Contains Nonbinding Recommendations 
 
Submission of Plans for Cigarette 
Packages and Cigarette 
Advertisements (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. EDT. 
 
Additional copies are available online at https://www.fda.gov/tobacco-products/products-
guidance-regulations/rules-regulations-and-guidance. You may send an e-mail request to 
SmallBiz.Tobacco@fda.hhs.gov to receive an electronic copy of this guidance. You may send a 
request for hard copies to U.S. Food and Drug Administration, Center for Tobacco Products, 
Attn: Office of Small Business Assistance, Document Control Center, Bldg. 71, Rm. G335, 
10903 New Hampshire Ave., Silver Spring, MD 20993-0002.  
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Tobacco Products 
 
July 2021 
 
 
 
 
OMB Control Number: 0910-0877 
Expiration Date: 4/30/2023 
See additional PRA statement in Section IV of the guidance 
 
 
 
 
 
*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..............................................................................................................3 
II.  BACKGROUND ................................................................................................................4 
A.  Definitions .....................................................................................................................5 
B.  Overview of Required Warnings ................................................................................6 
C.  Overview of Cigarette Plan Requirements ................................................................7 
III.  DISCUSSION .....................................................................................................................8 
A. Who Submits a Cigarette Plan? ...................................................................................8 
B. What Is the Scope of a Cigarette Plan? .....................................................................10 
C. When Should a Cigarette Plan Be Submitted? ........................................................11 
D. What Information Should Be Submitted as Part of a Cigarette Plan? ..................12 
E. Where Should a Cigarette Plan Be Submitted? .......................................................14 
F. What Does It Mean to Receive FDA Approval of a Cigarette Plan? ......................15 
IV.   PAPERWORK REDUCTION ACT OF 1995 ...............................................................15 
V.  DOCUMENT HISTORY ................................................................................................16 
 
 
APPENDIX  EXAMPLE OF CIGARETTE PLAN FOR CIGARETTE PACKAGES AND 
CIGARETTE ADVERTISEMENTS   
2 
 
  Contains Nonbinding Recommendations 
 
Submission of Plans for Cigarette 
Packages and Cigarette 
 
Advertisements (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 assist persons (you) submitting cigarette plans2 for 
cigarette packages and cigarette advertisements, as required by the Family Smoking Prevention 
and Tobacco Control Act (Tobacco Control Act) (Public Law 111-31), amending the Federal 
Cigarette Labeling and Advertising Act (FCLAA) (15 U.S.C. 1333). This guidance provides 
recommendations related to 21 CFR 1141 and the FCLAA requirements regarding the 
submission of cigarette plans for cigarette packages and advertisements. This guidance document 
also discusses, among other things: 
 
  The regulatory requirements to submit cigarette plans  
  Definitions  
  Who submits a cigarette plan  
  The scope of a cigarette plan 
  When to submit a cigarette plan 
  What information should be submitted as part of a cigarette plan 
  Where to submit a cigarette plan 
  What approval of a cigarette plan means  
 
 
1 This guidance was prepared by the Office of Compliance and Enforcement and the Office of Regulations in the 
Center for Tobacco Products at FDA. 
2 As described in Section II, for the purposes of this guidance, cigarette plan or cigarette plans refers 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. 
3 
  Contains Nonbinding Recommendations 
 
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 
specific regulatory or statutory requirements are cited. The use of the word should in Agency 
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 regulations 
requiring color graphics depicting the negative health consequences of smoking to accompany 
new textual warning statements. 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. Section 201(b) of the Tobacco 
Control Act provides that the warning requirements are to become effective 15 months after the 
date the final rule publishes in the Federal Register.3   
 
The Tobacco Control Act also modified the FCLAAs requirements regarding the submission of 
cigarette plans for cigarette packages and advertisements and requires that such cigarette 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 (FTC).   
 
FDA issued a final rule4 on required warnings for cigarette packages and advertisements on 
March 18, 2020 (85 FR 15638). The rule specifies the textual warning label statements that are 
required and the color graphics that must accompany them. The final rule establishes marketing 
requirements that include the random and equal display and distribution of the required warnings 
for cigarette packages and quarterly rotation of the required warnings in cigarette advertisements. 
The marketing requirements also require submission of a cigarette plan 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.  
 
On April 3, 2020, the final rule was challenged in the U.S. District Court for the Eastern District 
 
3 In the Federal Register of June 22, 2011 (76 FR 36628), FDA issued a final rule entitled Required Warnings for 
Cigarette Packages and Advertisements, which specified nine images to accompany the nine textual warning 
statements for cigarettes set out in the Tobacco Control Act. However, the final rule was challenged in court and on 
August 24, 2012, the U.S. Court of Appeals of the District of Columbia vacated the rule. In the following years, 
FDA conducted comprehensive research and development activities in support of the new cigarette health warnings 
final rule issued in March 2020.   
4 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 also issued a proposed rule on required 
warnings for cigarette packages and advertisements on August 16, 2019 (84 FR 42754). 
 
4 
  Contains Nonbinding Recommendations 
 
of Texas.5 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. For efficiency of review, FDA requests that, to the extent possible, 
manufacturers, distributors, and retailers submit a single cigarette plan that covers both 
packaging and advertising. This guidance provides recommendations related to preparing and 
submitting those cigarette plans.  
 
A. Definitions 
 
For purposes of this guidance, FDA intends to use the following definitions.  
 
Amendment. FDA considers a submission to be an amendment if the manufacturer, 
distributor, or retailer is submitting additional information to a cigarette plan that is 
currently under review at FDA.  
 
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 means 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 purposes of this part. (21 CFR 1141.3) 
 
Manufacturer means any person, including any repacker or relabeler, who 
manufactures, fabricates, assembles, processes, or labels a finished cigarette product; or 
 
5 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 
  Contains Nonbinding Recommendations 
 
imports any cigarette that is intended for sale or distribution to consumers in the United 
States. (21 CFR 1141.3) 
 
Original submission. FDA considers the submission of a cigarette plan for a specific 
brand(s) to be an original submission if it is the first time the manufacturer, 
distributor, or retailer has submitted a cigarette plan for cigarette packaging or 
advertising to FDA for that brand(s).  
 
