Bradley attorney Whitt Steineker was quoted in Food Quality & Safety on a memorandum prohibiting government litigators in civil cases from using noncompliance with guidance documents to prove violations of federal law.
“In a nutshell, Department of Justice (DOJ) litigators in a civil case may not use an informal agency guidance document as evidence that a person or entity broke the law,” said Steineker.
Federal agencies, including the FDA, regularly issue guidance documents to inform manufacturers, distributors, retailers, and the public about the agency’s current thinking regarding how statutes and regulations should be interpreted.
“These guidance documents—which are not subject to traditional public notice and comment periods like formal rules and regulations—have been used by civil litigants for decades to prove compliance and non-compliance with federal law,” Steineker explained. “Legally speaking, such guidance documents do not carry the force of law because they are neither enacted by Congress nor through formal regulatory processes.”
The complete article, “What DOJ’s Policy on FDA Guidance Really Means,” appeared in Food Quality & Safety on April 5, 2018.