'FUNCTIONAL FOODS' FACE HURDLES

PAT NATSCHKE LENIUS

CHICAGO -- Marketing the new class of products called "nutraceuticals" or "functional foods" won't be easy. A jumble of regulations, proprietary data and marketing jurisdictions may discourage some food companies from even developing so-called functional foods -- a food, or part of a food, with medical or health benefits.

That was the consensus of speakers here at the 15th symposium on nutrition and food technology. The conference was sponsored by the Chicago Nutrition Association, the Chicago Section of the Institute of Food Technologists and the Chicago Center for Clinical Research. One of the speakers, Kathie Wrick, senior consultant at Arthur D. Little, Cambridge, Mass., said there are no incentives in place to make cost effective the research and development investment and clinical trials necessary for functional foods.

"The petition process for health claims is still evolving," she said. "It doesn't favor proprietary data. In making a petition for health claims, I have to publish everything I know about my ingredients and give all my secrets away to competitors. They can come to market with a similar product as soon as my ingredient or product is approved. That takes away the incentive." Wrick called for a process or application for patents, or some kind of licensing arrangement. Another speaker recommended that food ingredient suppliers have a clear regulatory strategy before spending much money on the development of functional foods. "Know what the claims will be and know in what countries those claims are likely to be allowed. Have compelling medical evidence," said David Trecker, senior vice president of food science at Pfizer Inc., Groton, Conn. "This will not be won by smoke and mirrors. You will need persuasive studies, lengthy and costly studies," he said. "Regarding proprietary position, our view is you will be able to get a proprietary position and you had better, or it won't be worth the effort." While functional foods should ultimately result in better health for the American consumer, the price of progress will be an initial period of confusion. There will exist the potential for misunderstanding and even fraud, said Robert Smith, senior vice president of research at Nabisco Foods Group, Parsippany, N.J., also a speaker. Smith said the critical considerations in regulating functional foods should include: demonstration of safety, scientific consensus on efficacy, rationale for specific product and health claims in context of total diet.

Said Pfizer's Trecker: "Over the next decade or two, we will see a good many attractive products that will lend themselves to the functional food business," he said. "Where will the greatest receptivity be? Where the culture will provide a receptive public. "In Japan, Germany, France, Canada, China and the European Union," he continued, "there is at least a promise for some kind of national regulatory framework that will deal with claims. Look at Japan as a model. Japan has a regulatory process in place to allow for claims to be made for functional foods." The concept of functional foods originated in Japan, where the government has approved certain ingredients for use in functional foods, said Wrick of Arthur D. Little. A functional food in Japan is a product that delivers a health benefit to the consumer while meeting sensory requirements and contributing basic nutritional needs, she said. The health benefit may be delivered by an ingredient that occurs naturally in the product or that has been added to the product, she said. Wrick adds there will have to be a rethinking of regulations due to the lack of clear-cut language delineating whether something can be an additive for the purpose of delivering a specific health benefit to the consumer. "[Additives as health enhancers] is one avenue of approach," she said. "Another avenue would be pre-approval for claims using proprietary data." Wrick pointed to another issue: where and how can exclusivity of the research and development investment be incorporated? "Food and drug law is not structured to accommodate that," she said. Pfizer's Trecker said a second generation of functional foods is being devised where benefits and claims will be critical to their promotion and marketing. "One change we are going through is the difference in time to get a product of this sort on the market. With the first-generation food ingredient, regulatory submissions are not needed. It takes one to five years to introduce. Where submissions are required, depending on what is required, the time line can be extended up to 10 to 12 years, and in some extreme cases longer than that," he said. "Where a good bit of information is available and the data is compelling and evidence persuasive, moving a product of this sort to market will take place in about the same time frame that an unregulated ingredient now takes," he said. But when starting from scratch with a new ingredient, the time frame for introduction could be open-ended, Trecker said. "I don't know how long it will take, but it will be a lengthy procedure. That will influence the number and type of projects that food ingredient suppliers will take in going after candidates of this sort," he said. The general outlook for nutraceuticals includes heightening consumer awareness and an evolving regulatory framework. A framework is in place in Japan, is being put in place in Canada and is not too far off in the European Union, Trecker said. Nabisco's Smith said, "There is also the issue of legality and definition. What is a food and what is a drug?" Food and Drug Administration's definition states a drug is something intended for "use in the diagnosis, cure, medication, treatment and prevention of disease in man or animal and substances other than food that are intended to affect the structure or any function of the body in people or animals," Smith said. It is time for FDA to offer applications for new food, just as it offers new drug applications, Smith said.

"A new food cannot be any less safe nor should it be expected to be any more safe than its traditional counterpart. We have to do an initial chemical comparison. If any genetic modification factor is involved, there may be a need for extensive animal studies. For those substances that are very different from the parent foods, we would need clinical trials," Smith said. Functional food will almost certainly alter the pattern of nutrients in food, according to Smith. Where will that fit into the 1990's food pyramid? For example, he pointed out, increasing calcium in a wide range of foods could dump too much into any one individual's diet. Is there such a thing as too much vitamin C or D?

According to Pfizer's Trecker, drug companies are beginning to pay serious attention to functional foods. "A multibillion dollar business is in place in alternative medicine. The pharmaceutical industry wants to participate in that growth. The boundaries between these two are blurring," he said. To exploit this trend, food ingredient suppliers will need different skills. They will have to marry the capabilities of drug companies with the capability of the food science industry, bringing clinicians, toxicologists and statisticians together with chemists, engineers and food scientists, he said. Said Wrick of Arthur D. Little: "What are functional foods likely to be today? Probably products that fall within current health claim regulations." The nutrition messages consumers are receiving from magazines, newspapers and television infomercials now outweigh information they get from doctors and package labels, Wrick said. "What people read about and see on TV will carry some of the functional foods through. They do not necessarily have to be well accepted by the scientific or regulatory community," she said. "For the near term, many functional foods will remain short-term cyclical options. Consumers will make their own [decisions] about self-care." Sales of oat bran and calcium supplements soared when positive media reports were released, but as soon as there was a negative media report, the balloon started to burst, she said. Anti-oxidants are on the rise, but likely to suffer the same fate, she added. The food ingredient supplier's challenges in the functional foods arena are somewhat different today than they will be in the future, said Trecker of Pfizer. "Our current targets for functional foods are based on the needs of our primary customer, the food processors of the world. They tell us they need a fat substitute or a reduced-calorie bulking agent. The guidelines for devising ingredients of this sort are pretty well defined and reasonably well understood. Safety testing is always debated, but there are fairly clear guidelines for the United States and other major countries," he said.

In the future, the ingredient supplier will be challenged to devise ingredients that contribute specific medical benefits, he said. This development will take different skills and outlooks. Benefits will be specified in a different way, such as reduction of incidence of a certain type of disease, Trecker said.

"Will they be regulated as a food or drug? That will vary country by country," he said. Good scientific data supported by good publicity can get a functional food off the ground, Trecker said.