A seat at the enforcement table: ‘I wish I would have acted sooner’
By Joseph A. Levitt
I will soon be retiring after 42-plus years, first 25 years at the Food and Drug Administration, and then 17 years in private practice, and I wanted to share the most important lesson I have learned from food companies facing food safety and compliance challenges. In one phrase, the lesson is: “I wish I’d acted sooner.” This spans a lot of examples, from: “I wish I’d recalled product sooner” to “I wish I’d called a microbiology consultant sooner” to “I wish I’d read my recall insurance policy sooner” to “I wish I’d secured a larger line of credit from my bank sooner.”
When I hear these, the thought that keeps going through my head is: “I wish they’d called us sooner” as an attorney could certainly have helped them reduce the costs, as well as anxiety, of going through a major food recall or situation of similar import without experienced guidance.
When I ask clients why they didn’t call us sooner — and I do ask — I generally get one of several responses. Either: (a) “I didn’t think I needed a lawyer” which translates as it’s not a strictly legal issue; (b) “We have a good in-house team, it just never occurred to me” which translates as overconfidence, or (c) “I didn’t even know your type of lawyer existed” which translates as I didn’t know what I didn’t know.
So as one of my parting gifts before I retire, I wanted to share with you why it is so important to call an outside food regulatory lawyer on food safety and compliance matters, and why doing so at the earliest available opportunity can save you endless grief, anxiety, and cost. And while my examples all apply to the FDA, the same principles apply to meat and poultry companies regulated by the U.S. Department of Agriculture.
Reasons why calling a food regulatory lawyer early can be invaluable
First, you have to think of outside food regulatory lawyers as more than just lawyers who handle legal issues. Instead, it is far more accurate to think of us as FDA regulatory experts. If you have any food safety or compliance issues with FDA, the chances are very high you need one of us. The FDA has enormous powers, from shutting down your facility to mandating a recall, to, in an extreme case, recommending a criminal investigation. You don’t ever want your situation to get this far — but to ensure that, you need to find help before the matter escalates.
Second, to quote from the old Broadway show “The Music Man,” “…but you got to know the territory.” Here, the “territory” is FDA — their house, their rules. So when faced with a new problem, you need someone with experience, someone who has dealt with this type of situation before. Just like you get an interpreter or guide when visiting a foreign country when dealing with the FDA, you want and need someone who speaks the language and knows the terrain.
A key part of knowing the territory is knowing what types of communications work with FDA by building confidence, and, conversely, what types of arguments can backfire or otherwise would inadvertently undermine your case with the regulators. Only people who do this every day have the experience base to build up that list of do and don’ts. For example, a definite “do” is to say “we take your concerns seriously and we will fix things period.” Whereas, a definite “avoid” is something like, “why pick on me when others are doing the same thing?” FDA wants companies to take responsibility, not deflect to others.
The theme across all the examples below is that many companies are facing these issues for the first time, and their biggest handicap is they don’t know what they don’t know. So calling in a food regulatory legal expert — who has experienced this type of situation before — gives you added insight right away, often when time is of the essence. It’s just like seeing a medical specialist when your general practitioner can’t help you.
Examples: Top 10 list
As noted above, the FDA has a number of powerful regulatory tools that, if utilized, could cause serious or irreparable damage to your business. For example, your products can be seized or your business shut down. And, in extreme cases, the Justice Department can bring criminal charges against you. The FDA can also require you to recall products already in the marketplace, sometimes when manufactured over a considerable period of time. Nearly all of these sanctions can be headed off at the pass or nipped in the bud. But you need to understand the warning signals. So here’s my Top 10 list of when you need to call a food regulatory lawyer.
- Notification of Outbreak: You have been contacted by the FDA and/or CDC that your company’s product has been associated with an outbreak of foodborne illness. This means your product has made people sick — the last thing you ever wanted to happen. You need help right away, to help you determine if the product needs to be recalled if your plant needs to be shut down, and if so, what will be needed to restart.
- Bad results from FDA Swab-a-Thon: You have been contacted by FDA and told that they took environmental swabs in your facility and found one or more positive findings of a food pathogen, such as Salmonella or Listeria. If not handled properly, this could be the beginning of bad things to come. That is because FDA will do DNA fingerprinting, called Whole Genome Sequencing, of your sample, keep it on file, and if they come back a year later and find the same thing, FDA could make you recall all product made in the intervening time under the “resident strain” theory.
