Draft Guidance for Industry
 
Submission of Warning Plans for 

Cigarettes and Smokeless Tobacco
 
Products
 
DRAFT GUIDANCE 
This guidance document is being distributed for comment purposes 
only. 
Written comments and suggestions may be submitted within 60 days of publication in the 
Federal Register of the notice announcing the availability of the draft guidance.  Submit 
comments to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Room 1061, Rockville, MD  20852. Alternatively, 
electronic comments may be submitted to http://www.regulations.gov.  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For questions regarding this draft guidance, contact the Center for Tobacco Products at 
(Tel) 1-877-CTP-1373 (1-877-287-1373) Monday-Friday, 9:00 a.m.  4:00 p.m. EDT. 
Additional copies are available online at 
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/defaul 
t.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, Building 71, Room G335, 10903 New Hampshire 
Avenue, Silver Spring, MD 20993-0002. 
U.S. Department of Health and Human Services
 
Food and Drug Administration
 
Center for Tobacco Products
 
September 2011  Contains Nonbinding Recommendations
 
Draft  n  Not for Implementation
 
Table of Contents 
I.  Introduction 
II.  Background 
III.  Discussion 
Appendix A  Example Cigarette Warning Plan 
Appendix B  Example Smokeless Tobacco Warning Plan  Contains Nonbinding Recommendations
 
Draft  n  Not for Implementation
 
1 
Draft Guidance for Industry
Submission of Warning Plans for 

Cigarettes and Smokeless Tobacco 

Products 

This draft guidance, when finalized, will represent the Food and Drug 
Administration's (FDA's) current thinking on this topic. It does not create or confer 
any rights for or on any person and does not operate to bind FDA or the public. You 
can use an alternative approach if the approach satisfies the requirements of the 
applicable statutes and regulations.  If you want to discuss an alternative approach, 
contact the FDA staff responsible for implementing this guidance.  If you cannot 
identify the appropriate FDA staff, call the appropriate telephone number listed on the 
title page of this guidance. 
I.  Introduction 
This guidance document is intended to assist persons submitting warning plans for 
cigarettes, as required by section 4 of the Federal Cigarette Labeling and Advertising Act 
(FCLAA), and warning plans for smokeless tobacco products, as required by Section 3 of 
the Comprehensive Smokeless Tobacco Health Education Act of 1986 (Smokeless 
Tobacco Act). This guidance document discusses, among other things: 
x  The statutory requirements to submit warning plans 
x  Definitions 
x  Who submits a warning plan 
x  The scope of a warning plan 
x  When to submit a warning plan 
x  What information should be submitted in a warning plan 
x  Where to submit a warning plan 
x  What approval of a warning plan means 
1 This guidance has been prepared by the Office of Compliance and Enforcement and the Office of 
Regulations in the Center for Tobacco Products at the U.S. Food and Drug Administration.  Contains Nonbinding Recommendations
 
Draft  n  Not for Implementation
 
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 
something is suggested or recommended, but not required. 
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 tobacco products to protect the public health and to reduce tobacco use by 
minors. 
Section 201 of the Tobacco Control Act amended section 4 of FCLAA, 15 U.S.C. 1333, to 
prescribe nine health warning statements that must appear on cigarette packages and 
advertisements.  It also modified FCLAA's requirements regarding the submission of 
warning plans for  cigarette packages and advertisements and requires that such warning 
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).  However, 
these requirements are currently not in effect, which means that the FTC will continue to 
review warning plans for current cigarette warnings that will be in effect until 15 months 
after FDA issues regulations as directed by Section 201(b).  Section 4(d) of FCLAA 
requires FDA to issue regulations that require color graphics depicting the negative health 
consequences of smoking to accompany those warning statements. 15 U.S.C. 1333(d). 
Section 201(b) of the Tobacco Control Act states that the requirements take effect 15 
months after FDA issues these regulations.  Under the provision, however, 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 thirty 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.  FDA 
issued a proposed rule regarding these requirements on November 12, 2010.  75 FR 
69524. FDA issued final regulations on June 22, 2011. 76 FR 36628. Accordingly, the 
requirements for the warnings for cigarettes will become effective on September 22, 
2012. 
Similarly, section 204 of the Tobacco Control Act amended section 3 of the Smokeless 
Tobacco Act, 15 U.S.C. 4402, to prescribe requirements for four warning statements that 
must appear on smokeless tobacco product packages and advertisements, and to require 
the submission of warning plans for smokeless tobacco product packages and 
advertisements to FDA for review and approval, rather than to the FTC.  These 
requirements are currently in effect. 
A.  Cigarettes  Contains Nonbinding Recommendations
 
