80
Views
17
CrossRef citations to date
0
Altmetric
Research Article

Scientific and Regulatory Aspects of Nutraceutical Products in the United States

Pages 1177-1195 | Published online: 20 Oct 2008

References

  • Vogel M. R. Natural products issue, Pharm. Today 1998; 4(2)14–24
  • Tyler V. E., Foster F. Herbs and phytochemicals. Handbook of Nonprescription Drugs, T. R. Covington, R. R. Berardi, L. L. Young, S. C. Kendall, M. J. Hickey. American Pharmaceutical Association, Washington, DC 1996; 695–713
  • DeFelice S. L. The Nutraceutical Initiative: A Proposal for Economic and Regulatory Reform. 1991
  • Food Focus. Toronto, Ontario, Nutraceuticals/functional foods: An exploratory survey on Canada's potential: Summary report. J. Nutr. Func. Med. Foods 1997; 1(1)83–99
  • Bloch A., Thomson C. A. Position of the American Dietetic Association: Phytochemicals and functional foods. J. Nutr. Func. Med. Foods 1997; 1(1)33–45
  • Evers B., Mason A. Functional foods: Opening the door to better health. Elec. Food Rap. 1996; 6((16))
  • Marcus C., Coulston A. M. The vitamins. Goodman and Gilman's The Pharmacological Basis of Therapeutics, 9th ed, J. G. Hardman, L. E. Limbird. McGraw-Hill, New York 1996; 1547–1590
  • Lowe F. C., Ku J. C. Phytotherapy in treatment of benign prostatic hyperplasia: A critical review. Urology 1996; 43(1)12–20
  • Mobarhan S. Micronutrient supplementation trials and the reduction of cancer and cerebrovascular incidence and mortality. Nutr. Rev. 1994; 52(3)102–105
  • Monteleone C. A., Sherman A. R. Nutrition and asthma. Arch. Intern. Med. 1997; 157: 23–34
  • de Rijk M. C., Breteler M. M. B., den Breeijen J. H., et al. Dietary antioxidants and Parkinson disease. Arch. Neurol. 1997; 54: 762–765
  • Agus D. B., Gambhir S. S., Pardridge W. M., et al. Vitamin C crosses the blood-brain barrier in the oxidized form through the glucose transporters. J. Clin. Invest. 1997; 100(11)2842–2848
  • Jialal I., Fuller C. J. Effect of Vitamin E, Vitamin C and beta-carotene on LDL oxidation and atherosclerosis. Can. J. Cardiol. 1995; 11((Suppl. G))97G–103G
  • Food and Drug Administration. Rules and regulations, food labeling; nutrient content claims: Definition for “high potency” and definition of “antioxidant” for use in nutrient content claims for dietary supplements and conventional foods. Fed. Register 1997; 62(184)49868–49881
  • Burney P. G., Comstock G. W., Morris J. S. Serologic precursors of cancer: Serum micronutrients and the subsequent risk of pancreatic cancer. Am. J. Clin. Nutr. 1989; 49(5)895–900
  • Mathew P., Wyllie R., Van Lente F., Steffen R. M., Kay M. H. Antioxidants in hereditary pancreatitis. Am. J. Gastroenterol. 1996; 91(8)1558–1562
  • Clark L. C., Combs G. F., Turnbull B. W., et al. Effects of selenium supplementation for cancer prevention in patients with carcinoma of the skin. JAMA 1996; 276: 1957–1963
  • Nelson A. B., Lau B. H. S., Ide N., Rong Y. Pycnogenol inhibits macrophage oxidative burst, lipoprotein oxidation, and hydroxyl radical-induced DNA damage. Drug Dev. Ind. Pharm. 1998; 24(2)139–144
  • Hennekens C. H., Buring J. E., Manson J. E., et al. Lack of effect of long-term supplementation with beta carotene on the incidence of malignant neoplasms and cardiovascular disease. N. Engl. J. Med. 1996; 334(18)1145–1149
  • Omenn G. S., Goodman G. E., Thornquist M. D., Balmes J., et al. Effects of a combination of beta carotene and vitamin A on lung cancer and cardiovascular disease. N. Engl. J. Med. 1996; 334(18)1150–1155
  • Birt D. F., Julius A. D., Runice C. E., White L. T., Lawson T., Pour P. M. Enhancement of BOP-induced pancreatic carcinogenesis in selenium-fed Syrian golden hamsters under specific dietary conditions. Nutr. Cancer 1988; 11(1)21–33
  • Braeckman J. The extract of Serenoa repens in the treatment of benign prostatic hyperplasia: A multicenter open study. Curr. Ther. Res. 1994; 55(7)776–785
  • Wheatley D. LI 160.an extract of St. John's wort, versus amitriptyline in mildly to moderately depressed outpatients—A controlled 6-week clinical trial. Pharmacopsychiatry 1997; 30((Suppl. 2))77–80
  • Kasper S. Treatment of seasonal affective disorder (SAD) with hypericum extract. Pharmacopsychiatry 1997; 30((Suppl. 2))89–93
  • Linde K., Ramirez G., Mulrow C. D., Pauls A., Weidenhammer W., Melchart D. St. John's wort for depression—An overview and meta-analysis of randomised clinical trials. BMJ 7052; 313: 253–258, (1996)
  • Wagner H., Bladt S. Pharmaceutical quality of hypericum extracts. J. Geriatr. Psychiatry Neurol. 1994; 7((Suppl. 1))S65–S68
  • Melchart D., Linde K., Worku F., Sarkady L., Holzmann M., Jurcic K., Wagner H. Results of five randomized studies on the immunomodulatory activity of preparations of Echinacea. J. Alt. Complement. Med. 1995; 1(2)145–160
