On June 10, United States Court of Appeals for the District of Columbia Circuit upheld the FDA regulation prohibiting raw butter in interstate commerce; the regulation bans all raw dairy products from crossing state lines other than cheese aged 60 days. In its ruling the court affirmed a federal district court decision supporting FDA‘s denial of a citizen petition filed by California dairy farmer Mark McAfee and the Farm-to-Consumer Legal Defense Fund (FTCLDF) to lift the raw butter ban. The appellate court’s ruling, in effect, gives the agency the power to ban a food in interstate commerce that has little or no history of making people sick. There wasn’t a single foodborne illness outbreak definitively attributed to the consumption of commercially produced raw butter in the record before the court.
In ruling the way it did, the court authorized FDA to substitute its judgment for that of Congress on a matter Congress had specifically addressed. The federal regulation banning raw butter in interstate commerce conflicts with a statute in the federal Food, Drug and Cosmetic Act (FDCA) that does not require butter to be pasteurized. A separate statute in the FDCA mandates that “no definition and standard of identity and no standard of quality shall be established for…butter.” The U.S. Supreme Court has held that a standard of identity exists for purposes of the FDCA, whenever the government, “by regulation, fixes the ingredients of any food” such that “a commodity cannot be introduced into interstate commerce which purports to be [that] food…unless [the food commodity] is comprised of the required ingredients. The regulation governing the interstate 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.” FDA issued the regulation under the authority Congress granted the agency through the Public Health Service Act to regulate communicable disease.
In its opinion the court found that the purpose of the standard of identity requirement is to ensure that consumers know what they are buying; pasteurization is a safety measure—“FDA’s public health regulatory authorities are distinct from and serve different purposes than and do not conflict with its standard of identity rules.” The court’s distinction ignores the Supreme Court ruling that for a food to be in compliance with its standard of identity it must contain the required ingredients. The federal regulation establishing the interstate raw dairy ban requires that the cream used to make butter be pasteurized; the federal statute defining butter does not have that requirement.
The U.S. Supreme Court recently held that the Environmental Protection Agency (EPA) exceeded the authority granted it by Congress when EPA issued regulations concerning “climate change”. The court has also struck down an order by the Centers for Disease Control (CDC) issued under its power to regulate communicable disease to stay any conviction of residential tenants by landlords during the COVID crisis; in so doing, the 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.”
It’s time for the high court to end FDA‘s power grab to ban any food it wants, especially foods that make few, if any, sick. Otherwise, an agency that willingly approved the sale of genetically modified foods and lab-grown meat will be in a stronger position to help grow the market for synthetic food, something that the agency’s primary clients—the biotechnology and pharmaceutical industry—are both pushing for.
McAfee and FTCLDF are not appealing the ruling to the U.S. Supreme Court.