Full Opinion

(Slip Opinion) Public Disclosure of Supply Chain Information in Foodborne Illness Outbreaks and Recalls Current FDA regulations generally do not authorize government disclosure of supply chain information for purposes of the Trade Secrets Act. FDA has authority pursuant to 21 U.S.C. § 375(b) to amend its regulations to permit disclosure of supply chain information in situations involving imminent danger to health or gross deception of the consumer. Such regulations would constitute legal authorization such that disclosure would not create liability under the Trade Secrets Act. October 26, 2026 MEMORANDUM OPINION FOR THE ACTING GENERAL COUNSEL DEPARTMENT OF HEALTH AND HUMAN SERVICES Self-government requires an informed citizenry. As James Madison put it, “‘[a] popular Government, without popular information . . . is but a Prologue to a Farce or a Tragedy.’” Bd. of Educ., Island Trees Union Free Sch. Dist. No. 26 v. Pico, 457 U.S. 853, 867 (1982) (quoting 9 Writings of James Madison 103 (G. Hunt ed. 1910)). And “those who execute the laws” must also have the means of “securing the information and data necessary for the most effective and intelligent conduct of Government.” Shapiro v. United States, 335 U.S. 1, 53 (1948) (Frankfurter, J., dissent- ing). With increased regulation, “federal agencies’ demands for infor- mation about the activities of private individuals and corporations” have also increased. Chrysler Corp. v. Brown, 441 U.S. 281, 285 (1979). This accumulation of proprietary information in the files of the federal gov- ernment requires compromise between the rightful confidentiality of such information and the needful transparency in government decision-making. See Critical Mass Energy v. NRC, 975 F.2d 871, 872 (D.C. Cir. 1992). Congress struck such a compromise in the Trade Secrets Act. 18 U.S.C. § 1905. Dating to 1864, see Revenue Act of 1864, § 38, 13 Stat. 238, the Act prohibits government officers and employees from “publish[ing], divulg[ing], disclos[ing], or mak[ing] known in any manner or to any extent not authorized by law any information” obtained by the federal government and relating to “the trade secrets, processes, operations, style of work, or apparatus” of business actors. 18 U.S.C. § 1905. But the Act permits disclosure of such information if “authorized by law.” Id. 1 50 Op. O.L.C. __ (Oct. 26, 2026) You have asked if the Food and Drug Administration (“FDA”) is au- thorized by law to disclose supply chain information in foodborne illness outbreak and recall scenarios. Under current regulations, FDA’s disclo- sure authority is limited, as described below. But under 21 U.S.C. § 375(b), the Secretary of Health and Human Services and his delegees may amend those regulations to allow further disclosure. I. FDA—under the purview of the Department of Health and Human Services (“HHS”)—is charged with “protect[ing] the public health by ensuring,” among other things, that “foods are safe, wholesome, sanitary, and properly labeled” and that “drugs are safe and effective.” 21 U.S.C. § 393(b). To fulfill its statutory duties, FDA wields authority delegated from the Secretary of HHS to gather relevant information from interstate and foreign commercial actors, including through review of business records. See id. §§ 373(a), 374(a), 381(a), 384a(d); 2 FDA Staff Manual Guides: Delegations of Authority, No. 1410.10, at 1 (2023), https://perma.cc/DH7T- 4YMV (delegating authorities granted by the Federal Food, Drug, and Cosmetic Act to the FDA Commissioner). Pursuant to the same delegation, the FDA Commissioner may also promulgate regulations governing the collection and disclosure of needed business information. See 21 U.S.C. § 371(a). In addition, FDA has delegated authority to issue regulations “necessary to prevent the introduction, transmission, or spread of com- municable diseases.” 42 U.S.C. § 264(a). During its investigation of a foodborne illness outbreak, FDA often ob- tains proprietary information, including the names and locations of vari- ous entities in a supply chain. FDA considers supply chain information to be confidential commercial information because it is “valuable data or information which is used in one’s business and is of a type customarily held in strict confidence.” 