Supplement GMP Inspections Slowing As FDA Makes 'Potential' Data Useful
This article was originally published in The Rose Sheet
FDA doesn't expect o continue increasing GMP inspections at the rate established from fiscal 2013 through 2017, says Cara Welch, assistant director of the office in the agency's Office of Dietary Supplement Programs."We're not going to keep growing at that rate because we have a lot of regulations we have to inspect and we're always resource strapped," she said at a recent industry conference.
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Georgia business records indicate the firm FDA warned on 21 May was established in 2017 by Jared Wheat and is registered with an address in an Atlanta suburb also used for Wheat’s Hi-Tech Pharmaceuticals. Wheat is facing 18 criminal charges listed in a 2017 indictment alleging he distributed steroid-spiked supplements and falsified regulatory compliance documents.
FDA's notice for a May 16 public meeting say it intends to ensure its "regulatory framework is flexible enough to adequately evaluate product safety without unnecessarily restricting innovation." But FDA makes clear adherence with its NDI notification requirement is focus of the spurring improvement in VMS product industry's overall compliance with regulatory framework established by DSHEA.
"You begin to see FDA telegraphing that this is important. That was lacking in the past two budgets," said Mike Greene, Council for Responsible Nutrition's chief congressional liaison. White House's budget request recommends $67m increase from FY 2019 to $1.4bn for FDA's food industry programs in CFSAN, which includes the Office of Dietary Supplement Programs, and for the Office of Regulatory Affairs' related field activities.