FDA Guidance: Do I Have to Comply?
Updated: Nov 22, 2018
With the rollout of numerous guidance documents related to FSMA and other regulations, the question often arises with our clients as to whether the guidance is binding. A recent announcement from the Department of Justice addressed this very point.
So, what authority do FDA, USDA (or any other federal agency’s) guidance documents really have, and can you be held judicially liable if your facility is found to be out of compliance with guidance? It is a question that was recently addressed by the Department of Justice (DOJ) with the answer that “litigators are prohibited from using guidance documents—or noncompliance with guidance documents—to establish violations of law in affirmative civil enforcement actions.”
While this may seem to indicate that food facilities need not follow or even review guidance documents, it is only part of the story. The first thing to understand is that guidance has never been considered binding, and FDA documents typically include the topline statement “Contains Nonbinding Recommendations” along with further explanation of this within its pages. (There are, however, exceptions. As we discussed in an October 2017 newsletter, FDA’s Facility Registration Guidance is binding; it does establish legally enforceable responsibilities.) So, any decision to not follow guidance should be made with discretion and full understanding of the regulation to which it applies.
DOJ addressed the question because of a memorandum filed in November by Attorney General Jeff Sessions in which he stated, “It has come to my attention that the Department has in the past published guidance documents – or similar instruments of future effect by other names, such as letters to regulated entities – that effectively bind private parties without undergoing the rulemaking process.” Because federal regulation requires that notice-and-comment rulemaking be used (in most cases) “when purporting to create rights or obligations binding on members of the public or the agency.” Guidance does not follow this process, thus, according to law, it cannot create binding requirements.
Although the DOJ memos were directed toward DOJ personnel and components, there should be no question that it applies to all guidance documents from any government agency. Thus, litigation in any pending or future litigation cannot use noncompliance with guidance documents as a basis for proving violations of applicable law, nor can an agency use its own authority to convert guidance documents into binding rules. Or, as expressed in the memo, “That a party fails to comply with agency guidance expanding upon statutory or regulatory requirements does not mean that the party violated those underlying legal
requirements; agency guidance documents cannot create any additional legal obligations.”
But, let’s jump back to my comment that a decision to not follow guidance should be made with discretion and full understanding of the regulation. FDA’s purpose in issuing guidance is generally to clarify and provide advice and examples for the application of the regulatory requirements. As such, as I also previously noted, the documents state that they are nonbinding, that they “do not establish legally enforceable responsibilities,” and they generally include a statement such as, “You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.”
It is the second part of that phrase that is particularly important “…if it satisfies the requirements of the applicable statutes and regulations.” If we take guidance as intended to “supply (a person) with advice or counsel” as its definition states, then we can see guidance helping the industry comply with the regulation to which it applies. As such, guidance documents from FDA are typically very helpful for us to understand what FDA is thinking and what the FDA expectations are regarding regulatory compliance. FDA even addresses a statement made in the DOJ memo that “Guidance documents should not use mandatory language such as ‘shall,’ ‘must,’ ‘required,’ or 'requirement’” with its comment that “The use of the word should in FDA guidances means that something is suggested or recommended, but not required.”
So, all of this takes us back to the original question: What authority does guidance carry and can you be held liable for non-compliance?
My answer: Although guidance does not carry the legally enforceable authority of regulation, and you can’t be held liable for not following “advice or counsel” only in the guidance, you can be held liable for non-compliance with the fundamentals behind the words. You are legally bound to comply with the regulation to which the guidance applies. So, if you’d rather read, study, and apply every component of the regulation in your facility, without regards to any FDA guidance, it is certainly your right. Just be sure you do completely understand every provision and facet of the regulation and how it applies to your product, process, and facility.
The recent guidance from FDA about environmental monitoring programs for Listeria monocytogenes is a good example with regard to the recommendation around zone 1 testing. The guidance recommends zone 1 testing and some of our clients have been told by FDA, “You had better be doing zone 1 testing when we (FDA) next come back.” But, if you are controlling the risks without doing zone 1 testing, then I believe you are meeting the regulatory requirements and are not out of compliance. But make sure you have read the guidance even if you don’t follow every aspect of it.
Personally, I am a big fan of guidance documents and, with FSMA’s Preventive Controls rule and other regulations going over thousands of pages, I appreciate a bit of guidance and clarification from those who wrote them.
About The Acheson Group (TAG)
Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG's team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com