DOJ: FDA Could Expand Supply-Chain Disclosure Under Statutory Conditions

The Justice Department’s Office of Legal Counsel says the Department of Health and Human Services and its delegates could amend FDA regulations to permit public disclosure of food supply-chain information under either of two statutory grounds: an imminent danger to health or gross deception of consumers. The opinion, issued Oct. 26, 2026, does not change current rules or require FDA to act.

The eight-page opinion was addressed to HHS’s acting general counsel. It interprets provisions of the Federal Food, Drug, and Cosmetic Act, including 21 U.S.C. §§ 375(b) and 371(a), as allowing regulations that authorize disclosure when the FDA commissioner determines one of the statutory conditions exists. The two grounds are alternatives; the opinion does not say both must be present.

How the opinion differs from current rules i

Current FDA regulations generally treat confidential commercial information as unavailable for public disclosure. That can include the names and locations of businesses involved in a food’s supply chain, under regulations cited by the opinion: 21 C.F.R. §§ 20.61, 20.82(b)(1) and 20.111(d)(3).

There is an existing, narrower exception. Under 21 C.F.R. § 20.91, FDA may disclose information when necessary to carry out an administrative or court enforcement action, such as a recall. The opinion describes that as a case-by-case route: a recall alone does not automatically make every supplier’s identity public; the disclosure must be necessary to effectuate the enforcement action.

A new regulation could establish a broader route in advance, but only within the statutory conditions OLC describes. That distinction answers a common practical question: a food-safety concern or recall, by itself, would not establish that supplier information could be made public under the proposed interpretation.

Limits and unresolved questions i

OLC says the statutory test would not cover every foodborne-illness outbreak or recall. It also says a rule authorizing disclosure after an outbreak has ended would likely conflict with the law. Its opinion therefore describes a potential path for disclosure under specified conditions, not a general authorization to publish supply-chain information whenever an investigation is underway.

The opinion is an executive-branch legal interpretation, not a regulation or court ruling. Any broader disclosure authority would require a rule change and a qualifying determination by the FDA commissioner. The opinion does not direct HHS or FDA to begin rulemaking or set a timetable.

Businesses identified in food supply chains could be affected if a future rule allowed their information to be disclosed; consumers could gain access to that information in the specified circumstances. OLC’s discussion of the Trade Secrets Act is qualified: it assumes for its analysis that supply-chain information is covered, but questions whether supply-chain partners’ identities fit the law’s protected categories. The opinion does not resolve that issue.