Blog Post #4: Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling

Rosalyn Finlayson

November 20, 2010

Name of Guidance:

Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling

Status of Guidance

Draft Guidance

Date of Guidance

January 1999

Link to the Guidance

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070076.pdf

Target audience

Industry, governing agencies and drug manufacturers

Laws An Regulations Referenced

21 CFR 201.10(g) and (h), 202.1(b): addresses products containing two or more active ingredients.

21 CFR 201.10 (c)): addresses the placement of one active ingredient in relation to the prominence of the proprietary and established names for human and animal prescription drug products

21 CFR 610.62: specifies that regulations for biological products apply only to the container and package labels.

Summary

This guidance is intended to clarify the requirements for product name placement on human and animal prescription drugs. Outlined are the specific requirements for the text size and prominence of the proprietary name and the established trade name on prescription products. The regulations and recommendations address products with one active ingredient as well as products with two or more active ingredients.

Rationale

The recommendations in this guidance were developed to help ensure the safe and effective use of prescription drugs and to assist the following agencies that deal with violations and inquiries about the placement, size, and prominence of the proprietary name and established trade name in promotional materials: The Division of Drug Marketing, Advertising, and Communications (DDMAC), Center for Drug Evaluation and Research (CDER), the Division of Epidemiology and Surveillance (DES), Center for Veterinary Medicine (CVM), and the Advertising and Promotional Labeling Staff (APLS), Center for Biologics Evaluation and Research (CBER). The violations and inquiries frequently addressed by these agencies are the visual contrasting effect of the proprietary and established trade names in relation to certain graphic presentations and problems that stem from the vague presentation of or minimizing disclosure of the established trade name.

Resulting Recommendations

The following recommendations are suggested for products containing one active ingredient:

The Placement of the Proprietary Name and the Established Trade Name

• The text for the proprietary name or established trade name will not be separated by a logo, trademark or other graphic designs.
• The text for the established trade name will be placed to the right of or directly under the proprietary name.
• There are to be no items pertaining to the graphic matter (text, logo or visual graphic) that de-emphasize the product name or interfere in a way that would cause the proprietary name or established trade name to become unclear or unintelligible to the consumer.

Print Size of Proprietary and Established Trade Names

• The proprietary name and established trade names are to be presented in the same size type within the running text of advertisements and promotional labeling,
• The established trade name is be printed in letters that are at least half as large as the letters used for the proprietary name when the proprietary name is used in headlines or has a type size larger than the established trade name in the running text of the promotional materials.
• The print size requirement refers to the actual size of the letters not the point size.
• The print size is independent of whether or not the established trade name is printed in upper or lower-case letters.

Prominence of Proprietary and Established Trade Names in Printed Materials

• The established trade name will have a position equal to that of the proprietary name in terms of the typography, layout, and contrast.

Proprietary and Established Trade Names in Audio-Visual and Broadcast Advertisements and Promotional Labeling

• Audio-visual and broadcast advertisements, and promotional labeling are to utilize the same requirements for printed materials in regards to printing features such as typography, layout, and contrast.
• During audio-visual promotional labeling and broadcast advertisements, the established trade name is to be displayed at the same time as the proprietary name. The size and prominence of the text will follow all of the requirements listed under Print Size of Proprietary and Established Trade Names.
• The established trade name and the proprietary name are to have the same amount of exposure time within the broadcast.

Proprietary and Established Trade Names in the Running Text of Electronic and Computer-based Advertisements and Promotional Labeling

Although electronic and computer based media do not contain text pages in the same manner as print media, sponsors can meet the requirements by using one of the following approaches:

• Present the established trade name along with the proprietary name each time the proprietary name is used in the running text of the promotional materials.
• Present the established trade name along with the proprietary name once in each paragraph of the promotional materials.
• Present the established trade name along with the proprietary name in regular intervals such as every fifth paragraph throughout the running text of promotional materials.
• Present the established trade name along with the proprietary name at the beginning, middle or end of the running text of promotional materials.
• Present the established trade name at least once along side the proprietary name and in type size that is at least half as large as the type used for the most noticeable position of the proprietary name when the proprietary name in the running text has a larger type size than the established trade name.

Two or more active ingredients

Products with two or more active ingredients may not have an established trade name equivalent to the proprietary name. In such instances the quantitative ingredient information is to be placed directly with the most prominent display of the proprietary name. The text of the ingredient information is to have a reasonable relationship to the prominence of the proprietary name in terms of text size, layout and contrast.

Impact

The implementation of the regulations of this guidance will assist the industry in the proper identification of and disclosure of established names and ingredients in the promotional labeling and advertising for all prescription human and animal drug and biological products. The effective disclosure of all product names and ingredients with help ensure safe and effective use of the product in consumer health.