Listing of Ingredients in 
Tobacco Products 
(Revised)* 
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 
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Room 1061, Rockville, MD 20852. All comments should be identified with Docket No. FDA- 
2009-D-0524. 
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 20993-0002. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Tobacco Products 
March 2023 
OMB control number: 0910-0650 
Current expiration date available at https://www.reginfo.gov 
See additional PRA statement in section IV of the guidance 
*This is the sixth revision of the first edition of this guidance. Revisions are noted by date at the
end of the 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. Who Submits Ingredient Information? ....................................................................... 5 
C. What Is FDAs Compliance Policy for Regulated Tobacco Products? ..................... 5 
D. What Information Is Submitted With the List of Ingredients? ................................. 7 
1. Manufacturer/Importer Identification ...................................................................... 7 
2. Product Identification ............................................................................................... 7 
3. Ingredient Identification ........................................................................................... 9 
4. Part to Which the Ingredient Is Added ................................................................... 13 
5. Ingredient Quantity ................................................................................................ 13 
E. How Do You Submit Ingredient Information? ......................................................... 15 
F. When Do You Submit Ingredient Information? ....................................................... 16 
G. Will FDA Maintain the Confidentiality of the Ingredient Information You
Submit? ......................................................................................................................... 19 
IV. PAPERWORK REDUCTION ACT OF 1995 .................................................................. 19 
i  Contains Nonbinding Recommendations 
Listing of Ingredients in 
Tobacco Products 
1
Guidance for Industry
 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
 
Age ncy) on this topic. It does not establish any rights for any person and is not binding on FDA 
or th e public. You can use an alternative approach if it satisfies the requirements of the 
app licable 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 persons making tobacco product ingredient 
submissions to FDA. This guidance is intended for manufacturers and importers of tobacco 
products.   
The guidance document explains, among other things: 
  The statutory requirement to submit a list of all ingredients in tobacco products 
  Definitions 
  Who submits ingredient information 
  What information is included in the submissions 
  How to submit the information 
  When to submit the information 
  FDAs compliance policies 
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 Science 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), enacted on 
June 22, 2009, amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) and provides FDA 
with the authority to regulate the manufacture, marketing, and distribution of tobacco products to 
protect the public health generally and to reduce tobacco use by minors (Pub. L. 11131, 123 Stat. 
1776). Among its many provisions, the Tobacco Control Act added section 904 to the FD&C Act 
(21 U.S.C. 387d), establishing requirements for tobacco product ingredient submissions. 
Cigarettes, cigarette tobacco, RYO, and smokeless tobacco were immediately covered by FDAs 
tobacco product authorities in chapter IX of the FD&C Act, including section 904, when the 
Tobacco Control Act went into effect.2 As for other types of tobacco products, section 901(b) of 
the FD&C Act (21 U.S.C. 387a(b)) grants FDA authority to deem those products subject to 
chapter IX as well. Pursuant to that authority, FDA issued a proposed rule seeking to deem all 
other products that meet the statutory definition of tobacco product, set forth in section 201(rr) of 
the FD&C Act (21 U.S.C. 321(rr)) (except for accessories of those products) (79 FR 23142, 
April 25, 2014).3 After review and consideration of comments on the proposed rule, the final rule 
published on May 10, 2016, with the effective date of August 8, 2016. As a result, all products 
that meet the statutory definition of a tobacco product are subject to the tobacco product 
authorities in chapter IX of the FD&C Act, including section 904, except those accessories not 
made subject to FDAs tobacco product authorities by the deeming rule.4 
Section 904(a)(1) of the FD&C Act requires each tobacco product manufacturer or importer, or 
agent thereof, to submit a listing of all ingredients, including tobacco, substances, compounds, 
and additives that are added by the manufacturer to the tobacco, paper, filter, or other part of 
each tobacco product by brand and by quantity in each brand and subbrand. For cigarettes, 
cigarette tobacco, RYO, and smokeless tobacco products on the market as of June 22, 2009, the 
list of ingredients had to be submitted by December 22, 2009. For cigarettes, cigarette tobacco, 
RYO, and smokeless tobacco products not on the market as of June 22, 2009, section 904(c)(1) 
requires that the list of ingredients be submitted at least 90 days prior to delivery for introduction 
into interstate commerce. Section 904(c) of the FD&C Act also requires submission of 
information whenever any additive, or the quantity of any additive, is changed. 
 
2 At the time this guidance was originally published, the statutory term tobacco product in section 201(rr) of the 
D&C Act was limited to products made or derived from tobacco.  On March 15, 2022, the Consolidated 
Appropriation Act (CAA) of 2022, amended the term tobacco product in the FD&C Act to include products that 
contain nicotine from any source. Under section 901(b) of the FD&C Act, as amended by the CAA, tobacco 
products containing nicotine that is not made or derived from tobacco are subject to Chapter IX without needing to 
be deemed by regulation.   
3 Accessories of tobacco products subject to the deeming rule are explicitly excluded from the rules deeming 
provision. 
4 Examples of currently marketed products that are subject to the deeming rule include: cigars, pipe tobacco, 
nicotine gel, certain dissolvable nicotine products, and electronic nicotine delivery systems (ENDS), including 
electronic cigarettes (also known as e-cigarettes or e-cigs), e-hookah, e-cigars, vape pens, personal vaporizers (also 
known as advanced personal vaporizers or APVs), electronic pipes, and nicotine-containing liquids, including the 
e-liquids used with ENDS products, among other products. 
2  Contains Nonbinding Recommendations 
The failure to provide any information required by section 904 is a prohibited act under section 
301(q)(1)(B) of the FD&C Act (21 U.S.C. 331(q)(1)(B)). In addition, under section 
903(a)(10)(A) of the FD&C Act (21 U.S.C. 387c(a)(10)(A)), a tobacco product is deemed 
misbranded if there was any failure or refusal to comply with any requirement prescribed under 
section 904. Violations relating to section 904 are subject to regulatory and enforcement action 
by FDA, including, but not limited to, seizure and injunction. 
