b'Requirement That \xe2\x80\x9cPrivate Citizens\xe2\x80\x9d Be\nAppointed From \xe2\x80\x9cPrivate Life\xe2\x80\x9d to the\nNational Council for the Humanities\nBecause state and local public officials, including a county commissioner, are not \xe2\x80\x9cprivate citizens\xe2\x80\x9d\nwho would be appointed \xe2\x80\x9cfrom private life\xe2\x80\x9d within the ordinary meaning of those terms in 20 U.S.C.\n\xc2\xa7 957(b), such officials are disqualified from appointment to the National Council for the Humanities.\n\nAugust 27, 2004\n\nMEMORANDUM OPINION FOR THE DEPUTY COUNSEL TO THE PRESIDENT\nYou have asked for our opinion whether the statutory requirement that members of the National Council for the Humanities (\xe2\x80\x9cNCH\xe2\x80\x9d) be appointed \xe2\x80\x9cfrom\nprivate life\xe2\x80\x9d and \xe2\x80\x9cselected from among private citizens of the United States,\xe2\x80\x9d 20\nU.S.C. \xc2\xa7 957(b) (2000), bars appointment of a state or local government official.\nWe understand, in particular, that this question concerns the possible appointment\nof a part-time county commissioner. We conclude that because state and local\npublic officials, including a county commissioner, are not \xe2\x80\x9cprivate citizens\xe2\x80\x9d who\nwould be appointed \xe2\x80\x9cfrom private life\xe2\x80\x9d within the ordinary meaning of those\nterms, such officials are disqualified from appointment to the NCH under section\n957(b).\nThe statute authorizing the President to appoint members of the NCH provides:\nThe Council shall be composed of the Chairperson of the National\nEndowment for the Humanities, who shall be the Chairperson of the\nCouncil, and twenty-six other members appointed by the President,\nby and with the advice and consent of the Senate, from private life.\nSuch members shall be individuals who (1) are selected from among\nprivate citizens of the United States who are recognized for their\nbroad knowledge of, expertise in, or commitment to the humanities,\nand (2) have established records of distinguished service and scholarship or creativity and in a manner which will provide a comprehensive representation of the views of scholars and professional\npractitioners in the humanities and of the public throughout the United States.\nId. \xc2\xa7 957(b) (emphases added).1\n1\nThe National Endowment for the Humanities (\xe2\x80\x9cNEH\xe2\x80\x9d) was created in 1965 to promote scholarly,\neducational, and public projects in the humanities. See 20 U.S.C. \xc2\xa7\xc2\xa7 956\xe2\x80\x93958. The NEH is headed by\nthe Chairperson of the Endowment, who is authorized to enter into contracts, issue grants and loans,\nand make other arrangements consistent with advancing the humanities. Id. \xc2\xa7 956(b)\xe2\x80\x93(c). The Chairperson is advised by the NCH, which consists of 26 members appointed to staggered six-year terms. Id.\n\n231\n\n\x0cOpinions of the Office of Legal Counsel in Volume 28\n\nThe requirement that NCH members be selected from \xe2\x80\x9cprivate life\xe2\x80\x9d and from\namong the \xe2\x80\x9cprivate citizens of the United States\xe2\x80\x9d generally disqualifies all\ngovernment officials, whether federal, state, or local, from appointment to the\nNCH. The plain meaning of the statute, particularly the phrase \xe2\x80\x9cprivate citizens,\xe2\x80\x9d\ngoverns the question at issue. The word \xe2\x80\x9cprivate\xe2\x80\x9d is derived from the Latin\npr\xc4\xabv\xc4\x81tus, meaning \xe2\x80\x9capart from the state, deprived of office.\xe2\x80\x9d Webster\xe2\x80\x99s Third Int\xe2\x80\x99l\nDictionary of the English Language 1804 (2002). According to its ordinary\ndefinition and usage, the adjective \xe2\x80\x9cprivate,\xe2\x80\x9d specifically when used in the phrase\n\xe2\x80\x9cprivate citizen,\xe2\x80\x9d means \xe2\x80\x9cnot invested with or engaged in public office or employment (a ~ citizen).\xe2\x80\x9d Id. at 1805. See also Funk & Wagnall\xe2\x80\x99s Standard College\nDictionary 1072 (1969) (\xe2\x80\x9cHaving no official rank, character, office, etc.: a private\ncitizen\xe2\x80\x9d); American Heritage Dictionary of the English Language 1442 (1992)\n(\xe2\x80\x9cNot holding an official or public position\xe2\x80\x9d); Random House Dictionary of the\nEnglish Language 1540 (2d ed. 1987) (\xe2\x80\x9cnot holding public office or employment:\nprivate citizens\xe2\x80\x9d). The word \xe2\x80\x9cprivate\xe2\x80\x9d has similar meaning when used in the\nphrase \xe2\x80\x9cprivate life.\xe2\x80\x9d See id. (\xe2\x80\x9cnot of an official or public character: private life\xe2\x80\x9d).\nThese phrases, by their plain terms, exclude all persons who hold public office.\nConsistent with this plain meaning, this Office has interpreted similar statutes\nthat require appointment \xe2\x80\x9cfrom private life\xe2\x80\x9d to preclude appointment of persons\nwho hold government office, whether federal or state, at the time of the appointment.2 See Memorandum for Dudley H. Chapman, Associate Counsel to the\nPresident, from Leon Ulman, Acting Assistant Attorney General, Office of Legal\nCounsel, Re: The Status of Members of the Board of Trustees of the Woodrow\n\xc2\xa7 957(b)\xe2\x80\x93(c). The NCH advises generally on matters relating to the Endowment\xe2\x80\x99s mission, and the\nChairperson is required to seek the recommendation of the NCH on any application for funding that\nexceeds $30,000. Id. \xc2\xa7 957(f). The recommendation of the NCH does not bind the Chairperson,\nhowever; the Council is advisory only. Id. Because the NCH is strictly advisory, members of the NCH\nare not \xe2\x80\x9cOfficers of the United States\xe2\x80\x9d for purposes of the Appointments Clause, and thus the\nqualifications on NCH appointments set forth in section 957(b) do not violate the Constitution. See The\nConstitutional Separation of Powers Between the President and Congress, 20 Op. O.L.C. 124, 144\n(1996); Common Legislative Encroachments on Executive Branch Authority, 13 Op. O.L.C. 248, 249\n(1989).\n2\nSimilar appointment requirements are found in a number of other federal statutes. For statutes\nrequiring appointment of \xe2\x80\x9cprivate citizens,\xe2\x80\x9d see 12 U.S.C. \xc2\xa7 4703(d) (2000) (Community Development\nAdvisory Board); 16 U.S.C. \xc2\xa7 19f (2000) (National Park Foundation Board); 42 U.S.C. \xc2\xa7 4273(a)(1)\n(2000) (Advisory Commission on Intergovernmental Relations); 20 U.S.C. \xc2\xa7 955(b)(C)(i) (2000)\n(National Council on the Arts). For statutes requiring appointment \xe2\x80\x9cfrom private life,\xe2\x80\x9d see 2 U.S.C.\n\xc2\xa7 352(1) (2000) (Citizens\xe2\x80\x99 Commission on Public Service and Compensation); 12 U.S.C. \xc2\xa7 2402(a)(13)\n(2000) (National Commission on Electronic Fund Transfers); 20 U.S.C. \xc2\xa7 80f(b)(9) (2000) (Board of\nTrustees for the Woodrow Wilson International Center for Scholars); 20 U.S.C. \xc2\xa7 2103(b)(1)(B) (2000)\n(Board of Trustees for the American Folklife Center); 22 U.S.C. \xc2\xa7 290f(g) (2000) (Board of Trustees\nfor the Inter-American Foundation); 22 U.S.C. \xc2\xa7 290h-5(a)(1) (2000) (Board of Directors for the\nAfrican Development Foundation); 29 U.S.C. \xc2\xa7 656(b) (2000) (National Advisory Committee on\nOccupational Safety and Health). The courts have not construed these appointment provisions, and we\nare not aware of relevant case law interpreting the phrases \xe2\x80\x9cpublic citizen\xe2\x80\x9d or \xe2\x80\x9cpublic life\xe2\x80\x9d in a manner\ninconsistent with our analysis.\n\n232\n\n\x0cRequirement That \xe2\x80\x9cPrivate Citizens\xe2\x80\x9d Be Appointed From \xe2\x80\x9cPrivate Life\xe2\x80\x9d to the NCH\n\nWilson International Center for Scholars (June 27, 1975) (opining that members\nmay remain on the board of the Wilson Center after becoming public officials but\nmay not hold public office at the time of their appointment); Memorandum for the\nDeputy Attorney General from W. Wilson White, Assistant Attorney General,\nOffice of Legal Counsel, Re: H.R. 1131, Commission on Voter Participation in\nFederal Elections (June 20, 1957) (pointing out that a requirement in proposed\nlegislation (never enacted into law) that certain commission members be state or\nlocal government representatives would be inconsistent with language in the same\nbill prescribing appointment \xe2\x80\x9cfrom private life\xe2\x80\x9d). We also note that in other\ncontexts, we have acknowledged a distinction between \xe2\x80\x9cprivate citizens\xe2\x80\x9d and state\ngovernment officials. See, e.g., Common Legislative Encroachments On Executive\nBranch Authority, 13 Op. O.L.C. 248, 250 (1989) (listing \xe2\x80\x9cprivate citizens\xe2\x80\x9d\nseparate from \xe2\x80\x9cstate officials\xe2\x80\x9d); Delegation of Authority to State Governors in\nEnd-user Gasoline Allocation Program, 3 Op. O.L.C. 231, 232 (1979) (discussing\n\xe2\x80\x9cState officers\xe2\x80\x9d separate from \xe2\x80\x9cprivate citizens\xe2\x80\x9d).\nIn prescribing generally that NCH members be appointed \xe2\x80\x9cfrom private life\xe2\x80\x9d\nand \xe2\x80\x9cfrom among private citizens,\xe2\x80\x9d Congress did not intend, in our view, to\ndistinguish federal government officials, on the one hand, from state and local\ngovernment officials, on the other. Congress has used specific language when it\nintends to disqualify only federal officials from appointment to particular offices.\nSee, e.g., 42 U.S.C. \xc2\xa7 242m(b)(2)(C) (2000) (requiring that members of peer\nreview groups advising the Secretary of Health and Human Services be appointed\n\xe2\x80\x9cfrom among persons who are not officers or employees of the United States\xe2\x80\x9d).\nSee also 42 U.S.C. \xc2\xa7 289a-1(b)(5)(C) (2000) (Ethics Advisory Boards for the\nNational Research Institute); 42 U.S.C. \xc2\xa7 5616(a)(2)(A) (2000) (Coordinating\nCouncil on Juvenile Justice and Delinquency Prevention); 49 U.S.C. \xc2\xa7 30306(c)(1)\n(2000) (National Driver Register Advisory Committee); 50 U.S.C. app. \xc2\xa7 1989b5(c)(1) (2000) (Civil Liberties Public Education Fund Board of Directors). These\nexamples of other statutes specifically precluding appointment of federal officials\nreinforce the plain meaning of section 957(b); language requiring appointees to be\n\xe2\x80\x9cprivate citizens\xe2\x80\x9d selected \xe2\x80\x9cfrom private life\xe2\x80\x9d is deliberately broader than a\nproscription against appointment of federal officials.3\nWe are informed that in at least one instance a state official was appointed to a\nsimilar body, the National Council for the Arts (\xe2\x80\x9cNCA\xe2\x80\x9d). As with the NCH, NCA\n3\nWe are aware of an instance in which some members of Congress, in legislative history, appeared\nto equate the phrase \xe2\x80\x9cnot Federal officers or employees\xe2\x80\x9d with \xe2\x80\x9cprivate-life members.\xe2\x80\x9d See H.R. Conf.\nRep. No. 105-599, at 197 (1998) (describing statutory membership requirements for the Internal Revenue Service Oversight Board, codified at 26 U.S.C. \xc2\xa7 7802 (2000)). But in that instance the terms\n\xe2\x80\x9cprivate life\xe2\x80\x9d and \xe2\x80\x9cprivate citizen\xe2\x80\x9d did not appear in the statute, which specifically prescribed only that\nmembers of the IRS Oversight Board be \xe2\x80\x9cindividuals who are not otherwise Federal officers or\nemployees.\xe2\x80\x9d 26 U.S.C. \xc2\xa7 7802(b)(1)(A). That statutory language supports our view that Congress\nwould use more specific language if it intended to bar only federal officials from appointment to the\nNCH.\n\n233\n\n\x0cOpinions of the Office of Legal Counsel in Volume 28\n\nappointees must be \xe2\x80\x9cprivate citizens.\xe2\x80\x9d 20 U.S.C. \xc2\xa7 955(b)(C)(i) (2000). We\nunderstand that, in 1989, a state senator from New York was appointed to the\nNCA. This Office evidently did not opine on that appointment. We do not believe\nthat this single appointment constitutes a history and practice that may overcome\nthe plain meaning of the statutory text governing appointments to the NCH. See\nNat\xe2\x80\x99l Fed\xe2\x80\x99n of Fed. Emps., Local 1309 v. Dep\xe2\x80\x99t of Interior, 526 U.S. 86, 95\xe2\x80\x9396\n(1999) (\xe2\x80\x9c[A] single, unreviewed decision [based on an executive order that\npreceded the statute] does not demonstrate the kind of historical practice that one\nmight assume would be reflected in the Statute.