The Prior Notice of Import Foods calls for companies manufacturing or importing food for humans and animals into the US to submit prior notification to the FDA. Food firms only have until May 30 to offer their input on the particulars of the rule; this edition, the third, includes the questions and answers submitted since the second edition was published 10 years ago.
Why do food manufacturers need to pay attention to draft guidances?
While the guidance states “contains nonbinding recommendations,” the answers given by the FDA in guidance documents shows how the agency is going to enforce the regulation, or law, for a specific situation. These guidance documents provide insight to the FDA’s thinking.
Explain the most important aspects about this particular guidance.
This guidance covers all the changes implemented by the US FDA, as required by the Food Safety and Modernization Act (FSMA), and those changes from the final rule published November 7, 2008. The required change from FSMA is that any company importing a product to the US must notify the FDA if the product was previously refused or rejected by another country.
Other changes are related to organizing the process, procedures and regulations, such as clarifying the definitions of country, meaning of full address, etc. Added into this guidance are the answers to all those questions asked of the FDA about prior guidance so the FDA doesn’t have to repeat itself.
This is the third draft of the draft DG—what has changed since its first iteration?
Generally, the initial guidance was basic information that established a foundation for complying with requirements on the prior notification of food imports into the US. The second guidance was more specific, addressing the questions that would have been considered more unusual.
In your opinion, what (if anything) should be changed about the draft guidance in its current form?
The help desk opening hours and days should be added. This information is available on the login website.
Who’s responsible for giving the notice about the food—the manufacturer, exporter, or the importer?
The responsible party is the person/company that has knowledge of the food, or feed, that is going to be imported into the US. This may be the manufacturer, exporter or importer; most of the time it is the exporter or importer.
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