# 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
> **Food and Drug Administration** · Final rule. · Published 2023-11-21 · Effective 2024-05-20 · 88 FR 80958
## Document
- **Document number:** 2023-25428
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 88 FR 80958
- **CFR reference:** 21 CFR 202
- **Publication date:** 2023-11-21
- **Effective date:** 2024-05-20
- **HHS docket:** Docket No. FDA-2009-N-0582
## 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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2023/11/21/2023-25428/direct-to-consumer-prescription-drug-advertisements-presentation-of-the-major-statement-in-a-clear)
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