\xe2\x80\x9d).\nNor do we believe the statutory text could bear a distinction between state\nofficials, on the one hand, and local government officials, such as a county\ncommissioner. One who holds or is invested with a public office, whether part of\nstate or local government, is not a \xe2\x80\x9cprivate citizen\xe2\x80\x9d or in \xe2\x80\x9cprivate life\xe2\x80\x9d within the\nordinary sense of those terms. Congress appears to have recognized this ordinary\ndistinction between private citizens and local officials in statutory language: \xe2\x80\x9c[the\nDirector may appoint] one or more advisory committees composed of such private\ncitizens and officials of Federal, State, and local governments.\xe2\x80\x9d 42 U.S.C.\n\xc2\xa7 285a-2(b)(7) (2000) (National Cancer Institute Advisory Committee) (emphases\nadded). See also 49 U.S.C. \xc2\xa7 1113(b)(1)(E) (2000) (Advisory Committees to the\nNational Transportation Safety Board must be \xe2\x80\x9ccomposed of qualified private\ncitizens and officials of the Government and State and local governments\xe2\x80\x9d).\nAgain, the inference from these examples is clear: \xe2\x80\x9cprivate citizens\xe2\x80\x9d are distinguished from local government officials.\nIn one instance, under a different statute, we did conclude that a municipal\nemployee could be appointed to a position reserved for those from \xe2\x80\x9cprivate life.\xe2\x80\x9d\nMemorandum for the Vice President from Nicholas deB. Katzenbach, Assistant\nAttorney General, Office of Legal Counsel, Re: Appointment to the United States\nCitizens Commission on NATO (Mar. 1, 1961). That opinion addressed an appointment to the United States Citizens Commission on NATO (\xe2\x80\x9cNATO Commission\xe2\x80\x9d), a two-year advisory commission intended to meet with citizens in other\nNATO countries to facilitate greater cooperation and unity of purpose within\nNATO. See Pub. L. No. 86-719, 74 Stat. 818 (1960). As with the NCH, appointees\nto the NATO Commission were to be appointed from \xe2\x80\x9cprivate life.\xe2\x80\x9d Id. In that\nopinion, we relied solely on the legislative history of the provision, which\nindicated that Congress wanted only to insure that appointees to the NATO\nCommission were not connected with the foreign policy of the United States.\nSpecifically, Congress desired an objective perspective on foreign policy and went\nso far as to vest the authority to make appointments to the NATO Commission in\nCongress, not in the President. Based on that unique legislative history, we\nconcluded that a Chicago municipal employee\xe2\x80\x94who obviously had no prior\nconnection with the foreign policy of the United States\xe2\x80\x94qualified for appointment\nto that particular commission.\n\n234\n\n\x0cRequirement That \xe2\x80\x9cPrivate Citizens\xe2\x80\x9d Be Appointed From \xe2\x80\x9cPrivate Life\xe2\x80\x9d to the NCH\n\nLegislative history, of course, cannot trump the clear words of a statute, and we\nquestion the continued validity of our 1961 opinion for that reason. In any event,\nhere, by contrast, there is no such legislative history indicating that Congress was\nspecifically concerned to ensure only that appointees to the NCH be unaffiliated\nwith the federal government, as distinct from local government. Indeed, there is no\nrelevant legislative history at all on the \xe2\x80\x9cprivate life\xe2\x80\x9d and \xe2\x80\x9cprivate citizen\xe2\x80\x9d\nappointment requirement for NCH. To the extent the legislative history discusses\nthe appointment requirements of section 957(b), it is only to emphasize the other\ncriteria set forth in section 957(b)\xe2\x80\x94that NCH appointees should broadly represent\nthe humanities and be individuals of distinction in and commitment to the\nhumanities. See S. Rep. No. 91-879, at 3 (1970). See also 20 U.S.C. \xc2\xa7 957(b)\n(NCH appointees must be \xe2\x80\x9crecognized for their broad knowledge of, expertise in,\nor commitment to the humanities,\xe2\x80\x9d \xe2\x80\x9chave established records of distinguished\nservice,\xe2\x80\x9d and \xe2\x80\x9cprovide a comprehensive representation of the views of scholars\nand professional practitioners in the humanities\xe2\x80\x9d). The fact that only private\ncitizens may be appointed suggests that Congress was seeking more than just\nexpertise from the NCH; it specifically wanted the NCH appointees to be nongovernmental.\nWe believe the same conclusion holds when the local government official\nexercises his or her duties on a part-time basis only, even if the public official also\nholds a full-time private job. The dictionary definition of \xe2\x80\x9cprivate citizen\xe2\x80\x9d\nreinforces this view: a person is a private citizen if he or she does not hold a public\noffice and is not engaged in public employment. Webster\xe2\x80\x99s Third Int\xe2\x80\x99l Dictionary\nat 1805. A person who holds such an office, whether full-time or part-time, is not a\nprivate citizen. The definition indicates that whether persons are public officials\nturns on the nature of their position, not the number of hours occupied in their\nofficial duties. Many important government officials are or have been part-time.\nIndeed, the first twenty-three Attorneys General of the United States were parttime and continued to represent private clients. See Luther A. Huston, The\nDepartment of Justice 11 (1967). Nonetheless, even a part-time Attorney General\nsurely would not be classified as a private citizen. According to the National\nConference of State Legislatures, only eleven states have legislatures whose public\nduties occupy eighty percent or more of the time equivalent of a full-time job.\nNational Conference of State Legislatures, available at http://www.ncsl.org/\nprograms/legman/about/partfulllegis.htm (last visited Aug. 26, 2004). Whether fulltime or part-time, legislators are elected officials who exercise lawmaking powers\nand are clearly public officials disqualified from appointment to the NCH. If parttime officials could be considered private citizens, then numerous local government officials, including county commissioners, state legislators, state and local\njudges, and city council members, would have to be deemed private citizens.4 We\n4\nThe average city council member spends only 22 hours per week on council-related duties. National\nLeague of Cities, Serving on City Councils: America\xe2\x80\x99s City Councils in Profile (Part II), at 2\xe2\x80\x933 (2003),\n\n235\n\n\x0cOpinions of the Office of Legal Counsel in Volume 28\n\nthink that in light of the considerable governmental powers exercised by such\nofficials, they cannot be deemed private citizens consistent with the ordinary usage\nof that term. We therefore conclude that local government officials who exercise\nlawmaking or policymaking powers pursuant to their office cannot be considered\nprivate citizens regardless of whether they are full-time or part-time.\nSTEVEN G. BRADBURY\nPrincipal Deputy Assistant Attorney General\nOffice of Legal Counsel\n\navailable at http://www.nlc.org/nlc_org/site/files/pdf/council_brief2.pdf (last visited Aug. 26, 2004). Most\ncounty commissioners are part-time. National Association of Counties, What Do County Commissioners\nDo All Day? at 3, available at http://www.naco.org/ContentManagement/ContentDisplay.cfm?Content\nID=12026 (last visited Aug. 26, 2004). Part-time local judges are sufficiently common that the ABA\nModel Code of Judicial Conduct distinguishes ethical rules for part-time versus full-time judges. See\nModel Code of Judicial Conduct Application \xc2\xa7\xc2\xa7 C\xe2\x80\x93E (1990).\n\n236\n\n\x0c'


b'(Slip Opinion)\n\nWhether the Food and Drug Administration\nHas Jurisdiction over Articles Intended for\nUse in Lawful Executions\nMay 3, 2019\nArticles intended for use in executions carried out by a State or the federal government\ncannot be regulated as \xe2\x80\x9cdrugs\xe2\x80\x9d or \xe2\x80\x9cdevices\xe2\x80\x9d under the Federal Food, Drug, and Cosmetic Act. The Food and Drug Administration therefore lacks jurisdiction to regulate\narticles intended for that use.\n\nMEMORANDUM OPINION FOR THE ATTORNEY GENERAL\nThe Federal Food, Drug, and Cosmetic Act (\xe2\x80\x9cFDCA\xe2\x80\x9d), 21 U.S.C.\n\xc2\xa7 301 et seq., grants the Food and Drug Administration (\xe2\x80\x9cFDA\xe2\x80\x9d) the\nauthority to regulate all \xe2\x80\x9cdrugs\xe2\x80\x9d and \xe2\x80\x9cdevices,\xe2\x80\x9d which include any \xe2\x80\x9carticles (other than food) intended to affect the structure or any function of\nthe body,\xe2\x80\x9d as well as any components of such articles. Id. \xc2\xa7 321(g)(1)(C)\xe2\x80\x93\n(D), (h)(3). Your office has asked us whether FDA has authority to regulate articles used in historically accepted methods of execution. Some of\nthose articles\xe2\x80\x94like electric chairs and gas chambers\xe2\x80\x94exist for the sole\npurpose of effectuating capital punishment. Others\xe2\x80\x94like substances used\nin lethal-injection protocols and firearms used by firing squads\xe2\x80\x94have\nother intended uses.\nFDA has not historically exercised jurisdiction over articles intended to\ncarry out a lawful sentence of capital punishment. In connection with\nchallenges to FDA\xe2\x80\x99s regulatory inaction, the federal courts have addressed\nwhen the agency may lawfully decline to enforce the FDCA against such\narticles. See, e.g., Heckler v. Chaney, 470 U.S. 821 (1985); Cook v. FDA,\n733 F.3d 1 (D.C. Cir. 2013). Yet they have not squarely addressed\nwhether FDA has administrative jurisdiction in the first place. Congress\nhas repeatedly authorized the death penalty on the assumption that there\nare lawful means to carry it out, but the regulation of such articles under\nthe FDCA would effectively require their prohibition because they could\nhardly be found \xe2\x80\x9csafe and effective\xe2\x80\x9d for such an intended use. See FDA\nv. Brown & Williamson Tobacco Corp., 529 U.S. 120, 137\xe2\x80\x9339 (2000).\nConsistent with the agency\xe2\x80\x99s practice in this area for several decades\nbefore 2017, we thus conclude that, when an article\xe2\x80\x99s intended use is to\n\n1\n\n\x0cOpinions of the Office of Legal Counsel in Volume 43\n\neffectuate capital punishment by a State or the federal government, it is\nnot subject to regulation under the FDCA. 1\nI.\nThe FDCA was first enacted in 1938. Act of June 25, 1938, ch. 675, 52\nStat. 1040. Then, as well as now, the United States and several States\nauthorized the imposition of capital punishment for the most serious\noffenses. From the time of the FDCA\xe2\x80\x99s enactment until very recently,\nFDA had never claimed authority over the methods by which the federal\nand state governments carry out executions. That is in no small part\nbecause one of the FDCA\xe2\x80\x99s fundamental purposes is to ensure that drugs\nand devices marketed in interstate commerce are safe and effective for\ntheir intended uses\xe2\x80\x94a goal that markedly conflicts with the purpose of an\nexecution. In this Part, we summarize the regulatory structure of the\nFDCA and the history of its intersection with capital punishment.\nA.\nThe FDCA authorizes FDA to regulate drugs and devices. The FDCA\ndefines \xe2\x80\x9cdrug\xe2\x80\x9d to mean:\n(A) articles recognized in the official United States Pharmacopoeia,\nofficial Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and\n(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and\n(C) articles (other than food) intended to affect the structure or any\nfunction of the body of man or other animals; and\n(D) articles intended for use as a component of any article specified\nin clause (A), (B), or (C).