How to Respond to an FDA Warning Letter
Answered November 12 2020
Getting a regulatory letter from the Food and Drug Administration (FDA) or the United States Department of Agriculture (USDA) means that you are in trouble, whether you believe it or not. Hence, responding to that letter is very critical. It not only carries the weight of law, but it has a non-negotiable tight timeline for a response and becomes public record.
How do you promise what sustainable actions to take in your plant when there are too many options? How many functions do you need to get aligned, or does it even matter? And should you potentially sacrifice production volume and profits, and take the risk of irritating customers?
This article will help you with this by sharing a number of real-life examples of companies who got in trouble from the FDA or USDA, as well as tips on what to do if and when you are in this type of situation. I have many decades of experience in food manufacturing plants and have seen good and bad strategies for addressing these letters. Let’s learn from them.
Regulatory Information Sources from FDA and USDA
For background from the FDA on its types of letters and related actions, see Types of FDA Enforcement Actions. Similarly, the USDA has its own overview of Enforcement Actions. To find trade recalls which a company has had to execute, review the FDA's Recalls, Withdrawals, and Safety Alerts and the USDA's Recalls and Public Health Alerts. For a tally of which companies (food, drug, medical device, etc.) have gotten FDA Warning Letters, review the chronological and searchable list at Warning Letters.
Examples of Regulatory Infractions
Let's review a number of issues the U.S. food industry had in 2020 because these are instructive in terms of the kinds of issues to be aware of when discussing an FDA letter. In the discussion below, the names of these companies are not explicitly mentioned, but they include multinationals and some of the largest food companies in the U.S. They also include some of the smaller companies, many of them suppliers to the larger companies. Since all of this is a matter of public record, the reader is invited to use the above sources should more specific information be needed.
Through the course of its own audits and documentation reviews, a company can discover that there are issues which should, in the interest of the consumers’ health, lead to a recall of product that is already in the trade. A common reason for this action is an "undeclared allergen,” which means that the product may contain an allergenic ingredient (e.g., peanut, soy) that is not listed on the label. This could have been caused by a label misprinting, the wrong label being applied in error, or a supplier notifying the manufacturer after the product has shipped that they (the supplier) accidentally introduced an allergen into their ingredient (which the manufacturer used).
However, even if the company's systems are rigorous and vigilant about catching its own errors, the USDA can ask the company to initiate a recall because of its own inspections, and even because a consumer brought an issue up to the USDA!
In January 2020, a regional soup manufacturer shipped soups containing noodles, but used labels that did not mention the noodles. This is an undeclared allergen issue (wheat and egg). The error was not caught by the company but by a consumer. Since this was early in the process, the company only had to recall a small amount of soup. But note that as "small" as this seems, it could have been a much larger public health issue had the consumer not called. Additionally, and notably, the company still had to pay the public relations price of having its name associated with a recall.
In May 2020, a large international company accidentally mislabelled a chicken-containing product as just a sauce-containing product. The company did not discover this on its own; rather, multiple consumers figured it out first. The company did the right thing by the law ("misbranded product") and recalled over 14 tons of product.
In October 2020, a meat product company was caught by USDA inspectors as having made and shipped product during hours that a USDA inspector was not on site ("produced without benefit of federal inspection"). This is not allowed, so over 11 tons of product had to be recalled.
USDA Public Health Alerts
In the case of a potential recall that a company and the USDA might be discussing, the USDA typically gives the company time to assess the risks and suggest corrective actions. If, however, the company decides not to execute a recall (e.g., in the belief that the product has sold through), yet the USDA still believes that the public health risks are substantial (e.g., the product could still be in a consumer's freezer), the USDA can still publish a very public "health alert." This means that the company still pays a public relations price because the USDA puts the company's name in the press. These public announcements lead with: "The U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) is issuing a public health alert because…."
In May 2020, a retail store associate found an incorrect label on a soup product. The front label was correct, but the back label was not. (Another lesson: even though the consumer in the store will typically only see the front-facing label, all labels on a container need to be correct.) This error affected over 17 tons of product, which the company determined was no longer on the shelf, so they chose not to conduct a recall. The USDA disagreed with the public health risk and issued a Public Health Alert. This cost the company something, didn’t it?
In July 2020, a company found during its own review of documentation that they used the wrong label on a diced chicken product (leading to an undeclared allergen) which affected over eight tons of sold product. They voluntarily told the USDA, and were convinced that no product remained in the trade. However, they still ended up with the USDA issuing a Public Health Alert.
When a company and/or the FDA decides to issue a recall notice, it requires an ongoing public notification and follow-up. One of the toughest "pills" for a company to swallow is when the recall is due to an error that their supplier made. At first blush, the company did not do anything wrong. But upon further consideration (especially in the eyes of the FDA), perhaps the company was indeed partially at fault for not having the right checks and balances ("preventive controls") in place to catch supplier errors.
