Product Quantity Change SE Report

Guidance for Industry

Demonstrating the Substantial

Equivalence of a

New Tobacco Product:

Responses to Frequently Asked

Questions

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-2011-D-0147.
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 [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, Document Control Center, Building 71, Room G335, 10903 New
Hampshire Avenue, Silver Spring, MD 20993-0002.

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Tobacco Products

Document Issued on March 4, 2015

Contains Nonbinding Recommendations

Table of Contents
I.

INTRODUCTION.........................................................................................................1

II.

RESPONSES TO FREQUENTLY ASKED QUESTIONS ............................................2
A.

Label Changes ...........................................................................................................3

B.

Product Quantity Changes ........................................................................................9

C.

Additives/Specifications ..........................................................................................15

D.

General Questions About Section 905(j)/SE Reports................................................18

i

Contains Nonbinding R ecommen dations

Guidance for Industry1

Demonstrating the Substantial
Equivalence of a New Tobacco Product:
Responses to Frequently Asked Questions
This guidance represents the Food and Dmg Administration's (FDA's) current thinking on this
topic . It does not create or confer any rights for or on any person and does not operate to bind
FDA or the public. You can use an alternative approach if the approach satisfies the requirements
of the applicable statutes and regulations. If you want to discuss an alternative approach, contact
the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate
FDA staff, call the appropriate number listed on the title page of this guidance.

I.

INTRODUC TION

This guidance provides information in response to fi:equently asked questions (F AQs)
that the Center for Tobacco Products (CTP) is receiving from manufacturers and other
interested stakeholders (you) on demonstrating the substantial equivalence (SE) of a new
tobacco product. After carefully reviewing and considering comments and information
submitted in response to the draft guidance,2 which covered a range of topics on
demonstrating the substantial equivalence of a new tobacco product, FDA is fmalizing
this guidance on many of the topics. In addition, this guidance expla ins that a
manufacturer may submit streamlined SE rep011s for ce1tain modifications to labels and
changes to product quantity. In reviewing this guidance, please note the following
information:
• In generaL a tobacco product manufacturer must submit a premarket application and
obtain a marketing authorization order before the manufacturer may introduce a new
tobacco product into interstate commerce (section 910 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) as amended by the Family Smoking Prevention and
Tobacco Control Act (Tobacco Control Act) (21 U.S .C. 387j)).

1

This guidance was prepared by the Office ofScience and Office of Regulations in the Center for Tobacco

Products at FDA.

2
The notice ofavailability for the draft guidance published on September 9, 2011 (7 6 Federal Register

55927).

1

Contains Nonbinding Recommendations

• A premarket application and a marketing authorization order under section
910(c)(1)(A)(i) of the FD&C Act are not required, however, if a manufacturer
submits a substantial equivalence report (SE Report) under section 905(j) (21 U.S.C.
387e(j)) and obtains an order under section 910(a)(2) finding that the new tobacco
product is (1) substantially equivalent to a tobacco product commercially marketed in
the United States as of February 15, 2007 and (2) in compliance with the
requirements of the FD&C Act. 3
• If a new tobacco product has been modified by adding or deleting a tobacco additive
or increasing or decreasing the quantity of an existing tobacco additive, the
manufacturer may, instead of a premarket application under section 910(b), submit an
exemption request under 21 CFR 1107.1. FDA may grant the exemption request if it
determines that (1) the modification is a minor modification of a tobacco product that
can be sold under the FD&C Act, (2) a report demonstrating substantial equivalence
is not necessary to ensure that permitting the product to be marketed would be
appropriate for protection of the public health, and (3) an exemption is otherwise
appropriate.
• If FDA grants an exemption from the substantial equivalence requirements,
manufacturers must also submit a report under section 905(j)(1)(A)(ii), at least 90
days prior to introduction or delivery of the product into interstate commerce, stating
(1) the tobacco product is modified within the meaning of the exemptions provision,
(2) the modifications are to a product that is commercially marketed and in
compliance with the requirements of the FD&C Act, (3) all of the modifications are
covered by exemptions granted under section 905(j)(3) of the FD&C Act, and (4)
actions taken to ensure that the tobacco product is in compliance with section 907.
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.

RESPONSES TO FREQUENTLY ASKED QUESTIONS

This section provides our responses to questions that you have asked us on the substantial
equivalence provisions. Many of the questions use the term “new tobacco product.”
Rather than repeat the definition in every response, FDA provides the definition here, and
you should refer back to it as necessary.

3

Please refer to the guidance for industry and FDA staff, Section 905(j) Reports: Demonstrating
Substantial Equivalence for Tobacco Products (Demonstrating SE Guidance), available on the Internet at
http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM23902
1.pdf.

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Contains Nonbinding Recommendations

The term new tobacco product means:
A. any tobacco product (including those products in test markets) that was

not commercially marketed in the United States as of February 15, 2007;

or

B. any modification (including a change in design, any component, any part,

or any constituent, including a smoke constituent, or in the content,

delivery or form of nicotine, or any other additive or ingredient) of a

tobacco product where the modified product was commercially marketed

in the United States after February 15, 2007.

(Section 910(a)(1) of the FD&C Act (21 U.S.C. 387j(a)(1)).)

The term tobacco product is defined as “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)(1) of the FD&C
Act (21 U.S.C. 321(rr)(1))). This term does not include an article that is a drug, a device,
or a combination product as defined in the FD&C Act (see section 201(rr) of the FD&C
Act).
The answers provided in this guidance are specific to premarket requirements of the
FD&C Act and are not intended to speak to any other requirements of the FD&C Act.
Manufacturers are encouraged to review the FD&C Act, the regulations in effect, and any
available guidances. A new tobacco product that does not comply with the premarket
requirements of sections 905(j) and 910 of the FD&C Act is both misbranded and
adulterated (sections 902(6)(A) and 903(a)(6) of the FD&C Act (21 U.S.C. 387b(6)(A)
and 387c(a)(6))).
A.

