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June 17, 2022

D.C. Court of Appeals Upholds FDA Denial of Rulemaking Petition to Allow Interstate Sale of Unpasteurized Butter

The Court of Appeals for the D.C. Circuit upheld the U.S. FDA’s denial of a citizen petition for rulemaking to require FDA to allow the interstate sale of raw, unpasteurized butter.  The plaintiff initially had submitted a petition for rulemaking requesting FDA to rescind its existing ban and implement a rule expressly allowing the sale of unpasteurized butter, because the existing ban violates the statutory definition of butter under the Food, Drug, and Cosmetic Act (FDCA). The FDA denied the petition on three grounds. First, the FDA found that the Public Health Service Act gave the agency authority to require pasteurization of butter. Second, the FDA found that substantial evidence supported the agency's rule requiring pasteurization of butter. Lastly, the FDA found that requiring pasteurization of butter did not conflict with the FDA's statutory definition of butter. The D.C. Circuit found on appeal that the plaintiff's sole surviving claim that the FDA rule conflicted with the statutory definition of butter was meritless.

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