- FDA sends you a Warning Letter: This means FDA has already determined that your product is legally adulterated or misbranded — you are officially on the naughty list — and if not remedied promptly, it could lead to any of the regulatory actions mentioned above. Note that FDA generally only sends one Warning Letter per facility, so just receiving it means you are in legal jeopardy.
- FDA invites you to a Regulatory Meeting: This is an in-person version of the Warning Letter and carries all of the same cautions and risks.
- You receive a second 483 Inspectional Observations report in the same facility: This is a red flag for the FDA. It means they feel they cannot trust you to fix your problems on your own. An escalation is almost certain to follow if you do not immediately change course and nip this in the bud. How you respond to that second 483 will be very important, and an experienced food regulatory lawyer can help you put your best foot forward.
- You receive your first 483 for a facility, but it is long, scary or the inspection itself was verbally contentious. FDA can escalate its activities even after a single bad inspection if the agency feels it went badly enough. At a minimum, you need a second opinion from an experienced food regulatory lawyer.
- Your finished product testing program shows a product positive for a food pathogen – usually Salmonella or Listeria. It is highly unusual to get even a single product positive, so this is an incredibly important warning signal. If an outbreak is a 5-alarm fire, a finished product positive is still a 3-alarm fire. You need to act quickly or the house could burn down. In addition to a food regulatory lawyer, you will also probably need an external scientific consultant to help you find the root cause and take necessary remedial action.
- You have a series of positive environmental findings in your facility for Salmonella or Listeria. This is an example of: Where there’s smoke, fire may follow. Remember that FDA will have access to those testing records, so these findings will become immediately visible to an FDA inspector. You need an objective viewpoint to assess whether or not your corrective actions will be seen by the FDA as sufficient. Always best to act before the FDA inspector is in your plant.
- You have findings that make you question if you need to file with FDA a Reportable Food Registry (RFR) report. This is sometimes a tricky decision and, especially if you decide not to file, warrants clear written documentation as to your rationale, and an objective second opinion that it is legally defensible.
- You have findings that make you question if you need to recall a product, or if you should continue to ship a product. Often this will be related to the RFR decision-making above. You may have had an adverse incident at your plant, an unexpected spike in environmental test findings, or even a foreign material or quality issue. The same principle applies — make the right decision and document it well — and get experienced advice in doing so.
How calling a food regulatory lawyer can help
In any of these situations, a food regulatory lawyer can provide invaluable assistance in several ways:
- Providing you an independent assessment of how serious your situation is. Remember, we have likely seen something similar before, even if you have not.
- Recommending a scientific expert who can help you identify the root cause and determine necessary remedial action. Food regulatory lawyers have worked with a number of such experts and can help identify the best match for your needs as well as potentially retain the expert in order to preserve confidentiality under attorney-client privilege.
- Frame and prepare the best possible written response for the FDA. How you respond really matters, and your written response will be FDA’s first data point as to whether you are moving up or down on their worry list.
- Open a line of communication with the FDA. It really helps to have an intermediary known and respected by the FDA. This can result in invaluable intelligence on what the FDA thinks of your case — FDA might tell your attorney things they might not tell you directly. It also serves to reassure the FDA that you have retained an experienced food regulatory lawyer and are on the road to compliance.
- Recommend if it is worthwhile to seek a preemptive meeting with the FDA, sit down face-to-face and seek to convince the FDA that you have taken the necessary steps to come into compliance. This is often the best way to turn things around quickly, assuming you have taken the necessary steps with your plant.
Each of these steps, both individually and in combination, is designed to reduce your risk of FDA escalating to formal regulatory action and, quite the opposite, to increase the likelihood of de-escalating matters and persuading the FDA you are bringing the matter under control voluntarily. And remember that, under the FDA Food Safety Modernization Act (FSMA), good documentation really matters.
If it isn’t documented, it didn’t happen. An attorney can help you with that, too. All go to mitigating the risk of matters escalating with the FDA. Doing so, I promise you, will pay dividends.
About the author: Joseph A. Levitt is a former partner and currently senior counsel in the Washington D.C. office of Hogan Lovells US LLP and a former director of FDA’s Center for Food Safety and Applied Nutrition. The law firm handles FDA and USDA food safety and compliance matters.
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