Tobacco Product Master Files 
  
 
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  Docket No.  
FDA-2015-D-2325.  
 
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/GuidanceComplianceRegulatoryInformation/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

   May  2016
	
   Contains Nonbinding Recommendations  
 
Table  of  Contents	 

 
 
 
I.   INTRODUCTION  .........................................................................................................1
	 
II.   DISCUSSION  ................................................................................................................2
	 
A.   How  to  establish  a  master  file  ...................................................................................................  2
	 
B.     Additional  considerations  for  TPMF  owners  in  maintaining  TPMF  submissions  .................. 2
	 
C.   How  others  can use  a  TPMF .....................................................................................................  3
	 
D.   FDAs  role  .................................................................................................................................  3
	 
i  
  Contains Nonbinding Recommendations  
 
Tobacco  Product  Master Files	
 
 
 
 
1
	
Guidance  for  Industry  
 
 
This guidance repr esents 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 provides recommendations to industry  on tobacco product master files (TPMFs).   
TPMFs are used to permit the person  that owns  the TPMF (TPMF owner) to  authorize other  
persons  to  rely on information in the TPMF to support a submission to FDA without  the TPMF  
owner  having to disclose  that information to  other persons.  These files typically contain trade 
secret and/or confidential commercial  information that  the TPMF owner does not wish to make 
public.   Authorization to reference a TPMF  may  be especially useful to manufacturers or  
applicants preparing premarket submissions  for  tobacco products.   Other parties that  obtain a 
right  of reference from a TPMF owner can reference information  in a TPMF that  the TPMF  
owner does not want  to make public, but  that  the other party would otherwise need to develop on  
its own to make a complete submission to FDA.   For example, a filter  manufacturer might  
provide  another person a right  of reference to  its  TPMF which contains the  full listing of  
materials,  ingredients, and composition  information of the filter.   This  information could then  be 
used by the other person to support requirements in  a premarket application  for a finished  
cigarette that uses the filter as a component.    
 
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 Science and Office of Regulations in the Center for  Tobacco Products  
at FDA.  
1 

  Contains Nonbinding Recommendations  
 
 
II.		  DISCUSSION      
 
A.		  How to  establish  a  master  file  
 
1. What to submit.  For purposes  of this guidance, a  TPMF  is a voluntary submission to  the FDA  
that  contains  information about a  tobacco product  (including but not limited  to  materials, parts,  
components and accessories of tobacco products,  or  the facilities, processes, or articles used  in  
the manufacturing, processing, packaging, and storing of tobacco products), that the  
manufacturer does not want  to share with other  persons.  To establish a TPMF,  FDA 
recommends that  the following  information be submitted  to FDA,  in English,  and  with the  pages  
numbered sequentially:  
 
	   A  cover letter  that  includes:  
(i) 	  A  statement  that the  information is  being submitted as a TPMF;  
(ii) 	  A  brief description of the content  of the TPMF;  
(iii) 	  The name,  mailing address, email address, and phone number of the TPMF owner  
(the person establishing and holding the TPMF);  
a. 	  If an authorized representative can grant a right  of  reference to  the TPMF  on  
behalf of the  owner  and will  communicate  on behalf of the owner, the  name,  
mailing address, email address, and phone  number of that individual;  
b. 	  If the TPMF owner  or authorized representative does not  reside in or have a 
place of business the United States,  the name,  mailing address, email address,  
and phone number  of a U.S. agent;  
 	  A current table of contents;  
 	  The information that is to be made part  of the TPMF;  
 	  A  list of each person currently authorized to reference the TPMF  (including name,  
mailing address, email address, and phone  number); and  
	   Identification of any limitations on each  authorization  (e.g., if the TPMF  owner  is  
authorizing others to use only certain sections  and, if so, identification of those sections).  
 
2.  Where to submit.   The TPMF  owner  (or authorized agent)  should submit this  information to 
FDA,  via the FDA Electronic Submission Gateway (http://fda.gov/esg) using eSubmitter  or  mail  
the information  to  the following address:  
Food and Drug Administration 
 
Center for  Tobacco Products  

Document Control Center  

Building 71, Room G335 
 
10903 New Hampshire Avenue
  
Silver Spring, MD 20993-0002 

 
B.   Additional  considerations  for TPMF  owners  in  maintaining  TPMF 
submissions  
 
1.  Updates to information.  If any  informat ion  in the TPMF changes, the TPMF  owner should  
update the TPMF,  identifying the sections that have changed.  
2 

  Contains Nonbinding Recommendations  
 
 
2.  Closure of a TPMF.  If  a TPMF owner wishes to close  its  TPMF,  the TPMF owner should  
notify  the  FDA in writing  and  include,  in the notification,  the reason for  requesting closure of  the  
file  and the date the TPMF should  be closed.   Additionally,  it  is recommended that  the TPMF  
owner notify  all persons currently authorized to  reference the TPMF of the closure, as once 
closed the TPMF will no  longer  be available for reference.   
 
C.   How  other  persons can  use  a  TPMF  
 
The TPMF  owner  may,  in writing,  grant authorization to  reference the TPMF to  other  persons, 
including applicants and manufacturers.   The  written  authorization should describe the specific 
sections of the TPMF to which the TPMF owner is authorizing  right of reference.  Persons  who  
have  been granted written authorization to reference the TPMF,  or a portion thereof,  may rely on 
the information in the TPMF  to support a submission  to FDA without  the TPMF  owner  having to  
disclose this  information to  them.  If there are any  questions about  the content  of the TPMF,  the 
other  person  should discuss the questions with the TPMF  owner.   The ability to refer to a TPMF  
can be helpful  to  other  persons  that are preparing premarket applications, such as substantial  
equivalence reports or  premarket tobacco  product applications.  
 
D.   FDAs  role  
 
1.  Review of a TPMF.  FDA does not  intend to  conduct a scient ific  review  of a TPMF at the time 
of its  submission, and   establishment  of a TPMF  should not be construed as a conclusion 
regarding  its contents by FDA. Instead, FDA typically reviews the information  in a TPMF only  
in the context of  reviewing a particular submission, e.g., when an authorized  applicant or  
manufacturer  references material in a TPMF  in its  application or submission.  
 
2.  FDA Initiation  of TPMF  Closure.  FDA  intends  to begin a closure process  if the TPMF  has  not  
been referenced within three years  and there have  been no  updates  during this time.  Prior to  
closure of any TPMF, FDA  intends to issue a notification  letter  to  the TPMF owner  of the intent  
to close.  The TPMF owner may respond to  the notification  letter  within the time period 
specified  to  keep the TPMF active.  
3