In April 2020, a major national distributor of juice drinks had to recall a production lot of drinks because it contained undeclared sulfites. Again, although the manufacturer itself did not directly do anything wrong, they had a contract manufacturer produce this lot of juice who erroneously added the sulfites. Consumer complaints (again, not the contract manufacturer nor the distributor) led to an investigation by the contract manufacturer, which identified the processing error. Since the amount of sulfites exceeded the allowable level, all of the product had to be recalled from the trade.
In August 2020, a supplier of fruit to a popular high-end grocery store notified the company that the fruit had the potential to be contaminated with Listeria, an organism that can cause serious issues in susceptible people. (The FDA and USDA have a zero tolerance policy for this organism.) The company at that point had no recourse other than to execute a full recall of all products containing that fruit.
FDA Warning Letters
Official letters from the FDA are very serious (see About Warning and Close-Out Letters). Once received, a letter requires a formal response within 15 days. This is an extremely short amount of time, and it stresses the urgency that the FDA is placing on correcting the issues and risks it has identified via inspection. Also, typically, the company receives no advance notice that a letter is coming so is often caught off-guard. Receipt of such a letter usually means some or all of the following:
- There are repetitive food safety violations over multiple inspections.
- Some violations cause a very high and undue risk to public health.
- Sanitary conditions are believed to have been compromised (e.g., by worrisome findings of Listeria in the plant).
In December 2019, a large bakery company conducted a recall for undeclared allergens (peanut) in some of its baked goods. The FDA even officially terminated that recall. So imagine the company's surprise at receiving a Warning Letter in March 2020.
In April 2020, a regional sandwich company received a Warning Letter for failing to respond to the FDA's inspection reports.
In August 2020, another sandwich company received a Warning Letter for not putting the right preventive controls in place to ensure a sanitary production environment. The FDA found Listeria over multiple inspections and over multiple years.
In September 2020, a major producer of potato chips was issued a Warning Letter because it blamed a single error ("human error") on an undeclared allergen issue, which led to a recall, but then did not put controls in place to prevent this issue from happening again.
In October 2020, a supplier of fresh cut fruit had to execute a recall of an entire week's production because the FDA discovered Listeria on equipment used in an area where the fruit products were packed. Either this did not go as well as the FDA wanted, and/or there were other issues in play, and/or the company did not put substantiated and sustainable preventive controls in place, because in December 2020, the FDA issued a Warning Letter to the fruit supplier.
So, You Got a Letter!
The examples above demonstrate that a wide food safety net is needed around the entire company because regulatory action can be initiated from sources totally unexpected, especially if your focus is purely internal.
Now let's suppose that there are a myriad of programs and protections in place, yet your company still gets a letter. Besides getting mad, feeling like a victim, and/or wanting to lash out at the agency, what are the next steps? Here are some suggestions to make the response effective far beyond simply responding quid pro quo to the FDA's specific observations.
Set Emotion Aside
Receiving a letter is a highly charged situation for a company, affecting all functions at all levels since business survival may be at risk. Also at risk is the potential for a public notification of the issues (said another way, your customers will find out). All parties need to focus immediately on corrective actions and take personal responsibility for doing so. A corporate decision also needs to be made immediately on how proactive to be with customers. That can be a very difficult decision. This is not Safe Quality Food (SQF)! A low score in an SQF audit can be problematic with customers, but for the most part, a low score would only be embarrassing. A "low score" from the FDA is far more fraught with risk since the FDA has the legal authority to "turn the lights out" on the company. Don't get mad, get…started.
Get the Truth
Whatever happened, really happened in the eyes of the agency. So rather than get mired in discussions about who was at fault, or concluding that this is just a one-off issue, get focused immediately on getting to the truth of what happened. Opinions do not matter; data matter, as do eyewitness accounts and documentation. Remember from the examples at the beginning of this article, if the FDA believes a half-hearted job was done to correct an issue, it will inspect again and/or deliver a surprise Warning Letter to your company.
The unvarnished truth needs to be shared with all leaders in the organization. This could be faulty documentation, a true screwup, standard operating procedures (SOPs) which no longer reflect current practices, or behaviors that have not been instilled into the organization at the floor level or across shifts. The truth of the situation must be identified in order to put in place actions which will truly make a difference in the eyes of the FDA.
