December 7, 2022

Volume XII, Number 341

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December 06, 2022

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December 05, 2022

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FDA Updates Prior Notice of Imported Food Draft Guidance

  • On September 13, the FDA announced the availability of the 4th edition of a draft guidance for industry entitled “Prior Notice of Imported Food Questions and Answers; Draft Guidance for Industry (Edition 4).” The draft guidance adds three additional questions.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  • As per the Notice of Availability, the update to the draft guidance clarifies that the existence of a Systems Recognition Arrangement with or an equivalence determination of a foreign country does not exempt imported foods from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  • Stakeholders may submit comments on the draft guidance by November 14.

© 2022 Keller and Heckman LLPNational Law Review, Volume XII, Number 257
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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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