Label Changes

In the draft of this guidance issued September 2011, FDA indicated that it would consider

the “label” of the tobacco product to be a “part” of that tobacco product, and,

accordingly, any modification to a tobacco product’s label after February 15, 2007,

would make the product a new product subject to premarket review. After reviewing the

comments and information submitted in response to the September 2011 draft guidance,

FDA has carefully reconsidered this policy.

We have concluded that a label is not a “part” of the tobacco product. 4 FDA does

conclude, however, that if a product’s label is modified in any way that renders the

product distinct from the predicate, even if its characteristics remain the same, the

modified product is a new product under section 910(a)(1)(A) of the FD&C Act because

that product was not commercially marketed in the United States as of February 15, 2007.

4

Please note that the misbranding provisions of section 903 of the FD&C Act, including the provision that
states a tobacco product shall be deemed to be misbranded if its labeling is false or misleading in any
particular, continue to apply to all tobacco products subject to FDA’s Chapter IX authorities.

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Contains Nonbinding Recommendations

Whether a product with a label change results in a distinct product depends on the
circumstances. Some types of changes that might result in a distinct product are changes
to logo, identifiable patterns of color, product descriptors, or any combination
thereof. One consideration would be whether the label change would lead consumers to
believe that the product is different from the predicate. Therefore, when a company
changes the label of a tobacco product, FDA believes it is a new product if consumers are
likely to perceive it as “new” by virtue of the different label. This interpretation is
consistent with provisions throughout the FD&C Act, in which individual tobacco
products are distinguished primarily on the basis of brands 5 and subbrands. 6 If a product
is new because it is distinct, but the product has the same characteristics as the predicate
tobacco product, then the manufacturer or importer may opt to submit a “Same
Characteristics SE Report”7 (e.g., the name or logo of the tobacco product is modified in
a way that makes it distinct) as discussed in more detail in the following questions and
answers.
In contrast, a change to a logo, colors, product descriptors, or other aspects of the label
that is unlikely to lead consumers to believe that the product is different from the
predicate would not result in a new tobacco product. This chart provides some basic
examples.
Label Change

Background Color
Logo Image

Product Descriptors

Examples that May
Result in a Distinct
Product
Green to Red
Changing the object
depicted in the logo (e.g.,
star to lion)
Addition of “Premium
Tobacco”

5

Examples that May Not
Result in a Distinct
Product
White to Cream
The same object on the
logo, but reduced size on
label
Italicizing product
descriptors that are on the
label

Section 900(2) of the FD&C Act (21 U.S.C. 387(2)) defines brand as “a variety of tobacco
product distinguished by the tobacco used, tar content, nicotine content, flavoring used, size, filtration,
packaging, logo, registered trademark, brand name, identifiable pattern of colors, or any combination of
such attributes.”
6
For example, sections 904 and 915 of the FD&C Act (21 U.S.C. 387d and 387o) require reporting of
ingredient information and HPHCs by brand and subbrand. This position is also reflected in another
guidance interpreting section 905. Specifically, the guidance for industry Registration and Product Listing
for Owners and Operators of Domestic Tobacco Product Establishments states that “[e]ach product [in a
listing] is to be clearly and uniquely identified by the product category (e.g., cigarette, smokeless tobacco,
paper, filter) and unique name (i.e., brand/sub-brand or other commercial name used in commercial
distribution)”
(http://www fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm189539.htm).
7
As described in this section, the Same Characteristics SE Report would be an alternative to submitting a
full SE report or a premarket application under section 910(b) of the FD&C Act.

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Contains Nonbinding Recommendations

Question 1:
Would a tobacco product be a “new tobacco product,” and subject to the substantial
equivalence provisions of the FD&C Act, if the tobacco product was commercially
marketed as of February 15, 2007 and the manufacturer changed the name of the
product? In other words, if a manufacturer changes the name of its product, does this
modify the product in a way that makes it distinct?
Response:
Yes. If a tobacco product was commercially marketed as of February 15, 2007, but
subsequently the manufacturer changes the tobacco product’s name, this is a modification
that makes the product distinct. Therefore, the modified product is a new tobacco
product under section 910(a)(1)(A) of the FD&C Act. If, however, the product’s
characteristics are the same as the predicate, the manufacturer may submit a Same
Characteristics SE Report for this change as discussed in the response to question 3. For
example, if the logo on a tobacco product’s label is modified in a way that makes the
tobacco product distinct, but the characteristics of the product remain the same, the
manufacturer may submit the “Same Characteristics SE Report.”
Question 2:
When I have a tobacco product that is distinct from, but has the same characteristics as, a
product of mine that was commercially marketed as of February 15, 2007 (or a product of
mine that has been found by FDA to be SE), what information should I submit to
demonstrate substantial equivalence?
Response:
If you have a tobacco product that is distinct, e.g., it has a different name, but has the
same characteristics as either a tobacco product that you manufactured that was
commercially marketed as of February 15, 2007, or a product that has been found by
FDA to be substantially equivalent, you may submit an SE Report that contains a brief,
specific set of information (Same Characteristics SE Report). We believe the information
included in the Same Characteristics SE Report should be sufficient for FDA to make its
SE determination in this situation. This Same Characteristics SE Report should be easier
for industry to prepare and for FDA to review than would typically be the case for SE
reports involving other changes to a tobacco product and, therefore, FDA expects to
review these reports more quickly. FDA intends to review these in a queue separate from
SE Reports involving other changes to a tobacco product. More information related to
the Same Characteristics SE Report is provided in the following questions and responses.
Question 3:
What information should a Same Characteristics SE Report contain?
Response:
The following items should be included in your Same Characteristics SE Report:
• A cover letter that prominently identifies the submission as “Same

Characteristics SE Report.”

