Why Raw Butter Producers Are Suing the FDA

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Late last month, the Farm-to-Consumer Legal Defense Fund (FTCLDF)—a nonprofit membership organization that advocates on behalf of independent farmers, artisanal food producers, and their consumers, and that counts me as a board member—sued the Food and Drug Administration (FDA) to overturn the agency’s wrongheaded, illegal, decades-old ban on the interstate shipment and sale of raw (unpasteurized) butter. The Raw Milk Institute, Weston A. Price Foundation, and FTCLDF helped to fund the lawsuit.

FTCLDF filed suit along with Mark McAfee, a California member who founded Organic Pastures Dairy Company, which sells raw butter in California and which would sell outside the state—if only the FDA allowed them to do so. As the lawsuit notes, FTCLDF members across the country are in the same boat as Organic Pastures; they want to sell raw butter across state lines but cannot do so legally thanks only to the FDA.

The suit, filed in U.S. District Court in Washington, D.C., asks the court to compel the FDA to amend its regulations, which currently prohibit the “transportation of unpasteurized ‘milk or milk products’ across state lines, to explicitly exclude unpasteurized butter from the prohibition.” It also seeks to force the FDA to excise butter from its definition of “milk products.” As the lawsuit notes, Congress has already done this last thing. 

Congress, via the Food, Drug, & Cosmetic Act (FDCA), precluded the FDA from adopting regulations to define butter. That’s due in part to the fact Congress itself codified the definition of butter nearly a century ago as a “food product… made exclusively from milk or cream, or both, with or without common salt, and with or without additional coloring matter, and containing not less than 80 per centum by weight of milk fat.” 

Though that definition explicitly excludes any pasteurization requirements, the FDA ban on interstate shipment of raw butter has been in place since 1987, when a federal court ordered the FDA to prohibit the interstate shipment or sale of unpasteurized fluid milk and cream.

FTCLDF filed the lawsuit last month only after the FDA ignored a petition the group filed in 2016, asking the agency to lift its ban. In the lawsuit, the group argues the FDA’s raw-butter ban is “inconsistent both with Congress’ intent and with the FDA’s own positions regarding the relative safety of raw butter and other manufactured products created from raw milk.” And it argues “the FDA contravened both the FDCA and legal precedent” in establishing the raw-butter ban.

Why do some consumers prefer raw butter? Many consumers who choose raw butter do so because they believe it conveys health benefits that pasteurized butter does not. Others do so because they find raw butter to be “absolutely delicious.” Big-wave surfing legend Laird Hamilton is among raw butter’s devotees.

While food-safety zealots tend to freak out at any mention of unpasteurized dairy products—fluid, butter, or cheese—they might want to chill out a bit when it comes to butter. For starters, pathogens don’t grow well in butter. A European study published earlier this year found that “the chance of growth of Listeria monocytogenes in raw milk homestead butter is small.” (Unpasteurized butter is common in many countries, including those in Europe.)

The FTCLDF suit cites numerous studies—including research by the FDA itself—that supports the contention raw butter is not a good medium for pathogenic growth. It also cites the federal government’s own data, which suggests “at most–one” reported case of foodborne illness has occurred in recent decades as a result of consuming unpasteurized butter. That illness, in Utah in 2007, was caused by consuming homemade (rather than commercially sold) butter.

Not surprisingly, foodborne illnesses caused by raw butter are virtually unknown. For example, the suit notes there have been no cases of foodborne illness traced to raw butter from McAfee’s dairy, Organic Pastures, which has sold more than 2 million pounds of raw butter in California since 2001.

This isn’t rocket science.

“This decision should have been a no-brainer for the FDA,”” says Joe Ramagli, FTCLDF’s board president and a dairy farmer, in an email to me this week. “We aren’t asking them to do anything inconsistent with previous rulings on the matter. Butter is not milk nor cream, the processing involved changes its composition making it less risky as a raw product and should therefore be regulated differently.”

Both science and the law dictate that the FDA lift its ban on the interstate shipment and sale of raw butter. Hopefully, FTCLDF’s lawsuit will help make that a reality.

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