Antonie van Leeuwenhoek

, Volume 76, Issue 1–4, pp 293–315 | Cite as

Bringing a probiotic-containing functional food to the market: microbiological, product, regulatory and labeling issues

  • Mary Ellen Sanders
  • Jos Huis in't Veld


Properly formulated probiotic-containing foods offer consumers a low risk, low cost dietary component that has the potential to promote health in a variety of ways. Several such products are available commercially, although markets in Japan and Europe are more developed than in the USA. Once healthful attributes of a probiotic product have been identified, there remain microbiological, product, regulatory and labeling issues to be addressed prior to marketing. Microbiological and product issues include safety, effective scale-up for manufacturing, definition of probiotic activity, probiotic stability in the product over the course of product manufacture, shelf-life and consumption, definition of effective dose and target population(s), and development of quality assurance approaches. Examples of probiotic-containing foods are given. Regulatory and labeling issues are complicated because they differ for each country, but are likewise critical because they provide the means for c ommunication of the product benefits to the consumer. The regulatory climate worldwide appears to be one of caution about overstating the benefits of such products but at the same time not preventing corporate commitment to marketing.


Marketing Quality Assurance Effective Dose Regulatory Climate Target Population 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. Adams MR & Marteau P (1995) On the safety of lactic acid bacteria from food. Int. J. Food Microbiol. 27: 263-264Google Scholar
  2. Aguirre M & Collins MD (1993) Lactic acid bacteria and human clinical infection. J. Appl. Bacteriol. 75: 95-107Google Scholar
  3. Anon. (1996) Is yogurt the health food it's cracked up to be? Tufts Univ. Diet Nutr. Let. November, pp. 3-5Google Scholar
  4. Anon. (1998) FDA denies numerous structure/function claims. Food Regulation Weekly, Nov. 23, 1998Google Scholar
  5. Arthur M & Courvalin P (1993) Genetics and mechanisms of glycopeptide resistance in enterococci. A minireview. Antimicrob. Agents Chemother. 37: 1563-1571Google Scholar
  6. Arthur M, Reynolds P & Courvalin P (1996) Glycopeptide resistance in enterococci. Trends in Microbiol. 4: 401-407Google Scholar
  7. Aso Y & Akazan H (1992) Prophylactic effect of Lactobacillus casei preparation on the recurrence of superficial bladder cancer. BLP study group. Urol. Int. 49: 125-129Google Scholar
  8. Berner LA & O'Donnell JA (1998) Functional foods and health claims legislations: applications to dairy foods. Int. Dairy J. 8: 355-362Google Scholar
  9. Canganella F, Paganini S, Ovidi M, Vettraino AM, Bevilacqua L, Massa S & Trovatelli LD (1997) A microbiological investigation on probiotic pharmaceutical products used for human health. Microbiol. Res. 152: 171-179Google Scholar
  10. Collins JK, Thornton G & Sullivan GO (1998) Selection of probiotic strains for human applications. Int. Dairy J. 8: 487-490Google Scholar
  11. Donohue DC, Deighton M, Ahokas JT & Salminen S (1993) Toxicity of lactic acid bacteria. In: Salminen and von Wright (Eds.) Lactic Acid Bacteria, (pp 307-313). Marcel Dekker, Inc., New YorkGoogle Scholar
  12. Dunne C, Murphy L, Flynn S, O'Mahony L, O'Halloran S, Feeney M, Morrisey D, Thornton G, Fitzgerald G, Daly C, Kiely B, Quigley EMM, O'Sullivan GC, Shanahan F & Collins JK (1999) Probiotics: from myth to reality. Demonstration of functionality in animal models of disease and in human clinical trials. These proceedings.Google Scholar
  13. Fonden R, Mogensen G, Tanaka R & Salminen S (1999) Effect of fermented dairy products on intestinal microflora, human nutrition and health: current knowledge and future perspectives. IDF Document. (In press)Google Scholar
  14. Gasser F (1994) Safety of lactic acid bacteria and their occurrence in human clinical infections. Bull. Inst. Pasteur 92: 45-67Google Scholar
  15. Giraffa G, Carminati D & Neviani E (1997) Enterococci isolated from dairy products: a review of risks and potential technological use. J. Food Protect. 60: 732-738Google Scholar
  16. Goldin BR, Gorbach SL, Saxelin M, Barakat S, Gualtieri L & Salminen S (1992) Survival of Lactobacillus species (Strain GG) in human gastrointestinal tract. Dig. Dis. Sci. 37: 121-128Google Scholar
