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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.” wheras, 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.
How calling a food regulatory lawyer can help
In any of these situations, a food regulatory lawyer can provide invaluable assistance in several ways:
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.
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