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.

The post Appellate Court Upholds Raw Butter Ban  appeared first on Real Milk.

On May 24, U.S. District Judge Rudolph Contreras (2021)¹ rubber-stamped the U.S. Food and Drug Administration‘s (FDA’s) denial of a citizen petition² filed by the Farm-to-Consumer Legal Defense Fund and dairy farmer Mark McAfee (petitioners) to lift the interstate ban on raw butter, disposing of petitioners’ appeal³ by granting FDA‘s motion for summary judgment. The upshot of the judge’s decision is that FDA can ban any food in interstate commerce it wants under its power to regulate communicable disease;⁴ FDA did not provide any evidence in the case specifically establishing that commercially produced raw butter has ever been blamed for causing a foodborne illness outbreak in the U.S.⁵

FDA had rejected the petition in February 2020⁶, and FTCLDF and McAfee appealed to the U.S. District Court for the District of Columbia. Two issues were before Judge Contreras: whether FDA had the statutory authority to require pasteurization for butter, and second, whether FDA acted arbitrarily when it banned a food in interstate commerce that had little or no record of making people sick.

Through a statute in the Federal Food, Drug and Cosmetic Act (FFDCA, 21 USC 341⁷), Congress has given FDA the power to issue standard of identity regulations for most foods; standard of identity regulations 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 ultra-pasteurized and that it contain not less than 8.25% non-fat milk solids and not less than 3.25% milkfat.⁸ FDA’s long-held position is that the pasteurization requirement can be part of the standard of identity. As Judge Contreras noted in his opinion (p. 6),⁹ standards of identity “promote honesty and fair dealing in the interest of consumers.”

There are several foods that Congress prohibits issuing standard of identity regulations for and one of those is butter. Congress has defined butter in the FFDCA which serves as a standard of identity for the food; that definition does not require that butter be pasteurized. When FDA violated the FFDCA by requiring that butter in interstate commerce be pasteurized, they claimed it had the power to do so under the authority given it to regulate communicable disease⁴. The Public Health Service Act (PHSA) authorizes FDA “to make and enforce such regulations as in its judgment are necessary to prevent the introduction, transmission or spread of a communicable disease from foreign countries into the states or possessions or from one state or possession into any other state or possession” (42 USC 264).¹⁰ There is little or no evidence that Congress intended to give FDA the power to ban a food completely in interstate commerce under the PHSA, but that is what the judge found in his opinion.

In discussing the conflict between the FDA’s pasteurization requirement under the PHSA and the FFDCA’s statutory definition of butter, the judge stated:

• [T]he two statues hardly touch on the same topic, much less conflict in such a way that one would have to supersede the other. While the PHSA is concerned with containing the spread of infectious diseases regardless of the means of transmission, standards of identity are meant to ensure that consumers know what foods they are buying. Rarely do two statutes with such different purposes conflict.⁹ (p. 7)

What the judge ignored in making this statement is that both standard of identity regulations and Congress’ definition of butter are concerned with public health; the 60-day aging requirement for raw cheese and the pasteurization requirement for milk and other dairy were implemented by FDA because of the agency’s health concerns. When Congress passed the law creating the definition for butter, it didn’t think a pasteurization requirement was necessary to protect the public health; it could have amended the definition at any time since to require pasteurization but has never done so.

The second issue before the court was petitioners’ claim that the pasteurization requirement for butter was scientifically “unsupported” and therefore “arbitrary, capricious, an abuse of discretion or otherwise not in accordance with law” (pp. 4, 17).³ On this issue, the judge’s holding against McAfee and FTCLDF was even more troubling. The most important consideration in determining whether there is scientific support for banning a food in interstate commerce is looking at the food’s history of making people ill. In the court record before Judge Contreras, there are only two foodborne illness outbreaks since 1908 where raw butter is definitively listed as the suspected cause of illness; in both outbreaks the butter was homemade.¹¹ In its letter to McAfee and FTCLDF rejecting the petition, FDA included a table listing 13 foodborne illness outbreaks attributed to butter from 1908 through 2003. There is a column in the chart indicating pasteurization status; only one of the outbreaks has “unpasteurized” in the column while the other 12 have either “not specified” or “not specified but commonly unpasteurized” in the table (pp. 18-22).¹¹

The judge upheld the ban on raw butter in interstate commerce even though FDA failed to specifically link a single outbreak to commercially produced raw butter. There are a dozen states that allow the sale or distribution of raw butter, including California where Organic Pastures Dairy Company, a business McAfee founded, has sold well over 2 million pounds of raw butter the past 20 years without incident (p.14).³

The judge justified his decision by indicating FDA’s findings that raw butter could contain pathogens that may cause illness were sufficient for him to uphold the ban, but shouldn’t the number of illnesses a food has caused be a more important consideration? Moreover, any food that is improperly produced or handled is capable of making people sick. FDA shouldn’t have the power to ban any food under its authority to regulate communicable disease; under the judge’s ruling, there isn’t a food the agency conceivably couldn’t ban.

