FDA Finalizes Guidance on Name Placement, Size and Prominence

Dec. 15, 2017 – The FDA announced this week that it has finalized its guidance document covering how industry should treat product name placement, size and prominence in promotional labeling and ads, largely keeping intact the draft guidance document it issued on the matter in 2013, and reiterating the agency’s position that “the disclosure of the product name in promotional labeling and advertisement is important for proper identification and to ensure safe and effective use.”

The agency’s recommendations in the final guidance apply to product names in traditional print media promotional labeling and ads (e.g., journal ads, detail aids, brochures), audiovisual promotional labeling (e.g., videos shown in a healthcare provider’s office), broadcast ads (e.g., television and radio ads), and electronic and computer-based promotions (e.g., internet, social media, emails, CD-ROMs, DVDs) (

The final guidance is divided into two sections — one for products with one active ingredient and one for products with two or more active ingredients – that cover the juxtaposition, size and prominence of proprietary and established names.

The agency also covers the frequency of disclosure of proprietary and established names, and clarifies that “although the regulations state the established name ‘shall 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 spread where the proprietary name most prominently appears.”

For audiovisual and broadcast treatments that contain superimposed text (“supers”), the agency states that for supers that “are equivalent to a headline or tagline, FDA does not intend to object to fewer appearances of the established name it the established name is placed in direct conjunction with the most prominent display of the proprietary name.”