A group of death row inmates petitioned the Food and Drug Administration (FDA) to take enforcement action to prevent states from using certain FDA-approved drugs in lethal injections. The drugs had been approved for therapeutic purposes, but not for execution; the inmates argued that their use in executions rendered them "unapproved" or "misbranded" under the Federal Food, Drug, and Cosmetic Act (FDCA), and they asked the FDA to seize the drugs, take enforcement action against manufacturers and state officials, and otherwise prohibit the practice. The FDA declined, explaining that its enforcement decisions are individualized and discretionary; that the FDCA's enforcement provisions do not mandate action in every instance of potential statutory violation; that the agency historically does not regulate the practice of medicine; and that the use at issue was undertaken by state officials for executions, not by manufacturers promoting a new intended use. The inmates sued under the APA to compel enforcement, arguing the FDA's refusal was arbitrary, capricious, and contrary to law. The district court sided with the FDA, but the D.C. Circuit reversed, holding that the refusal to enforce was reviewable and remanding for further consideration. The Supreme Court granted certiorari.
Are an agency's decisions not to take enforcement action—here, the FDA's refusal to initiate proceedings to prevent use of drugs in lethal injections—subject to judicial review under the APA, or are they unreviewable because they are committed to agency discretion by law?
Under APA § 701(a)(2), agency action is unreviewable when the statute is drawn so that a court would have no meaningful standard against which to judge the agency's exercise of discretion—i.e., when action is committed to agency discretion by law. As a general matter, an agency's refusal to initiate enforcement proceedings is presumptively unreviewable because it is akin to a prosecutor's decision not to indict and involves a complex balancing of factors peculiarly within the agency's expertise (including resource allocation, enforcement priorities, likelihood of success, and fit with broader policies). This presumption can be rebutted where (1) Congress has provided substantive guidelines or meaningful standards limiting discretion, (2) the agency's refusal rests on a belief that it lacks legal authority (a reviewable legal interpretation), or (3) the agency has consciously and expressly adopted a general policy that amounts to an abdication of its statutory responsibilities.
The FDA's decision not to undertake enforcement action to prevent the use of drugs in lethal injections is presumptively unreviewable under APA § 701(a)(2) and, on the record presented, falls within the agency's enforcement discretion. The Court reversed the D.C. Circuit.
The Court, per Justice Rehnquist, emphasized that agency nonenforcement decisions are generally unsuitable for judicial review. Such decisions mirror prosecutorial discretion: they require agencies to weigh resource constraints, assess the strength of cases, consider whether enforcement would serve statutory objectives, and set priorities among numerous potential violations. Courts lack manageable standards to second-guess these policy-laden judgments. The FDCA's enforcement provisions, including 21 U.S.C. § 336 (the "minor violations" clause), reflect congressional intent to afford the FDA broad discretion regarding whether and when to pursue enforcement. Critically, while the FDCA defines what constitutes a violation, it does not supply a judicially administrable standard dictating when the FDA must act upon a suspected violation. The mere existence of a statutory violation does not eliminate enforcement discretion. The Court rejected the D.C. Circuit's approach that treated the FDA's refusal as reviewable simply because the FDCA sets substantive requirements. Those requirements speak to the merits of whether conduct violates the statute, not to the separate question of whether the agency must bring an enforcement action. The Court also explained that nonenforcement typically does not impose coercive effects on regulated parties, further counseling against review. At the same time, the Court articulated limits: if Congress has provided meaningful standards for enforcement (e.g., "shall" language tied to ascertainable criteria), courts may review refusals to act. Likewise, if the agency's refusal rests on an erroneous view that it lacks jurisdiction, that legal determination is reviewable. Finally, if the agency adopts an expressed policy of blanket nonenforcement that amounts to abdication of statutory duties, courts may intervene. None of those conditions were present here, and the FDA's explanation fell within the core of prosecutorial-like discretion.
Chaney is the leading case on enforcement discretion and APA reviewability. It creates a strong presumption that refusals to enforce are unreviewable, shaping litigation strategy for challengers and agency counsel alike. Law students should internalize both the presumption and its exceptions: meaningful statutory standards, jurisdictional errors, and abdication of duty. The framework is frequently invoked in fields like environmental law (e.g., Massachusetts v. EPA distinguishing when Congress cabins discretion), immigration enforcement, and consumer protection. Practically, Chaney channels challenges away from nonenforcement choices and toward rulemaking, adjudication, or legally reviewable interpretations, unless the challenger can show that Congress has constrained agency discretion or that the agency has effectively renounced its statutory mission.
Heckler v. Chaney draws a firm line around the judicial role in reviewing agency nonenforcement, recognizing that such choices are inherently policy-laden and resource-dependent. By analogizing agency nonenforcement to prosecutorial discretion, the Court set a baseline that protects internal priority setting and preserves agency flexibility in administering broad statutory schemes.