Formulating for Life
October 1995 -- Cover Story

By: John Spizzirri
Contributing Editor

  Chemists who concern themselves with the structure of nature consider amino acids the building blocks of life. These combine to form the proteins that create and sustain life.

  We rely on amino acids and proteins for numerous reasons. Our bodies produce and recycle them for energy and proper digestion, for building and strengthening muscles and, in general, for keeping us healthy. But they also play havoc with our immune systems.

  Chemists who deal with the science and structure of foods cannot avoid proteins and amino acids, the enigmatic part of the food chain that not only helps and hinders the human body but inevitably alters the process of food formulation.

  Food manufacturers often boast their product's proteinaceous attributes, some without considering the full impact their product may have on even a small percentage of their market. And the truth is that many consumers have little need to be concerned over which proteins they ingest, much less from what source they obtain them. Yet, through the various stages of life and health, our bodies have special needs that require the addition or exclusion of one or more of these protein sources.

  While some manufacturers have focused their attention on developing products for specialty needs -- baby formulas, aerobic and dietetic supplements, medical foods -- only recently have the mainstream marketers become sensitive to issues facing consumers with specific dietary needs, particularly those with food allergies.

Trouble with proteins

  Milk, eggs, peanuts, tree nuts (walnuts and pecans), fish, shellfish, wheat and soy are all excellent sources of protein, and they are the staple ingredients for innumerable food products. Besides their individual contributions to our daily diets, they also serve the food industry as flavorings and fillers, binders and substitutes. Unfortunately, these same eight foods and food groups comprise about 90% of all food allergies.

  Why has it taken so long for the industry to address this issue? A confusing mixture of statistics and marketing has helped keep product developers from making major formulation decisions based on a product's allergenicity. The numbers certainly don't speak in favor of the consumer. While many people complain of allergic-like reactions to various foods and additives, only 1% to 2% of the American adult population actually has a food allergy. Some industry sources suggest that this number may even be lower -- skewed by the addition of people suffering from food intolerances to lactose or sulfites, for example, and not true allergies.

  "The problem that you have, of course, is that not only do a small percentage of adults have these problems, but they're sensitive to different kinds of foods," says Steve Taylor, Ph.D., head of the Department of Food Science and Technology at the University of Nebraska, Lincoln. "The number of people that have a sensitivity to wheat is probably about one in every 3,000 people, and they're dispersed all over the country. So how do you get the product to the right market? I don't think any supermarket would commonly sell a product that only attracts one in every 3,000 customers."

  The expense of creating a hypoallergenic line for such a small audience also would keep food manufacturers at bay. This would mean creating new production lines to prevent the possibility of cross-contamination, a problem currently faced by manufacturers using shared equipment. Mars Inc., for example, the makers of M&Ms, lists peanuts as an ingredient on the plain M&Ms ingredients label.

  People with peanut allergies tend to have greater sensitivity to this specific allergen than do many other food allergy sufferers. While peanuts are not an ingredient in plain M&Ms, even trace amounts left over from peanut M&M production could set off an allergic reaction. If not treated immediately, this reaction could cause anaphylaxis, which lowers blood pressure, constricts breathing and, in some cases, may result in death.

  The food industry has come a long way in its ability to process away certain unwanted elements like fats and cholesterol, and it can even affect some proteins. But Mother Nature did well in protecting the integrity of the more allergenic proteins found in foods such as peanuts and milk, both of which tend to be among the highest sources of natural food proteins. For now, a peanut is a peanut, and despite current advances in biotechnology the industry is still unable to manipulate or genetically alter its multiple-protein structure.

  The industry has had better success in reducing the allergenic properties of milk through the process of acid or enzymatic hydrolysis. Hydrolyzed casein, whey and soy are most commonly used in baby formulas -- one of the few markets, if not the only one, to employ the process mainly for this purpose.