III.  DISCUSSION 
A.  What Definitions Apply to This Guidance? 
For the purposes of this guidance, FDA intends to use the following definitions:  
  Accessory: The term accessory means any product that is intended or 
reasonably expected to be used with or for the human consumption of a 
tobacco product; does not contain tobacco and is not made or derived from 
tobacco; and meets either of the following: 
(1)  Is not intended or reasonably expected to affect or alter the performance, 
composition, constituents, or characteristics of a tobacco product; or 
(2)  Is intended or reasonably expected to affect or maintain the performance, 
composition, constituents, or characteristics of a tobacco product but 
(i)  Solely controls moisture and/or temperature of a stored tobacco 
product; or 
(ii)  Solely provides an external heat source to initiate but not maintain 
combustion of a tobacco product. 
  Additive: The term additive means any substance the intended use of which 
results or may reasonably be expected to result, directly or indirectly, in its 
becoming a component or otherwise affecting the characteristic of any tobacco 
product (including any substances intended for use as a flavoring or coloring or 
in producing, manufacturing, packing, processing, preparing, treating, 
packaging, transporting, or holding), except that such term does not include 
tobacco or a pesticide chemical residue in or on raw tobacco or a pesticide 
chemical. (section 900(1) of the FD&C Act (21 U.S.C. 387(1)). 
  Component or part: The term component or part means any software or 
assembly of materials intended or reasonably expected: 
(1)  To alter or affect the tobacco products performance, composition, 
constituents, or characteristics; or 
(2)  To be used with or for the human consumption of a tobacco product. 
Component or part excludes anything that is an accessory of a tobacco 
product. FDA notes that component and part are separate and distinct 
terms within chapter IX of the FD&C Act. However, for purposes of this 
guidance, FDA is using the terms component and part interchangeably 
3  Contains Nonbinding Recommendations 
and without emphasizing the distinction. FDA may clarify the 
distinctions between component and part in the future. 
  Finished tobacco product: The term finished tobacco product means a tobacco 
product, including all components and parts, sealed in final packaging intended 
for consumer use (e.g., filters or filter tubes sold separately to consumers or as 
part of kits). 
  Importer: The term importer means any person who imports any tobacco 
product that is intended for sale or distribution to consumers in the United 
States.  
  Per weight composition: The term per weight composition means the manner 
in which the materials (e.g., ingredients, additives, and biological organisms) 
are arranged and integrated to produce a finished tobacco product.  
  Pouch: The term pouch means a permeable material, intended to be filled with pre-
portioned tobacco product and placed in the oral cavity with the tobacco product.  
  Small-scale tobacco product manufacturer: The term small-scale tobacco 
product manufacturer means a manufacturer of any regulated tobacco product 
that employs 150 or fewer full-time equivalent employees and has annual total 
revenues of $5 million or less. FDA considers a manufacturer to include each 
entity that it controls, is controlled by, or is under common control with.  
  Tobacco product: The term tobacco product is defined in section 201(rr) of the 
FD&C Act, which states in relevant part: 
(1)  The term tobacco product means any product made or derived from 
tobacco, or containing nicotine from any source, that is intended for 
human consumption, including any component, part, or accessory of a 
tobacco product (except for raw materials other than tobacco used in 
manufacturing a component, part, or accessory of a tobacco product). 
(2)  The term tobacco product does not include an article that under the 
Federal Food, Drug, and Cosmetic Act is: a drug (section 201(g)(1)); a 
device (section 201(h)); a combination product (section 503(g)); or a 
food (section 201(f)) if such article contains no nicotine, or no more than 
trace amounts of naturally occurring (section 201(rr)(5). 
Note that this definition includes accessories and components and parts of tobacco 
products, whether they are made or derived from tobacco or contain nicotine, and 
whether they are sold or distributed as finished tobacco products.5  
 
5 However, and as explained above, accessories of tobacco products subject to the deeming rule are explicitly 
excluded from the rules deeming provision. Thus, although they meet the definition of tobacco product, such 
accessories are not currently subject to chapter IX of the FD&C Act (including section 904(a)(1)). 
4  Contains Nonbinding Recommendations 
  Tobacco Product Manufacturer: The term tobacco product manufacturer 
means any person, including any repacker or relabeler, who (A) manufactures, 
fabricates, assembles, processes, or labels a tobacco product; or (B) imports a 
finished tobacco product for sale or distribution in the United States (section 
900(20) of the FD&C Act (21 U.S.C. 387(20)). Thus, the term is not limited to 
persons who manufacture products containing tobacco, but includes anyone 
who manufactures any tobacco product as defined above. 
B.  Who Submits Ingredient Information? 
The requirements under section 904(a)(1) apply to each tobacco product 
manufacturer or importer. We interpret this to mean that domestic manufacturers 
are to submit the required ingredient information for products they manufacture and 
that either the foreign manufacturer or the importer of the tobacco product is to 
submit the required ingredient information for imported tobacco products. 
For tobacco products that are imported, the foreign manufacturer and the importer 
or importers of an imported product will need to work together to ensure that the 
ingredient information is submitted to FDA as required by section 904. If there is a 
failure or refusal to comply with the ingredient listing requirements, then  among 
other things  the product is deemed misbranded under section 903(a)(10)(A) and 
therefore subject to refusal of admission into the United States. 
Submissions under section 904(c) are required to be made by the tobacco product 
manufacturer. An importer of a finished tobacco product for sale or distribution in 
the United States falls within the definition of a manufacturer. An importer that is 
not a manufacturer required to submit information or reports under section 904(c) 
may, however, submit the information as an agent on behalf of the manufacturer.  
C.  What Is FDAs Compliance Policy for Regulated Tobacco Products? 
At this time, with respect to all tobacco products, including cigarettes, cigarette 
tobacco, RYO, smokeless tobacco, as well as other tobacco products now regulated 
as a result of the deeming rule, FDA intends to enforce the ingredients submission 
requirements of section 904(a)(1) with respect to finished tobacco products only. 
