FDA announced the draft approach in August 1997 and requested comments. The notice grounded it in existing advertising law and regulations.
The draft guidance is intended to provide information to enable product sponsors to fulfill the requirements for consumer-directed broadcast advertisements, while providing consumers with required risk information about the advertised products.
Federal Register pp. 43171-43173; PDF p. 1
FDA announced the draft approach in August 1997 and requested comments. The notice grounded it in existing advertising law and regulations. Docket 97D-0302; signed August 5 and published August 12, 1997.