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Contains Nonbinding Recommendations

• Full identification of your new tobacco product:8
— manufacturer (We expect the manufacturer of the new product will generally
be the same as the manufacturer of the predicate product. If this is not the
case, FDA would need adequate assurances that the new product has the same
characteristics as the predicate product, and believes the certification below
would not suffice. In such a case, we strongly encourage the applicant to
contact CTP to request a meeting 9 about possible ways to provide adequate
assurances that the characteristics remain the same.),
— unique name (i.e., brand name/subbrand or other commercial name used in
commercial distribution),
— product category (e.g., cigarette),
— product subcategory (e.g., conventional filtered), and
— package size/count (e.g., 7.8 oz. or 20 cigarettes per pack)
— if portioned, portion size (e.g., 0.5 gram bag of snus)
— package type (e.g., soft pack, box, plastic can with metal lid, bag).
• Full identification of a predicate tobacco product:10
— manufacturer
— unique name (i.e., brand name/subbrand or other commercial name used in
commercial distribution),
— product category (e.g., cigarette),
— product subcategory (e.g., conventional filtered), and
— package size/count (e.g., 7.8 oz. or 20 cigarettes per pack)
— if portioned, portion size (e.g., 0.5 gram bag of snus)
— package type (e.g., soft pack, box, plastic can with metal lid, bag).
• If you have previously submitted an SE Report for the new tobacco product, you
should include the Submission Tracking Number (STN) assigned by FDA to that
previous SE Report. (You should also review the responses to questions 4 and 5.)
• Statement of whether you intend to commercially market both the predicate
tobacco product and the new tobacco product, or only the new tobacco product
(please also see the response to question 7).
• Environmental Assessment (please also see the response to question 26).
• Health Information Summary or a statement that the “information will be made
available upon request by any person” (section 910(a)(4) of the FD&C Act).

8

The new tobacco product is the tobacco product that is distinct because, e.g., of its different name, logo,
packaging font or color, but is otherwise identical (i.e., has exactly the same characteristics as a predicate
tobacco product).
9
For additional information on meetings, please refer to the CTP guidance, “Meetings with Industry and
Investigators on the Research and Development of Tobacco Products” (CTP Meetings Guidance) available
on the Internet at
http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM30528
2.pdf. This guidance provides information on how to request a meeting, along with recommendations about
what to include in a request, etc.
10
The predicate tobacco product is a tobacco product commercially marketed (other than for test
marketing) as of February 15, 2007, or a tobacco product that has been found substantially equivalent.

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Contains Nonbinding Recommendations

• Statement of action taken to comply with the requirements under section 907 of
the FD&C Act that are applicable to the tobacco product (or a statement that
“requirements under section 907 are not applicable to the tobacco product”).
• Certification statement that is signed by a responsible official who is authorized to
act on behalf of the company and that states the following:
I, [insert name of responsible official], on behalf of [insert name of company],
certify that [insert new tobacco product name] has a different [identify
distinction] from [insert name of predicate tobacco product] but is otherwise
identical to [insert name of predicate tobacco product]. I certify that [insert name
of company] understands this means there is no modification, except for [identify
distinction] from the predicate tobacco product, including any change in
materials, ingredients, design features, heating source, or any other features. I
certify that this information and the accompanying submission are true and
correct, and that I am authorized to submit this on the company’s behalf. I
understand that under section 1001 of title 18 of the United States Code, anyone
who makes a materially false, fictitious, or fraudulent statement to the
Government of the United States is subject to criminal penalties.
Question 4:
If I currently have an SE Report pending with FDA, may I use the Same Characteristics
SE Report instead?
Response:
If your pending report is for a new tobacco product that is distinct because, e.g., it has a
different name, but it has the same characteristics as the predicate tobacco product, you
may submit a Same Characteristics SE Report for the new product, or if this is to a
provisional SE Report, you may you may amend your pending report with information to
support a same characteristics SE report.
Question 5:
What if I wish to modify my tobacco product in a way that makes it distinct if my product
is the subject of a “provisional” 11 SE Report that is pending review at FDA?
Response:
Under section 905(j)(1)(A)(i) of the FD&C Act, SE reports may compare the new
product to only products that were commercially marketed as of February 15, 2007, or
products that FDA has previously determined to be substantially equivalent to a predicate
tobacco product. Products that are the subject of “provisional” SE Reports, while legally
sold or distributed, may not serve as predicate tobacco products under the FD&C Act
unless they have been previously found to be SE.
11

A “provisional” SE Report is one that was submitted prior to March 23, 2011, for a new tobacco product
that was first commercially marketed between February 15, 2007, and March 22, 2011. New tobacco
products that are the subjects of provisional SE Reports may remain on the market unless FDA finds the
products not substantially equivalent (NSE) to a predicate product.