  In hydrolyzation, proteins are "predigested" in production tanks, or enzymatically broken down into their smaller constituents, namely, peptides and amino acids, according to Patti Ann Kelly, Ph.D., technical sales manager for DMV International, Fraser, NY. Used in health and medical applications, peptides are better absorbed by the body for protein synthesis in patients under catabolic stress, in body builders and in atheletes.

  Whether for health or allergy, the hydrolyzed proteins can be administered in liquids, instant dry powders, tablets and capsules. Kelly maintains that the hypoallergenic hydrolysates are not primarily used in mainstream food manufacturing because, again, most companies aren't developing foods for people with allergies. They're letting the health food industry and small niche companies fill these particular market needs.

  John Allred, Ph.D., of Ohio State University, Columbus, notes that it goes back to cost efficiency. "Now you've added an extra step in the formulation process, and I doubt the benefits would be worth the cost -- particularly in terms of formulating the product," he says. "For example, the gluten in wheat has certain properties that it gives to the bread. When you hydrolyze the glutens, you lose that property. I would imagine that you would have that kind of thing with virtually all foods that use protein in their texture."

When protein is absent

  Ener-G Foods in Seattle is one company that makes gluten-free products for people with gluten intolerance, commonly known among its sufferers as celiac sprue disease. Manufacturing such products proved quite a challenge for company chairman Sam Wylde Sr.

  Gluten is the protein in wheat, corn and rye that forms the structure which holds leavening gasses. Without it, bakers would produce a flat, lifeless bread.

  While people with wheat allergies have to stay away from wheat-based products, they can eat other grains. However, those who suffer from celiac sprue disease cannot eat foods that include any of the gluten containing grains because their digestive system lacks the enzyme to break down the gluten.

  This is much the same problem faced by people with a lactose intolerance. In fact, lactose intolerance also may appear as a symptom of celiac sprue disease. Gluten eats away at the villi of the small intestine that are responsible for the production of lactase which, in turn, would allow the lactose found in milk products to be absorbed.

  Despite gluten's negative effect on some people, Wylde still offers it up as a miracle of nature. "It's the only product that when you punish it -- when you mix it -- it becomes elastic," he says. "It's this elasticity that makes cakes and breads rise because it traps the carbon dioxide gas given off when yeast ferments or when baking powders react."

  Cereal chemists measure this reaction by means of a mixing tolerance index (MTI) which determines the point of greatest resistance or elasticity of the dough. Almost all big bakeries use the MTI to evaluate the glutens in their flour so that their bread is at peak point, according to Wylde.

  "So that was our problem -- baking without this miracle that nobody's been able to duplicate in the lab," he says.

  Wylde could only partially resolve the problem by using various gums. One of them is xanthan gum, which is manufactured through microbial fermentation. The other is methylcellulose, which is derived from plant fiber. While they help bind the products together, gums still do not offer the same rising properties that gluten does.

  "Believe me, (the gums) are not as good as glutens, but they do allow us to get by," Wylde says.

  And for a niche market, get by they do, Wylde maintains. When Ener-G Foods first introduced a wheat starch bread, the product really took off. The starch, being a filtered derivative of wheat flour, had a reduced gluten content. But because it still contained traces of the protein it was only marketed toward consumers who require a low-protein diet instead of a gluten-free one.

  Today, Ener-G Foods relies solely on gluten-free grains and flours to produce its line of breads, pastas, cookies and pizza skins. The company stays away from cereal grains by using starches from root plants like potato and tapioca, which comes from the cassava root. Commonly used flours include rice flour, poi flour made from the taro root, arrowroot flour, and corn flour.

  Corn seems to be something of an enigma in the area of food allergies, and its standing as a common source of allergies runs the gamut. Some sources regard it as highly allergenic, while others suggest it has little or no allergenic properties.

  Wylde maintains that corn does contain gluten, but the gluten is made up of two molecules, gluten and gliadin. Gliadin, which acts as the causative agent, is missing from corn flour, he says.