Work as a Cross-Functional Team
It is highly unlikely that the solution to a significant regulatory issue can be implemented by a single function (e.g., quality assurance (QA)/food safety). Although this is the pervasive culture in many organizations, heaping everything on the QA team will not lead to a long-term change. Putting preventive controls in place requires all functions, from the purchasing group choosing an ingredient supplier, to the receiving group making sure that ingredients have been shipped correctly, to maintenance ensuring that all equipment runs in a sanitary and efficient manner, and to sales understanding customers' food safety needs
"We are all in this together" needs to be the mantra, and individual functions must set aside their narrow-minded needs (e.g., shipping product simply to meet service metrics, making sure a customer keeps store shelves stocked, installing new equipment to increase volume throughput). Even QA must relook at its own SOPs and sign-offs, since something may continually be missed (e.g., an allergen check on labels).
The executive team and CEO/president must demand from the outset that everyone is accountable for success in this endeavor, and that everyone bears responsibility for long-term, sustainable solutions. This is the essence of "preventive" – solutions that will minimize the chance of the problem occurring again.
Develop Sustainable Solutions
As is clear from the examples at the beginning of this article, one of the common reasons companies receive Warning Letters is that they do not develop corrective actions that solve the underlying root causes of the issue(s) that the FDA/USDA identifies. Rather, the companies fixed the immediate issue (e.g., pulled product from the trade, blamed a one-off and retrained an employee) but did not put new systems, procedures, and behaviors in place. And it is the behaviors (and pervasive corporate culture) that are the hardest to change. This is not the time to tell QA to fix the issue; it is the time for all functions to contribute changes and improvements. Shifting the paradigm in this manner can lead to remarkable and creative solutions which would never have been thought of by a solitary function on its own.
In the long run, getting to a sustainable solution will be best for the business. So what is a sustainable solution? It means that the right systems are now in place across all interrelated functions, such that the chance of the same issue occurring again has been minimized. Sustainable also means that the underlying new behaviors are truly being practiced by employees on the floor, i.e., not just platitudes from management or new verbiage in an SOP.
How do you tell if you have succeeded, other than lack of another issue? When you prove to yourself that the new procedures and practices are verified and validated to attack the underlying issue, and when you see over time that the new practices have become such habits that no one realizes any more that they are new/different than before.
In the short run, however, functions such as sales and finance will have to be open to immediate solutions which might hurt the business in terms of sales and volume. It is possible that some portions of the plant will need to be shut down, or that time is needed to implement changeover equipment or employee training. Doing so means being appropriately transparent with customers for the greater good, even though immediate shipments may be delayed.
Respond with Knowledge
On the assumption that "truth" has been determined and communicated within the organization, then it is far easier to review the regulations and science governing the nonconformances identified by the FDA/USDA. The regulations (and related guidance documents) need to be reviewed, so that the company can come to its own point of view on whether or not the regulations were violated and to what extent (if any, again, in the company's opinion). These assessments should be reviewed with an attorney well-versed in food regulations and/or with trusted regulatory consultants.
Similarly, the underlying science should be studied. This could be items such as time/temperature studies, shelf life data, consumer complaint data, and pathogen kill data. It could very well be that the agency's observations can be contradicted by the data, and/or the procedures being used by your company are quite well-founded in the science. Although such an analysis might not make the FDA change its mind totally, it serves to make it clear to an outside observer (remember, all of these government interactions become public) that the company is using a well-reasoned approach to risk assessment and risk management.
A benefit to focusing on the regulations and the science is that it makes it easier to draft a response to the FDA that is devoid of emotional bias. This makes the tone of your response much more conciliatory, and, of course, credible.
The pyramid below provides a visual representation of the key steps to take upon receiving regulatory correspondence from a food safety agency (federal or otherwise). Never forget that time is not on your side! This is particularly stressful because truly sustainable solutions are needed. These take time to forge consensus in the organization and then to force action. In a time crunch, it is far too easy to apply a quick fix only – and this will lead to a letter!
It all starts with finding out the truth of what happened, owning that truth, and then getting everyone involved to create a new truth going forward. If all of this happens effectively, then behaviors are improved and new habits are created. Processes and procedures will succeed because behavior and the resultant company culture support them.
When all of this goes well, management of food safety will increase, along with the organization's and employees' confidence in their own work and in the products being sold to consumers. And with all of that will come renewed support from your customers, who can't help but be impressed with your actions, especially when the FDA closes out its Warning Letter publicly.
Bob Lijana is a Food Safety and Quality Assurance Consultant with 35+ years of practical plant experience in food quality and food safety risk management—in concert with driving improved employee behaviors and plant profitability. He has hands-on experience with RTE products (refrigerated foods), prepared foods (cooked foods), and pasteurized juices; excellent technical understanding of microbiology (including pathogens such as Listeria), environmental monitoring programs, sanitation, and food science; involvement with regulated products over entire career, including GMPs, HACCP, SQF, FSMA, and a wide variety of corporate quality systems. Bob is an experienced writer to handle USDA and FDA issues, with 30 publications.