SAFETY

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The Safety of Immunocal


 Immunocal is a broad-spectrum nutraceutical food derivative with biologic capability to modulate cellular function.  More than 100,000 people have used Immunocal with no significant adverse side effects.

Production of Immunocal meets or exceeds the requirements of the USDA for dairy products.

The total bacterial count is less than 1000/g with no detectable pathogens and/or antibiotics.

The whey protein concentrate (WPC) marketed as Immunocal has been tested in hundreds of laboratory experiments on mice (20% in formula diets) from 1980 to 1992 without any signs of toxicity. WPC fed mice were not distinguishable from controls, in terms of growth rate, hair appearance, serum protein, etc. 1-8

Immunocal has also been administered in clinical trials in adults and children in doses varying from 10/g to 40/g per day without side effects. 9-12

In addition, Immunocal is sold in Canada, United States, Europe, Japan, Malaysia, Taiwan and other countries to thousands of customers and no clinically relevant complications have been reported.

* 21 Code of Federal Regulations §184.1979c affirms whey protein concentrates as GRAS and the FDA has determined there are no questions regarding safety for human consumption.

    REFERENCES

  1. Bounous G, Stevenson MM, Kongshavn PAL. Influence of dietary lactalbumin hydrolysate on the immune system of mice and resistance to Salmonellosis. J Infect Dis 144: 281, 1981.

  2. Bounous G, Letourneau L, Kongshavn PAL. Influence of dietary protein type on the immune system of mice. J Nutr 113: 1415-21, 1983.

  3. Bounous G, Kongshavn PAL. Influence of protein type in nutritionally adequate diets on the development of immunity. In: Absorption and Utilisation of Amino Acids. M. Friedman (Ed.). Boca Raton, Florida: CRC Press, vol. 2, 219-32, 1989.

  4. Bounous G., Batist G, Gold P. Immunoenhancing property of dietary whey protein in mice: role of glutathione. Clin Invest Med 12: 154-61, 1989.

  5. Bounous G, Shenouda N, Kongshavn PAL, Osmond DG. Mechanism of altered B-cell response induced by changes in dietary protein type in mice. J Nutr 115: 1409-17, 1985.

  6. Bounous G, Papenburg R, Kongshavn PAL, Gold P., Fleiszer D. Dietary whey protein inhibits the development of dimethylhydrazine-induced malignancy. Clin Invest Med 11: 213-7, 1988.

  7. Papenburg R, Bounous G, Fleiszer D, Gold P. Dietary milk proteins inhibit the development of dimethylhydrazine-induced malignancy. Tumor Biol 11: 129-136, 1990.

  8. Bounous G., Batist G., Gold P. Whey proteins in cancer prevention. Cancer letters 57, 91-94, 1991.

  9. Bounous G, Baruchel S, Falutz J, Gold P. Whey proteins as a food supplement in HIV seropositive individuals. Clin Invest Med 16: 204-209, 1993.

  10. Baruchel S, Viau G, Olivier R, Bounous G, Wainberg M.A. – Nutriceutical Modulation of Glutathione with a Humanised Native Milk Serum Protein Isolate, Immunocal®.

  11. Application in AIDS and Cancer. In: Oxidative Stress in Cancer, AIDS, and Neurodegenerative Diseases. Ed. L. Montagnier, Olivier R., Pasquier C. Publ Dekker M., New York, 447-461, 1998.

  12. Lands L, Grey VL, Smountas AA. The Effect of Supplementation with a Cysteine Donor on Muscular Performance. Journal of Applied Physiology Vol. 87: 1381-1385, 1999.

  13. Lotian B, Grey V, Kimof RJ, Lands L. Treatment of Obstructive Airway Disease with a Cysteine Donor Protein Supplement: A Case Report. Chest; 117: 914-916, 2000.