A decade ago, the whole concept of “functional foods” seemed distantly futuristic, if not a bit faddish, to much of the conventional food and beverage industry. Because all food is intrinsically functional, early-stage pioneers were sometimes viewed as opportunists traversing thin ice. To suggest that some foods or ingredients offered health benefits beyond the conventional was occasionally derided as outright heresy. The first ventures bringing functional products to market faced a gauntlet of brutal entry barriers: skeptical regulatory advisors, a lack of in-depth scientific substantiation for new ingredients and a consuming public still content with standard food fare.

Today, a solid functional products marketplace is emerging, along with an improving regulatory climate, a growing body of scientific substantiation to back up specific ingredient health claims, and increasing consumer awareness that diet remains the primary key to a healthier lifestyle. Touting multiple organoleptic and physical characteristics of a given ingredient remains the cornerstone of progressive functional ingredient marketing, but the twenty-first century functional food and beverage arena is awash with a new generation of product offerings making hundreds of nutritionally oriented health claims. The cutting edge in this still-germinal marketplace is the growing wave of ingredients promoted for multi-tiered functionality--numerous and diverse health benefits attributed to a single ingredient, nutrient or constituent--which represents a significant departure from the long-standing marketing approach of tying one major health benefit to each functional ingredient.

The evolution of marketing approaches for ingredients, products and brands with multi-tiered functionality follows a classic new product evolution. Revenue-hungry managers push marketing and research teams to “think outside the box,” and they, in turn, press ever-cautious legal departments to allow these once-fringy new concepts into the market. Armed with highly complex product positioning platforms--essentially equivalent to ingredient and brand multi-tasking--managers torque features and benefits into multi-headed product medusas with endless new product positions.

While well-informed consumers seeking greater health value from their purchases may see this new approach to functional product promotion as a bonus, the potential for disconnect exists. Information overload at point-of-purchase may delay or even kill purchasing decisions with consumers who are initially confused by multiple claims or turned off by ingredients with names that are hard to pronounce. Even worse, forging ahead without adequate science-based substantiation may inhibit long-term loyalty for ingredients when skepticism from medical professionals is broadcast in debilitating media coverage.

With the links between a given ingredient, food or dietary supplement and proclaimed health benefits often less than crystal clear, the budding functional products industry struggles for horizontal validation. Oat products, whey proteins and omega fatty acids are among the handful of ingredients that appear to be reaching the sanctuary of large-scale acceptance at the regulatory, medical, media and consumer levels. In broad terms, Food and Drug Administration (FDA) criteria allow limited health claims for a few select ingredients based on scientific data that is strong, compelling and of significant quantity. Additionally, product labels must qualify the purported benefits by also describing the limitations of the data linking the ingredient and its benefits. The inherent nature of many food and beverage ingredients offers a multitude of market-ripe platforms and positions, but there remains a risk of letting the proverbial cart get ahead of the horse if health-benefit value claims reach beyond reasonable (scientific) and allowable (regulatory) limits.

A report issued in March 2005 by the Institute of Food Technologists (IFT, Chicago) suggests consumers are missing out on the full potential of functional foods because industry and government are failing to keep up with advances in science and food technology. The new report, entitled “Functional Foods: Opportunities and Challenges,” makes specific recommendations to expedite the R&D, regulation and marketing of functional foods. Fergus Clydesdale, Ph. D., chair of the IFT expert panel that authored the report, maintains that functional foods should play an integral role in public health programs aimed at reducing risks of specific diseases, and that health claims on food labels should serve as the foundation of consumer education about the benefits of dietary components. At the heart of the report are seven core recommendations, including advice for manufacturers to work harder to ensure safety and efficacy when bringing functional foods to market. The report also encourages adoption of “generally recognized as efficacious” (GRAE) review panels and regulatory criteria.

Nutritional Product and Ingredient Functionality Flourish at Trade Shows

Recent trade shows have spotlighted a wide range of multi-functional ingredients and finished consumer products. For example, in March 2005, at the sprawling Natural Products Expo West trade show in Anaheim, Calif., a record 37,000 attendees previewed one thousand new healthy lifestyle products and ingredients within the show's new products showcase alone. Many products offered a portfolio of attributes within one product (for example, low-calorie, heart healthy and fat-free).

Walter Robb, chief operating officer of Whole Foods Market (Austin, Texas), notes Whole Foods research discovered that 32% of their customers are "foodies," 16% shop for organics, 16% are interested in sports and fitness, 13% shop for healthy family products, 13% are interested in environmental issues and 10% are vegetarian. This is timely news for manufacturers offering multiple line items targeted to increasingly fragmented demographic niches or products touting multiple functions (or both)--if they are able to clearly communicate important benefits to consumers.

