GFI CDER PNP in Promotional Labeling

Product Name
Placement, Size, and
Prominence in
Promotional Labeling
and Advertisements
Guidance for Industry

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Veterinary Medicine (CVM)
November 2017
Advertising
OMB Control Number [xxxx-xxxx]
Expiration Date: [xx/xx/xxxx]
The information collection provisions in this guidance regarding third-party disclosure are
under OMB review and are not for current implementation.
See additional PRA statement in section IV of this guidance.

Product Name Placement,
Size, and Prominence in
Promotional Labeling and
Advertisements
Guidance for Industry
Additional copies are available from:
Office of Communications, Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor
Silver Spring, MD 20993-0002
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353
Email: [email protected]
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

and/or
Office of Communication, Outreach, and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave, Bldg. 71, Room 3128
Silver Spring, MD 20993-0002
Phone: 800-835-4709 or 240-402-8010
Email: [email protected]
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm
and/or
Policy and Regulations Staff, HFV-6
Center for Veterinary Medicine
Food and Drug Administration
7519 Standish Place, Rockville, MD 20855
http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Veterinary Medicine (CVM)
November 2017
Advertising

Contains Nonbinding Recommendations
TABLE OF CONTENTS
I. 

INTRODUCTION ............................................................................................................................................ 11 

II. 

PRODUCTS WITH ONE ACTIVE INGREDIENT ....................................................................................... 2 

A.  JUXTAPOSITION OF PROPRIETARY AND ESTABLISHED NAMES ......................................................................... 2 
B.  SIZE OF PROPRIETARY AND ESTABLISHED NAMES ......................................................................................... 33 
C.  PROMINENCE OF PROPRIETARY AND ESTABLISHED NAMES ........................................................................... 44 
D.  FREQUENCY OF DISCLOSURE OF PROPRIETARY AND ESTABLISHED NAMES ................................................... 44 
1.  Traditional Print Promotional Labeling and Advertisements .................................................................. 44 
2.  Audiovisual Promotional Labeling and Broadcast Advertisements ......................................................... 55 
3.  Electronic and Computer-Based Promotion............................................................................................. 66 
III. 

PRODUCTS WITH TWO OR MORE ACTIVE INGREDIENTS ........................................................ 66 

IV. 

PAPERWORK REDUCTION ACT OF 1995 .......................................................................................... 77 

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Product Name Placement, Size, and Prominence in Promotional
Labeling and Advertisements
Guidance for Industry1
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 office responsible for this guidance as listed on the
title page.

I.

INTRODUCTION

This guidance clarifies the requirements for product name placement, size, prominence, and
frequency2 in promotional labeling and advertisements for prescription drugs.3 The disclosure of
the product name in promotional labeling and advertisements is important for proper
identification and to ensure safe and effective use. This guidance also articulates the
circumstances under which FDA intends to refrain from taking enforcement action regarding
these requirements. We believe that following this guidance will allow for appropriate
advertising and promotion without presenting any public health risk to patients.
The Office of Prescription Drug Promotion in the Center for Drug Evaluation and Research; the
Office of Surveillance and Compliance in the Center for Veterinary Medicine; and the
Advertising and Promotional Labeling Branch in the Center for Biologics Evaluation and
Research frequently receive inquiries about the placement, size, prominence, and frequency of
the proprietary name4 and established name5 in promotional materials (promotional labeling and
1

This guidance has been prepared by the Office of Prescription Drug Promotion in the Center for Drug Evaluation
and Research in coordination with the Center for Biologics Evaluation and Research and the Center for Veterinary
Medicine at the Food and Drug Administration.
2

See 21 CFR 201.10(g) and (h) and 202.1(b), (c), and (d).

3
For the purposes of this guidance, the term prescription drug means human prescription drugs, including
prescription biological products, and animal prescription drugs. With respect to biological products, the
recommendations in this guidance apply to biological products that are approved for marketing under section 351 of
the Public Health Service Act (PHS Act) and that are also regulated under the drug provisions of the Federal Food,
Drug, and Cosmetic Act (FD&C Act). For such products, the provisions of the FD&C Act applicable to drugs also
apply, as well as the regulations implementing these provisions, except that a biological product licensed under
section 351 of the PHS Act is not required to have an approved new drug application under section 505 of the
FD&C Act (21 U.S.C. 355). See section 351(j) of the PHS Act (42 U.S.C. 262(j)). This guidance does not apply to
over-the-counter drugs.
4

