On April 8 at 9:30 a.m. eastern, the United States Court of Appeals for the District of Columbia Circuit will hear oral argument in the case of Mark McAfee and Farm-to-Consumer Legal Defense Fund (FTCLDF) v. United States Food and Drug Administration (FDA). McAfee and FTCLDF are appealing a federal district court decision upholding FDA’s denial of appellants’ Citizen Petition to lift the interstate ban on raw butter. Appellants filed the Citizen Petition in June 2016. Minnespolis attorney and FTCLDF board member, Mahesha Subbaraman, is representing the appellants.

Raw dairy products are the only foods for human consumption banned in interstate commerce. A question for the court of appeals to consider is: does FDA have the power to prohibit raw butter from crossing state lines when the record before the court does not list a single foodborne illness outbreak definitively attributed to the consumption of commercially produced raw butter?

FDA is claiming it can ban raw butter in interstate commerce under its authority to regulate communicable disease [1], a power granted the agency by the Public Health Services Act (PHSA). Thirty years ago FDA issued a regulation banning all raw dairy products in interstate commerce other than cheese aged 60 days [2].

Does FDA have the power to issue a blanket ban on a food? Or is its authority limited to instances when a specific batch or a lot is suspected of being adulterated and/or making people sick?

The Department of Health and Human Services (HHS) has been getting lots of mileage out of its authority to regulate communicable disease. In 2020 the Centers for Disease Control (CDC) used that power to justify an order staying any eviction of residential tenants by landlords during the COVID crisis. In striking down the order, the Supreme Court found that “regulations under this authority have generally been limited to quarantining infected individuals and prohibiting the import or sale of animals known to transmit disease” [3].

Another question for the court is: can FDA require that butter be pasteurized under its power to regulate communicable disease, when the Federal Food, Drug and Cosmetic Act (FDCA) seemingly prohibits the agency from doing just that?

There is a conflicting statute in the FDCA defining butter that does not require it to be pasteurized [4]. A separate statute in the FDCA specifically mandates that “[n]o definition and standard of identity and no standard of quality shall be established for … butter” [5]. Standards of identity are requirements for prescribing what a food product must contain to be marketed under a certain name in interstate commerce; they are intended to promote honesty and fair dealing for the benefit of consumers.

The U.S. Supreme Court has held that a standard of identity exists, for purposes of the FDCA, whenever the government, “by regulation, fix[es] the ingredients of any food,” such that “a commodity cannot be introduced into interstate commerce which purports to be … [that] food … unless [the commodity] is composed of the required ingredients” [6]. The regulation governing the interstate raw dairy ban provides, in part, “No person shall cause to be delivered into interstate commerce or shall sell, or otherwise distribute…any milk or milk product [e.g., butter]…unless…made from dairy ingredients… that have all been pasteurized…” [7].

The demand for raw dairy in the U.S. is booming. There are around a dozen states that currently allow the distribution or sale of raw butter. A court decision in favor of McAfee and FTCLDF will increase that number rapidly in a short period of time as well as reduce the power of an agency that is a major threat to bodily autonomy and freedom of choice and that has long placed the profits of the pharmaceutical and biotech industries ahead of the public health.

The oral argument before the court of appeals will be livestreamed.

For more background on the Raw Butter case and related documents, go to the Farm-to-Consumer Legal Defense Fund website at https://www.farmtoconsumer.org/campaign-for-raw-food/

FOOTNOTES
1. See 42 USC 264(a)
2. 21 CFR 1240.61
3. Ala. Ass’n of Realtors v. HHS 141 S. Ct. 2485, 2487-2488.
4. 21 USC 321a
5. Subbaraman, M. Principal Brief of Appellants Mark McAfee & Farm-to-Consumer Legal Defense Fund. USCA Case 21-5170 (Document #1929731, filed 01/07/2022), p. 24 citing 21 USC 341. https://www.farmtoconsumer.org/wp-content/uploads/2022/01/Raw.Butter.1.07.22.ECF-Stamped-Opening-Merits-Brief.pdf
6. Subbaraman, p. 24 citing 62 Cases of Jam v. United States 340 U.S. 589, 593 (1951) (internal quotation marks omitted)
7. 21 CFR 1240.61(a)

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