Functional Ingredients--Summarized Successes

The first allowable health claim sanctioned by FDA for a food ingredient was for oats in 1997. The FDA based its approval on overwhelming proof that oats can reduce the risk of heart disease by lowering cholesterol. Typical oat label health claims have revolved around FDA-approved heart health claims such as "may prevent heart disease" or "helps lower cholesterol."

What follows is a sampling of promising multi-function ingredients, with a review of some health claims currently allowed by FDA and the emerging scientific evidence potentially validating future ingredient positioning.


  • Oats

    Specific claims about the cardiovascular benefits of oat beta-glucans are allowed by the FDA for oats and oat-based ingredients consumed in specific levels as foods according to specific criteria, with a minimum effective daily dose of 3g. There is mounting evidence that oats can reduce blood pressure, furthering their reputation as a heart-friendly food.1 In addition, a number of oat-based ingredient suppliers are investing in clinical research to support a further expansion of claims, which might include management of blood sugar levels through lowered glycemic response and weight control support via satiation effects.



  • Omega-3 Fatty Acids

    The evidence for the health benefits of essential fatty acids (EFAs) is so compelling that the U.S. Department of Agriculture has officially recommended that Americans get more omega-3s in their diet. For decades, credible research in this area has been accumulating, showing that diets high in certain types of fish are associated with a lowered risk of heart disease.2 More recently, convincing research has suggested that these healthy oils may fight inflammation, lower triglycerides and cut stroke risk.3,4

    Currently, the FDA allows food manufacturers to make health claims for two omega-3 EFAs commonly found in cold-water fish oil: eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Under specific FDA product label criteria, manufacturers may tell consumers that food products containing these constituents provide some protection against heart disease. However, the label claims must be worded according to an outline prescribed by FDA, as in the following example: “Supportive, yet not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.� A label displaying such a statement must identify the amount of EPA and DHA in the product.

    Research on additional specific rationales for boosting intake of omega-3 fatty acids is now amassing. Heart disease, inflammation-based disorders (including arthritis, autoimmune disease, psoriasis and eczema) and even mood disorders all offer potential for future omega-3 health claims, if and when adequate substantiation exists and regulatory mandates shift.5,6








  • Whey Proteins

    Interest in the marketing and functionality of whey proteins is escalating, as witnessed by the Fourth International Whey Conference to be held in Chicago in September, 2005. Many of the world's top dairy researchers, processors and nutrition professionals will join product marketers to discuss new applications--including significant developments in whey research (beyond traditional applications for the dairy products industry) and whey proteins as multi-functional ingredients. According to conference promoters, researchers will also discuss emerging science demonstrating that whey-derived bioactive components “enhance the performance of physically active adults, help to increase lean muscle tissue, support cardiovascular health, weight management, and improve immune defenses.�

    Michael Zemel, Ph. D., professor of nutrition and medicine and director of the Nutrition Institute at the University of Tennessee (Knoxville), notes that whey proteins have diverse consumer products applications. “The emerging role of whey components both in weight management and in supporting healthy, active lifestyles has garnered overwhelming scientific support over the past five years. From a manufacturing perspective, it has great functionality as an ingredient for various consumer products designed to promote health and wellness--from protein powders and bars through shakes and smoothies to other products.�








  • Flax

    Flaxseed contains a mix of beneficial nutrients, including soluble and insoluble fibers and lignans, and the seed oil provides a rich, natural source of EFAs and other important nutrients. Flaxseed oil contains omega-3, -6 and -9 EFAs. Flaxseed EFAs provide alpha-linoleic acid (ALA) instead of the EPA and DHA found in fish oils; the effects and potential benefits may be similar, but are not identical.

    Flaxseed is also the richest source of plant lignans, a phytonutrient found in unrefined grains, legumes, and certain vegetables and seeds. Lignans are phytoestrogens, or naturally occurring plant estrogens, that also exhibit antioxidant activity. Some research suggests lignans may help to prevent prostate and breast cancer, alleviate menopause symptoms, enhance cardiovascular health, reduce inflammation and support immune system function.7-9 Until long-term research validates these potentially invaluable benefits, proclamations connecting flax to a healthy diet through intake of EFAs remain most common on product labels.








