The U.S. Court of Appeals for the D.C. Circuit has upheld a lower court’s ruling finding a challenge to the U.S. Food and Drug Administration’s (FDA’s) prohibition on interstate sales of unpasteurized butter to be meritless. McAfee v. FDA, No. 21-5170 (D.C. Cir., entered June 10, 2022). A lower court previously dismissed a challenge filed by a dairy farmer who argued that FDA’s definition of butter does not require pasteurization and thus the rule banning the sale of unpasteurized butter under the Public Health Service Act (PHSA) made an “unlawful change to butter’s statutory definition.” FDA had denied the farmer’s 2016 petition to exclude butter from the rule requiring pasteurization of milk products, finding that “the ban on raw butter helps prevent the spread of communicable diseases” and that “manufacturing controls intended to ensure safety [] may exist independent of any standards of identity.”

The D.C. Circuit was unpersuaded, agreeing that the farmer’s argument “rests on the false premise that the pasteurization rule works a change to butter’s standard of identity,” as the district court held. “That is incorrect: The pasteurization rule did not amend the statutory standard of identity for butter, either formally or functionally,” the appeals court stated. “Raw-cream butter, though unpasteurized, is still ‘butter’ notwithstanding the FDA’s determination that its interstate sale would threaten public health.”

“[T]he statutory definition at issue here contains no mention of pasteurization nor any other suggestion that undergoing that process prevents a product from qualifying as butter,” the court held. “[The plaintiff] may be correct that unpasteurized butter has a distinct taste, texture, and other qualities, but Congress did not speak to those qualities as part of butter’s statutory standard of identity. That statutory provision neither references pasteurization nor requires qualities that pasteurized butter lacks. At least in this case, then, the standard-of-identity statute does not extinguish the agency’s authority under the PHSA to ensure food safety.”

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