Tobacco Product User Fees:  
Responses to Frequently Asked 
Questions 
Guidance for Industry
Comments may be submitted at any time for Agency consideration.  Electronic comments may 
be submitted to https://www.regulations.gov.  Alternatively, submit written comments to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.  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 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 20993-0002. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Tobacco Products 
December 2021  Contains Nonbinding Recommendations 
Table of Contents 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  QUESTIONS AND ANSWERS ....................................................................................... 2 
 
  i 
Final Guidance - Tobacco Product User Fees--Reponses to Frequently  Asked Questions 
  Contains Nonbinding Recommendations 
Tobacco Product User Fees:  Responses to 
Frequently Asked Questions 
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 provides information in response to frequently asked questions related to tobacco 
product user fees assessed and collected under section 919 of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act).  In particular, this guidance provides information regarding: 
 the submission of information needed to assess user fees owed by each domestic
manufacturer or importer of tobacco products; and
 how FDA determines whether a company owes user fees in each quarterly assessment.
The contents of this document do not have the force and effect of law and are not meant to bind 
the public in any way, unless specifically incorporated into a contract. This document is intended 
only to provide clarity to the public regarding existing requirements under the law. FDA 
guidance documents, including this guidance, 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.  
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 
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 
 
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, in accordance with that section, to 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 specified 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 to add 21 Code of Federal Regulations (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.  In the Federal Register of May 
10, 2016 (81 FR 28707), FDA finalized a rule which, among other things, amended part 
1150 to include user fee requirements for domestic manufacturers and importers of cigars 
and pipe tobacco.  
 
III.  QUESTIONS AND ANSWERS 
 
A.  How does FDA determine which companies are included in the quarterly tobacco 
user fee assessments? 
 
Companies are included in quarterly user fee assessments when they meet the definition of a 
domestic manufacturer or importer of tobacco products during the fiscal quarter being assessed 
(assessment quarter).  Under 21 CFR 1150.3, a domestic manufacturer is a person who is 
required to obtain a permit from the Alcohol and Tobacco Tax and Trade Bureau (TTB) with 
respect to the production of tobacco products under title 27 of the CFR.  Under 21 CFR 1150.3, 
an importer is a person who is required to obtain a permit from TTB with respect to the 
importation of tobacco products under title 27 of the CFR.   
 
 
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 
 
FDA considers a company maintaining a TTB permit for the production or importation of 
tobacco products at any point during the assessment quarter as evidence that the company meets 
the definition of a domestic manufacturer or importer during such quarter.  FDA receives 
information as to a companys permit status directly from TTB every fiscal quarter and as 
requested.  For each assessment quarter, each company meeting the definition of a domestic 
manufacturer or importer during such quarter will receive a user fee assessment, with such 
amount determined under the calculations set forth in 21 CFR 1150.9. 
 
If a company never meets the definition of a domestic manufacturer or importer during a fiscal 
quarter, then FDA generally does not intend to include it in the user fee assessments for such 
fiscal quarter.  In this case, this can mean that even though the company had taxable removals in 
a prior fiscal quarter (for tobacco products except cigars) or fiscal year (for cigars), it will not 
receive a user fee assessment for the fiscal quarter being assessed.  Regardless of whether a 
company meets the definition of a domestic manufacturer or importer during a given quarter, a 
company may still receive, and be liable for, a user fee assessment adjustment for a past fiscal 
quarter in which it did meet either definition (see section III.G. [setting out the circumstances 
and process by which FDA makes user fee assessment adjustments]).   
 
B.  How does FDA determine that a company is no longer a domestic manufacturer or 
importer subject to user fee assessments? 
 
FDA considers a company no longer maintaining a TTB permit for the production or importation 
of tobacco products as evidence that the company no longer meets the definition of a domestic 
manufacturer or importer. Generally, FDA considers this to occur beginning on the date that the 
companys TTB permit is closed or expires.  FDA refers to TTB permit status dates (date issued 
and date closed, if applicable), which FDA receives directly from TTB (as stated in section 
III.A.), as the primary source for determining status as a domestic manufacturer or importer; 
however, FDA may determine that a company stopped meeting the definition of a domestic 
manufacturer or importer on a different date (e.g., a date that differs from the date(s) shown in 
the TTB data), where established by sufficient documentation provided by the company.  
Examples of sufficient documentation may include, but are not necessarily limited to: 
  Bond expiration or termination letters; 
  State documents showing the closure or dissolution of the business that held the TTB 
permit; and 
  Proof that the company surrendered the permit to TTB and requested permit closure or 
termination. 
 