In this guidance, the term proprietary name refers to the trademark or brand name of a drug or biological product.
The proprietary name is the exclusive name of a drug or biological product owned by a company under trademark
law regardless of registration status with the United States. Patent and Trademark Office. The proprietary name for
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advertisements). Generally, the inquiries address two topics: (1) the juxtaposition of the
proprietary and established names in relation to certain graphic presentations and (2) problems
that stem from obscuring the presentation of or minimizing disclosure of the established name.
The placement, size, prominence, and frequency of the proprietary and established names for
prescription drugs are specified in labeling and advertising regulations (21 CFR 201.10(g) and
(h) and 202.1(b), (c) and (d)). These regulations are applicable to prescription drugs that contain
one or more active ingredient(s).
The recommendations in this guidance pertain to product names in traditional print media
promotional labeling and advertisements (e.g., journal ads, detail aids, brochures), audiovisual
promotional labeling (e.g., videos shown in a health care provider’s office), broadcast
advertisements (e.g., television advertisements, radio advertisements), and electronic and
computer-based promotions (e.g., internet, social media, emails, CD-ROMs, DVDs). In this
guidance, FDA further clarifies issues relating to the direct conjunction of the proprietary and
established names, as well as the frequency of use of the established name on printed pages or
spreads, in running text or columns, in the audio portion of audiovisual promotions, and in
electronic media.
In general, FDA’s guidance documents 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.

PRODUCTS WITH ONE ACTIVE INGREDIENT
A.

Juxtaposition of Proprietary and Established Names

For products with one active ingredient, the regulations describe when and how the established
name must accompany the proprietary name in labeling and advertisements. The regulations in
21 CFR 201.10(g)(1) and 202.1(b)(1) state that:
Where the established name is required to accompany or to be used in association with
the proprietary name or designation, the established name shall be placed in direct
conjunction with the proprietary name or designation, and the relationship between the
prescription drug and biological products is proposed by the applicant and undergoes review and final approval by
FDA.
5

In this guidance, the term established name refers to both the established name of a drug product and to the proper
name of a biological product. The established name with respect to a drug product or ingredient thereof is the
applicable official name designated pursuant to section 508 of the FD&C Act; or if there is no such official name,
and such drug, or such ingredient, is an article recognized in an official compendium (such as the United States
Pharmacopeia), then the official title thereof in such compendium; or if neither applies, the drug product’s or
ingredient’s common or usual name (see 21 U.S.C. 352(e)(3)). The proper name of a biological product is the name
designated in the license for use upon each package of the product (21 CFR 600.3(k)).
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Contains Nonbinding Recommendations
proprietary name or designation and the established name shall be made clear by use of a
phrase such as “brand of” preceding the established name, by brackets surrounding the
established name, or by other suitable means. (Emphasis added)

FDA recommends that the established name be placed either directly to the right of or directly
below the proprietary name. FDA also recommends that the proprietary name and the
established name not be separated by placement of intervening matter that would in any way
detract from, obfuscate, or de-emphasize the established name of the product or obscure the
relationship between the proprietary name and the established name. For example, FDA
recommends that the proprietary and established names not be separated by intervening matter,
such as a logo, tagline, or other graphics. Note: FDA does not consider trademark symbols
associated with proprietary names (e.g., registered trademark symbols (®) or unregistered
trademark symbols (™)) or controlled substance symbols (e.g., CII) to be intervening matter.
Examples of appropriate juxtaposition include, but are not limited to, the following:
PROPRIETARY NAME® (established name)

♠6 PROPRIETARY NAME™ (established name)
PROPRIETARY NAME® CII
(established name)
B.

Size of Proprietary and Established Names

When the established name is required to accompany the proprietary name in the running text of
promotional labeling and advertisements, the regulations also require, in general, that the
proprietary and established names be presented in the same type size (21 CFR 201.10(g)(1) and
202.1(b)(1)). FDA interprets the running text to mean the body of text in a promotional piece, as
distinct from headlines, taglines, logos, graphs, or pictures.
When the proprietary name is presented within the running text in larger-sized type than that of
the surrounding running text, the established name is required to be printed at least once in letters
that are at least half as large as the letters of the most prominent presentation of the proprietary
name in such running text (21 CFR 201.10(g)(1) and (2) and 202.1(b)(1) and (2)). In addition,
when the proprietary name is presented outside the running text, such as in a headline, the
established name is also required to be printed in letters that are at least half as large as the letters
of the proprietary name within that designated section (e.g., headline) (21 CFR 201.10(g)(1) and
(2) and 202.1(b)(1) and (2)).
Please note that FDA interprets this type-size requirement to relate to actual size, not point size,
of uppercase and lowercase letters in the proprietary and established names. For example, in
situations when the established name is required to be printed in letters at least half as large as
the letters of the proprietary name, FDA recommends that the smallest letter of the established
6

The “♠”symbol represents a logo or graphic representation.
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name (upper- or lowercase letters) be printed in letters at least one half the actual size of the
largest letter of the proprietary name (upper- or lowercase letters).
C.