\n21 U.S.C. \xc2\xa7 321(g)(1) (paragraph breaks added). Congress has made only\nsuperficial changes to this definition since 1938. Compare Act of June 25,\n1938, \xc2\xa7 201(g), 52 Stat. at 1041.\n\n1 In reaching this conclusion, we have solicited and considered the views of FDA and\nof the Office of the Associate Attorney General.\n\n2\n\n\x0cWhether FDA Has Jurisdiction over Articles Intended for Use in Lawful Executions\n\nThe FDCA defines \xe2\x80\x9cdevice\xe2\x80\x9d as any \xe2\x80\x9cinstrument, apparatus, implement,\nmachine, contrivance, implant, in vitro reagent, or other similar or related\narticle\xe2\x80\x9d that does not \xe2\x80\x9cachieve its primary intended purposes through\nchemical action within or on the body\xe2\x80\x9d; is not \xe2\x80\x9cdependent upon being\nmetabolized for the achievement\xe2\x80\x9d of those purposes; and is:\n(1) recognized in the official National Formulary, or the United\nStates Pharmacopeia, or any supplement to them,\n(2) intended for use in the diagnosis of disease or other conditions,\nor in the cure, mitigation, treatment, or prevention of disease, in\nman or other animals, or\n(3) intended to affect the structure or any function of the body of\nman or other animals.\n21 U.S.C. \xc2\xa7 321(h) (paragraph breaks added). The definition of \xe2\x80\x9cdevice\xe2\x80\x9d\nalso includes \xe2\x80\x9cany component, part, or accessory\xe2\x80\x9d of such articles. Id. 2\nAs the statutory definitions indicate, whether FDA may regulate an\narticle as a \xe2\x80\x9cdrug\xe2\x80\x9d or \xe2\x80\x9cdevice\xe2\x80\x9d often depends not just on that article\xe2\x80\x99s\neffect on a human or animal body, but also on whether that effect is\nintended. Id. \xc2\xa7 321(g)(1), (h). An article may be a \xe2\x80\x9cdrug\xe2\x80\x9d or \xe2\x80\x9cdevice\xe2\x80\x9d\nfor some uses but not for others, depending on the manufacturer\xe2\x80\x99s or\ndistributor\xe2\x80\x99s intent. For instance, FDA regulates \xe2\x80\x9cmedical gases,\xe2\x80\x9d but not\nchemically identical industrial gases. As FDA has explained, \xe2\x80\x9cindustrial\ngases . . . are not drugs\xe2\x80\x9d because manufacturers and distributors of industrial gases do not intend their products to treat disease or other conditions,\nor to otherwise affect the structure or function of the body. Medical\nGas Containers and Closures; Current Good Manufacturing Practice\nRequirements, 71 Fed. Reg. 18,039, 18,044 (Apr. 10, 2006); see 21 C.F.R.\n\xc2\xa7\xc2\xa7 201.161, 211.94(e). In a similar vein, FDA considers hot tubs, saunas,\nand treadmills as \xe2\x80\x9cdevices\xe2\x80\x9d only when they are \xe2\x80\x9cintended for medical\npurposes.\xe2\x80\x9d Physical Medicine Devices; General Provisions and Classification of 82 Devices, 48 Fed. Reg. 53,032, 53,034, 53,044, 53,051\xe2\x80\x9352\n2 Initially, the FDCA defined \xe2\x80\x9cdevice\xe2\x80\x9d as \xe2\x80\x9cinstruments, apparatus, and contrivances,\nincluding their components, parts, and accessories\xe2\x80\x9d if they were \xe2\x80\x9cintended\xe2\x80\x9d either \xe2\x80\x9cfor use\nin the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other\nanimals\xe2\x80\x9d or \xe2\x80\x9cto affect the structure or any function of the body of man or other animals.\xe2\x80\x9d\nAct of June 25, 1938, \xc2\xa7 201(h), 52 Stat. at 1041. In 1976, Congress expanded the definition of \xe2\x80\x9cdevice\xe2\x80\x9d to its current scope. Medical Device Amendments of 1976, Pub. L. No.\n94-295, sec. 3(a)(1)(A), \xc2\xa7 201(h), 90 Stat. 539, 575.\n\n3\n\n\x0cOpinions of the Office of Legal Counsel in Volume 43\n\n(Nov. 23, 1983); see 21 C.F.R. \xc2\xa7\xc2\xa7 890.5100, 890.5250, 890.5380. Thus,\npowered treadmills intended \xe2\x80\x9cto redevelop muscles or restore motion\nto joints\xe2\x80\x9d are \xe2\x80\x9cdevices,\xe2\x80\x9d but those sold solely for recreational purposes\nare not. 48 Fed. Reg. at 53,044, 53,052; 21 C.F.R. \xc2\xa7 890.5380. Likewise,\nFDA considers tape recordings as \xe2\x80\x9cdevices\xe2\x80\x9d when they are \xe2\x80\x9cintended\nfor use in the mitigation, treatment, and cure of disease and other medical\nconditions\xe2\x80\x9d (as in hypnotherapy), but not when they are intended\n\xe2\x80\x9cfor behavior modification, self-improvement, habit correction, learning\ntechniques, and simple relaxation.\xe2\x80\x9d FDA, Compliance Policy Guide\n\xc2\xa7 335.300.\nMany of the FDCA\xe2\x80\x99s prohibitions are keyed to a product\xe2\x80\x99s intended\nuse. The FDCA prohibits distribution of a \xe2\x80\x9cnew drug\xe2\x80\x9d that FDA has\nnot approved as safe and effective for its intended use. See 21 U.S.C.\n\xc2\xa7 355(a), (d)(1), (d)(5); United States v. Caronia, 703 F.3d 149, 152\xe2\x80\x9353\n(2d Cir. 2012). Similarly, the FDCA prohibits distribution of certain\ndevices that present \xe2\x80\x9ca potential unreasonable risk of illness or injury,\xe2\x80\x9d\nunless FDA has approved them as safe and effective for their intended\nuses. 21 U.S.C. \xc2\xa7 360c(a)(1)(C); see id. \xc2\xa7\xc2\xa7 331(a), 351(f )(1), 360e(a),\n(d)(2)(A)\xe2\x80\x93(B). The FDCA also bars distribution of \xe2\x80\x9cmisbranded\xe2\x80\x9d drugs\nand devices, including those whose labeling lacks adequate directions for\ntheir intended uses, id. \xc2\xa7 352(f )(1), or adequate warnings against unsafe\ndosages or methods of administration for those uses, id. \xc2\xa7 352(f )(2).\nFinally, the FDCA provides that FDA \xe2\x80\x9cshall\xe2\x80\x9d block the importation of\ndrugs and devices that appear to be unapproved for their intended use or\nmisbranded. Id. \xc2\xa7 381(a)(3).\nEven if FDA has approved an article for one intended use, it still may\nnot be imported, sold, or distributed for another, unapproved use. See\nWash. Legal Found. v. Henney, 202 F.3d 331, 332\xe2\x80\x9333 (D.C. Cir. 2000).\nFDA\xe2\x80\x99s regulations define the \xe2\x80\x9cintended use\xe2\x80\x9d of a drug or device with\nreference to \xe2\x80\x9cthe objective intent of the persons legally responsible for the\nlabeling\xe2\x80\x9d of the article. 21 C.F.R. \xc2\xa7\xc2\xa7 201.128 (drugs), 801.4 (devices).\nThat intent \xe2\x80\x9cis determined by such persons\xe2\x80\x99 expressions\xe2\x80\x9d or from \xe2\x80\x9cthe\ncircumstances surrounding the distribution of the article.\xe2\x80\x9d Id. \xc2\xa7\xc2\xa7 201.128,\n801.4. The regulations emphasize that \xe2\x80\x9c[t]he intended uses of an article\nmay change after it has been introduced into interstate commerce by its\nmanufacturer.\xe2\x80\x9d Id. \xc2\xa7\xc2\xa7 201.128, 801.4. \xe2\x80\x9c[F]or example, a packer, distributor, or seller [may] intend[] an article for different uses than those intended by the person from whom he received the\xe2\x80\x9d drug or device, in which\ncase \xe2\x80\x9csuch packer, distributor, or seller is required to supply adequate\n4\n\n\x0cWhether FDA Has Jurisdiction over Articles Intended for Use in Lawful Executions\n\nlabeling in accordance with the new intended uses.\xe2\x80\x9d Id. \xc2\xa7\xc2\xa7 201.128,\n801.4. Likewise, a manufacturer could lawfully distribute an article intending that it be used for an approved purpose, and then later violate the\nFDCA by distributing the same article intending that it be used for a\ndifferent, unapproved purpose.\nAs a general matter, FDA does not regulate the practice of medicine,\nwhich includes \xe2\x80\x9coff-label\xe2\x80\x9d prescribing\xe2\x80\x94that is, when physicians prescribe\nFDA-approved drugs or devices for non-FDA-approved uses. 3 As the\nSupreme Court has explained in the context of medical devices, \xe2\x80\x9c\xe2\x80\x98offlabel\xe2\x80\x99 usage . . . (use of a device for some other purpose than that for\nwhich it has been approved by the FDA) is an accepted and necessary\ncorollary of the FDA\xe2\x80\x99s mission to regulate in this area without directly\ninterfering with the practice of medicine.\xe2\x80\x9d Buckman Co. v. Plaintiffs\xe2\x80\x99\nLegal Comm., 531 U.S. 341, 350 (2001); see also Caronia, 703 F.3d at\n153. Thus, while the FDCA bars a manufacturer or distributor from selling any drug or device for an unapproved use, physicians may, with\nlimited exceptions, prescribe and administer FDA-approved drugs and\ndevices for unapproved uses.\nB.\nCapital punishment in the United States predates the Republic. For\nmost of the Nation\xe2\x80\x99s history, the federal government and the States employed the gallows. Starting in the late nineteenth century, States began\nusing the electric chair and, to a lesser degree, the gas chamber. At least\nsince Thomas Edison\xe2\x80\x99s New Jersey laboratory supplied parts for New\nYork\xe2\x80\x99s first electric chair in 1890, prison authorities have used interstate\nsuppliers to procure articles necessary for executions. 4 Today, every\n3 See Citizen Petition Regarding the Food and Drug Administration\xe2\x80\x99s Policy on Promotion of Unapproved Uses of Approved Drugs and Devices; Request for Comments,\n59 Fed. Reg. 59,820, 59,821 (Nov. 18, 1994) (\xe2\x80\x9c\xe2\x80\x98[O]nce a [drug] product has been approved for marketing, a physician may prescribe it for uses or in treatment regimens o[f ]\npatient populations that are not included in approved labeling.\xe2\x80\x99\xe2\x80\x9d) (quoting 12 FDA Drug\nBulletin 5 (Apr. 1982)); see also 21 U.S.C. \xc2\xa7 396.\n4 See Stuart Banner, The Death Penalty: An American History 183, 197 (2002) (describing New York\xe2\x80\x99s purchase of electric-chair components, and Nevada\xe2\x80\x99s purchase of\nhydrocyanic acid for use in the gas chamber from a California source); Scott Christianson,\nThe Last Gasp: The Rise and Fall of the American Gas Chamber 6 (2010) (explaining that\nEaton Metal Products in Colorado built gas chambers for most of the States that used\nthem); Carol J. Williams, Maker of Anesthetic Used in Executions is Discontinuing Drug,\n\n5\n\n\x0cOpinions of the Office of Legal Counsel in Volume 43\n\nmethod of execution appears to involve some component that traveled in\ninterstate or foreign commerce.\nBeginning in the late 1970s, many States and the federal government\nadopted lethal injection as the preferred method of execution. Those\nexecutions generally used sodium thiopental, a widely administrered\nsurgical anaesthetic. Although patients typically received a dose of around\n300 milligrams of sodium thiopental during surgical procedures, the dose\nin a lethal injection was anywhere from \xe2\x80\x9cseven to sixteen times higher.\xe2\x80\x9d\nMark Dershwitz & Thomas K. Henthorn, The Pharmacokinetics and\nPharmacodynamics of Thiopental as Used in Lethal Injection, 35 Fordham Urb. L.J. 931, 932 (2008); see also Glossip v. Gross, 135 S. Ct. 2726,\n2742 (2015) (noting that the dose of midazolam in Oklahoma\xe2\x80\x99s more\nrecent execution protocol \xe2\x80\x9cis many times higher than a normal therapeutic\ndose\xe2\x80\x9d).\nIn 1980, death-row inmates petitioned FDA to seize lethal-injection\nsubstances from several States, arguing that, although the substances were\napproved for other uses, their use in executions would violate the FDCA\xe2\x80\x99s\nprohibitions against the distribution of unapproved new drugs and misbranded drugs. FDA denied the petition, reasoning that it lacked authority\nto regulate States\xe2\x80\x99 use of FDA-approved drugs in capital punishment.\nFDA also stated that, even if it had such authority, it would decline to\nregulate in its enforcement discretion. When the issue reached the Supreme Court, the United States argued more broadly that FDA lacked\njurisdiction over articles intended for use in capital punishment. See\nHeckler, 470 U.S. 821; Br. for Pet\xe2\x80\x99r at 13\xe2\x80\x9314, 44\xe2\x80\x9346, Heckler v. Chaney,\n470 U.S. 821 (1985) (No. 83-1878) (\xe2\x80\x9cHeckler Pet\xe2\x80\x99r Br.\xe2\x80\x9d). The Court\nfound it \xe2\x80\x9cimplausible . . . that the FDA is required to exercise its enforcement power to ensure that States only use drugs that are \xe2\x80\x98safe and effective\xe2\x80\x99 for human execution.