Relentless, Inc. v. Dep’t of Commerce

Justine E. Lenehan & T. Daniel Logan*

Why It Made the List

The discerning reader will note two facts about this case that may give rise to questions as to the reason for its inclusion in this compendium. First, although Relentless relates to fish, the agency facing challenge is not the U.S. Food and Drug Administration (FDA). Second, the paramount decision in this case is still pending with SCOTUS (although the appellate court decision was handed down in 2023), so the potential impacts of the case are yet to be determined. However, one need only crack an administrative law textbook or look to the last four decades of agency litigation to see the outsized importance of the doctrine at the heart of this case—Chevron deference.

While the appellate-level decision presents a fairly rote application of the doctrine, the Supreme Court took up the case as an opportunity to reconsider whether Chevron should be ditched entirely. Accordingly, it is the potential sea change in administrative law and corresponding implications for administrative agencies, including FDA, that make this case worthy of inclusion in this year’s tome.


Background: Chevron Deference

In 1984, the Supreme Court first articulated the Chevron doctrine, which generally holds that a court reviewing an agency action under the Administrative Procedure Act (APA) should defer to an administrative agency’s interpretation of a statute if:  1) Congress has not “directly spoken to the precise the question at issue,” and 2) the agency’s interpretation is “based on a permissible construction of the statute.”[1] Under Chevron “step one,” courts are to “employ traditional tools of statutory construction” to determine whether Congress has addressed the question before the court.[2] If Congress has done so, courts must “give effect to the unambiguously expressed intent of Congress.”[3] Under Chevron “step two,” if Congress was instead silent or ambiguous on the issue, whether explicitly or implicitly leaving a gap for an agency to fill, courts are to defer to the agency interpretation if it is “permissible.”[4] Agency interpretations that are the result of formal adjudication or notice-and-comment rulemaking are more likely to receive Chevron deference as compared to informal agency interpretations.[5]

Undergirding this approach is the philosophy, espoused by the Court, that “[j]udges are not experts in the [technical] field, and are not part of either political branch of the Government.”[6] Conversely, these technical, scientific, and/or specialized areas of regulation are arguably well suited for interpretation using an agency’s expertise and experience. Executive branch administrative agencies make “policy choices—resolving the competing interests which Congress itself either inadvertently did not resolve, or intentionally left to be resolved by the agency charged with the administration of the statute in light of everyday realities.”[7]

Over the past forty years since Chevron was handed down, trial courts have diligently applied the Chevron “two-step” framework as gospel, even while higher courts have restricted its applicability[8] and questioned its workability.[9] The Chevron doctrine has been viewed by some as a beacon of stability, while others believe it distorts the branches of government and bestows too much power on executive agencies. Despite all of this debate, the Court has not actually engaged in a Chevron analysis since 2016.[10]

Notably, while the Chevron framework is most relevant to Relentless, readers would be remiss to overlook other key legal doctrines that may inform the Court’s reasoning in the instant case or how the Court’s decision in Relentless may impact the future of Chevron. For instance, many have opined that the Major Questions Doctrine (MQD), which the Court first referred to by name in 2022,[11] foretold the future irrelevance of Chevron deference. Separately, where Chevron does not apply, courts may still afford agency actions some deference under the Skidmore doctrine, pursuant to which agency interpretations are entitled to respect to the extent they have the “power to persuade.”[12]

Procedural History

While the subject of Relentless—Atlantic herring fishing—is not of particular relevance here, some factual background will be helpful in bringing the potential impacts of this case to life.

The Magnuson-Stevens Fishery Conservation and Management Act (the MSA)[13] created eight regional councils to manage the fisheries in their regions and charged them with each promulgating fishery management plans that specify conservation measures “necessary and appropriate” to prevent overfishing and promote sustainability.[14] These plans (and any amendments) are subject to review by an administrative agency (the National Marine Fisheries Service, NMFS) for compliance with the MSA and notice and comment rulemaking. Since 2000, the fishery management plan in New England for Atlantic herring has included monitoring by government-funded observers to measure bycatch (fish unintentionally caught) on fishing trips. In 2020, the New England regional council amended its fishery management plan to provide for a monitoring program funded, at least in part, by industry.[15]

Plaintiffs in Relentless argued that their unique fishing style (involving longer trips in which they may not catch herring) rendered them disproportionately burdened by the amended plan and that the MSA did not authorize its issuance, among other statutory and constitutional violations.

