FDA Releases Draft of New Version of Prior Notice Guidance
The FDA on Oct. 13 released a final version of its updated guidance on prior notice for imported food. The agency said it is adopting the draft of Version 4 issued in September 2022 with little change (see 2209130038), including…
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"minor editorial changes to improve clarity, such as replacing the term 'animal feed' with 'animal food.'" The new, final Version 4 replaces a previous version of the guidance issued in 2016, adding additional information on the effect of systems recognition or equivalency determinations on prior notice requirements and the timeframe for making requests for FDA review of a refusal or hold for inadequate prior notice. That includes clarification that FDA systems recognition arrangements and equivalence determinations don't exempt food imports from prior notice requirements, as well as new language saying that requests for review of a prior notice refusal or hold must be submitted within five calendar days of the refusal or hold, starting at the time notice is provided to the filer of the prior notice.