In the United States, responsibility is split across regulators. As a general rule, the
Federal Trade Commission oversees advertising for OTC drugs and other consumer health products, while the Food and Drug Administration oversees OTC labeling and most prescription drug advertising and labeling. State laws, platform policies, industry codes, and privacy requirements can add another layer.
For OTC advertising, the core standard is straightforward to state and demanding to execute. Express and implied claims must be truthful, not misleading, and supported before the ad runs. The
FTC Health Products Compliance Guidance explains that health benefit and safety claims generally require competent and reliable scientific evidence. The review must cover the full impression of the ad, including imagery, demonstrations, testimonials, and omissions.
Branded prescription drug promotion follows FDA requirements. Consumer ads cannot be false or misleading, omit material facts, or present benefits without a fair balance of risk information. Print ads generally carry a consumer-directed summary of risks. Broadcast product-claim ads must include the most important risks in a major statement and provide access to the FDA-approved labeling.
The
FDA rule for television and radio ads also requires the major statement to be presented in a clear, conspicuous, and neutral manner. In practice, risk communication has to be designed with the concept. Audio pace and volume, on-screen text, contrast, placement, and competing visuals all affect whether a viewer can understand it.
Digital formats need the same early discipline. A short post does not create extra room for an unsupported claim, and a link cannot always repair an unbalanced message. FDA’s current
draft guidance on space-limited platforms advises companies to consider whether the format can carry both benefit and risk information before using it for a product claim.
Creator partnerships bring an additional disclosure requirement. The FTC expects a material connection between the brand and an endorser to be clear to the audience, including on social platforms. Its
Endorsement Guides resources also make clear that advertisers remain responsible for the claims made on their behalf.
Data use deserves a separate review. Health-related searches, site behavior, app data, and patient support interactions can be sensitive even when a marketing team does not consider them medical records. HIPAA applies to covered entities and business associates, while the FTC Health Breach Notification Rule covers certain health apps and related services outside HIPAA. The
FTC’s 2024 update explicitly clarified the rule’s application to health apps and similar technologies.