Ted Labuza, Ph.D.
Food Law: To Litigate or Legislate

Professor Ted Labuza of the University of Minnesota is one of the most highly regarded experts on food law in the nation. Having received his graduate and doctorate degrees from the Massachusetts Institute of Technology, where he subsequently taught for eight years, Labuza learned the regulatory ropes from Peter Hut, former Chief Counsel for the FDA, and from Mike Taylor of the USDA. Today, in addition to teaching courses on food law (“It helps me keep up with all the changing regulations”), Labuza serves as a consultant for 3M Corporation, with whom he coholds a patent for a new state-of-the-art time/temperature integrator tag.

FoodTechSource: What is the hot topic in food law today?

Ted Labuza, Ph.D.: There are several. The hottest is what’s happening under DSHEA—the Dietary Supplement Health Education Act. It’s causing a graying of the definitions of food, drugs, and vitamins and minerals. Companies are interpreting the law to suit their own means. I am particularly worried that some products out there, in terms of structure/function claims, are making borderline drug claims. And I am very concerned with people self-diagnosing and self-treating.

FTS: Are you referring to nutraceuticals?

Labuza: Yes. It’s one of the biggest growth areas: the supermarket as part of the health care industry. I get worried when we allow things like anticholesterol products to be labeled as a food additive. Soon, when you go to the grocery shelves you’re not going to know what is a food, what is a drug and what is a dietary supplement. On the other hand, nutraceuticals represent great opportunities for the food industry.

FTS: But, basically right now it’s a non-regulated portion of the industry?

Labuza: What DSHEA did was to tie the FDA’s hands. In the past if you were going to add a substance to a food you would have to do extensive testing to get it approved as a food additive. And that took a lot of money. Under DSHEA you can notify the FDA that you intend to add this as a dietary supplement ingredient, and have minimal data in your files regarding its safety and toxicology—and it’s really minimal data, no where near the data previously required. The FDA can say no, but it is being inundated by everything under the sun right now. There’s no FDA data on half this stuff.

“What DSHEA did was to tie the FDA’s hands. The FDA can say no (to a supplement), but there’s no data on half this stuff.”

FTS: What is the danger?

Labuza: The danger is that the public can be subjected to substances with severe side effects like strokes, heart arrhythmia, and the like—or they can be sold ineffective products. If you look at the history of the drug industry, most drug discoveries came from centuries-old medicinal uses of herbs and botanicals. The drug companies analyzed them, found the active ingredient and then improved the active ingredient by modifying it to get rid of certain side effects. Then it was put into tablets or capsules to improve its stability. And the drugs have to meet strict guidelines—the FDA says you have to label it with an expiration date that’s based on loss of no more than 10% of the active ingredient in terms of the efficacy level. That doesn't happen with nutraceuticals. Producers say that because it’s natural, in a natural state, therefore it’s safe. Well, that’s not necessarily the case. And efficacy levels are all over the map. For example, a lot of companies use the additive St. John’s Wort, which is supposed to fight depression. Well, there are all varieties of St. John’s Wort. You have no idea what the concentration of the active ingredient is. It think it was Good Houskeeping that did a study about six months ago, testing a variety of brands, and found from zero to 16-fold differences in concentration.

FTS: And the FDA does nothing?

Labuza: The FDA wants to impose a new GMP for the nutraceutical industry, but there’s a lot of opposition to that. Of course they are covered under current GMPs but this new one would include measurement of the active ingredient to ensure you’re delivering to the consumer.

FTS: Has the issue been litigated yet?

Labuza: There are two potential cases. One is being litigated right now. A company called Farmamex allegedly found a rice-fermented product with a red mold that they dry and they’re selling it as a dietary supplement for lowering cholesterol. First of all, they’re making a drug claim on the label that it lowers cholesterol by, I believe, 10 or 20%, and DSHEA doesn’t allow you to do that. In other words, the company is selling it as a drug and calling it a dietary supplement. So, the FDA asked U.S. Customs to block list the product to prevent it from being imported. And in terms of due process, the company had the right to go before a judge to address the issue because, in effect, it represented an injunction against the company. What Farmamex showed was that this product generated 80% of their sales, and if they were block listed they were going to be out of business. So the judge told the FDA to cease and desist. So now the FDA has to go through the courts to have the ruling overturned, and essentially the courts are going to have to interpret DSHEA, and there’s a chance DSHEA could be found unconstitutional in the way it’s written because it circumvents the Food, Drug and Cosmetic Act—it strips the FDA of its power. I’m sure the company will try to get the venue put in Utah, because Utah is where a lot of the Dietary Supplement producers are, and the Utah judges are very sympathetic to these issues.

