Contains Nonbinding Recommendations  
 
 
  
 
  
 
 
 
 
  
  
  
   
 
 
  
  
  
  
 
 
 
 
  
 
 
 
 
 
 
  
 
i  Required Warnings for Cigarette 
Packages and Advertisements 
Small Entity Compliance Guide 
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 20993-2000. 
U.S. Department of Health and Human Services  
Food and Drug Administration 
Center for Tobacco Products  
March 2020  Contains Nonbinding Recommendations  
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Table of Contents  
I. I NTRODUCTION.............................................................................................................  1 
II. BACKGROUND  ................................................................ ................................ ...............  2  
A. Definitions……………………………………………………………………………..2  
III. QUESTIONS AND ANSWERS…………………………………………………………4  
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Required Warnings for Cigarette 
Packages and Advertisements  
Small Entity Compliance Guide   
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1 Guidance for Industry1
  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.  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
  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.  FDA (Agency, we) is issuing this guidance to help small businesses understand and comply with 
FDA’s final rule,  “Required Warnings for Cigarette Packages and Advertisements,” which 
establishe s new required cigarette healt h warni ngs for cigarett e package s and advertisements. 
The final rule implement s a provision of t he Famil y Smoking Preventi on and Tobacco Control 
Act (Tobacco Cont rol Act) (Publi c Law 111-31) tha t require s FDA to iss ue regulati ons requiring 
color graphic s depicting t he negati ve healt h consequence s of smoking t o accompany ne w textual 
warning statements . The Tobacco Cont rol Act amen ds the Federa l Cigarett e Labeling and 
Advertising Ac t (FCLAA) (15 U.S.C. 1333) to requi re each cigarett e packag e and advertisement 
to bear one of the new required warnings . FDA has prepared thi s Smal l Entity Complianc e Guide 
in accordanc e with section 212 of t he Smal l Busines s Regulatory Enforceme nt Fairnes s Act 
(Publi c Law 104-121). 2
FD
A’s guidanc e documents, includi ng this guidance , do not establish legally enforceable  
responsibilities. Instead, guidance s describe   FDA ’s curren t thinking on a topic and should be  
viewed only a s recommendations, unles s specifi c regulatory or statutory requirement s are cited. 
The use of the word shoul d  in FDA ’s guidance s means that something i s suggested or 
recommended, but not required.   
 
  
 
 
 
  
 
  
 
    
 
  
 
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2 II. BACKGROUND
The Tobacco Control Act was enacte d  on June 22, 2009, and grante d FDA important new  
authorit y to regulat e  the manufacture, marketi ng, and distribution of tobacco products. The  
Tobacco Control Act  also amended section 4 of t he  FCLA A  to direc t  FDA to issue new cigarette  
health warnings that would include a  color graphi c  component depicting the negative health 
consequences of smoki ng to accompany the new textual warnings (section 201 of t he  Tobacco 
Control Act). In enacting this legislation, Congress also provided that FDA may adjust the  
require d warnings if FDA found that such a  change  would promote greater public unde rstanding 
of the risks associated with the use of tobacco products (section 202 of the Tobacco Control  
Act). Additionally, as required unde r  the  FCLAA, the rule establishes marketing requirements  
that include  the random and equa l  displa y and distribution of the required warni ngs  on cigarette  
packages and quarterly rotations of the required warni ngs  in cigarette advertisements.  
Section 201(a) of the Tobacco Control Act require s  manufacturers, distributors, and retailers of 
cigarette s  to submit plans for t he  random  and equa l  display and distribution of required warnings  
on cigarettes packages and th e  quarterl y rotation of require d  warnings on cigarette  
advertisements, a  nd to obtain FDA approval of their plans before produc ts required to bea r such  
warnings enter the market . The  Tobacco Control Act also modifie d the  FCLAA’s requirements  
regarding the submission of plans for cigarett e  packages and advertisements and requires that  
such plans be submitted t o FDA (as delegated by the Secretary of Health and Human Services) 
for revi
ew and approval, rather tha n to the  Federa l  Trade Com mission.  
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.   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 .  Accordingly, the  
requirements for the warnings for cigarettes will become effective on June 18, 2021. FDA also  
strongly encourages entities to submit  their cigarette  plans  as soon  as possible after 
publication of th e final rule, a nd in any eve nt  withi n  5 m onths after publication of t he final rule  
in the  Feder al Registe r  to ensure timel y FDA revie w prior to t he  effecti ve date of the required 
warnings.  43
  In the  Federal Register  of August 16, 2019 (84 FR 42754), FDA issued a notice of  proposed rulemaking (NPRM)  
to amend 21 CFR 1141.  
  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.  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   
 
 
  
 
   
  
 
 
 
 
  
  
 
 
    
 
 
  
 
 
   
 
  
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to be offered to, or purchased by, consumers as a cigarette described in subparagra ph (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 Dis trict 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 fro m 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 pa nel 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 ).  
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 pers on 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 W eb 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   
 
 
  
 
 
  
 
 
  
 
  
  
  
 
   
  
  
  
 
   
 
  
 
 
   
   
 
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oa, 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. S ection 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). 
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, 
dis 
tributes, 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   
 
 
   
 
 
  
 
 
 
 
    
 
 
 
 
  
     
 
    
   
 