Package or packaging 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 and 21 CFR 1141.  
 
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. (21 CFR 1141.3) 
 
Supplement. FDA considers a submission to be a supplement if the manufacturer, 
distributor, or retailer is seeking approval of a change to an FDA-approved cigarette plan. 
 
United States. As defined in section 3(3) of the FCLAA, the term 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) 
 
B. Overview of Required Warnings 
 
Under section 4 of the FCLAA, each cigarette package and advertisement must bear a textual 
warning label statement accompanied by a color graphic depicting the negative health 
consequences of cigarette smoking. The final rule on required warnings for cigarette packages 
and advertisements contains 11 required warnings, consisting of textual warning label 
statements paired with concordant photorealistic images.  
 
Under the final rule, the required warnings must comprise at least the top 50 percent of the front 
and rear panels of cigarette packages and at least 20 percent of the area of the advertisement in a 
conspicuous and prominent format and location at the top of each cigarette advertisement within 
the trim area, if any. 21 CFR 1141.10(c) and (d). Required warnings must be indelibly printed on 
or permanently affixed to cigarette packages and cigarette advertisements. 21 CFR 1141.10(e).  
 
6 
  Contains Nonbinding Recommendations 
 
According to section 201(b) of the Tobacco Control Act, if a cigarette product was manufactured 
prior to the effective date of the final rule, but its package does not contain a required warning, 
the product may be introduced into commerce in the United States within 30 days from such 
effective date. After the 30-day period, manufacturers must not introduce into domestic 
commerce any cigarette the package of which does not contain a required warning, irrespective 
of the date of manufacture. 
 
C. Overview of Cigarette Plan Requirements  
 
The requirement for submission of cigarette plans for cigarette packages and advertisements and 
the specific requirements relating to the random and equal display and distribution of required 
warnings on cigarette packaging and quarterly rotation of required warnings in cigarette 
advertising appear at section 4(c) of the FCLAA and 21 CFR 1141.10. Pursuant to section 201(b) 
of the Tobacco Control Act, packages and advertisements of cigarettes will be required to bear 
the required warnings once the rule goes into effect.6 In addition, under section 201(c) of the 
Tobacco Control Act and 21 CFR 1141.10(g), the Agency must review and approve cigarette 
plans in advance of any person displaying or distributing packages or advertisements for 
products that are required to carry the required warnings on packages and in advertisements.   
 
FDA strongly encourages entities to submit cigarette plans as soon as possible after publication 
of the final rule. 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. Early 
submission will facilitate timely FDA review of plans prior to the effective date of the required 
warnings, encourage dialogue with entities regarding any implementation concerns, and provide 
time to consider proposals by entities in a timely manner. 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 by the recommended date for submitting cigarette plans for FDA 
review,7 and who work in good faith with FDA to complete its review, FDA intends to ensure 
that entities are not delayed or prevented from distributing cigarette packages or advertising their 
products due to the Agencys not having approved their plans by the effective date of the final 
rule. 
 
 
6 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. 
7 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. 
 
7 
  Contains Nonbinding Recommendations 
 
More specifically, under section 4(c)(1) of the FCLAA and 21 CFR 1141.10(g), cigarette plans 
for cigarette packages must provide that all of the required warnings are:  
 
  Randomly displayed during each 12-month period on each brand of the product;  
  Displayed on each brand of the product in as equal a number of times as possible during 
each 12-month period;  
  Randomly distributed in all areas of the United States in which the product is marketed; 
and  
  Displayed at the same time.  
 
In reviewing the cigarette plans, FDA will apply the criteria specified in section 4(c)(3) of the 
FCLAA and 21 CFR 1141.10(g)(3). For FDA to approve a cigarette plan for cigarette packaging, 
the plan must provide that all of the required warnings are randomly displayed in each 12-month 
period, in as equal a number of times as is possible on each brand of the product and randomly 
distributed in all areas of the United States in which the product is marketed; and the plan must 
assure that all of the required warnings will be displayed by the manufacturer, distributor, or 
retailer at the same time. Sections 4(c)(1) and (c)(3) of the FCLAA and 21 CFR 1141.10(g)(1) 
and (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. Sections 4(c)(2) and (c)(3) of the FCLAA and 21 CFR 1141.10(g)(2) and 
(g)(3). In general, we recommend that for efficiency of review and to the extent possible, each 
manufacturer, distributor, or retailer submit a single cigarette plan that covers both packaging 
and advertising, rather than submitting each plan separately, when applicable.  
 
III.  DISCUSSION 
 
A. Who Submits a Cigarette Plan? 
 
This section describes what FDA believes are the relevant considerations in determining whether 
the manufacturer, distributor, or retailer is best suited to submit a cigarette plan. These 
considerations will help ensure the applicable requirements are met as well as avoid duplication 
or situations where multiple persons unnecessarily submit a cigarette plan applicable to the same 
distribution chain. 
 
1.  Packages  
 
As explained above, when the cigarette plan requirements are in effect, it will be unlawful for 
any person to manufacture, package, sell, offer to sell, distribute, or import for sale or 
distribution within the United States any cigarettes unless the package bears one of the required 
warnings in accordance with section 4 of the FCLAA and 21 CFR 1141. In addition, required 
warnings on 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 be randomly distributed in all 
areas of the United States in which the product is marketed in accordance with a cigarette plan 
8 
  Contains Nonbinding Recommendations 
 
submitted by the manufacturer, distributor, or retailer to, and approved by, FDA. Section 4(c)(1) 
of the FCLAA and 21 CFR 1141.10(g)(1).  
 
For a particular brand, this cigarette plan may be submitted by the manufacturer, distributor, or 
retailer. Although the cigarette plan may be submitted by someone other than you, before you 
manufacture, package, sell, offer to sell, distribute, or import for sale or distribution within the 
United States a brand of cigarettes, to ensure you are in compliance with the FCLAA and 21 
CFR 1141, it is important that you make sure there is an applicable FDA-approved cigarette plan 
for that cigarette brand and that you comply with the approved plan.  
 
Based on FDAs experience reviewing plans for other tobacco products, we believe it is likely 
that for domestic products only one cigarette plan will be submitted for each brand and that the 
brands manufacturer will submit this plan (because, in most instances, the brands manufacturer 
is the entity best able to ensure that a plan meets the relevant requirements). One plan may also 
be submitted for multiple brands. 
 
