Exhibit 984

Guidance for Industry: Consumer-Directed Broadcast Advertisements

Exhibit 984 · Agency guidance

Guidance for Industry: Consumer-Directed Broadcast Advertisements

A sponsor wishing to use consumer-directed broadcast advertisements may meet the adequate provision requirement through an approach that will allow most of a potentially diverse audience to have reasonably convenient access to the advertised product’s approved labeling.

Final guidance describing one approach to meeting the “adequate provision” requirement of 21 CFR 202.1(e)(1) for broadcast prescription-drug ads, as an alternative to a brief summary: a toll-free number with labeling by mail or phone, a referenced print advertisement, a web address, and a statement that health professionals can supply information. The approach presumes the ad is not false or misleading, presents fair balance and includes a major statement of risks. Non-binding.

Source: U.S. Food and Drug Administration (CDER, CBER, CVM)
Date: August 1999
Quoted from: Part III
Grade: Primary record
Document: https://www.fda.gov/media/75406/download
Accessed: 2026-11-10
Cited by: Findings citing this exhibit

Cited by

Finding INF-1.8: Primary record FDA issued final guidance on consumer-directed broadcast advertisements in August 1999, after announcing a draft on 12 August 1997. The Food and Drug Administration Amendments Act of 27 September 2007 required FDA to set standards for a clear, conspicuous and neutral major statement in television and radio drug advertisements within 30 months; FDA proposed a rule on 29 March 2010 and published the final rule on 21 November 2023, with compliance required from 20 November 2024.