The FDA on Line One

Clients usually feel anxious when they meet Mark DuVal of DuVal & Associates in Minneapolis. Not that he is intimidating. It’s more that by the time they call him, they’re in trouble.

“Clients don’t seek my services until the future of their company is on the line,” he says. “That’s when the stress kicks in. Many folks in the food industry come into our office not even realizing that the FDA is a part of their life. Then they put a whole bunch of time and money into producing a product that runs afoul of regulations.”

It usually starts with a letter, which basically says to cease production immediately.

“As you can imagine, it can cause a great deal of upheaval, especially in a small company,” says DuVal associate David Teicher.

How the letter is labeled matters. An FDA inspection can be marked either routine or “For Cause.” When it’s the latter, clients freak, and rightly so.

“They are more than nervous,” DuVal says. “They are very concerned about what is bringing the FDA to their facility. That’s when business owners want competent, experienced counsel. I just spent two and a half days at a client’s facility, observing an inspection. The CEO wanted me there—for his own peace of mind.”

Robert Klepinski and Richard Wegener are the resident FDA specialists at Fredrikson & Byron.

“We often wish clients had done some work before meeting with us,” Klepinski says. “But it’s human nature to let things slide until something bad occurs. A lot of them only show up when something forces their hand.”

“A lot of people jump into the food production or restaurant business—it’s an industry that is relatively easy to enter,” Wegener adds. “They don’t really do their homework.”

Large food producers understand how to make products that abide by FDA regulations, DuVal says, but the industry still tends to be “wild and woolly.”

“When a big company like General Mills or Cargill decides to produce a new product, they will be very thoughtful about their process,” he says. “They’ll dot their i’s and cross their t’s. They’ll meet with their attorneys. It’s pretty seamless. In a smaller company the lessons often come in the school of hard knocks.”

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The FDA regulates not just the food we eat, but dietary supplements, toothpaste, mouthwash, medical devices, implanted drugs and other products.

Because Minnesota is home to a thriving agricultural industry, as well as a burgeoning bioscience sector, one would think we would have plenty of FDA attorneys. But we don’t. Most FDA attorneys are based near FDA headquarters in Washington, D.C., Wegener says. Even though Minnesota can claim one of the nation’s oldest food regulatory bodies—the Minnesota Dairy Commission, which was founded in the late 1800s (see sidebar)—only a handful of qualified FDA attorneys practice here.

“Like everybody, I went to school on the idea that all FDA lawyers reside in D.C.,” DuVal says. “There’s no question that there is a market here that is not being served.”

Wegener agrees, pointing out that too much Beltway camaraderie isn’t a good thing.

“The large concentration of FDA attorneys in Washington, D.C., are former government employees, and a lot of them still refer to the FDA as ‘we,’” he says. “That can be pretty disturbing, and not all that helpful for a businessperson.”

What’s Safe to Eat?

While DuVal is confident in the safety of food available in the United States, he doesn’t expect the system to be perfect. “I don’t think any country in the world has the resources needed to do a complete job policing their food supply,” he says. With that in mind, DuVal has some simple advice. “Read labels,” he says. Also, “I stick to brands I have some confidence in. I would be suspect of any Chinese-sourced products.” (Last year the FDA went public with growing unease with what it calls China’s “manufacturing control issues” and recalled thousands of imported products, including many pet foods.)

DuVal says part of the problem is that the FDA is simply overextended. “Frankly, I think that China has skated by on a free pass for many years,” he says. “The economics of their massive, cheap production has overwhelmed the FDA, and the administration’s lack of resources combined with their inability to inspect everything has become a real recipe for trouble.”

Though it would be impossible to sanitize every piece of food that comes into this country, Wegener and Klepinski believe food in the United States remains the safest in the world.

“Sure, we don’t want to eat a bunch of bland, flavorless food just because it is considered ‘clean,’” Klepinski says. “Spice and variety are what makes the food in this country so great. Any FDA lawyer is going to tell you we are lucky to have an institution like this looking out for the health of the citizens of this country. I agree, but there are people out there who think that if a little regulation is good, then more must be better. It is part of our job to work for that balance, to recognize the need for public health and safety while respecting the rights of business owners.”