September 26, 2022

Volume XII, Number 269

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September 23, 2022

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DC Circuit Upholds FDA Ban on Raw Butter

  • 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.

 

© 2022 Keller and Heckman LLPNational Law Review, Volume XII, Number 164
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About this Author

Lisa P. Alsobrook Attorney Keller Heckman DC Office
Associate

Lisa Alsobrook practices in the area of food and drug law. She advises domestic and foreign clients on regulatory requirements for foods, dietary supplements, cosmetics, and food and drug packaging in jurisdictions around the world. Her main focus is regulatory and compliance matters of the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture relating to human food, food packaging material, animal feed, food additives and ingredients, and dietary supplements.

Prior to attending law school, Lisa earned a master’s degree in Food Science. She worked as a...

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Melvin S. Drozen, FDA, regulatory lawyer, Keller Heckman, law firm
Partner

Melvin S. Drozen joined Keller and Heckman in 1987.

Mr. Drozen advises clients on a broad spectrum of FDA, FTC, USDA and EPA (pesticides) regulatory matters, ranging from premarket approval requirements for food additives, dietary supplement ingredients, drugs, and medical devices to advertising and labeling provisions applicable to all of these products. Prior to joining Keller and Heckman, he was an Assistant District Attorney in Brooklyn, N.Y., and then an attorney in the General Counsel's Office of the Food and Drug Administration for seven...

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Jill M Mahoney Associate Attorney Keller Heckman
Associate

Jill Mahoney advises clients on regulatory requirements for food, animal feed, food additives, dietary supplements, and cosmetics. She counsels clients on labeling and advertising compliance and claims substantiation issues, including nutrition labeling, ingredient declarations, nutrient content claims, structure function claims, and Country of Origin labeling. She assists food, animal feed, and dietary supplement manufacturers in preparing self-determined GRAS positions, GRAS Notifications for Food and Drug Administration (FDA) submissions, New Dietary Ingredient Notification submissions...

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Richard Mann Partner Keller Heckman DC
Partner

Richard (Rick) Mann represents his clients in business and trade association disputes relating to food advertising, promotional and labeling claims, food safety and compliance issues, and general business and corporate law matters.

Rick works extensively with clients in the development of compliant advertising, promotional, and labeling claims and campaigns, and the development of appropriate support for such claims. His regulatory experience allows him to represent his clients in proceedings at the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), the National...

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Paula S. Pastuskovas San Francisco Food and Drug Attorney Keller and Heckman
Associate

Paula Pastuskovas counsels domestic and international clients on regulatory and compliance matters in food and drug law. She assists clients in obtaining regulatory clearances for food additives and food-contact materials from the U.S. Food and Drug Administration (FDA), Health Canada, and other comparable international agencies. She advises clients on food labeling, ingredient, and substantiation issues. 

As a resident of the firm’s San Francisco office, Paula also advises companies on compliance with California’s state and local laws. This...

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