Budget Good For FDA Supplement Sector Oversight? Congress Wants To Know
A report submitted with appropriations legislation negotiated by conference committee and approved by both chambers instructs FDA to report to Congress about its activities and staffing for oversight of supplement manufacturers and marketers. In an indication members are aware of the scope of FDA's responsibilities in the sector, report also asks agency to provide information on work related to "manufacturers and marketers of products claiming to be dietary supplements."
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Consolidated Appropriations Act gives FDA $5.58bn overall, 8.7% more than allocated in FY 2018. FDA received $268.8m in additional budget authority and $178.3m in additional user fee funds. FY 2019 funding would have lapsed Feb. 16 and another government shutdown would have started if President Trump didn't sign the bill on Feb. 15.
Commissioner Scott Gottlieb announces FDA's plan for policy changes to implement "one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years." Plan includes steps to ensure its regulatory framework is flexible enough to adequately evaluate product safety while also promoting innovation, particularly finalizing NDI notifications guidance and fostering submissions of the notifications.
FDA's warnings to industry "about safety have not always been met adequately or even uniformly accepted," says Steve Tave, director of the agency's dietary supplement programs.