Submission of Warning Plans 
for Cigars (Revised)* 
Guidance for Industry 
Comments may be submitted at any time for Agency consideration.  Electronic  comments  may 
be submitted to http://www.regulations.gov. Alternatively, submit written comments to the 
Division of Dockets Management (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 
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 
August 2018 
OMB control number: 0910-0768 
Expiration Date: 10/31/2022 
See additional PRA statement in section IV of the guidance 
*This is the first revision to this guidance. The first edition was published in December 2016.  Contains Nonbinding Recommendations 
Table of Contents 
I.  INTRODUCTION .............................................................................................................1 
II.  BACKGROUND ...............................................................................................................2 
III.  DISCUSSION ....................................................................................................................4 
A.  What Definitions Apply to This Guidance?......................................................................................... 4 
B.  Who Submits a Warning Plan? ..............................................................................................................5 
C.  What Is the Scope of a Warning Plan? ..........................................................................................7 
D.  When Should a Warning Plan Be Submitted? ..................................................................................7 
E.  What Information Should Be Submitted as Part of a Warning Plan? .......................................8 
F.  Where Should a Warning Plan Be Submitted? ..............................................................................10 
G.  What Does It Mean to Get FDA Approval of  a Warning Plan? ...............................................10 
IV.  PAPERWORK REDUCTION ACT OF 1995 ..................................................................11 
V.  DOCUMENT HISTORY ......................................................................................................11 
APPENDIX A  EXAMPLE CIGAR WARNING PLAN 
i  Contains Nonbinding Recommendations 
Submission of Warning Plans for Cigars 
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 
This guidance document is intended to assist persons submitting warning plans for cigars, as 
required by Title 21, Code of Federal Regulations (CFR), part 1143 (21 CFR part 1143). This 
guidance document discusses, among other things: 
  The regulatory requirements to submit warning plans 
  Definitions 
  Who submits a warning plan 
  The scope of a warning plan 
  When to submit a warning plan 
  What information should be submitted in a warning plan 
  Where to submit a warning plan 
  What approval of a warning plan means 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agencys current thinking on a topic and 
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. 
1 This guidance was preparedby the Office of Compliance and Enforcement andthe Office of Regulations in 
the Center for Tobacco Products at FDA. 
1  Contains Nonbinding Recommendations 
II.  BACKGROUND 
On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco 
Control Act (Tobacco Control Act) (Public Law 111-31) into law. The Tobacco Control 
Act granted FDA important new authority to regulate the manufacture, marketing, and 
distribution of cigarettes, cigarette tobacco, roll-your-own tobacco (RYO), and smokeless 
tobacco products to protect the public health and to reduce tobacco use by minors. 
The Tobacco Control Act also gave FDA the authority to issue a regulation deeming all other 
products that meet the statutory definition of a tobacco product as subject to FDA regulatory 
authority (deeming) (section 901(b) of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act)) (21 U.S.C. 387a(b))). On May 10, 2016, FDA issued the deeming rule, extending 
FDAs tobacco product authority to cigars, among other products (81 FR 28973). Among the 
requirements that now apply to newly deemed products such as cigars are health warning 
statements prescribed under section 906(d) of the FD&C Act (21 U.S.C.
387f(d)), which permits restrictions on the sale and distribution of tobacco products that are 
appropriate for the protection of public health. 
Under  1143.5, each cigar package and advertisement must bear one of six textual warning 
statements. 
Packages. Once the required warning statements take 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 cigar unless the product package bears one of 
the following required warning statements listed in  1143.5(a):2 
  WARNING: This product contains nicotine. Nicotine is an addictive chemical. 
  WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do 
not inhale. 
  WARNING: Cigar smoking can cause lung cancer and heart disease. 
  WARNING: Cigars are not a safe alternative to cigarettes. 
  WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, 
even in nonsmoke rs. 
  WARNING: Cigar use while pregnant can harm you and your baby. 
Or 
SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, 
Stillbirth and Low Birth Weight. 
You may choose to display either one of the warning statements regarding reproductive 
health. FDA is allowing the use of the reproductive health warning statement as required 
2 Retailers may continue to sell and distribute tobacco products with packaging that does not bear the 
required health warning statements after the effective date, but only if the products were manufactured 
before the effective date of the warning statement requirements. See 21 CFR1143.13(a). For more 
information on compliance dates, see FDAs guidance for industry, Extension of Certain Tobacco 
Product Compliance Deadlines Related to the Final Deeming Rule (August, 2018), available at: 
https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm557714.htm. 