The brands manufacturer is also typically the entity responsible, either directly or through a 
contractor or other agent, for placing or directing the placement of the required warnings on the 
brands cigarette packages and for directing distribution. The cigarette plan should describe how 
the required warnings will be randomly placed, in as equal a number of times as possible, on 
packages and how the required warnings on packages will be randomly distributed to all areas in 
the United States where the product is marketed.  
 
If a product is manufactured under contract, such as for a private label brand, it is likely that the 
contracting entity, typically the private label brands distributor, specifies or otherwise directs the 
placement of the required warnings on the product package. Therefore, in these situations, FDA 
believes the private label brand distributor would be best suited to submit the cigarette plan.  
 
For cigarettes that are imported, the importer (included in the definition of manufacturer) usually 
directs distribution of the packages after they are imported. Therefore, for imported cigarettes, 
the importer is likely best-positioned to submit the plan.  
 
Under section 4 of the FCLAA and 21 CFR 1141.1(c), retailers are not in violation of the 
requirements of section 4 of the FCLAA or 21 CFR 1141.10 for cigarette packaging that (1) 
contains a warning; (2) is supplied to the retailer by a license- or permit-holding tobacco product 
manufacturer or distributor; and (3) 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. We believe most, if not all, retailers 
would fall under this scenario. 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. We note that retailers who are also manufacturers would be 
subject to both the requirements for retailers and manufacturers, as applicable. 
 
2.   Advertisements  
 
When the required warnings are in effect, it will be unlawful for any manufacturer, distributor, or 
retailer to advertise or cause to be advertised within the United States any cigarette product 
9 
  Contains Nonbinding Recommendations 
 
unless its advertising bears one of the required warnings in accordance with the requirements of 
section 4 of the FCLAA and 21 CFR 1141.8 Under these requirements, the required warnings in 
advertisements must be rotated quarterly in alternating sequence for each brand in accordance 
with a cigarette plan submitted by the tobacco product manufacturer, distributor, or retailer to, 
and approved by, FDA. Section 4(c)(2) of the FCLAA and 21 CFR 1141.10(g)(2).  
 
For a particular brand, the cigarette plan may be submitted by the manufacturer, distributor, or 
retailer. Thus, although the cigarette plan may be submitted to FDA by someone other than you, 
before you advertise a brand of cigarettes, it is important that you make sure there is an 
applicable FDA-approved cigarette plan for the quarterly rotation of the required warnings for 
cigarette advertisements and that you comply with the approved plan.  
 
In most circumstances, the person who creates advertising, causes advertising to be created, or is 
otherwise responsible for inclusion of the required warnings in advertising for a brand of 
cigarettes is most able to ensure a cigarette plan contains sufficient information for approval by 
FDA. FDA recommends such persons submit a cigarette plan that covers all of the brands it 
advertises.   
 
A retailer typically would not submit a cigarette plan for advertising supplied by the 
manufacturer of a tobacco product if the advertising is already covered by an FDA-approved 
cigarette plan submitted by the manufacturer. The retailer should comply with the cigarette plan, 
such as by following the manufacturers instructions for displaying advertising. However, under 
section 4 of the FCLAA and 21 CFR 1141.1(d), a retailer would not be relieved of liability if the 
retailer displays, in a location open to the public, an advertisement that does not contain a 
warning or that contains a warning that has been altered by the retailer in a way that is material 
to the requirements of section 4 of the FCLAA or the requirements of 21 CFR 1141.  
 
B. What Is the Scope of a Cigarette Plan? 
 
For efficiency of review, FDA asks that, to the extent possible, each cigarette plan cover both 
packages and advertisements, rather than submitting each plan separately. The cigarette 
manufacturer, distributor, or retailer should describe its plan to achieve the random and equal 
display and distribution of the required warnings on packages and the quarterly rotation of the 
required warnings in advertisements. 
 
 
8 For advertisements, Section 1141.10(d)(1) of the final rule states as follows: (1)  For print advertisements and 
other advertisements with a visual component (including, for example, advertisements on signs, retail displays, 
internet web pages, digital platforms, mobile applications, and email correspondence), the required warning must 
appear directly on the advertisement. Further, the preamble to the final rule also explains that [t]he final rule 
applies to advertisements appearing in or on, for example, promotional materials (point-of-sale and non-point-of-
sale), billboards, posters, placards, published journals, newspapers, magazines, other periodicals, catalogues, 
leaflets, brochures, direct mail, shelf-talkers, display racks, internet web pages, electronic mail correspondence, or 
be communicated via mobile telephone, smartphone, microblog, social media website, or other communication tool; 
websites, applications, or other programs that allow for the sharing of audio, video, or photography files; video and 
audio promotions; and items not subject to the sale or distribution restriction in  1140.34. 
 
10 
  Contains Nonbinding Recommendations 
 
A cigarette plan may cover a single brand or multiple brands. Manufacturers may state in their 
original submission that the plans apply to all brands in their product listing(s) under section 
905(i) of the FD&C Act and incorporate any new brands into their approved plan, so long as no 
other changes are made to the plan. For retailer-generated advertising, retailers may list all 
brands in their plan, which would cover future brands, so long as the plan provides for the same 
schedule for quarterly rotation of the required warnings for all brands.  
 
C. When Should a Cigarette Plan Be Submitted? 
 
FDA strongly encourages entities to submit cigarette plans as soon as possible after publication 
of the final rule. 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. 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 time to 
consider proposals by entities in a timely manner. 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 by the recommended date for submitting cigarette plans for FDA review,9, and 
who work in good faith with FDA to complete its review, FDA intends to ensure that entities are 
not delayed or prevented from distributing cigarette packages or advertising their products due to 
the Agency's not having approved their plans by the effective date of the final rule.  
 
After FDA approval of an initial plan, a supplement to the approved plan should be submitted to 
FDA for review and approval before making changes to the random and equal display or 
distribution of required warnings on packages or the quarterly rotation of required warnings in 
advertisements. For a new brand, a new plan or a supplement to an FDA-approved plan is 
required to be submitted and approved before displaying or distributing packages and 
advertisements for that new brand.   
 
