What DOJ’s Policy on FDA Guidance Really Means

In January, Associate Attorney General Rachel Brand issued 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,” says Whitt Steineker, JD, partner and co-chair, Food and Beverage Team, Bradley Arant Boult Cummings LLP, Birmingham, Ala.

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 says. “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 guidance should not be viewed as gospel,” adds Food Quality & Safety magazine’s Purnendu C. Vasavada, PhD, professor emeritus, University of Wisconsin—River Falls, and fellow, PCV & Associates, LLC, River Falls, Wis. “Guidance documents issued by various agencies are designed to represent the agency’s current thinking, and to educate regulated parties through plain-language restatements of existing legal requirements, or to provide non-binding advice on technical issues through examples or practices to guide the application or interpretation of statues and regulations.” Guidance documents do not go through the rule-making process required under the Administrative Procedure Act. “The recent DOJ memorandum clarifies that the agency ‘may not use its enforcement authority to effectively convert agency guidance documents into binding rules’ and noncompliance with guidance documents may not be used as a basis for proving violations of applicable regulations.”

What Food Industry Should Know

The Brand memo restores federal enforcement of laws governing the food industry, but not the current thinking of federal agencies. “The food industry should welcome this restoration and the return of certainty and predictability in federal policy,” Steineker says. “Critics of the memo can turn to Congress and federal agencies to engage in formal lawmaking and rulemaking as necessary to effectively regulate the food industry.”

Nathan A. Beaver, Esq., partner, Foley & Lardner LLP, Washington, D.C., says the change will make it more challenging for FDA to pursue violations, especially where FDA has chosen to issue guidance documents rather than set rules.

Michael Blume, partner, Venable, LLP, New York, NY, 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,” he 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.”

Food companies are likely to continue looking to FDA guidance to avoid drawing the attention of FDA investigators and civil complaints, and there remains ample opportunity to regulate the food industry as necessary, Steineker says.

The bottom line, Dr. Vasavada says, is to abide by the law as best you can. “If you are asked to take action based solely on the guidance document, it may be contrary to the current policy,” he says.

Beaver points out that one of the first steps that the Trump administration took was an executive action that requires agencies to remove two rules for every new rule they finalize. Given this, FDA is likely to continue to avoid rulemaking except where absolutely necessary.