By Pete Kennedy, Esq.
On June 22 Mark McAfee, the president of Organic Pastures Dairy Company (OPDC), and the Farm-to-Consumer Legal Defense Fund submitted a citizen petition to FDA requesting that the agency lift the interstate ban on raw butter; McAfee has withdrawn an earlier petition he filed in March 2015 making the same request.1,2
The ban has been in place since 1987 when FDA issued a regulation in response to a court order (Congress, the people’s branch, had no say in instituting the ban). The case1 leading to the ban, interestingly, was never about manufactured dairy products such as butter and cheese but was only concerned with fluid dairy products such as milk and cream.
FDA has banned raw butter and all other raw dairy products (except aged raw cheese) under power given the agency by the Public Health Service Act (PHSA) to regulate communicable disease. FDA’s assertion of this power in banning raw butter is dubious for two reasons: first, the ban violates the Federal Food and Drug Cosmetic Act (FFDCA); and second, FDA is trying to prohibit a food in interstate commerce that has little or no record of making anyone sick.
FDA’s butter ban is illegal according to a statute in the FFDCA that governs standards of identity for food.3 Standards of identity are requirements prescribing what a food product must contain to be marketed under a certain name in interstate commerce. For instance, the standard of identity for milk in final package form requires that it be pasteurized or ultrapasteurized and that it contain not less than 8.25 percent non-fat milk solids and not less than 3.25 percent milkfat.4,5 FDA’s long-held position is that the pasteurization requirement can be part of the standard of identity. Standards of identity are intended to promote honesty and fair dealing for the benefit of consumers.
Congress has given FDA power to issue regulations establishing standard of identity requirements for most foods, but there are exceptions, and one of those is butter. The FFDCA specifically prohibits FDA from establishing a standard of identity for butter;6 Congress has passed a law defining butter, which serves as a standard of identity for the product.7 That definition does not require butter to be pasteurized. The petition asks FDA to obey the law and abide by the statutory standard of identity for butter.
FDA is, in effect, claiming that its power to regulate communicable disease justifies its violation of the standard of identity law. According to the PHSA, “The Surgeon General, with the approval of the Secretary [of Health and Human Services], is authorized to make and enforce such regulations as are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the states or possessions, or from one state or possession into any other state or possession. For the purposes of carrying out and enforcing such regulations, the Surgeon General may provide for such inspection, fumigation, disinfection, sanitation, pest extermination, destruction of animals or articles found to be so infected or contaminated as to be sources of dangerous infection to human beings, and other measures, as in his judgment may be necessary.”8
The claim that this power authorizes FDA to ban raw butter is definitely a stretch. The citizen petition notes that since the Centers for Disease Control (CDC) created the Foodborne Outbreak Online Database in 1998, not even one foodborne illness outbreak has been attributed to the consumption of commercially produced raw butter.9 There was one 2007 outbreak in Utah where what appears to be homemade butter is listed as a possible cause as are raw milk and homemade soft raw cheese;10 given raw butter’s history of complete safety, it is more likely that either the milk or cheese was the cause of the illnesses. OPDC has sold over 2 million pounds of raw butter since 2001 without a single case of foodborne illness linked to such sales.11
So where is the communicable disease threat with raw butter? How can FDA ban a food responsible for few, if any, cases of foodborne illness? FDA is getting lots of mileage out of its power to regulate communicable disease; the agency claims that the PHSA enables it to impose federal Current Good Manufacturing Practices (CGMP) requirements on food businesses operating exclusively in intrastate commerce. According to FDA, its power to regulate communicable disease gives it authority to impose requirements for the following: “plants and grounds; sanitary facilities, controls and operations; equipment and utensils; warehousing and distribution; and natural or avoidable defect levels.”12 FDA has indicated that there is no exemption from the CGMP mandates for a business operating only in intrastate commerce.
There is nothing in any section of the PHSA—nor in its legislative history—indicating the FDA has authority to inspect an intrastate food business when there is no credible evidence that the business is producing food under unsanitary conditions or is responsible for a foodborne illness outbreak, but FDA is carrying on like there are no limitations to its powers to regulate communicable disease.
Is it farfetched to think that FDA can regulate private kitchens, pantries, refrigerators and freezers in the name of regulating communicable disease? Sure, but it was farfetched at one time to think that FDA could ban a food in interstate commerce that makes few, if any, people sick—while violating a law it was charged with enforcing.
Congratulations to attorney and FTCLDF board member Judith McGeary and microbiologist Peg Coleman for their work on the petition. Updates on the citizen petition to lift the interstate raw butter ban will be posted as developments warrant.
- Public Citizen v. Heckler 653 F. Supp. 1229
- Mark McAfee and Farm-to-Consumer Legal Defense Fund, “Citizen Petition Seeking Legalization of Interstate Transport of Unpasteurized Butter,” June 22, 2016, p. 5
- United States Code, 21 USC 341
- Code of Federal Regulations, 21 CFR 131.110
- Petition, p. 8
- 21 USC 341, “No definition and standard of identity and no standard of quality shall be established for fresh or dried fruits, fresh or dried vegetables, or butter, except that definitions and standards of identity may be established for avocadoes, cantaloupes, citrus fruits, and melons.”
- 21 USC 321a, “For the purposes of the Food and Drug Act of June 30, 1906 (Thirty-fourth Statutes at Large, page 768) ‘butter’ shall be understood to mean the food product usually known as butter, and which is 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, all tolerances having been allowed for.”
- 42 USC 264(a)
- Petition, p. 9
- Petition, p.10
- Petition, p. 11
- Federal Register, 78 FR 3646, 3651
This article first appeared in the Fall 2016 issue of Wise Traditions, the quarterly journal of the Weston A. Price Foundation.
About the Author
Pete Kennedy is an attorney from Sarasota, Florida and president of the Farm-to-Consumer Legal Defense Fund (farmtoconsumer.org). He compiled the state milk laws posted at realmilk.com. He advises many farmers and members about legal issues surrounding raw milk.