However, in lieu of a supplement to an FDA-approved plan for a new brand, manufacturers may 
reference in their initial plan all brands in their product listing(s) under section 905(i) of the 
FD&C Act and incorporate any new brands into their approved plan, so long as no other changes 
are made to the plan.  
  
For planning purposes, as with original submissions, we recommend that you allow up to 6 
months for FDA to review and approve a supplement. The amount of time it will take FDA to 
 
9 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. 
 
11 
  Contains Nonbinding Recommendations 
 
review a supplement, however, will depend upon the quality of the submission and the diligence 
and responsiveness of the submitter. 
 
FDA intends to request an amendment to a plan under review if FDA needs clarification of 
information in the plan or other additional information to determine whether FDA can approve 
the plan. The need for any such amendments will likely increase the overall review time.   
 
D. What Information Should Be Submitted as Part of a Cigarette Plan? 
 
The following information should be submitted to FDA as part of a cigarette plan. The appendix 
to this guidance provides an example of what FDA considers to be an adequate cigarette plan. 
 
1.  Cover Letter 
To facilitate FDAs review, FDA requests that your cigarette plan be accompanied by a 
cover letter. Section I of the appendix provides an example of a cover letter that would 
accompany the submission of a cigarette plan. Please note that these are suggested elements 
of the cover letter and any omissions will not prevent the plan from being accepted and 
approved. However, FDA encourages the submission of the following suggested elements 
to facilitate timely FDA review of your cigarette plan: 
  The date of the submission; 
  The following subject line: RE: CIGARETTE PLAN FOR CIGARETTES (Original, 
Amendment, or Supplement); 
  A list of any previous submissions made to FDA relating to the cigarette plan, identified 
by the Submission Track Number (STN) and the date of submission, if applicable; 
  A statement as to whether the cigarette plan covers packaging only, advertising only, or 
both packaging and advertising;  
  The name, address, and phone number of the person making the submission; 
  The name of the most responsible official if the submitter is a company;  
  Identification of the submitter as the manufacturer, distributor, or retailer of the tobacco 
products covered by the cigarette plan; 
  The Data Universal Numbering System (D-U-N-S) number of the person making the 
submission;  
  The name, address, phone number, fax number, and email address of the individual 
authorized to act as the contact point for the cigarette plan; 
  A list of all cigarette brands covered by the plan, preferably identifying cigarettes using 
the unique name and identifying number (e.g., SKU, catalog number, UPC) that was 
provided when the product was listed under section 905 of the FD&C Act (21 U.S.C 
387e). Alternatively, if desired, a manufacturer may refer to all brands in its product 
listing(s) under section 905(i) of the FD&C Act and state that the cigarette plan 
incorporates any and all future brands listed with FDA. Likewise, a retailer may state, 
all brands; and 
  If the submitter is a third party, FDA recommends that the cover letter also include a 
statement by an authorized official of the manufacturer, distributor, or retailer that the 
third-party agent is authorized to submit the cigarette plan on its behalf. If a statement is 
12 
  Contains Nonbinding Recommendations 
 
not included in the cover letter, FDA will confirm with the manufacturer, distributor, or 
retailer that the submitter is an authorized third-party agent before reviewing the plan. 
 
2.  Information to Include in the Cigarette Plan for Packaging  
 
Section II of the appendix provides an example of a cigarette plan for cigarette packages that 
FDA believes would meet the applicable requirements for approval. 
 
The submitter must ensure that a cigarette plan: 
 
  Contains sufficient information for approval by FDA; 
  Provides for the random and equal display and distribution of the required warnings on 
cigarette packages; and 
  Assures that all required warnings will be displayed at the same time. 
 
For each cigarette brand (or for a set of brands), your plan should list each specific element of 
the cigarette plan requirement and provide a detailed description of how each element will be 
met. Specifically, you should explain how:  
 
  Each of the required warnings will be randomly displayed during each 12-month period 
on each brand of the product;  
  Each of the required warnings will be displayed on each brand of the product in as equal 
a number of times as possible during each 12-month period;  
  Product packages will be randomly distributed in all areas of the United States in which 
the product is marketed; and  
  Each of the required warnings will be displayed at the same time.  
 
The cigarette plan for packaging should include a discussion of how the requirements are to be 
implemented based on the specific manufacturing processes and distribution procedures to 
ensure random display, in as equal a number of times as is possible, in each 12-month period on 
each brand of the product. We recognize and understand that achieving conformity with the 
narrowest possible reading of the random and equal display requirement within a 12-month 
period would pose some difficulties, and we agree that allowing some level of deviation is 
appropriate particularly given the language of the FCLAA, which includes the phrase as equal a 
number of times as is possible. As described in the final rule, different required warnings may 
be placed on the front and rear panels of the cigarette package, which may facilitate achieving 
the random display of the required warnings, in as equal a number of times as is possible.  
 
Manufacturers with concerns about complying with this requirement for their products should 
promptly 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 this requirement. 
We encourage manufacturers to submit their cigarette plans to FDA as soon as possible so that 
we can discuss these concerns and consider proposals with manufacturers in a timely manner. 
 
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FDA expects that a plan for random and equal display and distribution of warnings on packages 
will ordinarily be based on the date of manufacture or shipment of the product. FDA would not 
consider a plan that merely restated the regulatory requirements to be sufficiently detailed to 
enable FDA to approve the plan.   
 
3.  Information to Include in the Cigarette Plan for Advertising 
 
Section III of the appendix provides an example of a cigarette plan for cigarette advertisements 
that FDA believes would meet the applicable requirements for approval. 
 
The submitter must ensure that a cigarette plan: 
 
  Contains sufficient information for approval by FDA; 
  Provides for the quarterly rotation of required warnings, in alternating sequence, in 
advertisements for each brand; and 
  Assures that all required warnings will be displayed at the same time. 
 