FTS: What is the current state of HACCP?

Labuza: Right now we have HACCP for the fish, meat and poultry industries, but the FDA wants HACCP introduced for every sector of the food industry. And that may prove problematic. HACCP is a good concept, but it doesn’t work well unless, along the way, you have a total kill step. And you can’t have a total kill step on anything but thermal processing. The canning industry hasn’t had HACCP and it’s worked fine. Botulism is kept in check because you cook the hell out of the food. In the fish, meat and poultry industries, on the other hand, a lot of the plants are not meeting their HACCP plans, and that’s because it requires so much record keeping, which they don't understand. If the goal of HACCP, as it was for the NASA space program, is to have zero microbes present, it’s not going to work—at least it won’t be fool-proof—in the practical world.

FTS: Who’s next, the fruit and vegetable people?

Labuza: Next is fruit juice. The FDA has already said that the pasteurized juice industry has to have HACCP. Or if they don’t pasteurize they must use warning labels. The juice industry is saying, “Hey we’re pasteurizing the juice and the juice is okay. Why do we need to go through all this other stuff?” I mean it’s a regulatory nightmare.

“The juice industry is saying, ‘Hey we’re pasteurizing the juice and the juice is okay. Why do we need HACCP?’”

FTS: And then you get into the issue of imported fruits and juices...

Labuza: Right. How do you verify those?

FTS: Are there plans to implement HACCP in the food service industry?

Labuza: It’s real hot in food service. There are a lot of food service companies already requiring HACCP training, and it’s almost useless because if you look at your labor force in food service, which is the lowest of the low pay, how can you expect them to implement a plan? As it is they’re shouting back and forth behind the counter, and nobody is understanding anything, and you can see they’re sloppy.... I mean you can do HACCP if you have a high quality restaurant and you pay these people $10-$15 an hour, but no owner can make money doing that. And again, if you apply good GMPs in a restaurant, you should have no problem. It’s an understanding of food microbiology and cross contamination, and quick cooling and proper holding temperatures. And I don’t think the restaurants have the capabilities of doing all the record keeping and the verification studies that would be necessary under HACCP. I mean they can do it but the cost of food is going to go up.

FTS: Many in the food industry feel, because it’s being done at the Federal level, HACCP is being shoved down their throats.

Labuza: Yes, they do. And the argument can be made that, constitutionally, the protection of health is an issue left up to the states to regulate. However, Federal food law came about not so much as a food safety issue but because of interstate commerce. That’s why we have the Food, Drug and Cosmetic Act. And the Meat Act. States still regulate at the grocery store level and at the restaurant level. And they actually do inspections of food plants as well. They have the authority to do that. And through the Conference of Food Protections—attended by the state regulators, the food industry people, the FDA and the USDA—they’ve put together this food code, which is a model food code. And while there are people who say that it’s not based on science, well, you don’t have to base things on science. Opponents say, “Why do we worry about insects? No one has ever proven that somebody in the U.S. has gotten sick from food poisoning because an insect crawled on the food.” Well, that’s stupid. In a regulation you tend to overregulate, then you fall back if eventually you show you can fall back. But it’s better to be on the safe side. Because you get bashed otherwise.

FTS: The Clinton Administration got bashed for being soft on substance with early environmental legislation. How is the Clinton Food Safety initiative being received?

Labuza: From the standpoint of food safety for the public, I thinks it’s had a positive effect—but not so positive for the industry as a whole. For example, there are now, I believe, eight CDC “Sentinel Network sites” set up around the country where doctors and hospitals can log in data from people who have been treated for food poisoning, and do it on-line. In the past, what doctors would do if someone came to them with food poisoning was to fill out a form. Then, once they got a stack of forms they would send that information to either the local public health department or the CDC, depending upon the state. And if it went to the CDC it would sit in a pile there and six months later they would go through the pile and say, “Oh my God! Symptoms of Salmonella in New York City and Cincinnati and Los Angeles—this has got to be from a nationally distributed food.” Then they would call the person and ask what he ate that made him sick six months earlier. Now this information is on-line. There are people who are analyzing the data, there are programs that will flag that data, and in 24 to 48 hours they know what food it is. This means companies can’t hide behind the fact that it took so long in the past to do that, and with the fingerprinting we can identify it as the same sero type of organism. We can positively identify the food that caused the outbreak. So the Internet, and all the DNA technology has made identification of a commercially processed food that much easier.

