• Mark McAfee, a dairy farmer who wishes to sell raw, unpasteurized butter beyond his home state of California, and a co-plaintiff, the Farm-to-Consumer Legal Defense Fund, appealed FDA’s February 27, 2020 denial of McAfee’s 2016 citizen petition for a rulemaking by FDA to exclude butter from the requirement under 21 CFR 1240.61 that “milk products” in interstate commerce must be pasteurized.

• In a June 10, 2022 opinion, No. 21-5170, the U.S. Court of Appeals for the District of Columbia Circuit upheld a lower court’s decision against the plaintiffs, rejecting McAfee’s argument on appeal that a rulemaking is necessary because FDA’s regulation banning interstate sale of raw butter violates the statutory definition of butter, fully agreeing with the district court and finding the challenge meritless.  By way of background, in a May 24, 2021 Memorandum Opinion, the U.S. District Court for the District of Columbia found that the raw butter ban was a “straightforward” exercise of FDA’s authority under the Public Health Service Act (PHSA), which gives FDA broad authority “to make . . . regulations . . . necessary to prevent the introduction, transmission, or spread of communicable diseases,” and that requiring butter to be pasteurized to eradicate disease-causing pathogens poses no conflict with the standard of identity of butter, which is defined in the Food, Drug, and Cosmetic Act (FDCA) in terms of permitted ingredients and milk fat content, but without mention of pasteurization.  The district court also rejected McAfee’s arbitrary-and-capricious challenges, finding that FDA presented a “great deal of scientific evidence” in support of its judgment that raw butter presents a food safety risk.

• This ruling in the McAfee case does not impact intrastate sales of raw, unpasteurized milk products, including butter, in the states where this is permitted.  Further, in its February 2022 guidance on Food Safety and Raw Milk, while urging consumers to understand the health risks involved, FDA affirmed that it does not intend to take enforcement action against an individual who purchased and transported raw milk across state lines solely for his or her own personal consumption.

Nicholas Prust, Natalie E. Rainer, and Frederick A. Stearns also contributed to this article.