Requirements for the Submission of 
Data Needed to Calculate User Fees for 
Domestic Manufacturers and Importers 
of Tobacco Products 
(Revised)* 
 
 
Guidance for Industry 
 
Small Entity Compliance Guide 
 
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-2014-D-0917.  
 
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. 
 
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 Food and Drug Administration, Center 
for Tobacco Products, Document Control Center, ATTN: Office of Small Business Assistance, 
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 
 
May 2016 
 
* This is a revision to the first edition of this guidance, which was issued in July 2014.  Revisions are noted by 
date at the end of the guidance.  Contains Nonbinding Recommendations 
 
Table of Contents 
 
 
 
 
I.  INTRODUCTION .........................................................................................................1 
II.  BACKGROUND ............................................................................................................2 
III.  QUESTIONS AND ANSWERS ....................................................................................2 
i 
  Contains Nonbinding Recommendations 
 
Requirements for the Submission of Data Needed 
to Calculate User Fees for  
Domestic Manufacturers and Importers  
of Tobacco Products 
 
 
1
 Guidance for Industry  
Small Entity Compliance Guide 
 
 
 
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 is intended to help small businesses understand and comply with FDAs 
requirements for the submission of information needed to calculate the amount of user fees owed 
by each domestic manufacturer or importer of tobacco products under section 919 of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act).  Domestic manufacturers and importers of 
cigarettes, snuff, chewing tobacco, and roll-your-own tobacco are currently required to submit 
the information to FDA.  Domestic manufacturers and importers of cigars and pipe tobacco must 
begin submitting the information to FDA by the 20th day of August, 2016.  FDA has prepared 
this Small Entity Compliance Guide in accordance with section 212 of the Small Business 
Regulatory Enforcement Fairness Act (Public Law 104-121). 
 
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 Management and the Office of Regulations in the Center for Tobacco 
Products at FDA. 
  1  Contains Nonbinding Recommendations 
 
II.  BACKGROUND 
 
The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) was enacted 
on June 22, 2009 (Public Law 111-31), amending the FD&C Act and providing FDA with the 
authority to regulate tobacco products.  Included in the Tobacco Control Act is the requirement 
that FDA assess and collect user fees. 
 
Section 919(a) of the FD&C Act requires FDA to, in accordance with that section, assess user 
fees on, and collect such fees from, each manufacturer and importer of tobacco products subject 
to the tobacco product provisions of the FD&C Act (chapter IX of the FD&C Act).  Under the 
calculations required by section 919 of the FD&C Act, the tobacco products that are subject to 
user fee assessments are cigarettes, snuff, chewing tobacco, roll-your-own tobacco, cigars, and 
pipe tobacco.  The total amount of user fees for each fiscal year is specified in section 919(b)(1) 
of the FD&C Act, and under section 919(a) we are to assess and collect one-fourth of that total 
each quarter of the fiscal year.  The FD&C Act provides for the total quarterly assessment to be 
allocated among classes of tobacco products.  The class allocation is based on each tobacco 
product class volume of tobacco products removed2 into commerce.  Within each class of 
tobacco products, an individual domestic manufacturer or importer is assessed a user fee based 
on its market share for that tobacco product class. 
 
In the Federal Register of May 31, 2013 (78 FR 32581), FDA issued a notice of proposed 
rulemaking (NPRM) to add 21 CFR part 1150 to require domestic tobacco product 
manufacturers and importers to submit to FDA information needed to calculate the amount of 
user fees to assess each domestic manufacturer and importer under the FD&C Act.  In the 
Federal Register of July 10, 2014 (79 FR 39302), FDA finalized portions of the User Fee 
proposed rule related to cigarettes, snuff, chewing tobacco, and roll-your-own tobacco, which is 
codified at 21 CFR part 1150.  FDA did not finalize portions of the proposed rule relating to 
cigars and pipe tobacco because those product classes were not subject to FDAs authority at the 
time.  In the Federal Register, FDA published the final rule, Deeming Tobacco Products To Be 
Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking 
Prevention and Tobacco Control Act (Deeming Rule), which brought cigars and pipe tobacco 
under FDAs FD&C Act authority and, among other things, the user fee requirements of section 
919.  In accordance with this new Deeming Rule authority, FDA finalized the remaining portions 
of the User Fee rule related to cigars and pipe tobacco in the Federal Register, amending 21 CFR 
part 1150 to include requirements for domestic manufacturers and importers of cigars and pipe 
tobacco. 
 
