Draft Guidance on Product
Name Placement, Size, and
Prominence in Advertising and
Promotional Labeling
Cynthia Ng
Regulatory Counsel
Office of Prescription Drug Promotion
Food and Drug Administration
1
Guidance Issued November 2013
• Addressed questions received after the
January 2012 guidance
• Disclosure of the product name in
promotional labeling and advertising is
important for proper identification and to
ensure safe and effective use of products.
2
Topics Covered
• Juxtaposition of Proprietary and Established
Names
• Size of Proprietary and Established Names
• Prominence of Proprietary and Established
Names
• Frequency of Disclosure of Proprietary and
Established Names
3
Juxtaposition of Proprietary and
Established Names
• FDA recommends that the established
name be placed either directly to the right
of, or directly below, the proprietary name.
– PROPRIETARY NAME® (established name)
– ♠ PROPRIETARY NAME™ (established name)
– PROPRIETARY NAME® CII
(established name)
4
Juxtaposition of Proprietary and
Established Names
• FDA recommends that the proprietary name
and established name not be separated by
intervening matter.
• 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
5
Size of Proprietary and
Established Names
• When established name is required to
accompany the proprietary name in the
running text, they should be the same type
size.
• Outside the running text (e.g. headline), or
within the running text in larger sized type
– the established name is required to be printed in
letters that are at least half as large as the letters of
the proprietary name
6
Prominence of Proprietary
and Established Names
When required, the established name should
have commensurate prominence as the
proprietary name
– FDA considers all methods of emphasis
• including typography, layout, contrast, and other
printing factors
– E.g. if proprietary name is printed in bold black text
against a white background, FDA recommends that
the established name be presented with
commensurate emphasis and contrast.
7
Frequency of Disclosure of
Proprietary and Established Names
(Traditional Print Media)
• When the proprietary name is featured (e.g.
headlines, taglines, logos, graphs or pictures),
– FDA does not intend to object if the established name
accompanies the proprietary name at least once per
page or spread where the proprietary name most
prominently appears
8
Frequency of Disclosure of
Proprietary and Established Names
(Traditional Print Media)
• Proprietary name is only in the running text
– The established name is required to accompany the
proprietary name at least once in the running text
– If more than one page or spread, then at least once
per page or spread
• Columns
– FDA does not intend to object if the established name
accompanies the proprietary name at least once per
page or spread
9
Frequency of Disclosure of
Proprietary and Established Names
(AudioVisual/Broadcast)
• FDA does not intend to object if the established
name is in direct conjunction with the most
prominent display of the proprietary name
– For superimposed text equivalent to a headline or
tagline (not required for text along bottom of screen)
– Established name should be displayed for the same
amount of time as the proprietary name
• Established name does not need to be included
in the audio portion
10
Frequency of Disclosure of
Proprietary and Established Names
(Electronic and Computer-Based)
• FDA does not intend to object if the established
name accompanies the proprietary name at
least once per Web page or screen where the
proprietary name most prominently appears.
• If 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.
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