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Institutionalising the Medical Evaluation of CAM: Dietary and Herbal Supplements as a Peculiar Example of (Differential) Legitimisations of CAM in the USA

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In this chapter, we present a specific aspect of our socio-anthropological research focusing on the federal institutionalisation of CAM in the USA: the case of ‘dietary and herbal supplements’ (D/HS). We show how the case provides a good example of different and specific configurations of medical research on CAM since the 1990s through the creation of three federal entities. Based on an analysis of controversies and challenges around specific ‘D/HS’, we interrogate the manners in which a plurality of federal and non-federal agents involved in this mixed social space collaborates and competes on the medical evaluation of CAM—particularly around ideas of efficacy, safety, authenticity, and integration—shaping and re-shaping the places they assign to CAM within the broader American health system.

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Fig. 12.1


  1. 1.

    We chose the term ‘dietary and herbal supplements’ from NCCIH to illustrate both the legal wording and use of most D/HS (sold as dietary supplements) and the focus on botanical-based dietary supplements in the following examples, thus questioning different distinctions between conventional and lab-synthesised drugs and plant-derived dietary supplements.

  2. 2.

    Congressional findings related to Dietary Supplements Health and Education Act of 1994, Pub. L. No. 103–417, § 2, 15 (A), 108 Stat. 4325; 4326, October 25 1994 (s).

  3. 3.

    For the most recent one, see: Clarke et al. 2015 (s).

  4. 4.

    As defined by the NCCIH: ‘a product that is intended to supplement the diet, contains one or more dietary ingredients (including vitamins, minerals, herbs, or other botanicals), a plant or part of a plant used for its flavor, scent, or potential therapeutic properties (includes flowers, leaves, bark, fruit, seeds, stems, and roots, amino acids, and certain other substances) or their constituents, is intended to be taken by mouth, in forms such as tablet, capsule, powder, softgel, gelcap, or liquid, and is labeled as being a dietary supplement’ ( Federal institutions such as NCCIH and NCI mention different CAM categories related to botanicals: ‘natural products’, ‘complex natural products’, ‘dietary supplements’, ‘nutritional therapeutics’, ‘botanicals’, ‘herbs’, ‘special diets’.

  5. 5.

    An inductive socio-anthropological ‘networked ethnography’ (Atlani-Duault 2009; Olivier de Sardan 2008), or what we might call ‘starfish ethnography’, departing from the institutions and expanding back and forth from the investigation to their networks of interactions with other agents involved in this mixed social space of medical research on CAM and cancer CAM.

  6. 6.

    We compiled sources from the institutions we studied (‘institutional corpus’), archives from newspapers, scientific journals, legal texts, online sources, and so on. See the ‘Sources’ section in bibliography.

  7. 7.

    We conducted about 60 formal and informal ethnographic interviews, many informal discussions, and observations between November 2014 and June 2017.

  8. 8.

    See Bothwell and Podolsky 2016; Meldrum 2000.

  9. 9.

    Manufacturers only bear the responsibility of their safety before their release on the market, they do not need to report it to the FDA.

  10. 10.

    US Department of Health & Human Services Food and Drug Administration, Center for Drug Evaluation and Research (June 2004), ‘Botanical Drug Products’ (s).

  11. 11.

    For a long-term history of Ephedra , see: Lee 2011.

  12. 12.

    Haller and Benowitz 2000 (s).

  13. 13.

    US Department of Health and Human Services, Office of Inspector General 2001 (s).

  14. 14.

    New York Times 1993 (s).

  15. 15.

    Public Citizen 2001 (s).

  16. 16.

    Bodley 2003 (s); Connolly 2008 (s).

  17. 17.

    NCCIH, ‘Minutes’, March 2003 (s).

  18. 18.

    Fontanarosa et al. 2003 (s).

  19. 19.

    Wolfe 2003 (s ).

  20. 20.

    FDA, 6 February 2004 (s).

  21. 21.

    FDA, June 2004 (s).

  22. 22.

    Regulatory science is defined by the FDA as ‘the science of developing new tools, standards and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products’ See: FDA, October 2010. (s).

  23. 23.