  17. Guarner F & Schaafsma GJ (1998) Probiotics. Int. J. Food Microbiol. 39: 237-238Google Scholar
  18. Hamilton-Miller JMT, Shah S & Smith CT (1996) 'Probiotic' remedies are not what they seem. Brit. Med. J. 312: 55-56Google Scholar
  19. Hamilton-Miller JMT, Shah S & Winkler JT (1999) Public health issues arising from microbiological and labelling quality of foods and supplements containing probiotic microorganisms. Public Health Nutr. (in press)Google Scholar
  20. Hata Y, Yamamoto M, Ohni M, Nakajima K, Nakamura Y & Takano T (1996) A placebo-controlled study of the effect of sour milk on blood pressure in hypertensive subjects. Amer. J. Clin. Nutr. 64: 767-771Google Scholar
  21. Havenaar R & Huis in't Veld JHJ (1992) Probiotics: a general view. In: Wood BJB (Ed.) The lactic acid bacteria: Vol. I The lactic acid bacteria in health and disease. (pp 151-170). Elsevier Applied Science, LondonGoogle Scholar
  22. Holzapfel WH, Haberer P, Snel J, Schillinger U & Huis in't Veld JHJ (1998) Overview of gut flora and probiotics. Int. J. Food Microbiol. 41: 85-101Google Scholar
  23. Hosono A, Lee J, Ametani A, Natsume M, Hirayama M, Adachi T & Kaminogawa S (1997). Characterization of a water-soluble poly-saccharide fraction with immunopotentiating activity from Bifidobacterium adolescentis M101-4. Biosci. Biotech. Biochem. 61: 312-316Google Scholar
  24. Huis in't Veld JHJ & Havenaar R (1997) Selection criteria and application of probiotic microorganisms in man and animal. Microecol. Ther. 26: 43-57Google Scholar
  25. Jett BD, Huycke MM & Gilmore MS (1994) Virulence of enterococci. Clin Microbiol. Rev. 7: 462-478Google Scholar
  26. Kampman E, Goldbohm RA, van den Brandt PA & van't Veer P (1994) Fermented dairy products, calcium and colorectal cancer in the Netherlands cohort study. Cancer Res. 54: 3186-3190Google Scholar
  27. Kurtzweil P (1998) Staking a claim to good health. FDA and science stand behind health claims on foods. FDA Consumer, Nov-Dec. Scholar
  28. Langseth L (1996) Nutritional epidemiology: possibilities and limitations. ILSI Press, Washington, DCGoogle Scholar
  29. Maeno M, Yamamoto N & Takano T (1996) Identification of antihypertensive peptides from casein hydrolysate produced by a proteinase from Lactobacillus helveticus CP790. J. Dairy Sci. 73: 1316-1321Google Scholar
  30. Marin ML, Lee JH, Murtha J, Ustunol Z & Pestka JJ (1997) Differential cytokine production in clonal macrophage and T-cell lines cultured with bifidobacteria. J. Dairy Sci. 80: 2713-2720Google Scholar
  31. Marteau P, Minekus M, Havenaar R & Huis in't Veld JHJ (1997) Survival of lactic acid bacteria in a dynamic model of the stomach and small intestine: validation and the effect of bile. J. Dairy Sci. 80: 1031-1037Google Scholar
  32. McNamara SH (1998) So you want to market a food and to make health-related claims — How far can you go? What rules of law will govern the claims you want to make? Food Drug Law J. 53: 421-436Google Scholar
  33. Micanel N, Haynes IN & Playne MJ (1997) Viability of probiotic cultures in commercial Australian yogurts. Aust. J. Dairy Technol. 52: 24-27Google Scholar
  34. Millar MR, Bacon C, Smith SL, Walker V & Hall MA (1993) Enteral feeding of premature infants with Lactobacillus GG. Arch. Dis. Childhood 69: 483-487Google Scholar
  35. Minekus M, Smeets-Peeters M, Bernalier A, Marol S, Havenaar R, Marteau P, Alric M, Fonty G & Huis in't Veld JHJ (1999) A computer-controlled model of the large intestine with peristaltic mixing, absorption of fermentation products and a high-density microflora. (in press)Google Scholar
  36. Minekus M, Marteau P, Havenaar R & Huis in't Veld JHJ (1995) A multicompartmental dynamic computer-controlled model simulating the stomach and small intestine. ATLA (Alternative To Laboratory Animals) 23: 197-209Google Scholar
  37. Molin G, Jeppsson B, Johansson M-L, Ahrne S, Nobaek S, Stahl M & Bengmark S (1993) Numerical taxonomy of Lactobacillus spp. associated with healthy and diseased mucosa of the human intestines. J. Appl. Bacteriol. 74: 314-323Google Scholar
  38. Monique GLe, Moulton LH, Hill C & Kramar A (1986) Consumption of dairy produce and alcohol in a case-control study of breast cancer. J. Nat. Cancer Instil. 77: 633-636.Google Scholar
  39. Noble WC, Virani Z & Cree RGA (1992) Co-transfer of vancomycin and other resistance genes from Enterococcus faecalis NCTC 12201 to Staphylococcus aureus. FEMS Microbiol. Lett. 93: 195-198Google Scholar