Your plan should state the specific applicable cigarette plan requirements. Then, for each 
cigarette brand (or a set of brands), your plan must provide a description of how the required 
warnings will be rotated quarterly in advertisements and how the quarterly rotations will occur 
in alternating sequence. Section 4 of the FCLAA and 21 CFR 1141.10(g)(2).  
Among other things, the plan should specify the initial rotation timeframe on which quarterly 
rotation is based and, if the rotation timeframe varies for different types/forms of advertising, 
specify the reference date(s) that will be used to select the required warning for each type of 
advertising in each quarter, and describe the quarterly schedule for rotating each of the required 
warnings for each cigarette brand. A cigarette plan may consider practical constraints on the 
production and distribution of advertising. FDA would not consider a plan that merely restated 
the regulatory requirements to be sufficiently detailed to enable FDA to approve the plan.   
 
4.  Representative Packaging and Advertising 
 
FDA requests that plans submitted for review include representative samples of packages and 
advertisements with each of the required warnings. Such samples would place the plan in context 
and, therefore, facilitate FDAs review of the plan; FDAs review would not include a review of 
the content of the package labels and advertisements. By representative samples, we mean 
different types of cigarette product packaging and a range of package sizes for each type of 
product. Samples of advertising could include examples of different types of advertising 
materials for various brands, prototypes of actual advertising materials, the required warning as it 
would appear in different sizes of advertisements, or acetates or other facsimiles for the required 
warning as it would appear in different sizes of advertisements.  
 
E. Where Should a Cigarette Plan Be Submitted?  
 
Although electronic submission is not mandatory, FDA strongly encourages electronic 
submission to facilitate efficiency and timeliness of submission and processing. To submit your 
14 
  Contains Nonbinding Recommendations 
 
cigarette plan electronically, please use FDAs Electronic Submissions Gateway, available at 
https://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm.  
For cigarette plans submitted in electronic format, we recommend that all content (including the 
cover letter), be a Portable Document Format (PDF) file compatible with Adobe Acrobat 6.0 or 
higher. Files should not be password protected or encrypted. In preparing your submission in 
PDF format, we recommend that:  
  You create PDF files directly from an electronic source such as a word processing file or 
spreadsheet;  
  If you scan a document to create a PDF file, we recommend that you capture text by 
optical character recognition (OCR) software so that the text of the resulting electronic 
documents is reasonably accessible and searchable. (Avoid image-only based PDF files 
whenever possible because scanned images are more difficult to read and search); and 
  You create a submission table of contents and format it using bookmarks designed to help 
the reader navigate through the document efficiently.  
 
Written submissions should be addressed to the Office of Compliance and Enforcement and 
directed to:  
Food and Drug Administration  
Center for Tobacco Products  
Office of Compliance and Enforcement  
Document Control Center  
Building 71, Room G335  
10903 New Hampshire Avenue  
Silver Spring, MD 20993-0002 
 
F. What Does It Mean to Receive FDA Approval of a Cigarette Plan? 
 
FDAs review of a cigarette plan is only for the purpose of determining compliance with the 
statutory and regulatory criteria for approval of a cigarette plan, as set forth in section 4(c)(3) of 
the FCLAA and 21 CFR 1141.10(g)(3). Approval of a cigarette plan does not represent a 
determination by FDA that any specific package or advertisement complies with any of the other 
requirements regarding the placement, font type, size, and color of the required warnings found 
in section 4 of the FCLAA and 21 CFR 1141, or any other requirements under the FD&C Act 
and its implementing regulations. 
 
IV.  PAPERWORK REDUCTION ACT OF 1995   
 
This guidance contains information collection provisions that are subject to review by The Office 
of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3520). 
 
The time required to complete this information collection is estimated to average 153 hours per 
response, including the time to review instructions, search existing data sources, gather the data 
15 
  Contains Nonbinding Recommendations 
 
needed, and complete and review the information collection. Send comments regarding this 
burden estimate or suggestions for reducing this burden to:  
Food and Drug Administration  
Center for Tobacco Products  
Document Control Center  
Building 71, Room G335 10903 New Hampshire Avenue  
Silver Spring, Md 20993-0002 
 
 
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of 
 
information unless it displays a currently valid OMB control number. The OMB control number 
 
for this information collection is 0910-0877 (expires April 30, 2023). 
 
 
 
V.  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.,  
by December 16, 2020).  
 
  Section IV  Added OMB control number and information related to the Paperwork 
Reduction Act of 1995. 
 
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: 
 
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  Contains Nonbinding Recommendations 
 
  Section II  Added reference to order postponing the effective date of the final rule to 
January 14, 2022.  
 
  Section II (and throughout)  Changed effective date of the final rule from October 16, 
2021, to January 14, 2022. 
 
  Section II (and throughout)  Changed language stating that FDA strongly encourages 
entities to submit cigarette plans to FDA as soon as possible after publication of the final 
rule, and in any event within 5 months and 120 days after the publication of the final 
rule (i.e., December 16, 2020) to by March 16, 2021.  
 
July 2021  Guidance is revised to remove references to specific dates and replace dates with the 
following statement:  The effective date of the final rule is subject to a court order. Please 
see 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.  Specific revisions include the following: 
 
  Appendix  Changed dates in examples of quarterly rotation schedules of warnings in 
cigarette advertisements. 
 
Appendix  Cigarette Plan Example 
 
Note:  This document is intended to serve as an example of a plan that FDA believes would  
meet the applicable requirements for approval and provide information that would help  
facilitate FDAs review; however, alternative approaches may also satisfy the applicable 
requirements. 
 
I. Cover Letter 
 
Date 
 
Food and Drug Administration 
Office of Compliance and Enforcement 
FDA Center for Tobacco Products 
Document Control Center 
Building 71, Room G335 
10903 New Hampshire Avenue 
Silver Spring, MD 20993-0002 
 
RE:   CIGARETTE PLAN FOR CIGARETTES 
  ([insert: Original, Amendment, or Supplement]) 
 
Previously Related Original/Amendment/Supplement Cigarette Plan Number(s) (if applicable): 
[insert: RPXXXXXXX] 
 
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Pursuant to section 4 of the FCLAA and 21 CFR 1141, [insert: Company Name] submits the 
attached proposed Cigarette Plan covering [insert: packages and advertisements or 
packages or advertisements] for cigarettes. See attached. 
 