Draft  n  Not for Implementation
 
Under 15 U.S.C. 1333, each cigarette package and advertisement must bear one of nine 
textual warning statements. 
Packages.  Once the required warnings 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 cigarette unless the product package bears one of the 
required warnings (i.e., one of the nine textual warning statements and its accompanying 
color graphic) in accordance with the requirements set forth in 15 U.S.C. 1333 and 
applicable regulations.  In certain situations described in 15 U.S.C. 1333(a)(4), retailers 
of cigarettes are exempt from this requirement. To fall within this exemption, the retailer 
must ensure that cigarette packaging: 1) contains a health warning; 2) is supplied to the 
retailer by a license- or permit-holding tobacco product manufacturer, importer, or 
distributor; and 3) is not altered by the retailer in a way that is material to the 
requirements of 15 U.S.C. 1333(a).  However, a retailer is still responsible for complying 
with other applicable requirements relating to cigarettes, including those contained in 21 
CFR Part 1140. 
Advertisements.  Once the required warnings take effect, it will be unlawful for any 
tobacco product manufacturer, importer, distributor, or retailer of cigarettes to advertise 
or cause to be advertised within the United States any cigarette unless its advertising 
bears one of the required warnings in accordance with the requirements set forth in 15 
U.S.C. 1333 and applicable regulations.  As with packaging, retailers may be exempt 
from this requirement under certain circumstances, which are described in 15 U.S.C. 
1333(c)(4). 
Warning Plans.  The requirement for submission of warning plans for cigarettes, and the 
specific requirements relating to the random display of required warnings on cigarette 
packaging and quarterly rotation of required warnings in cigarette advertising, appear at 
15 U.S.C. 1333(c). 
In particular, warning plans for cigarette packaging must provide that all of the required 
warnings: 
x  Are randomly displayed in each 12-month period on each brand of the product, 
x  Are randomly displayed in as equal a number of times as is possible on each 
brand of the product, and 
x  Are randomly distributed in all areas of the United States in which the product is 
marketed. 
15 U.S.C. 1333(c)(1).  For FDA to approve it, a warning plan must provide for the 
required equal distribution and display of required warnings on packaging and must 
assure that all of the required warnings will be displayed by the manufacturer, importer, 
distributor, or retailer at the same time.  15 U.S.C. 1333(c)(3). 
For FDA to approve it, a warning plan for cigarette advertising must provide that all of 
the required warnings are rotated quarterly in alternating sequence in advertisements for 
each brand of cigarettes.  15 U.S.C. 1333(c)(2) and (3).  Contains Nonbinding Recommendations
 
