Regulatory Focus™ > News Articles > FDA Provides New Guidance for Promotional Labeling and Advertising

FDA Provides New Guidance for Promotional Labeling and Advertising

Posted 25 January 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) released a new guidance for industry on 24 January on the placement, size and prominence of a product name in promotional labeling and advertising.

The final guidance, Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling, "is intended to clarify the requirements" for prescription medicinal products for both humans and animals.

FDA notes that the proper use of a product's name is important in ensuring its "proper identification and ensuring [the product's] safe and effective use."

FDA further notes that it frequently receives inquiries from industry regarding the juxtaposition of the proprietary and established names in relation to advertising or promotional materials and the problems that arise when the established name is obscured or minimally disclosed.

For products with one active ingredient, FDA takes the advertising regulations to mean that the established substance name should be placed "either directly to the right of, or directly below, the proprietary name." Additionally, FDA recommends that the link between the proprietary name and established name not be obscured, detracted from, obfuscated or de-emphasized through the use of logos, taglines or other graphics. Copyright, trademark or controlled substance symbols are acceptable to use, however.

FDA also requires that the size of the established name be at least half the size of the proprietary name when it is placed in the headline or otherwise outside of the "running text" (any text distinct from headlines, taglines, logos, footnotes, graphs or pictures), and that this text size reflect the actual size of the text. Upper-case letters are thus looked at differently than lower-case letters in the same point font.

FDA recommends that the names receive the same level of prominence and emphasis relative to one another. Regulatory professionals should take in to account "pertinent factors, including typography, layout, contrast and other printing features." A proprietary name that is printed in black text on a white background should not be compared to an established name in light-gray text on a dark-grey background, for instance.

Regulations also stipulate that if the established name does not accompany the proprietary name outside of the running text (e.g. in the headline), the established name must accompany the proprietary name in every instance in the promotional or advertising material. In the case of a two-page advertisement, FDA recommends that the established name accompany the proprietary name at least once per page. In the case of newspaper-style columned advertisements and multi-page internet advertisements, the two names should be present together at least once per column or once per page.

For audio-visual presentations, such as those on television, the established name should be present in conjunction with the most prominent instance of the proprietary name. Both names should be present for the same amount of time. For audio presentations, including the audio portion of visual advertisements, the established name should be presented in conjunction with the most prominent presentation of the proprietary name.

For products with multiple active ingredients that may not have a single established name, the quantitative ingredient information should be placed in direct conjunction with the proprietary name.

Comments on the guidance may be submitted at any time.

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