2 Contains Nonbinding Recommendations 
by the Federal Trade Commission (FTC) consent decrees as an optional alternative to the 
FDA warning, WARNING: Cigar use while pregnant can harm you and your baby. FDA 
expects that providing this optional alternative will benefit entities bound by the FTC consent 
decrees, and the statement is appropriate for the protection of public health. 
In certain situations described in  1143.5(a)(4), retailers of cigars are exempt from this 
requirement. The retailer will not be in violation of this section for cigar packaging that: (1) 
contains a health warning; (2) is supplied to the retailer by the tobacco product 
manufacturer, importer, or distributor who has the required state, local, or Alcohol and 
Tobacco Tax and Trade Bureau (TTB)-issued license or permit, if applicable; and (3) is 
not altered by the retailer in a way that is material to the requirements of  1143.5(a) 
( 1143.5(a)(4)). However, a retailer is still responsible for complying with other 
applicable requirements relating to cigars, including those contained in part 1143. 
Cigars that are sold individually, without any packaging, are exempt from the packaging 
requirements. In this circumstance, retailers must post a warning sign that lists all six of 
the required warning statements at the point-of-sale, in accordance with the requirements set 
forth in  1143.5(a)(3). Retailers of cigars sold individually and not in product packaging are 
not required to submit a warning plan for warnings on packages, because the warning signs 
posted at the retailers point-of-sale will include all  six  warnings  applicable to cigars. Cigar 
retailers are responsible for creating and posting these signs in accordance with  
1143.5(a)(3)(i)-(iv). 
Advertisements. Once the required warning statements take effect, it will be unlawful for any 
cigar manufacturer, packager, importer, distributor, or retailer to advertise or cause to be 
advertised within the United States any cigar unless the advertising bears one of the required 
warning statements, in accordance with an FDA-approved warning plan ( 1143.5(b)(1) and 
(b)(2)). As with packaging, retailers may be exempt from this requirement under certain 
circumstances, which are described in  1143.5(b)(3). Specifically, the warning statement 
requirements for advertisements outlined in  1143.5(b) apply to a retailer only if that retailer 
is responsible for or directs the required warning statements. However, this does not relieve a 
retailer of liability if the retailer displays, in a location open to the public, an advertisement that 
does not contain a health warning or contains a health warning that has been altered by the 
retailer in a way that is material to the requirements of  1143.5. 
Warning Plans. The requirement for submission of warning plans to FDA for cigars and 
the specific requirements relating to random display and distribution of required warning 
statements on cigar packaging and quarterly rotation of required warning statements in 
cigar advertising appear at  1143.5. The requirement to submit a warning plan to FDA will 
take effect 12 months after May 10, 2016 ( 1143.13(b)). Twenty-four months after May 
10, 2016, the requirement to carry warning statements on cigar packages and 
advertising becomes effective ( 1143.13(a)). Under the warning plan requirements set 
forth in  1143.5, each person required to randomly display and distribute or rotate 
warnings in accordance with an FDA-approved plan under this part shall submit a 
proposed warning plan to FDA no later than either 12 months after May 10, 2016, or 12 
months before advertising or commercially marketing a product that is subject to such 
requirement, whichever is later ( 1143.5(c)(3)). 
3 Contains Nonbinding Recommendations 
In particular, in accordance with ( 1143.5(c)(1), warning plans for cigar packaging 
must provide that all of the required warning statements: 
  Are randomly displayed in each 12-month period on each brand of the product 
  Are randomly displayed in as equal a number of times as is possible on each 
brand of the product 
  Are randomly distributed in all areas of the United States in which the product is 
marketed 
For FDA to approve a warning plan, the plan must provide for the required random 
distribution and display of required warning statements on packaging, in a 12-month 
period, and must ensure that all of the required warning statements will be displayed by 
the manufacturer, importer, distributor, or retailer ( 1143.5(c)). 
Warning plans for cigar advertising must provide that all of the required warning 
statements are rotated quarterly in alternating sequence in advertisements for each brand 
of cigar ( 1143.5(c)(2)). 
III.  DISCUSSION 
A.  What Definitions Apply to This Guidance ? 
For purposes of this guidance, FDA intends to use the following definitions, some of which  
are included in  1143.1: 
Cigar means a tobacco product that: (1) is not a cigarette; and (2) is a roll of tobacco 
wrapped in leaf tobacco or any substance containing tobacco. 