\xe2\x80\x9d 470 U.S. at 827. Rather than \xe2\x80\x9caddress the\nthorny question of the FDA\xe2\x80\x99s jurisdiction,\xe2\x80\x9d however, the Court held that\nFDA\xe2\x80\x99s exercise of enforcement discretion is not subject to judicial review.\nId. at 828.\n\nL.A. Times (Jan. 22, 2011), http://articles.latimes.com/2011/jan/22/local/la-me-executiondrug-20110122 (discussing California\xe2\x80\x99s use of sodium thiopental produced in North\nCarolina); Deborah W. Denno, Getting to Death: Are Executions Constitutional?, 82 Iowa\nL. Rev. 319, 354 & n.207 (1997) (explaining that the sole commercial suppliers of\nelectric-chair equipment were in Massachusetts and Arkansas).\n\n6\n\n\x0cWhether FDA Has Jurisdiction over Articles Intended for Use in Lawful Executions\n\nIn 2009, the sole American manufacturer of sodium thiopental ceased\nproduction. See Glossip, 135 S. Ct. at 2733. Since then, several States\nhave imported sodium thiopental from foreign suppliers. Cook, 733 F.3d\nat 4. In 2012, however, the U.S. District Court for the District of Columbia held that, although FDA has unreviewable discretion when enforcing\nthe FDCA\xe2\x80\x99s domestic prohibitions, FDA\xe2\x80\x99s discretion is more limited with\nrespect to the Act\xe2\x80\x99s importation provisions. The court issued a permanent\ninjunction requiring FDA to block the importation of sodium thiopental\non the grounds that it was unapproved and misbranded. See Beaty v. FDA,\n853 F. Supp. 2d 30 (D.D.C. 2012), aff \xe2\x80\x99d, Cook, 733 F.3d 1. Neither the\nparties nor the district court, however, addressed the government\xe2\x80\x99s previous argument in Heckler that FDA lacks jurisdiction over articles intended\nfor use in capital punishment. See Beaty, 853 F. Supp. 2d at 34. Following\nthe Beaty injunction, FDA expressly stated in a letter ruling, apparently\nfor the first time, that it had jurisdiction over a substance intended for that\nuse, though, significantly, the State seeking the ruling had conceded the\npoint. See Letter from Todd W. Cato, Director, Southwest Import District\nOffice at 5 (Apr. 20, 2017).\nAs of December 31, 2016, there were over 2,750 inmates with state\ndeath sentences. Elizabeth Davis & Tracy L. Snell, Bureau of Justice\nStatistics, U.S. Dep\xe2\x80\x99t of Justice, Capital Punishment, 2016, at 3 tbl.1\n(2018). And there are now approximately 62 civilian prisoners with federal death sentences. See Federal Bureau of Prisons, Statistics: Sentences\nImposed, https://www.bop.gov/about/statistics/statistics_inmate_sentences.\njsp (last updated Apr. 13, 2019). In response to difficulties in obtaining\nappropriate substances for lethal injection, some States are considering\nturning to different methods of execution, including the electric chair and\nnitrogen gas. Tom Barton, SC Senators Resurrect Bill to Bring Back the\nElectric Chair, Add Firing Squad, The State (Jan. 30, 2019), https://www.\nthestate.com/news/politics-government/article225312765.html; Denise\nGrady & Jan Hoffman, States Turn to an Unproven Method of Execution:\nNitrogen Gas, N.Y. Times (May 7, 2018), https://www.nytimes.com/\n2018/05/07/health/death-penalty-nitrogen-executions.html.\nII.\nWith this background in mind, we turn to whether FDA may regulate\narticles intended for use in capital punishment. The Supreme Court recognized some time ago that \xe2\x80\x9cCongress fully intended that the [FDCA]\xe2\x80\x99s\n7\n\n\x0cOpinions of the Office of Legal Counsel in Volume 43\n\ncoverage be as broad as its literal language indicates\xe2\x80\x94and equally clearly,\nbroader than any strict medical definition might otherwise allow.\xe2\x80\x9d United\nStates v. Bacto-Unidisk, 394 U.S. 784, 798 (1969). Nevertheless, in Brown\n& Williamson, the Court recognized one limitation to such coverage in the\ncontext of reviewing FDA\xe2\x80\x99s authority to regulate tobacco products.\nIn Brown & Williamson, the Court considered whether FDA had\nproperly determined that tobacco products as customarily marketed could\nbe regulated as \xe2\x80\x9cdrugs\xe2\x80\x9d or \xe2\x80\x9cdevices\xe2\x80\x9d under the FDCA. FDA had conducted a rulemaking in which it concluded that the definitional phrase, \xe2\x80\x9cintended to affect the structure or any function of the body,\xe2\x80\x9d is \xe2\x80\x9cbroad in\nscope and encompass[es] a range of products wider than those ordinarily\nthought of as drugs or medical devices.\xe2\x80\x9d Analysis Regarding the Food and\nDrug Administration\xe2\x80\x99s Jurisdiction over Nicotine-Containing Cigarettes\nand Smokeless Tobacco Products, 60 Fed. Reg. 41,453, 41,463 (Aug. 11,\n1995); Nicotine in Cigarettes and Smokeless Tobacco Is a Drug and These\nProducts Are Nicotine Delivery Devices Under the Federal Food, Drug,\nand Cosmetic Act: Jurisdictional Determination, 61 Fed. Reg. 44,619,\n44,658 (Aug. 28, 1996). FDA deemed nicotine to be regulable as a \xe2\x80\x9cdrug\xe2\x80\x9d\nbecause it was \xe2\x80\x9cintended\xe2\x80\x9d to have \xe2\x80\x9cpsychoactive, or mood-altering, effects on the brain\xe2\x80\x9d that foster addiction, stimulate and depress the nervous\nsystem, and suppress appetite, thus mirroring the effects of tranquilizers,\nstimulants, weight-loss drugs, and other articles long subject to FDA\njurisdiction. 61 Fed. Reg. at 44,631\xe2\x80\x9332.\nThe Supreme Court rejected FDA\xe2\x80\x99s conclusion, holding that the\nFDCA\xe2\x80\x99s jurisdictional provisions must be read in the context of the entire\nstatute, and of later-enacted laws, to ensure \xe2\x80\x9ca symmetrical and coherent\nregulatory scheme.\xe2\x80\x9d Brown & Williamson, 529 U.S. at 133. \xe2\x80\x9cViewing the\nFDCA as a whole,\xe2\x80\x9d the Court concluded that it would \xe2\x80\x9ccontravene[] the\nclear intent of Congress\xe2\x80\x9d to treat tobacco products as subject to FDA\nregulation. Id. at 132, 133. Were tobacco products regulated as \xe2\x80\x9cdrugs\xe2\x80\x9d or\n\xe2\x80\x9cdevices,\xe2\x80\x9d the FDCA would prohibit their sale, because they could not be\n\xe2\x80\x9csafe\xe2\x80\x9d or \xe2\x80\x9ceffective\xe2\x80\x9d for their intended use. Id. at 134\xe2\x80\x9337. Yet such \xe2\x80\x9ca ban\nwould contradict Congress\xe2\x80\x99s clear intent as expressed in its more recent,\ntobacco-specific legislation,\xe2\x80\x9d which reflected the \xe2\x80\x9ccollective premise . . .\nthat cigarettes and smokeless tobacco will continue to be sold in the\nUnited States.\xe2\x80\x9d Id. at 137, 139, 143\xe2\x80\x9356. Furthermore, Congress had enacted this tobacco-specific legislation \xe2\x80\x9cagainst the background of the FDA\nrepeatedly and consistently asserting that it lacks jurisdiction under the\nFDCA to regulate tobacco products as customarily marketed.\xe2\x80\x9d Id. at 155\xe2\x80\x93\n8\n\n\x0cWhether FDA Has Jurisdiction over Articles Intended for Use in Lawful Executions\n\n56. The Court concluded: \xe2\x80\x9cThe inescapable conclusion is that there is no\nroom for tobacco products within the FDCA\xe2\x80\x99s regulatory scheme. If they\ncannot be used safely for any therapeutic purpose, and yet they cannot be\nbanned, they simply do not fit.\xe2\x80\x9d Id. at 143. 5\nCongress subsequently ratified the Court\xe2\x80\x99s conclusion in the Tobacco\nControl Act, 21 U.S.C. \xc2\xa7 387 et seq., which confirmed that tobacco products as customarily marketed are not regulable as \xe2\x80\x9cdrugs\xe2\x80\x9d or \xe2\x80\x9cdevices\xe2\x80\x9d\nunder the FDCA. See id. \xc2\xa7 321(rr)(1)\xe2\x80\x93(2). At the same time, Congress\ngranted FDA the authority to impose other regulations on tobacco products. See id. \xc2\xa7 387a(a) (\xe2\x80\x9cTobacco products . . . shall be regulated . . .\nunder this subchapter and shall not be subject to the [drug-and-device]\nprovisions of subchapter V.\xe2\x80\x9d); Sottera, Inc. v. FDA, 627 F.3d 891, 898\n(D.C. Cir. 2010).\nUnder Brown & Williamson, FDA lacks jurisdiction to regulate articles\nintended for a use not traditionally regulated by FDA, when those articles\ncannot be safe and effective for such intended use, and Congress has\notherwise made clear its expectation that at least some of those articles\nshall remain lawful and available for that use. See Sottera, 627 F.3d at\n896 (interpreting Brown & Williamson); see also Massachusetts v. EPA,\n549 U.S. 497, 530\xe2\x80\x9331 (2007) (explaining that Brown & Williamson rested\non \xe2\x80\x9cthe unlikel[ihood] that Congress meant to ban tobacco products\xe2\x80\x9d and\n\xe2\x80\x9can unbroken series of congressional enactments that made sense only if\nadopted against the backdrop of the FDA\xe2\x80\x99s consistent and repeated statements\xe2\x80\x9d disclaiming jurisdiction (internal quotation marks omitted));\nVerizon v. FCC, 740 F.3d 623, 638 (D.C. Cir. 2014) (similar).\nIII.\nApplying Brown & Williamson, we conclude that the FDCA does not\nallow FDA to regulate an article intended for use in capital punishment in\nthe United States. The FDCA\xe2\x80\x99s regulatory framework for \xe2\x80\x9cdrugs\xe2\x80\x9d and\nThe Brown & Williamson Court declined to give the agency deference under Chevron, U.S.A., Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. 837 (1984), because \xe2\x80\x9cCongress\ncould not have intended to delegate a decision of such economic and political significance\nto an agency in so cryptic a fashion.\xe2\x80\x9d 529 U.S. at 160; see also King v. Burwell, 135 S. Ct.\n2480, 2489 (2015) (similarly concluding that \xe2\x80\x9c[w]hether [tax] credits are available on\nFederal [Health Insurance] Exchanges is . . . a question of deep \xe2\x80\x98economic and political\nsignificance\xe2\x80\x99\xe2\x80\x9d that Congress did not implicitly delegate to the agency) (quoting Brown &\nWilliamson, 529 U.S. at 160)).\n5\n\n9\n\n\x0cOpinions of the Office of Legal Counsel in Volume 43\n\n\xe2\x80\x9cdevices\xe2\x80\x9d cannot sensibly be applied to such articles. If the FDCA applied\nto electric chairs, gallows, gas chambers, firearms used in firing squads,\nand substances used in lethal-injection protocols, the statute would effectively ban those articles. Yet the Constitution and laws of the United\nStates presuppose the continued availability of capital punishment for the\nmost heinous federal and state crimes. FDA did not expressly assert the\nauthority to regulate articles intended for use in executions at any time\nbefore 2017, and we believe that such an assertion cannot be reconciled\nwith the FDCA and other federal law.\nA.\nArticles used in capital punishment do literally \xe2\x80\x9caffect the structure or\nany function of the body\xe2\x80\x9d by causing all bodily functions to cease. 21\nU.S.C. \xc2\xa7 321(g)(1)(C), (h)(3). Hanging, gas asphyxiation, a firing squad,\nlethal injection, and electrocution are all intended to achieve the same\neffect: they cause death. When a prison official seeks to purchase an\narticle essential to one of these methods of execution, the seller will often\nknow that the item will be used in an execution and is thus \xe2\x80\x9cintended\xe2\x80\x9d\nto affect the structure or any function of the body. Id.; see 21 C.F.R.\n\xc2\xa7 201.128 (a drug\xe2\x80\x99s \xe2\x80\x9cintended use\xe2\x80\x9d can \xe2\x80\x9cbe shown by the circumstances\nsurrounding the distribution of the article\xe2\x80\x9d); id. \xc2\xa7 801.4 (same for devices); cf. United States v. Kaminski, 501 F.3d 655, 671 (6th Cir. 2007)\n(concluding that egg powders were \xe2\x80\x9cdrugs\xe2\x80\x9d because defendants \xe2\x80\x9cdistributed them to consumers for the express purpose of treating and/or preventing diseases\xe2\x80\x9d as evidenced by, among other things, \xe2\x80\x9cthe methods of\nsale and distribution\xe2\x80\x9d).\nNevertheless, Brown & Williamson prevents us from interpreting the\nFDCA in a manner that would depart from its \xe2\x80\x9csymmetrical and coherent\nregulatory scheme,\xe2\x80\x9d 529 U.S. at 133, and interpreting the FDCA to authorize regulation of articles intended for use in executions would do\nexactly that. See also Weyerhaeuser Co. v. U.S. Fish & Wildlife Serv.,\n139 S. Ct. 361, 368 (2018) (\xe2\x80\x9c[S]tatutory language cannot be construed in\na vacuum . . . so we must also consider [the term] in its statutory context.