    NCCAM, ‘Minutes’, November 2000 (s).

  24. 24.

    NCCAM, ‘Minutes’, October 2014 (s).

  25. 25.

    Berman and Larson 1995, x (s).

  26. 26.

    Ibid., ix. (s).

  27. 27.

    Burton 2002 (s).

  28. 28.

    NCCAM, ‘Press Release’, 5 October 2000 (s).

  29. 29.

    NCCAM, ‘Director Testimony’, November 2001 and ‘Congressional Justification’, 2002 (s).

  30. 30.

    Dipaola et al. 1998 (s).

  31. 31.

    NCCIH, ‘Minutes’, 2004 (s).

  32. 32.

    Burton 2000 (s).

  33. 33.

    Chan et al. 1993 (s); Cumberford 2012 (s).

  34. 34.

    NCCAM, ‘Congressional Justification’, 2003 (s).

  35. 35.

    NCCAM, ‘Congressional Justification’, 2004 (s).

  36. 36.

    NCCAM, ‘Strategic Plan’, 2004 (s).

  37. 37.

    NCCAM, ‘Strategic Plan’, 2004 (s).

  38. 38.

    Interview with a researcher working on D/HS, February 2017.

  39. 39.

    This term was employed by different researchers when the question of research protocols on CAM was raised.

  40. 40.

    FDA, June 2004 (s).

  41. 41.

    Miller et al. 2004 (s).

  42. 42.

    This first wave of CAM research initiated at NCCAM echoes the decision of extending RCT to every research domain in medicine. It also originates in the 1970s from a FDA recommendation to use such a regime of proof in new drug research and development (Bothwell and Podolsky 2016). Oncology has been the major field of expansion for RCTs, see: Bourret and Le Moigne 2014; Cambrosio and Keating 2008; and Cambrosio et al. 2014.

  43. 43.

    Hopp 2015 (s).

  44. 44.

    This term was mentioned during a conference on integrative medicine held at a renowned centre for integrative medicine in the USA, in March 2017.

  45. 45.

    Seifried et al. 2004 (s).

  46. 46.

    Cheng 2011 (s).

  47. 47.

    See, for example, the scholarly work of the former director of the Office of Alternative Medicine (previous name of NCCAM until 1998) who works on a reorganisation of proof production when CAM is concerned: Jonas 2005 (s).

  48. 48.

    Eisenberg et al. 1993 (s).

  49. 49.

    From a booklet given to us by a researcher in integrative medicine: Abrams et al. (2015) ‘PRIMIER, A National Integrative Medicine Database’, The Bravewell Collaborative (s).

  50. 50.

    Hopp 2015 (s); Barnes et al. 2008 (s).

  51. 51.

    Wang and Arnold 2002 (s); Ron et al. 2002 (s); Mansky and Strauss 2002 (s).

  52. 52.

    In 2009, the FDA released a warning letter with ethical concerns about ‘antineoplaston’ and the Burzinsky Research Institute investigating and providing this alternative therapy: FDA (5 October 2009), ‘Warning Letter, “Burzynski Research Institute/IRB”’, ref: 10-HFD-45-09-0 (s). This controversy is also present within the NCCAM unprocessed archives at the Office of NIH History (Cheung Series, Box 8, folder 3; Jonas Series, Box 24, folder 7; OAM series, Box 14, folder 8 & box 25, folder 8; etc.) (s).

  53. 53.

    We anonymised the disease to protect agents we met as they could be easily identified if we had mentioned the specific disease and herbs used in their research study.

  54. 54.

    Zia and White 2009 (s).

  55. 55.

    For an example, see: Banerji et al. 2008 (s).


  • Atlani-Duault, L. (2009). Au Bonheur des autres: anthropologie de l’aide humanitaire. Paris: Armand Colin.

    Google Scholar 

  • Baszanger, I. (1986). Les maladies chroniques et leur ordre négocié. Revue Française de Sociologie, 27(1), 3–27.

    CrossRef  Google Scholar 

  • Bothwell, L. E., & Podolsky, S. H. (2016). The history of clinical trials: The emergence of the randomized, controlled trial. New England Journal of Medicine, 375, 501–504.

