Pay Now For Better Supplement Industry Enforcement, Or Foot Higher Bill Later
This article was originally published in The Tan Sheet
Executive Summary
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.
You may also be interested in...
In Brief: Acetaminophen Warnings, OTC HSA Bill, Durbin’s Supplement Reg Bill
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.
FDA Revision Of NDI Draft Guidance Starts With Grandfathered List
Trade groups say FDA committed to revisiting issues in the NDI draft guidance including how firms prove ingredients’ grandfathered status, notifications required for ingredients or finished products and data necessary to demonstrate NDI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.
Food Safety User Fees On Hold Until FDA Creates Waiver Process
Dietary supplement and food product firms will not incur user fees for facility or import re-inspections or mandatory recalls until FDA establishes a waiver process for small businesses.