Package or packaging means a pack, box, carton, or container of any kind or, if no other 
container, any wrapping (including cellophane), in which a tobacco product is offered for 
sale, sold, or otherwise distributed to consumers. 
Principal display panels means the panels of a package that are most likely to be displayed, 
presented, shown, or examined by the consumer. 
Required warning statement means a textual warning statement required to be on packaging 
and in advertisements for cigarette tobacco, RYO, cigars, and other covered tobacco 
products. 
Original submission: FDA considers the submission of a warning plan to be an original 
submission if it is the first time the submitter has provided to FDA a warning plan for the 
cigar products. 
Amendment: FDA considers a submission to be an amendment if the submitter is 
submitting additional information to a warning plan that is currently under review at FDA. 
4 Contains Nonbinding Recommendations 
Supplement: FDA considers a submission to be a supplement if the submitter is seeking 
approval of a change to an FDA-approved warning plan. 
B.  Who Submits a Warning Plan? 
This section describes what FDA believes are the relevant considerations in determining 
whether the cigar manufacturer, importer, distributor, or retailer is best suited to submit a 
warning plan. These considerations will help ensure the applicable requirements are met as 
well as avoid duplication  or situations where multiple  persons unnecessarily  submit  a 
warning plan applicable to the same distribution chain. 
1.  Packaged Cigars 
As explained above, when the warning statement 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 cigar unless the package bears one of the 
required warning statements set forth in  1143.5(a)(1). In addition, required warning 
statements on packages must be randomly displayed on each brand and randomly 
distributed in all areas of the United States in accordance with a warning plan submitted to, 
and approved by, FDA ( 1143.5(c)(1)). For a particular brand, this warning plan may be 
submitted by the tobacco product manufacturer, importer, distributor, or retailer.  Although 
the warning 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 cigar product, it is important that you make sure there is an applicable FDA-
approved warning plan for that cigar brand and you comply with the approved plan. 
Based on FDAs experience reviewing warning plans for smokeless tobacco products, we 
believe it is likely that, for domestic products, only one plan will  be submitted  for  each 
brand, and that the brands manufacturer will submit this plan. 
In most circumstances, the brands manufacturer is the entity most able to ensure that a 
warning plan: 
  contains sufficient information for approval by FDA 
  provides for random distribution and random display of warning statements on 
packaging 
  demonstrates that all of the required warning statements will be displayed in each 
12-month period 
The brands manufacturer is also usually the entity responsible, either directly or through a 
contractor or other agent, for placing or directing the placement of the required warning 
statements on the brands packages and for directing distribution of the packages. Placing 
the required warning statements on the packages and directing distribution of the packages 
are the key elements of a warning plan. 
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 warning statements on the product package. 
5 Contains Nonbinding Recommendations 
In these situations, FDA believes the private label brand distributor would be best suited to 
submit the warning plan. 
A retailer typically would not submit a warning plan for cigar packaging that is supplied by a 
manufacturer, importer, or distributor who has the required state, local, or Alcohol and 
Tobacco Tax and Trade Bureau (TTB)-issued license or permit, if applicable.  In this case, 
the retailer would need to ensure that the package displays a health warning and that the 
retailer does not alter the warning in a material way (e.g., the retailer cannot cover up the 
warning label) ( 1143.5(a)(4)). If a retailer is responsible for or directs the placement of 
required warning statements on packaging, the retailer would be best suited to submit the 
warning plan. 
For finished cigars that are imported, distribution is usually handled by the products importer 
or importers. Because importers typically direct the packaging and placement of the required 
warning statements for distribution in the United States, we recommend that the importer or 
importers of a brand of cigar submit the plan. Compared with the manufacturer or other 
entities, importers are in a position to create a warning plan that best meets the legal 
requirements, particularly the requirement that the warnings will be randomly distributed in all 
areas of the United States in which the product is marketed. 