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Contains Nonbinding Recommendations

However, FDA does not intend to object to the commercial distribution of a new product,
that is distinct from, but has the same characteristics as, a product subject to a
“provisional” SE Report prior to FDA’s issuance of an order under section 910(a) of the
FD&C Act in the following situation:
• The manufacturer submits a Same Characteristics SE Report as outlined in the
response to question 3 above. The Same Characteristics SE Report should
identify the STN assigned by FDA for the original provisional SE Report, and
provide information on the provisional product in lieu of the predicate
information described in question 3; and
• The manufacturer does not commercially market the product until 90 days after
FDA’s receipt of the complete Same Characteristics SE Report (as outlined in the
response to question 3 above); or for products already on the market as of the date
of issuance of this guidance, if the manufacturer submits the complete Same
Characteristics SE Report to be received by CTP within 30 calendar days of the
date of the issuance of this guidance (refer to the cover page of this guidance
document for date of issuance).
FDA intends to issue its order on the product that is distinct only after it has completed its
review of the original “provisional” SE Report because, as stated, products that are the
subject of “provisional” SE reports may not serve as predicate tobacco products under the
FD&C Act unless they have been previously found SE. Ultimately, if the product that is
the subject of the original “provisional” SE Report is found substantially equivalent to a
predicate tobacco product, FDA intends to issue a subsequent order for the product with
the modification. If the product that is the subject of the original “provisional” SE Report
is found not substantially equivalent (NSE) to the predicate tobacco product, then the
compliance policy described above will no longer apply. If the original “provisional” SE
Report is found NSE, neither the product subject to the original provisional report, nor
the product that is distinct, may be introduced or delivered for introduction into interstate
commerce for commercial distribution; doing so would render the product adulterated
and misbranded (sections 902(6)(A) and 903(a)(6) of the FD&C Act; 21 U.S.C.
387b(6)(A), 387c(a)(6)). We note that all products on the market, including the products
identified in this response, are subject to enforcement at any time for violations of the
FD&C Act.
Question 6:
What if I have a tobacco product that is legally sold because it was commercially
marketed as of February 15, 2007, but I have changed the product label in a way that
makes it distinct and I am now selling that product with that change?
Response:
The tobacco product with the modified label is a new tobacco product subject to
premarket requirements under section 910(a) of the FD&C Act. New tobacco products
may not be sold or distributed in interstate commerce without an order from FDA under
either section 910(c)(1)(A)(i) or section 910(a)(2)(A) of the FD&C Act. As outlined in

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Contains Nonbinding Recommendations

the responses to questions 2 and 3, you may submit a Same Characteristics SE Report for
a label change, and FDA will determine whether the new tobacco product is substantially
equivalent.
However, FDA does not intend to object to the commercial distribution of a new product
that is distinct from, but has the same characteristics as, a product that is currently being
sold or distributed in interstate commerce prior to FDA’s issuance of an order under
section 910(a) of the FD&C Act in the following situation:
• The manufacturer submits a Same Characteristics SE Report as outlined in the
response to question 3 above, to be received by CTP within 30 calendar days of
the date of issuance of this guidance (refer to the cover page of this guidance
document for the date of issuance).
If, after review of the Same Characteristics SE Report, FDA finds that the new product
that is the subject of the Same Characteristics SE Report is not SE (i.e., NSE) to the
predicate tobacco product, then the compliance policy described above will no longer
apply. In that case, the product could no longer be legally marketed and would be
adulterated or misbranded under section 902(6) and 903(a)(6) of the FD&C Act.
Question 7:
If a manufacturer commercially markets a tobacco product as “Brand X” as of February
15, 2007, and, after that date, continues to commercially market “Brand X” but also
intends to commercially market an otherwise identical (i.e., same characteristics) tobacco
product under the additional name “Brand Y,” would “Brand Y” be a “new tobacco
product” and subject to the substantial equivalence provisions?
Response:
Yes. “Brand Y” would be a new tobacco product under section 910(a)(1)(A) of the
FD&C Act. If Brand Y is otherwise identical (i.e., same characteristics) to Brand X, the
manufacturer may submit a Same Characteristics SE Report for the new product as
discussed in the response to question 3. The Same Characteristics SE Report should
indicate whether the manufacturer intends to commercially market the product both as
Brand X and Brand Y.
B.

Product Quantity Changes

FDA has determined that the introduction of a product for which the product quantity in
the package 12 has changed (e.g., the number of portioned parts per package has changed
such that the new product would hold 24 cigarettes per pack instead of 20; the weight of
the product has changed such that the new smokeless package would change from 24

12

For example, the pack, box, carton, container, or wrapping (such as cellophane), in which a tobacco
product is sold to consumers.

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Contains Nonbinding Recommendations

grams to 5 grams), even if the per weight composition 13 of additives, ingredients, and
other features remains the same, renders it a new product under section 910(a)(1) of the
FD&C Act because the characteristics (e.g., amounts of ingredients) have changed.
However, we have determined that changes to product quantity (when all other product
characteristics remain the same) will require a reduced set of information in order for
FDA to determine whether the new product is substantially equivalent within the
meaning of section 910(a)(3). Thus, if a product quantity has changed, but the per weight
composition, design features, heating source, and all other features are otherwise identical
to the predicate tobacco product, the manufacturer or importer may opt to submit a
“Product Quantity Change SE Report”14 as discussed in more detail in the following
questions and answers.
Question 8:
Would a tobacco product be a “new tobacco product,” and subject to the substantial
equivalence provisions of the FD&C Act, if the tobacco product was commercially
marketed as of February 15, 2007, but subsequently the quantity of product sold in a
package is changed (e.g., the number of portioned parts per package has changed such
that the new product would hold 24 cigarettes per pack instead of 20; the weight of the
product has changed such that the new smokeless package would change from 24 grams
to 5 grams)?
Response:
Yes. If a tobacco product was commercially marketed as of February 15, 2007, but
subsequently the quantity of the tobacco product is changed, the product is a new tobacco
product under section 910(a)(1) of the FD&C Act. If the only change is a change to
product quantity and the per weight composition inside the package remains identical, the
manufacturer may submit a Product Quantity Change SE Report as an alternative to a full
(more detailed) SE report or premarket application under section 910(b) of the FD&C
Act (as discussed in the response to question 10).
Question 9:
When I have a tobacco product that is to be marketed in a different quantity, but is
otherwise identical to one of my products that was commercially marketed as of February
15, 2007 (or one of my products that has been found by FDA to be SE), what information
should I submit to demonstrate substantial equivalence?
Response:
If you have a tobacco product that is provided in a different quantity, but is otherwise
identical (i.e., the per weight composition, design features, heating source, and other
features of the product all remain the same) to either a tobacco product that was
13

The manner in which the materials (e.g., ingredients, additives, and biological organisms) are arranged

and integrated to produce a finished tobacco product.