Draft  n  Not for Implementation
 
B.  Smokeless Tobacco Products 
Under 15 U.S.C. 4402, each smokeless tobacco product package and advertisement must 
bear one of four textual warning statements. 
Packages.  It is unlawful for any person to manufacture, package, sell, offer to sell, 
distribute, or import for sale or distribution within the United States any smokeless 
tobacco product unless the product package bears one of the following required warning 
statements: 
x  WARNING: This product can cause mouth cancer. 
x  WARNING: This product can cause gum disease and tooth loss. 
x  WARNING: This product is not a safe alternative to cigarettes. 
x  WARNING: Smokeless tobacco is addictive. 
15 U.S.C. 4402(a)(1). 
In certain situations described in 15 U.S.C. 4402(a)(5), retailers of smokeless tobacco 
products are exempt from this requirement. To fall within this exemption, the retailer 
must ensure that smokeless tobacco packaging: 1) contains a health warning; 2) is 
supplied to the retailer by a license- or permit-holding tobacco product manufacturer, 
importer, or distributor; and 3) is not altered by the retailer in a way that is material to the 
requirements of 15 U.S.C. 4402(a).  15 U.S.C. 4402(a)(5). However, a retailer is still 
responsible for complying with other applicable requirements relating to smokeless 
tobacco products, including those contained in 21 CFR Part 1140. 
Advertisements.  It is also unlawful for any smokeless tobacco product manufacturer, 
packager, importer, distributor, or retailer to advertise or cause to be advertised within the 
United States any smokeless tobacco product unless the advertising bears one of the 
required warning statements. 15 U.S.C. 4402(b)(1). As with packaging, retailers may be 
exempt from this requirement under certain circumstances, which are described in 42 
U.S.C. 4402(b)(3)(D). 
In an important change from prior law, outdoor billboard advertising for smokeless 
tobacco products must now include the required warning statements.  Prior to its 
amendment by the Tobacco Control Act, the Smokeless Tobacco Act exempted outdoor 
billboard advertising from the requirement that smokeless tobacco product 
advertisements bear required warning statements,2 but the Tobacco Control Act 
amendments eliminated this exemption.  15 U.S.C. 4402(b). Thus, it is unlawful for any 
smokeless tobacco product manufacturer, packager, importer, distributor, or retailer to 
advertise or cause to be advertised a smokeless tobacco product on an outdoor billboard 
unless the advertisement bears one of the required warning statements. 
2 This exemption had been codified at 15 U.S.C. 4402(a)(2). Contains Nonbinding Recommendations
 
Draft  n  Not for Implementation
 
Warning Plans.  The requirement for submission of warning plans for smokeless tobacco 
products and the specific requirements relating to random display of required warning 
statements on smokeless tobacco product packaging and quarterly rotation of required 
warning statements in smokeless tobacco product advertising appear at 15 U.S.C. 
4402(b)(3). 
In particular, warning plans for smokeless tobacco product packaging must provide that 
all of the required warning statements: 
x  Are randomly displayed in each 12-month period on each brand of the product, 
x  Are randomly displayed in as equal a number of times as is possible on each 
brand of the product, and 
x  Are randomly distributed in all areas of the United States in which the product is 
marketed. 
15 U.S.C. 4402(b)(3)(A).  For FDA to approve it, a warning plan must provide for the 
required equal distribution and display of required warning statements on packaging and 
must assure that all of the required warning statements will be displayed by the 
manufacturer, importer, distributor, or retailer at the same time. 15 U.S.C. 
4402(b)(3)(C)(ii). 
Warning plans for smokeless tobacco product advertising must provide that all of the 
required warning statements are rotated quarterly in alternating sequence in 
advertisements for each brand of smokeless tobacco product. 15 U.S.C. 4402(b)(3)(B). 
Because section 9(1) of the Smokeless Tobacco Act, 15 U.S.C. 4408(1) (as amended by 
Section 101(c) of the Tobacco Control Act), defines smokeless tobacco, by reference to 
section 900(18) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387(18)), as 
any tobacco product that consists of cut, ground, powdered, or leaf tobacco and that is 
intended to be placed in the oral or nasal cavity, smokeless tobacco products intended to 
be placed in the nasal cavity must now comply with the warning requirements in section 
3 of the Smokeless Tobacco Act.  At this time, as an exercise of enforcement discretion, 
FDA does not intend to commence or recommend enforcement of the requirement that 
smokeless tobacco products marketed solely for use in the nasal cavity bear either the 
WARNING: This product can cause mouth cancer. or the WARNING: This product 
can cause gum disease and tooth loss. so long as a warning plan providing that packages 
and advertising for such products will bear the other two warnings has been submitted to 
FDA and implemented. FDA will give further consideration to the warnings smokeless 
tobacco products marketed solely for use in the nasal cavity should bear.  FDA intends to 
provide further public notice prior to revising or rescinding this enforcement policy. 
III.  Discussion 
A.  Definitions 
For purposes of this guidance, FDA intends to use the definitions in section 4 of FCLAA, 
in Section 3 of the Smokeless Tobacco Act, and in any implementing regulations, as well 
as the following definitions:  Contains Nonbinding Recommendations
 