2.  Advertisements 
When the required warning statements are in effect, it will be unlawful for any tobacco 
product manufacturer, importer, distributor, or retailer to advertise or cause to be advertised 
within the United States any cigar unless its advertising bears one of the required warning 
statements in accordance with  1143.5(b)(1) and (b)(2). The regulation specifies that the 
required warning statements in advertisements be rotated quarterly in alternating sequence 
for each brand in accordance with a warning plan submitted to, and approved by, FDA 
( 1143.5(c)(2)). For a particular brand, this warning plan may be submitted by the tobacco 
product manufacturer, importer, distributor, or retailer. Although the warning plan may be 
submitted by someone other than you, before you advertise a brand of cigar, it is important 
that you make sure there is an applicable FDA-approved warning plan, and your actions in 
rotating the required warning statements in advertising 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  warning  statements on  advertising 
for a brand of cigars is most  able  to ensure a warning  plan  contains  sufficient  information 
for approval by FDA  that it provides for  quarterly  rotation  of required  warning 
statements in advertising  for the brand.  FDA recommends that each manufacturer, 
importer, distributor, and retailer who creates advertising, causes advertising to be created, or 
is otherwise responsible for inclusion of the warning on advertising for a brand of cigar submit 
a warning plan that covers all of the brands it advertises.  A retailer typically would not 
submit a warning plan for advertising supplied by the manufacturer of a tobacco product if 
the advertising is already covered by a plan submitted by the manufacturer. 
However, the retailer would be held responsible for the requirements if the retailer is 
responsible for or directs the warning label statement on the advertisements, publicly 
displays an advertisement that does not contain a warning label statement, or alters a 
6 Contains Nonbinding Recommendations 
required warning statement in a material way (e.g., covers up the warning label) 
( 1143.5(b)(3)). 
C.  What Is the Scope of a Warning Plan? 
For the efficiency of review, FDA asks that each warning plan cover both packaging and 
advertising to the extent applicable.  The cigar product manufacturer, distributor, importer, 
or retailer should demonstrate how they plan  to achieve  the random distribution and 
random display of the required warning  statements on packages and the quarterly  rotation 
on advertisements. 
D.  When Should a Warning Plan Be Submitted? 
Required warning statements for cigars must be randomly distributed and randomly 
displayed on packages, and rotated quarterly in advertisements, in accordance with an 
approved warning plan ( 1143.5(c)(1) and (2) (emphasis added)). 
  Warning plans should be submitted to FDA no later than either 12 months after May 10, 
2016, or 12 months before advertising or commercially marketing a product that is subject 
to such requirement, whichever is later ( 1143.5(c)(3)).  On May 10, 2017, FDA issued a 
guidance, which, among other things, provided a compliance date of August 10, 2017 for 
the warning plan requirement.  Therefore, warning plans for tobacco products on the 
market as of August 8, 2016 that are subject to these requirements were expected to be 
submitted to FDA by August 10, 2017. 
  Cigars will be required to carry warnings beginning 24 months after May 10, 2016. 
FDA issued a guidance on May 10, 2017 which, among other things, provided a 
compliance date of August 10, 2018 for this requirement.  On July 5, 2018, the U.S. 
District Court for the District of Columbia enjoined FDA from enforcing the warning 
requirements for cigars and pipe tobacco (21 CFR  1143.3 and 1143.5) until 60 days 
after the final disposition of the plaintiffs appeal in the case: Cigar Assn of America v. 
FDA, No. 1:16-cv-01460 (D.D.C.) (order granting injunction pending appeal); see also 
Cigar Assn of America v. FDA, No. 18-5195 (D.C. Cir.). FDA will not seek to enforce 
the warning requirements for cigars and pipe tobacco until that order is lifted. 
After FDA approval of an initial cigar warning plan, a supplement to the approved warning 
plan must be submitted to FDA and approved before making changes to the distribution or 
display of required warning statements on packages or the rotation of required warning 
statements in advertisements. For a new brand, a new warning plan or a supplement to an 
approved warning plan must be submitted and approved before distributing or displaying 
packages and advertisements for that new brand. For retailer-generated advertising, retailers 
may list all brands in their warning plan, which will cover future brands, so long as the plan 
provides for the same schedule for quarterly rotation of the required warning 
statements for all brands. 
To afford FDA sufficient time to review a supplement to an approved warning plan, FDA 
strongly recommends that you allow up to 6 months for FDA to review and approve a 
supplement. The amount of time it will take FDA to review a supplement, however, will 
depend upon the volume and quality of the submissions. 
7 Contains Nonbinding Recommendations 
FDA may request an amendment to a warning plan under review or to a supplement to an 
approved warning plan if FDA needs clarification of information in the warning plan or 
other additional information to determine whether it can approve the warning plan or 
supplement. Any such amendments will likely increase the overall review time. 