14
As described in this section, the Product Quantity Change SE Report would be an alternative to

submitting a full SE report or a premarket application under section 910(b) of the FD&C Act.

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Contains Nonbinding Recommendations

commercially marketed as of February 15, 2007, or a product that has been found by
FDA to be substantially equivalent, you may submit an SE Report that contains a brief,
specific set of information (Product Quantity Change SE Report). This may occur where
the number of portioned parts per package has changed such that the new product would
hold, e.g., 24 cigarettes per pack instead of 20, or the weight of smokeless package would
change, e.g., from 24 grams to 5 grams. We believe the information included in the
Product Quantity Change SE Report should be sufficient for FDA to make its SE
determination in this situation. This Product Quantity Change SE Report should be easier
for industry to prepare and for FDA to review than would typically be the case for SE
reports involving other changes to a tobacco product and, therefore, FDA expects to
review these reports more quickly. More information related to the Product Quantity
Change SE Report is provided in the following questions and responses.
Question 10:
What information should a Product Quantity Change SE Report contain?
Response:
The following items should be included in your Product Quantity Change SE Report:
• A cover letter that prominently identifies the submission as “Product Quantity
Change SE Report.”
• Full identification of your new tobacco product:15
— manufacturer (We expect the manufacturer of the new product will generally
be the same as the manufacturer of the predicate product. If this is not the
case, FDA would need adequate assurances that the new product has the same
characteristics as the predicate product, and believes the certification below
would not suffice. In such a case, we strongly encourage the applicant to
contact FDA about possible ways to provide adequate assurances that the
characteristics remain the same.),
— unique name (i.e., brand name/subbrand or other commercial name used in
commercial distribution),
— product category (e.g., cigarette),
— product subcategory (e.g., conventional filtered), and
— package size/count (e.g., 7.8 oz. or 20 cigarettes per pack)
— if portioned, portion size (e.g., 0.5 gram bag of snus)
— package type (e.g., soft pack, box, plastic can with metal lid, bag).
• Full identification of a predicate tobacco product:16
— manufacturer,

15

The new tobacco product is the tobacco product that has a different product quantity, but the per weight
composition inside the package is unchanged.
16
The predicate tobacco product for a Product Quantity Change SE Report is a tobacco product
commercially marketed (other than for test marketing) as of February 15, 2007, or a tobacco product that
has been found substantially equivalent and that is otherwise identical (i.e., the per weight composition of
the product inside the package is unchanged) to the new tobacco product, except that the new tobacco
product is packaged in a different product quantity.

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Contains Nonbinding Recommendations

•

•
•
•
•

— unique name (i.e., brand name/subbrand or other commercial name used in
commercial distribution),
— product category (e.g., cigarette),
— product subcategory (e.g., conventional filtered), and
— package size/count (e.g., 7.8 oz. or 20 cigarettes per pack)
— if portioned, portion size (e.g., 0.5 gram bag of snus)
— package type (e.g., soft pack, box, plastic can with metal lid, bag).
Scientific data demonstrating that the change in product quantity is not likely to
alter consumer use behavior of the new product compared to the predicate product
o Some examples of scientific data include but are not limited to:
 Studies on purchasing frequency that demonstrate that the amount
of product used per day or per week is similar between the
predicate and new tobacco products. For example, if you double
the count of a portioned tobacco product (e.g., cigarette, pouched
snus) or the total amount of an unportioned tobacco product in a
single package (e.g., loose moist snuff) offered for purchase, the
amount of product per use and per week that users consume is
similar.
 Studies showing that young adults are not more likely to purchase
packages that are of lower total quantity compared to older adults.
 Studies showing that products of lower quantity are not more likely
to be purchased as impulse purchases.
 Peer-reviewed publications supporting that this specific change in
product quantity does not substantially alter consumer behavior.
 Biomarkers of exposure that reflect product use and demonstrate
that exposure is similar between use of the predicate and new
tobacco products.
Statement of whether you intend to commercially market both the predicate and
new tobacco products, or only the new tobacco product, if it is found SE.
Environmental Assessment (please also see the response to question 26).
Health Information Summary or a statement that the “information will be made
available upon request by any person” (section 910(a)(4) of the FD&C Act).
Statement of action taken to comply with the requirements under section 907 of
the FD&C Act that are applicable to the tobacco product (or a statement that
“requirements under section 907 of the FD&C Act are not applicable to the
tobacco product”).