Submitter Information: 
Company Name:   
Name of Most Responsible Official:   
Title/Position/Authority of Most Responsible   
Individual 
Company Role (manufacturer (including   
importer), distributor, or retailer): 
Street Address:   
City, State, and Zip Code:   
Phone Number:   
DUNS Number:   
 
 
Company Contact Individual (if different from the submitter information): 
Name of Contact for the Cigarette Plan:   
Title/Position/Authority of Contact    
Street Address (if different):   
City, State, and Zip Code:   
Phone Number:   
Fax Number:   
Email Address:   
 
 
Transmitter Information (if different from the submitter and company contact individual): 
Name of Individual Transmitting the Cigarette   
Plan on Behalf of the Submitter: 
Title/Position/Authority of Transmitter    
Company Name:   
Street Address:   
City, State, and Zip Code:   
Phone Number:   
Fax Number:   
Email Address:   
 
 
This plan covers the following cigarettes: 
 
  Brand Name  Product   Unique  Type of Unique Identifier 
(Subbrand)  Identifier/Number  (SKU, Catalog #, UPC) 
1  Brand X  Silver 100s Hard Pack  99999 99999  UPC 
2         
 
If you have questions regarding the attached Cigarette Plan submission, contact [insert: name 
of company contact person provided above]. 
 
Sincerely, 
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  Contains Nonbinding Recommendations 
 
 
Name / Title of Submitting Individual 
 
 
AUTHORIZATION 
 
All information submitted in the attached Cigarette Plan dated [INSERT date], which covers 
cigarette [select: packaging and/or advertising] was authorized by me. 
   
   
___________________________________  ___________________________________ 
Printed Name of Authorized Company Official  Signature of Authorized Company Official 
   
   
  ___________________________________ 
Title of Authorized Company Official   Date 
 
 
 
 
 
 
 
[If applicable, insert: [Name and title of agent authorized to submit Cigarette Plan 
submission] is authorized to submit the attached Cigarette Plan submission on behalf of 
[name of company]. 
 
   
___________________________________  _________________________________ 
Printed Name of Authorized Company Official   Printed Name of Agent Authorized to Submit 
  Cigarette Plan Submission 
 
   
  ___________________________________ 
Title of Authorized Company Official   Title of Agent  
   
   
___________________________________  ___________________________________ 
Signature of Authorized Company Official   Signature of Agent  
   
   
___________________________________  ___________________________________ 
Date  Date 
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  Contains Nonbinding Recommendations 
 
 
II. Cigarette Plan for Cigarette Packages 
 
In accordance with section 4 of the FCLAA and 21 CFR 1141, each cigarette package will bear 
one of the required warning statements and its accompanying color graphic on the front and 
rear panels of the package. Under 21 CFR 1141.10(b), each required warning, comprising a 
combination of a textual warning label statement and its accompanying color graphic, will 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. The cigarette packages 
will bear the required warnings in accordance with 21 CFR 1141.10(c).  
 
This plan provides the manner by which the 11 required warnings on packages will be: 
 
  Randomly displayed during each 12-month period on each brand of the product;  
  Displayed in each 12-month period, in as equal a number of times as is possible on each 
brand of the product; 
  Randomly distributed in all areas of the United States in which the product is marketed; 
and 
  Displayed at the same time. 
 
[Example 1] 
 
Plan for Random and Equal Display of Required Warnings (Hardpacks): 
 
To ensure that the required warnings are randomly displayed in each 12-month period, in as 
equal a number of times as is possible on each brand of the product (e.g., based on the date of 
manufacture), and that all required warnings are displayed at the same time, for hardpack 
packages we will: 
 
1.  Utilize an 8x3 cylinder layout (i.e., 8 columns with 3 rows each). 
2.  Print each of the required warnings on packages in sequential order (i.e., 1, 2, 3, 4, 5, 6, 
7, 8, 9, 10, 11), with different required warnings on the front and rear panels of each 
package. The last two package impressions (see shaded cells in the grid below) will 
display four of the eleven required warnings. The four required warnings will be 
randomly selected without replacement (i.e., the additional randomly selected required 
warnings will not repeat, to avoid increasing over-representation), for each brand as 
illustrated in the grid below (represented as A, B, C, and D). [Alternatively: The last two 
package impressions will be left blank; therefore, the required warnings will all be equally 
printed.] 
3.  Produce a total of 12,000 package labels displaying 24,000 required warnings for 
hardpack packages for each print run, with four of the eleven required warnings 
(represented as A, B, C, and D in the grid below) being produced 2,500 times each and 
seven of the eleven required warnings being produced 2,000 times each. [Alternatively: 
The last two package impressions are left blank; therefore, the required warnings will all 
be equally printed.]  
 
 
 
 
 
20 
  Contains Nonbinding Recommendations 
 
 
The required warnings will be arranged on the 8x3 cylinder layout as follows: 
 
8x3  Hardpack Cylinder Layout of the 11 Required Warnings 
 Each Side of the Package Displays a Different Required Warning  
(number represents the corresponding required warning*) 
 
1  7  2  8  3  9  4  10 
2  8  3  9  4  10  5  11 
3  9  4  10  5  11  6  A+ 
4  10  5  11  6  1  7  B+ 
5  11  6  1  7  2  8  C+ 
6  1  7  2  8  3  9  D+ 
+Note: Each box in the grid above represents one package. The two different 
numbers in each box represent that different required warnings will be printed 
on the front and rear panels of each package. Letters A-D in these shaded cells 
represent the four randomly selected required warnings without replacement for 
each brand. 
 
 
*Required Warning Statements (to include the accompanying color graphics): 
 
1.  WARNING: Tobacco smoke can harm your children.  
2.  WARNING: Tobacco smoke causes fatal lung disease in nonsmokers. 
3.  WARNING: Smoking causes type 2 diabetes, which raises blood sugar.  
4.  WARNING: Smoking reduces blood flow to the limbs, which can require amputation.  
5.  WARNING: Smoking causes cataracts, which can lead to blindness.  
6.  WARNING: Smoking causes bladder cancer, which can lead to bloody urine.  
7.  WARNING: Smoking reduces blood flow, which can cause erectile dysfunction. 
8.  WARNING: Smoking causes head and neck cancer. 
9.  WARNING: Smoking can cause heart disease and strokes by clogging arteries.  
10. WARNING: Smoking during pregnancy stunts fetal growth. 
11. WARNING: Smoking causes COPD, a lung disease that can be fatal. 
 