Draft  n  Not for Implementation
 
Required warning means the combination of a textual warning statement and its 
accompanying color graphic required pursuant to section 4 of FCLAA to be on packaging 
and in advertising for cigarettes. 
Required warning statement means a textual warning statement required pursuant to 
section 3 of the Smokeless Tobacco Act to be on packaging and in advertising for 
smokeless tobacco products. 
Warnings refers to the required warnings (for cigarettes) and the required warning 
statements (for smokeless 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 cigarettes or smokeless tobacco 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. 
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 manufacturer, importer, distributor, or retailer is best suited to submit a 
warning plan.  These considerations will help ensure the applicable requirements are 
complied with as well as avoid situations where multiple persons unnecessarily submit a 
warning plan applicable to the same distribution chain. 
Packages 
As explained above, when the warning requirements are in effect, it is unlawful for any 
person to manufacture, package, sell, offer to sell, distribute, or import for sale or 
distribution within the United States any cigarette or smokeless tobacco product unless 
the product package bears one of the warnings required by 15 U.S.C. 1333 and 4402, 
respectively.  In addition, warnings 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.  15 U.S.C. 1333(c) (cigarettes) and 15 
U.S.C. 4402(b)(3) (smokeless tobacco products). For a particular brand, this warning 
plan may be submitted by the tobacco product manufacturer, importer, distributor, or 
retailer.  While 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 cigarettes or smokeless tobacco product, it is  Contains Nonbinding Recommendations
 
Draft  n  Not for Implementation
 
important that you make sure a warning plan has been approved covering your actions 
and you comply with this plan. 
Based on the FTCs experience reviewing warning plans, 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.  Moreover, in most circumstances, the brands 
manufacturer is the entity that is most able to ensure a warning plan would be sufficient 
for approval by FDA  that it would provide for equal distribution and display on 
packaging and assure that all of the warnings that are required will be displayed at the 
same time.  This is because the brands manufacturer is usually the entity responsible, 
either directly or through a contractor or other agent, for placing or directing the 
placement of the warnings on the brands packages and for directing distribution of the 
packages.  Placing the warning 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 warnings on 
the product package. In such situations, FDA believes the private label brand distributor 
would be best suited to submit the warning plan.  If a retailer is responsible for or directs 
the placement of warnings on packaging, the retailer would be best suited to submit the 
warning plan. 
For finished cigarettes and smokeless tobacco products that are imported, distribution is 
usually handled by the products importer or importers.  Because importers typically 
either direct the foreign manufacturers placement of the warnings on the product 
package or direct the packaging and placement of the warnings in the United States, we 
recommend that the importer or importers of a brand of cigarettes or smokeless tobacco 
product 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. 
Advertisements. 
When the required warnings are in effect, it is unlawful for any tobacco product 
manufacturer, importer, distributor, or retailer to advertise or cause to be advertised 
within the United State any cigarette or smokeless tobacco product unless its advertising 
bears one of the required warnings in accordance with the requirements of 15 U.S.C. 
1333 and 4402, respectively.  One requirement is that the warnings in advertisements be 
rotated quarterly for each brand in accordance with a warning plan submitted to, and 
approved by, FDA. 15 U.S.C. 1333(c) (cigarettes) and 15 U.S.C. 4402(b)(3) (smokeless 
tobacco products).  For a particular brand, this warning plan may be submitted by the 
tobacco product manufacturer, importer, distributor, or retailer.  While the warning plan 
may be submitted by someone other than you, before you advertise a brand of cigarettes 
or smokeless tobacco product, it is important that you make sure a warning plan has been 
approved covering your actions, and your actions in rotating warnings in advertising 
comply with this plan.  Contains Nonbinding Recommendations
 
