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US FDA Sets Rates For FSMA User Fees It Won’t Collect In FY 2021: Re-inspections, Recalls

 
• By Malcolm Spicer

Announcing rates for user fees authorized by Food Safety Modernization Act, FDA says supplement and food firms would be charged $263 an hour should agency officials need to re-inspect a US facility in FY 2021 and $310 an hour for facilities in other countries. Without a guidance for small businesses to request lower rates, the fees won't be imposed.

Money in sack on wooden table

US Food and Drug Administration warning letters during fiscal year 2021 on dietary supplement good manufacturing practices problems will continue noting user fees that firms could but won’t be required to pay.

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More from Policy & Regulation

Deleting Self-Affirmed GRAS Option Could Stretch FDA’s Already Thin Food Safety Resources

 
• By Malcolm Spicer

FDA introduced the option because it didn’t have sufficient staff to handle the volume of GRAS submission reviews requested by food and other firms for ingredients. Requiring submissions for all GRAS determinations “would just be an unworkable situation for the food industry if somehow submitting notice, submitting notices for FDA review and concurrence, was required,” says food and drug attorney Federick Stearns.

Loper Bright Could Trip FDA On Self-Affirmed GRAS

 
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French Agency Proposes Effective EU Ban On CBD In Foods And Cosmetics

 
• By David Ridley

France's food safety regulator ANSES is proposing a reproductive toxicity category 1B classification for CBD under the EU's CLP regulation, which would mean an effective ban on CBD in cosmetics and foods. However, French hemp industry association UIVEC hopes that new evidence coming out of a European Commission review will put the issue to bed before it gets that far.