FDA Releases Guidance on Prior Notice of Imported Food

The Food and Drug Administration posted an updated guidance on prior notice for imported foods (here). The agency had not updated the questions and answers document since 2004, and in the meantime formally adopted the interim final rule that established prior notice requirements and issued another final rule requiring importers notify the FDA if an article has previously been refused entry. The agency requested public comments on a draft version of the guidance in 2014 (see 14032819), but made "no substantive changes" for the final guidance, the FDA said in a Federal Register notice (here).

New questions and answers since the 2004 version of the document titled "Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3)” are as follows:

5.1 Is prior notice required for placebos that are imported for testing purposes?

“If the product is for pharmaceutical testing purposes, e.g., for use in a clinical trial involving a prescription or non-prescription drug, then prior notice is not required. However, if the product is being imported for use in the testing of dietary supplements or dietary ingredients, prior notice is required.”

6.1 Is prior notice required for popcorn that is used as a packing material for shipping?

“When a substance is capable of having a food use and a nonfood use, FDA will consider the substance to be 'food' for the purpose of prior notice if it is reasonably likely to be directed to a food use (73 FR 66294 at 66301; November, 7, 2008). Therefore, prior notice is required if the popcorn used as a packing material is reasonably likely to be directed to a food use.”

12.3 Is prior notice required for casings?

Under Food Safety and Inspection Service (FSIS) Directive 9000.2, “products labeled as … intestines are derived from the intestinal tract of livestock … and are meat byproducts. As meat byproducts, intestines are under FSIS jurisdiction. Products labeled as … casings are derived from the intestines of livestock … and are used as containers to prepare sausage and other meat food products. Casings are under the jurisdiction of the FDA. Therefore, prior notice is required for … casings, but not … intestines. Artificial casings that are not edible, e.g., those made of plastic, do not require prior notice.”

8.1 What name and address should be submitted as the ultimate consignee?

“A significant number of people have asked this question, and there has been a lot of variation in what people have been submitting as the ultimate consignee. FDA considers the location where the imported food is to be delivered as the ultimate consignee for the purposes of prior notice.” Requiring the location where the imported food is delivered to be the ultimate consignee allows it “to prevent delivery to these parties, such as when the food is delivered to a third party’s storage facility on behalf of, and accessible by, the importer or owner.” (NOTE: abridged.)

9.1 Title 21 CFR 1.281 (a)(18), (b)(12), and (c)(19) requires the name of any country that has refused entry of the article of food to be reported through prior notice. Specifically, what types of entry refusals should be reported through prior notice?

“You should report refusals of entry/admission (also known as refusals) of food, including food for animals, based on food safety reasons given by the government of the country that refused entry/admission. See 78 FR 32359 at 32360; May 30, 2013. Food safety refusals include, but are not limited to, refusals for intentional or unintentional contamination, including the presence of biological, microbiological, chemical, or radiological contaminants. Refusals for commercial or other non-food safety reasons (e.g., product quotas, taxes, import permitting, and documentation issues) should not be reported. ‘Any country’ refers to the country or countries, including the U.S., where an agency or representative of the government of the country has refused the article of food.”

9.2 If an article of food is refused entry/admission upon arrival at a U.S. port, must the refusal be reported in subsequent prior notice(s) if the article is then offered for import at another U.S. port?

Yes. If the refusal was for a food safety reason, in a subsequent prior notice the refusal must be reported by indicating “U.S.” as the country of refusal.

9.3 Does ‘article’ refer to only the food in the specific shipment, or does it also refer to food from the same batch or lot numbers that was shipped to other countries?

“For the purpose of reporting the information required under 21 CFR 1.281 (a)(18), (b)(12), and (c)(19), 'article' refers to the specific food item for which prior notice is being submitted in a specific shipment. Here, the term 'article' does not refer to food from the same batch or lot numbers that is not being imported or offered for import into the U.S. and for which prior notice will not be submitted at the time of the specific shipment, or food of a similar type that was previously refused entry by a country.”