OTC Homeopathic Market Could Shrink Under US FDA Risk-Based Oversight, Trade Groups Say
US FDA’s draft guidance for homeopathic products could result in consumer confusion, force sales of the products largely online and create a three-year backlog in review of products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.
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FDA has yet to finalize about one-third of its OTC monographs and several hundred ingredients do not have a final GRASE determination. Sorting will help the agency determine which of the 800 active OTC monograph ingredients are designated as needing more information to establish GRASE under a faster system based on administrative orders.
Problems stated in a draft guidance where FDA will "prioritize enforcement and regulatory actions" includes products with routes of administration other than oral and topical or intended to be used for the prevention or treatment of serious or life-threatening diseases and conditions.
Products with routes of administration other than oral and topical or intended to be used for the prevention or treatment of serious or life-threatening diseases and conditions will be among those prioritized for enforcement and "regulatory actions," draft guidance notes.