Re-inspection Fees, Spiked Coffee, Recalls: Health And Wellness Industry News

Nearly $500,000 In re-inspection fees uncollected; ED drugs In AMPT Life coffee ; and more protein bars caught In Listeria-contamination recall.

FDA in fiscal 2016 sent bills totaling around $468,000 to dietary supplement and food firms for re-inspections of facilities and imports without collecting the fees, the agency’s Office of Regulatory Affairs says. FDA is not asking firms that are billed the user fees authorized by the Food Safety Modernization Act because it has not published a guidance for waivers from paying the fees. ORA’s Office of Management Division of Financial Operations has submitted the bills since the re-inspection user fees became effective in fiscal 2012. “Each inspection is different and the cost, of course, is predicated on the amount of time our inspectors spend on each trip,” said Jason Lewis, a program analyst in the division. FDA on Aug. 2 published a notice of its fiscal 2018 user fee rates for re-inspections and mandatory recalls: $248 per hour in the US and $285 per hour outside the country. Facility registration user fees FSMA also authorized are collected from the supplement and food industries, with rates set in a separate notice. (Also see "FSMA Re-inspection Fees MIA As Waiver Guidance Remains AWOL" - HBW Insight, 2 August, 2017.)

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