Summary

Requires the Food and Drug Administration to use the “least burdensome appropriate means” when evaluating requests to declare an over‑the‑counter (OTC) monograph drug as generally recognized as safe and effective (GRASE). When published reports are insufficient, the FDA must meet with a requester who asks in writing, give recommendations on evidence and study design/size as appropriate, produce meeting minutes, and include those recommendations and a meeting summary in the administrative record while retaining existing completeness and GRASE standards.

• Directs FDA to use the 'least burdensome appropriate means' when evaluating OTC monograph GRASE requests.
• Requires FDA to meet with a requester who asks in writing if published data are insufficient to support a GRASE finding.
• Mandates that FDA provide recommendations on evidence and study design/size when appropriate.
• Requires FDA to prepare and give meeting minutes to the requester and include recommendations and a meeting summary in the administrative record.
• Preserves existing completeness/format requirements for administrative requests and the statutory GRASE standard.
• No new appropriations, tax changes, or emergency provisions are created.
• Aims to increase transparency and dialogue between FDA and requesters, potentially speeding access to some OTC determinations.
• Places modest extra administrative duties on FDA (meetings, documentation) but does not change safety standards legally required for GRASE determinations.