United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued April 8, 2022 Decided June 10, 2022

No. 21-5170

MARK MCAFEE AND FARM-TO-CONSUMER LEGAL DEFENSE 

FUND,

APPELLANTS

v.

UNITED STATES FOOD AND DRUG ADMINISTRATION,

APPELLEE

Appeal from the United States District Court

for the District of Columbia

(No. 1:19-cv-03161)

Mahesha P. Subbaraman argued the cause for appellants. 

With him on the briefs was Samantha J. Ellingson.

Aditya Dynar was on the brief for amicus curiae Pacific 

Legal Foundation in support of appellants. 

Marisa C. Maleck was on the brief for amici curiae The 

Weston A. Price Foundation, et al. in support of appellants.

Cynthia A. Barmore, Attorney, U.S. Department of 

Justice, argued the cause for appellee. With her on the brief 
2

were Brian M. Boynton, Acting Assistant Attorney General, 

and Daniel Tenny, Attorney.

Before: SRINIVASAN, Chief Judge, TATEL* and PILLARD, 

Circuit Judges.

Opinion for the Court filed by Circuit Judge PILLARD.

PILLARD, Circuit Judge: Dairy farmer Mark McAfee sells 

raw, unpasteurized butter within his home state of California. 

Looking to expand his market, McAfee petitioned the FDA to 

revoke the agency’s decades-old rule under the Public Health 

Service Act (PHSA) that bars the interstate sale of raw butter 

and replace it with a rule that allows such sale. McAfee told 

the FDA that his proposed rule was legally required because 

the Food, Drug, and Cosmetic Act (FDCA) exhaustively 

defines “butter” without describing it as pasteurized. In 

McAfee’s view that makes the FDA’s rule banning raw butter 

sales an unlawful change to butter’s statutory definition. The 

FDA denied McAfee’s petition. It concluded that the PHSA

authorizes the agency to require pasteurization, that substantial 

evidence justified doing so, and that regulating butter for safety 

does not contravene its FDCA definition. McAfee challenged 

the FDA’s action in court, and on cross motions for summary 

judgment the district court ruled in the agency’s favor. 

On appeal, McAfee raises only one preserved claim: that a 

rulemaking is necessary because the FDA’s regulation banning 

interstate sale of raw butter violates the FDCA’s definition of 

butter. Because we agree with the district court that challenge 

is meritless, and because McAfee has forfeited his other claims 

by failing to raise them below, we affirm.

* Judge Tatel assumed senior status after this case was argued and 

before the date of this opinion.
3

I.

An agency decision to deny a petition for rulemaking is 

subject to only “extremely limited and highly deferential” 

review, Massachusetts v. EPA, 549 U.S. 497, 527-28 (2007) 

(internal quotation marks omitted), under which we may 

reverse the agency’s choice “only for compelling cause, such 

as plain error of law or a fundamental change in the factual 

premises previously considered by the agency,” Nat’l Customs 

Brokers & Forwarders Ass’n of Am., Inc. v. United States, 883 

F.2d 93, 97 (D.C. Cir. 1989). See generally WildEarth 

Guardians v. EPA, 751 F.3d 649, 653 (D.C. Cir. 2014); Harry 

T. Edwards & Linda A. Elliott, Federal Standards of Review: 

Review of District Court Decisions and Agency Actions 195-

96 (3d ed. 2018). 

McAfee’s rulemaking petition turns on the interaction of 

two statutes. The first is the Public Health Service Act, which 

provides the statutory basis for the FDA’s pasteurization 

requirement. That Act authorizes the Surgeon General “to 

make and enforce such regulations as in his judgment 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.” 42 U.S.C. § 264(a). It includes a 

non-exhaustive list of appropriate ways to do so, including 

through “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 [the 

Surgeon General’s] judgment may be necessary.” Id. 

The FDA today exercises that authority as it relates to food 

and other products. See, e.g., 21 C.F.R. § 1240.62 (banning 

certain turtles known to carry salmonella); id. § 1240.60 
4

(regulating shellfish). The FDA determined that raw cream 

may contain dangerous bacteria and that pasteurization 

disinfects and sanitizes it by killing those bacteria. 

