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.
The policy change was not a surprise. Attorney General Jeff Sessions called out the practice on Nov. 16, 2017, in a memorandum that said: “the department has in the past published guidance documents — or similar instruments of future effect by other names, such as a letter to regulated entities — that effectively bind private parties without undergoing the rulemaking process.”
The open market advocate Washington Legal Foundation in December reported FDA had issued more than 2,000 guidance and draft guidance documents in recent years. The foundation said guidance documents are used to cover topics that were once covered by formal regulations.
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…”
In December, the Washington Legal Foundation’s chief counsel Richard Samp said FDA’s “embrace of informal rulemaking ” was imposing “significant and unwarranted regulatory burdens on affected businesses.”
Samp contends FDA was using guidance documents as an end-run around the notice and comment provisions of the federal Administrative Procedure Act (APA) of 1946.
In every guidance document, FDA says the publication represents its “current thinking,” but without establishing any “rights for any person” nor binding upon the agency.
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