E.  What Information Should Be Submitted as Part of a Warning Plan? 
The following information should be submitted to FDA.  Appendix A provides an example of 
what FDA considers to be an acceptable warning plan for cigars. 
1.  Cover Letter 
To facilitate FDAs review of warning plans, FDA requests that your warning plan be 
accompanied by a cover letter that includes: 
  Date of the submission. 
  The following subject line: RE: WARNING PLAN FOR CIGARS (Original, 
Amendment, or Supplement). 
  A statement as to whether the warning plan covers packages, advertising, or 
both packages and advertising. 
  The name, address, and phone number of the person making the submission; the 
name of the most responsible individual if the submitter is a company; identification 
of the person as the manufacturer, distributor, retailer, or importer 
of the tobacco products covered by the warning plan; and 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 person 
authorized to act as the FDA contact point for the warning plan. 
  A list of any previous submissions made to FDA relating to the warning plan, 
identified by CTP-assigned reference number and the date of submission, if 
applicable. 
  A list of all cigars covered by the plan, preferably identified 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). 
  A certification by an authorized official of the company making the submission 
that all information submitted has been reviewed prior to filing. 
Section I of Appendix A provides an example of a cover letter to accompany the 
submission of a warning plan. 
2.  Information to Include in the Warning Plan for Packaging 
For each cigar brand, your plan should list each specific element of the warning plan 
requirement and provide a detailed description of how each element will be met. 
Specifically, you should explain how: 
8 Contains Nonbinding Recommendations 
  Each of the warnings will be randomly displayed during each 12-month period on 
each brand; 
  Each of the warnings will be displayed in as equal a number of times as possible on 
each brand of the product; and 
  Product packages will be randomly distributed in all areas of the United States in 
which the product is marketed 
The plan for packaging should include a detailed discussion of how the regulatory 
requirements will be met and how the plan will be implemented based on the firms specific 
manufacturing processes and distribution procedures.  The FTC previously  defined as 
equal number of times as possible as permitting deviations of 4 percent or less in a 12  
month period, and FDA considers that to be a good rule-of- thumb (see 16 CFR  307.11, 
which as part of 16 CFR part 307 was rescinded by FTC on September 28, 2010 (75 FR 
59609) because of the transfer of jurisdiction to FDA). 
FDA expects that a plan for random distribution and random display of warnings on 
packages will ordinarily be based on the date of manufacture or shipment of the product. 
FDA does not consider a plan that merely re-states the regulatory requirements for random 
distribution and display of warnings on packages to be sufficiently detailed to enable FDA 
to determine whether it can approve a warning plan. 
Section II of Appendix A provides an example of a warning plan for cigar packaging that 
FDA believes would meet the applicable requirements for approval. 
3.  Information to Include in the Warning Plan for Advertising 
Your plan should list each specific element of the warning plan requirement. Then, for 
each cigar brand, your plan should provide a sufficiently detailed description of how the 
required warning statements will be rotated quarterly in advertisements and how the 
quarterly rotations will occur in alternating sequence. 
Among other things, your plan should specify the date on which quarterly rotation is based 
and, if the date varies for different types/forms of advertising, specify both the dates and 
their associated types/forms of advertising, and describe the schedule for rotating warnings 
for each brand. A warning plan may take into account practical constraints on the 
production and distribution of advertising. FDA does not consider a warning plan that 
merely re-states the regulatory requirement for quarterly rotation of warnings on advertising 
to be sufficiently detailed to enable FDA to determine whether it can approve a warning 
plan. 
Section III of Appendix A provides an example of a warning plan for cigar advertisements 
that FDA believes would meet the applicable requirements for approval. 
4.  Representative Packaging and Advertising 
FDA requests that your warning plan include representative samples of packages and 
advertisements with each of the required warning statements. Such samples will place the 
9 Contains Nonbinding Recommendations 
warning plan in context and, therefore, facilitate FDAs review. By representative samples, 
we mean different types of cigar packaging and a range of package sizes and colors, if 
applicable. Samples of advertising could include examples of different types of advertising 
materials for various brands, prototypes of actual advertising materials, the required warning 
statement as it would appear in different sizes and colors of advertisements, or acetates or 
other facsimiles for the warning as it would appear in different sizes and colors of 
advertisements. 