Prominence of Proprietary and Established Names

The regulations require that “the established name shall have a prominence commensurate with
the prominence with which such proprietary name or designation appears, taking into account all
pertinent factors, including typography, layout, contrast, and other printing features” (21 CFR
201.10(g)(2) and 202.1(b)(2)). Generally, FDA considers all methods used to achieve
prominence in promotional labeling or advertisements when evaluating whether the established
name is presented with a prominence commensurate with that of the proprietary name.
The following hypothetical examples7 of established name presentations do not have
commensurate prominence with the proprietary names, considering factors such as contrast, type
size, and spacing:

D.

Frequency of Disclosure of Proprietary and Established Names

The regulations in 21 CFR 201.10(g)(1) and 202.1(b)(1) state that:
If an advertisement for [or the label or labeling of] a prescription drug bears a proprietary
name or designation for the drug or any ingredient thereof, the established name, if such
there be, corresponding to such proprietary name or designation shall accompany such
proprietary name or designation each time it is featured in the advertisement [or on the
label or in the labeling] for the drug . . . . On any page of an advertisement [or any label
or page of labeling] in which the proprietary name or designation is not featured but is
used in the running text, the established name shall be used at least once in the running
text in association with such proprietary name or designation . . . . If any advertisement
[or any labeling] includes a column with running text containing detailed information as
to composition, prescribing, side effects, or contraindications and the proprietary name or
designation is used in such column but is not featured above or below the column, the
established name shall be used at least once in such column of running text in association
with such proprietary name or designation . . . . (Emphasis added)

1.

Traditional Print Promotional Labeling and Advertisements

For traditional print promotional labeling and advertisements, the established name is required to
accompany the proprietary name when the proprietary name is featured (e.g., headlines, taglines,
logos, graphs, or pictures). Although the regulations state that the established name “shall
7

The examples involve fictitious products and are not an endorsement of the fictitious product names.

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Contains Nonbinding Recommendations
accompany such proprietary name . . . each time it is featured,” FDA does not intend to object to
fewer appearances of the established name, provided that the established name accompanies the
proprietary name at least once per page or spread8 where the proprietary name most prominently
appears. For example, if the established name follows the proprietary name in a headline, FDA
does not intend to object if the established name does not also follow the proprietary name in
sub-headlines, appear in the running text on the same page or spread, or appear in columns on
the same page or spread.
If the proprietary name is not featured but is only part of the running text, the established name is
required to accompany the proprietary name at least once in the running text. If the running text
spans more than one page or spread, FDA recommends that the established name accompany the
proprietary name at least once per page or spread.
The regulations in 21 CFR 201.10(g)(1) and 202.1(b)(1) include information regarding the
frequency of the proprietary and established names if columns are used in a promotional labeling
piece or advertisement (e.g., a newspaper advertisement). FDA interprets a column to mean one
of two or more vertical sections of a printed page, separated by a rule or blank space. If the
proprietary name appears in more than one column of running text (but does not appear outside
of the text, above or below the column), FDA does not intend to object, provided that the
established name accompanies the proprietary name at least once per page or spread.
2.

Audiovisual Promotional Labeling and Broadcast Advertisements

Audiovisual promotional labeling (e.g., videos shown in a health care provider’s office) and
audiovisual broadcast advertisements (e.g., television ads) do not contain text pages like print
media. However, promotional labeling and advertisements in such media often contain
superimposed text or “supers.” For superimposed text that is equivalent to a headline or tagline,
FDA does not intend to object to fewer appearances of the established name if the established
name is placed in direct conjunction with the most prominent display of the proprietary name in
the audiovisual promotional labeling or broadcast advertisement.9 When the established name
accompanies the proprietary name, FDA recommends that the established name be displayed on
the screen for the same amount of time as the proprietary name. For superimposed text that
typically appears along the bottom of the screen, the established name does not have to be
included with the proprietary name. FDA does not intend to object if the established name is not
included in the audio portion of audiovisual promotional labeling or in an audiovisual broadcast
advertisement.
For radio and telephone advertisements, FDA does not intend to object if the established name is
disclosed in direct conjunction with the most prominent presentation of the proprietary name.
Under most circumstances, this is the first occurrence in the broadcast.
8

In this guidance, the term spread refers to adjacent pages of promotional material with related matter or connecting
elements extending across the fold.

9

When determining the most prominent display of the proprietary name, consideration should be given to all
pertinent factors, including typography, layout, contrast, and other printing features, such as type size. The most
prominent display of the proprietary name is generally the largest display in audiovisual promotional labeling and
broadcast advertisements.
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3.