In his ruling, Judge Contreras stated that the court had to be “highly deferential” on FDA‘s decision to ban raw butter, citing a legal doctrine called Chevron Deference, a doctrine which basically leaves the courts powerless to overturn agency decisions (p. 4).¹ As long as Chevron Deference is in effect, lawyers for the agencies before the court might as well write the opinions themselves. If the courts ever want to reestablish their independence in reviewing agency decisions, this doctrine needs to go.

The best path to overturning the sham that is the raw butter ban is to legalize its sale or distribution one state at a time. Tennessee legalized the retail sale of raw butter in 2019.¹² Utah did the same in 2020,¹³ and Montana has legalized the sale from producer direct to consumer in 2021.¹⁴ The petition has further established the excellent track record for food safety of raw butter; the move to legalize sales of the product in the state legislatures should continue.

Alexia Kulwiec, executive director of the Farm-to-Consumer Legal Defense Fund, offered this statement, “FTCLDF is very disappointed¹⁵ in the decision, and has until late July to decide whether it will appeal. FTCLDF is considering all available options at this time.”¹⁶

Photo Credit: “Bread and Butter” by Marina Shemesh on PublicDomainPictures.net

References

1. Contreras, R. (2021, May 24). Order: Denying plaintiffs’ motion for summary judgment and granting defendant’s motion for summary judgment. [19-3161 (RC)] U.S. District Court for District of Columbia. https://www.realmilk.com/wp-content/uploads/2021/07/2021-05-24-Order-Denying-Plaintiff_Granting-Def-SJ.pdf

2. McAfee, M., & Farm-to-Consumer Legal Defense Fund. (2016, June 22). Citizen petition seeking legalization of interstate transport of unpasteurized butter. p. 5.
https://www.realmilk.com/wp-content/uploads/2020/03/1-CitPetFDA-Butter-062216-1-1.pdf

3. McAfee, M., & Farm-to-Consumer. (2020, May 25). Second amended complaint [Civil Action No. 19-3161]. https://www.realmilk.com/wp-content/uploads/2021/07/Filed-Second-Amended-Complaint-5.26.20.pdf

4. Kennedy, P. (2017, April 14). Raw butter, a communicable disease? A Campaign for Real Milk. https://www.realmilk.com/raw-butter-communicable-disease/ (Originally published 2016, June 23 at
Farm-to-Consumer

5. Kennedy, P. (2016, March 17). OPDC citizens petition for raw butter. A Campaign for Real Milk. Citing “the CDC has no outbreaks, no cases of illness or death recorded in its databases related to commercially produced raw butter illness or pathogen defects.” https://www.realmilk.com/opdc-citizens-petition-for-raw-butter/

6. Kennedy, P. (2020, March 18). FDA Denies Petition to Lift Interstate Ban on Raw Butter. A Campaign for Real Milk. https://www.realmilk.com/fda-denies-petition-to-lift-interstate-ban-on-raw-butter/

7. United States Code. (1938/1993). 21 USC 341 – Definitions and standards for food: “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.” Legal Information Institute, Cornell Law School. Retrieved July 4, 2021 from https://www.law.cornell.edu/uscode/text/21/341

8. Department of Health and Human Services. (1993/2020, November 10). 21 CFR 131.110(a) – Milk. Code of Federal Regulations. Retrieved July 4, 2021 from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=131.110

9. Contreras, R. (2021, May 24). Memorandum opinion: Denying plaintiffs’ motion for summary judgment and granting defendant’s motion for summary judgment. U.S. District Court for District of Columbia. [McAfee et al v. U.S. Food and Drug Administration, No. 1:2019cv03161 – Document 23 (D.D.C. 2021). https://law.justia.com/cases/federal/district-courts/district-of-columbia/dcdce/1:2019cv03161/212153/23/] Accessible at https://www.realmilk.com/wp-content/uploads/2021/07/2021-05-24-Memorandum-Opinion-on-SJ-Orders.pdf

