The Facts on Functional Foods

July 2003

Many would argue that all foods are “functional” because they contribute to nutrition in one way or another. However, nutritional and regulatory communities require “functional foods” to take a step beyond that definition. The Washington, D.C.-based International Food Information Council Foundation (IFIC) defines “functional foods” as “foods that provide health benefits beyond basic nutrition.” These foods are consumed as a part of a varied diet, as regular food and at levels effective to achieve their health goals.

But do consumers recognize that such a distinction in their food supply exists? IFIC has been tracking consumer awareness through quantitative data collected in surveys since 1998. It finds that 94% of consumers agree that certain foods have health benefits beyond basic nutrition, and 85% of Americans have some level of interest in learning more about functional foods. At least 79% of consumers are aware of the connection between calcium and osteoporosis, 54% are aware of the connection between antioxidants and cancer, and 35% are aware of the connection between soy proteins and heart health.

Consumers’ range of knowledge, however, does not go very far beyond the “awareness” level, so the potential for an improvement in nutritional education is very high. Media coverage of nutritional issues has greatly improved over the last five years, but much remains to be done to improve consumer nutrition. The benefits to consumer well-being, as well as to the future of companies engaged in research on functional ingredients are enormous. IFIC believes that improved education is possible: It cites the success of media coverage regarding the relationship of increased calcium intake and a reduced chance of osteoporosis as a success story, stating that 91% of consumers believe in the efficacy of this interrelationship.

How can the food industry build on this type of faith? IFIC says: “When communicating about functional foods, it is important to translate quality science into understandable and usable messages that meet consumer needs. The following are specific communication strategies.”
• Cite the need for credible, scientific criteria as the basis for messages about functional foods and the development of new products;
• accentuate the “good news” about food;
• place new research findings into context with the overall body of scientific evidence;
• discuss the benefits of particular components within the context of familiar foods and overall eating patterns; and
• do not overstate potential benefits, and ensure that any claims made on- or off-label are based on reasonable and responsible information.

This is definitely food for thought, and a good starting point for a discussion on where the industry is today and some of the potential claims for the future. This article will look at how regulations have progressed over the last 10 to 15 years, then discuss functional ingredients, both old and new, and how they have progressed toward established health claims.

Claiming functionality
The food industry throws around many terms to describe the market now known as “functional foods,” and the different rules established for foods versus dietary supplements have further misled the consumer. According to Natural Foods Merchandiser, June 2002, this $20 billion market has grown 24% to 39% annually, so the definitions and rules are important, as FDA well knows. FDA has long recognized two categories of food — conventional food and dietary supplements. FDA recognizes any conventional food making a health claim as a functional food and tightly controls the ability of companies producing functional foods to make such claims — all require agency approval.

Claims approved by FDA through the Nutritional Labeling and Education Act of 1990 (NLEA) must be based on significant scientific agreement among experts regarding the relationship between the substance and a health condition. Accordingly, only 12 claims have currently met these stringent requirements.

FDA later enacted the Dietary Supplement Health and Education Act of 1994 (DSHEA), which exempted dietary supplements from the rules applied to food-additive approval and allowed the use of “structure/function” claims without prior FDA approval. With this, a company can make a statement such as: “Helps support cartilage and joint function.” This claim does not link a product’s functionality to a specific disease — if it did, FDA would regulate the product as a drug.

Restating the requirements
Naturally, some companies chose the fast and easy route to market through DSHEA rather than the long approach to establishing an approved health claim. FDA gradually became increasingly concerned by the proliferation of unsubstantiated and misleading claims being made by certain unscrupulous dietary-supplement marketers. With this in mind, FDA issued a letter on Feb. 5, 2001, to restate the requirements for marketing conventional foods containing novel ingredients, including botanicals, under DSHEA. In this letter, FDA clearly defines the difference in claims under three designations.

Health claim. This category defines a claim that characterizes the relationship between a food substance and a disease or health-related condition.

Nutrient-content claim. This relates to a claim that characterizes the level of a nutrient in a food.

Structure/function claim. This designation relates to any claim that characterizes the effect of a food on the structure or function of the body.

Limited company
NLEA-authorized procedures have resulted in these FDA-approved health claims, accompanied by example statements, from Title 21 of the Code of Federal Regulations (CFR), where the specific health claims are listed.