Electronic and Computer-Based Promotion

Promotion in electronic and computer-based media also does not contain text pages like print
media. However, promotion in such media often contains information or running text equivalent
to many pages of traditional printed text. FDA does not intend to object to fewer appearances of
the established name, provided that the established name accompanies the proprietary name at
least once per web page where the proprietary name most prominently appears on the web
page.10 However, if the proprietary name is not featured but is part of the running text, the
established name is required to accompany the proprietary name at least once in the running text
(21 CFR 201.10(g)(1) and 202.1(b)(1)). Columns of running text should be treated similarly to
columns on the printed page.
III.

PRODUCTS WITH TWO OR MORE ACTIVE INGREDIENTS

A product with two or more active ingredients might not have a single established name
corresponding to the proprietary name. In such instances, the regulations in 21 CFR
201.10(h)(1) and 202.1(c) state that:
[T]he quantitative ingredient information required on the label by section 502(e) of the
act [or in the advertisement by section 502(n) of the act] shall be placed in direct
conjunction with the most prominent display of the proprietary name or designation.
The prominence of the quantitative ingredient information shall bear a reasonable
relationship to the prominence of the proprietary name. (Emphasis added)

Similarly, a proprietary name might refer to a combination of active ingredients present in more
than one preparation (e.g., individual preparations differing from each other as to quantities of
active ingredients and/or the form of the finished preparation), and there might not be an
established name corresponding to the proprietary name. In such instances, the advertising
regulations in 21 CFR 202.1(d)(1) provide that:
[A] listing showing the established names of the active ingredients shall be placed in
direct conjunction with the most prominent display of such proprietary name or
designation. The prominence of this listing of active ingredients shall bear a reasonable
relationship to the prominence of the proprietary name and the relationship between such
proprietary name or designation, and the listing of active ingredients shall be made clear
by use of such phrase as “brand of”, preceding the listing of active ingredients. (Emphasis
added)
In both of these situations, FDA recommends that the active ingredients be placed either directly
to the right of or directly below the proprietary name. FDA also recommends that the
proprietary name and the required information regarding the active ingredients not be separated
10

When determining the most prominent display of the proprietary name, consideration should be given to the
placement of the proprietary name and how the web page is displayed when viewed on different devices (e.g.,
desktop computer monitors, mobile devices, tablets). The most prominent display of the proprietary name is
generally near the top of the relevant web page when viewed on most electronic devices.
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by placement of intervening matter that would in any way detract from, obfuscate, or deemphasize the active ingredients of the product or obscure the relationship between the
proprietary name and the active ingredients. For example, FDA recommends that the proprietary
name and the required information regarding the active ingredients not be separated by
intervening matter, such as a logo, tagline, or other graphics. As noted in section II.A of this
guidance, FDA does not consider trademark symbols associated with proprietary names (e.g.,
registered trademark symbols (®) or unregistered trademark symbols (™)) or controlled
substance symbols (e.g., CII) to be intervening matter.
Examples of appropriate juxtaposition include, but are not limited to, the following:
PROPRIETARY NAME® (active ingredient 1 and active ingredient 2)

♠ PROPRIETARY NAME™ (active ingredient 1 and active ingredient 2)
PROPRIETARY NAME® CII
active ingredient 1/active ingredient 2
The regulations described in this section also require that the presentation of the active
ingredients “bear a reasonable relationship to the prominence of the proprietary name” (21 CFR
201.10(h)(1) and 202.1(c)). Thus, FDA recommends that the active ingredients be presented
with a prominence commensurate with the prominence of the presentation of the proprietary
name. For example, if the proprietary name is printed in bold, black text against a white
background, FDA recommends that the active ingredients be presented with commensurate
emphasis and contrast.
IV.

PAPERWORK REDUCTION ACT OF 1995

This guidance contains information collection provisions that are subject to review by the Office
of Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). The time required to complete this information collection is estimated to
average 3 hours per disclosure. Send comments regarding this burden estimate or suggestions
for reducing this burden to:
Office of Prescription Drug Promotion, Center for Drug Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Avenue, Bldg. 51, Silver Spring, MD
20993-0002
This guidance also refers to previously approved collections of information found in FDA
regulations. The collections of information in 21 CFR 202.1 have been approved under OMB
control number 0910-0686.
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 information
collection provisions in this guidance have been submitted to OMB for review as required by
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section 3507(d) of the Paperwork Reduction Act of 1995 and are not for current
implementation. Before implementing the information collection provisions contained in this
guidance, we will publish a notice in the Federal Register announcing OMB's decision to
approve, modify, or disapprove those information collection provisions.

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