FSMA: What Every Food Industry Executive Should Do & Why
With six of the seven rules implemented under the 2011 Food Safety Modernization Act (FSMA) currently being enforced, what should you know and do? Here are some considerations for facilities that manufacture, pack, process, hold, label, transport or sell food products:
Is your product what it purports to be? Many product recalls are caused by unlabeled allergens or other unlabeled ingredients. While you may rely on manufacturing documents, from time to time, you should review finished product testing results to ensure the accuracy of your product labeling.
Is your supplier what it purports to be? While you may rely on reputation and prior experience, from time to time you need to independently verify that your suppliers are compliant with the law, because if your supplier is not compliant, neither are its products.
Are your documents in order? You should be able to demonstrate whether you are subject to or exempt from each of the six (seven in July 2018) FSMA rules, and prove what you are doing to ensure that you and your suppliers are compliant. For example:
- Are you or your suppliers subject to the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (PC Rule)? If so, does the Food Safety Plan meet FDA requirements, including CGMP, preventive controls, and supply chain program and records requirements?
- Do you or your suppliers directly import ingredients or finished products? The importer of records must have a Foreign Supplier Verification Program (FSVP). If you or your supplier purchase items from the importer can you document steps taken to ensure the importer complied?
- If you or your suppliers deal in anything other than finished products in sealed packages not subject to temperature control, have you reviewed your vendor and freight contracts and verified your compliance with the Sanitary Transportation of Human and Animal Food (SFT) Rule?
- Do you, your suppliers, and vendors have the necessary state and county permits and licenses?
- Are you and your suppliers required to be registered with the Food and Drug Administration (FDA)?
- Do you have any documents demonstrating that promotional materials, whether written, broadcast, or online, do not possess claims that render products misbranded?
Why does having this evidence matter for senior executives? There are two reasons: (1) the Department of Justice’s position on pursuing executives as stated in the now infamous “Yates Memo” and (2) the Park Doctrine, a no-fault criminal prosecution doctrine.
The Park Doctrine evolved from a 1943 Supreme Court opinion that permits the government to pursue criminal and civil claims against senior executives for violations of the Food Drug and Cosmetic Act (FDCA). There have been numerous writings in recent years regarding the “Park Doctrine,” which is named after the owner of a food plant and allows the government to hold company principals criminally and civilly liable for the acts of those who work under them. In U.S. v Park, the Supreme Court observed:
“the [FDCA] imposes the highest standard of care and permits conviction of responsible corporate officials who, in light of this standard of care, have the power to prevent or correct violations of its provisions.” 421 U.S. 658, 676 (1975).
This doctrine was responsible for sending the owners and a number of junior employees at the Peanut Co. of America to jail. Despite the hope that a new administration might change direction in how it enforces the FDCA, the government recently filed a brief with the Supreme Court in response to a petition in U.S. v DeCoster in which the defendants (senior executives of a food facility) sought to overrule Park on Due Process grounds.
In its opposition brief at the Supreme Court, the government reiterated the rule in Park stating that:
“[f]or more than 70 years, this Court has construed the FDCA to impose criminally enforceable legal duties not merely on the lower-level employees who physically produce, package, and ship a covered product, but also on corporate officials who control the production and distribution process.” Brief at 23.
In response, the Supreme Court denied the petition and two food industry executives were sentenced to jail for eighteen months on a misdemeanor plea. When the Park Doctrine is coupled with the DOJ’s position stated in the Yates Memo that the government will pursue criminal charges against individuals in cases involving corporate wrongdoing, senior executives have good reason to take heed and ensure they document compliance.
Conclusion. The FDA refers to FMSA as a paradigm shift for regulating food in the U.S. as the law focuses on “prevention” of food borne illness as opposed to a pre-FSMA focus on responding to outbreaks and the allocation of responsibility. This paradigm shift to prevention places duties on supply chain participants to ensure not only their own compliance, but the compliance of their suppliers. The days of simply conducting a root cause, finding culpable parties and relying on contractual indemnification is no longer sufficient. Today, executives must be able to demonstrate that policies and procedures are in place to ensure the compliance of suppliers, and that those policies and procedures are followed.
There is a common saying in FDA regulated industry: “If it isn’t written down, it didn’t happen.” A corollary statement is “If it is written down, you better do it.” FSMA essentially codifies these notions. Today under FSMA, the rules require those in the supply chain to have written procedures and the new paradigm requires participants to ensure that they and their suppliers actually dowhat the rules require.
Mike devotes much of his practice to counseling clients in regulated industry on issues related to manufacturing, labeling, compliance and transportation. He has extensive experience defending clients in complex administrative law and litigation matters, and has served as national coordinating counsel, regional trial counsel and as local Texas counsel in environmental and toxic tort litigation. Mike has practiced in Dallas since 1994. Prior to 1994, he practiced in New York City as a trial lawyer handling a broad range of matters including securities, commercial, real estate, intellectual property, pharmaceutical, toxic tort and environmental contamination matters. He is the author of the law book, The Supply and Distribution of FDA Regulated Products published by Thompson Reuters. Mike is a frequent writer and speaker on issues related to compliance and litigation for regulated industry and is regularly published on issues concerning toxic exposure, compliance and marketing. Mike is the founder of a daylong educational program designed for lawyers and senior industry executives in industry regulated by the federal Food and Drug Administration.