  Ener-G Foods is among those manufacturers who are resolute in their effort to avoid cross-contamination in the processing environment. Wylde notes that his company discontinued its original wheat flour bread to assure that even minute traces of gluten wouldn't contaminate the other gluten-free products.

To use, or not to use

  Cross-contamination is an issue strongly supported by baby food manufacturers like St. Louis-based Beech-Nut Nutrition Corp., makers of Beech-Nut Stages. "You certainly don't want the dust from one soy (a known potential allergen) product settling into another," says Richard Theuer, Ph.D., Beech-Nut's vice president of research and development. "In our cereal plants, for instance, the best way to avoid this transfer of soy from one product to another is to put soy in no product.

  "That's one of the things we use as a guideline, and it creates more problems because some of (the ingredients) that we avoid are pretty functional," he continues. "The original tag line for the Stages system was 'The right food for the right stage.' Well, allergy helps define what the right food is."

  Beech-Nut Stages is meant to be a system built upon a child's nutritional foundation, which is mainly the mother's breast milk or the infant formula. Basic foods like single-grain cereals are introduced to the child one at a time in Stage 1, allowing parents to monitor for any allergic reactions.

  The company tries to keep reports of allergic reactions negligible by taking a proactive stance during the manufacturing process, altogether avoiding ingredients known to have allergic properties wherever it can. Soy, despite its use as a cow's milk substitute for baby formulas, is even kept out of the mix because it has proven reactive to some babies.

  Beech-Nut recently changed its Stage 2 creamed corn product for the same reason. Where it originally contained corn, starch and milk, it is now a combination of corn and sweet potatoes. This negates the risk of a reaction to the milk. And because sweet potatoes and other foods in combination meals would have already been introduced in the first stage, parents can better determine the source of a reaction.

  "We delay the introduction of some of the more allergic foods until about six to nine months. I think that's where we are different from our competition," notes Theuer. "In our Stage 2 foods, which start at about six months, we add wheat only to those products where the name would suggest that there's wheat in it, like pasta and noodles. So if you find a turkey rice dinner from Beech-Nut and compare it to the competition, you'll see wheat flour in theirs and none in ours.

  "So, while the challenge is sometimes leaving out all the stuff that might be useful from a food product development point of view, I would say that formulating for food allergies is more critical than nutrition or the Nutrition Facts on the side of the label," Theuer emphasizes.

The labeling issues

  But Beech-Nut's manufacturing principles seem to run counter to the rest of the food manufacturing world, where the issue of making a product line hypoallergenic is not a product development issue, but rather a product labeling issue.

  According to Anne Munoz-Furlong, founder of the Food Allergy Network, over the last few years food manufacturers have become more aware of the risk of food allergies. This new reckoning may have come in the face of tougher labeling regulations set by the Food and Drug Administration or through an influx of medical research and information collected and disseminated by industry watchdogs like the International Food Information Council and the Food Allergy Network.

  Whether caused by stricter standards, more information or a combination of both, the trend has been set toward more concise ingredient labeling and better product identification, according to Munoz-Furlong.

  "For example, if you have an apple muffin that has nuts in it, call it an apple-nut muffin so that people will know clearly that it contains nuts," she says. "We've seen this with some confectionery products like ice cream as well, but this is something manufacturers can improve on."

  Ingredient identity issues are still under fire because of regulations that allow manufacturers to lump ingredients under a single heading or disregard them altogether. When a label lists "natural flavors," for example, those ingredients don't have to be explained, notes Munoz-Furlong. Some breakfast cereals and candy bars use milk as a natural flavor, while ice creams might use almond extract, both of which could prove harmful to people with those particular allergies.

  Wylde recalls an incidence in which a customer called complaining of a reaction to one of Ener-G Foods' gluten-free products. The problem was not with the product, but in the fact that the customer used it in combination with baking powder. Most of the companies that make baking powder put corn starch in it to keep it from lumping, he explains.

