Regulation Of US Supplement Industry Needs ‘Really Hard Look’ – FDA's Woodcock
Acting commissioner's comment on supplement industry regulation was her most definitive statement about the agency’s work in consumer health sector at CHPA's regulatory conference. Pandemic, she says, heightened consumer interest in self-care along with demand for OTC drugs and supplements.
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Stacy Cline Amin expects publication in “near future” of draft guidance on FDA’s NDI notification requirement, a document the agency says it expects to provide within a year. Amin, now with Morrison & Foerster as partner in Washington, also acknowledged FDA’s predicament with regulating products containing cannabinoids.
Compliant industry drove US market growth to $55bn in 2020, and faster growth and higher sales are ahead if FDA’s Office of Dietary Supplement Programs has sufficient funding to eliminate non-compliant businesses.
Former FDA Commissioner Scott Gottlieb says OTC drug switch sponsors could expedite introduction of agency’s long-awaited proposed rule on switch NDAs by submitting applications. During CHPA webinar, he said innovation by industry guides agency in rulemaking.