  40. Perdigon G, Nader de Macias ME, Alvarez S, Oliver G & Pesce de Ruiz Holgado AA (1986) Effect of perorally administered lactobacilli on macrophage activation in mice. Infect. Immun. 53: 404-410Google Scholar
  41. Peters RK, Pike MC, Garabrant D & Mack TM (1992) Diet and colon cancer in Los Angeles County, California. Cancer Causes and Control 3: 457-473Google Scholar
  42. Reuter G (1997) Present and future of probiotics in Germany and in Central Europe. Biosci. Microflora 16: 43-51Google Scholar
  43. Roberfroid MB (1998) Prebiotics and synbiotics: concepts and nutritional properties. Brit. J. Nutr. 80: S197-S202Google Scholar
  44. Salminen S, von Wright A, Morelli L, Marteau P, Brassart D, de Vos WM, Fonden R, Saxelin M, Collins K, Mogensen G, Birkeland S-E & Mattila-Sandholm T (1998). Demonstration of safety of probiotics — a review. Int. J. Food. Microbiol. 44: 93-106Google Scholar
  45. Salminen S, Isolauri E & Salminen E (1996) Clinical uses of probiotics for stabilizing the gut mucosal barrier: successful strains for future challenges. Antonie Van Leeuwenhoek 70: 347-358Google Scholar
  46. Sanders ME (1998) Development of consumer probiotics for the US market. Brit. J. Nutr. 80: S213-S218Google Scholar
  47. Sanders ME, Walker DC, Walker KM, Aoyama K & Klaenhammer TR (1996) Performance of commercial cultures in fluid milk applications. J. Dairy Sci. 79: 943-955Google Scholar
  48. Savaiano DA, AbouElAnouar A, Smith DE & Levitt MD (1984) Lactose malabsorption from yogurt, pasteurized yogurt, sweet acidiohilus milk, and cultured milk in lactase-deficient individuals. Amer. J. Clin. Nutr. 40: 1219-1223Google Scholar
  49. Saxelin M, (1997) Lactobacillus GG — a human probiotic strain with thorough clinical documentation. Food Rev. Int. 13: 293-313Google Scholar
  50. Saxelin M, Rautelin H, Salminen S & Makela PH (1996a) Safety of commercial products with viable lactobacillus strains. Infect. Dis. Clin. Pract. 5: 331-335Google Scholar
  51. Saxelin M, Chuang MH, Chassy B, Rautelin H, Makela PH, Salminen S & Gorbach SL (1996b) Lactobacilli and bacteremia in southern Finland, 1989-1992. Clin. Infect. Dis. 22: 564-566Google Scholar
  52. Solis Pereyra B & Lemonnier D (1993) Induction of human cytokines by bacteria used in dairy foods. Nutr. Res. 13: 1127-1140Google Scholar
  53. Spanhaak S, Havenaar R & Schaafsma G (1998) The effect of consumption of milk fermented by Lactobacillus casei strain Shirota on the intestinal microflora and immune parameters in humans. Europ. J. Clin. Nutr. 52: 899-907Google Scholar
  54. Storlie J, O'Flaherty MJ & Hare K (1998) Food or Supplement? Choosing the appropriate regulatory path. Food Technol. 52: 62-69Google Scholar
  55. Tannock GW (1999) Probiotics: A critical review. Horizon Press, Wymondham (Norfolk), UKGoogle Scholar
  56. Tannock GW (1998) Studies of the intestinal microflora: a prerequisite for the development of probiotics. Int. Dairy J. 8: 527-533Google Scholar
  57. Titze A, Kuhn C, Lorenz A, de Vrese M & Barth C (1996) The influence of viable lactobacilli on lactose degradation in the gut of gnotobiotic animals. XIIth International Symposium on Gnotobiology, Honolulu, pp. 43Google Scholar
  58. Tomera JF (1996) Yogurt: probiotic pharmacology. Drugs of Today 32: 539-551Google Scholar
  59. Tomioka H & Saito H (1992) Lactic acid bacteria in the support of immuno-compromised hosts. In: Wood BJB (Ed.) The lactic acid bacteria: Vol. I The lactic acid bacteria in health and disease. (pp 263-296) Elsevier Applied Science, LondonGoogle Scholar
  60. van't Veer P, Dekker JM, Lamers JWJ, Kok FJ, Schouten EG, Brants HAM, Sturmans F & Hermus RJJ (1989) Cancer Res. 49: 4020-4023Google Scholar
  61. Vesa TH, Marteau Ph, Zidi S, Briet F, Pochart Ph & Rambaud JC (1996) Digestion and tolerance of lactose from yoghurt and different semi-solid fermented dairy products containing Lactobacillus acidophilus and bifidobacteria in lactose maldigesters — Is bacterial lactase important? Euro. J. Clin. Nutr. 50: 730-733Google Scholar

Copyright information

© Kluwer Academic Publishers 1999

Authors and Affiliations

  1. 1.Dairy and Food Culture TechnologiesLittletonUSA
  2. 2.Dairy Products Technology CenterCalifornia Polytechnic State UniversitySan Luis ObispoUSA
  3. 3.School of Veterinary MedicineUtrecht UniversityUtrechtThe Netherlands
  4. 4.Yakult Europe B.V., Prof. J.HAmstelveenThe Netherlands

Personalised recommendations