 
III.  QUESTIONS AND ANSWERS 
 
A.  Who must submit information to FDA? 
                                                
2 Removal is defined at 26 U.S.C. 5702 as the removal of tobacco products or cigarette papers or tubes, or any 
processed tobacco, from the factory or from internal revenue bond under section 5704, as the Secretary [of Treasury] 
shall by regulation prescribe, or release from customs custody, and shall also include the smuggling or other 
unlawful importation of such articles into the United States. 
  2  Contains Nonbinding Recommendations 
 
 
The final rules apply to domestic manufacturers and importers of six classes of tobacco products:  
cigarettes, snuff, chewing tobacco, roll-your-own tobacco, cigars, and pipe tobacco.   
 
B.  What information must be submitted to FDA by domestic tobacco product 
manufacturers and importers? 
 
Each domestic manufacturer and importer must submit the following information and documents 
to FDA: 
  Its name and the mailing address of its principal place of business;  
  The name and a telephone number, including area code, of an office or individual that 
FDA may contact for further information;  
  The email address and postal address for receipt of FDA notifications;  
  Its Alcohol and Tobacco Tax and Trade Bureau (TTB) Permit Number(s);  
  Its Employer Identification Number(s) (EIN); 
  For each TTB tobacco permit:   
  The units of product (i.e., number of sticks for cigarettes and pounds for other 
o
tobacco products), by class, removed and not tax exempt for the prior month 
and  
  The Federal excise tax paid, by class, for such removal;  
o
  If the domestic manufacturer or importer did not remove any amount of tobacco 
product, it must report that no tobacco product was removed into domestic 
commerce;  
  Certified copies of the returns and forms that relate to: 
  The removal of tobacco products into domestic commerce (as defined by 
o
section 5702 of the Internal Revenue Code of 1986); and  
  The payment of the Federal excise taxes imposed under chapter 52 of the 
o
Internal Revenue Code of 1986. 
( 1150.5(b)) 
 
This information is currently submitted on TTB Forms 5210.5, 5000.24, and 5220.6 and 
Customs CBP Form 7501. 
 
Each domestic manufacturer and importer of cigars must provide additional data as part of the 
first report required under this rule.  Because section 919(b)(5) of the FD&C Act requires FDA 
to allocate user fees to individual manufacturers and importers of cigars based upon the total 
amount of excise taxes that each cigar firm paid in the prior fiscal year, the rule requires that 
cigar firms report the information above for each prior month in the fiscal year as part of the first 
monthly report of data under this rule.  After this first report, domestic manufacturers and 
importers of cigars must report data for the prior month, like manufacturers and importers of the 
other classes of tobacco products are required to do. 
( 1150.5(c)) 
 
C.  When must this information be received by FDA? 
  3  Contains Nonbinding Recommendations 
 
 
  For cigarettes, snuff, chewing tobacco, roll-your-own tobacco, cigars, and pipe tobacco, this 
information must be received by FDA by the 20th of each month.  
  
  Cigar and pipe tobacco companies must begin submitting this information by the 20th day of 
August, 2016.  
 
The information must be submitted on a monthly basis, even in months when no tobacco product 
is removed into domestic commerce.  (See  1150.5(a).) 
 