• Certification statement that is signed by a responsible official who is authorized to
act on behalf of the company and that states the following:
I, [insert name of responsible official], on behalf of [insert name of company],
certify that [insert new tobacco product name] is packaged in a different quantity
from [insert name of predicate tobacco product] but is otherwise identical to
[insert name of predicate tobacco product]. I certify that [insert name of
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Contains Nonbinding Recommendations

company] understands this means there is no modification, except in product
quantity from the predicate tobacco product, including any change in per weight
composition, design features, heating source, or other features. I certify that this
information and the accompanying submission are true and correct, and that I am
authorized to submit this on the company’s behalf. I understand that under
section 1001 of title 18 of the United States Code, anyone who makes a materially
false, fictitious, or fraudulent statement to the Government of the United States is
subject to criminal penalties.
Question 11:
If I currently have an SE Report pending with FDA, may I use the Product Quantity
Change SE Report instead?
Response:
If your pending report is for a new tobacco product that has only a different product
quantity, but is otherwise identical to a predicate tobacco product, you may submit a
Product Quantity Change SE Report for the new product, or if this is to a provisional SE
Report, you may amend your pending report with all the information to support the
product quantity change.
Question 12:
Can I change the quantity of product sold in a package if the product is the subject of a
“provisional” 17 SE Report that is pending review at FDA?
Response:
Under section 905(j)(1)(A)(i) of the FD&C Act, SE reports may compare the new
product to only products that were commercially marketed as of February 15, 2007, or
products that FDA has previously determined to be substantially equivalent to a predicate
tobacco product. Products that are the subject of “provisional” SE Reports, while legally
sold or distributed, may not serve as predicate tobacco products under the FD&C Act
unless they have been previously found to be SE.
However, FDA does not intend to object to the commercial distribution of a new product
that has a different product quantity than, but is otherwise identical to, a product subject
to a “provisional” SE Report prior to FDA’s issuance of an order under section 910(a) of
the FD&C Act in the following situation:
• The manufacturer submits a Product Quantity Change SE Report as outlined in
the response to question 10 above. The Product Quantity Change SE Report
should identify the STN assigned by FDA for the original provisional SE Report,

17

A “provisional” SE Report is one that was submitted prior to March 23, 2011, for a new tobacco product
that was first commercially marketed between February 15, 2007, and March 22, 2011. New tobacco
products that are the subjects of provisional SE Reports may remain on the market unless FDA finds the
products not substantially equivalent (NSE) to a predicate product.

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Contains Nonbinding Recommendations

and provide information on the provisional product in lieu of the predicate
information described in the response to question 10; and
• The manufacturer does not commercially market the product until 90 days after
FDA’s receipt of the complete Product Quantity Change SE Report (as outlined in
the response to question 10 above); or for products with a changed product
quantity already on the market as of the date of issuance of this guidance, if the
manufacturer submits the complete Product Quantity Change SE Report to be
received by CTP within 30 calendar days of the date of the issuance of this
guidance (refer to the cover page of this guidance document for date of issuance).
FDA intends to issue its order on the product with the changed product quantity only
after it has completed its review of the original “provisional” SE report because, as stated,
products that are the subject of “provisional” SE reports may not serve as predicate
tobacco products under the FD&C Act unless they have been previously found SE.
Ultimately, if the product that is the subject of the original “provisional” SE Report is
found substantially equivalent to a predicate tobacco product, FDA intends to issue a
subsequent order for the product with the modification. If the product that is the subject
of the original “provisional” SE Report is found not substantially equivalent (NSE) to the
predicate tobacco product, then the compliance policy described above will no longer
apply. If the original “provisional” SE Report is found NSE, neither the product subject
to the original provisional report, nor the product with the modification, may be
introduced or delivered for introduction into interstate commerce for commercial
distribution; doing so would render the product adulterated and misbranded (sections
902(6)(A) and 903(a)(6) of the FD&C Act; 21 U.S.C. 387b(6)(A), 387c(a)(6)). We note
that all products on the market, including the products identified in this response, are
subject to enforcement at any time for violations of the FD&C Act.
Question 13:
What if I have a tobacco product that is legally sold in one quantity because it was
commercially marketed as of February 15, 2007, but I have changed the quantity of
product sold in a package (e.g., the number of portioned parts per package has changed
such that the new product would hold 24 cigarettes per pack instead of 20; the weight of
the product has changed such that the new smokeless package would change from 24
grams to 5 grams) and I am now commercially marketing that product with the product
quantity change?
Response:
The tobacco product with the product quantity change is a new tobacco product subject to
premarket requirements under section 910(a) of the FD&C Act. New tobacco products
may not be sold or distributed in interstate commerce without an order from FDA under
either section 910(c)(1)(A)(i) or section 910(a)(2)(A) of the FD&C Act. As outlined in
the responses to questions 9 and 10, you may submit a Product Quantity Change SE
Report, and FDA will determine whether the new tobacco product is substantially
equivalent.

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Contains Nonbinding Recommendations

However, FDA does not intend to object to the commercial distribution of a new product
that has a different product quantity than, but is otherwise identical to, a product that is
currently being sold or distributed in interstate commerce prior to FDA’s issuance of an
order under section 910(a) of the FD&C Act in the following situation:
• The manufacturer submits a complete Product Quantity Change SE Report as
outlined in the response to question 10 above, to be received by CTP within 30
calendar days of the date of issuance of this guidance (refer to the cover page of
this guidance document for the date of issuance).
If, after review of the Product Quantity Change SE Report, FDA finds that the new
product that is the subject of the Product Quantity Change SE Report is NSE to the
predicate tobacco product, then the compliance policy described above will no longer
apply.
Question 14:
If, in addition to changing the product quantity, a manufacturer makes another change to
the product, e.g., a name change or a change in design, can both changes be addressed
through a Product Quantity Change SE Report?
Response:
The Product Quantity Change SE Report is a streamlined report only intended to address
changes in quantity of product placed in a package. If you have made other changes to
your new product, you should submit a full SE report that addresses all of the changes,
not just the product quantity change.
Question 15:
If I change the product quantity in a portioned product (e.g., change from 0.5g to 1g
sachets of moist snuff or king-size to 100s cigarettes) can I use the Product Quantity
Change SE Report?
Response:
No. The Product Quantity Change SE Report is a streamlined report only intended to
address changes in quantity of product placed in a package. A change in portion is
independent from a change in product quantity. If portion size is changed, you should
submit a full SE report that addresses all of the changes, not just the product quantity
change.
C.