Calcium and osteoporosis. “Regular exercise and a healthy diet with enough calcium helps teen and young adult white and Asian women maintain good bone health and may reduce their high risk of osteoporosis later in life.”

Sodium and hypertension. “Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors.”

Dietary fat and cancer. “Development of cancer depends on many factors. A diet low in total fat may reduce the risk of some cancers.”

Dietary saturated fat and cholesterol and risk of coronary heart disease (CHD). “While many factors affect heart disease, diets low in saturated fat and cholesterol may reduce the risk of this disease.”

Fruits, vegetables, and grain products that contain fiber, and cancer. “Low-fat diets rich in fiber-containing grain products, fruits and vegetables may reduce the risk of some types of cancer, a disease associated with many factors.”

Fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of CHD. “Diets low in saturated fat and cholesterol and rich in fruits, vegetables, and grain products that contain some types of dietary fiber, particularly soluble fiber, may reduce the risk of heart disease, a disease associated with many factors.”

Fruits and vegetables and cancer. “Low-fat diets rich in fruits and vegetables (foods that are low in fat and may contain dietary fiber, vitamin A or vitamin C) may reduce the risks of some types of cancer, a disease associated with many factors. Broccoli is high in vitamins A and C, and it is a good source of dietary fiber.”

Folate and neural-tube birth defects. “Healthful diets with adequate folate may reduce a woman’s risk of having a child with a brain or spinal-cord birth defect.”

Dietary sugar alcohol and dental caries (cavities). “Frequent between-meal consumption of foods high in sugars and starches promotes tooth decay. The sugar alcohols in this food do not promote tooth decay.” On small packages only, manufacturers can claim, “Does not promote tooth decay.”

Dietary soluble fiber, such as that found in whole oats and psyllium seed husk, and CHD. “Diets low in saturated fat and cholesterol that include 3 grams of soluble fiber from whole oats per day may reduce the risk of heart disease. One serving of this whole-oats product provides __ grams of this soluble fiber.”

Plant sterol/plant stanol esters and CHD. For plant sterol esters: “Foods containing at least 0.65 gram per serving of plant sterol esters, eaten twice a day with meals for a daily total intake of at least 1.3 grams, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of (name of food) supplies __ grams of plant sterol esters.” For plant stanol esters, a claim might read: “Diets low in saturated fat and cholesterol that include two servings of foods that provide a daily total of at least 3.4 grams of plant stanol esters in two meals may reduce the risk of heart disease. A serving of (name of food) supplies __ grams of plant stanol esters.”

Soy protein and CHD. “Diets low in saturated fat and cholesterol that include 25 grams of soy protein a day may reduce the risk of heart disease. One serving of (name of food) provides __ grams of soy protein.”

All of these claims have certain restrictions regarding other components of the food, as well as the amount per serving in some cases. FDA allows three claims that are stated as “qualified”— that is, FDA allows a claim, but the claim also states that FDA does not endorse it. This applies to the use of higher levels of folic acid than initially recommended by FDA to reduce the risk of neural-tube birth defects, the effect of B vitamins on risk of CHD and the effect of omega-3 fatty acids on risk of CHD.

An authoritative statement
The process of approving a health claim under this regulation is a long one — in addition to the required studies, it takes more than a year to complete the scientific review and approval processes. Seven health claims were approved in 1993 as an initial part of NLEA, and five more were approved through 2000.

In 1997, the Food and Drug Administration Modernization Act (FDAMA) was approved, allowing a different route to a health claim. With this act, a health claim can be based on an authoritative statement of a scientific body of the U.S. government or the National Academy of Sciences (NAS). This process is significantly faster — a claim notification must be submitted at least 120 days before the first introduction of the food and its label. Under FDAMA, the following three additional health claims were approved.

Whole-grain foods. This claim reads, “Diets rich in whole-grain foods and other plant foods and low in total fat, saturated fat, and cholesterol, may help reduce the risk of heart disease and certain cancers,” and is based on a statement in the NAS report “Diet and Health: Implications for Reducing Chronic Disease.”

Potassium. This says, “Diets containing foods that are good sources of potassium and low in sodium may reduce the risk of high blood pressure and stroke,” and is based on two statements in the above NAS report.

