Public safety and dietary supplementation

Annals of the New York Academy of Sciences

Volumn 1190, Issue , 2010, Pages 104-117

  Gershwin, M Eric ^a   Borchers, Andrea T ^a   Keen, Carl L ^b   Hendler, Sheldon ^c   Hagie, Frank ^d   Greenwood, M R C ^b  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d Allergen Safe Homes   (United States)

Author keywords

Dietary supplements; Food and drug association; Foods

Indexed keywords

CONFERENCE PAPER; DIET SUPPLEMENTATION; DRUG INDUSTRY; FOOD AND DRUG ADMINISTRATION; FOOD CONTAMINATION; FOOD SAFETY; FOOD STORAGE; HARVESTING; HEALTH HAZARD; HERBAL MEDICINE; INJURY; MEDICOLEGAL ASPECT; PHYSICAL DISEASE; QUALITY CONTROL; RISK FACTOR;

EID: 77950295311     PISSN: 00778923     EISSN: 17496632     Source Type: Book Series    
DOI: 10.1111/j.1749-6632.2009.05270.x     Document Type: Conference Paper

References (78)

1. U.S. Department of Health and Human Services, Commission on Dietary Supplement Labels. 1998. Background on dietary supplements. Available at: http://web. health.gov/dietsupp/ch2.htm: accessed April 18, 2007.
2. FDA. 1966. Dietary supplements and vitamin- and mineral-fortified foods. Fed. Register 31: 15730-15736.
3. Hegefeld, H.A. 2000. Overview of federal regulation of dietary supplements: past, present, and future trends. Available at: http://leda.law.harvard.edu/leda/ data/242/Hegefeld, Heather.pdf
4. McNamara, S.H. 1996. FDA regulation of ingredients in dietary supplements after passage of the Dietary SupplementHealth and Education Act of 1994: an update. Food Drug Law J . 51: 313-318.
5. Amin, R. Health claims for dietary supplements: regulatory history and summary with a focus on qualified health claims. Available at: http://www.herbalgram.org/ default.asp?c-health claims: accessed April16, 2007.
6. Nutrition Labeling and Education Act of 1991. 1991. Public Law No. 101-535 codified at 21 United States Code U.S.C. §§ 301 et seq. November 8, 1990.
7. Dietary Supplement Health and Education Act of 1994. 1994. Public Law No. 103-417 codified at 21 United States CodeU.S.C. §§ 321 et seq. Available at: http://www. fda.gov/opacom/laws/dshea.html: accessed April 16, 2007.
8. Pinco, R.G. &T.H. Halpern. 1999. Guidelines for the promotion of dietary supplements: examining government regulation five years after enactment of the Dietary Supplement Health and Education Act of 1994. Food Drug Law J . 54: 567-586.
9. FDA. 2003. Guidance for industry and FDA: interim procedures for qualified health claims in the labeling of conventional human food and dietary supplements. U.S. Food and Drug Administration. Available at: http:// www.cfsan.fda.gov/?dms/hclmgui3.html: accessedMay 21, 2007.
10. FDA. 2003. Guidance for industry: interim evidencebased ranking system for scientific data. Consumer health information for better nutrition initiative. Task Force Final Report. Attachment B. U.S. Food and Drug Administration. Available at: http://www.cfsan. fda.gov/?dms/nuttf-b.html: accessed May 21, 2007.
11. FDA. 2004. Guidance for industry: substantiation for dietary supplement claims made under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act. Draft Guidance. U.S. Food and Drug Administration. Available at: http://www.cfsan.fda.gov/?dms/dsclmgui.html: accessed May 21, 2007.
12. 2005. Annual industry overview 2005. Nutr. Bus. J. 10 (issue 5/6).
