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 
http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm. 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 
 
July 2021 
 
 
 
 
 
 
 
*This is a revision to the third edition of this final guidance, which issued in February 2021. A 
summary of the revisions is at the end of the guidance.
 
   Contains Nonbinding Recommendations 
 
 
 
Table of Contents 
 
 
I.  INTRODUCTION..................................................................................1 
II.  BACKGROUND....................................................................................2 
  A. Definitions.........................................................................................3 
III.  QUESTIONS AND ANSWERS..................................................................4 
IV.   DOCUMENT HISTORY........................................................................15 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
i 
   Contains Nonbinding Recommendations 
 
 
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 
FDAs 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 FDAs 
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 FCLAAs 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 The 
effective date of the final rule is subject to a court order. Please see FDAs 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). 
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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   Contains Nonbinding Recommendations 
 
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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   Contains Nonbinding Recommendations 
 
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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   Contains Nonbinding Recommendations 
 
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. FDAs 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. CTPs 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 Nonbinding Recommendations 
 
 
  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? 
 
 The effective date of the final rule is subject to a court order. Please see FDAs 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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   Contains Nonbinding Recommendations 
 
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. 
 
7 The effective date of the final rule is subject to a court order. Please see FDAs 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 The effective date of the final rule is subject to a court order. Please see FDAs 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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The textual warning label statements are as follows: 
 
  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 
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as Encapsulated PostScript (.eps) files,9 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 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 
 
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) 
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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top of each advertisement within the trim area, if any. Section 4(b) of the FCLAA and 21 
CFR 1141.10(d)(2).  
 
  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 
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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.   
 
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 advertisers 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 
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facilitate a solution that reflects the requirements and is also technically feasible for the 
manufacturer or other responsible entity. 
 
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.    
 
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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 
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 Printers 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 
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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 FDAs website at 
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, 10and 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 Agencys 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.  
 
10 Please see FDAs 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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U.  Where can I find information on the submission of cigarette plans for cigarette  
packages and advertisements? 
 
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 FDAs 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 
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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 
FDAs 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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