Draft  n  Not for Implementation
 
In most circumstances, the person who creates advertising, causes advertising to be 
created, or is otherwise responsible for inclusion of the warning on advertising for a 
brand of cigarettes or smokeless tobacco products is most able to ensure a warning plan 
would be sufficient for approval by FDA  that it would provide for quarterly rotation of 
warnings 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 cigarettes or smokeless tobacco products 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. The retailer would need to comply 
with the plan, such as by following the manufacturers instructions for displaying 
advertising. 
C.  What is the scope of a warning plan? 
If you are submitting warning plans for both cigarettes and smokeless tobacco products, 
you must submit one warning plan for cigarettes and one warning plan for smokeless 
tobacco products -because the requirements for submission of these warning plans rest 
on separate, albeit similar, statutory authority and the text and number of the applicable 
warnings is different for cigarettes and smokeless tobacco products -but you may submit 
these plans as a single document or together in the same envelope.  For the efficiency of 
review, FDA asks that each warning plan cover both packaging and advertising to the 
extent applicable. 
D.  When should a warning plan be submitted? 
Warnings must be equally distributed and displayed on packages, and rotated quarterly in 
advertisements, for cigarettes and smokeless tobacco products in accordance with an 
approved warning plan.  15 U.S.C. 1333(c)(1), (2) and 15 U.S.C. 4402(b)(3)(A), (B) 
(emphasis added).  As discussed in the Background section, the required warnings for 
cigarettes will become effective on September 22, 2012. In order to afford FDA 
sufficient time to review and approve proposed warning plans for cigarettes before the 
effective date, FDA strongly recommends that the warning plans for cigarettes be 
submitted to the agency as soon as possible.  Given the volume of submissions FDA 
currently believes it will receive and that all of these will be initial submissions under the 
requirements, our best estimate is that it will take at least six months for the agency to 
review a submission.  If the volume is greater than anticipated, or the quality of the 
submissions is poor, then it will likely take FDA longer to review them.  You should keep 
these factors in mind in deciding when to submit your warning plan. 
Under section 204 of the Tobacco Control Act, the requirement for an FDA approved 
warning plan for smokeless tobacco products became effective June 22, 2010. On June 
8, 2010, FDA announced by guidance its intent not to enforce the requirement that a 
brand of smokeless tobacco product must have an FDA-approved warning plan so long as  Contains Nonbinding Recommendations
 
