{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations concerning direct-to- consumer (DTC) advertisements (ads) for human prescription drugs presented in television or radio format and stating the name of the drug and its conditions of use (DTC TV/radio ads). Specifically, the final rule implements a requirement of the Federal Food, Drug, and Cosmetic Act (FD&C Act), added by the Food and Drug Administration Amendments Act of 2007 (FDAAA), that in such DTC TV/radio ads, the major statement relating to side effects and contraindications must be presented in a clear, conspicuous, and neutral manner. As directed by FDAAA, FDA is establishing standards to determine whether the major statement in DTC TV/radio ads is presented in a clear, conspicuous, and neutral manner.","action":"Final rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2023/11/21/2023-25428.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"202","title":21}],"citation":"88 FR 80958","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective May 20, 2024. The compliance date of this rule is November 20, 2024.","disposition_notes":null,"docket_ids":["Docket No. FDA-2009-N-0582"],"dockets":[{"supporting_documents":[{"title":"56 Reference 56 Effect of Presentation Modality in Direct-to-Consumer (DTC) Prescription Drug Television Advertisements_Wogalter_2014 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format","document_id":"FDA-2009-N-0582-0118"},{"title":"53 Reference 53 The Implications of the FTC's Clear and Conspicuous Standards for the Communication of Credit Card Information to Young Consumers_Thomas_2011 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format","document_id":"FDA-2009-N-0582-0115"},{"title":"50 Reference 50 H. Rept. No.102-839_1992 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the\nMajor Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format","document_id":"FDA-2009-N-0582-0112"},{"title":"48 Reference 48 Quantifying Perceived Differences in Type Styles An Exploratory Study_Tantillo_1995 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the\nMajor Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format","document_id":"FDA-2009-N-0582-0110"},{"title":"46 Reference 46 Provision of Effective Information_Baker_2006","document_id":"FDA-2009-N-0582-0108"},{"title":"43 Reference 43 Aging and Direct-to-Consumer Prescription Drug Television Ads The Effects of Individual Differences and Risk Presentation_O'Donoghue_2019 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the\nMajor Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format","document_id":"FDA-2009-N-0582-0105"},{"title":"41 Reference 41 Age Affective Experience and Television Use_Depp_2010","document_id":"FDA-2009-N-0582-0103"},{"title":"38 Reference 38 Sources of Miscomprehension in Television Advertising_Hoyer_1984 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the\nMajor Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format","document_id":"FDA-2009-N-0582-0100"},{"title":"37 Reference 37 Distraction and Attitude Change A Resolution_Regan_1973 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the\nMajor Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format","document_id":"FDA-2009-N-0582-0099"},{"title":"35 Reference 35 Music is as Distracting as Noise The Differential Distraction of Background Music and Noise on the Cognitive Test Performance of Introverts and Extraverts_Furnham_2002 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the\nMajor Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format","document_id":"FDA-2009-N-0582-0097"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-11-21","updated_at":"2023-11-21T10:00:43.137-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2009-N-0582-0061","allow_late_comments":null,"id":"FDA-2009-N-0582-0061","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":86,"id":"FDA-2009-N-0582","title":"Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner"}],"document_number":"2023-25428","effective_on":"2024-05-20","end_page":80984,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/11/21/2023-25428.xml","html_url":"https://www.federalregister.gov/documents/2023/11/21/2023-25428/direct-to-consumer-prescription-drug-advertisements-presentation-of-the-major-statement-in-a-clear","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-25428?publication_date=2023-11-21","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-11-21/2023-25428/mods.xml","not_received_for_publication":null,"page_length":27,"page_views":{"count":15105,"last_updated":"2026-10-30 02:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-11-21/pdf/2023-25428.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-25428.pdf?1700487925","publication_date":"2023-11-21","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/11/21/2023-25428.txt","regulation_id_number_info":{"0910-AG27":{"issue":"202310","html_url":"https://www.federalregister.gov/regulations/0910-AG27/direct-to-consumer-prescription-drug-advertisements-presentation-of-the-major-statement-in-a-clear-c","title":"Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, Neutral Manner in Advertisements in Television and Radio Format ","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202310&RIN=0910-AG27&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AG27"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"56 Reference 56 Effect of Presentation Modality in Direct-to-Consumer (DTC) Prescription Drug Television Advertisements_Wogalter_2014 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format","document_id":"FDA-2009-N-0582-0118"},{"title":"53 Reference 53 The Implications of the FTC's Clear and Conspicuous Standards for the Communication of Credit Card Information to Young Consumers_Thomas_2011 RE:Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format","document_id":"FDA-2009-N-0582-0115"},{"title":"50 Reference 50 H. 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