In a recent guidance issued by FDA entitled Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements (here), the Agency provides current guidance on the various aspects of proprietary and established names in advertising.

The document clarifies the relationship between the size (and not type size) of the proprietary name and established name in running text in advertisements and promotional material where the established name must be at least one-half the actual size of the proprietary name.  In addition, FDA describes the juxtaposition of the names (either to the right of or directly below the proprietary name), and notes that a registered trademark or Controlled Substance designations are the only intervening  text that can come between them.

FDA discusses the prominence of the proprietary name to that of the established name based on layout and other factors, and provides example where they do not believe that the prominence of the two is appropriate.  The guidance also discusses the frequency of appearance of the established name in running text, and while the regulations clearly state the requirements in 21 CFR 201.10(g)(1) and 202.1(b)(1) the Agency notes that “[A]lthough the regulations state that 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 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 guidance provides additional clarifications for

  • Audiovisual Promotional Labeling and Broadcast Advertisements
  • Electronic and Computer-Based Promotion
  • How to deal with products with products with two or more active ingredients

These clarifications should help firms prepare advertising and promotional pieces that will be consistent with current FDA expectations.