13. Center for Food Safety and Applied Nutrition. (U.S. Food and Drug Administration). Economic characterization of the dietary supplement industry. 1999 Available at: http://vm.cfsan.fda.gov/?comm/ds-econt.html: accessed May 2, 2007.
14. United States General Accounting Office. Health products for seniors: "anti-aging" products pose potential for physical and economic harm. Report to Chairman, Special Committee on Aging, U.S. Senate. 2001.
15. Office of Inspector General (Department of Health and Human Services). 2001. Adverse event reporting for dietary supplements. Report No. OEI-01-00-00180. Available at: http://www.dhhs.gov/oig/oei: accessed April 18, 2007.
16. Timbo, B.B.,M.P. Ross, P.V.McCarthy &C.T. Lin. 2006. Dietary supplements in a national survey: prevalence of use and reports of adverse events. J. Am. Diet Assoc. 106: 1966-1974.
17. Blendon, R.J. et al. 2001. Americans' views on the use and regulation of dietary supplements.Arch. Intern.Med. 161: 805-810.
18. Eskin, S.B. 2001. AARP Public Policy Institute. Dietary supplements and older consumers. Available at: http://research.aarp.org/ppi: accessed April 18, 2007.
19. Radimer, K. et al. 2004. Dietary supplement use by US adults: data from the National Health and Nutrition Examination Survey, 1999-2000. Am. J. Epidemiol. 160: 339-349.
20. Kaufman,D.W. et al. 2002.Recent patterns of medication use in the ambulatory adult population of the United States: the Slone survey. JAMA 287: 337-344.
21. Eisenberg, D.M. et al. 1998. Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. JAMA 280: 1569-1575.
22. Ni,H., C. Simile& A.M.Hardy. 2002.Utilization of complementary and alternative medicine by United States adults: results from the 1999 National Health Interview Survey. Med. Care 40: 353-358.
23. Kelly, J.P. et al. 2005. Recent trends in use of herbal and other natural products. Arch. Intern.Med. 165: 281-286.
24. Bent, S., H. Goldberg, A. Padula &A.L. Avins. 2005. Spontaneous bleeding associated with Ginkgo biloba: a case report and systematic review of the literature. J.Gen. Intern. Med. 20: 657-661.
25. Clouatre, D.L. 2004. Kava kava: examining new reports of toxicity. Toxicol. Lett. 150: 85-96.
26. Ernst, E. 1998. Harmless herbs? A review of the recent literature. Am. J. Med. 104: 170-178.
27. Palmer, M.E., C. Haller &P.E. McKinney, et al. 2003. Adverse events associated with dietary supplements: an observational study. Lancet 361: 101-106.
28. Stickel, F., E. Patsenker &D. Schuppan. 2005. Herbal hepatotoxicity. J. Hepatol. 43: 901-910.
29. Stickel, F. &H.K. Seitz. 2000. The efficacy and safety of comfrey. Public Health Nutr. 3: 501-508.
30. FDA. Dietary supplement warnings and safety information. Available at: http://www.cfsan.fda/gov/?dms/dswarn. html: accessed April 18, 2007.
31. Foster, B.C., J.T. Arnason &C.J. Briggs. 2005. Natural health products and drug disposition. Annu. Rev. Pharmacol. Toxicol. 45: 203-226.
32. Fugh-Berman, A. &E. Ernst. 2001. Herb-drug interactions: review and assessment of report reliability. Br. J. Clin. Pharmacol. 52: 587-595.
33. Hu, Z. et al. 2005. Herb-drug interactions: a literature review. Drugs 65: 1239-1282.
34. Zhou, S. et al. 2004. Pharmacokinetic interactions of drugs with St John's wort. J. Psychopharmacol. 18: 262-276.
35. Piscitelli, S.C. et al. 2000. Indinavir concentrations and St. John's wort. Lancet 355: 547-548.