\xe2\x80\x9d\n(internal quotation marks and citation omitted)). If such articles were\nregulated as \xe2\x80\x9cdrugs\xe2\x80\x9d or \xe2\x80\x9cdevices,\xe2\x80\x9d the FDCA would effectively ban them\nand FDA could seek fines or prosecutions against those involved in their\nsale or distribution. The FDCA \xe2\x80\x9cgenerally requires the FDA to prevent the\nmarketing of any drug or device where the potential for inflicting death or\n10\n\n\x0cWhether FDA Has Jurisdiction over Articles Intended for Use in Lawful Executions\n\nphysical injury is not offset by the possibility of therapeutic benefit.\xe2\x80\x9d\nBrown & Williamson, 529 U.S. at 134 (internal quotation marks omitted).\nIn the case of tobacco products, their short-term physiological effects\nwere greatly outweighed by their demonstrated carcinogenic qualities.\nId. at 134\xe2\x80\x9335. Thus, if tobacco products had been regulated as \xe2\x80\x9cdrugs\xe2\x80\x9d\nor \xe2\x80\x9cdevices,\xe2\x80\x9d the FDCA would have effectively rendered them unlawful.\nId. at 135\xe2\x80\x9337.\nThe same conclusion follows here, because the articles used in capital\npunishment are intended to cause death\xe2\x80\x94for some articles that is their\nsole purpose. Under the FDCA, a \xe2\x80\x9cnew drug\xe2\x80\x9d may not go to market unless\nFDA determines, based on \xe2\x80\x9cadequate and well-controlled investigations,\xe2\x80\x9d\nthat the substance is \xe2\x80\x9csafe\xe2\x80\x9d and \xe2\x80\x9ceffective[]\xe2\x80\x9d for the \xe2\x80\x9cuse . . . prescribed,\nrecommended, or suggested in the proposed labeling thereof.\xe2\x80\x9d 21 U.S.C.\n\xc2\xa7 355(d)(1), (5); see also 21 C.F.R. \xc2\xa7 314.50(d)(5). To approve a substance for use in a lethal-injection protocol, then, FDA would have to find\nthat clinical-trial data established that the substance was \xe2\x80\x9csafe\xe2\x80\x9d for executions\xe2\x80\x94that is, that the harm inflicted by the product would be \xe2\x80\x9coffset by\nthe possibility of therapeutic benefit\xe2\x80\x9d to the inmate. Brown & Williamson,\n529 U.S. at 134. It would not be sufficient to show that the substance is\nsafer or more effective than other means of execution. Brown & Williamson dismissed such an interpretation of \xe2\x80\x9csafety\xe2\x80\x9d as involving a \xe2\x80\x9cqualitatively different inquiry\xe2\x80\x9d from that required by the FDCA. Id. at 140.\nInstead, FDA must find \xe2\x80\x9cthat the product itself is safe as used by consumers.\xe2\x80\x9d Id. But there is no way products intended to carry out capital\npunishment could ever satisfy that test, under which \xe2\x80\x9ca drug is unsafe\nif its potential for inflicting death . . . is not offset by the possibility of\ntherapeutic benefit.\xe2\x80\x9d United States v. Rutherford, 442 U.S. 544, 556\n(1979).\nThe same would be true if electric chairs, gallows, or firing squads\xe2\x80\x99\nfirearms were regulated as \xe2\x80\x9cdevices.\xe2\x80\x9d Those articles would require premarket approval because they \xe2\x80\x9cpresent[] a potential unreasonable risk of\nillness or injury.\xe2\x80\x9d 21 U.S.C. \xc2\xa7 360c(a)(1)(C)(ii)(II). And FDA could\napprove them only if the applicant provided \xe2\x80\x9creasonable assurance\xe2\x80\x9d that\nthey were \xe2\x80\x9csafe\xe2\x80\x9d and \xe2\x80\x9ceffective\xe2\x80\x9d for the intended use of carrying out\ncapital punishment, id. \xc2\xa7 360e(d)(1)(A), (2)(A)\xe2\x80\x93(B), after \xe2\x80\x9cweighing any\nprobable benefit to health from the use of the device against any probable\nrisk of injury or illness from such use,\xe2\x80\x9d id. \xc2\xa7 360c(a)(2)(C). Again, FDA\n\n11\n\n\x0cOpinions of the Office of Legal Counsel in Volume 43\n\ncould not possibly approve \xe2\x80\x9cdevices\xe2\x80\x9d that are intended to effectuate\nexecutions as \xe2\x80\x9csafe\xe2\x80\x9d and \xe2\x80\x9ceffective.\xe2\x80\x9d 6\nNor would it matter whether an article intended for use in capital punishment was designed solely for that purpose or had other, FDA-approved\nuses. 7 Either way, whenever manufacturers or distributors intended that\nan article be used in capital punishment, the FDCA would prohibit distributing it for that use. For example, FDA has approved midazolam for\nuse as a sedative and anesthetic in certain procedures. But if a manufacturer or distributor of midazolam sold it to prison officials specifically for\nuse in capital punishment, the drug\xe2\x80\x99s \xe2\x80\x9cintended use\xe2\x80\x9d would be different\nfrom any approved use. See 21 C.F.R. \xc2\xa7 201.128. A drug\xe2\x80\x99s labeling must\nbear adequate directions for use for all of its intended uses; otherwise it\nis misbranded. See 21 U.S.C. \xc2\xa7 352(f )(1); 21 C.F.R. \xc2\xa7 201.128. Accordingly, the manufacturer or distributor would violate the FDCA\xe2\x80\x99s new drug\nprohibition where the product\xe2\x80\x99s labeling suggested its use in capital\npunishment. Drugs intended for use in lethal injection that were FDAapproved only for other uses would also be misbranded because their\nFDA-approved labeling would, by definition, lack adequate warnings\nagainst unsafe dosages or methods of administration for use in capital\npunishment. See 21 U.S.C. \xc2\xa7 352(f )(2). 8 In sum, if articles intended for\nApplications to market drugs and devices both require the submission of wellcontrolled clinical investigations. 21 U.S.C. \xc2\xa7\xc2\xa7 355(d), 360c(a)(2), (3)(A)\xe2\x80\x93(B); 21 C.F.R.\n\xc2\xa7 860.7(c). Given that the articles at issue here are intended to cause death during lawful\nexecutions, it is difficult to envision how the articles could be studied in clinical investigations involving humans.\n7 The FDCA\xe2\x80\x99s practice-of-medicine exception does not extend to articles used in executions. That exception applies only when an article is \xe2\x80\x9cprescribe[d] or administer[ed]\xe2\x80\x9d to\ntreat a \xe2\x80\x9ccondition or disease within a legitimate health care practitioner-patient relationship.\xe2\x80\x9d 21 U.S.C. \xc2\xa7 396 (devices); see James M. Beck & Elizabeth D. Azari, FDA, OffLabel Use, and Informed Consent: Debunking Myths and Misconceptions, 53 Food &\nDrug L.J. 71, 77\xe2\x80\x9378 (1998) (discussing history behind section 396, which shows it was\nenacted to extend to devices the practice-of-medicine exception that already applied to\ndrugs).\n8 The law-enforcement exception in 21 C.F.R. \xc2\xa7 201.125 exempts a drug from the\nrequirement in section 502(f )(1) of the FDCA that labeling include \xe2\x80\x9cadequate directions\nfor use.\xe2\x80\x9d 21 U.S.C. \xc2\xa7 352(f )(1). That exception, however, does not extend to section\n502(f )(2), which requires \xe2\x80\x9cadequate warnings . . . against unsafe dosage or methods or\nduration of administration.\xe2\x80\x9d Id. \xc2\xa7 352(f )(2). Thus, even if executions qualified as an\nexcepted law-enforcement use, substances used in executions would be misbranded under\nsubsection (f )(2).\n6\n\n12\n\n\x0cWhether FDA Has Jurisdiction over Articles Intended for Use in Lawful Executions\n\nuse in capital punishment were regulated as \xe2\x80\x9cdrugs\xe2\x80\x9d or \xe2\x80\x9cdevices,\xe2\x80\x9d then the\nFDCA would prohibit them altogether.\nIn the past, FDA has avoided such regulatory consequences by declining to regulate the domestic sale and distribution of articles intended for\nuse in executions as a matter of enforcement discretion. But the D.C.\nCircuit recently upheld a district court order enjoining FDA from permitting the importation of foreign-manufactured sodium thiopental, on the\ngrounds that it was misbranded and unapproved. Cook, 733 F.3d 1. And\nthe question now is whether FDA\xe2\x80\x99s regulatory authority encompasses\narticles intended for use in lethal injection or other methods of capital\npunishment, not whether FDA may use its enforcement discretion to\nalleviate the regulatory consequences. FDA equally had discretion not to\nenforce the FDCA against domestic tobacco sales that, in FDA\xe2\x80\x99s view,\nwould have violated the FDCA\xe2\x80\x99s prohibitions on misbranding or unapproved new drugs or devices. What mattered in Brown & Williamson was\nthat the FDCA would have rendered the sale of tobacco products per se\nunlawful, not that FDA could have tempered that ban by selectively\nsparing particular manufacturers from civil and criminal penalties. See,\ne.g., 529 U.S. at 136 (\xe2\x80\x9c[T]he Act admits no remedial discretion once it is\nevident that the device is misbranded.\xe2\x80\x9d). The prospect that articles intended for use in capital punishment could be sold or distributed at FDA\xe2\x80\x99s\nsufferance does not alter the fact that the FDCA, by its terms, would\neffectively require a ban of such articles if they were regulated under the\nFDCA as \xe2\x80\x9cdrugs\xe2\x80\x9d or \xe2\x80\x9cdevices.\xe2\x80\x9d\nB.\nEven if the FDCA could be interpreted to authorize regulation of articles intended for use in executions without requiring them to be banned,\nany attempt to do so would create serious tension with other provisions of\nthe Act. We do not conclude that, in order for FDA to have jurisdiction\nover an article as a \xe2\x80\x9cdrug\xe2\x80\x9d or \xe2\x80\x9cdevice,\xe2\x80\x9d every drug- or device-related\nprovision of the FDCA must apply neatly to the article\xe2\x80\x99s intended use. But\nthe sheer number of FDCA provisions here that would make no sense as\napplied reinforces the conclusion that FDA lacks jurisdiction over articles\nintended for use in capital punishment. For example, with respect to\narticles intended for use in capital punishment, FDA could not assess\n\xe2\x80\x9c[t]he seriousness of the disease or condition that is to be treated with the\ndrug\xe2\x80\x9d or \xe2\x80\x9c[t]he expected benefit of the drug with respect to such disease\n13\n\n\x0cOpinions of the Office of Legal Counsel in Volume 43\n\nor condition.\xe2\x80\x9d 21 U.S.C. \xc2\xa7 355-1(a)(1)(B)\xe2\x80\x93(C). Execution drugs address\nno \xe2\x80\x9ccondition\xe2\x80\x9d suffered by, and produce no \xe2\x80\x9cbenefit\xe2\x80\x9d for, the end user;\ninstead, they exclusively inflict harm upon that user. For the same reason,\nwhen reviewing a new drug application for an article intended for use\nin capital punishment, FDA could not provide for review of scientific\ndisputes by a \xe2\x80\x9cpanel[] of experts\xe2\x80\x9d that includes members with \xe2\x80\x9cexpertise\nin the particular disease or condition for which the drug . . . is proposed\nto be indicated.\xe2\x80\x9d Id. \xc2\xa7 355(n)(1), (3)(D) (emphasis added); see also id.\n\xc2\xa7 360bbb-1; 8 C.F.R. \xc2\xa7 10.75(b)(2). In the context of an execution, there\nis no applicable \xe2\x80\x9cdisease or condition.\xe2\x80\x9d\nFurther, with respect to articles intended for use in capital punishment,\n\xe2\x80\x9cpatient experience data\xe2\x80\x9d\xe2\x80\x94which includes \xe2\x80\x9cinformation about patients\xe2\x80\x99\nexperiences with a disease or condition,\xe2\x80\x9d such as \xe2\x80\x9cpatient preferences\nwith respect to treatment of such disease or condition\xe2\x80\x9d\xe2\x80\x94would never be\navailable. 21 U.S.C. \xc2\xa7 360bbb-8c(b)(1), (c)(2). Other FDCA provisions\ntreat death as a serious side effect that triggers mandatory reporting and\nFDA oversight. See, e.g., id. \xc2\xa7 355(k)(3)(C)(i)(II) (requiring drug manufacturers to \xe2\x80\x9creport[] . . . on all serious adverse drug experiences,\xe2\x80\x9d including death); 21 C.F.R. \xc2\xa7 314.80 (detailing exhaustive reporting requirements for each \xe2\x80\x9cadverse drug experience,\xe2\x80\x9d including those resulting in\ndeath). These provisions cannot sensibly be read to allow an article\xe2\x80\x99s\nintended use to be the causing of death in an execution.