One measure of the food industry's growing involvement in probiotics is the staggering $1.4 billion in sales these products enjoyed last year.
So what's driving this flourishing market, which experts project will grow exponentially in the next decade? Health concerns, certainly. With consumers more aware than ever of the dangers of overusing antibiotics and pharmaceuticals, as well as the adverse side effects of such products, now is the perfect time for food companies to educate consumers about probiotics, and perhaps invest in them, too.
Simply put, the role of probiotics is to replenish the intestine with viable, healthful bacteria while enhancing the health of the host. Among other functions, they promote mineral absorption by decreasing the amount of harmful bacteria in the intestine, and by stimulating immunity or producing short-chain fatty acids, which increase colon acidity. However, the benefits of probiotics extend well beyond gastrointestinal concerns.
What are probiotics?
The Food and Agriculture Organization (FAO) of the United Nations and the World Health Organization (WHO) defines probiotics as "live microorganisms which, when administered in adequate amounts, confer a health benefit on the host." Their guidelines for use require that the probiotics amount declared relates to those living at the time of use and not at the time of manufacture, and that the viable colony-forming unit count be at the level proven to confer a health benefit in humans or animals. Based on peer-reviewed publications of human studies, the FAO/WHO Expert Consultation lists the following benefits: prevention of diarrhea and a reduction of its duration; prevention of atopic dermatitis; and prevention of urogenital infections. However, studies under way suggest that probiotics may also decrease the risk of certain forms of cancer, reduce Helicobacter pylori stomach infections, enhance mucosal immunity, reduce oxaluria and serum cholesterol, and even reduce irritable bowel syndrome and inflammatory bowel disease.
In the U.S., probiotics are sold to consumers as food or as dietary supplements, and to processors as ingredients. While the potential benefits of probiotic cultures seem vast, the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have adopted cautious positions with regard to enforcing food regulations. In fact, increased enforcement activity by the FTC against manufacturers and distributors of dietary supplements has spilled over to the food sector, especially sectors that rely upon less conventional ingredients such as probiotics. Consequently, there is growing demand from food companies for assistance in complying with the new regulations.
It is imperative that R&D departments not prioritize profits over quality ingredients. Although some inexpensive probiotic strains have been shown to be detrimental in certain patient populations, there is a large quantity of high-quality research on probiotic strains. Karen Weaver of the Chicago-based law firm Weaver & Amin, which specializes in regulatory compliance, cautions that simply because research proves a specific use for probiotics in human health, it doesn't necessarily follow that a marketing department can develop a campaign based upon that research. Certain claims, no matter how true, cannot be used without violating the Federal Food, Drug, and Cosmetic Act. The FDA scrutinizes food claims very narrowly and has made unofficial negative comments regarding the use of probiotic claims on food product labeling.
The number one issue with probiotics is shelf-stability. Microorganisms degrade easily when exposed to oxygen, light, temperature changes, humidity and stomach acidity. Hence, a combination of techniques is required to ensure survival of the bacteria through processing, distribution, storage , virtually all phases until the product arrives at the appropriate site in the body. Further, the outcomes of the selected preservation processes -- which are often complex and mutually exclusive -- must all be authenticated. A mixture of calcium alginate (as the microencapsulating material), Hi-Maize starch (used as a prebiotic to feed the bacteria) and glycerol (the cryo-protectant) may, for instance, enhance survival of bacteria in the capsule but affect survival in acid or bile, illustrating the complexity of the issue.
While Lactobacillus and Bifidobacteria are the bacterial genera most commonly associated with probiotic activity, Escherichia, Enterococcus, and Saccharomyces also have been shown to be probiotic. Recently, Escherichia coli strain BU-230-98 entered this category following a patent application from U.S.-based Bio Balance Corp. Commercial interests develop and guard their microbiological strains zealously.
That comprehensive health entails a multispecies probiotic approach is well established, and companies are racing to file composition patents for greater competitive insulation than method-of-use patents. Particularly noteworthy is Korean ProBionic Corp's. patent filing for Probio-16, with anti-rotavirus and anti-diarrhoeal activities.
Innovation in processing
Probiotics have been largely proven for five key conditions , gastrointestinal well-being and diarrhea prevention, ulcers, immunity, women's urogenital health and post-surgical care. Mounting scientific research demonstrating the clinical efficacy of probiotics has prompted significant innovation in the development of new technologies to ensure the products have high viability and that high numbers reach the intended target.