FDA recommends that a company submit information establishing the date on which its TTB 
permit expired, closed, or was otherwise terminated, or on which the business was closed or 
dissolved (especially where such information establishes a date prior to the one reflected in TTB 
data) with its final monthly user fee report or as soon as the company is able to provide it.  Block 
7 of the Form FDA 3852 provides a box for companies to check indicating the report is their 
final Form FDA 3852 submissioncompanies that have returned their permit to TTB (or 
otherwise had their TTB permit closed), had their TTB permit expire, or closed or dissolved their 
business, should check this box and attach relevant documentation with date of 
closure/expiration/dissolution.  If a company stops meeting the definition of a domestic 
  3  Contains Nonbinding Recommendations 
manufacturer or importer before the beginning of a fiscal quarter (and does not meet either 
definition at any point in time during the quarter), but then nonetheless receives a user fee 
assessment for such quarter, it may dispute the assessment in accordance with 21 CFR 1150.15. 
C. Is hookah or water pipe tobacco subject to user fee requirements?
FDAs regulations at 21 CFR part 1150, apply to domestic manufacturers and importers of six 
classes of tobacco products as they are defined in 26 U.S.C. 5702: cigarettes, snuff, chewing 
tobacco, roll-your-own tobacco, cigars, and pipe tobacco.3  Hookah or water pipe tobacco is 
subject to user fees when it is subject to federal excise taxestypically, as pipe tobaccoand 
removed into interstate commerce.  
D. How should a company submit its monthly report to FDA?
Domestic manufacturers and importers must use Form FDA 3852 and attach copies of the 
appropriate supporting TTB and U.S. Customs and Border Protection (CBP) forms 
(currently TTB Forms 5210.5, 5000.24, and 5220.6 and CBP Form 7501).4 This form is 
available online and in paper form.  The required information may be submitted to FDA via 
e-mail (preferred method), fax, or mail; only one method is needed.  Submit Form FDA
3852 and supporting documents to FDA
electronically: TOBACCOUSERFEES@fda.hhs.gov 
by fax: 301-595-1429 or 301-595-1430, or 
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. 
E. Are tobacco product user fee assessments based on federal excise taxes owed (i.e.,
federal excise tax liability) or federal excise taxes paid?
Tobacco product user fee assessments are based, in part, on the gross domestic volume of 
tobacco products (i.e., gross removals not exempt from tax).5  Accordingly, FDA uses the 
associated federal excise tax amounts owed for gross removals to calculate assessments.6 
3 See 21 C.F.R.  1150.3 (defining [c]lass of tobacco products as referring to each of these six classes as defined at 
26 U.S.C.  5702). 
4 See 21 C.F.R.  1150.5. 
5 See 79 FR 39302, 39306 (July 10, 2014). 
6 Section 919 of the FD&C Act instructs FDA to determine class allocations and individual company assessments 
using the percentages determined under the Fair and Equitable Tobacco Reform Act of 2004 (FETRA, Pub. L. 108-
357 (7 U.S.C.  518 et seq.)).  See FD&C Act  919(b)(2)(B)(ii) & (b)(4).  FETRA, in turn, determines percentages 
4  Contains Nonbinding Recommendations 
 
 
F.  How should adjustments to gross removals be reported by companies? 
 
Companies should report their gross removals and associated federal excise taxes on Form FDA 
3852.  Any adjustments affecting gross removals should be included in a companys monthly 
submission (i.e., increase or decrease the volume and tax amounts reported on the Form FDA 
3852 accordingly); these adjustments should be reported on the TTB Form 5000.24, Excise Tax 
Return, submitted as part of the monthly report to FDA, in the sections designated for Schedule 
A and B adjustments.  Please note, the Schedule B adjustments identified on TTB Form 5000.24 
for claims associated with withdrawn/destroyed product should not be included in the Form FDA 
3852 volume or tax totals as these claims do not affect a companys gross domestic volume.7 
 
FDA recommends companies include further documentation identifying what type of adjustment 
to gross removals is reflected on the TTB 5000.24 form (to include period of activity  month 
and year  and tobacco product class associated with the adjustment) if the description of the 
adjustment is not clearly listed on the TTB 5000.24 form. 
 
In order to ensure that user fee market share calculations are correct for any particular fiscal 
quarter, when a company makes an adjustment to gross removals previously reported in a 
monthly report to FDA, it should submit an amended monthly report (for the month in which the 
adjustment occurred) that includes such adjustment, as soon as possible.  
 
