FDA Releases Draft of New Version of Prior Notice Guidance
FDA released on Sept. 13 a draft of a new version of its draft guidance on prior notice for imported food. Version 4 of the industry guidance would replace the previous version finalized 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. Comments on the draft changes are due Nov. 14.
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In one new answer that would be added to the guidance, FDA said systems recognition arrangements and equivalence determinations do not exempt food imports from prior notice requirements. “The existence of an SRA with a given country does not exempt imported foods from that country from FDA prior notice requirements,” FDA said. Similarly, “since FDA’s prior notice requirements fall outside the scope of an equivalence determination, imported foods covered by a final equivalence determination are not exempt from FDA prior notice requirements,” the agency said.
As for the time frame for requesting review of a prior notice refusal or hold, FDA said that such requests “must be submitted within 5 calendar days of the refusal or hold.” That five-day clock starts “at the time FDA provides notice of the refusal or hold to the relevant party who submitted the prior notice (i.e., submitter or transmitter) upon arrival of the article,” and the clock runs five calendar days, not 120 hours. “For example, if we provide the notice at 10:00am on January 1, you would submit the request no later than 11:59pm on January 6,” FDA said.
Other proposed changes to the prior notice guidance include replacing references to the Automated Commercial System with references to ACE, and removing references to requirements that some prior notice submissions be submitted in FDA’s Prior Notice Systems Interface, FDA said.