10. United States Code. (1944/2002). 42 USC 264 – Regulations to control communicable diseases. Legal Information Institute, Cornell Law School. Retrieved July 4, 2021 from https://www.law.cornell.edu/uscode/text/42/264

11. FDA. (2020, February 27). Letter from FDA to Mark McAfee and Pete Kennedy, Re: Docket No. FDA-2016-P-1852 [Letter]. https://www.realmilk.com/wp-content/uploads/2021/07/FDA-RawButterPetition-Response-2-27-2020.pdf

12. Kennedy, P. (2019, May 7). Raw butter sales now legal in Tennessee. A Campaign for Real Milk. https://www.realmilk.com/tennessee-raw-butter-sales-now-legal/

13. Kennedy, P. (2020, April 19). Raw Butter and Raw Cream Sales Now Legal in Utah. A Campaign for Real Milk. https://www.realmilk.com/raw-butter-and-raw-cream-sales-now-legal-in-utah/

14. Kennedy, P. (2021, May 10). Montana Local Food Choice Act Now Law. A Campaign for Real Milk. https://www.realmilk.com/montana-local-food-choice-act-now-law/

15. Kennedy, P. (2020, March 21). FTCLDF Takes the FDA to Court Over Raw Butter Petition. A Campaign for Real Milk. https://www.realmilk.com/ftcldf-takes-the-fda-to-court-over-raw-butter-petition/

16. Kulwiec, A. (personal communication via email, 2021, June 16).

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The Farm-to-Consumer Legal Defense Fund has agreed to represent Organic Pastures Dairy Company (OPDC) over OPDC’s citizens petition to modify the interstate ban on raw butter. FTCLDF general counsel Gary Cox will be representing McAfee. The petition filed by OPDC founder and president Mark McAfee requests that “salted or cultured raw butter that is tested, state inspected, state regulated, carries a ‘government approved warning statement’, and labeled for retail sale in one state may be transported to another state if that other state allows the sale of unpasteurized dairy products.” McAfee had previously filed a petition to modify the interstate ban on raw milk but had abandoned that effort shortly after FDA rejected his petition in 2013 (see OPDC Case Update, Spring 2013).

OPDC filed the raw butter petition on March 2, 2015 and has yet to receive an answer from FDA; under federal law the agency has six months to submit a response to a citizens petition.

With the evidence provided in the petition it is difficult to see how raw butter could ever have been banned in interstate commerce. In response to the Freedom of Information Act (FOIA) requests filed by McAfee, neither the California Department of Public Health (CDPH) nor the California Department of Food and Agriculture (CDFA) could find a single case of foodborne illness being attributed to raw butter consumption; CDPH’s search went back 20 years while CDFA’s search went back 40. Further, according to the petition, “the CDC has no outbreaks, no cases of illness or death recorded in its databases related to commercially produced raw butter illness or pathogen defects.” The petition claims there is only one foodborne illness outbreak linked to non-commercially made butter. The petition points out that during the court case leading to the ban (Public Citizen v. Heckler), “there were no illness or evidence of risk presented on raw butter” and that the case actually involved only raw milk.

McAfee also filed a FOIA request with FDA asking for any data or information on raw butter consumption being linked any case of human illness but has not received an answer.

There is much at stake in the case; there are around 30 states that allow the sale of raw dairy products (usually milk and cheese aged 60 days). Most of these states do not allow the sale of raw butter, meaning that—if the petition were to be successful—there would be access for many consumers who currently cannot obtain it. The granting of the petition could also spur state legislatures to pass laws legalizing the sale of butter and other raw dairy products. It will be interesting to see what defense FDA has for banning a product that has a better track record for food safety than most “legal” foods. FTCLDF will be providing updates on the case as events warrant.

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Those looking to buy only the highest quality cheeses should also keep an eye out for cheese made from pastured animals. According to a recent article, High Quality Raw Milk Cheese is Healthy, cheese made from grass-fed cows has the ideal omega-6 to omega-3 fat ratio of 2:1 whereas pasteurized cheese has a 25:1 ratio, which is already excessive in Americans’ fatty diets. Furthermore, grass-fed cheese “…is considerably higher in calcium, magnesium, beta-carotene, and vitamins A, C, D and E.”

Gouda, Brie and Edam cheese are safe bets. Read it for more tips on how to pick out the healthiest cheeses.

The Campaign for Real Milk is a project of the Weston A. Price Foundation, a nutrition education non-profit based in Washington, D.C. To learn more about raw milk and other nutrient dense foods, attend one of the upcoming Wise Traditions conferences.

