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FEDERAL - LAWSUIT OVER FDA RAW BUTTER PETITION
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 Wise Traditions Spring 2020
issue 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, unconvinc-
ingly 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 associ-
ated 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characterized outbreak investigations, the FDA relied on summaries in chapters in an outdated encyclopedia of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 Tech-
nologists (“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.

2000 Raw milk available in 27 states

2020 Raw milk available in 43 states
(thanks to the efforts of A Campaign for Real Milk)

Our Goal: Raw Milk available in all 50 states! Help us
make raw milk sales legal in the remaining 7 states.

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