co. et al. v. United States Food and Drug
Administration et al., No. 6:20-cv-00176 (E.D. Tex. December 2, 2020), to further postpone the
effective date of the final rule on required warnings for cigarette packages and advertisements
(until January 14, 2022). Specific revisions include the following:
• 	Section II – Added reference to order postponing the effective date of the final rule to
January 14, 2022.
• 	Section II (and throughout) – Changed effective date of the final rule from October 16,
2021, to January 14, 2022.
• 	Section II (and throughout) – Changed language stating that FDA strongly encourages
entities to submit cigarette plans to FDA as soon as possible after publication of the final
rule, and in any event “within 5 months and 120 days after the publication of the final
rule (i.e., December 16, 2020)” to “by March 16, 2021.”
July 2021 – Guidance is revised to remove references to specific dates and replace dates with the
following statement: “The effective date of the final rule is subject to a court order. Please see

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FDA’s website at https://www.fda.gov/tobacco-products/labeling-and-warning-statements-
tobacco-products/cigarette-labeling-and-health-warning-requirements for updates regarding the
effective date of the rule and related timelines, including the recommended date for submitting
cigarette plans for FDA review.”
September 2024 – Guidance is revised to update the litigation information in footnote 4 and to
delete the following sentence: “The effective date of the final rule is subject to a court order.”