\nOther provisions presuppose that an approved device may not be intended to effectuate an execution. A manufacturer\xe2\x80\x99s application for FDA\napproval \xe2\x80\x9cshall include\xe2\x80\x9d a \xe2\x80\x9cdescription of any pediatric subpopulations\nthat suffer from the disease or condition that the device is intended to\ntreat, diagnose, or cure,\xe2\x80\x9d 21 U.S.C. \xc2\xa7 360e-1(a)(2)(A), which suggests that\na device must be intended to improve a patient\xe2\x80\x99s circumstances. FDA\nmust also submit any new device to a panel of experts with \xe2\x80\x9cadequate\nexpertise . . . to assess . . . the disease or condition which the device is\nintended to cure, treat, mitigate, prevent, or diagnose.\xe2\x80\x9d Id. \xc2\xa7 360c(b)(1),\n(5)(B)(i)(I). But again, it would make no sense to apply those provisions\nto articles for use in executions, which are not intended to produce any\nbenefit for the end user.\nCongress has treated certain articles intended to cause death as falling\noutside FDA\xe2\x80\x99s jurisdiction. For instance, the Federal Insecticide, Fungicide, and Rodenticide Act (\xe2\x80\x9cFIFRA\xe2\x80\x9d) expressly gives the Environmental\nProtection Agency rather than FDA jurisdiction over \xe2\x80\x9cpesticides,\xe2\x80\x9d which\ninclude \xe2\x80\x9cany substance . . . intended for preventing, destroying, repelling,\n14\n\n\x0cWhether FDA Has Jurisdiction over Articles Intended for Use in Lawful Executions\n\nor mitigating any pest\xe2\x80\x9d but exclude \xe2\x80\x9cany article that is a \xe2\x80\x98new animal\ndrug\xe2\x80\x99 within the meaning\xe2\x80\x9d of the FDCA. 7 U.S.C. \xc2\xa7 136(u). FIFRA thus\nsuggests that Congress generally views substances intended to harm or\nkill pests (such as mosquitos and rats, see id. \xc2\xa7 136(t)) as outside FDA\xe2\x80\x99s\njurisdiction.\nOver the years, FDA has disclaimed jurisdiction over several other articles intended to kill or harm humans or animals. In 1969, for instance,\nFDA\xe2\x80\x99s Chief Counsel testified that even though \xe2\x80\x9cpistols and bullets are\nintended to affect the function or structure of the body in the same way\xe2\x80\x9d\nas mace, the agency \xe2\x80\x9cconcluded that the products could not properly be\nclassified as drugs under the definition\xe2\x80\x9d in the FDCA. Public Sale of\nProtective Chemical Sprays: Hearings Before the Consumer Subcomm. of\nthe S. Comm. on Commerce, 91st Cong. 37 (1969) (statement of William\nGoodrich). FDA reiterated that position when asserting jurisdiction over\ntobacco products in 1996, explaining that it \xe2\x80\x9chas never construed the\nstructure-function provision to include products such as guns, airbags, and\nchemical sprays,\xe2\x80\x9d despite their intended effects on the structure or function of the body. 61 Fed. Reg. at 44,684. That same rationale extends to\narticles intended for use in executions. 9\n9 Since 1977, FDA has asserted jurisdiction over articles intended for animal euthanasia. FDA first asserted jurisdiction over Beuthanasia-D. See United States v. Articles\nof Drug Beuthanasia-D Regular, Food Drug Cosm. L. Rep. (CCH) \xc2\xb6 38,265 (D. Neb.\nAug. 1, 1979). A district court agreed that FDA had jurisdiction, both because Beuthanasia-D\xe2\x80\x99s two active ingredients were listed in the United States Pharmacopoeia (a\ndifferent component of the FDCA\xe2\x80\x99s definition of \xe2\x80\x9cdrug\xe2\x80\x9d), id. \xc2\xb6 39,129 (citing 21 U.S.C.\n\xc2\xa7 321(g)(1)(A) (1972)), and because \xe2\x80\x9ceuthanasia\xe2\x80\x94the cessation of all bodily functions\xe2\x80\x94\n. . . constitute[s] an effect on the function, if not the structure, of the animal\xe2\x80\x99s body,\xe2\x80\x9d id.\n\xc2\xb6 39,130 (citing 21 U.S.C. \xc2\xa7 321(g)(1)(C) (1972)). In 1980, FDA issued a two-paragraph\nguidance statement, opining that \xe2\x80\x9cproducts intended for animal euthanasia . . . conform\nto the definition of a drug\xe2\x80\x9d under the FDCA \xe2\x80\x9csince they are clearly intended to affect\nthe function of the body by inducing death.\xe2\x80\x9d FDA, Compliance Policy Guide \xc2\xa7 650.100\n(Oct. 1, 1980). FDA\xe2\x80\x99s guidance in this area predates Brown & Williamson, and no court\nhas revisited the matter. Although it may be difficult to view animal-euthanasia articles as\n\xe2\x80\x9csafe\xe2\x80\x9d for their intended use (at least where such articles are used on healthy but unwanted animals), FDA has regulated such articles since 1977; it has approved five applications\nfor these articles; its regulation does not raise constitutional concerns; and we are aware\nof no legislation that suggests FDA\xe2\x80\x99s assertion of jurisdiction over articles intended for\nanimal euthanasia is contrary to the intent of Congress. Additionally, animal euthanasia\nhas long been an accepted part of veterinary practice, whereas capital punishment has not\nbeen a part of medical practice. Therefore, whether or not animal euthanasia may be\ndistinguishable from executions, we do not view FDA\xe2\x80\x99s practice of regulating the former\n\n15\n\n\x0cOpinions of the Office of Legal Counsel in Volume 43\n\nC.\nThe FDCA cannot be read as authorizing FDA to effectively ban capital\npunishment, because that reading would contravene or render moot a host\nof federal statutes that presuppose the lawfulness of capital punishment.\nIn Brown & Williamson, the Court held that FDA was not authorized to\nprohibit tobacco products because Congress had repeatedly confirmed that\nsuch products would remain available. That reasoning applies equally\nwell to articles intended for use in capital punishment. The Constitution\nand numerous federal statutes presuppose that capital punishment will\nremain available and that the federal government will defer to States over\nmethods of execution. Interpreting the FDCA to bar the importation, sale,\nand distribution of articles intended for use in executions would conflict\nwith that settled understanding. By contrast, the conclusion that articles\nintended for use in executions cannot be regulated under the FDCA would\nbe consistent with how FDA has traditionally exercised its authority; and\nit would avoid the serious federalism concerns that would arise from a\ncontrary interpretation.\n1.\nAs the Supreme Court recently observed, the Constitution expressly\n\xe2\x80\x9callows capital punishment.\xe2\x80\x9d Bucklew v. Precythe, 139 S. Ct. 1112, 1122\n(2019). Indeed, \xe2\x80\x9cthe Fifth Amendment, added to the Constitution at the\nsame time as the Eighth, expressly contemplates that a defendant may be\ntried for a \xe2\x80\x98capital\xe2\x80\x99 crime and \xe2\x80\x98deprived of life\xe2\x80\x99 as a penalty, so long as\nproper procedures are followed.\xe2\x80\x9d Id. Federal law, accordingly, has authorized the imposition of the death penalty since 1790, when the First\nCongress mandated that several federal crimes, including treason and\nmurder on federal land, be punished by death. Act of Apr. 30, 1790, ch. 9,\n\xc2\xa7\xc2\xa7 1, 3, 33, 1 Stat. 112, 112, 113, 119. By 1938, federal statutes authorized the death penalty for dozens of offenses. And, in the decades since\nthe FDCA\xe2\x80\x99s enactment, Congress has acted numerous times to make\nadditional federal crimes punishable by death. 10 In providing that the\nas sufficient to overcome the force of the arguments against FDA\xe2\x80\x99s authority to regulate\nthe latter.\n10 See, e.g., Act of June 8, 1940, ch. 286, 54 Stat. 255, 255\xe2\x80\x9356 (authorizing capital\npunishment if anyone is killed by the willful derailment of any train in interstate commerce); Uniform Code of Military Justice, Act of May 5, 1950, ch. 169, 64 Stat. 107,\n\n16\n\n\x0cWhether FDA Has Jurisdiction over Articles Intended for Use in Lawful Executions\n\ndeath penalty is an available punishment for dozens of federal crimes,\nCongress has presupposed there would be a lawful means for carrying out\nsuch a sentence.\nFrom 1790 until 1937, federal law prescribed hanging as the method of\nexecution. Act of Apr. 30, 1790, \xc2\xa7 33, 1 Stat. at 119; Andres v. United\nStates, 333 U.S. 740, 745 n.6 (1948). Congress then mandated that each\nfederal execution be carried out in \xe2\x80\x9cthe manner prescribed by the laws of\nthe State within which the sentence is imposed,\xe2\x80\x9d or, if that State did not\nhave the death penalty, in accordance with the laws of another State\ndesignated by the sentencing court. Act of June 19, 1937, ch. 367, 50 Stat.\n304, 304 (repealed 1984). At the time, nearly 30 States were using cyanide gas or the electric chair, but the States adopted at least six different\nmethods of execution between then and the early 1980s. See Deborah A.\nDenno, Getting to Death: Are Executions Constitutional?, 82 Iowa L.\nRev. 319, 439\xe2\x80\x9364 (1997). After that provision was repealed in 1984,\nfederal regulations required the government to propose to the sentencing\ncourt that any death sentence be carried out by lethal injection. 28 C.F.R.\n\xc2\xa7 26.2(a)(2). Unless the court ordered otherwise, they required the Director of the Federal Bureau of Prisons to \xe2\x80\x9cdetermine[]\xe2\x80\x9d which \xe2\x80\x9csubstance or\nsubstances\xe2\x80\x9d to use. Id. \xc2\xa7 26.3(a)(4).\nToday, capital sentences imposed under the Federal Death Penalty Act\nof 1994 are again required to be implemented \xe2\x80\x9cin the manner prescribed\nby\xe2\x80\x9d either (i) \xe2\x80\x9cthe law of the State in which the sentence is imposed,\xe2\x80\x9d or\n(ii) if that State does not have the death penalty, the law of another State\ndesignated by the sentencing court. 18 U.S.C. \xc2\xa7 3596(a). The Army\xe2\x80\x99s\nexecutions are by \xe2\x80\x9cintravenous administration of a lethal substance, or\nsubstances, in a quantity sufficient to cause death.\xe2\x80\x9d Army Regulation 19055, U.S. Army Corrections System: Procedures for Military Executions\n\xc2\xa7 3-1, -2 (Jan. 17, 2006).\n135\xe2\x80\x9340 (articles 85, 90, 94, 99, 100, 101, 102, 104, 106, 110, 113, 118, and 120, establishing 13 military offenses punishable by death); Organized Crime Control Act of 1970,\nPub. L. No. 91-452, sec. 1102, \xc2\xa7 844(d), 84 Stat. 922, 957 (authorizing capital punishment\nif death results from the use of explosives to maliciously destroy government property);\nAnti-Drug Abuse Act of 1988, Pub. L. No. 100-690, \xc2\xa7 7001(a), 102 Stat. 4181, 4387\xe2\x80\x9388\n(codified at 21 U.S.C. \xc2\xa7 848(e)) (authorizing capital punishment for intentional killing\nwhile engaging in criminal enterprises or drug felonies); Federal Death Penalty Act of\n1994, Pub. L. No. 103-322, \xc2\xa7\xc2\xa7 60001\xe2\x80\x9360026, 108 Stat. 1796, 1959\xe2\x80\x9382 (codifying procedures for federal death sentences and authorizing capital punishment for 60 offenses\nunder 13 existing and 28 new federal statutes).\n\n17\n\n\x0cOpinions of the Office of Legal Counsel in Volume 43\n\nThis extensive backdrop of legislative and regulatory action precludes\nany suggestion that the FDCA prohibits the importation, sale, or distribution of articles intended for use in executions; to the contrary, these statutory and regulatory schemes unambiguously assume the continued availability of such articles. Before and after the FDCA\xe2\x80\x99s enactment, Congress\nextended the federal death penalty and required the federal government\nto adopt States\xe2\x80\x99 preferences as to methods of execution. Such provisions\nwould be nonsensical if the FDCA had rendered it a crime to distribute\nin interstate commerce, including through importation (see 21 U.S.C.\n\xc2\xa7 321(b)), the very articles that States and the federal government need to\neffectuate capital sentences. By expressly recognizing States\xe2\x80\x99 discretion to\nselect methods of execution (subject to constitutional limits), Congress\nprecluded any role for FDA in supplanting States\xe2\x80\x99 judgments about those\nmethods.\n2.