- The U.S. Department of Justice Office of Legal Counsel (OLC) recently issued an opinion concluding that the Food and Drug Administration (FDA) has authority under existing law to amend its regulations to permit broader disclosure of supply chain information during certain food safety events. The opinion addresses circumstances involving foodborne illness outbreaks, recalls, and other situations that may present risks to public health.
- According to the OLC, current FDA regulations generally treat supply chain information, such as the identities and locations of entities within a product’s distribution chain, as confidential commercial information. As a result, FDA’s ability to disclose this information publicly or share it with state and local partners is currently limited except in specific circumstances, such as when disclosure is necessary to effectuate an enforcement action or recall.
- The opinion explains that these regulatory limitations arise primarily from FDA regulations rather than from a statutory prohibition in the Federal Food, Drug, and Cosmetic Act (FDCA). While the Trade Secrets Act generally restricts federal employees from disclosing certain confidential business information, it permits disclosures that are “authorized by law.”
- The OLC concluded that FDA possesses authority under Section 705(b) of the FDCA (21 U.S.C. § 375(b)) to promulgate regulations allowing broader disclosure of information regarding regulated products in situations involving “imminent danger to health” or “gross deception of the consumer.” If FDA were to adopt such regulations, disclosures made pursuant to them would be considered legally authorized and therefore would not violate the Trade Secrets Act.
- Although the opinion does not itself change FDA policy, it provides legal support for future regulatory changes that could expand information sharing during public health emergencies. Any such changes would require FDA to revise its regulations and would remain subject to the statutory limitations set forth in 21 U.S.C. § 375(b), including the requirement that disclosure relate to circumstances involving an imminent danger to health or gross deception of consumers.
- Keller and Heckman will continue to track developments in this area, including any FDA rulemaking or policy changes related to the disclosure of supply chain information during food safety events.
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