Choline. A label can state “good source of choline”; “contains choline”; “provides choline”; “excellent source of choline”; “rich in choline”; and “high in choline,” provided the label also says “Contains X% of the Daily Value for choline per serving. The Daily Value for choline is 550 mg.” This is based on “Dietary Reference Intakes for Thiamine, Riboflavin, Niacin, vitamin B6, Folate, vitamin B12, Pantothenic Acid, Biotin, and Choline,” authored by the Food and Nutrition Board, Institutes of Medicine (IOM) and NAS.

Why choline? Choline is an essential nutrient also known as vitamin B4, with reported benefits linked to memory, heart function, liver function and brain development. Choline deficiency, on the other hand, has been linked to CHD, cirrhosis, hypertension and fatty degeneration of the liver. Choline is found naturally in significant concentrations only in eggs, red meats, liver and soy lecithin. Central Soya Co., Inc., Ft. Wayne, IN, which filed the petition for the new claim, promotes fortifying foods with lecithin to increase their choline content, with primary applications in baked goods. However, manufacturers could fortify a wider variety of foods with lecithin, including chocolate.

Changing directions
It is evident from these Acts and subsequent regulations that FDA intended to promote innovation while still guaranteeing that false statements would not mislead the consumer. The environment for approval of health claims, however, was becoming clouded and not easily understood by consumers — the efforts under NLEA, FDAMA, DSHEA and the Federal Trade Commission needed a more directed effort.

In its position statement on functional foods, the Chicago-based American Dietetic Association noted that this regulatory environment led to “a proliferation of claims on a variety of products,” creating “an environment of confusion and distrust among health professionals and consumers.” On Dec. 18, 2002, FDA commissioner Mark B. McClellan, M.D., Ph.D., announced “The Consumer Health Information for Better Nutrition Initiative,” which related to FDA’s desire for a “marketplace of ideas” relating to health information of foods.

According to McClellan, “the problem is that right now, there’s not much of a path to enable such health claims to be made. So there have been only limited incentives for the food industry to develop better health-promoting foods … right now, consumers turn to unproven and potentially dangerous remedies for weight loss, such as dietary supplements and even smoking.”

FDA stated the objectives of the Initiative were to “encourage marketers of conventional foods and dietary supplements to make accurate claims about the health benefits of their products” and “create strong disincentives for dietary-supplement marketers to make false and misleading health claims.”

A statement from The Grocery Manufacturers of America, Inc. (GMA), Washington, D.C., says: “This FDA policy shift brings the agency’s food claim evaluation in line with the FTC’s 20 years of oversight experience using this same standard for advertising claims.

Additionally, the FDA will allow food companies to include appropriate health claims on foods that may provide well-recognized nutritional or health benefits, as is common practice for manufacturers of dietary supplements.”

Discovering what’s next
Given the growing open atmosphere encouraged by FDA, what claims are we likely to see in the future? Naturally, any of the claims previously permitted are among consumers’ top interest areas: the links between calcium and osteoporosis; saturated fat and cholesterol; sodium and hypertension; fiber; and soy protein. But other functional ingredients and their sources may offer potential benefits as well.

• Carotenoids, such as alpha- and beta-carotene, lutein, lycopene, or zeaxanthin, provide associated potential benefits. For example, studies show that tomatoes and tomato products, sources of lycopene, may reduce the risk of prostate cancer. Green vegetables, which supply lutein, help maintain healthy vision.

• Gelatin, via its collagen-hydrolysate content, may help improve some symptoms associated with osteoarthritis.

• Various cereal grains provide dietary fiber, a functional element that — in its various forms and in recommended daily amounts — can help reduce the risk of colon or breast cancer, or reduce the risk of cardiovascular disease (CVD). Oats, psyllium and other whole grains can sport an FDA-approved claim in this regard.

• Omega-3 fatty acids are commonly found in tuna, and certain fish and marine oils. They may reduce the risk of CVD, and improve mental and visual functions. Another member of the fatty-acid group, conjugated linoleic acids (CLA) — common in certain cheese and meat products — may improve body composition or decrease the risk of contracting certain types of cancer.

• Various flavonoids, such as anthocyanidins, catechins, flavanones and flavones, are found in citrus and other fruits, vegetables, and some types of tea. These flavonoids can neutralize free radicals and may reduce the risk of certain cancers.

• Cruciferous vegetables, such as broccoli and kale, and horseradish supply sulphoraphane, which also neutralizes free radicals and may help reduce the risk of certain cancers.

• Phenols, which include caffeic and ferulic acid, are found in various fruits, vegetables and citrus products, and supply antioxidant-like activities to help reduce the risk of degenerative diseases that affect the heart or eyes.

