ALERT - FDA Issues First Two Interim Rules Under Food Safety Modernization Act

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May 5, 2011

The Food Safety Modernization Act (FSMA), enacted in January 2011, broadened the authority of the Food and Drug Administration (FDA) in certain respects. On May 4, 2011, the FDA announced its first two interim final rules issued under this new authority. The new interim rules take effect July 3, 2011.

The first new rule, 21 C.F.R. § 1.378, significantly lowers the threshold for when the FDA can order an administrative detention of human or animal food. Formerly, the FDA needed “credible evidence or information indicating that the … food present[ed] a threat of serious adverse health consequences or death to humans or animals” to order detention. Now, the FDA can detain if it “has reason to believe that the … food is adulterated or misbranded.” (21 C.F.R. § 1.393, regarding the detention order, is similarly amended.)

In the notice, the FDA states that whether the FDA has "'reason to believe' a food is adulterated or misbranded would be made on a case-by-case basis because such decisions are fact specific.” Notably, an adverse health consequence possibility is no longer required for detention. For example, a nutrient content claim that is “reasonably believed” by the FDA to be untrue could support detention.

The second new rule, 21 C.F.R. § 1.281, relates to imported human or animal food. It adds to the items of information required in a “prior notice” of import submitted to the FDA, the identification of any countries to which the food has been refused entry.

Comments on the interim final rules, to be considered before promulgation of the final rule, are due August 3, 2011.

These two new rules are likely just the beginning. Other significant provisions of the FSMA, such as those addressing hazard analysis, produce safety, food allergy/anaphylaxis management and recordkeeping requirements, provide later deadlines for FDA rulemaking. New proposed or interim rules under the authority of these FSMA sections can be expected to issue in accordance with those timetables.

For more information please contact your Briggs and Morgan attorney or a member of the Food Industry practice group at Briggs and Morgan, P.A.