FDA Issues Final Rule on Prior Notice for Imported Food

On May 29, 2013, the U.S. Food and Drug Administration (FDA) issued a final rule that adopts, without change, the Interim Final Rule (IFR), entitled “Information Required in Prior Notice of Imported Food,” that was published in the Federal Register (76 FR 25542) on May 5, 2011. In particular, the final rule adopts the IFR’s requirement that a prior notice of imported food for humans or animals include the name of any country to which the article has been previously refused entry. You can read the final rule here.

Pursuant to section 801(m) of the Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, an article of food imported or offered for export may be refused admission into the United States if adequate prior notice has not been provided. 21 CFR §1.281 explains the information that must be submitted in a prior notice. The 2011 IFR and final rule now require a party submitting a prior notice to report the name of any country to which an article of food has been refused entry. While, the FDA currently requires that only the identity of the country and not the reasons for the refusal be submitted, other information could be required on a case-by-case basis. As noted in the preamble to the final rule, the FDA, after reviewing the prior notice, may request that the submitter provide additional information.

According to the FDA, only refusals of entry or admission that are based on food safety reasons must be reported in a prior notice. The agency is primarily concerned with identifying foods that present a health risk to consumers. However, as we have seen with most regulatory authority and interpretations thereunder, “public health” has been interpreted very broadly. In sum, when there is a violation of the prior notice regulations, the FDA will take the totality of the circumstances into account in deciding whether to enforce the violation. For example, it will look at the severity of the violation and any previous violations, particularly if they were similar.

You can read more about the FDA’s guidelines for the prior notice of imported foods here. If you have any questions about prior notice requirements or how a FDA regulatory attorney can help you comply with the FDCA and accompanying FDA regulations, please contact us at: contact@giannamore-law.com.

Prior Notice

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