FDA does not, at this time, intend to enforce these requirements with respect to 
products that are sold or distributed solely for further manufacturing. 
As defined above, the term finished tobacco product means a tobacco product, 
including all components and parts, sealed in final packaging intended for consumer 
use (e.g., filters or filter tubes sold separately to consumers or as part of kits). 
Components and parts that are sold separately from other tobacco products are finished 
tobacco products if they are sold in final packaging intended for consumer use. 
5  Contains Nonbinding Recommendations 
At this time, with regard to components and parts either sold separately as finished 
products or as components or parts of other finished products, FDA intends to 
enforce the ingredient listing submission requirement of section 904(a)(1) only with 
respect to those components or parts: (1) made or derived from tobacco, or (2) 
containing ingredients that are burned, aerosolized or ingested during tobacco 
product use. For example, cigarette paper is burned during use of a cigarette and 
produces constituents that are inhaled by the smoker, therefore, ingredients in 
cigarette paper should be submitted to the agency. These components or parts 
include the following: 
  Cigar filler 
  Cigar binder 
  Cigar wrapper 
  Pipe tobacco 
  Waterpipe tobacco 
  E-liquids 
  Cigarette tobacco 
  Cigarette paper 
  Smokeless tobacco 
  Roll-your-own (RYO) tobacco 
  RYO rolling paper 
  RYO tube 
  Cigarette filter that contains any ingredient that burns, aerosolizes, or is 
ingested during use (e.g., cigarettes filter with menthol because the menthol 
will aerosolize during cigarette smoking).  
Examples of components or parts for which FDA does not intend to enforce the 
ingredient listing submission requirement of section 904(a)(1) at this time include, 
but are not limited to, the following: 
  Electrical components including, but not limited to, batteries, charging 
systems, circuit boards, wiring, and connectors 
  System software 
  Digital display, lights, and buttons to adjust settings 
  Connection adapters 
  Cartomizers 
  Coils 
  Wicks 
  Tanks 
  Mouthpieces 
  Pipes 
  Waterpipes 
  Hoses 
6  Contains Nonbinding Recommendations 
 Bowls
 Charcoal
 Cigarette filter that does not contain any ingredient that is burned, aerosolized,
or ingested during tobacco use
With regard to ingredient listing submissions under section 904(a)(1), FDA intends 
to focus on components or parts made or derived from tobacco, or containing 
ingredients that are burned, aerosolized or ingested during tobacco product use 
because we believe these components and parts of a finished tobacco product are 
generally the most important in determining the constituents to which users are 
exposed. However, FDA recognizes that the ingredients of other components and 
parts can also be important in determining the public health impact of tobacco 
products. FDA will receive ingredient information for these other components and 
parts during our pre-market review of finished tobacco products (e.g., Premarket 
Tobacco Applications and Substantial Equivalence Reports). Should FDA find that 
additional information is helpful to protect the public health, the Agency may 
reconsider this compliance policy. We intend to communicate any compliance 
policy changes by guidance.  
D. What Information Is Submitted With the List of Ingredients?
1. Manufacturer/Importer Identification
You should include the name and address of each tobacco product manufacturer 
(and importer, where applicable) with your submission. You should also include the 
name and address of any agent submitting ingredient information on behalf of a 
manufacturer or importer. FDA requests that you also provide the following 
information to assist us in communicating with you: 
 Your corporate email address
 Your Data Universal Numbering System (D-U-N-S) number or other unique
identifier6
 The facility establishment identifier (FEI) number assigned to your
establishment by FDA7
6  D-U-N-S numbers are proprietary to, and controlled by, Dun & Bradstreet. If the D-U-N-S number for a location 
has not been assigned, a business may obtain one for no cost directly from Dun & Bradstreet (http://www.dnb.com). 
Please note that registrants who wish to obtain a new D-U-N-S number should obtain one well in advance of FDAs 
deadline, because it may take 30 days (or longer) to process a new number. Alternatively, you may elect to receive a 
D-U-N-S number within one business day by paying a fee. The business entity identifier recognized by the FDA
Data Standards Council is the D-U-N-S number, and providing the site-specific D-U-N-S number for an entity will
help prevent inaccuracies in FDAs database.
7 You should use the same FEI number for this submission that you have used for prior ingredient listing
submissions or establishment registration.
7  Contains Nonbinding Recommendations 
2. Product Identification
Under section 904(a)(1) of the FD&C Act, tobacco product manufacturers or 
importers are required to submit ingredient lists for each tobacco product by brand 
and by quantity in each brand and subbrand. We interpret this to require that 
tobacco product manufacturers or importers submit ingredient lists individually for 
tobacco products that differ in any way. 
If a tobacco product manufacturer or importer sells tobacco products with different 
brands/subbrands or product sizes8 that have identical per weight composition of 
ingredients with respect to their components and parts, FDA believes that tobacco 
product manufacturers or importers can satisfy the ingredient listing requirement 
under section 904(a)(1) by providing one listing that corresponds to multiple 
products, provided they identify all the different brands/subbrands and product sizes 
for the associated tobacco products in the submission. Examples of situations 
allowing a single ingredient listing for multiple products are as follows:  
 Identical per weight composition of ingredients for tobacco products sold
under multiple brands/subbrands:
Pipe tobacco with identical per weight composition of ingredients sold
o
under 30 brands/subbrands
E-liquids with identical per weight composition of ingredients sold under
o
200 brands/subbrands
Waterpipe (shisha) tobacco with identical per weight composition of
o
ingredients sold under 15 brands/subbrands
 Identical per weight composition of ingredients for tobacco products sold in
multiple product size:
E-liquid with identical per weight composition of ingredients sold in
o
volumes of 30mL, 60mL, 90mL or sold in a range of product sizes (e.g.,
20mL-100mL)
Pipe tobacco with identical per weight composition of ingredients sold in
o
product sizes of 5g, 10g, 50g
Waterpipe (shisha) tobacco with identical per weight composition of
o
ingredients sold in product sizes of 100g, 200g, 500g
Pouched snus with identical per weight composition of ingredients sold in a
o
can of 12 snus sachets or a can of 15 snus sachets
For e-liquids, FDA believes that tobacco product manufacturers or importers can 
satisfy the ingredient listing requirement under section 904(a)(1) by providing one 
listing that corresponds to multiple products if the tobacco product manufacturer or 
importer sells tobacco products that (1) are identical in chemical composition to one 
another or (2) are identical in chemical composition to one another except the 
quantities of propylene glycol (PG), vegetable glycerin (VG), and/or nicotine 
differ.8 For example: 