Plan for Random Distribution of Required Warnings: 
 
To ensure that the required warnings are randomly distributed in all areas of the United States 
in which the product is marketed: 
 
Upon cigarettes being manufactured, we will store products in shipping containers. Each 
container will include all required warnings in as equal numbers as is possible. When an order is 
placed, we will distribute such container(s) on a first in, first out basis. 
 
 
 
 
 
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  Contains Nonbinding Recommendations 
 
[Example 2] 
 
Plan for Random and Equal Display of Required Warnings (Softpacks): 
 
To ensure that the required warnings are randomly displayed in each 12-month period, in as 
equal a number of times as is possible on each brand of the product (e.g., based on the date of 
manufacture), and that all required warnings are displayed at the same time, for softpack 
packages we will: 
 
1.  Utilize an 9x5 cylinder layout (i.e., 9 columns with 5 rows each). 
2.  Print each of the required warnings on packages in sequential order (i.e., 1, 2, 3, 4, 5, 6, 
7, 8, 9, 10, 11), with the same warning on the front and rear panels of each package. 
The last package impression (see shaded cell in the grid below) will display one of the 
eleven required warnings. The one required warning will be randomly selected without 
replacement (i.e., the additional randomly selected required warning will not repeat, to 
avoid increasing over-representation) for each brand, as illustrated in the grid below 
(represented as A). [Alternatively: The last package impression will be left blank; 
therefore, the required warnings will all be equally printed.] 
3.  Produce a total of 11,250 package labels displaying 22,500 required warnings for 
softpack packages for each print run, with one of the eleven required warnings 
(represented as A in the grid below) being produced 2,500 times each and ten of the 
eleven required warnings being produced 2,000 times each. [Alternatively: The last 
package impression is left blank, therefore, the required warnings will all be equally 
printed.] 
 
The required warnings will be arranged on the 9x5 cylinder layout as follows: 
 
9x5  Softpack Cylinder Layout of the 11 Required Warnings 
Each Side of the Package Displays the Same Required Warning 
(number represents the corresponding required warning*) 
 
1  6  11  5  10  4  9  3  8 
1  6  11  5  10  4  9  3  8 
2  7  1  6  11  5  10  4  9 
2  7  1  6  11  5  10  4  9 
3  8  2  7  1  6  11  5  10 
3  8  2  7  1  6  11  5  10 
4  9  3  8  2  7  1  6  11 
4  9  3  8  2  7  1  6  11 
5  10  4  9  3  8  2  7  A+ 
5  10  4  9  3  8  2  7  A+ 
+Note: Each box in the grid above represents one package. The two identical numbers in each box 
represent that the same required warning will be printed on the front and rear panels of the package. Letter 
A in this shaded cell represents the one randomly selected required warning without replacement for each 
brand. 
22 
  Contains Nonbinding Recommendations 
 
 
*Required Warning Statements (to include the accompanying color graphics): 
 
1.  WARNING: Tobacco smoke can harm your children.  
2.  WARNING: Tobacco smoke causes fatal lung disease in nonsmokers. 
3.  WARNING: Smoking causes type 2 diabetes, which raises blood sugar.  
4.  WARNING: Smoking reduces blood flow to the limbs, which can require amputation.  
5.  WARNING: Smoking causes cataracts, which can lead to blindness.  
6.  WARNING: Smoking causes bladder cancer, which can lead to bloody urine.  
7.  WARNING: Smoking reduces blood flow, which can cause erectile dysfunction. 
8.  WARNING: Smoking causes head and neck cancer. 
9.  WARNING: Smoking can cause heart disease and strokes by clogging arteries.  
10. WARNING: Smoking during pregnancy stunts fetal growth. 
11. WARNING: Smoking causes COPD, a lung disease that can be fatal. 
 
Plan for Random Distribution of Required Warnings: 
 
To ensure that the required warnings are randomly distributed in all areas of the United States 
in which the product is marketed: 
 
Upon cigarettes being manufactured, we will store products in shipping containers. Each 
container will include all required warnings in as equal numbers as is possible. When an order is 
placed, we will distribute such container(s) on a first in, first out basis. 
 
OR ALTERNATIVELY 
 
We will separate cigarette packages by required warning at the time of manufacture. When an 
order is placed, we will fill the order with as equal a number of packages as is possible from 
each separate inventory of these required warnings. 
 
[Example 3] 
 
Plan for Random and Equal Display of Required Warnings: 
 
To ensure that the required warnings are randomly displayed in each 12-month period, in as 
equal a number of times as is possible on each brand of the product (e.g., based on the date of 
manufacture), and that all required warnings are displayed at the same time, we will: 
 
Plan for producing and displaying the required warnings on as equal a number of packages as 
possible for each product during a 12-month period: 
 
1.  Produce a total of 11,000 packages for each print run. 
 
2.  Print each of the required warnings* on packages in sequential order (i.e., 1, 2, 3, 4, 5, 6, 
7, 8, 9, 10, 11), for a total of 11,000 required warnings (1,000 of each required warning). 
 
OR ALTERNATIVELY 
 
2.  Equally print 1,000 of each of the required warnings* on batches of packages 
simultaneously (1,000 of required warning 1, 1,000 of required warning 2, etc.) for each 
print run. 
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  Contains Nonbinding Recommendations 
 
 
This should result in an equal display of each of the different required warnings for each brand 
during a 12-month period, subject to minor variations due to normal commercial printing and 
manufacturing practices.10 
 
*Required Warning Statements (to include the accompanying color graphics): 
 
1.  WARNING: Tobacco smoke can harm your children.  
2.  WARNING: Tobacco smoke causes fatal lung disease in nonsmokers. 
3.  WARNING: Smoking causes type 2 diabetes, which raises blood sugar.  
4.  WARNING: Smoking reduces blood flow to the limbs, which can require amputation.  
5.  WARNING: Smoking causes cataracts, which can lead to blindness.  
6.  WARNING: Smoking causes bladder cancer, which can lead to bloody urine.  
7.  WARNING: Smoking reduces blood flow, which can cause erectile dysfunction. 
8.  WARNING: Smoking causes head and neck cancer. 
9.  WARNING: Smoking can cause heart disease and strokes by clogging arteries.  
10. WARNING: Smoking during pregnancy stunts fetal growth. 
11. WARNING: Smoking causes COPD, a lung disease that can be fatal. 
 