36. Ruschitzka, R. et al. 2000. Acute heart transplant rejection due to Saint John's wort. Lancet 355: 548-549.
37. Ang-Lee, M.K., J. Moss &C.S. Yuan. 2001. Herbal medicines and perioperative care. JAMA 286: 208-216.
38. Au, A.M. et al. 2000. Screening methods for drugs and heavymetals in Chinese patent medicines. Bull. Environ. Contam. Toxicol. 65: 112-119.
39. Garvey, G.J., G. Hahn, R.V. Lee &R.D. Harbison. 2001. Heavy metal hazards of Asian traditional remedies. Int. J. Environ. Health Res. 11: 63-71.
40. Ko, R.J. 1998. Adulterants in Asian patent medicines. N. Engl. J. Med. 339: 847.
41. Saper, R.B. et al. 2004.Heavymetal content of Ayurvedic herbal medicine products. JAMA 292: 2868-2873.
42. Dolan, S.P., D.A. Nortrup, P.M. Bolger &S.G. Capar. 2003. Analysis of dietary supplements for arsenic, cadmium, mercury, and lead using inductively coupled plasma mass spectrometry. J. Agric. Food Chem. 51: 1307-1312.
43. Huggett, D.B. et al. 2001. Organochlorine pesticides and metals in select botanical dietary supplements. Bull. Environ. Contam. Toxicol. 66: 150-155.
44. Ko, R. 2006. Safety of ethnic &imported herbal and dietary supplements. Clin. Toxicol. (Phila.) 44: 611-616.
45. Marcus, D.M. &A.P. Grollman. 2002. Botanical medicines-the need for new regulations.N. Engl. J. Med. 347: 2073-2076.
46. FDA. 2003. Current Good Manufacturing Practice in Manufacturing, Packing, orHoldingDietary Ingredients and Dietary Supplements: Proposed Rule. Fed. Register 68: 12157-12263.
47. Halt, M. 1998. Moulds and mycotoxins in herb tea and medicinal plants. Eur. J. Epidemiol. 14: 269-274.
48. Khan, I.A. et al. 2001. Determination of heavy metals and pesticides in ginseng products. J. AOAC Int. 84: 936-939.
49. Raman, P., L.C. Patino & M.G. Nair. 2004. Evaluation of metal and microbial contamination in botanical supplements. J. Agric. Food Chem. 52: 7822-7827.
50. Tournas, V.H., E. Katsoudas &E.J. Miracco. 2006. Moulds, yeasts and aerobic plate counts in ginseng supplements. Int. J. Food Microbiol. 108: 178-181.
51. Sas, D., M.A. Enrione &R.H. Schwartz. 2004. Pseudomonas aeruginosa septic shock secondary to "gripe water" ingestion. Pediatr. Infect. Dis. J. 23: 176-177.
52. Slifman, N.R. et al. 1998. Contamination of botanical dietary supplements by Digitalis lanata.N. Engl. J. Med. 339: 806-811.
53. Draves, A.H. &S.E. Walker. 2003. Analysis of the hypericin and pseudohypericin content of commercially available St John's wort preparations. Can. J. Clin. Pharmacol. 10: 114-118.
54. Harkey, M.R. et al. 2001. Variability in commercial ginseng products: an analysis of 25 preparations.Am. J. Clin. Nutr. 73: 1101-1106.
55. Schwertner, H.A., D.C. Rios &J.E. Pascoe. 2006. Variation in concentration and labeling of ginger root dietary supplements. Obstet. Gynecol. 107: 1337-1343.
56. Shohet, D., R.B. Wills &D.L. Stuart. 2001. Valepotriates and valerenic acids in commercial preparations of valerian available in Australia. Pharmazie. 56: 860-863.
57. Wurglics, M. et al. 2001. Comparison of German St. John's wort products according to hyperforin and total hypericin content. J. Am. Pharm. Assoc. (Wash.) 41: 560-566.
58. Ye, F. et al. 2004. Quality evaluation of commercial extracts of Scutellaria baicalensis.Nutr. Cancer 49: 217-222.
59. Wurglics, M. et al. 2001. Batch-to-batch reproducibility of St. John's wort preparations. Pharmacopsychiatry 34(Suppl 1): S152-S156.
