Raw dairy products are the only foods for human consumption banned in interstate commerce. A question for the court of appeals to consider is: does FDA have the power to prohibit raw butter from crossing state lines when the record before the court does not list a single foodborne illness outbreak definitively attributed to the consumption of commercially produced raw butter?

FDA is claiming it can ban raw butter in interstate commerce under its authority to regulate communicable disease [1], a power granted the agency by the Public Health Services Act (PHSA). Thirty years ago FDA issued a regulation banning all raw dairy products in interstate commerce other than cheese aged 60 days [2].

Does FDA have the power to issue a blanket ban on a food? Or is its authority limited to instances when a specific batch or a lot is suspected of being adulterated and/or making people sick?

The Department of Health and Human Services (HHS) has been getting lots of mileage out of its authority to regulate communicable disease. In 2020 the Centers for Disease Control (CDC) used that power to justify an order staying any eviction of residential tenants by landlords during the COVID crisis. In striking down the order, the Supreme 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” [3].

Another question for the court is: can FDA require that butter be pasteurized under its power to regulate communicable disease, when the Federal Food, Drug and Cosmetic Act (FDCA) seemingly prohibits the agency from doing just that?

There is a conflicting statute in the FDCA defining butter that does not require it to be pasteurized [4]. A separate statute in the FDCA specifically mandates that “[n]o definition and standard of identity and no standard of quality shall be established for … butter” [5]. Standards of identity are requirements for prescribing what a food product must contain to be marketed under a certain name in interstate commerce; they are intended to promote honesty and fair dealing for the benefit of consumers.

The U.S. Supreme Court has held that a standard of identity exists, for purposes of the FDCA, whenever the government, “by regulation, fix[es] the ingredients of any food,” such that “a commodity cannot be introduced into interstate commerce which purports to be … [that] food … unless [the commodity] is composed of the required ingredients” [6]. The regulation governing the interstate raw 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…” [7].

The demand for raw dairy in the U.S. is booming. There are around a dozen states that currently allow the distribution or sale of raw butter. A court decision in favor of McAfee and FTCLDF will increase that number rapidly in a short period of time as well as reduce the power of an agency that is a major threat to bodily autonomy and freedom of choice and that has long placed the profits of the pharmaceutical and biotech industries ahead of the public health.

The oral argument before the court of appeals will be livestreamed.

• For the archive of Oral Argument Recordings, find links at

https://www.cadc.uscourts.gov/recordings/recordings.nsf

A recording of all Oral Arguments for April 8, 2022, will also be posted on YouTube at https://www.youtube.com/watch?v=jyWi9futNwg

Livestream link – https://www.cadc.uscourts.gov/internet/home.nsf/Content/VL%20-%20Calendars%20-%20Live%20Audio%20Streams%20of%20Oral%20Arguments

For more background on the Raw Butter case and related documents, go to the Farm-to-Consumer Legal Defense Fund website at https://www.farmtoconsumer.org/campaign-for-raw-food/

FOOTNOTES
1. See 42 USC 264(a)
2. 21 CFR 1240.61
3. Ala. Ass’n of Realtors v. HHS 141 S. Ct. 2485, 2487-2488.
4. 21 USC 321a
5. Subbaraman, M. Principal Brief of Appellants Mark McAfee & Farm-to-Consumer Legal Defense Fund. USCA Case 21-5170 (Document #1929731, filed 01/07/2022), p. 24 citing 21 USC 341. https://www.farmtoconsumer.org/wp-content/uploads/2022/01/Raw.Butter.1.07.22.ECF-Stamped-Opening-Merits-Brief.pdf
6. Subbaraman, p. 24 citing 62 Cases of Jam v. United States 340 U.S. 589, 593 (1951) (internal quotation marks omitted)
7. 21 CFR 1240.61(a)

Photo Credit: congerdesign on pixabay.com

The post Raw Butter Ban Before U.S. Appellate Court 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).

The post Judge Upholds FDA Raw Butter Ban appeared first on Real Milk.