Draft  n  Not for Implementation
 
a warning plan for the brand was submitted to FDA by July 22, 2010, and implemented. 
(See 75 FR 32481).  FDA expects to begin enforcing the requirement under section 204 
that there be an approved warning plan 6 months after the publication of the notice of 
availability of a final guidance on the Submission of Warning Plans for Cigarettes and 
Smokeless Tobacco Products or 6 months after the publication of a final regulation 
regarding the submission of warning plans, whichever comes first. 
Because warnings must be equally distributed and displayed on packages, and rotated 
quarterly in advertisements, for cigarettes and smokeless tobacco products in accordance 
with an approved warning plan, a new warning plan or supplement to an approved 
warning plan must be submitted and approved before making changes to the distribution 
or display of warnings on packages or rotation of warnings in advertisements.  Likewise, 
a new plan or a supplement to an approved warning plan must be submitted and approved 
before distributing or displaying packages and advertisements for a new brand. In order 
to afford FDA sufficient time to review a supplement to an approved warning plan, FDA 
strongly recommends that you allow at least three 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. 
FDA may request an amendment to a warning plan or to a supplement to a warning plan 
if FDA needs clarification of information in the warning plan or minor 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 cigarettes. 
Appendix B provides an example of what FDA considers to be an acceptable warning 
plan for smokeless tobacco products. 
1.	 Cover letter 
In order to facilitate FDAs review of warning plans, FDA requests that your warning 
plan be accompanied by a cover letter that includes: 
x 	 Date of the submission; 
x 	 One of the following subject lines: 
	 RE: WARNING PLAN FOR CIGARETTES (Original, Amendment, 
o 
or Supplement), or 
	 RE: WARNING PLAN FOR SMOKELESS TOBACCO PRODUCTS 
o 
(Original, Amendment, or Supplement); 
x  A statement as to whether the warning plan covers packages, advertising, or both 
packages and advertising; 
x 	 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,  Contains Nonbinding Recommendations 
Draft  n  Not for Implementation 
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; 
x  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; 
x  A list of any submissions made to FDA relating to the warning plan, identified by 
CTP-assigned reference number and the date of submission; 
x  A list of all cigarettes or smokeless tobacco products 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 Federal Food, Drug, and Cosmetic Act; and 
x  A certification by an authorized official of the company making the submission 
that all information submitted has been reviewed prior to filing. 
2.  Information to include in the warning plan for packaging 
For each cigarette or smokeless tobacco product brand, your plan should state the specific 
applicable statutory or regulatory warning plan requirements and provide a detailed 
description of how: 
x  Each of the warnings will be randomly displayed during each 12-month period on 
each brand; 
x  Each of the warnings will be displayed in as equal a number of times as possible 
on each brand of the product; 
x  Product packages will be randomly distributed in all areas of the United States in 
which the product is marketed; and 
x  Each of the warnings will be displayed at the same time. 
The plan for packaging should include a discussion of how the requirements are to be 
implemented based on the specific manufacturing processes and distribution procedures. 
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). 
For the reasons discussed in section II above, warning plans for smokeless tobacco 
products marketed solely for use in the nasal cavity should provide for the equal 
distribution and display of two warnings: WARNING: This product is not a safe 
alternative to cigarettes. and WARNING: Smokeless tobacco is addictive. 
FDA expects that a plan for equal distribution and 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 statutory requirements for equal distribution and 
display of warnings on packages to be sufficiently detailed to enable FDA to determine 
whether it can approve a warning plan.  Contains Nonbinding Recommendations
 
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Appendices A and B provide an example of a warning plan for cigarettes and an example 
of a warning plan for smokeless tobacco products, respectively, that FDA believes would 
meet the applicable requirements for approval. 
3. Information to include in the warning plan for advertising 
Your plan should state the specific applicable warning plan requirements.  Then, for each 
cigarette or smokeless tobacco brand, your plan must provide a sufficiently detailed 
description of how the warnings will be rotated quarterly in advertisements, including 
outdoor billboard advertisements. 
For the reasons discussed in section II above, warning plans for smokeless tobacco 
products marketed solely for use in the nasal cavity should provide for the quarterly 
rotation of two warnings: WARNING: This product is not a safe alternative to 
cigarettes. and WARNING: Smokeless tobacco is addictive. 
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 statutory requirement for quarterly rotation of 
warnings on advertising to be sufficiently detailed to enable FDA to determine whether it 
can approve a warning plan. 
4. Representative packaging and advertising 
FDA requests that your warning plan include representative samples of packages and 
advertisements with each of the warnings.  Such samples will place the warning plan in 
context and, therefore, facilitate FDAs review.  By representative samples, we mean 
different types of cigarette or smokeless tobacco product packaging and a range of 
package sizes for each type of product. Samples of advertising could include actual 
examples of different types of advertising materials for various brands, prototypes of 
actual advertising materials, the warning as it would appear in different sizes of 
advertisements, or acetates or other facsimiles for the warning as it would appear in 
different sizes of advertisements. 
G.  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  Contains Nonbinding Recommendations
 
