OTC Homeopathic Market Could Shrink Under US FDA Risk-Based Oversight, Trade Groups Say
This article was originally published in The Pink Sheet & The Rose Sheet
Executive Summary
US FDA’s draft guidance for homeopathic products could result in consumer confusion, force sales of the products largely online and create a three-year backlog in review of products that have a safe track record, industry trade tells the agency. Agency plans to replace the existing compliance policy guide that largely delegated oversight to the Homeopathic Pharmacopeia of the US with risk-based enforcement by FDA.