  • Mullins R. J. Echinacea-associated anaphylaxis. Med. J. Aust. 1998; 168(4)170–171
  • Food and Drug Administration. Proposed rule, dietary supplements containing ephedrine alkaloids. Fed. Register 1997; 62(107)30677–30724
  • Wargovich M. J. Experimental evidence for cancer preventative elements in foods. Cancer Lett. 1997; 114: 11–17
  • Salmeron J., Manson J. E., Stampfer M. J., et al. Dietary fiber, glycemic load, and risk of non-insulin-dependent diabetes mellitus in women. JAMA 1997; 277: 472–477
  • Slavin J., Jacobs D., Marquart L. Whole-grain consumption and chronic disease: Protective mechanisms. Nutr. Cancer 1997; 27(1)14–21
  • Chang R. Functional properties of edible mushrooms. Nutr. Rev. 1996; 54(11)S91–S93
  • McCarron D. A., Oparil S., Chait A., et al. Nutritional management of cardiovascular risk factors. Arch. Intern. Med. 1997; 157: 169–177
  • Chapman D. P., Giles W. H. Pharmacologic and dietary therapies in epilepsy: Conventional treatments and recent advances. South. Med. J. 1997; 90(5)471–480
  • Sayegh R., Schiff I., Wurtman J., Spiers P., McDermott J., Wurtman R. The effect of a carbohydrate-rich beverage on mood, appetite and cognitive function in women with premenstrual syndrome. Obstet. Gynecol. 1995; 86((4, Pt. 1))520–528
  • Wurtman J. J., Brzezinski A., Wurtman R. J., Laferrere B. Effect of nutrient intake on premenstrual depression. Am. J. Obstet. Gynecol 1989; 161(5)1228–1234
  • Wurtman J. J. Depression and weight gain: The serotonin connection. J. Affect. Disord. 1993; 29((2–3))183–192
  • Kaufman F. R., Halvorson M., Kaufman N. D. A randomized, blinded trial of uncooked cornstarch to diminish nocturnal hypoglycemia at Diabetes Camp. Diabetes Res. Clin. Pract. 1995; 30: 205–209
  • Kaufman F. R. Zbar as part of the diabetes regimen. Clin. Res. Reg. Aff. 1997; 14(1)75–82
  • Alton G., Kjaergaard S., Etchison J. R., Skovby F., Freeze H. H. Oral ingestion of mannose elevates blood mannose levels: A first step toward a potential therapy for carbohydrate-deficient glycoprotein syndrome Type I. Biochem. Mol. Med. 1997; 60: 127–133
  • Buist N. R. M., Prince A. P., Huntington K. L., Tuerck J. M., Waggoner D. D. A new amino acid mixture permits new approaches to the treatment of phenylketonuria. Acta Paediatr., Suppl. 1994; 407: 75–77
  • Food and Drug Administration. Advance Notice of Proposed Rulemaking, eligibility criteria for considering additional conditions in the Over-the-Counter Drug Monograph System; request for information and comments. Fed. Register 1996; 61(193)51625–51631
  • Food and Drug Administration. Final Rule, food labeling regulation, amendments; food regulation uniform compliance date; and new dietary ingredient premarket notification. Fed. Register 1997; 62(184)49825–49858
  • Food and Drug Administration. Final Rule, food labeling; requirements for nutrient content claims, health claims, and statements of nutritional support for dietary supplements. Fed. Register 1997; 62(184)49859–49868
  • Food and Drug Administration. Final Rule, food labeling; notification procedures for statements on dietary supplements. Fed. Register 1997; 62(184)49883–49886
  • Food and Drug Administration. Final Rule, premarket notification for a new dietary ingredient. Fed. Register 1997; 62(184)49868–49881
  • Strobos J. Medical foods. Clin. Res. Reg. Aff. 1997; 14(1)5–13
  • Food and Drug Administration. Advance Notice of Proposed Rulemaking, regulation of medical foods. Fed. Register 1996; 61(231)60661–60671
  • Food and Drug Administration. Proposed Rule, regulations on statements made for dietary supplements concerning the effect of the product on the structure or function of the body. Fed. Register 1998; 63(82)23623–23632
  • Food and Drug Administration. Comments on Report of the Commission on Dietary Supplement Labels. Fed. Register 1998; 63(82)23633–23637
  • Allen L. V., Jr. Nutritional products. Handbook of Nonprescription Drugs, T. R. Covington, R. R. Berardi, L. L. Young, S. C. Kendall, M. J. Hickey. American Pharmaceutical Association, Washington, DC 1997; 361–392
  • Sharp K., Chi-Lum B. Nutritional basics, Health Insight 1997, posted May, 30
  • Duke J. A. The Green Pharmacy. Rodale Press, Emmaus, PA 1997
  • Food and Drug Administration. Center for Food Safety and Applied Nutrition, A Food Labeling Guide. 1994, updated May 1997 September
  • Knodel L. C., Kendall S. C., Young L. L., Hickey M. J. Nonprescription Products: Formulations and Features '96–97. American Pharmaceutical Association, Washington, DC 1997; 263–270; 276–281
  • Martin E. A., Guidos B. The Bantam Medical Dictionary, rev. ed. Bantam Books, New York 1990
  • Mueller C., Nestle M. Regulation of medical foods: Toward a rational policy. NCP 1995; 10(1)8–15

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.