Plan for Random Distribution of Required Warnings: 
 
To ensure that the required warnings are randomly distributed in all areas of the United States 
in which the product is marketed: 
 
Upon cigarettes being manufactured, we will store products in shipping containers. Each 
container will include all required warnings in as equal numbers as is possible. When an order is 
placed, we will distribute such container(s) on a first in, first out basis. 
 
OR ALTERNATIVELY 
 
We will separate cigarette packages by required warning at the time of manufacture. When an 
order is placed, we will fill the order with as equal a number of packages as is possible from 
each separate inventory of these required warnings. 
 
 
 
 
 
 
 
 
 
 
 
 
 
10 FDA recognizes and understands that achieving conformity with the narrowest possible reading of the random and 
equal display requirement within a 12-month period would pose some difficulties, and we agree that allowing some 
level of deviation is appropriate particularly given the language of the FCLAA, which includes the phrase as equal 
a number of times as is possible. 
 
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  Contains Nonbinding Recommendations 
 
III. Cigarette Plan for Cigarette Advertisements 
 
In accordance with Section 4 of the FCLAA and 21 CFR 1141, each cigarette advertisement will 
bear one of the required warnings. Under 21 CFR 1141.10(b), each required warning, 
comprising a combination of a textual warning label statement and its accompanying color 
graphic, will 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. The 
cigarette advertisements will display the required warnings in accordance with 21 CFR 
1141.10(d). 
 
This plan provides the manner by which the 11 required warnings on cigarette advertising will 
be rotated quarterly in alternating sequence in advertisements for each brand of cigarettes. 
 
The required warnings will be quarterly rotated in advertisements according to the following 
schedule for each brand of product. For each subsequent quarter beyond the schedule below, 
we will continue, in perpetuity, the quarterly rotation of the required warnings in the established 
order for each brand. 
 
Schedule of Quarterly Rotation: 
 
[Example1] 
 
Schedule of Quarterly Rotation of the 11 Required Warnings (number represents the 
corresponding required warnings*) on Cigarette Advertisements 
(Table 1  Schedule is Applicable to All Brands) 
 
Quarterly  Jun 1   Sept 1  Dec 1   Mar 1   Jun 1   Sept 1  Dec 1   Mar 1   Jun 1   Sept 1  Dec 1   Mar 1  
Period  Aug 31   Nov  Feb 28  May 31  Aug 31    Nov  Feb 28  May31  Aug 31    Nov  Feb 28  May 3111  
(Year  30  30  30 
2022) 
All 
1  2  3  4  5  6  7  8  9  10  11  1 
Brands 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
11 Will continue in perpetuity for subsequent quarters 
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  Contains Nonbinding Recommendations 
 
[Example 2] 
 
Schedule of Quarterly Rotation of the 11 Required Warnings (number represents the 
corresponding required warnings*) on Cigarette Advertisements  
(Table 2  Schedule Varies for Each Brand) 
 
Quarterly  Jun 1   Sept 1  Dec 1  Mar 1  Jun 1   Sept 1  Dec 1   Mar 1   Jun 1   Sept 1  Dec 1   Mar 1  
Period  Aug 31   Nov   Feb   May  Aug 31    Nov  Feb 28  May31  Aug 31    Nov  Feb 28  May 
(Year  30  28  31  30  30  3112  
2022) 
Brand X  1  2  3  4  5  6  7  8  9  10  11  1 
Brand Y  4  5  6  7  8  9  10  11  1  2  3  4 
Brand Z  7  8  9  10  11  1  2  3  4  5  6  7 
 
*Required Warning Statements (to include the accompanying color graphics): 
 
1.  WARNING: Tobacco smoke can harm your children.  
2.  WARNING: Tobacco smoke causes fatal lung disease in nonsmokers. 
3.  WARNING: Smoking causes type 2 diabetes, which raises blood sugar.  
4.  WARNING: Smoking reduces blood flow to the limbs, which can require amputation.  
5.  WARNING: Smoking causes cataracts, which can lead to blindness.  
6.  WARNING: Smoking causes bladder cancer, which can lead to bloody urine.  
7.  WARNING: Smoking reduces blood flow, which can cause erectile dysfunction. 
8.  WARNING: Smoking causes head and neck cancer. 
9.  WARNING: Smoking can cause heart disease and strokes by clogging arteries.  
10. WARNING: Smoking during pregnancy stunts fetal growth. 
11. WARNING: Smoking causes COPD, a lung disease that can be fatal. 
 
 
Reference Date(s) for Quarterly Rotation for Each Type of Advertising 
 
Cigarette brands will be advertised using the types of media listed in the table below. Each type 
of advertising media will display the required warning in accordance with the schedule of 
quarterly rotation of the required warnings noted above. The reference date(s) will be used to 
select the appropriate quarter and corresponding required warning for each medium, as 
indicated in the table below: 
 
 
 
 
 
 
 
 
 
 
 
 
12 Will continue in perpetuity for subsequent quarters 
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  Contains Nonbinding Recommendations 
 
Type of Advertising  Reference Date(s) for Quarterly Rotation** 
 
Advertising in periodicals (newspapers,  [cover date], [periodical publication date], 
magazines)  or [date of publication] 
Posters and placards  [scheduled ad appearance date] 
Email advertisements, direct mail  [date of dissemination], [campaign start 
advertisements, and mobile coupons  state] 
Digital media, including websites, banner  [date of posting], [scheduled ad 
ads, mobile applications, and social media  appearance date] 
Other advertisements (describe intended  [date of issuance], [order date], [date of 
advertisement, e.g., Billboard, Point of Sale  dissemination], [campaign start state], [air 
Shelf Talker)  date], [date of posting], [date of 
production"] 
 
(**Note: Do not provide a calendar date in this column; use the examples provided or similar 
terms to identify the reference date(s) that will be used to assign the corresponding required 
warning, as described above in Tables 1 and 2, Schedule of Quarterly Rotation.) 
 
 
 
27