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

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.)

Another coffee product advertised as a testosterone booster contains erectile-dysfunction ingredients sildenafil and tadalafil as AMPT Life LLC recalls its namesake instant coffee, which also contains undeclared milk. After FDA testing discovered the drug ingredients, the Dallas firm on Aug. 1 said it markets AMPT Coffee as “a libido booster” and distributed the spiked product nationwide from April 2016 through March. AMPT Life said it not received any reports of injuries or illnesses, the same report Bestherbs Coffee LLC made in July after it recalled all lots of New of Kopi Jantan Tradisional Natural Herbs Coffee, distributed between July 2014 and June 2016 and found to contain desmethyl carbodenafil, a chemical structurally similar to sildenafil. However, Caverflo Natural Herbal Coffee was recalled in May after the report of a user's death