\nIn addition, as in Brown & Williamson, \xe2\x80\x9c[t]he consistency of the FDA\xe2\x80\x99s\nprior position\xe2\x80\x9d concerning the absence of regulatory jurisdiction over\nmethods of execution, coupled with a corresponding history of nonenforcement, \xe2\x80\x9cprovides important context\xe2\x80\x9d for interpreting federal deathpenalty legislation postdating the FDCA. 529 U.S. at 157. Just as FDA\n\xe2\x80\x9casserted authority to regulate tobacco products as customarily marketed\xe2\x80\x9d\nonly late in its history, id. at 146, FDA does not appear to have asserted\njurisdiction to regulate articles intended for use in executions before 2017.\nBetween 1981 and 1985, FDA directly addressed its jurisdiction in the\nproceedings associated with Heckler, 470 U.S. 821. The challenge in\nHeckler involved state lethal-injection protocols, which required the\nunapproved use of drugs that were FDA-approved for other purposes.\nAlthough the Heckler Court found it \xe2\x80\x9cimplausible . . . that the FDA is\nrequired to exercise its enforcement power to ensure that States only use\ndrugs that are \xe2\x80\x98safe and effective\xe2\x80\x99 for human execution,\xe2\x80\x9d id. at 827, the\nCourt ultimately declined to resolve the \xe2\x80\x9cthorny question of the FDA\xe2\x80\x99s\njurisdiction\xe2\x80\x9d in that circumstance, id. at 828. Instead, the Court held\nthat FDA\xe2\x80\x99s decision not to enforce the FDCA was unreviewable. Id. at\n837\xe2\x80\x9338. Even so, we find instructive FDA\xe2\x80\x99s own statements about its\njurisdiction in the Supreme Court and in the underlying administrative\nproceeding.\n\n18\n\n\x0cWhether FDA Has Jurisdiction over Articles Intended for Use in Lawful Executions\n\nIn 1981, FDA rejected a petition from death-row inmates asking FDA\nto adopt a procedure for the seizure and condemnation of drugs destined\nor held for use in executions. See Letter for David E. Kendall, from Arthur Hull Hayes, Commissioner of Food and Drugs at 1 (July 7, 1981)\n(\xe2\x80\x9cHeckler Petition Response\xe2\x80\x9d). The inmates contended that the States\xe2\x80\x99\nacquisition of FDA-approved drugs for capital punishment constituted\nmisbranding because the drugs lacked adequate directions or warnings\nfor that use. Id. at 1\xe2\x80\x932. FDA denied the petition in the first instance because \xe2\x80\x9cthe use of lethal injection by State penal systems is a practice over\nwhich FDA has no jurisdiction.\xe2\x80\x9d Id. at 2. FDA concluded that the States\xe2\x80\x99\noff-label use of FDA-approved drugs in lethal-injection protocols was\nsufficiently analogous to the practice of medicine, including physicians\xe2\x80\x99\nlawful off-label use of FDA-approved drugs, to fall outside the FDCA\xe2\x80\x99s\nambit. Id. at 3\xe2\x80\x934. But FDA also emphasized that its lack of jurisdiction\nflowed from \xe2\x80\x9ca consideration of the proper role of the Federal Government with respect to the conduct of State criminal justice systems.\xe2\x80\x9d Id.\nat 2. FDA further recognized that, \xe2\x80\x9c[b]ecause . . . the [FDCA] does not\nprovide us with authority to declare unlawful the use by State governments of drugs for lethal injection,\xe2\x80\x9d concerns about the safety of lethalinjection protocols would \xe2\x80\x9cmore appropriately [be] addressed to the State\nlegislatures.\xe2\x80\x9d Id. at 4. 11\n\n11 FDA did contend that, \xe2\x80\x9c[u]nder the Supremacy Clause,\xe2\x80\x9d \xe2\x80\x9ca State could not legitimize the unlawful shipment of an unapproved new drug in interstate commerce or prevent\nits misbranding after shipment in interstate commerce by authorizing its use,\xe2\x80\x9d including\nfor purposes of execution. Heckler Petition Response at 3. But that reflected a general\nobservation that state law cannot trump the FDCA\xe2\x80\x99s provisions to the extent they apply to\na given drug or device, or effectively immunize prior conduct that violated the FDCA by\napproving a product\xe2\x80\x99s use at a later time. The government\xe2\x80\x99s opening brief in the Supreme\nCourt also represented in a footnote that \xe2\x80\x9c[t]his case concerns the FDA\xe2\x80\x99s authority to\nregulate the states\xe2\x80\x99 use of drugs, lawfully in interstate commerce, for the unapproved\npurpose of causing death, and not the marketing of drugs for an unapproved use.\xe2\x80\x9d Heckler\nPet\xe2\x80\x99r Br. at 45\xe2\x80\x9346 n.34; accord Reply Br. at 8, Heckler v. Chaney, 470 U.S. 821 (1985)\n(No. 83-1878) (\xe2\x80\x9cHeckler Reply Br.\xe2\x80\x9d) (\xe2\x80\x9cFDA lacks jurisdiction over the use of approved\ndrugs by state authorities for capital punishment purposes.\xe2\x80\x9d). The brief asserted that an\nFDCA violation would occur \xe2\x80\x9cif a drug were marketed for the purpose of causing death\nwithout being approved for that use,\xe2\x80\x9d but it noted that no one was alleged to have \xe2\x80\x9cdirectly or indirectly promote[d] the use of the drugs at issue\xe2\x80\x9d for executions. Heckler Pet\xe2\x80\x99r Br.\nat 45\xe2\x80\x9346 n.34. Those statements did not reserve FDA jurisdiction over unapproved\narticles used in executions because the government\xe2\x80\x99s briefs categorically disclaimed FDA\njurisdiction over any method of execution. See infra notes 12\xe2\x80\x9313 and accompanying text.\n\n19\n\n\x0cOpinions of the Office of Legal Counsel in Volume 43\n\nIn the resulting litigation, the D.C. Circuit divided over whether FDA\nhad jurisdiction over drugs intended for use in executions. See Chaney v.\nHeckler, 718 F.2d 1174 (D.C. Cir. 1983), rev\xe2\x80\x99d, 470 U.S. 821 (1985). The\nmajority rejected FDA\xe2\x80\x99s conclusions that administering capital punishment fell within the FDCA\xe2\x80\x99s \xe2\x80\x9cpractice of medicine\xe2\x80\x9d exception or, in the\nalternative, that actions taken by prison officials did not qualify as misbranding under the Act. See id. at 1179, 1181. Then-Judge Scalia, in\ndissent, recognized the incongruity in treating \xe2\x80\x9ca law designed to protect\nconsumers against drugs that are unsafe or ineffective for their represented use\xe2\x80\x9d as \xe2\x80\x9cmandating federal supervision of the manner of state executions.\xe2\x80\x9d Id. at 1192 (Scalia, J., dissenting). He would have held that FDA\nlacked jurisdiction because the drugs were not \xe2\x80\x9cheld for sale\xe2\x80\x9d in interstate\ncommerce. Id. at 1199\xe2\x80\x931200. Because FDA did not press the point, neither opinion addressed whether \xe2\x80\x9cthe unapproved use of drugs for lethal\ninjection is outside the general jurisdictional provisions of the Act\xe2\x80\x9d\xe2\x80\x94that\nis, whether drugs intended for use in lethal injection are subject to regulation under the FDCA. Id. at 1179.\nIn the Supreme Court, the government contended that FDA categorically lacked jurisdiction over articles used in capital punishment, and that\nFDA had denied the inmates\xe2\x80\x99 petition because it had concluded \xe2\x80\x9cthat it\nlacked authority under the FDCA to regulate the states\xe2\x80\x99 use of lethal\ninjections for capital punishment.\xe2\x80\x9d Heckler Pet\xe2\x80\x99r Br. at 13; see id. at 4\n(similar). The government repeatedly asserted that \xe2\x80\x9cCongress did not\nintend the FDA to regulate capital punishment,\xe2\x80\x9d id. at 45, and emphasized\nthat the assessment of lethal injections would be \xe2\x80\x9cfar removed from\n[FDA\xe2\x80\x99s] mission of protecting the consuming public from unsafe and\nimproperly labeled drugs,\xe2\x80\x9d id. at 10; see id. at 45 (similar). 12 The government concluded that FDA jurisdiction over the unapproved use of FDA12 See also Heckler Reply Br. at 8 (\xe2\x80\x9c[T]here is not a scintilla of evidence that Congress\nintended for the FDCA to regulate capital punishment.\xe2\x80\x9d); id. at 11 (\xe2\x80\x9cThe FDA has no\nexperience or particular expertise in making a comparative assessment of different\nmethods of capital punishment, nor does it have a congressional mandate to venture into\nthis field.\xe2\x80\x9d); Heckler Pet\xe2\x80\x99r Br. at 13 (\xe2\x80\x9c[T]here is not a hint in the legislative history that\nCongress had any intention to regulate the methods used by states in carrying out lawful\ndeath sentences.\xe2\x80\x9d); id. at 44 (\xe2\x80\x9cNeither the court of appeals nor respondents have produced\na shred of evidence that Congress wanted the FDA to regulate the methods of capital\npunishment used by the states.\xe2\x80\x9d); id. at 46 (\xe2\x80\x9c[T]here is absolutely no evidence that\nCongress intended to regulate the use of drugs or devices, pursuant to a lawful court\norder, for the purpose of capital punishment.\xe2\x80\x9d).\n\n20\n\n\x0cWhether FDA Has Jurisdiction over Articles Intended for Use in Lawful Executions\n\napproved drugs in executions \xe2\x80\x9cwould lead to the absurd result of requiring\nthe FDA to regulate such traditional means of capital punishment as the\ngas chamber, electric chair, and gallows.\xe2\x80\x9d Heckler Reply Br. at 8. 13\nAlthough Heckler did not resolve the question of the agency\xe2\x80\x99s jurisdiction, see 470 U.S. at 837\xe2\x80\x9338, for more than three decades thereafter, FDA\ncontinued to avoid regulating drugs intended for use in capital punishment. In 2011, FDA explained that \xe2\x80\x9c[r]eviewing substances imported\nor used for the purpose of state-authorized lethal injection clearly falls\noutside of FDA\xe2\x80\x99s explicit public health role,\xe2\x80\x9d and that as a matter of\n\xe2\x80\x9clongstanding policy,\xe2\x80\x9d FDA would \xe2\x80\x9ccontinue to defer to law enforcement\non all matters involving lethal injection.\xe2\x80\x9d E-mail for Nathan Koppel, from\nShelly Burgess, FDA Public Affairs Specialist (Jan. 4, 2011), Doc. 13-3,\nBeaty v. FDA, No. 11-cv-289 (D.D.C. Apr. 20, 2011).\nIn 2012, a group of death-row inmates sued FDA, alleging that it had\nviolated the FDCA by allowing shipments of a misbranded and unapproved new drug from an unregistered foreign establishment to enter the\nUnited States. The U.S. District Court for the District of Columbia held\nthat, unlike in the domestic context where FDA has unreviewable discretion when enforcing violations, the statutory scheme for imports under\n21 U.S.C. \xc2\xa7 381(a) is different, and the court enjoined FDA from permitting entry of foreign-manufactured sodium thiopental, on the grounds that\nit was unapproved and misbranded. Beaty, 853 F. Supp. 2d at 37\xe2\x80\x9341. The\nD.C. Circuit affirmed the injunction. Beaty and Cook, however, turned\nsolely on whether FDA could exercise enforcement discretion over the\nimported sodium thiopental. Although the district court assumed that\n\xe2\x80\x9cthiopental is both \xe2\x80\x98misbranded\xe2\x80\x99 and an unapproved \xe2\x80\x98new drug\xe2\x80\x99 under the\nFDCA,\xe2\x80\x9d id. at 34 n.2, neither the district court, nor the D.C. Circuit,\naddressed the broader question of FDA\xe2\x80\x99s jurisdiction.\nFollowing the Beaty injunction, in 2015, FDA blocked Texas\xe2\x80\x99s attempt\nto import sodium thiopental for use in capital punishment. FDA\xe2\x80\x99s Southwest Import District Office detained and then refused the shipment on the\n13 See also Heckler Pet\xe2\x80\x99r Br. at 13\xe2\x80\x9314 (if FDA had jurisdiction over FDA-approved\nlethal-injection drugs, then the FDCA would also \xe2\x80\x9cencompass many of the paraphernalia\ntraditionally used for executions, such as the gallows and the electric chair,\xe2\x80\x9d and would\npresumably oblige FDA \xe2\x80\x9cto regulate the use of these devices as well\xe2\x80\x9d); id. at 44 (\xe2\x80\x9cthe\nstate and federal governments regularly used\xe2\x80\x9d the electric chair and gallows in 1938, and\n\xe2\x80\x9cthere is no indication that any member of Congress even considered the possibility that\nenactment of the FDCA might affect these practices\xe2\x80\x9d).