F.  Where Should a Warning Plan Be Submitted? 
Written warning plans, including the cover letter addressed to the Office of Compliance and 
Enforcement, should be 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 
Although electronic submission of your warning plan package is not mandatory, FDA 
strongly encourages electronic submission to facilitate efficiency and timeliness of 
submission and processing. To submit your warning plan electronically, please use FDAs 
Electronic Submissions Gateway, available at 
http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm. 
For warning plans submitted in electronic format, we recommend that all content (including 
the cover letter), be in Portable Document Format (PDF) files 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; 
  Avoid image-only based PDF files whenever possible because scanned images are 
more difficult to read and search. 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; 
  Create a submission table of contents and format it using bookmarks designed to 
help the reader navigate through the document efficiently. 
G. What Does It Me an to Get FDA Approval of a Warning Plan? 
FDAs review of a warning plan is only for the purpose of determining compliance with the 
regulatory criteria for approval of a warning plan, as set forth in  1143.5(c). Approval of a 
warning plan does not represent a determination by FDA that any specific package or 
10 Contains Nonbinding Recommendations 
advertisement complies with any of the other requirements regarding the placement, font 
type, size, and color of the warnings found in part 1143. 
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 120 hours per 
response, including the time to review instructions, search existing data sources, gather the 
data needed, and complete and review the warning plan. Send comments regarding this 
burden estimate or suggestions for reducing this burden to: 
PRAStaff@fda.hhs.gov 
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 0910-0768 (expires 10/31/2022). 
V.  DOCUMENT HISTORY 
December 2016  First edition of guidance issued. 
August 2018  Section III.D of guidance is revised to reflect a stay of enforcement of the 
warning requirements for cigars and pipe tobacco (21 CFR  1143.3 and 1143.5) after the 
United States District Court for the District of Columbia granted plaintiffs motion for an 
injunction pending appeal. Cigar Assn of America v. FDA, No. 1:16-cv-01460 (D.D.C.) 
(order granting injunction pending appeal).  Clarifying and corrective edits made throughout 
the guidance. 
11 APPENDIX A  EXAMPLE CIGAR WARNING PLAN 
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 those requirements. 
I. Cover Letter (Cigar Sample) 
Date 
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 
RE:  WARNING PLAN FOR CIGAR PRODUCTS 
([INSERT: Original, Amendment, or Supplement]) 
To Whom It May Concern: 
Pursuant to 21 CFR part 1143, [INSERT: company name] submits the attached proposed warning plan 
covering [INSERT:  packaging and advertising or packaging or advertising] for cigars. See attached. 
This plan is being submitted by: 
Company Name: 
Name of most responsible individual: 
Company Role (manufacturer, distributor, importer, or retailer): 
Street Address: 
City, State, and Zip Code: 
Phone Number: 
DUNS Number: 
Contact information (if different from the submitter) 
Name of contact for the warning plan: 
Street Address (if different): 
City, State, and Zip Code (if different): 
Phone Number: 
Fax Number: 
Email Address: 
Transmitter information (if different from the submitter) 
Name of person transmitting the warning plan on behalf of the submitter: 
Company Name: 
Street Address: 
City, State, and Zip Code: 
Phone Number: 
Fax Number: 
Email Address: 
Previous Related Warning Plan Number(s) (if applicable): 
12 APPENDIX A  EXAMPLE CIGAR WARNING PLAN 
This plan covers the following cigars: 
Brand Name  Product  Unique Identifier  Type of Unique 
(Subbrand)  Identifier (SKU, 
Catalog #, UPC) 
1. Brand x  Churchill, Gordo,  12345  Catalog # 
Corona 
2. 
If you have any questions regarding the attached warning plan, please contact [INSERT: name of 
company contact listed above]. 
Sincerely, 
Name, Title 
CERTIFICATION 
This certifies that all of the information submitted in the attached Warning Plan 
dated [INSERT: date] which covers cigars [SELECT: packaging and/or advertising] 
was reviewed by me [IF APPLICABLE: and [INSERT: name of person transmitting 
warning plan] has the authority to transmit it on my behalf]. 
Printed Name of official of company who is authorized to submit plan and Date 
Signature of official of company who is authorized to submit plan and Date 
13 APPENDIX A  EXAMPLE CIGAR WARNING PLAN 
II. Warning Plan for Cigar Product Packaging 
In accordance with 21 CFR part 1143, each cigar package must bear one of six required warning 
statements on its two principal display panels. Additionally, the following warning statements must 
appear in black text if on a white background, or white text if on a black background, in a manner that 
contrasts by typography, layout, or color, with all other printed material on the package: 
1 = WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale. 
