DOJ Says FDA Can Expand Food Supply Chain Disclosure Rules

The U.S. Department of Justice says that the Food and Drug Administration has the legal authority to relax its restrictions on supply chain disclosures in the event of a foodborne illness outbreak.

According to an opinion issued by the DOJ on October 26, the FDA has the authority to change requirements that currently restrict it from publicly identifying companies involved in the distribution of contaminated food. Under existing rules outlined in the federal Trade Secrets Act, the names and locations of companies involved in foodborne illness investigations are considered proprietary, unless disclosure is needed to carry out specific enforcement actions such as recalls.

"Given FDA’s current regulations, the Trade Secrets Act largely prevents FDA from disclosing supply chain information," the DOJ's filing says. "But FDA has authority to amend its regulations to allow broader disclosure, should it choose to do so in the future."

The DOJ points to how the Federal Food, Drugs, and Cosmetics Act does not mandate the FDA's existing case-by-case approach to supply chain disclosures, and in fact grants the agency broad discretion to disseminate information regarding food, drugs, devices, tobacco products or cosmetics in situations where there is an imminent danger to public health, or a "gross deception" of consumers.

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