    CrossRef  Google Scholar 

  • Bourret, P., & Le Moigne, P. (2014). Essais cliniques, production de la preuve et mutation de la biomédecine. Sciences sociales et santé, 3(32), 5–11.

    CrossRef  Google Scholar 

  • Cambrosio, A., & Keating, P. (2008). Cancer clinical trials: The emergence and development of a new style of practice. In D. Cantor (Ed.), Cancer in the twentieth century (pp. 197–223). Baltimore: Johns Hopkins University Press.

    Google Scholar 

  • Cambrosio, A., Keating, P., & Nelson, N. (2014). Régimes thérapeutiques et dispositifs de preuves en oncologie: l’organisation des essais cliniques, des groupes coopérateurs aux consortiums de recherche. Sciences sociales et santé, 3(32), 13–42.

    CrossRef  Google Scholar 

  • Castel, P., & Friedberg, E. (2010). Institutional change as an interactive process: The case of the modernization of the French Cancer Centers. Organization Science, 21(2), 311–330.

    CrossRef  Google Scholar 

  • Chen, N. (2009). Food, medicine, and the quest for good health. New York: Columbia University Press.

    Google Scholar 

  • Dubet, F. (2002). Le déclin de l’institution. Paris: Le Seuil.

    Google Scholar 

  • Foster, S. (2011). A brief history of adulteration of herbs, spices, and botanical drugs. HerbalGram, 92, 42–57.

    Google Scholar 

  • Fuselier, B., & Marquis, N. (2009). Transaction sociale et négociation: deux notions à articuler. Négociations, 2(12), 23–33.

    CrossRef  Google Scholar 

  • Hess, D. J. (1999). Evaluating alternative cancer therapies: A guide to the science and politics of an emerging medical field. New Brunswick: Rutgers University Press.

    Google Scholar 

  • Hess, D. J. (2002). The raw and the organic: Politics of therapeutic cancer diets in the United States. The Annals of the American Academy of Political and Social Science, 583(1), 76–96.

    CrossRef  Google Scholar 

  • Jasanoff, S. (1990). The fifth branch: Science advisers as policymakers. Cambridge, MA and London: Harvard University Press.

    Google Scholar 

  • Jütte, R. (2001). Alternative medicine and medico-historical semantics. In R. Jütte, M. Eklöf, & M. C. Nelson (Eds.), Historical aspects of unconventional medicine – Approaches, concepts, case studies (pp. 11–26). Sheffield: European Association for the History of Medicine and Health Publications.

    Google Scholar 

  • Lee, M. R. (2011). The history of ephedra (Ma-Huang). Journal of the Royal College of Physicians of Edinburgh, 41(1), 78–84.

    CrossRef  Google Scholar 

  • Markle, G. E., & Petersen, J. C. (1980). Politics, science, and cancer: The laetrile phenomenon. Boulder, CO: Westview Press.

    Google Scholar 

  • Marks, H. (1997). The progress of experiment: Science and therapeutic reform in the United States (1900–1990). Cambridge: Cambridge University Press.

    Google Scholar 

  • Meimon, J. (2011). Sur le fil. La naissance d’une institution. In M. Offerlé & J. Lagroye (Eds.), Sociologie de l’institution (pp. 105–129). Paris: Belin.

    Google Scholar 

  • Meldrum, M. L. (2000). A brief history of the randomized controlled trial. From oranges and lemons to the gold standard. Hematology/Oncology Clinics of North America, 14(4), 745–760.

    CrossRef  Google Scholar 

  • Micollier, E. (2011). Un savoir thérapeutique hybride et mobile. Éclairage sur la recherche médicale en médecine chinoise en Chine aujourd’hui. Revue d’anthropologie des connaissances, 1(5), 41–70.

    CrossRef  Google Scholar 

  • Offerlé, M., & Lagroye, J. (Eds.). (2011). Sociologie de l’institution. Paris: Belin.

    Google Scholar 

  • Olivier de Sardan, J. P. (2008). La rigueur du qualitatif: les contraintes empiriques de l’interprétation socio-anthropologique. Lauvain-la-Neuve: Academia-Bruylant.

