April 05, 2018

Food Quality & Safety quotes Michael Blume about DOJ's memorandum prohibiting government litigators in civil cases from using noncompliance with guidance documents to prove violations of federal law

1 min

Michael Blume was quoted on April 5, 2018, in Food Quality and Safety in an article about the DOJ's new policy that states litigators in a civil case may not use an informal agency guidance document as evidence that a person or entity broke the law. The FDA regularly issues guidance documents.

According to the article, the Brand memo restores federal enforcement of laws governing the food industry, but not the current thinking of federal agencies.

Mr. Blume stated that he doesn't foresee that the new guidance will change much, because it doesn't mean that food companies can simply ignore FDA guidance. "The purpose behind most—if not all FDA guidance documents—is to ensure that companies comply with the statutory or regulatory requirements that govern food," Blume says. "Ignoring these guidance documents may lead a company to operate in a way that leaves them out of compliance with those requirements, and thus leaves them vulnerable to DOJ enforcement actions."