60. Schulte-Lobbert, S. et al. 2004.Comparison of the synaptosomal uptake inhibition of serotonin by St John's wort products. J. Pharm. Pharmacol. 56: 813-818.
61. Hilts, P. 2003. Protecting America's Health. Alfred Knopf. New York.
62. Patrick Noonan, W. &C. Noonan. 2004. Legal requirements for "functional food" claims. Toxicol. Lett. 150: 19-24.
63. FDA. 2007. Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements: Final Rule. Fed. Register. 72: 21. Available at: http://www.cfsan.fda.gov.?/ rd/fr07625a.html: accessed November 1, 2007.
64. Srinivasan, V.S. 2006. Challenges and scientific issues in the standardization of botanicals and their preparations. United States Pharmacopeia's dietary supplement verification program-a public health program. Life Sci. 78: 2039-2043.
65. Sullivan, D. &R. Crowley. 2006. Development and validation of analytical methods for dietary supplements. Toxicology 221: 28-34.
66. Sander, L.C., K.E. Sharpless &S.A. Wise. 2006. Dietary supplement standard reference materials. Life Sci. 78: 2044-2048.
67. Rajapakse, N., E. Silva &A. Kortenkamp. 2002. Combining xenoestrogens at levels below individual noobserved- effect concentrations dramatically enhances steroid hormone action. Environ. Health Perspect . 110: 917-921.
68. Silva, E., N. Rajapakse &A. Kortenkamp. 2002. Something from "nothing" - eight weak estrogenic chemicals combined at concentrations below NOECs produce significant mixture effects. Environ. Sci. Technol. 36: 1751-1756.
69. 2002.Widespread ignorance of regulation and labeling of vitamins, minerals and food supplements, according to a National Harris Interactive Survey. Available at: http:// www.harrisinteractive.com/news.allnewsbydate.asp? NewsID=560: accessed April 4, 2007.
70. Consumers Union. 2004. Consumers Union Dietary Supplements Survey: 9 of 10 consumers want dietary supplements to be proven safe before put onstore shelves. Available at: http://www.consumersunion.org/pub/ core product safety/001171.html: accessed April 18, 2007.
71. Wahlqvist, M., B Hsu-Hage &W. Lukito. 1999. Clinical trials in nutrition. Asia Pacific J. Clin. Nutr. 8: 231-241.
72. Bidlack, W. &W. Wang. 1999. Designing functional foods. In Modern Nutrition in Health and Disease. 9th Edn. Shils, M., et al., Eds.: 1825. Lippincott Williams &Wilkins. Baltimore, MD.
73. Kessler,D. 2001. AQuestion of Intent. BBS Public Affairs. New York.
74. Annual Reviews of Significant Advances in Dietary Supplement Research. Published by the Office of Dietary Supplements within the National Institutes of Health. 2007; 1999-2006. Available at: http://www.ods.od. nih.gov/Research/ Annual Bibliographies.aspx: accessed November 7, 2007.
75. Ball, M.A. et al. 1994. The antiviral effect of Keishi-nieppi- ichi-to, a traditional Chinese herbal medicine, on influenza A2(H2N2) virus infection in mice. Experientia 50: 774-779.
76. Haranaka, K. et al. 1985. Antitumor activities and tumor necrosis factor producibility of traditional Chinese medicines and crude drugs. Cancer Immunol. Immunother. 20: 1-5.
77. Iijima, K., M. Tanaka, K. Toriizuka &J-C. Cyong. 1994. Effects of Kampo medicines on the clearance of circulating immune complexes in mice. J. Ethnopharmacol. 41: 77-83.
78. Matsuura, K. et al. 1993. Role of B-lymphocytes in the immunopharmacological effects of a traditional Chinese medicine, Xiao-Chai-Hu-Tang (Shosaiko-to). Int. J. Immunopharmacol. 15: 237-243.