    Google Scholar 

  • Petryna, A. (2009). When experiments travel: Clinical trials and the global search for human subjects. Princeton: Princeton University Press.

    CrossRef  Google Scholar 

  • Smith, M. E. (1992). The Burzynski controversy in the United States and in Canada: A comparative case study in the sociology of alternative medicine. The Canadian Journal of Sociology/Cahiers Canadiens De Sociologie, 17(2), 133–160.

    CrossRef  Google Scholar 

  • Strauss, A. (1978). Negotiations: Varieties, contexts, processes, and social order. San Francisco: Jossey-Bass.

    Google Scholar 


    Institutional Archives

    • NCCAM unprocessed archives at the Office of NIH History and National Library of Medicine

      Google Scholar 

    Institutional Corpus

    Other Sources

    • Abrams, D. et al. (2015). PRIMIER: A National Integrative Medicine Database. The Bravewell Collaborative.

      Google Scholar 

    • Banerji, P., et al. (2008). Cancer patients treated with the Banerji protocols utilising homoeopathic medicine: A best case series program of the National Cancer Institute USA. Oncology Reports, 20(1), 69–74.

      Google Scholar 

    • Barnes, P. M., Blume, B., & Nahin, R. (2008). CDC national health statistics report #12. In Complementary and alternative medicine use among adults and children: United States, 2007. Atlanta: Centers for Disease Control.

      Google Scholar 

    • Berman, B. M., & Larson, D. B. (1995). Alternative medicine: Expanding medical horizon: A report to the National Institutes of Health on alternative medical systems and Practices in the United States (pp. 30–34). Washington, DC: US GPO.

      Google Scholar 

    • Bodley, H. (2003). Medical examiner: Ephedra a factor in Blecher death. USA Today.

      Google Scholar 

    • Burton, T. M. (2000). In trials, potion of herbs slows prostate cancer. Wall Street Journal, B1.

      Google Scholar 

    • Burton, T. M. (2002). Recall of herbal supplement highlights gaps in regulation. Wall Street Journal.

      Google Scholar 

    • Chan, T. Y., Chan, J. C., Tomlinson, B., & Critchley, J. A. (1993). Chinese herbal medicines revisited: A Hong Kong perspective. Lancet, 342(8886–8887), 1532–1534.

      CrossRef  Google Scholar 

    • Cheng, Y. C. (2011). Why and how to globalize traditional Chinese medicine. Journal of Traditional and Complementary Medicine, 1(1), 1–4.

      CrossRef  Google Scholar 

    • Clarke, T. C., Black, L. I., Stussman, B. J., Barnes, P. M., & Nahin, R. L. (2015). Trends in the use of complementary health approaches among adults: United States, 2002–2012. National Health Statistics Reports, 79, 1.

      Google Scholar 

    • Congressional findings related to dietary supplements health and education act of 1994, Pub. L. No. 103–417, § 2, 15 (A), 108 Stat. 4325; 4326, Oct. 25, 1994.

      Google Scholar 

    • Connolly, D. (2008). Steve Blecher’s Death Five Years Later. Baltimore Sun.

      Google Scholar 

    • Cumberford, G. (2012). EMI vs EMA: ‘Economically motivated integrity’ vs. economically motivated adulteration in the natural products supply chain. HerbalGram, 94, 40–41.

      Google Scholar 

    • DiPaola, R. S., Zhang, H., Lambert, G. M., et al. (1998). Clinical and biological activity of an estrogenic herbal combination (PC- SPES) in prostate cancer. New England Journal of Medicine, 339, 785–791.

      CrossRef  Google Scholar 

    • DSHEA, 21 U.S.C. § 321 (ff) (I) (A)–(F), 1994.

      Google Scholar 

    • Eisenberg, D. M., Kessler, R. C., Foster, C., Norlock, F. E., Calkins, D. R., & Del-Banco, T. L. (1993). Unconventional medicine in the United States: Prevalence, costs, and patterns of use. New England Journal of Medicine, 328(4), 246–252.