Additives/Specifications

Question 16:
Would a tobacco product be a “new tobacco product” subject to the substantial
equivalence provisions if the tobacco product was commercially marketed as of
February 15, 2007, but subsequently a new supplier was used for an ingredient,
additive, component, part, or material?

15

Contains Nonbinding Recommendations

Response:
It depends. If the tobacco product was commercially marketed in the United States on
February 15, 2007, and subsequently a new supplier is used for the same ingredient,
additive, component, part, or material with identical specifications, then this type of
change would not render the tobacco product a new tobacco product. For example, if a
tobacco product commercially marketed as of February 15, 2007, contained food-grade
sodium carbonate from one supplier and a subsequent product was identical in every
respect except that it contained food grade sodium carbonate in the same amount from a
second supplier, FDA would not consider the second product to be a new product;
therefore, submission of a marketing application such as an SE report would not be
required.
On the other hand, if a different supplier either uses a different ingredient, additive,
component, part, or material, then the product is a new tobacco product and the
manufacturer must follow a regulatory pathway to market for the new product (i.e., a
premarket tobacco application under 910(b), an SE Report under 905(j), or a request for
an exemption from the substantial equivalence requirements under 21 CFR 1107.1). For
example, the premarket requirements of sections 905(j) and 910(a) would apply if an
alternate cigarette paper supplier provided paper that is more porous than the paper used
in the product that was commercially marketed as of February 15, 2007. In that case, if
a manufacturer chooses to submit an SE report, it should be the full report listing all
characteristics of the new and predicate tobacco products.
Question 17:
Would a tobacco product be a “new tobacco product” and subject to the substantial
equivalence provisions if a tobacco blending change is made to address variation in
tobacco growing conditions?
Response:
At this time, FDA does not intend to enforce the requirements of sections 910 and 905(j)
for tobacco blending changes required to address the natural variation of tobacco (e.g.,
blending changes due to variation in growing conditions) in order to maintain a consistent
product. However, blending changes that are intended to alter the chemical or perception
properties of the new product (e.g., nicotine level, pH, smoothness, harshness, etc.)
compared to the predicate product, should be reported under 910 or 905(j). If you have
any questions regarding a specific tobacco blending change please contact us. 18
Question 18:
Would a tobacco product be a “new tobacco product,” and subject to the substantial
equivalence provisions if the tobacco product was commercially marketed as of February
15, 2007, but subsequently a specification for an additive was tightened (i.e., narrowed)
within the range of the original specification or the specification for an additive was
changed (for example, from .003 to .005)?
18

For additional information on meetings, please refer to the CTP Meetings Guidance.

16

Contains Nonbinding Recommendations

Response:
Any modification made to the level of an additive in a product after February 15, 2007,
renders the product a new tobacco product subject to one of the regulatory pathways to
market (i.e., a premarket tobacco application under section 910(b), an SE Report under
section 905(j), or a request for an exemption from the substantial equivalence
requirements under 21 CFR 1107.1). Changes in controls on production (such as
improved quality control) that would not affect the actual level of an additive in a product
would not make that product a “new tobacco product” under the FD&C Act.
Question 19:
Would a cigarette be a “new tobacco product,” and subject to the substantial equivalence
provisions, if the cigarette was commercially marketed as of February 15, 2007, but
subsequently the paper was changed to fire standard compliant (FSC) paper?
Response:
Yes. A modification made to the cigarette paper to change it to FSC paper after February
15, 2007, renders the product a new tobacco product and subject to one of the regulatory
pathways to market (such as a premarket tobacco application under section 910(b) or an
SE Report under section 905(j)). This is because the change to FSC paper leads to a
difference in design parameters, ingredients, and/or materials, and is therefore a
modification as defined under section 910(a)(1)(B) of the FD&C Act. If a manufacturer
chooses to submit an SE report, it should be the full report listing all characteristics of the
new and predicate tobacco products.
Question 20:
Would a tobacco product be a “new tobacco product” and subject to the substantial
equivalence provisions if the tobacco product was commercially marketed as of February
15, 2007, but subsequently a supplier of a component (e.g., the filter) began using a new
processing aid (e.g., an antimicrobial agent) for a subcomponent (e.g., paper used for the
filter’s plug wrap) and the change is so minor that it is not even capable of being
quantified in the finished product?
Response:
Yes. Any change in a tobacco product’s composition fits the definition of a modification
under section 910(a)(1)(B) of the FD&C Act and renders the product a new tobacco
product. The new tobacco product would be subject to one of the regulatory pathways to
market (e.g., a premarket tobacco application under section 910(b), an SE Report under
section 905(j), or a request for an exemption from the substantial equivalence
requirements under 21 CFR 1107.1).

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Contains Nonbinding Recommendations

D.

General Questions About Section 905(j)/SE Reports

Question 21:
May companies contact the Agency to determine if certain modifications convert an
existing product into a "new tobacco product" and require a substantial equivalence
filing?
Response:
Yes. If you have questions regarding whether a particular change would require
submission of an SE report, please contact CTP to request a meeting. 19
Question 22:
If a company currently commercially markets the exact same tobacco product (e.g.,
identical composition, specifications, design features) under multiple product names, can
the company make one substantial equivalence submission covering all of the products,
where it: (a) includes only one list of ingredients, specifications, design features, etc.; (b)
identifies all of the products that list covers; and then (c) compares that one list to a list
for a predicate product?
Response:
Yes. To avoid submitting identical section 905(j) SE Reports, manufacturers may submit
one SE Report for all products that differ only by names. However, because FDA will
have to unbundle the report administratively to create separate reports for each distinct
product, the manufacturer should structure the SE Report in a way that accurately
compares each new tobacco product to a predicate product. The cover letter should
identify all products covered in the submission, both the new tobacco products and the
predicate tobacco product to which they are being compared (see, e.g., section “V.A
Content/Data to Submit, Cover Letter” of the Demonstrating SE Guidance). The
manufacturer may also consider the applicability of the recommendations of this FAQs
guidance in section II.A on Same Characteristics SE Reports.
Question 23:
How do I know whether a characteristic should be reported as a material or ingredient?