The District Court for the District of Rhode Island and the U.S. Court of Appeals for the First Circuit upheld the rule codifying the amended plan by applying the Chevron doctrine. The district court granted NMFS’ request for summary judgment, finding that NMFS reasonably interpreted the MSA to permit industry-funded monitoring.[16] On appeal, the First Circuit affirmed the district court’s ruling, dutifully applying Chevron to find against the petitioners.[17] The First Circuit found that the MSA explicitly authorizes the placement of observers on fishing vessels and rejected petitioners’ argument that because the MSA contains no language allowing NMFS to place the cost burden on industry, NMFS lacks the authority to do so.

The Supreme Court granted petitioner’s writ of certiorari in October 2023 and expeditiously held oral arguments on January 17, 2024. While this timetable may seem more hurried than is typical for the Court’s docket, the Justices sought to hold oral arguments for both Relentless and a case with nearly identical facts, Loper Bright Enterprises, Inc. v. Raimondo, which the Court agreed to review in May,[18] on the same date in the January 2024 argument session.

Arguments Before the Supreme Court

Following oral arguments, the Court appears poised to overturn or limit the application of the Chevron framework. At argument, the government emphasized the doctrine’s “deep roots in this Court’s jurisprudence” and the need for a “truly extraordinary justification” to overrule the Court’s prior decision under the doctrine of stare decisis.[19] On the other hand, petitioners argued that application of the Chevron doctrine is “not consistent with the rule of law” given that it requires deference to an agency’s interpretation so long as it is reasonable, even if all Justices agree that an opposing interpretation is better.[20]

Justices Kagan, Sotomayor, and Jackson appeared to remain in favor of upholding the doctrine. According to the three liberal Justices, federal agencies that have scientific and technical expertise are better positioned than courts to resolve statutory ambiguities. Justice Jackson expressed concern over her prediction that, absent Chevron, the courts may inappropriately make policy decisions when filling in statutory gaps left by Congress.

The potential for a Chevron reversal appeared less concerning to Justices conventionally identified as the Court’s conservative bloc. For example, Justice Kavanaugh commented that Chevron deference enables “massive change[s]” to agency policy decisions every four or eight years with each new administration.[21] Separately, Justice Gorsuch expressed concern over Chevron’s impact on the “little guy” who is affected by the actions of federal agencies and often not protected by application of the doctrine.[22]

The petitioners and government also disagreed over the practical implications of overturning Chevron. The government warned that litigants would “come out of the woodwork” if the Court were to overrule its past precedent.[23] Instead, the government suggested that the Court could more narrowly rule in a way that “clarif[ies] and articulate[s] the limits of Chevron deference.”[24] However, the petitioners adamantly maintained that “the fundamental problem is Chevron itself.”[25] The Justices also sought engagement on what Chevron’s potential replacement would look like, which we discuss further in the next section.

Impact of the Decision

For forty years, the Chevron doctrine has been a bedrock of administrative law and practice, providing a source of certainty for the agencies that apply it, frustration for litigants seeking to challenge agency action, and debate amongst judges and legal scholars.[26] But in its review of Relentless, the Court will re-engage with the question of how much leeway agencies should receive in interpreting and fulfilling their congressional mandates. In our attempt to read the tea leaves, the Court’s forthcoming decision will likely meaningfully impact the contours of this doctrine, but the potential implications for FDA are more opaque.

Assessing the impact first requires understanding what the presence of Chevron deference means, in practical terms, to FDA. Many commenters have remarked on the “ossification” of agency rulemaking over the years—in that rulemaking efforts take longer, are more resource intensive, and accordingly, result in fewer completed rulemakings. The presence of the Chevron doctrine provides the agency a degree of certainty in rulemaking; specifically, provided that an agency’s “official” interpretation of a statute does not stray too far from the authorities delegated by Congress, there is a presumption that a reviewing court will defer to the agency’s interpretation of the statute rather than substitute its own.[27]

An agency, such as FDA, may be less willing to sink limited resources into multi-year rulemaking efforts if the fate of a final rule is less predictable in the event of challenge. Policymaking ambitions of executive agencies may be diminished, such that any rulemaking hews much closer to the actuating statutory text.[28]