      CrossRef  Google Scholar 

    • FDA. (2004). FDA issues regulation prohibiting sale of dietary supplements containing ephedrine alkaloids and reiterates its advice that consumers stop using these products. FDA Press Release.

      Google Scholar 

    • FDA. (2009). Warning Letter, Burzynski Research Institute/IRB. ref: 10-HFD-45-09-0.

      Google Scholar 

    • FDA. (2010). Advancing regulatory science for public health. Washington, DC: U.S. GPO.

      Google Scholar 

    • FDA, Center for Drug Evaluation and Research. (2004). Guidance for industry: Botanical drug products. Washington, DC: U.S. GPO.

      Google Scholar 

    • Fontanarosa, P. B., Rennie, D., & DeAngelis, C. D. (2003). The need for regulation of dietary supplements – Lessons from ephedra. JAMA, 289(12), 1568–1570.

      CrossRef  Google Scholar 

    • Haller, C. A., & Benowitz, N. L. (2000). Adverse cardiovascular and central nervous system events associated with dietary supplements containing ephedra alkaloids. New England Journal of Medicine, 343(25), 1833–1838.

      CrossRef  Google Scholar 

    • Hopp, C. (2015). Past and future research at national centre for complementary and integrative health (NCCIH) with respect to botanicals. HerbalGram, 107, 44–51.

      Google Scholar 

    • Jonas, W. (2005). Building an evidence house: Challenges and solutions to research in complementary and alternative medicine. Forsch Komplementärmed Klass Naturheilkd, 12(3), 159–167.

      Google Scholar 

    • Mansky, P. J., & Straus, S. E. (2002). St John’s wort: More implications for cancer patients. Journal of the National Cancer Institute, 94(16), 1187–1188.

      CrossRef  Google Scholar 

    • Miller, F. G., Emanuel, E. J., Rosenstein, D. L., & Straus, S. E. (2004). Ethical issues concerning research in complementary and alternative medicine. JAMA, 291(5), 599–604.

      CrossRef  Google Scholar 

    • New York Times. (1993). The 1993 Snake Oil Protection Act. New York Times, October 5.

      Google Scholar 

    • Public Citizens’ Health Research Group. (2001). Petition requesting a ban of Ephedra.

      Google Scholar 

    • Ron, H. J., Verweij, M. J., de Bruijn, P., Loos, W. J., & Sparreboom, A. (2002). Effects of St. John’s wort on irinotecan metabolism. Journal of the National Cancer Institute, 94(16), 1247–1249.

      CrossRef  Google Scholar 

    • Seifried, H. E., Sorkin, B. C., & Costello, R. B. (2004). Free radicals: The pros and cons if antioxidants – Summary report of the National Institutes of Health symposium. The Journal of Nutrition, 134(11), 3143–3163.

      CrossRef  Google Scholar 

    • U.S. Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research. (2004). Guidance for industry: Botanical drug products. Washington DC: U.S. GPO.

      Google Scholar 

    • U.S. Department of Health and Human Services, Office of Inspector General. (2001). Adverse event reporting for dietary supplements: An inadequate safety valve. Washington, DC: U.S. GPO.

      Google Scholar 

    • Wang, L., & Arnold, K. (2002). Press release herbal dietary supplement alters metabolism of chemotherapy drug. Journal of the National Cancer Institute, 94(16), 1183.

      CrossRef  Google Scholar 

    • Wolfe, S. (2003). Ephedra – Scientific evidence versus money/politics. Science, 300(5618), 437.

      CrossRef  Google Scholar 

    • Zia, F., & White, J. (2009). Letter to the Editor. Integrative Cancer Therapies, 8(2), 113–114.

      CrossRef  Google Scholar 

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    This research was funded by the French National Cancer Institute (INCa) from January 2015 to January 2018.

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    Carpier, G., Cohen, P. (2018). Institutionalising the Medical Evaluation of CAM: Dietary and Herbal Supplements as a Peculiar Example of (Differential) Legitimisations of CAM in the USA. In: Brosnan, C., Vuolanto, P., Danell, JA. (eds) Complementary and Alternative Medicine. Health, Technology and Society. Palgrave Macmillan, Cham.

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