Compliance  Policy for 

 
Required Warning Statements 

 
on Small-Packaged 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  FDA-2017
D-0121. 
 
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 
 
*This is the  first revision to this guidance.  The  first edition was published in September 2017.   Contains Nonbinding Recommendations  
 
Table of Contents  
 
 
I.   INTRODUCTION............................................................................................................. 1
  
II.   BACKGROUND  ............................................................................................................... 2 
 
III.   DISCUSSION  .................................................................................................................... 4 
 
A.   What Definitions Apply to This Guidance? .................................................................................  4
  
B.     FDAs Compliance Policy for Cigars in Small Packaging  .........................................................  4
  
IV.   DOCUMENT HISTORY  ................................................................................................. 5 
 
 
 
   
 
i  
  Contains Nonbinding Recommendations  
Compliance Policy for Required Warning 

Statements on Small-Packaged 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  any person who manufactures, packages, 
sells, offers to sell, distributes, or  imports cigars in small packages with respect  to  the 
warning statement  requirements  in Title 21, Code  of Federal Regulations (CFR), part 1143 
(21 CFR part 1143)  for product packaging. This guidance  document  discusses, among 
other  things:  
 
   The regulatory requirements to place specific warnings on cigar packaging   
   Definitions  
   FDAs  compliance policy for cigars in small packaging  
 
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  prepared  by  the  Office  of  Regulations  and the  Office  of  Compliance  and Enforcement in 
the Center  for  Tobacco  Products  at  FDA.  
 
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  Contains Nonbinding Recommendations  
II.   BACKGROUND  
 
On  June  22, 2009, the  Family  Smoking Prevention and Tobacco Control  Act  (Tobacco 
Control  Act)  (Public  Law  111-31)  was signed  into law.   The  Tobacco Control Act  
granted  FDA  the  authority to  regulate  the  manufacture, marketing, and distribution of  
cigarettes, cigarette tobacco, roll-your-own  (RYO)  tobacco, 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 other  
products  that meet the statutory definition of a tobacco product to be  subject to  chapter IX  
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (deeming) (section 901(b)  of the  
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  the public health.  
 
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.   Once the  warning  statement  requirements  take effect,2  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)3:  
 
 	  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.  
                                                 
 
2  The effective date  under  the  deeming rule  is  May 10,  2018.  FDA  issued  a  guidance  on May 10,  2017  
providing a  compliance  date of  August  10,  2018.  See  
https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM557716.pdf.   As 
stated  above,  FDA  will  not  enforce  the  warning  requirements for  cigars  and  pipe  tobacco at  this  time.  
    
3  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.  
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  Contains Nonbinding Recommendations  
	   WARNING:  Tobacco smoke increases the risk  of lung cancer and heart disease,  
even in nonsmokers.  
 	  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.4  
 
These required warning statements for packages  must be randomly displayed and 
distributed in accordance with a warning plan submitted to and approved by FDA (see the  
guidance, Submission of  Warning Plans for Cigars (August 2018).5  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.  
Section 1143.5(a)(2)  specifies that the required warning statements  for cigars  must  
comprise at  least 30 percent of  each of  the two principal display panels of the cigar package  
and must appear in  at least 12-point  font, among other display and formatting requirements.  
Section 1143.3 specifies the warning statement requirements for cigarette tobacco, RYO  
tobacco, and covered tobacco products other than cigars.  Section 1143.3(d) provides a  
small package exemption from the required warning statement  for  these tobacco products, 
but excludes cigars. According to this section, if a  tobacco product package is too small or  
otherwise unable to  accommodate a label with sufficient space to bear such information, it  
will be exempt from the requirement to place the required warning statement directly on the  
product package provided that  the required warning statement appears:  
 	  On the carton or other outer container or wrapper if the carton, outer container, or 
wrapper has sufficient space to bear the information; or  
 	  On a tag otherwise firmly and permanently affixed to the  tobacco product  package.  
Under this provision, the required warning statement must be printed using the  
specifications required in  1143.3(a)(2), including warning placement, size, and font. In 
these cases,  the carton, outer container, wrapper,  or tag would serve as the location for the 
principal display panels. If a tag is used for the principal display panels, both sides of  the  
                                                 
 
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  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.  
 
5  See https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm517680.htm  
3 

  Contains Nonbinding Recommendations  
tag must be visible to the consumer (81 FR 29060). The  required  warning statements must  
be printed on both sides  of the tag to comply with  1143.3(a)(2).  
Part 1143 has no similar  exemption for  cigars with  packaging that is too small or otherwise  
unable to  accommodate a label with  sufficient space to bear the required  warning  
statements. Cigars that are sold individually, without any packaging, may satisfy the  
warning requirements  for packages  with warning statements posted at the point of sale  as 
specified in   1143.5(a)(3). This guidance addresses cigars with packaging that  is too  small 
or otherwise unable to  accommodate a label with  sufficient space to bear the required  
warning statements.  
 
 
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 tobacco, cigars, and other covered 
tobacco products, pursuant to  1143.3 and  1143.5.  
 
B.     FDAs Compliance Policy for Cigars in Small  Packaging  
 
This guidance sets forth  FDAs compliance policy with respect to  cigars in packaging that  
is too small  or otherwise unable to  accommodate a label with  sufficient space to bear the 
required warning statements.  At this  time, FDA does not intend to  take  enforcement action  
with respect  to such cigars that do not comply with the size and placement requirements in 
 1143.5(a)(2)  when the  information and specifications  required under  1143.5(a)(1) and 
(a)(2) appear on the carton or other  outer container or  wrapper that could accommodate the  
required warning statements, or on a  tag otherwise firmly and permanently affixed to the  
cigar  package.6  This guidance does not apply to the other provisions of  1143.5, including 
                                                 
 
6  This  is  similar  to  the  approach  provided  in   1143.3(d)  for  cigarette  tobacco,  RYO  tobacco,  and covered 
tobacco products  other  than cigars.  
4 

  Contains Nonbinding Recommendations  
the  random  display and distribution of  cigar warning statements on packaging in 
accordance with an FDA-approved warning plan, as described in  1143.5(c).  
 
 
IV.   DOCUMENT HISTORY  
 
September 2017   First edition of guidance  issued. 
 
August 2018  Section  II  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. 
 
                                                 
 
 
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