8 The per weight composition of the ingredients other than PG/VG and nicotine cannot differ. 
8  Contains Nonbinding Recommendations 
  E-liquids with identical nicotine concentrations (e.g., 0.5 mg/ml nicotine) but 
varying PG/VG ratios (e.g., 20/80, 50/50, 80/20) and all other ingredients 
having identical per weight composition. 
  E-liquids with identical PG/VG ratio (e.g., 50/50) but different nicotine 
concentrations (e.g., 0.5, 1.0 1.5 mg/ml) and all other ingredients having 
identical per weight composition. 
  E-liquids with varying PG/VG ratios (e.g., 20/80, 50/50, 80/20) and different 
nicotine concentrations (e.g., 0.5, 1, 2 mg/mL) with all other ingredients having 
identical per weight composition. 
For e-liquids, the following examples should include separate listings to correspond 
to each brand/subbrand of tobacco product: 
  E-liquids that have identical PG/VG chemical structure, but the nicotine 
chemical structure is different (e.g., moving from free nicotine to nicotine salt), 
even with identical per weight composition of all other ingredients. 
  E-liquids that have identical PG/VG chemical structure and identical nicotine 
chemical structure but where the per weight composition of all other 
ingredients is different in anyway (e.g., increased amount of cherry flavor #1 
added when all other ingredient ratios stay the same). 
  E-liquids where the grade of the PG/VG is different in any way (e.g., percent 
purity changes). 
For each ingredient list, clearly and uniquely identify the product by brand and 
subbrand, including the type or category of tobacco product (e.g., cigarette, 
smokeless tobacco product, cigar, ENDS, waterpipe tobacco product) and 
subcategory.9 You should include additional identifiers (e.g., stock-keeping units 
(SKUs), Universal Product Codes (UPCs), and catalog numbers) as needed to 
uniquely identify the brand and subbrand of the product. 
Please visit our website at https://www.fda.gov/tobacco-
products/manufacturing/submit-ingredient-listing-tobacco-products for helpful tools 
and information.  
3.  Ingredient Identification 
Section 904(a)(1) of the FD&C Act sets forth the requirements for submission of 
ingredient information. The statute requires a listing of all ingredients, including 
tobacco, substances, compounds, and additives that are added by the manufacturer 
to the tobacco, paper, filter, or other part of each tobacco product as of the date of 
 
9 Lists of categories and subcategories are provided on Form FDA 3742 and the eSubmitter submission 
template. See section III.E How Do You Submit Ingredient Information. 
9  Contains Nonbinding Recommendations 
submission. Ingredients must be specified for each brand and subbrand of tobacco 
product.  
FDA considers all ingredients added directly by, or at the direction of, the tobacco 
product manufacturer to be added by the manufacturer. When the manufacturer 
knows or intends that an ingredient is formed through a chemical reaction during 
tobacco product manufacturing, FDA considers the resultant material to be an 
ingredient that is added by the manufacturer. Similarly, when the manufacturer 
knows or intends that an ingredient added to any type of packaging will become 
incorporated into the consumed product, that ingredient is considered to be added 
by the manufacturer to the tobacco product.  
Each listed ingredient is to be uniquely identified so as to distinguish it from similar 
or related materials. The information necessary to uniquely identify an ingredient 
varies based upon the type of ingredient as discussed below. For single chemical 
substances and complex purchased ingredients, FDA also requests that you provide 
additional information, including the expected functions of each ingredient. By 
asking for the functions of the ingredient, the agency requests that you identify all 
expected functions of the ingredient in the final product. As examples, an ingredient 
may function as a humectant, flavor, or chemo-sensory agent that affects perception 
of mainstream or side-stream smoke. 
a.  Single Chemical Substance  
Ingredients that are single chemical substances (e.g., sodium chloride, ammonium 
hydroxide), which may be purchased or prepared in-house and purified, are to be 
uniquely identified by using a unique scientific name or code, such as the FDA 
UNII (Unique Ingredient Identifiers) code, Chemical Abstracts Service (CAS) 
number, or International Union of Pure and Applied Chemistry (IUPAC) name. If 
you prepare a non-reactive mixture (e.g., a buffer) of single purified chemical 
substances, you are to report each of the single chemical substances in the mixture 
individually.  
To further identify each single chemical substance, FDA requests that you provide 
the quality (e.g., percent purity, a published standard) of the ingredient, any internal 
identification number (e.g., SKU, product code) used within your company to 
reference the ingredient, and the expected function(s) of each ingredient. 
We recommend using the FDA UNII code to uniquely identify single chemical 
substances. FDAs Substance Registration System (SRS) supports health 
information technology initiatives by generating unique ingredient identifiers for 
ingredients in FDA-regulated products. The FDA UNII is a nonproprietary, free, 
unique, nonsemantic, alphanumeric identifier based on a substances molecular 
structure and/or descriptive information. For the purposes of the SRS system, 
10  Contains Nonbinding Recommendations 
substances that form noncovalent interactions with other added substances are not 
new substances or mixtures of substances; they are defined as separate substances. 