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H.  What does it mean to get FDA approval of a warning plan? 
FDAs review of a warning plan is only for the purpose of determining compliance with 
the statutory criteria for approval of a warning plan, as set forth in 15 U.S.C. 1333(c)(3) 
and 4402(b)(3)(C). Approval of a warning plan does not represent a determination by 
FDA that any specific package or advertisement complies with any of the other 
requirements set forth in FCLAA or the Smokeless Tobacco Act, including the 
requirements set forth in 15 U.S.C. 1333(a)(2), and (b)(2), 4402(a)(2) and (b)(2), and 
applicable regulations regarding the placement, type, size, and color of the warnings.  Appendix A  Example Cigarette 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 the applicable 
requirements. 
I.  Cover Letter (Cigarette Sample) 
Date 
Office of Compliance and Enforcement 
FDA Center for Tobacco Products 
c/o Document Control Center 
9200 Corporate Boulevard 
Rockville, Maryland 20850 
RE:  WARNING PLAN FOR CIGARETTES 
([INSERT Original, Amendment, or Supplement]) 
To Whom It May Concern: 
Pursuant to Section 4 of the Federal Cigarette Labeling and Advertising Act (FCLAA), as amended by 
section 201 of the Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control Act), 
[INSERT: company name] submits this proposed warning plan cov ering [INSERT: packaging and 
advertising or packaging or advertising] for cigarettes. 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 
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): 
1
  Appendix A  Example Cigarette Warning Plan 
This plan covers the following cigarette products: 
Brand Name  Product  Unique Identifier  Type of Unique Identifier
(Subbrand)  (SKU, Catalog #, UPC) 
1. Brand x  Blues  12345  Catalog # 
100 Hard Pack 
2. 
If you hav e 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 cigarettes [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 
Signature of official of company who is authorized to submit plan 
2
  Appendix A  Example Cigarette Warning Plan 
II.  Warning Plan for Cigarette Packaging 
In accordance with Section 4 of the FCLAA, each cigarette package must bear one of nine warning 
statements and its accompanying graphic on the front and rear panels of the package. Additionally, the 
warning statement 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. 
This plan provides the manner by which the required warnings on packages will be: 
x  randomly displayed in each 12-month period on each brand of the product; 
x  randomly displayed in as equal a number of times as is possible on each brand of the 
product; 
x  randomly distributed in all areas of the United States in which the product is marketed; and 
x  displayed on product packages at the same time. 
To ensure display of required warnings in as equal a number of times as is possible on packaging for 
each brand, we will: 
1. 	 Produce a total of 9,000 packages for each print run. 
2. 	 Print each of the nine required warnings on packages in sequential order (1, 2, 3, 4, 5, 7, 8, 9 
and 1, 2, 3, 4, 5, 7, 8, 9 and 1, 2, 3, 4, 5, 7, 8, 9, etc.), for a total of 9,000 (1,000 each). 
OR 
2. 	 Print 1,000 of each of the nine required warnings 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 nine different required warnings for each 
brand of product, subject to minor variations due to normal commercial printing and 
manufacturing practices. 
To ensure that the required warnings are randomly displayed in as equal a number of times as is possible 
on each brand during a 12-month period, that all nine required warnings are displayed at the same time, 
and that the required warnings are randomly distributed in all areas of the United States in which the 
product is marketed, we will: 
Upon cigarettes being manufactured, store products in shipping containers.  Each container will 
include all required warnings in as equal numbers as possible. When an order is placed, we will 
distribute such container(s). 
OR 
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 warnings. 
3
  Appendix A  Example Cigarette Warning Plan 
III.  Warning Plan for Cigarette Advertising 
In accordance with Section 4 of FCLAA, each cigarette advertisement must bear one of the nine required 
warnings.  Additionally, the 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 warnings on cigarette advertising will be rotated 
quarterly in alternating sequence in advertisements for each brand of cigarettes. 
Our advertisements will rotate the nine required warnings according to the following schedule for each 
brand of product: 
Jan 1   April 1   July 1   Oct 1   Jan 1  April 1  July 1  Oct 1  Jan 1 
March  June 30  Sept 30  Dec 31       Sept   Dec   
31  March  June  30  31  March 
31  30  31 
Brand A  1  2  3  4  5  6  7  8  9 
Brand B  9  1  2  3  4  5  6  7  8 
Brand C  8  9  1  2  3  4  5  6  7 
1=WARNING: Cigarettes are addictive. 

2=WARNING: Tobacco smoke can harm your children.
 
3=WARNING: Cigarettes cause fatal lung disease. 

4=WARNING: Cigarettes cause cancer. 

5=WARNING: Cigarettes cause strokes and heart disease. 