  "It's not considered an ingredient so they don't put in on the label," says Wylde. "It's only considered a carrier, but it will still make people sick who have corn intolerance or corn allergy."

  Ingredient misinformation furnished by the manufacturer, while perhaps unintentional, also can lead to customer confusion. Spelt is a perfect example, according to Taylor. "Spelt is a grain that some entrepreneurs have said, 'Well, it's just as good as wheat, but it's safer for people with wheat allergies.' But it's not," he explains. "Spelt is an ancient variety of wheat that emanates from back in biblical times and, it turns out, it's every bit as allergenic as wheat. People were getting sick from it because it doesn't say wheat on the label."

  Consumers run into the same problem when confronted by an undefined food protein. Casein is a protein of milk and is one of its main allergens. But because it doesn't comprise the other basic structures of milk, FDA regulations warrant that it only need be labeled as casein.

  Some companies are now voluntarily adding "milk derivatives" or "milk proteins" next to casein on the ingredient panel to better inform consumers of its source, according to both Taylor and Munoz-Furlong. They recommend that more companies adopt such a strategy to help benefit those people who have food allergies.

  "You'll see companies using parenthetical statements like this to give consumers more information on specific food ingredients for a variety of reasons," notes Taylor. "They may say something like, 'This product is an antioxidant or a microbial agent' or 'This product enhances freshness.'"

  This same type of approach has been required of baby food manufacturers for some time. According to Theuer, they must follow different food ingredient labeling guidelines than mainstream food manufacturers because babies have a greater sensitivity to food allergies than adults. According to reports produced by the Food Allergy Network, about 5% to 7% of infants up to age three have food allergies.

  "The thing that baby food must do by law is identify the source of each ingredient by botanical or animal origin," says Theuer. "We can't use the term 'modified food starch' like you would find on an adult food label. We have to identify the sources. If it's a food starch or flour, is it wheat flour, is it wheat starch, is it corn starch, is it rice starch? We don't use 'modified starch,' but on another label you would see 'food starch modified - corn.' "

Additives and allergies

  While it's easy enough to blame food manufacturers for consumer concerns, it is sometimes the consumers themselves that create controversy or sustain long held assumptions. Munoz-Furlong attributes the controversy over certain food additives to consumers. Dyes, flavor enhancers and other food additives have, at one time or another, been accused of causing allergic reactions. In Chinese restaurants, some consumers invariably will say, "... and don't add MSG."

  But most of the clinically proven allergies are caused by foods and food allergies are caused by proteins, according to Munoz-Furlong.

  A food allergy is created in the immune system. The protective mechanism responsible for fending off foreign substances goes awry and attacks foods not typically seen as a threat. A person with an intolerance, such as for lactose or gluten, lacks a specific enzyme needed to break down a certain food.

  Additives are thought to cause types of food sensitivities, but these are not the same kinds of immune responses, so they're not true food allergies, adds Munoz-Furlong. They are called food intolerances, but most consumers don't make the distinction between the two.

  Even in many of the alleged illnesses related to food additives, the link between the additive and the illness is not firmly made, according to Taylor. This is true in the case of some of the more commonly maligned ones such as monosodium glutamate, or MSG. There's not a lot of solid evidence that MSG causes any kind of adverse reactions in people, he says.

  In fact, MSG is the sodium salt of glutamic acid, a naturally occurring amino acid found in the human body. Even if you avoid the additive, there's a lot of it present in other protein-containing foods such as cheese, meat and milk.

  "It's a commonly used food ingredient found in prepared soups, gravies, certain snack chips," notes Taylor. "It also has a very high natural occurrence in certain kinds of cheeses. The reason tomatoes are so nice to have as a food ingredient is because they contain monosodium glutamate, which has this flavor-enhancing capability."

  (Ed. note: See the Regulatory Insight section of this issue to learn about the latest reports on MSG.)

What's in store

  The future of manufacturing specialty foods and making mainstream foods safer for people with special dietary needs may be linked to processes such as hydrolyzation and the emerging science of food bioengineering. Both are not without problems and precautions.