G.  What process does FDA use to make user fee assessment adjustments? 
 
Under 21 CFR 1150.9(b), FDA will make any necessary adjustments to individual domestic 
manufacturer or importer assessments if needed to account for any corrections (for example, to 
include domestic manufacturers or importers that were not included in a relevant assessment 
calculation).  Assessment adjustments help ensure that no domestic manufacturer or importer 
pays a user fee in excess of its percentage share, as required under section 919(b)(3)(B) of the 
FD&C Act.    
 
Typically, FDA determines assessment adjustments through a year-end reconciliation process 
following the end of a fiscal year (end-of year reconciliation) and three years after a given fiscal 
year ends (three-year reconciliation).  As part of this process, FDA accounts for unreported and 
corrected information provided through late data submissions, amended data submissions, and 
annual tax records from TTB and CBP.  After performing any necessary individual market share 
percentage recalculations based on such information, FDA makes corresponding assessment 
adjustments for the subject fiscal period, which it includes in the quarterly user fee assessment 
notifications to companies.8  Under 21 CFR  1150.15(a), a company may dispute an assessment 
 
by using gross domestic volume, and defines gross domestic volume as based on federal excise tax amounts 
owed, rather than federal excise tax amounts paid.  See 7 U.S.C.  518d(a)(2) (defining gross domestic volume) 
& 518d(c), (e)(h) (process for determining percentages). 
7 See supra section III.E. (explaining that tobacco product user fee assessments are based, in part, on gross 
domestic volume).  
8 See 21 C.F.R.  1150.11(b)(4). 
  5  Contains Nonbinding Recommendations 
adjustment (as an assessment), provided it does so within 45 days of the date on the assessment 
adjustment.9   
FDA generally does not intend to further revise individual market share percentages for a fiscal 
period after it completes the three-year reconciliation for such fiscal period.  The only instances 
in which FDA anticipates potentially further revising individual market share percentages after a 
three-year reconciliation are when: 
 FDA determines, in reviewing a timely (i.e., received by FDA no later than 45 days after
the date on the notification) dispute of an assessment adjustment stemming from such
reconciliation, that there was an error related to the assessment adjustment; or
 FDA is made aware that a company was found liable for criminal activity that impacted
its individual market share percentage (e.g., trafficking in contraband cigarettes or
contraband smokeless tobacco).10
In these instances, FDA may adjust the individual market share percentage(s) of the impacted 
company and companies with products in the relevant class(es), and either issue revised invoices 
to the necessary companies that reflect corresponding assessment adjustments or include such 
adjustments in the next assessment.11  
H. How are tobacco product user fee invoices distributed to industry?
FDA distributes tobacco product user fee invoices primarily via email, based on the email 
address listed on page one of the Form FDA 3852.  If the email address is undeliverable or 
otherwise unavailable (and no other email addresses are associated with the company), invoices 
are distributed via mail to the mailing address listed on page one of the Form FDA 3852.  
Companies should provide the most current contact information in these fields when submitting 
the monthly Form FDA 3852.  Companies should also take steps to ensure 
tobaccouserfees@fda.hhs.gov and tobaccouserfeesupport@fda.hhs.gov are not blocked by email 
spam filters.  
I. Who should a company contact if they have questions or need further guidance with
supporting documents?
For questions about or assistance with TTB 5210.5, TTB 5000.24, and TTB 5220.6 forms, please 
visit: https://www.ttb.gov/contact-nrc. 
9 FDA must receive the dispute no later than 45 days after the date on the assessment notification and the dispute 
must include the basis for the dispute, be in writing, legible, in English, and sent to the address found on FDAs 
tobacco products website (http://www.fda.gov/tobaccoproducts).  See 21 C.F.R.  1150.15.  
10 See 18 U.S.C.  234146.  Please note that CTP generally does not intend to independently seek out this 
information.  
11 As a reminder, a domestic manufacturer or importer may contest an assessment, including an assessment 
adjustment issued in either of the instances described above, by submitting a written dispute that, among other 
things, is received by FDA no later than 45 days after the date on the assessment notification.  See 21 C.F.R. 
 1150.15(a); see also supra note 9.
6  Contains Nonbinding Recommendations 
 
For questions related to filling out the CBP 7501 forms, please visit: 
https://www.cbp.gov/trade/programs-administration/entry-summary/cbp-form-7501. 
 
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