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This Friday, on Independence Day, Farm-to-Consumer Legal Defense Fund turns 7 years old! That means 7 years of defending our rights to farm fresh, organic and beyond organic foods! And 7 years of helping small farmers through their worst nightmare, a farm shut down, seizure or raid. And, of course working on the federal and state level to pass farm friendly policies like the one that became law this week (See yesterday’s press release, Landmark Agricultural Bill Becomes Law in Virginia.

Celebrate Farm-to-Consumer Legal Defense Fund’s Birthday today! Give to the Annual Appeal: http://members.farmtoconsumer.org/donations/

The Campaign for Real Milk is a project of the nutrition education non-profit, The Weston A. Price Foundation. Donate to help fund research into the benefits of nutrient dense foods.  westonaprice.org/lab

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Happy Independence Day for Farmers and Consumers!

Today is the 6th birthday of Farm-to-Consumer Legal Defense Fund. Their mission is to promote wider consumer access to nutrient dense foods such as raw milk. We want to thank them for all they are doing to help spread the raw milk sunshine around our world!

Fan FTCLDF in Facebook!

Support their annual fundraising appeal by making your contribution to their great efforts.

The Campaign for Real Milk is a project of The Weston A. Price Foundation.

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Gary Cox addresses the crowd gathered at Jake Zook’s farm in Christiana, Pennsylvania for the launch of the Farm-to-Consumer Legal Defense Fund on July 4, 2007. Photo by Jill Nienhiser

People gather in the big tent at Jake Zook’s farm in Christiana, Pennsylvania to hear speakers at the launch of the Farm-to-Consumer Legal Defense Fund on July 4, 2007. Photo by Jill Nienhiser

The post FTCLDF Launch appeared first on Real Milk.

Farm-to-Consumer Legal Defense Fund (FTCLDF) was launched on Independence Day, July 4, 2007. FTCLDF is a non-profit organization recognized under the Internal Revenue Code as a Section 501(c)(4) organization.

FTCLDF protects the rights of the nation’s family farms, artisan food producers, consumers and affiliate communities to engage in direct commerce free of harassment by federal, state and local government interference; it protects the rights of farmers and artisanal producers to make their products available and the rights of consumers to access the foods of their choice from the source of their choice.

FTCLDF is a true grassroots organization and receives the bulk of its revenue from membership fees and private individual donations. “Corporate” donations come from small businesses that support local food production; FTCLDF receives no funding from any government agency.

Join the Fund today to protect your access to raw milk and other nutrient-dense foods!
Learn more and join at their website: farmtoconsumer.org

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Intrepid WAPF secretary Geoffrey Morell attended the 100th year meeting of the International Association for Food Protection (IAFP), held in Milwaukee, Wisconsin, July 31 through August 4. Twenty-five hundred people from across the world—from the U.S., China, Europe and Australia—attended the five-day event. IAFP was founded one hundred years ago with a focus on “making milk safe,” and later morphed into an organization dedicated to making all foods safe. The conference theme of “Good Safe Food” possibly reflected criticism voiced by Geoffrey at last year’s conference that complete “safety” results in food that is actually dangerous for our health.

Geoffrey attended a workshop on milk safety held on the first day. Only one speaker made any mention of the farmer’s role in producing clean, high quality milk from well tended cows. Virtually the entire focus was on treatment at the processing plant, but several admitted that these pasteurization plants are often filthy. One report showed that there were more bugs in the milk after pasteurization than before, due to contamination from the pasteurization machinery. Yet attendees appeared to speak in one voice in support of some kind of treatment of milk—if not pasteurization, then treatment with new technologies like ultra violet light—rather than providing good clean milk raw.

Likewise, for other foods, the emphasis was on some kind of treatment to make foods safe, with no one discussing how to build healthy immune systems. Instead the focus is on pasteurization, irradiation, sterilization, chemicalization and other treatments that so deaden the food as to render it an assault on the immune system.

There was a huge collection of exhibitors, some with very elaborate displays, and poster presentations, including one by food safety attorney Bill Marler to advertise his website realrawmilkfacts.com. It was clear from the displays that there is an enormous investment in food safety treatments, which translates into strong lobbying in government circles. An exhibit booth advertising sanitary wipes for the handles of supermarket carts epitomized the prevailing attitude—not children drinking raw milk and playing in the sand box to build up their immunity, but belief in a hostile world full of dangerous germs that must be sterilized and sanitized.

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