21 C.F.R. § 20.61(b). As a general matter under current regulations, such information is “not available for public disclo- sure.” Id. § 20.61(c); see also id. § 20.82(b)(1) (“The Commissioner shall not make available for public disclosure any record that is . . . [e]xempt from public disclosure pursuant to § 20.61.”); id. § 20.111(d)(3) (“Pro- duction, sales, distribution, and similar data and information” “are not available for public disclosure . . . .”). There are limited exceptions to this ban on disclosure, such as when nonpublic information has “previously 2 Disclosure of Supply Chain Information in Foodborne Illness Outbreaks and Recalls been disclosed in a lawful manner to any member of the public,” id. § 20.81(a), or when disclosure is required for “compliance with a final court order,” id. § 20.83(a). And because the owner of nonpublic proprie- tary information “can waive his right” to confidentiality, FDA may also disclose such information with the consent of the proprietors. Release to a Court of Trade Secret Information Protected Under the Federal Food, Drug, and Cosmetic Act, 2 Op. O.L.C. 193, 194 (1978). Under 21 C.F.R. § 20.91, FDA may also disclose supply chain infor- mation when “necessary to effectuate” an administrative or court en- forcement action such as a recall. Determining whether disclosure is authorized under this regulatory exception requires a case-by-case analy- sis that includes consideration of several factors, such as whether the food is likely to be available for consumption, whether the food is easily identi- fied as being subject to the recall from its retail packaging (or lack there- of), whether consumers are likely to have discarded the food labeling, and whether the food distribution was confined to a specific region. See FDA, Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls: Guidance for Industry and FDA Staff at 4–5 (Nov. 2020), https://perma.cc/YB52-VJXM. The Federal Food, Drug, and Cosmetic Act nowhere requires this ardu- ous analysis. And in practice, the exercise apparently proves onerous. We understand that supply chain information often does not qualify for dis- closure under section 20.91 for a variety of reasons, including because there has been no official administrative action to effectuate, or because the action is completed before FDA can collect the information. II. Liability under the Trade Secrets Act does not attach for the disclosure of protected information when the disclosure is “authorized by law.” 18 U.S.C. § 1905.1 The Supreme Court has held that “properly promulgated, 1 We assume for purposes of analysis that supply chain information falls within the categories of information protected by the Trade Secrets Act. For our part, we question whether that assumption is grounded in the best reading of the law, since the identity of partners in the supply chain is different in kind from the types of information listed in the Act, which all relate to internal business processes. See McLaughlin Chiropractic Assocs., Inc. v. McKesson Corp., 606 U.S. 146, 160 (2025) (“[T]he noscitur a sociis canon coun- 3 50 Op. O.L.C. __ (Oct. 26, 2026) substantive agency regulations” can serve as the requisite authorization. Chrysler Corp., 441 U.S. at 295–96. Thus, the permissibility of FDA disclosing confidential commercial information under the Act turns on relevant statutes and FDA’s substantive regulations issued pursuant to statutory authority. If the regulations do not authorize or otherwise limit disclosure, then the Act’s general bar on disclosure applies. But if the regulations affirmatively permit disclosure, then disclosure is “authorized by law,” and there can be no liability under the Act. As noted above, FDA’s regulations prohibit the public disclosure of confidential commer- cial information except under limited circumstances. Given FDA’s current regulations, the Trade Secrets Act largely pre- vents FDA from disclosing supply chain information. But FDA has au- thority to amend its regulations to allow broader disclosure, should it choose to do so in the future. A. From the above description of FDA’s current regulations on confiden- tial commercial information, supra Part I, it follows that disclosure of supply chain information is not authorized in the mine run of cases. The regulations dictate that such information is “not available for public disclosure” except under very limited circumstances. 