However, it is important to note that the Court may choose to clarify, pare back, or limit the application of Chevron rather than eliminate it entirely. Illuminating here is the Court’s 2019 decision in Kisor v. Wilkie, in which the Court elected to retain but restrict a parallel doctrine (“Auer deference”) that instructs courts to defer to an agency’s interpretation of its own rules.[29] The Court could “Kisor-ize” Chevron deference by restricting the circumstances in which a court could deploy the framework, although this has been criticized by certain members of the Court as a stay of execution rather than a solution.[30] Moreover, a decision by the Court that weakens the Chevron doctrine could bolster the MQD’s prominence as a basis to side-step Chevron altogether. Under the MQD, courts may never reach “step one” of Chevron if faced with “extraordinary cases . . . in which the history and the breadth of the authority that [the agency] has asserted, and the economic and political significance of that assertion, provide a reason to hesitate before concluding that Congress meant to confer such authority.”[31] That is, courts reticent to apply Chevron deference may more readily find that agency actions raise a “major question” demanding “clear congressional authorization.” Even if such result would have minimal impact on the policymaking function of FDA, the agency would be less likely to receive deference in case of challenge.[32]

If Chevron deference is fully uprooted and cast aside, however, the potential impacts to FDA are unclear.

At oral argument, the government warned of a torrent of litigation seeking to reopen past decisions “not [on the grounds of] whether the agency’s interpretation is reasonable and whether the regulation can be upheld on that basis, but how the statute should be interpreted without granting any deference to the agency’s interpretation.”[33] If this prediction is borne out, FDA’s legal interpretations (both formal and informal) would likely be a target for greater scrutiny. This could implicate a broad swath of agency actions, ranging from standard-setting rulemakings (for example, the definition of “adequate and well controlled investigation” in the context of drug approvals[34]) to interpretative guidance across all product areas.

This is not to say that FDA functions would grind to a halt. Even absent Chevron deference, FDA’s scientific or technical determinations are likely to still receive a heightened degree of deference,[35] although some conservative-minded Justices on the Court seem to indicate that they would be open to judicial review of every agency interpretation with “all the traditional tools of statutory interpretation.”[36] At oral argument, Justice Kagan pointedly questioned petitioners on the limits of this position, asking whether a court should be charged with assessing de novo if a new product designed to promote healthy cholesterol levels would be considered a drug or dietary supplement, noting that “sometimes the law runs out” and reliance on agency expertise is warranted.[37] Although it is likely that the status quo will be maintained for agency determinations which are obviously factual in nature, the majority of the Justices’ seeming willingness to remove Chevron and blur the lines between factual determination and legal interpretation raises questions about how long such a regime would last.

Finally, if the Court disposes of Chevron deference, what remains? Agency interpretations of statutes would likely remain entitled to Skidmore deference, based on a 1944 decision that was resurfaced at the turn of this century by the Court.[38] Under Skidmore, a court is not constrained to find in favor of the agency if the statute at issue is ambiguous; rather, a court independently interprets the statute and may elect to give weight to an agency’s interpretation as a factor in its analysis depending on the “thoroughness evident in its consideration, the validity of its reasoning, its consistency,” and even then, “all those factors . . . give it power to persuade,” not to “control.”[39] Agency officials should take caution—as Justice Kavanaugh intimated, “deference” is a misnomer; in application, Skidmore is closer to de novo review.[40]

Ultimately, the impacts of Chevron’s demise (if it comes to pass) remain to be seen; whether there is a “flood” of litigation or a ripple largely depends on the contours of the Court’s decision, expected later this year. Nevertheless and regardless of how the Court rules, given the prevailing winds, it seems likely that agencies such as FDA can expect an uphill battle in defending their interpretations in court.

*  Justine E. Lenehan and T. Daniel Logan are associates at Kleinfeld Kaplan & Becker LLP. They counsel clients on a variety of FDA regulatory issues relating to the food, cosmetic, drug, dietary supplement, and tobacco company industries and advise FDA-regulated companies throughout the product lifecycle, including labeling, advertising/promotion, enforcement risk, and regulatory strategy and compliance.

