Tobacco Product Initial Ingredient Listing

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 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-2009-D-0524].
For questions regarding this guidance, contact the Center for Tobacco Products at (Tel) 1-877CTP-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 [email protected] to receive an electronic copy
of this guidance. You may send a request for hard copies to U.S. Food and Drug Administration,
Center for Tobacco Products, Attn: Office of Small Business Assistance, Document Control
Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-2000.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Tobacco Products
January 2017
OMB control number: 0910-0650
Expiration Date: 6/30/2019
See additional PRA statement in section IV of the guidance
* This is a revision to the first edition of this guidance, which issued in November 2009. 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 ................................................................................................................4
A.

What Definitions Apply to this Guidance? .................................................................. 4

B.

Who Submits Ingredient Information? ....................................................................... 5

C.

What Is FDA’S Compliance Policy for Regulated Tobacco Products? ...................... 6

D.

What Information Is Submitted With the List of Ingredients? .................................. 7

1.
2.
3.
4.
5.
E.

Manufacturer/Importer Identification ............................................................................. 7
Product Identification..................................................................................................... 7
Ingredient Identification ................................................................................................. 8
Part to Which the Ingredient Is Added .......................................................................... 11
Ingredient Quantity ...................................................................................................... 12
How Do You Submit Ingredient Information? .......................................................... 13

F.

When Do You Submit Ingredient Information? ........................................................ 14

G.

Will FDA Maintain the Confidentiality of the Ingredient Information
You Submit? ............................................................................................................... 16

IV.

PAPERWORK REDUCTION ACT OF 1995………………………………………..17

DOCUMENT HISTORY ........................................................................................................18

i

Contains Nonbinding Recommendations

Listing of Ingredients in
Tobacco Products

1
2
3

Guidance for Industry1

4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24

This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on
this topic. It does not establish any rights for any person and is not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the
title page.

I.

INTRODUCTION

This guidance document is intended to assist persons making tobacco product ingredient
submissions to FDA. This guidance is intended for manufacturers and importers of cigarettes,
cigarette tobacco, roll your own tobacco (RYO), smokeless tobacco, and those tobacco products
subject to FDA’s 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 (81 FR 28974, May 10, 2016) (the deeming rule).
The guidance document explains, among other things:

25

•

The statutory requirement to submit a list of all ingredients in tobacco products;

26

•

Definitions;

27

•

Who submits ingredient information;

28

•

What information is included in the submissions;

29

•

How to submit the information;

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

30

•

When to submit the information; and

31

•

FDA’s compliance policies.

32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63

FDA’s guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe the Agency’s 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.

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. 111–
31, 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 FDA’s
tobacco product authorities in chapter IX of the FD&C Act, including section 904, when the
Tobacco Control Act went into effect. 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). 2 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 FDA’s tobacco product authorities by the deeming rule. 3
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,

2

Accessories of tobacco products subject to the deeming rule are explicitly excluded from the rule’s deeming
provision.

3

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 eliquids used with ENDS products, among other products.

2

Contains Nonbinding Recommendations

64
65
66
67
68
69
70
71
72
73
74
75
76
77
78
79
80
81
82
83
84
85
86
87
88
89
90
91
92
93

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. 4 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.
As described in the preamble to the deeming rule, for products other than cigarettes, cigarette
tobacco, RYO, and smokeless tobacco that are on the market as of August 8, 2016, FDA does
not intend to enforce the section 904(a)(1) ingredient listing submission requirement until 6
months after the effective date of the rule for most businesses and 12 months from the effective
date for small-scale tobacco product manufacturers (small-scale manufacturers).5 Under this
policy, FDA does not intend to enforce the ingredient list submission requirement until February
8, 2017, for businesses that are not small-scale manufacturers, and August 8, 2017, for smallscale manufacturers (81 FR 28974 at 29008). As for those products that are first marketed after
August 8, 2016, manufacturers must provide the ingredient listing information required under
section 901(a)(1) at least 90 days before the product is delivered for introduction into interstate
commerce, as was required for cigarettes, cigarette tobacco, RYO, and smokeless tobacco first
marketed after June 22, 2009 (section 904(c)(1)).
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.

4

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 compliance policy described in the November 2009 edition of this guidance.
5

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 FDA’s 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.

3

Contains Nonbinding Recommendations

94
95
96
97
98
99
100
101
102
103
104
105
106
107
108
109
110
111
112
113
114
115
116
117
118
119
120
121
122
123
124
125
126
127
128
129
130
131
132
133
134
135
136

III.

DISCUSSION
A.

What Definitions Apply to This Guidance?

FDA intends to use the following definitions to implement the ingredient listing requirements of
section 904 of the FD&C Act:
•

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 product’s 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 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).

4

Contains Nonbinding Recommendations

137
138
139
140
141
142
143
144
145
146
147
148
149
150
151
152
153
154
155
156
157
158
159
160
161
162
163
164
165
166
167
168
169
170
171
172
173
174

•

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.