D.  How must this information be submitted to FDA? 
 
Domestic manufacturers and importers must use Form FDA 3852 and attach copies of the 
appropriate supporting TTB and CBP forms (currently TTB Forms 5210.5, 5000.24, and 5220.6 
and CBP Form 7501).  This form is available online and in paper form.  (See  1150.5.) 
 
Submit Form FDA 3852 and supporting documents to FDA by mail:  
   
Food and Drug Administration, 
Center for Tobacco Products, 
  Document Control Center, 
  ATTN:  OM, Division of Financial Management, User Fee Team 
  Building 71, Room G335 
10903 New Hampshire Avenue, 
  Silver Spring, MD 20993-0002 
 
electronically:  TOBACCOUSERFEES@fda.hhs.gov, or  
 
by fax:  301-595-1429 or 301-595-1430.   
 
E.  How will FDA allocate the total assessment among the classes of tobacco products 
for each quarter of a fiscal year? 
 
FDA will calculate the percentage shares for each class as follows:  
  FDA will multiply the units of product removed and not tax exempt for the most 
recent full calendar year by the 2003 maximum Federal excise tax rate for that 
applicable class or subclass (class dollar figure).  The cigar class percentage share 
will be the sum of this calculation for the small and large cigar subclasses. 
  FDA will total the class dollar figures for all tobacco classes for the most recent full 
calendar year (total dollar figure).   
  FDA will divide the class dollar figure by the total dollar figure to determine the 
percentage share for each class.  
  FDA will calculate the allocation for each class of tobacco products by multiplying 
the percentage share for each class by the total assessment. 
  4  Contains Nonbinding Recommendations 
 
  FDA will reallocate the percentage share of any class of tobacco products that has 
not, by the beginning of the fiscal year, been deemed subject to chapter IX of the 
FD&C Act. 
( 1150.7(a))  
 
Because FDA can perform class allocations only on a full fiscal year basis, the percentage share 
for the cigar and pipe tobacco classes will be reallocated to the other tobacco product classes 
until October 1 of the first full fiscal year following the effective date of this rule. 
 
F.  How will FDA calculate the assessment owed by each domestic manufacturer or 
importer for each quarter? 
 
The assessment for each class of tobacco products is allocated among the domestic 
manufacturers and importers in that class, so that each domestic manufacturers or importers 
assessment is proportional to its percentage share within that class. 
 
  For the cigarette, snuff, chewing tobacco, roll-your-own tobacco, and pipe tobacco classes, 
FDA will calculate the percentage share for each domestic manufacturer and importer by 
dividing the Federal excise taxes that it paid for the class for the prior quarter by the total 
excise taxes that all domestic manufacturers and importers paid for the class for that same 
quarter.   
 
  For the cigar class, FDA will calculate the percentage share for each domestic manufacturer 
and importer by dividing the Federal excise taxes that it paid for the class for the prior fiscal 
year by the total excise taxes that all domestic manufacturer and importers paid for the class 
for the same fiscal year.   
 
If the percentage share calculated for a domestic manufacturer or importer is less than 0.0001 
percent, the manufacturer or importer does not have to pay an assessment.  Within each class of 
tobacco products, the assessment owed by a domestic manufacturer or importer for the quarter is 
the quarterly class allocation multiplied by the domestic manufacturers or importers percentage 
share for that class of tobacco products.  (See  1150.9(a).) 
 
G.  Will FDA make adjustments to individual domestic manufacturer or importer 
assessments? 
 
Yes.  Annually, FDA will make any necessary adjustments to individual domestic manufacturer 
or importer assessments if needed to account for any corrections (e.g., to include domestic 
manufacturers or importers that were not included in a relevant assessment calculation) 
( 1150.9(b)).  
 
H.  When will FDA notify each domestic manufacturer and importer of the amount of 
the quarterly assessment? 
 
  5  Contains Nonbinding Recommendations 
 
FDA will notify each domestic manufacturer and importer of the amount of the quarterly 
assessment no later than 30 calendar days before the end of each fiscal year quarter 
( 1150.11(a)). 
 