Many ingredients already have FDA UNIIs. For ingredients that are not already in 
SRS, you can request an FDA UNII by submitting necessary information to 
tobacco-UNII@fda.hhs.gov. More information regarding SRS is posted 
http://www.fda.gov/forindustry/datastandards/substanceregistrationsystem 
uniqueingredientidentifierunii/default.htm. 
b.  Leaf Tobacco  
Leaf tobacco (i.e., whole leaf or parts) that has been prepared solely by mechanical 
processing that involves no chemical, additive, or substance other than potable 
water is to be uniquely identified by providing the following information: 
  the type (e.g., burley, bright, oriental) 
  the variety 
  the cure method (e.g., flue, fire, sun, steam, air) and heat source (e.g., propane, 
wood) 
  a description of any recombinant DNA technology used to engineer the 
tobacco 
We consider the cure method and curing heat source necessary to uniquely identify 
tobacco derived materials because these factors change the tobacco composition by 
altering endogenous constituents (e.g., sugars) and, in some circumstances, adding 
exogenous constituents (e.g., from partially pyrolyzed organic matter), thus 
resulting in a distinctly different tobacco material. Similarly, we believe that 
tobacco derived from recombinant DNA technology (e.g., tobacco mosaic virus 
RNA vector) is intrinsically distinct from unmodified tobacco and that a description 
of the modification and technology used is, therefore, necessary as part of the 
identification.  
FDA requests that you further identify the leaf tobacco with any internal 
identification number (e.g., SKU, product code) used within your company to 
reference the ingredient.  
Tobacco that has been processed with any chemical, additive, or substance other 
than potable water is to be reported as described in section III.D.3.c below. Each 
type of leaf tobacco used in a tobacco product is to be reported as a separate 
ingredient. For example, if you purchase a tobacco leaf blend or reconstituted 
tobacco for use in manufacturing a tobacco product, you are to report the blend or 
reconstituted tobacco as described in section III.D.3.c below. The manufacturer 
responsible for assembling the blend or reconstituting the tobacco is to submit 
ingredient lists for its tobacco products and, in doing so, reporting each type of leaf 
tobacco used in the blend as described in this section. 
11  Contains Nonbinding Recommendations 
c.  Complex Purchased Ingredients  
Ingredients that are not single chemical substances or single types of leaf tobacco 
are considered complex ingredients to be identified as described in this section. 
Such ingredients include, for example, chocolate, flavor extracts, tobacco leaf 
blends, and reconstituted tobacco. Such ingredients also include naturally derived, 
mechanically processed ingredients (e.g., ground spice, fruit juice). Identifiers such 
as CAS numbers and FDA UNIIs are not sufficient to uniquely identify most 
complex ingredients, as they are comprised of multiple substances. This guidance 
divides the category of complex purchased ingredients into two groups  those that 
are made to your specifications and those that are not.  
Complex ingredients that are made to your specifications (i.e., not available as a 
commodity but custom prepared for you), including such ingredients purchased via 
contract or other commercial arrangements, are to be uniquely identified. For this, 
we believe it is necessary to provide: 
  the complete name of the manufacturer. 
  the uniquely identifying item name and/or number (e.g., catalog number or 
UPC) used by the manufacturer. 
  information to uniquely identify each specified ingredient (i.e., each ingredient 
you specified that the manufacturer use in manufacturing). Each specified 
ingredient is to be uniquely identified in the same manner as used for other 
ingredients. 
To further identify complex ingredients that are made to your specifications, FDA 
requests that you provide the quality (e.g., percent purity, a published standard) of 
each specified ingredient, the expected function(s) of each specified ingredient, any 
internal identification number (e.g., SKU, product code) used within your company 
to reference the complex ingredient, and any additional specifications for the 
complex ingredient (e.g., release specifications, acceptance criteria, a sample 
certificate of analysis).  
Complex ingredients that are not made to your specifications are also to be uniquely 
identified. For this, we believe it is necessary to provide: 
  the complete name of the manufacturer. 
  the uniquely identifying item name and/or number (e.g., catalog number or 
UPC) used by the manufacturer. The uniquely identifying name and/or number 
for a complex ingredient that is available for purchase by the general public is 
one assigned by the seller, not one internally assigned by your company. 
To further identify complex ingredients not made to your specifications, FDA 
requests that you provide the quality (e.g., percent purity, a published standard) of 
the complex ingredient, the expected function(s) of the complex ingredient, and any 
12  Contains Nonbinding Recommendations 
internal identification number (e.g., SKU, product code) used within your company 
to reference the complex ingredient. Many of the complex ingredients purchased for 
use in tobacco products are proprietary blends. You do not need to list any substance 
contained in a complex purchased ingredient where the ingredient is not made to 
your specifications. The manufacturer of the complex ingredient, however, may be 
subject to ingredient listing reporting requirements, as described in section III.B. 
If you use a complex ingredient provided by multiple suppliers interchangeably in a 
single tobacco product, you are to report all alternative sources in your ingredient 
listing, including sufficient information to link the ingredients you consider 
interchangeable.  
d.  Reaction Products 
When the manufacturer knows or intends that an ingredient will be formed through 
a chemical reaction during tobacco product manufacturing, FDA considers the 
resultant material to be an ingredient that is added by the tobacco product 
manufacturer. As such, these reaction products are to be included in the ingredient 
listing. Reaction products may result from, among other things, reactions that occur 
during a mixing or processing operation (e.g., casing and drying), during an in-
process holding step, or during a storage period. The reaction product(s) may result 
from a reaction between ingredients in the same part of a product (e.g., 
reconstituted tobacco) or between ingredients added to different parts of the product 
(e.g., tobacco, paper) or added at different manufacturing steps. Also, the reaction 
may occur between added ingredients or between ingredients and chemicals 
intrinsic to the cured tobacco leaf. 
Each reaction product ingredient is to be uniquely identified in the same manner 
used for single chemical substances. To further identify these reaction products, 
FDA requests that you state which added ingredients combined to form the reaction 
product and the expected function(s) of the reaction product ingredient.  