•

Pouch: The term pouch means a permeable material, intended to be filled with preportioned 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
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).”
(section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)).
(2) The term “tobacco product” does not include an article that is a drug under
[section 201(g)(1)], a device under [section 201(h)], or a combination product
[described in section 503(g) [of the FD&C Act (21 U.S.C. 353(g))].
Note that this definition includes accessories and components and parts of tobacco products,
whether they are made or derived from tobacco, and whether they are sold or distributed as
finished tobacco products.6

•

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

6

However, and as explained above, accessories of tobacco products subject to the deeming rule are explicitly
excluded from the rule’s 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)).

5

Contains Nonbinding Recommendations

175
176
177
178
179
180
181
182
183
184
185
186
187
188
189
190
191
192
193
194
195
196
197
198
199
200
201
202
203
204
205
206
207
208
209
210
211
212
213
214
215
216

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 FDA’S 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 also finished
tobacco products if they are sold in final packaging intended for consumer use. FDA intends to
enforce the requirements for submission of ingredient information under section 904(a)(1) with
respect to such products. Examples of components and parts that are sold or may be sold as
finished tobacco products include pipe tobacco filler, filter tubes, e-cigarette batteries, and eliquids, whether sold separately to consumers or as part of kits.
Based on our experience with cigarettes, cigarette tobacco, RYO and smokeless tobacco, we are
amending our previous compliance policy. Under our previous policy, FDA intended to enforce
the submission of the listing of ingredients requirements with respect to owners and operators
engaged in the manufacture of tobacco, papers, filters, and pouches whether or not such products
are for further manufacturing of, or for consumer use as, regulated tobacco products. However,
FDA is announcing a change to that policy because we believe we can obtain the necessary

6

Contains Nonbinding Recommendations

217
218
219
220
221
222
223
224
225
226
227
228
229
230
231
232
233

information about tobacco products components and parts through other means, such as
premarket applications for finished tobacco products and through the use of master files, as
explained in the guidance Tobacco Product Master Files. 7 Additionally, we are aligning our
compliance policy for cigarettes, cigarette tobacco, RYO, and smokeless tobacco with the
products now regulated as a result of the deeming rule to reduce burden on industry. Should
FDA find that additional information is needed to protect the public health, the Agency may
reconsider this compliance policy. We intend to communicate any compliance policy changes
by guidance or rulemaking.
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:

234

•

Your corporate email address;

235
236

•

Your Data Universal Numbering System (D-U-N-S) number or other unique
identifier; 8

237
238

•

The facility establishment identifier (FEI) number assigned to your establishment
by FDA. 9

239
240
241
242
243
244

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

7

This guidance is available on the CTP guidance Web page at
http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm.

8

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 FDA’s
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 FDA’s database.
9

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

245
246
247
248
249
250
251
252
253
254
255
256
257
258
259
260
261
262
263
264
265
266
267
268
269
270
271
272
273
274
275
276
277
278
279
280
281
282
283
284

importers submit ingredient lists individually for tobacco products that differ in any way, other
than packaging differences that do not affect characteristics of the product. For example, if a soft
pack and a hard pack of cigarettes have different moisture contents, shelf lives, or ingredient
compositions (including ingredients introduced in packaging but known or reasonably expected
to become incorporated into the consumed product), they are considered to be distinct products
requiring separate ingredient lists for purposes of section 904(a)(1). Conversely, if the cigarettes
sold in different packaging configurations are identical, a single ingredient list should be
submitted for the product, noting the different packaging configurations.
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. 10 You are to 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.
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 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.

10

Lists of categories and subcategories are provided on Form 3742 and the eSubmitter submission template. See
section III.E “How Do You Submit Ingredient Information.”

8

Contains Nonbinding Recommendations

285
286
287
288
289
290
291
292
293
294
295
296
297
298
299
300
301
302
303
304
305
306
307
308
309
310
311
312
313
314
315
316
317
318
319
320
321
322
323
324
325
326
327
328
329

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.
FDA’s 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
substance’s molecular structure and/or descriptive information. For the purposes of the SRS
system, 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 [email protected]. More
information regarding SRS is posted at
http://www.fda.gov/forindustry/datastandards/substanceregistrationsystemuniqueingredientidentifierunii/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 tobaccoderived 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

9

Contains Nonbinding Recommendations

330
331
332
333
334
335
336
337
338
339
340
341
342
343
344
345
346
347
348
349
350
351
352
353
354
355
356
357
358

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.
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:

359

•

the complete name of the manufacturer;

360
361

•

the uniquely identifying item name and/or number (e.g., catalog number or UPC) used by
the manufacturer; and

362
363
364

•

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.

365
366
367
368
369
370
371

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).