The Montreal-based Institut Rosell-Lallemand has made remarkable advances in microencapsulation technology. Its technique serves to buffer the microorganisms from extreme conditions typical of food processing and prevent resulting decreases in viability in yogurts, chocolates, drink powders and even extruded food products. One patent application incorporates vegetable oil, fish oil and tocopherol to protect probiotics from heat and acids.
Chr. Hansen has developed an enteric coating using a proprietary polysaccharide matrix that allows the organism to travel safely through the stomach, bypass the stomach acids and delay hydration until they reach the alkaline pH of the colon. The technology may be customized to protect the organisms from stomach acidity and bile salts or, conversely, to take advantage of acidity and help deliver the organisms rapidly to the stomach. Advances by Canacure in Montreal and Universal Preservation Technologies Inc. in California, will soon make it possible to preserve, protect and allow probiotics to be directed to specific sites in the body for pronounced benefits.
The retail sector
The U.S. Patent Office reported an exponential number of application filings in 2002, with Nestle and Nestec topping the list with applications for probiotics in cereals, dehydrated foods, frozen desserts -- even cosmetics.
While yogurt represents the largest probiotic food product category, health-oriented companies such as Stonyfield Farm offer several strains of probiotics plus inulin for a wide demographic , women, infants, and kids. Lifeway Foods introduced a colostrum kefir and Soytreat, a cultured soymilk drink. Yoplait and Glanbia joined forces to launch Everybody for everybody. There is even an entry in the high-protein sector from Brown Cow Farms called Yoghurt Quencher. New York-based Queensboro Farms recently launched a beverage PERQ, which is tailored to women, and PERQ-T, which is intended for the elderly.
More than a hundred companies in the U.S. market probiotic products in supplement form, including ConAgra, which produces Culturelle, a dietary supplement containing Lactobacillus GG in a capsule form. The new generation of products includes the lunch-pack market, many of which are targeted towards school children. Yakult and Actimel, with national reach in the health food market, are poised for mainstream North American distribution within two years.
Simply put, "prebiotics" are food for probiotics. A prebiotic is resistant to hydrolysis, digestion and fermentation by microflora in the upper digestive tract. The prebiotic selectively promotes the growth of beneficial bacteria in the colon and, if possible, suppresses pathogenic bacteria. Procter & Gamble recently filed a series of patents for health drinks with a soluble fiber that meets these criteria.
The term "synbiotic" describes the combination of live microbial probiotics and prebiotic compounds; the combination is designed to promote greater survival of the probiotic, with improved implantation in the colon. Although synbiotics are not yet available commercially, Nestle received a U.S. patent for an ice cream with synbiotic properties. Nestle's product contains probiotic lactic acid bacteria together with prebiotic fiber separated to forestall fermentation until consumption; the probiotics are incorporated in the ice cream and the prebiotic in the chocolate-coated wafer layers.
Consumers and manufacturers are become increasingly aware that the benefits of probiotics go beyond the gut and, as a result, the marketplace is bound to see a wide range of new probiotic products. Already in the making are confections, toothpastes, cosmetics, cheeses and fruit drinks and prepared ready-to-eat foods.
Natasha Trenev, founder of West Lake Village, Calif.-based Natren, pioneered the probiotics field and wrote the probiotic standards adopted by the National Nutritional Foods Association, which were read into the congressional record. Treney holds the largest library of research on probiotics and recently founded the National Institute of Probiotics, a non-profit organization dedicated to promoting probiotics research.
Noteworthy among recent university activity are studies at Cornell University that establish a genetic identification database for lactic acid bacteria. Research on bifidobacteria is being conducted at University of Minnesota, University of Nebraska and University of Wisconsin, while Utah State University and North Carolina State University are performing research on lactic acid bacteria.
Recent commercial probiotic strains
Manufacturer / Source
Arla Dairy (Sweden)
L. paracasei F19
Biogaia (Raleigh, N.C.)
L. reuteri MM2
L. reuteri SD2112
Chr. Hansen (Denmark)
L. acidophilus LA-1
L. paracasei CRL 431
Essum AB (Sweden)
Lactococcus lactis L1A
L. rhamnosus LB21
Institut Rosell (Canada)
L. rhamnosus R0052
L. acidophilus R0011
Lacteol Laboratory, (France)
L. acidophilus LB
Morinaga Milk Industry Co., Ltd. (Japan)
B. longum BB536
Nebraska Cultures, Inc. (Lincoln, Neb.)
L. acidophilus DDS-1
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