Pay Now For Better Supplement Industry Enforcement, Or Foot Higher Bill Later
This article was originally published in The Tan Sheet
By considering and addressing potential regulatory changes, the industry more likely can help shape changes and avoid greater regulatory burden such as pre-market review, suggests CRN President Steve Mister. User fees are an “issue that the industry is going to have to start looking at,” he says.
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Committee members' current priorities do not include authorizing user fee programs for the OTC monograph process or supplement GMP inspections, but proposals could get traction. "We think it is a happy medium of getting FDA the resources it needs," says Tiffany Guarascio, minority chief of staff.
FDA adds acetaminophen warnings; CHPA suggests 4-aminophenol standard; OTC HSA bill in House; supplement registration bill reintroduced; FSMA user fees still on hold; more scrutiny of energy drinks; and Public Citizen pans OTC Oxytrol.
Trade groups say FDA committed to revisiting issues in the NDI draft guidance including how firms prove ingredients’ grandfathered status, notifications required for ingredients or finished products and data necessary to demonstrate NDI safety. The agency’s decision followed a meeting between industry allies Sens. Hatch and Harkin and FDA Commissioner Hamburg.