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US FDA’s draft guidance for homeopathic products could result in consumer confusion, force sales of the products largely online and create a three-year backlog in review of products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.

US FDA’s draft guidance on OTC homeopathic products will confuse the industry, consumers and retailers and lead to the products being sold online only, the American Association of Homeopathy Pharmacists says in comments to the agency.

“Deleting the relative certainty in the current guidance would mean that many mass market sellers might find it difficult to...

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