4.  Part to Which the Ingredient Is Added 
Section 904(a)(1) of the FD&C Act requires a listing of ingredients that are added 
by the manufacturer to the tobacco, paper, filter, or other part.  FDA interprets this 
to mean that manufacturers/importers are to specify whether an ingredient is added 
to the tobacco, to the paper, to the filter, or to another part of the tobacco product.  
5.  Ingredient Quantity 
Under section 904(a)(1) of the FD&C Act, you must report ingredients by quantity 
by brand and subbrand. Under section 904(d) and (e), FDA is required to publish a 
list of harmful constituents by quantity in each tobacco product by brand and 
subbrand. FDA intends to rely on consistent reporting from manufacturers and 
13  Contains Nonbinding Recommendations 
importers to publish this list in a manner that is useful to the public and not 
misleading to laypersons. Therefore, ingredient information is to be provided using 
units that are consistent across all products. In addition, the reporting of ingredient 
quantities is intended to provide the Agency with information to assist with 
implementation of other provisions of the FD&C Act (e.g., developing tobacco 
product standards and making substantial equivalence determinations). As such, the 
quantities need to be reported in consistent units across all products using an 
absolute measurement that is conserved during chemical reactions. FDA, therefore, 
interprets the term quantity to mean a unit of mass (i.e., grams with a standard 
International System of Units prefix as appropriate) of an ingredient contained in 
tobacco product.  
For all tobacco products, quantity is to be expressed in terms of the unit of use for a 
portioned tobacco product (e.g., one cigarette, one cigar) or per gram of product for 
a nonportioned tobacco product (e.g., container of loose snuff, reconstituted 
tobacco, hookah tobacco, hookah charcoal, e-liquids).  
Solvents or other ingredients that are added and subsequently removed during 
manufacturing are still considered to be added ingredients under section 904(a)(1) 
of the FD&C Act. As such, the removed ingredient is to be identified and the 
residual quantity stated (with an appropriate detection limit if the quantity is 
approximated near zero).  
You are to report all ingredient quantities contained in the tobacco product. You 
may calculate the quantity based on the added amounts and adjusting for known or 
intended losses and chemical reactions during manufacturing. Alternatively, the 
quantity contained in the tobacco product may be derived from laboratory testing.  
You are to report ingredients as a single quantity whenever possible. FDA 
understands, however, that in some circumstances manufacturers add ingredients 
based upon manufacturing specifications to affect product characteristics (e.g., to 
adjust for total sugars or to achieve a particular pH) resulting in the manufacturer 
adding varying amounts from batch to batch. If you add a particular ingredient in 
this way, you are to give the quantity by providing both the range of permitted 
quantities (e.g., add between 1.01 and 1.05 mg to the product) and the targeted 
outcome (e.g., in order to achieve a pH of 7.1).  Both the range of permitted 
quantities and the targeted outcome are to be derived from the manufacturing 
specifications for the addition of the ingredient. Where no quantity range is 
contained in, or can be derived from, manufacturing specifications, it is to be 
derived from the actual range of historical quantities added to the product.  
Section 904(c) requires the submission of information whenever the quantity of an 
additive is changed. Almost all ingredients are additives, as that term is defined in 
section III.A. The quantity before and after the change are reported. A change to the 
manufacturing specifications for the addition of an additive or to the quantity of an 
14  Contains Nonbinding Recommendations 
additive as reported constitutes a change triggering the reporting requirements in 
section 904(c). 
E.  How Do You Submit Ingredient Information? 
FDA strongly encourages you to make your submission electronically. An 
electronic submission reduces paper and facilitates efficient (and timely) 
submissions to the Agency and efficient processing, review, and archiving of the 
submission once at FDA.  
The FDA eSubmitter tool (eSubmitter) is software provided by FDA for the 
preparation of electronic submissions. This tool provides a template form to report 
ingredient data and an automatic acknowledgement of FDA receipt and allows users 
to attach large numbers of files, such as PDF documents. 
To use eSubmitter, first download the tool from the FDA Web site at 
http://www.fda.gov/ForIndustry/FDAeSubmitter and install it on your computer.10 
Select the CTP Tobacco Product Ingredient Listing Submissions within the 
eSubmitter program and enter information about your ingredient listing directly into 
the software. You will not need to prepare additional documents with this 
information, and you will not need to complete Form FDA 3742.  
You can then use eSubmitter to enter data, attach files, and upload the completed 
submission through the CTP Portal or FDA Electronic Submissions Gateway (ESG). 
You will need to apply for a free account to upload data through either the CTP Portal 
(http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/
Manufacturing/ucm515047.htm) or ESG. Due to the time needed to create new 
accounts, FDA urges submitters to apply for accounts several weeks in advance of 
when you intend to submit.  
The FDA eSubmitter tool can also streamline the process for submitting updated 
ingredient listing information required by section 904(c). 
Although FDA strongly encourages electronic submission, Form FDA 3742, an 
alternative tool for paper submissions, is available at https://www.fda.gov/about-
fda/reports-manuals-forms/forms Paper submissions may be mailed to: 
Food and Drug Administration 
Center for Tobacco Products 
Document Control Center 
Building 71, Room G335 
10903 New Hampshire Avenue 
Silver Spring, MD 20993-0002  
 
10 The eSubmitter tool requires a computer that runs MS Windows. 
15  Contains Nonbinding Recommendations 
Submissions delivered to DCC by couriers or physical mail will be considered 
timely if received during delivery hours on or before the due date (see 
http://www.fda.gov/tobaccoproducts/aboutctp/contactus/default.htm); if the due 
date falls on a weekend or holiday, the delivery must be received on the prior 
business day. We are unable to accept regulatory submissions by e-mail. 
F.  When Do You Submit Ingredient Information? 
Manufacturers and importers of cigarettes, cigarette tobacco, RYO, and smokeless 
tobacco products that were introduced into interstate commerce before June 22, 
2009, were required by section 904(a)(1) of the FD&C Act to submit a list of all 
ingredients by December 22, 2009.11  
For cigarettes, cigarette tobacco, RYO, smokeless tobacco products, and products 
containing nicotine from any source that were first marketed after June 22, 2009, 
ingredient lists are due at least 90 days before the product is delivered for 
introduction into interstate commerce (section 904(c)(1)). Section 904(c) also 
requires submission of information whenever any additive, or the quantity of any 
additive, is changed. Submissions under section 904(a)(1) consist of a listing of all 
ingredients added as of the date of submission. 