• Ingredients such as corn, soy, wheat and wood oils supply plant stanols and sterol esters that help lower blood cholesterol levels and thereby help reduce the risk of CHD.

• Research has found pre- and probiotics help improve gastrointestinal (GI) health. Prebiotics, commonly based on fructooligosaccharides (FOS), are found naturally in Jerusalem artichokes, shallots and onion powder, while probiotics, such as lactobacillus, can be found in yogurt and other dairy products.

• Soy products, ranging from whole soybeans to foods containing soy proteins, contain saponnins, which may lower LDL cholesterol and contain anti-cancer enzymes. In addition, FDA has approved a health claim for soy proteins, allowing a label to state: “25 grams of soy protein per day may reduce the risk of heart disease.”

• Soybeans and soy-based foods contain phytoestrogens — the isoflavones daidzein and genistein — that may reduce menopausal symptoms, such as hot flashes. Flax, rye and certain vegetables also contain phytoestrogens in the form of lignans. These may offer protection against heart disease and certain cancers, and could possibly lower LDL cholesterol levels, total cholesterol or triglyceride levels.

• Sulfides or thiols may lower LDL cholesterol levels and help maintain a healthy immune system. Onions, garlic, leeks, scallions and certain cruciferous vegetables are some foods that may provide these functional components.

• Tannins — such as the proanthocyanidins found in cranberries and cranberry products, cocoa and chocolate — may improve urinary-tract health or reduce the risk of CVD.

This long list is not all-inclusive. Some ingredients have approved health claims; many others do not. But in each case, studies continue to build that substantiate their benefits. Many of the original claims favored consumption of whole foods, leaving many novel-food-ingredient manufacturers to seek qualified health claims (as in the case of omega-3 fatty acids) or to settle for structure/function claims. Will the new system favor research into novel food ingredients?

Picking off free radicals
Antioxidants are a broad range of compounds found naturally in fruits and vegetables. Past studies have shown that these compounds have a positive impact on well-being; this is addressed in current permitted health claims as “whole food” claims. But what of the individual components? Is there potential to build on our knowledge of antioxidants and establish claims on combinations?

Several companies, such as RFI Ingredients, Blauvelt, NY, have come halfway to establishing claims for combinations by blending fruit, vegetable and spice extracts toward an ORAC (oxygen radical absorbance capacity) value. ORAC, measured in mmoles Trolox equivalents (TE) per gram, compares a sample to Trolox (a noncommercial, water-soluble derivative of tocopherol) to state the ability of a substance to disarm oxygen free radicals. According to RFI, “single servings of fresh or freshly cooked fruits and vegetables supply an average of 600 to 800 ORAC units. … Scientists believe that increasing intake of foods that provide 2,000 to 5,000 units per day may be needed to increase serum and tissue antioxidant activities sufficiently to improve health outcomes.”

Vitamin E was first used more than 60 years ago to treat CHD, and many studies have established potential benefits in treating or reducing risk of cataracts, diabetes and cancer. A number of studies have shown vitamin C, which is often linked with vitamin E, to reduce blood pressure.

Research shows beta-carotene, the most abundant carotenoid identified in plants, reacts with free radicals, lowering risk of degenerative diseases such as cancer and CHD. Some studies have also shown a benefit in asthma treatment. Carrots are a good source of both beta-carotene and alpha-carotene, which is also an active antioxidant.

Studies show lutein, a carotenoid found in broccoli, spinach and kale, reduces the risk of macular degeneration by increasing the thickness of macular pigments. A recent Harvard study suggested an inverse relationship between lutein and zeaxanthin levels, and the development of severe cataracts; other studies have suggested that both are necessary to reduce risk of macular degeneration. Some studies have indicated that lutein may also reduce the risk of certain cancers.

More than 5,000 flavonoid compounds have been reported in plants, cereals and tea. Green tea contains a high concentration of catechins, shown to contribute to risk reduction of CHD, and of gastric, colon and esophageal cancers. A number of studies have compared the antioxidant activity of tea to that of fruits and vegetables.

So why are there no direct antioxidant claims? According to IFIC, the problem is the inconsistency of clinical trials, although research does indicate overall health benefits. IFIC says that current recommendations by health professionals are to consume a varied diet with at least five servings of fruits and vegetables and six to 11 servings of grains per day.

