FDA issues final guidance on major statement in DTC ads
Regulatory News | 03 January 2024 |
(Source: FDA)
The US Food and Drug Administration (FDA) last week published a final guidance detailing five standards drug manufacturers should follow to ensure direct-to-consumer (DTC) radio and television advertisements conform to its regulations. The guidance complements a November 2023 final rule that established the five standards for conveying a major statement in a “clear, conspicuous, and neutral manner.”
The questions and answers guidance addresses issues that manufacturers should consider when making a major statement about their product that the agency considers to be clear, conspicuous and neutral (CCN). (RELATED: FDA issues new standards for DTC prescription drug ads, Regulatory Focus 21 November 2023)
FDA restates the standards in the guidance and details how it expects manufacturers to comply with each standard.
The first standard requires the manufacturer's major statement to be presented in consumer-friendly language and readily understandable terminology.
“This means that firms must use consumer-friendly language and terminology that is readily understandable, rather than medical or technical jargon or terms usually more familiar to health care providers,” said FDA. “To comply with this standard, firms must also avoid language or terminology in the presentation of the major statement that is so vague as to be readily subject to different interpretations.”
The agency notes that the language does not need to meet any grade-level reading requirement since a high-grade level may be required to present certain information. It does, however, ask that the information be presented in a manner that is understandable to the ordinary consumer.
When complying with audio requirements for direct-to-consumer radio ads, FDA asks that it take into consideration the volume level, articulation and pacing of the audio to ensure the information is understandable. Similarly, when presenting ads on TV ads the agency states any accompanying text needs to be displayed long enough so it is easily read and that it remains on screen for as long as the corresponding audio.
The standards also require that the text portion of the TV ads conform to certain style, font, screen contrast and screen placement requirements.
“To comply with this standard, firms are required to ensure that the presentation of the text of the major statement is easily readable,” said FDA. “Firms are not required to use particular font colors, sizes, placement, or backgrounds but instead are required to ensure that these aspects of text in combination result in an easily readable presentation of the major statement.”
The fifth and final standard requires that audio or visual elements of the ad do not make the major statement less comprehensible. FDA notes that such elements combined can be used to reinforce risk information to consumers.
The guidance states that manufacturers can also reach out to FDA to discuss their ads before they are disseminated.
“Reviewers in FDA’s Office of Prescription Drug Promotion (OPDP) within the Center for Drug Evaluation and Research (CDER) and reviewers in the Advertising and Promotional Labeling Branch (APLB) within the Center for Biologics Evaluation and Research (CBER) will evaluate the draft materials that firms submit for, among other things, compliance with the CCN Final Rule,” the agency said. “Reviewers provide comments back to firms for their consideration.”
Final guidance
The questions and answers guidance addresses issues that manufacturers should consider when making a major statement about their product that the agency considers to be clear, conspicuous and neutral (CCN). (RELATED: FDA issues new standards for DTC prescription drug ads, Regulatory Focus 21 November 2023)
FDA restates the standards in the guidance and details how it expects manufacturers to comply with each standard.
The first standard requires the manufacturer's major statement to be presented in consumer-friendly language and readily understandable terminology.
“This means that firms must use consumer-friendly language and terminology that is readily understandable, rather than medical or technical jargon or terms usually more familiar to health care providers,” said FDA. “To comply with this standard, firms must also avoid language or terminology in the presentation of the major statement that is so vague as to be readily subject to different interpretations.”
The agency notes that the language does not need to meet any grade-level reading requirement since a high-grade level may be required to present certain information. It does, however, ask that the information be presented in a manner that is understandable to the ordinary consumer.
When complying with audio requirements for direct-to-consumer radio ads, FDA asks that it take into consideration the volume level, articulation and pacing of the audio to ensure the information is understandable. Similarly, when presenting ads on TV ads the agency states any accompanying text needs to be displayed long enough so it is easily read and that it remains on screen for as long as the corresponding audio.
The standards also require that the text portion of the TV ads conform to certain style, font, screen contrast and screen placement requirements.
“To comply with this standard, firms are required to ensure that the presentation of the text of the major statement is easily readable,” said FDA. “Firms are not required to use particular font colors, sizes, placement, or backgrounds but instead are required to ensure that these aspects of text in combination result in an easily readable presentation of the major statement.”
The fifth and final standard requires that audio or visual elements of the ad do not make the major statement less comprehensible. FDA notes that such elements combined can be used to reinforce risk information to consumers.
The guidance states that manufacturers can also reach out to FDA to discuss their ads before they are disseminated.
“Reviewers in FDA’s Office of Prescription Drug Promotion (OPDP) within the Center for Drug Evaluation and Research (CDER) and reviewers in the Advertising and Promotional Labeling Branch (APLB) within the Center for Biologics Evaluation and Research (CBER) will evaluate the draft materials that firms submit for, among other things, compliance with the CCN Final Rule,” the agency said. “Reviewers provide comments back to firms for their consideration.”
Final guidance
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