10

Contains Nonbinding Recommendations

372
373

Complex ingredients that are not made to your specifications are also to be uniquely identified.
For this, we believe it is necessary to provide:

374

•

the complete name of the manufacturer; and

375
376
377
378

•

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.

379
380
381
382
383
384
385
386
387
388
389
390
391
392
393

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 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.

394
395
396
397
398
399
400
401
402
403

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.

404
405
406
407
408
409
410
411
412

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.

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.

4.

Reaction Products

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

11

Contains Nonbinding Recommendations

413
414
415
416
417
418
419
420
421
422
423
424
425
426
427
428
429
430
431
432
433
434
435
436
437
438
439
440
441
442
443
444
445
446
447
448
449
450
451
452
453
454
455
456
457

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 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 a
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.

12

Contains Nonbinding Recommendations

458
459
460
461
462
463
464
465
466
467
468
469
470
471
472
473
474
475
476
477
478
479
480
481
482
483
484
485
486
487
488
489
490
491
492
493
494
495
496
497

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 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. 11 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/Manufacturi
ng/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, FDA Form 3742, an alternative tool
for paper submissions, is available at
http://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/Tobacco/default.htm
Paper submissions may be mailed to:

11

The eSubmitter tool requires a computer that runs MS Windows.

13

Contains Nonbinding Recommendations

498
499
500
501
502
503
504
505
506
507
508
509
510
511
512
513
514
515
516
517
518
519
520
521
522
523
524
525
526
527
528
529
530
531
532
533
534
535
536
537

Food and Drug Administration
Center for Tobacco Products
Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
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. 12
For cigarettes, cigarette tobacco, RYO, and smokeless tobacco products 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. 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 August 8, 2017. For smallscale 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 intend to enforce the
requirement to submit ingredient information according to section 904(a)(1) until February 8,
2018. FDA believes that this additional time will allow manufacturers to prepare higher quality

12

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..

14

Contains Nonbinding Recommendations

538
539
540
541
542
543
544
545
546
547
548
549
550
551
552
553
554
555
556

submissions. However, because we may receive a large number of submissions from certain
firms, we encourage manufacturers to begin the process as early as possible.

557
558

•

eliminates or decreases an existing additive, the change must be reported to FDA within 60
days of making the change;

559
560
561
562

•

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; or

563
564
565

•

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.

566
567

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:

FDA COMPLIANCE POLICY FOR INGREDIENT LIST SUBMISSIONS
FDA Intends to
Enforce Ingredient
Submissions for
These Products

Cigarettes, cigarette
tobacco, RYO, and
smokeless tobacco

• Finished tobacco
products

Date of Introduction
or Reintroduction
Products on the market
continuously since June
22, 2009, or earlier.
Previously marketed
products that were
discontinued or withdrawn
before June 22, 2009, and
reintroduced after June 22,
2009.

15

Submission
Type

Date to Submit

section
904(a)(1)

FDA did not begin
enforcing until June
22, 2010

section
904(c)(1)

90 days prior to
delivery for
reintroduction into
interstate commerce

Contains Nonbinding Recommendations

FDA Intends to
Enforce Ingredient
Submissions for
These Products

Date of Introduction
or Reintroduction

Submission
Type

Products marketed for the
first time after June 22,
2009

section
904(c)(1)

Products on the market as
of August 8, 2016
Tobacco products
other than cigarettes,
• Finished tobacco
cigarette tobacco,
products
RYO, and smokeless
tobacco

568
569
570
571
572
573
574
575
576
577
578
579
580
581
582
583
584
585
586
587

Previously marketed
products that were
discontinued or withdrawn
before August 8, 2016,
and reintroduced after
August 8, 2016
Products marketed for the
first time after August 8,
2016

G.

section
904(a)(1)

Date to Submit
90 days prior to
delivery for
introduction into
interstate commerce
•FDA does not intend
to enforce until August
8, 2017, for other
manufacturers
•FDA does not
intend to enforce
until February 8,
2018, for small scale
manufacturers

section
904(c)(1)

90 days prior to
delivery for
reintroduction into
interstate commerce

section
904(c)(1)

90 days prior to
delivery for
introduction into
interstate commerce

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 FDA’s 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

16

Contains Nonbinding Recommendations

588
589
590
591
592
593
594

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.

595

V.

596
597
598

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).

599
600
601
602

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:

603
604
605
606
607
608
609
610
611

FDA’s general regulations concerning the public availability of FDA records are contained in 21
CFR part 20.

PAPERWORK REDUCTION ACT OF 1995

Food and Drug Administration
Center for Tobacco Products
Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
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 (expires 6/30/2019).

612
613

17

Contains Nonbinding Recommendations

614

DOCUMENT HISTORY

615

November 2009 — First edition of guidance issued.

616
617
618
619

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:

620
621
622
623
624
625
626
627
628
629
630
631
632
633
634
635
636
637
638
639
640
641
642
643
644
645
646
647
648
649
650
651
652
653
654

•

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 — “FDA’s 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

18