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- On September 13, the FDA announced the availability of the 4th edition of a draft guidance for industry entitled “Prior Notice of Imported Food Questions and Answers; Draft Guidance for Industry (Edition 4).” The draft guidance adds three additional questions. One question discusses systems recognition or equivalency determinations. The other two questions relate to FDA’s notice of a refusal under 801(m)(1) of the Federal Food, Drug, & Cosmetic Act (FDCA) for inadequate prior notice or a hold if the food article is from a foreign facility that is not registered, and also address the timeframe for making requests for FDA review of such a refusal or hold.
- As per the Notice of Availability, the update to the draft guidance clarifies that the existence of a Systems Recognition Arrangement with or an equivalence determination of a foreign country does not exempt imported foods from that country from FDA’s prior notice requirements. It also intends to clarify when FDA will provide notice of the refusal or hold to the relevant party, and when the 5-calendar-day clock to request a review of the refusal or hold begins.
- Stakeholders may submit comments on the draft guidance by November 14. Please feel free to contact Keller and Heckman at fooddrug@khlaw.com for assistance providing FDA comments.
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