19

For additional information on meetings, please refer to the CTP guidance, “Meetings with Industry and
Investigators on the Research and Development of Tobacco Products” (CTP Meetings Guidance) available
on the Internet at
http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM30528
2.pdf.

18

Contains Nonbinding Recommendations

Response:
The statute defines “substantial equivalence” in terms of characteristics (section
910(a)(3)(A) of the FD&C Act). The statute also defines “characteristics” as the
materials, ingredients, design, composition, heating source, or other features of a tobacco
product (section 910(a)(3)(B) of the FD&C Act). However, the statute does not further
define each of the terms used in the definition of “characteristics.” The Demonstrating SE
Guidance provides recommendations related to characteristics
(http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInfor
mation/UCM239021.pdf). In general, in preparing your SE Report, it is important that
your comparison to a predicate include all characteristics. FDA recognizes that you may
be uncertain of the category (e.g., material or ingredient) in which a particular
characteristic best fits. For purposes of comparison, it is important that characteristics be
reported in the same category for both the new tobacco product and the predicate. FDA
will review your submission as a whole and consider the totality of the data presented
when making FDA’s determination of substantial equivalence. You may also consider
requesting a meeting with CTP.
Question 24:
Glue is not listed as an example of a component, part, or accessory of a tobacco product
in the Demonstrating SE Guidance. Is glue considered a component, part or accessory
such that a change in the glue might render a product a new tobacco product subject to
the substantial equivalence provisions?
Response:
It depends. For purposes of substantial equivalence, the characteristics of the new
tobacco product should be compared to the characteristics of a predicate. Characteristics
means the materials, ingredients, design, composition, heating source, or other features of
the tobacco product. If the glue is modified in a tobacco product after February 15, 2007,
the product is a new tobacco product and is subject to one of the pathways for legal
commercial marketing in the United States (e.g., a premarket tobacco application under
section 910(b) or SE Report under section 905(j)). As discussed in more detail in the
Demonstrating SE Guidance, for unfinished products (including products where glue is a
component, part or accessory), FDA intends to limit its enforcement of the requirements
of sections 910 and 905(j) of the FD&C Act to the finished, regulated products. To avoid
the submission of duplicative information, FDA does not at this time intend to enforce
the requirements of 910 and 905(j) for components, parts or accessories of regulated
tobacco products that are sold or distributed solely for further manufacturing into finished
tobacco products. We anticipate receiving all relevant information regarding such new
tobacco products in the 905(j) reports of the finished regulated tobacco products. It is
therefore the finished product manufacturer’s responsibility to ensure it has accurate
information regarding the components, parts and accessories included in its product. The
manufacturer must obtain appropriate market authorization for any changes to a tobacco
product, including modifications to components, parts, or accessories.

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Contains Nonbinding Recommendations

Question 25:
How should harmful and potentially harmful constituents (HPHCs) be reported in my SE
Report?
Response:
It is an applicant’s responsibility to provide appropriate scientific evidence and data if
FDA is to make a finding that the predicate and new products are substantially
equivalent. Reporting quantities of HPHCs in predicate and new products is a useful
mechanism for manufacturers to demonstrate that the differences in characteristics
between the predicate and new products do not cause the new products to raise different
questions of public health within the meaning of 910(a)(3)(A)(ii) of the FD&C Act.
When providing HPHCs in an SE Report, they should be appropriate for the type of
tobacco product (e.g., cigarette, smokeless, etc.) and predicate product used for
comparison. For example, when submitting an SE Report for a change to FSC paper in a
cigarette after February 15, 2007, many manufacturers have provided information for
TNCO (tar, nicotine, and carbon monoxide) as this type of modification may change
TNCO. However, for this FSC example you may not need to include information about
aflatoxin B1 in your SE Report as it is not expected to change due to this modification.
If you have additional questions regarding reporting of HPHCs in your SE Report and
would like to discuss your questions with the Agency, please contact CTP to request a
meeting. 20
Question 26:
Do I need to submit an environmental assessment as part of my section 905(j) SE Report?
Response:
Yes. FDA’s regulations implementing the National Environmental Policy Act (NEPA) of
1969 require that “[a]ll applications or petitions requesting agency action require the
submission of an [environmental assessment] or a claim of categorical exclusion” (21
CFR 25.15(a)). Currently, there are no categorical exclusions in place for tobacco
products;21 therefore, manufacturers submitting applications or reports for any of the
three regulatory pathways to commercially market a new tobacco product (including
reports under section 905(j)) must include environmental assessments as part of their
submissions. You should refer to 21 CFR part 25 for additional information. If you have
questions regarding what you should include in your environmental assessment, and
would like to discuss your questions with the Agency, please contact CTP to request a
meeting. 22

20

For additional information on meetings, please refer to the CTP Meetings Guidance.

On January 23, 2014, FDA issued a proposed rule that, if finalized, would provide categorical exclusions

for certain actions, including actions related to substantial equivalence (SE) reports (79 Federal Register

3742).

22
Please refer to the CTP Meetings Guidance.

21

20