I.  What information will be included in the notification from FDA? 
 
The notification sent to each domestic manufacturer and importer will include the following: 
  The amount of the quarterly assessment and the date that payment of the assessment 
must be received by FDA;  
  Class assessment information;  
  Domestic manufacturer or importer assessment information;  
  Any adjustments FDA has made under  1150.9(b);  
  The manner in which assessments are to be remitted to FDA;  
  Information about the accrual of interest if a payment is late; and  
  Information regarding where to send a dispute and when it needs to be sent. 
( 1150.11(b)) 
 
J.  When and how must payment of assessments be submitted to FDA? 
 
Payment of an assessment must be received by FDA no later than the last day of each fiscal year 
quarter.  In the event that FDA does not notify a domestic manufacturer or importer of the 
amount of the quarterly assessment at least 30 days before the end of the calendar year, payment 
of that assessment must be received by FDA no later than 30 days after such notification.  The 
payment must be in U.S. dollars and submitted to FDA in the manner specified in the 
notification.  (See  1150.13.) 
 
K.  Can a domestic manufacturer or importer dispute an FDA assessment? 
 
Yes, a domestic manufacturer or importer can dispute an FDA assessment but must still pay the 
assessment ( 1150.13(e)).  Section 1150.15 outlines the dispute process. 
 
L.  What is the penalty for failure to pay an assessed user fee? 
 
A tobacco product is deemed adulterated under section 902(4) of the FD&C Act (21 U.S.C. 
387b(4)) if the domestic manufacturer or importer fails to pay a user fee by the later of the 
following:  the date the assessment is due, 30 days from the date FDA sent notification of the 
amount owed, or 30 days after final Agency action on a resolution of any dispute about the 
amount of the fee.  ( 1150.17(a)) 
 
M.  What are the penalties for failure to report the information required by  1150.5? 
 
A tobacco product is deemed adulterated under section 902(4) of the FD&C Act if the domestic 
manufacturer or importer fails to report the information required by  1150.5 to calculate 
assessments.  Failure to report the information is also a prohibited act under section 301(e) of the 
FD&C Act (21 U.S.C. 331(e)).  (See  1150.17(b)-(c).) 
 
  6  Contains Nonbinding Recommendations 
 
 N.  Are there penalties related to the submission of false information under  1150.5? 
 
Yes.  Information submitted under  1150.5 is subject to 18 U.S.C. 1001 and other appropriate 
civil and criminal statutes ( 1150.17(d)). 
 
O.  When do these rules become effective? 
 
The first user fee rule became effective for domestic manufacturers and importers of cigarettes, 
snuff, chewing tobacco, and roll-your-own tobacco on August 11, 2014.  The new user fee rule 
will become effective for the cigars and pipe tobacco classes 90 days after the rule published in 
the Federal Register.  However, as explained in section III.C, the first submission of required 
information will be due by the 20th day of August 2016 for cigars and pipe tobacco. 
 
P.  Will FDA provide assistance for small businesses seeking additional information 
about this rule? 
 
FDAs Center for Tobacco Products has established an Office of Small Business Assistance in an 
effort to help small businesses access up-to-date information and comply with the requirements 
of the Tobacco Control Act.  CTPs Office of Small Business Assistance can be reached at 
SmallBiz.Tobacco@fda.hhs.gov or at 1-877-CTP-1373 (1-877-287-1373), Monday-Friday, 
9:00 a.m.  4:00 p.m.  
 
 
 
 
 
Document History: 
  July 2014  First edition of guidance was issued. 
  May 2016  Guidance was updated to address amendments to 21 CFR part 1150 that 
include requirements for domestic manufacturers and importers of cigars and pipe 
tobacco.  Guidance was also updated to include a new title format, a new Internet 
address, and minor editorial changes.  
  7