Table 1.

Types of Direct-to-Consumer Drug Advertisements and FDA Regulatory Requirements

Type of Ad	Requirement
Product claim ad: Names a drug and the indication(s); makes claims regarding safety and efficacy	Product claims are made, so “fair balance” does apply and risks are required to be included in a “brief summary.” or (for broadcast ads only) Risks must be included in “major statement,” and “adequate provision” for access to a “brief summary” is required.
Reminder ad: Names a drug, dosage form, and possibly cost, but not its uses	No product claims are made, so “fair balance” doesn’t apply and mention of risks in “brief summary,” “major statement,” or “adequate provision” is not required. However, the FDA does not allow this type of ad for drugs with serious risks (i.e., a boxed warning).
Help-seeking ad: Describes a disease or condition but doesn’t mention a specific drug that treats it	No product is mentioned, nor are any claims made, so “fair balance” doesn’t apply; inclusion of risks in “brief summary,” “major statement,” or “adequate provision” is not required.

From FDA. Basics of drug ads.¹⁴