21 C.F.R § 20.61(c). Confidential commercial information, including supply chain information, is expressly exempted from regulations allowing “[d]iscretionary disclo- sure by the Commissioner.” Id. § 20.82(b)(1). And even when supply chain information is voluntarily submitted to FDA, regulations generally prevent its disclosure. Id. § 20.111(d)(3). Exceptions are narrow, though they constitute authorization for disclosure for purposes of the Trade Secrets Act where they apply. See id. §§ 20.81(a), 20.83(a). sels against reading [a] term . . . to be different in kind and broader than the other[s]” in a statute.). But some federal appellate courts have held that “[the Trade Secrets Act] and [FOIA] exemption (b)(4) cover basically the same material.” Gen. Motors Corp. v. Marshall, 654 F.2d 294, 297 n.9 (4th Cir. 1981); McDonnell Douglas Corp. v. U.S. Dep’t of the Air Force, 375 F.3d 1182, 1185 (D.C. Cir. 2004). Because that exemption covers “commercial or financial information obtained from a person and privileged or confiden- tial,” 5 U.S.C. § 552(b)(4), there is a substantial likelihood that these courts and perhaps others will view confidential commercial information as subject to the Trade Secrets Act. 4 Disclosure of Supply Chain Information in Foodborne Illness Outbreaks and Recalls True, current regulations allow FDA to disclose supply chain infor- mation when “necessary to effectuate” administrative or court enforce- ment actions such as recalls. Id. § 20.91. This, too, is authorization precluding liability under the Trade Secrets Act. But based on our under- standing of how FDA implements section 20.91, this authorization is exceedingly narrow in practice. To start, it is limited to instances where there is an actual administrative or court enforcement action to effectuate. For example, FDA’s hands are tied before a recall is officially initiated. More complicated still is the reality that collecting certain confidential commercial information may be time-consuming such that, by the time it is collected, it is no longer necessary. Thus, section 20.91 only seldom authorizes disclosure of supply chain information. Consequently, under regulations currently in force, the Trade Secrets Act prevents FDA from publishing supply chain information in many cases. B. Notwithstanding limits imposed by FDA’s current regulations, FDA has statutory authority to amend those regulations to authorize disclosure of supply chain information more broadly. As noted above, the Federal Food, Drug, and Cosmetic Act nowhere mandates FDA’s current context- limited, case-by-case approach to authorizing disclosure of confidential commercial information. Instead, it grants the Commissioner broad dis- cretion to “cause to be disseminated information regarding food, drugs, devices, tobacco products, or cosmetics in situations involving, in the opinion of the [Commissioner], imminent danger to health or gross decep- tion of the consumer.” 21 U.S.C. § 375(b). That provision, combined with the authority to issue regulations to enforce it, id. § 371(a), enables the Commissioner to authorize by law the disclosure of confidential commer- cial information—including supply chain information—thereby foreclos- ing liability under the Trade Secrets Act for its disclosure. The Federal Food, Drug, and Cosmetic Act authorizes the Secretary of HHS, and the Commissioner as his delegee, to issue regulations that are “substantive,” such that they constitute legal authorization for purposes of the Trade Secrets Act. Chrysler Corp., 441 U.S. at 295. Substantive regulations—in contradistinction to mere interpretive regulations— “‘affect[] individual rights and obligations.’” Id. at 302 (quoting Morton v. Ruiz, 415 U.S. 199, 232 (1974)). The Supreme Court’s decision in 5 50 Op. O.L.C. __ (Oct. 26, 2026) Chrysler Corp. establishes that regulations “govern[ing] the public’s right to information”—as would regulations issued to enforce section 375(b)— satisfy this rubric. Id. at 303. Substantive regulations must also be “issued by an agency pursuant to statutory authority [to] implement the statute.” Batterton v. Francis, 432 U.S. 416, 425 n.11 (1977) (cleaned up). FDA regulations permitting disclosure of confidential commercial information under section 375(b) would satisfy this requirement because they would be issued pursuant to section 371(a), which empowers the Commissioner “to promulgate regulations for the efficient enforcement” of the statute. “[T]he distinct reference . . . to enforcement” in the statutory grant dispels any contention that FDA’s regulatory authority “merely concerns agency procedures” or “is solely administrative” rather than substantive. Am. Trucking Ass’ns v. United States, 344 U.S. 298, 311 (1953). Here, the category of information FDA is authorized to disseminate un- der section 375(b) encompasses confidential commercial information. The statute speaks of all “information regarding food, drugs, devices, tobacco products, or cosmetics,” without distinctions based on confidentiality or privilege. 