Accordingly, the agency exercised its PHSA authority to 

require that milk products, including butter, be pasteurized. Id.

§ 1240.61.

The second relevant statutory provision is a food-naming 

power in the FDCA, 21 U.S.C. § 341, designed to prevent 

confusion and ensure that consumers know what they are 

buying. See Fed. Sec. Adm’r v. Quaker Oats Co., 318 U.S. 218, 

230-32 (1943). That provision authorizes the FDA to set “a 

reasonable definition and standard of identity” for “any food, 

under its common or usual name,” to “promote honesty and fair 

dealing in the interest of consumers.” 21 U.S.C. § 341. The 

agency thus delineates the basic characteristics of foods 

associated with their common or usual names. For example, 

products labeled “fruit jam” must contain a certain amount of 

fruit, 21 C.F.R. § 150.160; those labeled “maple syrup” (or 

“maple sirup”) must contain a certain amount of maple sap, id.

§ 168.140; and so on. 

Importantly, however, Congress exempted butter and most 

fruits and vegetables from the FDA’s naming power and 

instead set those definitions itself in the statute. In 1938,

Congress set the standard of identity of butter as “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.” 21 U.S.C. § 321a. 

At the same time, Congress specified that “[n]o [other] . . . 

standard of identity . . . shall be established for . . . butter . . . .” 

Id. § 341. 
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The FDA in 1987 banned the interstate distribution of “any 

milk or milk product” that has not been pasteurized. 21 C.F.R. 

§ 1240.61. It did so following a district court ruling that the 

FDA had unreasonably delayed responding to a national 

consumer group’s petition for such a ban, which emphasized 

that the “overwhelming evidence of the risks associated with” 

consuming raw milk products supported a pasteurization 

requirement. Pub. Citizen v. Heckler, 653 F. Supp. 1229, 1238 

(D.D.C. 1986); see id. at 1242 (ordering FDA to promulgate “a 

rule banning the interstate sale of all raw milk and all raw milk 

products”). The FDA confirmed in 1992 that “milk product” 

includes “butter,” and that the Public Health Service Act is the 

statutory authority for the pasteurization rule. Control of 

Communicable Diseases; Definition of Milk and Milk 

Products, 57 Fed. Reg. 57,343, 57,343 (Dec. 4, 1992).

McAfee’s 2016 petition for a rulemaking to exclude butter 

from the rule requiring pasteurization of milk products—and 

thereby allow interstate sale of “raw” butter—argued that the 

FDA lacked sound legal or scientific grounds for its ban. 

Petition for Rulemaking at 1-24, J.A. 94-117. After some 

delay, the FDA denied the petition. FDA Denial of 

McAfee/FTCLDF Citizen Petition, dated Feb. 27, 2020 (FDA

1072-1093) [hereinafter Denial Letter] at 1-17, J.A. 459-75. It

reasoned that the pasteurization rule does not conflict with or 

change the statutory definition of butter, which does not 

mention pasteurization; “manufacturing controls intended to 

ensure safety,” it wrote, “may exist independent of any 

standards of identity.” Denial Letter at 4, J.A. 462. The FDA 

addressed McAfee’s arguments and the relevant scientific 

literature and concluded they did not alter the agency’s 

conclusion that the ban on raw butter helps prevent the spread 

of communicable diseases. Denial Letter at 4-17, J.A. 462-75.
6

The district court sustained the FDA’s denial of McAfee’s 

Rulemaking petition on the ground that the agency’s raw butter 

ban was a “straightforward” exercise of its PHSA authority, 

McAfee v. U.S. Food & Drug Admin, 541 F. Supp. 3d 21, 27 

(D.D.C. 2021), and that such food safety regulation posed no 

conflict with the standard of identity of butter in the FDCA, id. 

at 29. “Just because the FDA cannot alter the standard of 

identity for butter,” the court reasoned, “does not mean the 

agency cannot regulate butter for other purposes under other 

statutes.” Id. The district court also rejected McAfee’s 

arbitrary-and-capricious challenges: Given the “great deal of 

scientific evidence” the FDA presented in support of its 

judgment, id. at 34, the district court held these challenges 

“completely miss[ed] the mark” and were a “nonstarter,” id. at 

32-33. 