6=WARNING: Smoking during pregnancy can harm your baby.
 
7=WARNING: Smoking can kill you. 

8=WARNING: Tobacco smoke causes fatal lung disease in nonsmokers. 

9=WARNING: Quitting smoking now greatly reduces serious risks to your health.
 
Cigarette brands will be adv ertised using the following media and the rotation of the nine required 
warnings 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
  Appendix B  Example Smokeless Tobacco 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 (Smokeless Sample) 
Date 
Office of Compliance and Enforcement 
FDA Center for Tobacco Products 
c/o Document Control Center 
9200 Corporate Boulevard 
Rockville, Maryland 20850 
RE:  WARNING PLAN FOR SMOKELESS TOBACCO PRODUCTS 
([INSERT: Original, Amendment, or Supplement]) 
To Whom It May Concern: 
Pursuant to Section 3 of the Comprehensiv e Smokeless Tobacco Health Education Act of 1986 
(Smokeless Tobacco Act), as amended by section 204 of the Family Smoking Prev ention and Tobacco 
Control Act of 2009 (Tobacco Control Act), [INSERT: company name] submits the attached proposed 
warning plan covering [INSERT: packaging and advertising or packaging or advertising] for smokeless 
tobacco products. 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 
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): 
1
  Appendix B  Example Smokeless Tobacco Warning Plan 
This plan covers the following smokeless tobacco products: 
Brand Name  Product  Type of Unique Identifier  Type of Unique 
(Subbrand)  Smokeless  Identifier (SKU,
Tobacco  Catalog #, UPC) 
1.  Brand x  Long Cut Mint  Chew  12345  Catalog # 
2. 
If you hav e 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 smokeless tobacco products [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 
Signature of official of company who is authorized to submit plan 
2
  Appendix B  Example Smokeless Tobacco Warning Plan 
II.  Warning Plan for Smokeless Tobacco Product Packaging 
In accordance with Section 3 of the Smokeless Tobacco Act, each smokeless tobacco product package 
must bear one of four required warning statements on its two principal display panels.  Additionally, the 
warning statement 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. 
This plan provides the manner by which the required warning statements on packages will be: 
x  randomly displayed in each 12-month period on each brand of the product; 
x  randomly displayed in as equal a number of times as is possible on each brand of the 
product; 
x  randomly distributed in all areas of the United States in which the product is marketed; and 
x  displayed on product packages at the same time. 
To ensure display of the four 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 4,000 packages for each print run. 
2. 	 Print each of the four required warning statements on packages in sequential order (1, 2, 3, 
4, and 1, 2, 3, 4, and 1, 2, 3, 4, etc.), for a total of 4,000 (1,000 each). 
OR 
2. 	 Print 1,000 of each of the four 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 the four 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, that all four required warning statements 
are displayed at the same time, 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 smokeless tobacco 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). 
OR 
Separate smokeless tobacco product 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
  Appendix B  Example Smokeless Tobacco Warning Plan 
III.  Warning Plan for Smokeless Tobacco Product Advertising 
In accordance with Section 3 of the Smokeless Tobacco Act, each smokeless tobacco advertisement 
must bear one of the four required warning statements.  Additionally, the 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 smokeless tobacco product 
adv ertising will be rotated quarterly in an alternating sequence in advertisements for each brand of 
smokeless tobacco product. 
Our advertisements will rotate the four required warning statements according to the following schedule 
for each brand of product: 
Jan 1  March 31  April 1  June 30  July 1  Sept 30  Oct 1  Dec 31 
Brand A  1  2  3  4 
Brand B  2  3  4  1 
Brand C  3  4  1  2 
1 = WARNING: This product can cause mouth cancer. 
2 = WARNING: This product can cause gum disease and tooth loss. 
3 = WARNING: This product is not a safe alternative to cigarettes. 
4 = WARNING:  Smokeless tobacco is addictive. 
Smokeless tobacco brands will be advertised using the following media and the rotation of the four 
required warning statements will be based on the date indicated in the table below. 
Type of Advertising  Start of Quarterly Rotation 
Adv ertising 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