Section 807(b) of the Federal Food, Drug, and Cosmetic Act, added by section 306 of the Food Safety Modernization Act (FSMA) authorizes the U.S. Food and Drug Administration (FDA) to refuse imported food from being admitted into the United States if the Agency is not permitted to inspect the foreign establishment that produced the food.

Today, the FDA issued draft guidance to explain what type of actions by a foreign food establishment or government would constitute a “refusal of inspection.” The draft guidance provides a non-exhaustive list of examples to illustrate some of the situations that the FDA may encounter when attempting to conduct inspections. Prohibiting entry of FDA investigators, withholding records, causing delays during an inspection and rejecting FDA’s attempts to schedule an inspection by not agreeing to an inspection start date (and not giving a reasonable explanation for its failure to do so) are all listed as examples of situations that the FDA would consider to constitute a “refusal of inspection.”

FDA will be accepting comments on the draft guidance for 75 days following its imminent publication in the Federal Register.