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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 do es  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:  
• 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 1141.5
  For example, this would require that a retailer ensure that all cigarette packages  it  displays  or sells  contain a  
warning tha t is unobs cured by stickers, sleeves, or other materials on the packa ges.  21 CFR 1141.1(c). 
The requir
ements unde r 21 CFR 
1141.10 only apply to a cigarette retailer if th at retailer 
is responsible for or directs the warnings for advertising. 21 CFR 1141.1(d). However, this does   
 
 
    
     
 
    
    
 
  
   
      
 
 
 
 
  
 
 
 
    
 
 
 
 
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6 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 c igarette 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 manuf acturer , packer, 
or distributor). 
D.What is the timeframe for implementing this rule?
1. When does the new rule become effective?
Consistent with the language of section 201(b) of the Tobacco Control Act, the effective  
date of the final rule is  June 18 , 2021, 15 months from the date of publication of the final rule in  
the Federal  Register. Section 201(a) of the Tobacco Control Act requires manufacturers, 
distributors, and retailers of cigarette s  to submit plans for t he  random and equal  display and 
distribution of required warnings on cigarettes packages and the  quarterl y rotation of required 
warnings on cigarett e  advertisements ,  and to obtai n FDA approval of their plans before produc ts  
required to bea r such  warnings enter t he  market.  
Therefore, FDA strongly encourages entities to submit their cigarette plans as soon as  
possible after publication of the  final rule, and in any event  within  5  months after publication of 
the  final rule  in the  Federal Register  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
cigarett e packages and advertisements? 
Cigarette  packages and advertisements  must  bear the required warnings beginning 
15 months after March  18, 2020 , the  date of publication of the final rule in the Federal   
Register . Section 201(b) of the Tobacco Control Act. 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 as of June  18, 2021  . 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  , June 18 , 2021, 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  
 
 
   
 
 
 
 
     
     
 
 
 
    
 
  
   
 
 
 
  
   
  
   
  
  
  
  
   
   
   
 
 
 
  
 
   
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7 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: 
•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.   
 
 
  
 
 
 
 
 
       
 
 
 
 
 
 
 
 
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8 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 a nd  Drug Administration, Center for Tobacco 
Products, Docume nt Contro l Center, Bldg. 71, Rm . G335, 10903 Ne w Hampshi re Ave., Silver 
Spring, M D 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 differe nt  layouts based on the size  
and aspect ratio of the display area where the required warning must appear (i.e., on cigarette  
packages, i n cigarett e  advertisements). The rule includes an electronic portable document form at  
(.pdf) file containing all the required warnings as a referenc e  in the docket for the final rule (Ref. 
Require d Cigarett e  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 t o avoid technical implementati on 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,6
 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 
permitte d under the Copyright Act.   in different formats and aspect ratios designed to fit  
packagi ng and advertising of various shapes and sizes . The final rule does not require  the use of 
these .eps files, but we are provi ding the files as a resource to assist regulated entities implement  
21 CFR part 1141 and section 4 of t he  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 th at  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    
 
 
   
 
 
 
 
 
 
   
 
 
 
 
    
 
 
      
   
 
 
   
 
 
  
 
    
    
  
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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 21CFR 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-approvedcigarette  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
packag es 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 
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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?  
A
s described in the final rule, to incorporate the r equire d warning s  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.  
As illustrated in the preamble of the final rule, companies using 
“soft pack” style 
packagi ng could move only the uppe r boundary of the display area of the warning so tha t 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 th e required warni ng and then shi ft it down (so 
that it stays within the top 50 percent of the package), but companies who do this must ensure 
that, t o the extent the required warni ng is adapte d to fit the dimensions of the warning area below 
the closure , the proport ions of the required warni ng are maintained. In addition, t he closure and 
the portion of the packagi ng that appears between the top edge of the package and the uppe r 
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. H ow do I determin e if I should use the require d warnings with the white background or
 the black background?
As re
quired by section 4 of the FCLAA, the text of the cigarette health warnings on 
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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. 
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 predominantlanguage is the primary language used in the non-sponsored content in the
publication (e.g., stories or articles featured in or on newspapers, social mediaWeb 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.
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(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 theadvertisement 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 warningwould 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 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?  
 
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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 
Administrati on, Center for Tobacco Products, Document Cont rol 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 t he  Tobacco Control Act require s  manufacturers, distributors, and 
retailers of cigarette s  to submit plans for t he  random  and equa l  display and distribution of 
required warnings on cigarettes packages and th e  quarterl y  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, and in any event  within  5 months after 
publication of the  final  rule in the Federal  Register . 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.    
Give n the initia l high volum e of origina l submission s FDA may recei ve and based on our 
experienc e with revie w of pla ns for required warning s on other tobacco products, our best  
estimat e is that it will  take up to 6 m onths for th e Agency to revie w those origina l submissions.  
FDA will ensure  that its revie w of cigarett e plans  will be completed no later tha n 6  mont hs after 
receip t of an adequat e plan  from  persons who work in good faith wit h FDA  to complet e its  
revie w (e.g.,  persons shoul d  work diligently with FD A and be responsi ve by submitti ng any 
requested informati on  in a  timely manner ). If ther e is a highe r  volum e of submissi ons received 
than currently expected, for thos e entitie s who submi t an adequat e plan within 5 mont hs of 
publication of thi s final rule and who work in good faith wit h FDA to complet e 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 (June 18, 2021).  
In re viewi
ng 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 
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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?
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 . 
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