[1]   Chevron, U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 842–43 (1984).

[2]   Id. at 843.

[3]   Id.

[4]   Id. at 865.

[5]   See, e.g., Martin v. Occupational Safety & Health Rev. Comm’n, 499 U.S. 144, 157 (1991) (where the Court first suggested that Chevron does not apply to interpretative rules); Christensen v. Harris Cnty., 529 U.S. 576 (2000) (refusing to grant Chevron deference to a Department of Labor opinion letter).

[6]   Chevron, 467 U.S. at 865.

[7]   Id. at 865–66.

[8]   See, e.g., United States v. Mead Corp., 533 U.S. 218, 231–35 (2001).

[9]   See, e.g., Perez v. Mortg. Bankers Ass’n, 575 U.S. 92, 111 (2015) (Scalia, J., dissenting).

[10]  See Encino Motorcars, LLC v. Navarro, 579 U.S. 211 (2016).

[11]  This case, West Virginia v. Env’t Prot. Agency, was also the subject of a chapter in last year’s edition of FDLI’s Top Food and Drug Cases, 2022 & Cases to Watch, 2023, available at

[12]  Skidmore v. Swift & Co., 323 U.S. 134, 140 (1944).

[13]  16 U.S.C. §§ 1801 et seq.

[14]  16 U.S.C. §§ 1852-1853.

[15]  See Magnuson–Stevens Fishery Conservation and Management Act Provisions; Fisheries of the Northeastern United States; Industry-Funded Monitoring, 85 Fed. Reg. 7414 (Feb. 7, 2020).

[16]  See Relentless, Inc. v. U.S. Dep’t of Comm., 561 F. Supp. 3d 226, 237–38 (D.R.I. 2021).

[17]  See Relentless, Inc. v. U.S. Dep’t of Comm., 62 F. 4th 621, 628–34 (1st. Cir. 2023).

[18]  The Justices may have wished to consider both cases due, at least in part, to Justice Ketanji Brown Jackson’s recusal from Loper Bright, as she sat on the D.C. Circuit panel that originally heard the case.

[19]  Transcript of Relentless Oral Argument at 75 (Relentless Transcript), available at

[20]  Id. at 5.

[21]  Id. at 97.

[22]  See id. at 134–35.

[23]  Id. at 80–81.

[24]  Transcript of Loper Bright Oral Argument at 49, available at‌arguments/argument_transcripts/2023/22-451_o7jp.pdf.

[25]  Relentless Transcript, supra note 19, at 155.

[26]  According to the Solicitor General, the Supreme Court has relied on the Chevron framework in “more than 70 cases . . . to sustain an agency’s interpretation.” Id. at 75–76.

[27]  This deference is not assured, as FDA has discovered. See Food & Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000) (considered by many to be the first invocation of the MQD).

[28]  Of course, for the challengers in Relentless and others that view the current administrative state as overbroad, this appears to be the intended result.

[29]  See Kisor v. Wilkie, 139 S. Ct. 2400, 2419–23 (2019) (citing Auer v. Robbins, 519 U.S. 452 (1997)).

[30]  See Kisor, 139 S. Ct. at 2426.

[31]  West Virginia v. EPA, 142 S. Ct. 2587, 2608 (2022) (internal quotations omitted).

[32]  At oral argument, the government stated that lower courts granted Auer deference “far less frequently” following Kisor. See Relentless Transcript, supra note 19, at 91–92.

[33]  Id. at 80–81.

[34]  Id. at 67; 21 C.F.R. § 314.126(a).

[35]  Provided an agency’s factual conclusions have a substantial basis in the record, a reviewing court should refrain from substituting its judgement for that of the agency. Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 42, 43 (1983). This axiom is particularly true where the agency’s determination is technical, “at the frontiers of science,” or within the realm of the agency’s expertise. Baltimore Gas & Elec. Co. v. Nat. Res. Def. Council, Inc., 462 U.S. 87, 103 (1983).

[36]  Relentless Transcript, supra note 19, at 82–83.

[37]  Id. at 12–13.

[38]  See Christensen, 529 U.S. 576 (citing Skidmore, 323 U.S.).

[39]  Skidmore, 323 U.S. at 140.

[40]  See Relentless Transcript, supra note 19, at 52.