McAfee timely appealed. We have jurisdiction over this 

appeal from the district court’s final order under 28 U.S.C. 

§ 1291, and McAfee has standing as a raw butter manufacturer. 

He does not directly challenge the FDA’s 1987 or 1992 

pasteurization rules, but instead challenges the agency’s denial 

of his petition for a rulemaking to repeal the raw butter ban and 

allow interstate sale of unpasteurized butter.

II.

McAfee’s only preserved challenge is that a rulemaking is 

necessary because the FDA’s regulation under the Public 

Health Service Act barring interstate sale of raw butter violates 

the FDCA’s definition of butter. When Congress set the 

standard of identity for butter, it explicitly prevented the FDA 

from altering that definition. See 21 U.S.C. § 341. But, 

McAfee argues, the agency’s pasteurization requirement under 

the FDCA does just that. That is incorrect: The pasteurization 

rule did not amend the statutory standard of identity for butter, 
7

either formally or functionally. Raw-cream butter, though 

unpasteurized, is still “butter” notwithstanding the FDA’s 

determination that its interstate sale would threaten public 

health. As the district court succinctly observed, McAfee’s 

argument “rests on the false premise that the pasteurization rule 

works a change to butter’s standard of identity.” McAfee, 541 

F. Supp. 3d at 28. Particularly given our very limited review, 

we have no basis to overturn the FDA’s denial of McAfee’s 

request for rulemaking resting on that false premise.

The absence of the conflict McAfee perceives follows 

from the distinct roles of the food-naming and public-health

provisions. Congress and the FDA’s standards of identity 

under the FDCA ensure consumers know what they are buying. 

Recall, for instance, that a product labeled “fruit jam” must 

contain a certain amount of fruit. 21 C.F.R. § 150.160. 

Products containing a lower fruit content are not unsafe; they 

just must be marketed under a different name, such as “fruit 

topping.” See Food Standards; General Principles and Food 

Standards Modernization, 70 Fed. Reg. 29,214, at 29,216 (May 

20, 2005). Here, the statutory definition setting butter’s 

standard of identity determines only what may be marketed as 

“butter.” Products not meeting that definition may well be safe 

but must be called something else. 

Altogether separate is the FDA’s authority under the 

Public Health Service Act, which authorizes the agency to 

require processes including “inspection, fumigation, 

disinfection, [and] sanitation” to ensure that the food supply is 

safe and does not spread communicable diseases. 42 U.S.C. 

§ 264(a). Those public health requirements do not alter a 

food’s definition or standard of identity. Indeed, the FDA 

acknowledges that both pasteurized and unpasteurized butter 

are “butter,” Appellee Br. at 25, since each “is made 

exclusively from milk or cream, or both, with or without 
8

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.” 21 U.S.C. § 321a.

For safety reasons, however, the agency disallowed interstate 

sale of some (specifically, unpasteurized) butter. Even though 

raw cream butter may accurately be labeled “butter” at a local 

farmers’ market, the FDA has deemed it too dangerous to be 

sold interstate. Accordingly, the FDA permissibly concluded 

that the raw butter ban did “not purport to be a standard of 

identity rulemaking” and “did not serve to operate as one in 

practice either.” Denial Letter at 4, J.A. 462.