The preamble to the deeming rule (81 FR 28974) stated that FDA does not intend to 
enforce the requirement to submit ingredient listing for manufacturers and 
importers of newly deemed tobacco products that were introduced into interstate 
commerce on or before August 8, 2016 provided submissions are received by 
February 8, 2017, or August 8, 2017 for small-scale manufacturers.12 However, 
FDA recognizes that some manufacturers of newly deemed products are not 
familiar with the forms for listing ingredients and, therefore, may need additional 
time to complete them accurately. In addition, we are aware that some 
manufacturers may need to prepare and submit multiple lists. Therefore, at this 
time, for manufacturers and importers of newly deemed tobacco products (21 CFR 
part 1100) that were introduced into interstate commerce on or before August 8, 
2016, FDA does not intend to enforce the requirement to submit ingredient 
information according to section 904(a)(1) until May 8, 2018. For small-scale 
manufacturers of newly deemed tobacco products (21 CFR part 1100) that were 
introduced into interstate commerce on or before August 8, 2016, FDA does not 
 
11 FDA did not enforce the December 22, 2009, deadline in situations where the ingredient list was 
submitted on or before June 22, 2010, pursuant to a compliancy policy described in the November 2009 
edition of this guidance. 
12 For purposes of this compliance policy, FDA considers a small-scale tobacco product manufacturer to be a 
manufacturer of any regulated tobacco product that employs 150 or fewer full-time equivalent employees and 
has annual total revenues of $5 million or less. FDA considers a manufacturer to include each entity that it 
controls, is controlled by, or is under common control with. To help make FDAs individual enforcement 
decisions more efficient, a manufacturer may voluntarily submit information regarding employment and 
revenues. In this guidance, we use the shortened term small-scale manufacturer to refer to small-scale 
tobacco product manufacturer. 
16  Contains Nonbinding Recommendations 
intend to enforce the requirement to submit ingredient information according to 
section 904(a)(1) until November 8, 2018. Additionally, FDA is extending the 
compliance deadlines with respect to products on the market as of August 8, 2016, 
by an additional six months for small-scale tobacco product manufacturers and 
importers in the areas impacted by recent natural disasters to May 8, 2019.13  
Tobacco products introduced into interstate commerce after August 8, 2016, are 
required to submit the ingredient information required by section 904(a)(1) at least 
90 days before the product is introduced to interstate commerce. 
You are not required to submit ingredient lists for tobacco products that you 
discontinued and stopped manufacturing before the date of your submission under 
section 904(a)(1). Such discontinued products, if manufactured and reintroduced 
into the market, will, however, require the ingredient submission under section 
904(c)(1). Under that section, you are to submit the product ingredient list at least 
90 days prior to delivery for introduction into interstate commerce. When a tobacco 
product manufacturer makes a change to the additives in its cigarettes, cigarette 
tobacco, RYO, and smokeless tobacco products after June 22, 2009, sections 
904(c)(2) and (c)(3) require the manufacturer to report these changes. After August 
8, 2016, FDA intends to enforce sections 904(c)(2) and (c)(3) for changes in 
additives to all tobacco products except for accessories of newly deemed products.  
Specifically, under sections 904(c)(2) and (c)(3), if a manufacturer: 
 eliminates or decreases an existing additive, the change must be reported to
FDA within 60 days of making the change.
 adds or increases an additive that FDA has designated in regulations as a
tobacco additive that is not a human or animal carcinogen and is not otherwise
harmful to health under the intended conditions of use, the change must be
reported to FDA within 60 days of making the change.
 adds a new tobacco additive or increases the quantity of an existing tobacco
additive (not designated as described above), the change must be reported to
FDA at least 90 days prior to making the change.
13 For a complete list of the areas that have been impacted by recent natural disasters, please visit 
https://www.fda.gov/tobacco-products/ctp-newsroom/ingredient-listing-deadline-extended-small-scale-
manufacturers-and-importers-impacted-recent-natural. 
17  Contains Nonbinding Recommendations 
FDA COMPLIANCE POLICY FOR INGREDIENT LIST SUBMISSIONS 
FDA Intends to 
Enforce Ingredient  Date of Introduction  Submission 
Date to Submit 
Submissions for  or Reintroduction  Type 
These Products 
Products on the market  FDA did not begin 
section 
continuously since June  enforcing until June 22, 
904(a)(1) 
22, 2009, or earlier.  2010 
Previously marketed 
products that were 
90 days prior to 
discontinued or 
All tobacco  section  delivery for 
 Finished tobacco withdrawn before June 
products except  904(c)(1)  reintroduction into 
products 22, 2009, and 
deemed tobacco  interstate commerce 
reintroduced after June 
products  
22, 2009. 
90 days prior to 
Products marketed for  section  delivery for 
the first time after June  904(c)(1)  introduction into 
22, 2009  interstate commerce 
 FDA does not intend 
to enforce until May 
8, 2018
 FDA does not intend 
to enforce until 
November 8, 2018, 
Products on the market  section  for small scale 
as of August 8, 2016  904(a)(1)  manufacturers (or 
May 8, 2019, for 
small- scale 
manufacturers in 
areas impacted by 
recent natural 
Deemed   Finished tobacco disasters)14
products  products
Previously marketed 
products that were 
90 days prior to 
discontinued or 
section  delivery for 
withdrawn before 
904(c)(1)  reintroduction into 
August 8, 2016, and 
interstate commerce 
reintroduced after 
August 8, 2016 
Products marketed for  90 days prior to 
section 
the first time after  delivery for 
904(c)(1) 
August 8, 2016  introduction into 
interstate commerce 
14 For a complete list of the areas that have been impacted by recent natural disasters, please visit 
https://www.fda.gov/tobacco-products/ctp-newsroom/ingredient-listing-deadline-extended-small-scale-
manufacturers-and-importers-impacted-recent-natural. 
