FTCLDF Takes the FDA to Court Over Raw Butter Petition

By Pete Kennedy, Esq.

On October 22, 2019, the Farm-to-Consumer Legal Defense Fund (FTCLDF) and Mark McAfee, president of Organic Pastures Dairy Company (OPDC), filed suit in federal court seeking a court order to compel the U.S. Food and Drug Administration (FDA) to respond to a citizen petition filed by the parties in June 2016 to overturn the interstate ban on raw butter. Federal law gives the FDA six months to file a response to the petition but the agency has yet to provide a substantive answer, only sending petitioners a letter in December 2016 stating that it needed more time to respond. The Weston A. Price Foundation has donated $12,000 to this effort.

There has been a ban on raw dairy products (other than aged raw cheese) in interstate commerce since 1987. States can pass laws legalizing the sale of raw dairy products within their boundaries; less than a quarter of the states currently allow the sale or distribution of raw butter. A successful petition to lift the interstate ban would change that in a hurry. If there were no interstate prohibition, nearly all states would likely pass laws legalizing the production and sale of raw butter; most every state currently allows the production and sale of aged raw cheese.

There are several reasons the petition has a good chance of success. First, the FDA ban on raw butter violates the federal “standard of identity” law. A “standard of identity” is a requirement prescribing what a food product must contain to be marketed in interstate commerce. For instance, the standard of identity for milk is that it be either pasteurized or ultra-pasteurized and that it contain at least 3.25 percent milkfat and at least 8.25 percent non-fat milk solids. The FDA’s long-held position is that pasteurization can be part of a standard of identity requirement; standards of identity are meant to promote honesty and fair dealing for consumers.

The FDA has the power to issue standards of identity for most foods but there are exceptions and one of those is butter. The Federal Food, Drug and Cosmetic Act specifically prohibits the FDA from establishing a standard of identity for butter. Congress has passed a law defining butter, which serves as a standard of identity for the product; that definition does not require butter to be pasteurized.

Another strike against the FDA on the ban is that the case leading to the ban, Public Citizen v. Heckler, concerned only fluid milk and fluid milk products; manufactured milk products such as butter and cheese were never mentioned once in the court record. The judge ordered the FDA to issue a ruling prohibiting raw milk and raw milk products in interstate commerce but the FDA had excluded butter from its definition of “milk products” years earlier in the Pasteurized Milk Ordinance (PMO).

The PMO is a document that the FDA and others in the dairy industry have written which governs the production and sale of fluid milk and fluid milk products. The FDA exceeded its authority given by the judge in instituting the raw butter ban.

Finally, the ban on raw butter is weak because the product has little or no record of making anyone sick. CDC data from 1998 to 2016 list no cases of commercially made raw butter causing illness and only one foodborne illness outbreak where homemade raw butter was a possible suspect. Raw butter sales have been legal in California since the state’s inception, but as far back as its records go, not a single case of illness has been attributed to raw butter consumption. Organic Pastures Dairy Company has sold over two million pounds of raw butter without incident.

The McAfee/FTCLDF lawsuit asks the District of Columbia Federal District Court to order the FDA to file a response to the butter petition within thirty days. The FDA has not commented on the lawsuit.

This article was first published in the Winter 2019 issue of Wise Traditions in Food, Farming, and the Healing Arts, the quarterly journal of the Weston A. Price Foundation.