21 U.S.C. § 375(b). The word “regarding,” like its synonym “respecting,” has “a broadening effect, ensuring the scope of a provision covers not only its subject but also matters relating to that subject.” La- mar, Archer & Cofrin, LLP v. Appling, 584 U.S. 709, 717 (2018). Be- cause supply chain information—as well as other confidential commercial information collected by FDA—relates to regulated products, there can be no serious doubt that it is subject to disclosure under section 375(b). As for the circumstances that may trigger a lawful dissemination, sec- tion 375(b) specifies that there must be “imminent danger to health or gross deception of the consumer.” This provision places important limits on the Commissioner’s authority to permit disclosure of confidential commercial information. For example, a regulation purporting to author- ize disclosure after a foodborne illness outbreak has already ended would likely be inconsistent with section 375(b) and hence unlawful. But by using the words “in the opinion of the [Commissioner],” 21 U.S.C. § 375(b), the statute “clearly entrusts the decision” of when imminent danger exists “to the [Commissioner’s] discretion,” within the boundaries set by the statute itself, Kalkouli v. Ashcroft, 282 F.3d 202, 204 (2d Cir. 2002) (interpreting a similarly worded immigration statute); see also Loper Bright Enters. v. Raimondo, 603 U.S. 369, 394 (2024) (“[T]he 6 Disclosure of Supply Chain Information in Foodborne Illness Outbreaks and Recalls statute’s meaning may well be that the agency is authorized to exercise a degree of discretion.”). The grant of authority is not limited to instances where disclosure is “necessary to effectuate” an enforcement action, 21 C.F.R. § 20.91, or where current regulatory exceptions otherwise apply. Thus, FDA is free to revise its regulations, removing unnecessary re- strictions on disclosure of confidential commercial information and af- firmatively authorizing disclosure of such information when, in the Com- missioner’s opinion, either of the statutory conditions—imminent danger to health or gross deception of the consumer—has attained. So revised, the regulations would constitute “authoriz[ation] by law,” making disclo- sure of supply chain information pursuant to the regulations consistent with the Trade Secrets Act. Modifying such regulations would hardly be a “transformative expan- sion” of FDA’s powers. Util. Air Regul. Grp. v. EPA, 573 U.S. 302, 324 (2014). Indeed, as described above, current FDA regulations allow disclo- sure of proprietary information in limited circumstances, and FDA has in fact disclosed such information. Although dissemination of food-related information arguably affects “a significant portion of the American econ- omy,” FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 159 (2000), Congress clearly authorized such action “in situations involving . . . imminent danger to health or gross deception of the consumer,” 21 U.S.C. § 375(b). To the extent other statutes limit disclosure authorized by 21 U.S.C. § 375(b), FDA is bound to observe such limitations. Two possible statuto- ry restrictions have been suggested, but neither operates to restrain disclo- sure authorized by section 375(b). 21 U.S.C. § 331(j) does not limit dis- closure, because it forbids revealing only certain information collected by FDA “concerning any method or process which as a trade secret is enti- tled to protection.” Under the foregoing analysis, confidential commercial information properly authorized for disclosure pursuant to 21 U.S.C. § 375(b) is not entitled to protection and therefore is not covered by sec- tion 331(j). Likewise, 5 U.S.C. § 552(b)(4)—the FOIA exemption pertain- ing to confidential commercial information—does not prohibit FDA from disclosing such information as authorized by law. It merely means that FDA is not compelled to disclose such information at the public’s request. Chrysler Corp., 441 U.S. at 292 (“By its terms, subsection (b) demarcates the agency’s obligation to disclose; it does not foreclose disclosure.”). 7 50 Op. O.L.C. __ (Oct. 26, 2026) Under both statutes, FDA retains its authority, and obligations, to protect and disclose information consistent with the law. III. Under current regulations, FDA is generally not authorized to disclose supply chain information, and therefore the Trade Secrets Act prohibits divulging such information. But FDA has statutory authority to amend its regulations to allow broader disclosure of supply chain information in situations involving imminent danger to health, or gross deception of the consumer. Under properly issued regulations, such disclosure would not violate the Trade Secrets Act but would instead be authorized by law. WILLIAM D. HYDE, JR. Deputy Assistant Attorney General Office of Legal Counsel 8