  Evanston, IL-based Calgene Fresh, Inc.'s Flavr Savr tomato is a good example. Scientists remained under scrutiny while they manipulated DNA in the protein that causes softening in a tomato, explains Allred. By blocking the protein's synthesis, the tomato stays fresher longer. Although the process had nothing to do with allergenicity, the FDA kept a watchful eye on its outcome.

  "In the transfer of genes from one species to another the concern is always, 'Are you going to create something new that's allergenic?' " says Dr. Mary Lou Tortorello of the FDA's National Center for Food Safety and Technology. "That has been a concern for the FDA. If we're producing new proteins by transfer of genes, can we look at those new proteins and see if they resemble any of these known allergens?"

  Yet the question remains, if the manipulation of one protein can cause a tomato to remain fresh, can we genetically alter proteins to destroy their allergenic properties? Both Allred and Taylor agree that it is possible, though it probably would not be economically feasible based on current technologies.

  The use of hydrolysates, while limited, is clearly closer to reaching the mainstream market than genetically altered peanuts. They provide the extra protein many manufacturers want in creating value-added, nutritional products, with little concern for allergic reaction.

  In addition to protein hydrolysates, DMV International Nutritionals offers bioactive peptides and proteins for specific physiological benefits -- peptide bonded glutamine, lactoferrin, lactoperoxidase and milk calcium.

  New chemical, enzymatic, separation and drying technologies in this area have allowed DMV to broaden its product accessibility beyond milk or milk shake type protein drinks. Although casein and whey are suitable for these products, getting them into an iced tea or other form of clear beverage has been nearly impossible. Casein precipitates out because it is very acid-sensitive and the whey protein is not stable to heat, which is typically required to process these beverages.

  "We have hydrolysates that are clear in solution, soluble, and acid and heat stable," says DMV's Kelly. "So you can put protein in a juice or a clear acidic beverage and you wouldn't even know it's in there. It doesn't add any viscosity, so you can have a protein-fortified apple juice or sports drink."

  While we're waiting for new advances in technology to help create a safe middle ground between how food products are formulated and the special dietary needs of consumers, both Taylor and Munoz-Furlong offer product designers a few temporary solutions.

  One is that designers should be more cognizant in their selection of ingredients, avoiding those that have the potential for creating new allergy problems. For example, before the soybean entered the market, Taylor suspects no one had really asked the question, "Will soybeans cause allergies?" As the story goes, soybean allergies increased in direct proportion to the introduction of soybeans into infant formulas in the 1950s.

  The introduction of kiwis into the United States is a more recent example, as it has become the most common allergenic fruit in the American food supply, Taylor adds. He also suggests that the increased use of specific foods already on the market could have the same potential for exposure as soy did some 40 years ago. One of these is cottonseed protein, or cottonseed meal.

  Most of us, at one time or another, have ingested cottonseed oil, but the oil contains no protein. According to Taylor, cottonseed protein is used in several products and "people who habitually use those products seem to have a high tendency to develop allergic reactions to them.

  "Another kind of food that is not as uncommon an allergen as one might think is sesame seeds," Taylor adds. "If we found some fantastic new use for sesame seeds, if we were grinding them up and making bread out of them, we'd see more people with sesame seed allergy."

  Munoz-Furlong contends that the best way to keep allergens from the consumer is through proper labeling. The good news, she says, is that a lot of food manufacturers are going beyond the federal regulations to help people with allergies and special needs by listing, for example, all the products contained within the natural ingredients listings.

  "Yes, it's the responsibility of the consumer to really read the labels and avoid such products," Munoz-Furlong says. "But it's the responsibility of the manufacturer to provide enough information so that the consumer can make an intelligent decision that is ultimately a safe decision. So, in a sense, both have to work together toward the same goals."

  John Spizzirri is a Chicago-based freelance science writer. He also is editor of the Brain Exchange Electronic Mentorship Network.

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