On March 25, Governor Gary Hebert signed House Bill 134 (HB 134) into law. The bill legalizes the sale of raw butter and raw cream in Utah; HB 134 took effect immediately. Representative Kim Coleman (R) was the lead sponsor for the legislation.
With the Utah law taking effect, there are now around twenty states that allow the sale or distribution of raw cream for human consumption; around a dozen states allow the sale or distribution of raw butter. There are at least two other states considering the legalization of raw butter sales.
The United States Food and Drug Administration (FDA) remains the greatest roadblock to the legalization of raw dairy products in the U.S. On February 27, FDA rejected a petition to lift the interstate ban on raw butter filed by the Farm-to-Consumer Legal Defense Fund and Mark McAfee, the biggest producer of raw butter and cream in the country. In its rejection letter, one of the agency’s justifications for maintaining the prohibition was that raw butter was responsible for a foodborne illness outbreak occurring on average every 7 or 8 years; a standard that, if applied consistently across our food supply, would make many foods illegal in interstate commerce. As time goes on, an increasing number of states will no longer side with FDA, taking matters into their own hands by legalizing sales of raw dairy products in intrastate commerce.
HB 134 marks the third time in the last five years that a Utah raw milk bill has passed into law. In 2015, the mother-daughter team of Symbria and Sara Patterson were mainly responsible for the passage of a law legalizing the distribution of raw milk and raw milk products through micro-dairy herd share agreements. In 2018, Red Acre Center, a nonprofit formed by the Pattersons, was the driver in passing a law allowing the unlicensed on-farm sale of raw milk and the delivery of raw milk by licensed dairies. A bill similar to HB 134 nearly passed in the 2019 session; under the new law, licensed dairies can sell raw butter and raw cream on the farm, through delivery, and at a retail store if the dairy has a majority ownership interest in the store.
The passage of HB 134 comes at a time when, with the Covid-19 situation, demand for food direct from the farm is soaring. Legal raw butter and cream will move more of the food dollar to where it belongs–at the farms producing some of the safest, most nitrient-dense foods available.
As expected, the U.S. Food and Drug Administration has denied a citizen petition from the Farm-to-Consumer Legal Defense Fund (FTCLDF) and Organic Pastures Dairy Company (OPDC) to lift a ban on the interstate distribution and sale of raw butter.
In a February 27 letter to FTCLDF and OPDC, Mark Moorman, Director of FDA’s Office of Food Safety and Applied Nutrition, stated: “Your Petition does not contain facts demonstrating reasonable grounds…to allow the interstate delivery or sale or distribution of raw cream butter. Further, your petition does not substantially show that your proposal is in the public interest and will promote the public health objectives of FDA and the statutes we administer….”
Allowing access to a nutritious raw dairy product like butter is not a “public health objective” of FDA.
While FDA’s decision wasn’t a surprise, the weakness of its response to the petition was. At the end of the FDA letter was a five-page table on “Illnesses and deaths associated with butter not known to be pasteurized, (1908 to 2003).” There were 13 outbreaks during that 95-year timeframe attributed to raw butter consumption, with one of the outbreaks occurring in England.
Of those 13 outbreaks, all but one described the butter as “Not Specified but commonly unpasteurized” or “Not Specified.” The one entry listed as “Unpasteurized” is a 2001-2002 outbreak where 202 people in North Carolina allegedly became ill from butter. This entry is different from the CDC’s foodborne illness outbreak database, which attributes the illnesses to “other milk, unpasteurized”. According to published articles, homemade butter was served to elementary school students as part of a demonstration.
Seven of the 13 outbreaks fail to specify the “Total Number of Illnesses”; one shows “reports of consumer injuries” while six show “NA” (meaning, “Not Available / Not Reported”). One of the entries, a 1991 outbreak where 265 people became ill in California and Nevada, lists the implicated food as “blended butter and margarine products”. How often has raw butter been blended with margarine — ever?
Two of the 13 outbreaks indicate that someone was hospitalized — one person in one case, four in the other. The remainder indicate that no data is available. Only one of the 13 outbreaks specified whether there were any deaths (i.e., six in a 1913 Minnesota outbreak). Again, the remainder indicated that no data is available.
If a petitioner had submitted a graphic to FDA with data this incomplete, the agency would have rejected it out of hand. Even if FDA is correct on the number of outbreaks attributed to raw butter consumption, the total amounts to one outbreak every seven or eight years. If that is the standard for banning a food in interstate commerce, many foods would be illegal.
Much of FDA’s response consisted of disagreeing with the petitioners’ interpretation of various studies regarding butter and pathogenic bacteria, as well as citing challenge tests (such as studies in which butter is inoculated with pathogens, then observed to monitor what happens). Shouldn’t the ultimate determining factor be, from a scientific standpoint, how many people have gotten sick from consuming a food?
The CDC database on foodborne illness outbreaks from 1998-2016 that FTCLDF and OPDC used in their petition to FDA doesn’t blame a single outbreak on commercially produced raw butter, and only one outbreak is blamed on homemade raw butter [Utah in 2007].