18  Contains Nonbinding Recommendations 
G. Will FDA Maintain the Confidentiality of the Ingredient Information You
Submit?
Information submitted under section 904 of the FD&C Act may include, but is not
limited to, a company's nonpublic trade secret or confidential commercial
information.
Several laws govern the confidentiality of ingredient information submitted under
section 904 of the FD&C Act, including sections 301(j) and 906(c) of the FD&C
Act (21 U.S.C. 331(j) and 387f(c)), the Trade Secrets Act (18 U.S.C. 1905), and the
Freedom of Information Act (FOIA) (5 U.S.C. 552), as well as FDAs
implementing regulations.
Section 906(c) of the FD&C Act prohibits FDA from disclosing any information
reported to or otherwise obtained by FDA under section 904, among other
provisions, if that information is confidential commercial or trade secret
information exempt from disclosure under FOIA Exemption 4 (5 U.S.C. 552(b)(4)).
The provision contains exceptions allowing disclosure of the information to other
officers or employees concerned with carrying out the tobacco products chapter of
the FD&C Act and, when relevant, in any proceeding under the tobacco products
chapter of the FD&C Act. Section 301(j) of the FD&C Act generally prohibits
release of trade secret information obtained by FDA under section 904, among other
provisions, outside of the Department of Health and Human Services, except to
courts when relevant in any judicial proceeding under the FD&C Act and to
Congress in response to an authorized Congressional request.
FDAs general regulations concerning the public availability of FDA records are
contained in 21 CFR part 20.
IV.  PAPERWORK REDUCTION ACT OF 1995
This guidance contains information collection provisions that are subject to review by the Office 
of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 
U.S.C.3501-3520). 
The time required to complete this information collection is estimated to average 3.75 hours per 
response, including the time to review instructions, search existing data sources, gather the data 
needed, and complete and review the information collection. Send comments regarding this 
burden estimate or suggestions for reducing this burden to: 
Food and Drug Administration 
Center for Tobacco Products 
Document Control Center 
Building 71, Room G335 
10903 New Hampshire Avenue 
Silver Spring, MD 20993-0002 
19  Contains Nonbinding Recommendations 
An Agency may not conduct or sponsor, and a person is not required to respond to, a collection 
of information unless it displays a currently valid OMB control number. The OMB control 
number for this information collection is 0910-0650. To find the current expiration date, search 
for this OMB control number at https://www.reginfo.gov. 
   
20  Contains Nonbinding Recommendations 
DOCUMENT HISTORY 
November 2009  First edition of guidance issued 
January 2017  Listing of Ingredients in Tobacco Products guidance revised to reflect changes 
in FDA authorities over deemed tobacco products.  Revisions include minor clarifying and 
editorial changes to promote consistency throughout our guidances, incorporate plain 
language, and employ grammatically correct phrasing. Specific revisions include the following: 
  Section II  Background updated to reflect changes in FDA authorities over deemed 
tobacco products arising from deeming rule. 
  Section III  Definitions of accessory, component or part, small-scale tobacco product 
manufacturer, and finished tobacco product added; definition of importer and pouch 
updated. 
  Section III.B  Section B Who Submits Ingredient Listing? compliance policy for 
cigarettes, cigarette tobacco, RYO, and smokeless tobacco deleted. 
  Section III.C  FDAs Compliance Policy for Regulated Tobacco Products added. 
  Former section III.C  What Information Is Submitted With the List of Ingredients? 
becomes section III.D. 
  Section III.D  Information on Data Universal Numbering System is updated. 
  Former section III.D  How Do You Submit Ingredient Information? becomes 
section III.E. 
  Section III.E  Information on how to submit ingredient listing information updated.  
  Former section III.E  When Do You Submit Ingredient Listing Information? 
becomes section III.F. 
  Section III.F  Updated to include submission dates for newly deemed products and 
provide compliance policy explaining that for tobacco products that were manufactured 
prior to August 8, 2016, FDA does not intend to enforce the requirement to provide 
ingredient listing until August 8, 2017, or February 8, 2018, for small-scale 
manufacturers. 
  Former section III.F  Will the FDA Maintain the Confidentiality of the Ingredient 
Information You Submit? becomes section III.G. 
  PRA section updated.  
21  Contains Nonbinding Recommendations 
October 2017  Revised compliance dates (1) to reflect compliance dates in the Extension of 
Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule guidance 
issued in August 2017 and (2) to provide a six-month extension for tobacco product 
manufacturers and importers in areas impacted by recent natural disasters. 
November 2017  Revised compliance dates to provide a six-month extension for all tobacco 
product manufacturers and importers, regardless of whether the manufacturer or importer is in an 
area impacted by recent natural disasters, as described in the October 2017 edition of this 
guidance. 
April 2018  Listing of Ingredients in Tobacco Products guidance revised to reflect the 
following: 
  Section III.D  Clarification regarding ways in which tobacco product manufacturers 
or importers can provide ingredient listing submissions as required by section 904(a)(1) 
of the FD&C Act. 
  Section III.D  Compliance policy for components and parts either sold separately as 
finished products or as components or parts of other finished products that are not made 
or derived from tobacco, or do not contain ingredients that are burned, aerosolized, or 
ingested during tobacco product use. 
November 2018  Revised compliance date to provide a six-month extension for small- scale 
tobacco product manufacturers and importers impacted by recent natural disasters. 
March 2023  Guidance revised to reflect the following:  
  Section III.ADefinition of tobacco product and references to such products updated 
to reflect statutory amendments made by the Consolidated Appropriations Act, 2022 
(Pub. L. 117-103). Among other things, the legislation amends the definition of 
tobacco product in section 201(rr) of the FD&C Act to include products containing 
nicotine from any source. 
22