\n\n21\n\n\x0cOpinions of the Office of Legal Counsel in Volume 43\n\ngrounds that the drug was misbranded and unapproved. See Letter from\nTodd W. Cato, Director, Southwest Import District Office at 1\xe2\x80\x932 (Apr. 20,\n2017). FDA\xe2\x80\x99s 2017 notice of final action appears to be the first instance\nin which FDA expressly asserted jurisdiction over a substance intended\nfor use in capital punishment. Even then, Texas conceded that sodium\nthiopental \xe2\x80\x9cis a drug within the meaning of the [FDCA],\xe2\x80\x9d id. at 5, and\nFDA\xe2\x80\x99s decision was based upon the premise that \xe2\x80\x9cFDA is bound by the\nterms of the order issued by the District Court\xe2\x80\x9d in Beaty, id. at 2; see also\nid. at 6\xe2\x80\x937, 23, 24.\nAn agency may, of course, change its interpretation of an ambiguous\nstatute when the new interpretation falls within the permissible scope of\nthe agency\xe2\x80\x99s discretion and the agency shows \xe2\x80\x9cthat there are good reasons\nfor the new policy.\xe2\x80\x9d FCC v. Fox Television Stations, Inc., 556 U.S. 502,\n515 (2009); see Brown & Williamson, 529 U.S. at 156\xe2\x80\x9357. But for nearly\n80 years after the FDCA\xe2\x80\x99s enactment, FDA had never asserted jurisdiction\nover articles intended for use in capital punishment, notwithstanding\nthousands of cases that would have implicated FDA\xe2\x80\x99s enforcement discretion under such a theory. During that period, States carried out approximately 3,700 executions, and the federal government carried out approximately 192 civilian or military executions, employing a range of methods\n(hanging, the electric chair, firing squads, gas chambers, and lethal injections). 14 FDA did not regulate the method of execution in any of those\ninstances or assert the authority to do so.\n3.\nEven if there were genuine ambiguity about whether FDA has jurisdiction over articles intended for use in capital punishment, serious constitutional concerns would arise if FDA could regulate and take enforcement\naction against (including seizing and destroying) such articles. See Jennings v. Rodriguez, 138 S. Ct. 830, 842 (2018) (\xe2\x80\x9cWhen a serious doubt is\nraised about the constitutionality of an Act of Congress, it is a cardinal\nprinciple that this Court will first ascertain whether a construction of the\n14 See Glossip, 135 S. Ct. at 2732; Bureau of Justice Statistics, U.S. Dep\xe2\x80\x99t of Justice,\nPublications & Products: Executions, https://www.bjs.gov/index.cfm?ty=pbtp&tid=\n182&iid=1 (last visited Apr. 29, 2019); M. Watt Espy & John Ortiz Smykla, Executions\nin the United States, 1608-2002: The ESPY File, Inter-university Consortium for Political\nand Social Research (July 20, 2016), https://www.icpsr.umich.edu/icpsrweb/NACJD/\nstudies/8451.\n\n22\n\n\x0cWhether FDA Has Jurisdiction over Articles Intended for Use in Lawful Executions\n\nstatute is fairly possible by which the question may be avoided.\xe2\x80\x9d (internal\nquotation marks omitted)). As the Supreme Court recently explained,\n\xe2\x80\x9cbecause it is settled that capital punishment is constitutional, [i]t necessarily follows that there must be a [constitutional] means of carrying it\nout.\xe2\x80\x9d Glossip, 135 S. Ct. at 2732\xe2\x80\x9333 (internal quotation marks omitted);\nsee Bucklew, 139 S. Ct. at 1122\xe2\x80\x9323 (similar). It would present a serious\nintrusion on state sovereignty if Congress sought, under the guise of drugsafety regulation, to bar States from effectuating otherwise-lawful death\nsentences.\nThe Supreme Court requires an unambiguous statement of congressional intent before it will construe a federal statute as effecting a significant\nintrusion into an area of traditional state responsibility. Courts must \xe2\x80\x9cbe\ncertain of Congress\xe2\x80\x99 intent before finding that federal law overrides the\nusual constitutional balance of federal and state powers.\xe2\x80\x9d Bond v. United\nStates, 572 U.S. 844, 858 (2014) (internal quotation marks omitted).\nWhen States choose to impose and effectuate death sentences, they are\nengaged in \xe2\x80\x9cthe punishment of local criminal activity,\xe2\x80\x9d which is the\n\xe2\x80\x9cclearest example of traditional state authority.\xe2\x80\x9d Id. 15\nSo long as a State employs a method of execution that comports with\nthe Fourteenth Amendment\xe2\x80\x99s incorporation of the Eighth Amendment\xe2\x80\x99s\nCruel and Unusual Punishments Clause, \xe2\x80\x9cthe Constitution affords a\n\xe2\x80\x98measure of deference to a State\xe2\x80\x99s choice of execution procedures.\xe2\x80\x99\xe2\x80\x9d\nBucklew, 139 S. Ct. at 1125 (quoting Baze, 553 U.S. at 51 n.2). Thus,\nIn re Kemmler, 136 U.S. 436 (1890), held that the New York statute\nrequiring execution by electrocution was \xe2\x80\x9cwithin the legitimate sphere of\nthe legislative power of the State.\xe2\x80\x9d Id. at 449. And the plurality opinion in\nBaze v. Rees, 553 U.S. 35 (2008), explained that \xe2\x80\x9c[o]ur society has . . .\nSee also Danforth v. Minnesota, 552 U.S. 264, 280 (2008) (referring to \xe2\x80\x9c[t]he fundamental interest in federalism that allows individual States to define crimes, punishments, rules of evidence, and rules of criminal and civil procedure in a variety of different\nways\xe2\x80\x94so long as they do not violate the Federal Constitution\xe2\x80\x9d); State Farm Mut. Auto.\nIns. Co. v. Campbell, 538 U.S. 408, 422 (2003) (\xe2\x80\x9cA basic principle of federalism is that\n. . . each State alone can determine what measure of punishment, if any, to impose on a\ndefendant who acts within its jurisdiction.\xe2\x80\x9d); Ewing v. California, 538 U.S. 11, 24 (2003)\n(plurality opinion) (\xe2\x80\x9cThough three strikes laws may be relatively new, our tradition of\ndeferring to state legislatures in making and implementing such important policy decisions is longstanding.\xe2\x80\x9d); Patterson v. New York, 432 U.S. 197, 201 (1977) (\xe2\x80\x9c[W]e should\nnot lightly construe the Constitution so as to intrude upon the administration of justice by\nthe individual States.\xe2\x80\x9d).\n15\n\n23\n\n\x0cOpinions of the Office of Legal Counsel in Volume 43\n\nsteadily moved to more humane methods of carrying out capital punishment\xe2\x80\x9d because state legislatures have taken \xe2\x80\x9cthe steps they deem appropriate, in light of new developments, to ensure humane capital punishment.\xe2\x80\x9d Id. at 62 (opinion of Roberts, C.J.); accord Glossip, 135 S. Ct. at\n2731\xe2\x80\x9332 (similar). The Court has never endorsed an Eighth Amendment\nstandard that would \xe2\x80\x9ctransform [federal] courts into boards of inquiry\ncharged with determining \xe2\x80\x98best practices\xe2\x80\x99 for executions,\xe2\x80\x9d because that\n\xe2\x80\x9cwould substantially intrude on the role of state legislatures in implementing their execution procedures.\xe2\x80\x9d Baze, 553 U.S. at 51 (opinion of Roberts,\nC.J.).\nThe FDCA does not reflect any clear statement of congressional intent\nto regulate the States\xe2\x80\x99 administration of capital punishment. Had Congress\nsought to enable FDA to prohibit articles that States have chosen to use\nfor executions, it would have said so explicitly. But Congress did no such\nthing. The FDCA\xe2\x80\x99s definitions of \xe2\x80\x9cdrug\xe2\x80\x9d and \xe2\x80\x9cdevice\xe2\x80\x9d are broad, but\nbreadth alone fails to manifest the intent needed to alter federal-state\nrelations so dramatically with respect to capital punishment. See, e.g.,\nBond, 572 U.S. at 860 (\xe2\x80\x9cinsist[ing] on a clear indication that Congress\nmeant to reach purely local crimes [in a statute implementing a chemicalweapons treaty] before interpreting the statute\xe2\x80\x99s expansive language in a\nway that intrudes on [States\xe2\x80\x99] police power\xe2\x80\x9d). This principle of federalism\nprovides further support for the conclusion that the FDCA should not be\nread to regulate\xe2\x80\x94and therefore, effectively prohibit\xe2\x80\x94the States\xe2\x80\x99 administration of capital punishment.\nD.\nWe emphasize the narrowness of our conclusion that articles intended\nfor use in capital punishment may not be regulated under the FDCA. We\nare not concluding that the FDCA covers only \xe2\x80\x9cdrugs\xe2\x80\x9d or \xe2\x80\x9cdevices\xe2\x80\x9d that\nhave a medical or therapeutic purpose. For example, FDA has consistently\nregulated other products that affect the structure or function of the human\nbody for an aesthetic, rather than medical or therapeutic, purpose (e.g.,\nimplants to augment breasts, dermal fillers to correct wrinkles, and silicone injections to augment buttocks and breasts). Likewise, FDA has long\nregulated drugs with non-therapeutic or recreational uses, including\nnarcotics, street drugs, and their alternatives. See, e.g., FDA, Guidance for\nIndustry: Street Drug Alternatives (Mar. 2000), https://www.fda.gov/\ndownloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/\n24\n\n\x0cWhether FDA Has Jurisdiction over Articles Intended for Use in Lawful Executions\n\nucm070343.pdf. Unlike with tobacco products or articles intended for\nuse in capital punishment, however, federal statutes evince no \xe2\x80\x9ccollective\npremise\xe2\x80\x9d that drugs intended to be used in achieving a recreational high\n\xe2\x80\x9cwill continue to be sold in the United States.\xe2\x80\x9d Brown & Williamson, 529\nU.S. at 139. To the contrary, the manufacture and distribution of recreational drugs is already highly restricted by other federal statutes, such as\nthe Controlled Substances Act. See 21 U.S.C. \xc2\xa7 812.\nNor do we address whether FDA has jurisdiction over drugs intended\nfor use in physician-assisted suicide. In marked contrast with capital\npunishment and tobacco products, at the time of the FDCA\xe2\x80\x99s enactment,\nthere was not\xe2\x80\x94so far as we are aware\xe2\x80\x94any history of federal or state\nlaws authorizing human euthanasia. As with recreational drugs, there is no\ncongressional determination that human-euthanasia drugs remain lawfully\non the market, nor has FDA historically disclaimed jurisdiction over them.\nCf. Brown & Williamson, 529 U.S. at 137\xe2\x80\x9353. Accordingly, humaneuthanasia drugs lack the historical backdrop that weighs heavily against\nFDA jurisdiction over capital punishment.\nWe further note that a contrary conclusion regarding articles intended\nfor use in capital punishment could sweep well beyond execution-related\narticles. If FDA had jurisdiction over such articles simply because they\nare \xe2\x80\x9cintended to affect the structure or any function of the body,\xe2\x80\x9d 21\nU.S.C. \xc2\xa7 321(g)(1)(C), (h)(3), such reasoning would likely mean that FDA\nalso had jurisdiction in a host of other areas that have long been considered well beyond its purview. Any type of firearm, when used for hunting\nor by the military or law enforcement, is intended to affect the structure or\nfunction of the body by killing or disabling a person or animal. But FDA\nhas never sought to regulate firearms when they are intended to be used\nfor hunting, police operations, or military purposes, and such an implausible interpretation of the FDCA would raise serious constitutional questions of its own.\nFinally, there is nothing unusual about our conclusion that articles intended for use in capital punishment fall outside FDA\xe2\x80\x99s jurisdiction, even\nthough the same articles could be subject to regulation when intended for\nother uses. For example, as noted above, FDA has classified articles such\nas hot tubs, saunas, and treadmills as devices for some purposes, but not\nfor others. See supra pp. 3\xe2\x80\x934. Therefore, finding that substances fall\noutside FDA\xe2\x80\x99s jurisdiction when they are intended for use in capital\npunishment does not bear upon FDA\xe2\x80\x99s potential jurisdiction over other\nintended uses of the same substances.\n25\n\n\x0cOpinions of the Office of Legal Counsel in Volume 43\n\nIV.\nWe conclude that articles intended for use in capital punishment by a\nState or the federal government cannot be regulated as \xe2\x80\x9cdrugs\xe2\x80\x9d or \xe2\x80\x9cdevices\xe2\x80\x9d under the FDCA. FDA accordingly lacks jurisdiction to regulate such\narticles for that intended use.\nSTEVEN A. ENGEL\nAssistant Attorney General\nOffice of Legal Counsel\n\n26\n\n\x0c'