FDA tried to downplay raw butter’s impressive safety track record by pointing to the 1987 interstate ban as the reason there have been almost no outbreaks. However, raw butter sales have been legal in California since the state’s inception. Mark McAfee, OPDC’s president, stated that his company has sold well over 2 million lbs. of raw butter the past 20 years without illness. About 10 other states allow the sale or distribution of raw butter.
Aside from the small number of foodborne illness outbreaks attributed legitimately or otherwise to raw butter consumption over the past 112 years, the FDA denial of the petition could be vulnerable to a court challenge in other areas.
The butter ban is illegal according to a statute (21 USC 341) in the Federal Food, Drug and Cosmetic Act that governs “standard of identity” for food which are requirements prescribing what a food product must contain to be marketed under a certain product name in interstate commerce. For instance, the standard of identity for milk requires that it be pasteurized or ultra-pasteurized and that it contain not less than 3-¼ percent milkfat [21 CFR 131.110]. The citizen petition notes that FDA addressed the question of requiring pasteurization as part of a standard of identity regarding milk and found that such health-based requirements were properly addressed as standards of identity stating: “The Commissioner rejects the contention that section 401 of the act does not permit provisions of a standard of identity to be promulgated for health reasons. [39 Fed. Reg. 42,351 (Dec. 5, 1974)]”
Congress has given FDA power to establish standard of identity requirements for most foods but specifically prohibits the agency from doing so for butter. In its response FDA justified its violation of the standard of identity by claiming the Public Health Service Act gives it authority to require pasteurization for butter as part of its power to regulate communicable disease, a stretch given the food safety track record of raw butter. FDA, in its response, argued that standard of identity was about protecting consumers against economic adulteration and reflecting consumer expectations about food, contradicting its earlier statement that health reasons can also be a factor in these regulations.
A second area where FDA is on weak ground is that, in the lawsuit that resulted in the court order to FDA to impose the ban [Public Citizen v. Heckler, 653 F. Supp. 1229 (D.C. District, 1987)], butter is not mentioned at all in the court record of the case. Butter, like cheese, is considered a manufactured milk product. The lawsuit sought the ban of all raw milk and raw milk products in interstate commerce. The definition of “milk products” in the FDA Pasteurized Milk Ordinance (PMO)–the governing document for the production and distribution of milk and milk products in interstate commerce–does not include butter or cheese.
The court record only discussed dairy products that were listed in the PMO definition of “milk product.” When the court ordered FDA to ban “raw milk’ and ‘raw milk products’, it was only those products under that definition. In its response, FDA claimed the court order banned all products made from raw milk but, if the agency is correct in its interpretation, aged raw milk cheeses wouldn’t be legal in the U.S. as they have always been. The impetus for the litigation that resulted in the court order was the lack of FDA enforcement on standard of identity regulations requiring pasteurization for milk and various milk products–because of the statutory prohibition, there is no standard of identity regulation for butter.
Farm-to-Consumer Legal Defense Fund (FTCLDF) is appealing the FDA denial to the federal district in court in the District of Columbia. The appeal to challenge FDA is likely to be costly as it will require paying scientific experts as well as attorneys. FTCLDF could really use your financial support. Overturning the butter ban is a big step toward a day when all raw dairy products will be legal in interstate commerce.
To donate specifically to support the case to overturn the FDA decision, you may donate online or call 703-208-3276.
On April 30 Governor Bill Lee signed into law Senate Bill 358 (SB 358); the legislation legalizes the sale of raw butter by licensed producers in Tennessee. SB 358, sponsored by Senator Frank Niceley, a long-time champion of the small farmer and local food, goes into effect immediately.
SB 358, as amended in the House and passed, provides that
“the department [of agriculture] shall not regulate the production of unpasteurized butter provided that it is produced:
(A) In a facility separate from production of pasteurized products;
(B) Solely for intrastate commerce; and
(C) By a person licensed by the department as a dairy plant.
On any raw butter sold, the bill also requires a warning label stating, among other things, that the product has not been inspected and that butter “may contain disease-causing micro-organisms.”1
According to the Centers for Disease Control (CDC), between 1998 and 2016, there was not a single foodborne illness outbreak attributed to the consumption of commercially-produced raw butter2; during that time, California-based Organic Pastures Dairy Company (OPDC) sold over two million pounds of the product without incident3. The labeling requirement was a concession that had to be made if the bill was going to pass.
It’s not clear why the Tennessee Department of Agriculture (TDA) would not regulate the production of butter from a licensed dairy plant but the answer could possibly be because of some agreement the department has with the federal government.
SB 358 allows the retail sale of raw butter; Tennessee joins Arizona, California, Idaho, and Maine as states allowing the sale of the product in retail stores. There are around a dozen states that allow the sale or distribution of raw butter for human consumption.