Facing the fats
At this time, manufacturers can make a qualified health claim regarding omega-3 fatty acids on product labels with the following statement: “Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease. FDA evaluated the data and determined that, although there is scientific evidence supporting the claim, the evidence is not conclusive.”

According to Marianne O’Shea, Ph.D., manager of nutrition and technical services, Loders Croklaan, Channahon, IL, “While a recommended dose has not been established, some studies suggest that up to 1 gram per day of omega-3 fatty acids will positively impact health.”

Omega-3 fatty acids are an essential class of polyunsaturated fatty acids (PUFAs) found in fish oil. Studies have indicated that omega-3 fatty acids eicosapentoic acid (EPA) and docosahexanoic acid (DHA) help to reduce the risk of CHD, and are essential for membrane synthesis in the brain and retina, as well as neural development. In addition, research shows DHA improves visual functioning and cognitive development in preterm infants. The Dallas-based American Heart Association (AHA) recommends eating fatty fish, such as mackerel, lake trout, herring, sardines, albacore tuna and salmon, at least two times per week. AHA also recommends eating omega-3 fatty acids from other sources, such as soybeans, canola and flaxseed.

According to AHA: “People who have high triglycerides (blood fats) may benefit from a supplement of 2 to 4 grams of EPA and DHA per day. Even the 1 gram per day dose recommended for CHD patients may be more than they can get from the diet alone.”

Flaxseed, mentioned by the AHA as a source of omega-3 fatty acids, is another plant source that may have high potential for a future health claim. Flaxseed has been in the diet for thousands of years — Hippocrates used it to relieve intestinal discomfort — and it is a source of alpha-linoleic acid (an omega-3) as well as dietary fiber (two-thirds insoluble fiber and one-third soluble fiber). Flaxseed also contains 20 grams of protein per 100 grams dry weight and is rich in potassium, which has an existing health claim related to risk reduction of high blood pressure and stroke.

Although the health claim for plant stanols and sterols is relatively recent, their cholesterol-lowering effects have been known for years. Found naturally in fruits, vegetables, nuts, cereals and vegetable oils, stanols and sterols resemble cholesterol structurally and are essential components of plant cell walls. FDA has indicated it will consider expanding the current health claim to include a wider range of food products consisting of free stanols and sterols.

Fibers are very functional
Current claims recognize the importance of fiber in the diet, citing the importance of fiber from grains, fruits and vegetables in prevention of CHD and cancer, as well as the role of soluble fiber (whole oats, psyllium seed husk) in reduction of CHD risk. The St. Paul, MN-based American Association of Cereal Chemists (AACC) includes polysaccharides, oligosaccharides, lignin and associated plant substances in its definition of dietary fiber, and states, “Dietary fibers promote beneficial physiological effects including laxation, and/or blood cholesterol attenuation, and/or blood glucose attenuation.” The NAS proposed to define dietary fiber as that fiber intrinsic to plants, and proposed the creation of new term — functional fiber — to define fiber from other sources (novel ingredients). This has delayed any formal definition of dietary fiber, but one can hope that this will not delay claims related to new, novel fiber ingredients.

These would include resistant starch, inulin, fructooligosaccharides, polydextrose and beta-glucan. Previous articles (see “Raising the Sports Bar” in the May 2003 issue of Food Product Design) have reported on resistant starch, and previous reports have noted the benefits of inulin, fructooligosaccharide and polydextrose.

Developers have researched beta-glucan as an ingredient for many years, and have isolated beta-glucan from yeast, oats and barley. Yeast beta-glucan was first sold as an ingredient many years ago, and suppliers have marketed oat ingredients with 5% to 15% beta-glucan levels for the past 10 to 15 years. In the past few years, reports have placed beta-glucan levels from oats and barley at more than 70%. Beta-glucans are polysaccharides that, like other fibers, can lower cholesterol, absorb water in the GI tract to reduce appetite, act as antioxidants, slow absorption of glucose into the bloodstream and act as prebiotics.

Fenugreek, a fibrous herb with a high galactomannan content, has similar effects. Fenugreek exhibits hypocholesterolemic, hypolipidemic and hypoglycemic activity in healthy and diabetic animals and humans. The mechanism is uncertain, but its activity is associated with the defatted seed material, whose galactomannan fiber and saponin components may be the active components. Future claims could potentially link a wide range of high-fiber novel ingredients to their effects on well-being.

