Lawsuit Over FDA Raw Butter Petition

By Pete Kennedy, Esq.

The Farm-to-Consumer Legal Defense Fund and Mark McAfee responded to FDA’s denial of their citizen petition to lift the interstate ban on raw butter by filing a complaint on May 25 with the U.S. District Court for the District of Columbia, seeking a court ruling overturning the FDA rejection of the petition (see FDA Denies Raw Butter Petition for background.) Among other things, the complaint asks for a court declaration that the denial of the petition violates the Food, Drug and Cosmetic Act (FDCA). On July 24, FDA filed an answer to the complaint, unconvincingly denying petitioners’ allegations as to why the raw butter ban is illegal. If anything, the agency’s response to the lawsuit further exposed the weaknesses in its justification of the ban.

In its February 27 letter denying the petition, FDA included a five-page table on “Illnesses and deaths associated with butter not known to be pasteurized (1908 to 2003),” listing thirteen outbreaks during the ninety-five-year period attributed to raw butter consumption. The cause of five of those outbreaks was listed as typhoid fever with a sixth outbreak blamed on both diphtheria and tuberculosis. The only deaths listed in the table were six fatalities caused by a typhoid fever outbreak in 1913. The latest U.S. outbreak according to the table was 2002; one of the thirteen listed outbreaks occurred in England.

FTCLDF and McAfee’s complaint notes, “. . . the pathogens causing diseases, including typhoid fever, diphtheria, and tuberculosis, which the FDA attributes to butter in its data in Table 1 are not listed as pathogens of concern in butter in an independent report prepared for the FDA by the Institute of Food Technologists (“IFT”), (FDA/IFT 2001). Instead of using this study and others available to the FDA, or peer-reviewed publications regarding well characterized outbreak investigations, the FDA relied on summaries in chapters in an outdated encyclopedia of food microbiology, a trade newsletter, and a lawyer’s website for references to ‘illnesses and deaths associated with butter not known to be pasteurized’ in its Table 1.”

FDA’s response to this observation was, “Defendant admits that typhoid fever, diphtheria, and tuberculosis are not included as ‘pathogens of concern’ in Table 1 on page 11 of the report prepared by the Institute of Food Technologists (“IFT”) (FDA/IFT, 2001), available at fda.gov/files/food/published/Evaluation-and-Definition-of-Potentially-Hazardous-Foods, pdf.” In other words, FDA believes that six outbreaks with no recorded fatalities attributed to “pathogens of concern” over a period of one hundred twelve years (1908-2020) is justification for the ban. In addition, FDA is clearly violating the FDCA standard-of-identity law—standards-of-identity requirements prescribing what a food product must contain to be marketed under a certain product name in interstate commerce. FDA has claimed that pasteurization can itself be part of a standard-of-identity requirement. The FDCA prohibits the agency from issuing a standard-of-identity requirement for butter; FDA is claiming that its power to regulate communicable disease has precedence over the standard-of-identity law. The evidence in the case is increasingly showing that FDA is banning a food under its power to regulate communicable disease that has made few people sick. The appeal of the FDA’s denial of the raw butter petition will be a costly process. Those wanting to support this important effort to expand freedom of food choice can donate to FTCLDF online at farmtoconsumer.org/rawbutter or call 703-208-3276.

This article was first published in the Fall 2020 issue of Wise Traditions in Food, Farming, and the Healing Arts, the quarterly journal of the Weston A. Price Foundation.