Sessions clears way for food companies to ignore FDA guidance

Those guidance documents the Food and Drug Administration hands out to food manufacturers and others don’t mean as much as they once did. The Department of Justice has changed its policy so government lawyers will no longer rely on guidance documents to establish civil law infractions. In his memo on the subject, Sessions said the DOJ would no longer engage in the practice. Actions by an associate AG on Jan. 25 made the policy change official. In the future, DOJ’s civil litigators won’t be able “convert agency guidance documents into binding rules.” And more importantly, noncompliance with any guidance document cannot be used to prove violations involving federal civil enforcement actions.Megan E. Grossman, who chairs the life sciences practice group for the law firm of Segal McCambridge Singer & Mahoney in Philadelphia, is an expert on the policy change. She says FDA “routinely issues guidance documents for all areas under its control, including food, cosmetics, veterinary products, drugs, medical devices, and vaccines, blood, and biologics, among others.”Grossman expects the new DOJ policy “will likely have an effect on the amount of governmental actions” brought against FDA-regulated companies. She thinks DOJ’s civil attorneys will be under instructions that FDA guidance documents cannot be used to prove violations of affirmative civil enforcement actions…”