“Irrespective of how incredulous the consumer was, not in one (food safety) court case did the food company ever win.”

FTS: Is that why reported incidents of food poisoning appear to be on the rise?

Labuza: I don’t think people are reporting it any more than they did in the past, but now we’re able to identify the cause of the outbreak very quickly.

FTS: Is it effecting the statistics at all?

Labuza: We don’t know the statistics. People, including the Clinton Administration and most food safety people who are trying to get money, toss around the figures, 80 million cases and 9,000 deaths. We know those numbers are not true, but we don’t know what those numbers really are. In two to three years we will probably have a much better statistical handle on the scope of the problem.

FTS: One thing that strikes me is that with all the product recalls and all the widely reported cases of people coming down with food poisoning, you almost never hear of any civil liability suits being brought by the victims.

Labuza: Oh, there are plenty of lawsuits. The Salmonella incident involving Malto-Meal here in Minnesota, there are a number of outstanding lawsuits there. But most cases are settled out of court.

FTS: They get buried?

Labuza: Yes. A number of years ago, Mike Foster, who was the food safety guru at Wisconsin, decided to have some lawyers do a search for all the microbiologically oriented food safety cases that went to court. What he found was that not in one case, irrespective of how incredulous the consumer was, not in one case did the food company ever win. And now there’s a law firm called Outbreak, Inc., that’s comprised of people from both sides—lawyers who’ve defended companies and prosecuted companies, including the Jack-in-the-Box case—and they’re serving as litigation consultants to the food industry in the area of food-borne illnesses.

FTS: Were there criminal prosecutions in the Jack-in-the-Box case?

Labuza: No. FDA’s modis operandi is to get the product off the shelf first. They’ve got three options. First, they can seize product. To do that they have to send marshals to every location where that food is. So they prefer to get the companies to recall it. And their recall process is voluntary, but I don’t know of any firm that wouldn't comply—unless it’s a small fly-by-night outfit. The biggest case was the Bon Vivante vichyssoise case back in the 1970s. The FDA had to mobilize every state office to help get the product off the market. And that’s been one of the hot issues of the last two years—getting mandatory recall. But I think the issue’s dead. It’s not that relevant because no company is going to leave product out there unless they want to get more people sick and cause more lawsuits.

FTS: The liability issue takes care of that?

Labuza: Right. So it just doesn’t make sense. The second option the FDA has is to get an injunction against the company, or they can institute criminal prosecution. Usually, criminal prosecution is reserved for cases where the FDA has gone in and inspected and found something wrong and after telling the company to fix it, they go back two or three times, to find the company hasn’t done anything about it. Or major branding fraud, such as the Beechnut fake juice case, and the couple of cases of fake juice from companies in Chicago and Michigan, where these companies are making a lot of money. But on the processing side it’s very rare that the FDA would go for a criminal prosecution.

FTS: Is there anything on the horizon for food producers to watch out for?

Labuza: There is one other, and the FDA hasn’t come out with it yet, but back on November 22, 1996, there was a federal register notice for transportation—an Advanced Notice of Proposed Rule-Making (APNR)—for transportation and holding of potentially hazardous foods. Specifically this referred to the refrigerated and frozen food distribution system in respect to the growing amount of minimally processed foods on the market. Like fresh prepared salads, where they’re cut up at the plant, they’re transported, and the producer doesn’t know what kind of conditions they’re under during transport—and where independent truckers are notorious for shutting the refrigeration off to save money. I’ve done, and other people have done, surveys of temperatures in supermarkets, and what you find is tremendous abuse of holding temperatures. Dick Daniels, from Chicago, is just completing another study. At an IFT meeting about a month ago, he presented some preliminary data showing 20% or more of stores have improper temperature holding, which, when you’ve got a prepared meal you are courting danger. So at some point in time they’re going to come up with some proposed regulation in this area of how to control refrigeration.

FTS: Would that be under HACCP?

Labuza: That basically is HACCP. The HACCP concept, which people tend to forget, is divided into three areas: control of your ingredients in terms of ingredient specifications, second would be the process technology CCPs—your kill steps or whatever—and third is distribution—the kinds of things that can go wrong in distribution. And producers tend to forget about a product once its out the door. Especially with holding temperatures at the grocery store level. And if you know there is a potential for E. coli O157 in beef, then maybe you better be more concerned about keeping control of the temperature during distribution.

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