2 = WARNING: Cigar smoking can cause lung cancer and heart disease. 
3 = WARNING: Cigars are not a safe alternative to cigarettes. 
4 = WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in nonsmokers. 
5 = WARNING: Cigar use while pregnant can harm you and your baby. [or SURGEON GENERAL WARNING: 
Tobacco Use Increases the Risk of Infertility, Stillbirth and Low Birth Weight.3] 
6 = WARNING: This product contains nicotine. Nicotine is an addictive chemical. 
This plan provides the manner by which the required warning statements on packages will be: 
  randomly displayed in each 12-month period on each brand of the product; 
  randomly displayed 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 ismarketed. 
To ensure display of the six required warning statements in as equal a number of times as is possible on 
packaging for each brand, we will: 
1.  Produce a total of 6,000 packages for each print run. 
2.  Print each of the six required warning statements on packages in sequential order (1, 2, 3, 
4, 5, 6 and 1, 2, 3, 4, 5, 6 and 1, 2, 3, 4, 5, 6 etc.), for a total of 6,000 (1,000 each). 
OR 
2. Print 1,000 of each of the six required warning statements on batches of packages 
simultaneously (1,000 of warning 1, 1,000 of warning 2, etc.). 
This should result in an equal display of each of the six different required warning statements for each 
brand of product, subject to minor variations due to normal commercial printing and manufacturing 
practices. 
To ensure that the required warning statements are randomly displayed and in as equal a number of 
times as is possible on each brand during a 12-month period, and that the required warning statements 
are randomly distributed in all areas of the United States in which the product is marketed, we will: 
Upon cigar product being manufactured, store products in shipping containers. Each container will 
include all required warning statements in as equal a number as possible. When an order is placed, 
we will ship such container(s), on a first in, first out basis. 
OR 
Separate cigar packages by required warning statement at the time of manufacture. W hen 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 warning statements. 
3 You may choose to display either one of the warning statements regarding reproductive health. FDA is allowing 
the use of the reproductive health warning statement as required by the Federal Trade Commission (FTC) consent 
decrees as an optional alternative to the fifth FDA warning, WARNING: Cigar use while pregnant can harm you 
and your baby. FDA expects that providing this optional alternative will benefit entities bound by the FTC 
consent decrees, and the statement is appropriate for the protection of public health. 
14 Appendix A  Example Cigar Warning Plan 
III. Warning Plan for Cigar Product Advertising 
In accordance with 21 CFR 1143.5, each cigar advertisement must bear one of six required warning 
statements. Additionally, the required warning statement must appear in black text if on a white 
background or white text if on a black background. 
This plan provides the manner by which the required warning statements on cigar advertising will be 
rotated quarterly in an alternating sequence in advertisements for each brand of cigar product. 
Our advertisements will rotate the six required warning statements according to the following 
schedule for each brand of product: 
Jan 1   April 1   July 1   Oct 1   Jan 1   April 1  
March 31  June 30  Sept 30  Dec 31  March 31  June 30 
Brand A  1  2  3  4  5  6 
Brand B  1  2  3  4  5  6 
Brand C  1  2  3  4  5  6 
1 = WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale. 
2 = WARNING: Cigar smoking can cause lung cancer and heart disease. 
3 = WARNING: Cigars are not a safe alternative to cigarettes. 
4 = WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in nonsmokers. 
5 = WARNING: Cigar use while pregnant can harm you and your baby.; or 
SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth and Low 
Birth Weight4. 
6 = WARNING: This product contains nicotine. Nicotine is an addictive chemical. 
Cigar brands will be advertised using the following media and the rotation of the six required 
warning statements will be based on the date indicated in the table below. 
Type of Advertising  Start of Quarterly Rotation 
Advertising in periodicals (newspapers, magazines)  [Cover date] or [closing date of publication] 
Posters and placards  [Date of scheduled appearance of the 
advertisement.] 
Other Advertisements  [Order date] or [date of material dissemination] 
4 You may choose to display either one of the warning statements regarding reproductive health. FDA is 
allowing the use of the reproductive health warning statement as required by the Federal Trade Commission 
(FTC) consent decrees as an optional alternative to the fifth FDA warning, WARNING: Cigar use while pregnant 
can harm you and your baby. FDA expects that providing this optional alternative will benefit entities bound by 
the FTC consent decrees, and the statement is appropriate for the protection of public health. 
15