Compliance  Policy for  Certain 
 

Labeling  and  Warning 
 

Statement Requirements  for 

 
Cigars and Pipe Tobacco 
 
 
 
 

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-2018
D-3047.  
 
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  edition  of this guidance.   Contains Nonbinding Recommendations  
 
Table of Contents  
 
 
I.   INTRODUCTION ...................................................................................................... 1
  
II.   BACKGROUND ........................................................................................................ 2
  
III.   DISCUSSION ............................................................................................................. 3
  
A.   What Definitions Apply to This Guidance? .....................................................................  3
  
B.   FDAs Compliance Policy for Certain Labeling and Warning Statement Requirements for 
 
Cigars  and 

PipeTobacco...................................................................................................3 
 
 
 
   
 
i  
  Contains Nonbinding Recommendations  
Compliance Policy for  Certain  Labeling  and 
 
Warning  Statement  Requirements  for 
 
Cigars and Pipe Tobacco 
  
 
1
 
Guidance for  Industry  
 
 
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  or pipe  tobacco with respect to the  
labeling   requirements  in  sections  903(a)(2)  and 920(a) of the  Federal Food,  Drug,  and 
Cosmetic Act  (FD&C Act)  (21 U.S.C. 387c(a)(2), 387t(a)) and the  warning statement  
requirements  in  Title  21, Code  of Federal Regulations   (CFR),  part 1143  (21 CFR part  
1143).   This guidance  document  discusses,  among  other things:  
 
	   Certain  statutory  requirements  for pipe  tobacco and cigar  labeling    
	   The regulatory requirements  for cigar and pipe  tobacco  warning  statements  
	   Definitions  
	   FDAs compliance policy  for  certain  labeling   and warning  statement  
requirements  for  cigars  and pipe  tobacco  
 
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 
                                              
 
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.  
 
1 
 
  Contains Nonbinding Recommendations  
requirements  are  cited.  The use  of  the word should  in  Agency guidances  means that  
something is suggested or  recommended,  but not  required.   
 
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 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  final  deeming  rule,  extending FDAs tobacco product  
authority to  all  other products (other than accessories  of newly deemed products)  that  meet  
the statutory definition  of  tobacco product,  including   cigars  and pipe tobacco  (81  FR  
28973).    
 
When the regulation became effective in August  2016,  deemed products  immediately 
became subject  to  Chapter IX  of the FD&C Act  and its  implementing  regulations,  including 
the  misbranding  provision   at section 903 of  the FD&C  Act (21 U.S.C. 387c). The  
misbranding  provision   includes  a requirement  under  section 903(a)(2)  of the FD&C Act  (21 
U.S.C. 387c(a)(2)) that  a  tobacco product  in  package form  must  bear a label  that contains  
information  about  the name and place  of business  of  the  tobacco product  manufacturer, 
packer, or  distributor;   an accurate statement of  the quantity of  the  contents  in terms of  
weight,  measure,  or numerical  count;  an accurate statement of the percentage of domestic 
and foreign-grown  tobacco used in the product;  and the statement required by section 
920(a) of the FD&C Act  (21 U.S.C. 387t(a)) (i.e., sale  only allowed in the  United States).   
 
In addition,   the regulation  at  21 C.F.R.  part 1143 requires  that cigarette  tobacco,  roll-your
own tobacco, and covered tobacco products include  warning statements  on product package  
labels  and advertisements.  When FDA issued the final  deeming rule, it  recognized that  
making these required  label  changes at one time could  decrease  the  cost  of  compliance on 
industry; accordingly,   as provided for  in the preamble  to the final  deeming rule,  the  
compliance  date for the labeling  requirements  under  sections  903(a)(2)  and 920(a)  of the  
FD&C Act  matched  the effective date for the warnings  requirements.2   
 
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 
                                              
 
2  See  81 FR  at 29,006.  
2 
 
  Contains Nonbinding Recommendations  
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.).  
 
 
III.   DISCUSSION  
 
A.   What  Definitions  Apply to This  Guidance?  
 
For  purposes  of this  guidance,  FDA intends  to use the  following  definitions:  
 
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.   
 
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  Certain  Labeling and Warning Statement  
Requirements for Cigars  and Pipe Tobacco   
 
FDA intends  to comply with the courts  order  in  Cigar Association of America  and  will not  
enforce the warning statement  requirements  for cigars  and pipe  tobacco until  60 days after  
the final  disposition  of Plaintiffs  appeal.  In addition,   the  agency does not  intend to enforce  
the labeling  requirements  under  sections  903(a)(2)  and 920(a)  for cigars  and pipe  tobacco 
while  the  injunction  remains in effect.3  Cigar and pipe  tobacco firms,  however,  may  add the  
warnings  and make these labeling  changes while  the injunction  remains  in effect. The  
compliance  policy in this  guidance supersedes  the compliance  dates  included  in any other  
guidance issued prior to this guidance.    
 
 The courts order  does not  enjoin FDA from  enforcing the warning requirements  at 21 
C.F.R.   1143.3  for other covered tobacco products,  cigarette tobacco,  and roll-your-own 
                                              
 
3  This is consistent with the approach the agency took after the district court decision in  R.J. Reynolds  
Tobacco Co. v. U.S. Food and Drug Administration, 823 F.  Supp. 2d 36 (D.D.C.  2011), while  the case was on  
appeal, Nos. 11-553, 12-5063 (D.C. Cir.).  Due to ongoing litigation, the implementation of FDAs final rule 
entitled Required Warnings for Cigarette Packages and Advertisements was uncertain.   Although the  
requirement under section 903(a)(2) of the FD&C Act  was not the subject of that litigation, given the 
uncertainties caused by the ongoing litigation, the agency  explained that those who manufacture, package,  
sell,  offer to sell, distribute or import for sale or distribution cigarettes within the United States would not be 
expected to comply with section 903(a)(2) until further notice from FDA.  
3 
 
  Contains Nonbinding Recommendations  
tobacco.  Accordingly,   these categories of  products  would not  be subject  to the compliance 
policy described above.4  
 
                                              
 
4  FDA issued a Draft Guidance titled Interpretation of and Compliance Policy for Certain Label 
Requirement; Applicability of Certain Food, Drug, and Cosmetic Act Requirements to Vape Shops for  
public comment, which, among other things, included a compliance policy relating to section 903(a)(2)(C).  
When finalized, the guidance will reflect the agencys current thinking on the topics contained therein.  
4