McAfee offers no persuasive response. He insists that the 

FDA has at least functionally amended the definition of butter 

by adding a safety requirement—pasteurization—not found in 

21 U.S.C. § 321a. But as already discussed, the FDA did not 

alter the statutory definition because the FDA’s public health 

regulatory authorities are distinct from, serve different 

purposes than, and do not conflict with its standard-of-identity 

rules. To be sure, we need not rule out the possibility that in 

an unusual case a food-safety control might be so integral to a 

food’s identity that altering it would functionally amend how 

that food is defined under the FDCA. The FDA recognized that 

“sometimes standards of identity may also designate the 

manner in which products are produced when the 

manufacturing process has a bearing on the identity of the 

finished food,” although ordinarily “manufacturing controls 

intended to ensure safety may exist independent of any 

standards of identity.” Denial Letter at 5, J.A. 463. But the 

statutory definition at issue here contains no mention of 

pasteurization nor any other suggestion that undergoing that 

process prevents a product from qualifying as butter. McAfee 

may be correct that unpasteurized butter has a distinct taste, 

texture, and other qualities, but Congress did not speak to those 

qualities as part of butter’s statutory standard of identity. That 
9

statutory provision neither references pasteurization nor

requires qualities that pasteurized butter lacks. At least in this

case, then, the standard-of-identity statute does not extinguish 

the agency’s authority under the PHSA to ensure food safety.

McAfee argues that the FDA’s reading would give the 

agency sweeping authority to alter standards of identity 

through public health requirements. But the FDA may act 

under the Public Health Service Act only where “necessary” to 

prevent the spread of disease. 42 U.S.C. § 264(a). As the 

Supreme Court has recently emphasized, actions under that 

statute must “directly relate to preventing the interstate spread 

of disease.” Ala. Ass’n of Realtors v. Dep’t of Health & Hum. 

Servs., 141 S. Ct. 2485, 2488 (2021). Even then, they must also 

withstand arbitrary-and-capricious review. 

Indeed, it is McAfee’s interpretation that would produce 

odd consequences: It would substantially exempt from public 

health controls those products whose standards of identity 

Congress itself set by statute, including most fruits and 

vegetables, see 21 U.S.C. § 341, because on his approach any 

safety control not in the statutory standard of identity would 

seem to unlawfully supplement it. The majority of foods, 

however, would remain subject to FDA safety regulation 

because the statute authorizes the agency to set their standards 

of identity, leaving the FDA free to build safety requirements 

under the PHSA into those definitions. Nothing suggests 

Congress intended that anomalous bifurcated result.

McAfee raises several other issues for the first time on 

appeal, including (1) whether the FDA has authority under the 

PHSA, standing alone, to require that butter marketed interstate 

be made from pasteurized cream, Appellant Br. at 44; (2) 

whether the adulteration provisions of the FDCA at 21 U.S.C. 

§ 342 otherwise limit the FDA’s Public Health Service Act
10

authority, Appellant Reply Br. at 6-7, 8-10; and (3) whether the 

FDA’s exercise of rulemaking authority following department 

reorganization exceeds its authority under the Act, Appellant

Br. at 42-43. McAfee forfeited those arguments because he did 

not raise them before either the FDA or the district court. See, 

e.g., McAfee, 541 F. Supp. 3d at 27 (noting McAfee “do[es] not 

dispute” that the PHSA “would seem to give the FDA authority 

to mandate pasteurization”); Petition for Rulemaking at 5-9, 

J.A. 98-102; Plaintiffs’ Br. in Supp. Of. Mot. For Summ. J. at 

9-14, No. 19-3161 (D.D.C. Oct. 21, 2020), ECF 15-2, S.A. 15-

20; see also Koretoff v. Vilsack, 707 F.3d 394, 398 (D.C. Cir. 

2013) (per curiam) (holding challenge to statutory authority 

forfeited). McAfee’s counsel also clarified at oral argument 

that he does not raise a freestanding arbitrary and capricious 

challenge. Recording of Oral Arg. 10:39-11:33. Amici raise 

additional challenges, which rest on theories not raised by the 

parties and thus are not properly before us. See Metlife, Inc. v. 

Fin. Stability Oversight Council, 865 F.3d 661, 666 n.4 (D.C. 

Cir. 2017).

* * *

For the foregoing reasons, the judgment of the district 

court is affirmed.

So ordered.