FDA Issues Draft Guidance on Food Import Alert Rule

WASHINGTON—FDA has issued draft guidance governing a rule that requires prior notice of food that is imported into the United States.

The draft guidance, if finalized, is non-binding though it represents the agency's thinking concerning its rule.

FDA published its final rule on Nov. 7, 2008, requiring prior notice of food that is imported or offered for import into the United States, six years after Congress imposed the requirement in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Dietary supplements are among the foods that are subject to the notice requirements.

On May 30, 2013, pursuant to the Food Safety Modernization Act, FDA published a final rule that imposed an additional requirement: a person submitting prior notice of imported food must report the names of any countries to which an article of food has been refused entry.

Although FDA didn't make any changes to the previously issued interim final rule, it explained the circumstances under which the reporting obligation would be triggered.

"For purposes of this regulation, FDA considers 'refused entry' to mean a refusal of entry or admission of human or animal food based on food safety reasons, such as intentional or unintentional contamination of an article of food," the agency stated in the final rule. "This is consistent with the intent of the provision, which is to provide FDA with additional information to better identify imported food shipments that may pose a safety or security risk to U.S. consumers."

The person who provides the information to FDA is not required to submit the reason explaining why another country refused entry of the food headed for the United States, although the agency said it may reach out for additional information.

The agency first issued guidance on its prior notice import rule in December 2003, then issued revised guidance in May 2004.

FDA is currently soliciting comments on the draft guidance.

Foods subject to the prior notice import rule include fish and seafood, live food animals, dairy products, shell eggs, fruits, vegetables, raw agricultural commodities for use as food or as components of food and animal feed (including pet food), food and feed ingredients, food and feed additives, infant formula, beverages (including alcoholic beverages and bottled water), bakery goods, snack foods, candy, canned foods, and dietary supplements and dietary ingredients.