Niceley introduced a bill in 2018 that would have legalized raw butter sales, but that legislation didn’t make it out of House committee after passing the Senate. With the accelerating decline of the state dairy industry over the past year, SB 358 did not have any significant opposition. One point Niceley made during consideration of the bill was about the increasing competition from lab-grown dairy products to the conventional industry, saying that laboratories could produce pasteurized dairy products at a much lower price than the dairy industry could and that the industry needed to separate itself from that competition with the production and sale of raw dairy products.
It is uncertain at this time how many of the state’s licensed dairy plants are interested in selling raw butter but the potential is there. None of Tennessee’s neighbors allow raw butter sales; there could be out-of-state customers buying butter in Tennessee. Cheesemakers from other states could be moving in with an additional high-demand product to sell. If demand does take off, some of the state’s remaining dairies could obtain higher prices for their milk by selling some of their production to dairy plants instead of cooperatives where most are losing money with each load they ship.
The Farm-to-Consumer Legal Defense Fund (FTCLDF) has a citizen petition4 before the U.S. Food and Drug Administration (FDA) to lift the interstate ban on sales and distribution of raw milk and other raw dairy products (except aged cheese). If the petition is successful, it is likely raw butter sales would be legal in all states within a few years. Until that time, there should still be a steady increase in states allowing raw butter sales or distribution.
Brentwood Chapter Leader Shawn Dady lobbied for the bill on behalf of the Weston A. Price Foundation (WAPF). Congratulations to her, Senator Niceley, and the other Tennesseans supporting SB 358 for legal raw butter sales5, in time for the spring flush.
 House Amendment Number 1 to HB0532 (HA0116), Tenn. House § 1 (2019). Last accessed 5/7/2019 at http://www.capitol.tn.gov/Bills/111/Amend/HA0116.pdf
 Mark McAfee and Farm-to-Consumer Legal Defense Fund, “Citizen Petition Seeking Legalization of Interstate Transport of Unpasteurized Butter”, petition, June 22, 2016; p. 10
 Ibid. p. 11
 For more details about the citizen petition, read “FTCLDF Hires Jim Turner to Litigate Raw Butter Petition” at https://www.realmilk.com/turner-litigate-raw-butter-petition/
 Thanks to an opinion from the Attorney General, the state has allowed the distribution of raw butter and other dairy products since 2012 through herdshare agreements.
The Farm-to-Consumer Legal Defense Fund (FTCLDF) has hired veteran Washington, D.C. attorney, Jim Turner, to litigate an FDA Citizen Petition seeking to lift the interstate ban on raw butter for human consumption. FTCLDF and Mark McAfee, president of Organic Pastures Dairy Company (OPDC), filed the petition with the Food and Drug Administration (FDA) on July 1, 2016; to date, FDA has yet to provide a substantive response.
The Weston A. Price Foundation (WAPF) and the Communities Alliance for Responsible Eco-agriculture (CARE) are providing funding for Turner’s legal expenses. WAPF is the leading advocacy group in the U.S. for raw milk and raw milk products, including butter. CARE is a Pennsylvania-based food buyers club that has long been a strong supporter of freedom of food choice, especially raw dairy products.
Turner is no stranger to FDA, having dealt with the agency on various matters since the 1960s. His law practice consists of representing businesses, individuals, and consumer groups on regulatory issues concerning food, drug, health product safety and environmental matters.
In 1970 he was largely responsible for getting Cyclamate, an artificial sweetener, pulled off the market. For nearly ten years he fought against FDA and the G.D. Searle Corporation in an effort to take the artificial sweetener, aspartame, off the market. There have been more complaints filed with FDA about aspartame than any other food product.
Federal law requires FDA to file a response to a citizen petition within six months after receiving a copy. In December 2016 FDA sent FTCLDF and McAfee a letter stating it needed more time to review the petition; in the two years since, the agency has sent nothing to the two petitioners. If Turner can’t convince FDA to issue a substantive response to the petition, he will likely file a writ of mandamus motion in a federal district court to have the court compel FDA to respond. If FDA rejects the petition, petitioners can appeal the agency’s decision to a federal appellate court.
There has been a federal ban on raw milk and raw milk products for human consumption (other than raw cheese aged sixty days) in interstate commerce since 1987 when FDA issued a regulation (21 CFR 1240.61) establishing the ban in response to a court order. Three arguments Turner can make to lift the ban are: that FDA exceeded its authority in banning raw butter since the case resulting in the court order, Public Citizen v. Heckler, only concerned fluid milk products (milk, cream, yogurt) not manufactured milk products (butter, cheese); that federal statute (21 CFR 341) prohibits FDA from issuing a federal ‘standard of identity’ regulation for butter [standards of identity are requirements prescribing what a food product must contain to be marketed–pasteurization is one such requirement]; and that there isn’t a single foodborne illness outbreak attributed to the consumption of commercially produced raw butter [OPDC has sold over 2 million pounds of raw butter since 2001 without incident]. FDA is basically claiming that its power to regulate communicable disease allows it to ban a food that makes few, if any, sick.
The butter petition is a great opportunity to weaken the interstate raw dairy ban — a significant step towards the day when the transport of all raw dairy products across state lines will be legal. Jim Turner has the experience and ability to make that happen.