  • Probiotics and Prebiotics

    Definitions for these increasingly popular ingredients remain to be standardized, but in broadest terms, a probiotic is a live microbial organism beneficial to intestinal health, and thereby, presumably, to the entire body. It is non-pathogenic, non-toxic and resistant to low pH, which helps it survive during transit to the gastrointestinal tract. Most probiotics are members of two genera of lactic acid-producing bacteria (LAB), Lactobacillus and Bifidobacterium, although there are others. Prebiotics are non-digestible, food-grade ingredients that beneficially affect host bacterial colonies by selectively stimulating the growth and activity of one or more bacteria strains that have the potential to improve host health. A number of poorly digested carbohydrates fall into the prebiotics category, including certain fibers and resistant starches, but the most widely described prebiotics are non-digestible oligosaccharides (NDOs).

    Probiotic and prebiotic ingredients have charged beyond traditional use in supplements and fortified milk to a wide spectrum of fortified yogurts, functional drinks and snack foods. Health benefits that have been associated with LAB include improvement of lactose intolerance, regulation of gastrointestinal illness (including rotavirus-associated diarrhea in infants) and re-colonization of the gut with “friendly� bacteria after antibiotic treatment. More recently, probiotic research has suggested potential links between gut health (digestive tract microflora activity) and certain infectious digestive diseases, immunomodulation and even asthma.10,11

    Focused Health Messages

    Beyond the vital science-based ingredient substantiation needed to leverage sales through expanded health claims, the critical end game of how to communicate complex information to potential customers--trade and consumer--remains paramount. The path to success for marketers of multi-dimensional functional ingredients and consumer products requires two key elements: highly focused communication of complex nutritional science--in other words, constituent health benefits--to motivate consumer product purchases, and never-ending refinement of delivery technologies to optimize consumption compliance. Anything less is destined to get lost in a swirling tide of quasi-functional chaos. NS

    Brian Keating is the founder of Sage Group International (Seattle), a natural products industry consultancy providing market and product development services to natural foods, nutraceutical and specialty beverage companies worldwide. He can be contacted at: sagebk@aol.com.

    Evelyn Leigh is a natural products industry consultant and writer based in Boulder, Colo. She is co-author of the Herb Research Foundation's Encyclopedia of Popular Herbs.

    Sidebar: Mind and Body

    The human body is complex beyond understanding, and science continues to tease out the intricacies of many of its metabolic pathways. Just as scientists establish the benefits of a dietary component in one area, other researchers may unearth other healthful attributes. For example, chromium picolinate has been studied for its positive effect on heart disease, obesity, and of course, type 2 diabetes. Now, a variety of papers and presentations have been given for its use with atypical depression. This condition is associated with significant weight gain or increased appetite, fatigue and even dysfunction in personal relationships. For example, Jonathan Davidson and others concluded from a small study that “chromium picolinate shows promising antidepressant effects in atypical depression� and theorized several mechanisms (Biol Psychiatry. 2003. 53:261). Malcolm McLeod and Robert Golden (Int J Neuropsychopharmacol. 2000. 3:311) thought that the “putative antidepressant effects of chromium� may be due to enhancement of insulin utilization and related increases in tryptophan and/or its effects on norepinephrine release.� Dietary choices and their impact on “mood� is an emerging field. It will be interesting to watch chromium picolinate's part in this field.

    --Claudia D. O'Donnell, Chief Editor

    Sidebar 2: Functional Phytochemicals

    News on the value of antioxidants and phytochemicals appears nonstop. For example, the May 2005 issue of Experimental Neurology relays that rats fed diets preventatively enriched with blueberries, spinach or spirulina experienced less brain cell loss and improved recovery of movement following a stroke. The researchers reported that the “size of the stroke was 50% to 75% less� and theorized that that the antioxidant and anti-inflammatory substances in food reduced the nerve cell injury and death triggered by a stroke.

    The May 2005 issue of Tuft's University Health & Nutrition Letter reports on a Tufts study that looked at the effect of berry extracts on elderly rats. Rats with the supplemented diet had improved neuronal and cognitive behavioral activity as well as motor behavior. The newsletter also reports on interest in the curry spice curcumin, which appears to block beta-amyloid and reduce plaque levels in the brains of mice. The UCLA Alzheimer's Disease Center is conducting a trial on the impact of curcumin on individuals with mild to moderate Alzheimer's.

    --Claudia D. O'Donnell, Chief Editor








  • www.ift.org/cms/?pid=1001247 -- IFT's expert report on “Functional Foods: Opportunities and Challengesâ€?








  • www.cfsan.fda.gov/~dms/qhc-sum.html#antioxidant -- Status of FDA claims for antioxidants








  • www.hsc.usf.edu/news+releases+-+april+12,+2005.html -- Article on antioxidant-rich diets reducing brain damage from stroke