On May 19, 2003, inulin was officially given GRAS status by FDA. Inulin and oligofructose are not digested, and so act as soluble fiber. They are reduced in calories –compared to standard carbohydrates, stimulate the growth of beneficial bifidobacteria, and they do not lead to a rise in serum glucose or stimulate insulin secretion in diabetics. Studies have shown the benefits of inulin as a soluble fiber and prebiotic, as well as its improvement of calcium uptake.

Biological functionality
This brings us to prebiotics and probiotics, and their potential for functional-food health claims. Consumers in Europe and Asia are well aware of the importance of pre- and probiotics, but the knowledge of U.S. consumers remains limited to dairy products.

A prebiotic is a nondigestible food ingredient that benefits the consumer by selectively stimulating the growth and/or activity of one bacterium, or a limited number of bacteria, in the intestine, benefiting consumer health. A probiotic can be either a live microbial food supplement; or a microbial preparation (or food) containing live and/or dead microorganisms, and their metabolites. Examples of foods are yogurt, acidophilus milk or buttermilk. Positive health benefits related to pre- and probiotics include cholesterol reduction, protection from GI diseases (a “healthy gut”), improved immunity, reduced cancer risk and improved calcium absorption.

According to a report in the June 2002 Canadian Medical Association Journal: “Although traditional thinking has been that the presence of one form of bacteria rather than another in the gut is necessary to produce such actions, more recent evidence suggests that the secondary products produced by the flora are responsible for the bioactivity that leads to health benefits. These secondary products include short-chain fatty acids as well as short bioactive peptides resulting from milk or other proteins in the gut. This change in thinking will probably stimulate active research in exploring mechanisms that might explain the health benefits of probiotic and prebiotic materials.” This, in turn, will lead to applications for new claims with a cleaner definition than simply a “healthy gut.”

Premium proteins
High-protein and low-carbohydrate diets, as well as the success of nutritional bars, have kept the importance of dietary protein in the media spotlight. The media coverage on soy protein has made nearly all consumers aware of this ingredient, but whey protein has also made a comeback. Based on a number of studies and increased interest, expect the interest in both areas to continue. K.J. Burrington, coordinator, whey applications program, Wisconsin Center for Dairy Research, Madison, WI, says: “Whey proteins are naturally high in the branched-chain amino acids (BCCA) leucine, isoleucine and valine. BCCAs are more readily absorbed by the body, and available for muscle building and muscle repair.”

As was noted earlier, a manufacturer can make a claim about soy’s heart benefits if the food contains at least 6.25 grams of soy protein per serving — a quarter of the effective amount of 25.0 grams per day. FDA did not accept claims regarding the role of isoflavones from soy in cholesterol reduction. However, support for this claim continues to increase; expect to see activity toward a new claim for this in the near future. The United Soybean Board, Chesterfield, MO, states that soy is a unique source of isoflavones, which are active in risk reduction of heart disease, breast and prostate cancer, osteoporosis (by increasing bone density), and control of hot flashes (results were inconsistent, and benefits are perhaps modest). An intake of 30 to 100 mg per day of isoflavones is recommended.

Putting it all together
One line remains clear over the years: Eat a varied diet in moderation. This still remains true today as a part of the U.S. Dietary Guidelines, although consumers also need to limit saturated fats, increase fiber intake, and eat five to nine servings of fruits and vegetables per day. The need for physical activity, in conjunction with proper diet, is another factor experts emphasize more than ever before.

To date, FDA has exercised caution in its assessment of potential health claims, leaning toward whole-food claims through much of the ’90s. The next step has involved opening up dialogue on potential health claims to encourage the development of novel ingredients and to encourage responsible clinical studies. As stated earlier, clear consumer education is also key to this process. Before allowing a claim, careful consideration of the full body of scientific evidence — considering all benefits, but also considering any potential toxicity or negative interactions with essential nutrients that may threaten certain medical conditions — is necessary.

Ronald C. Deis, Ph.D., is the vice president of applications development and technical service at SPI Polyols, Inc., New Castle, DE. Deis has 20 years of experience in the food industry, both in food ingredients (starches, polyols, high-potency sweeteners, bulking agents) and in consumer-product companies (cookies, crackers, soups, sauces). He has been a short-course speaker (polyols, fat replacers) and a freelance writer on a number of food-science-related subjects in food journals, and has contributed chapters on sweeteners and fat replacers for several books.

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