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The Basis of Structure/Function Claims of Nutraceuticals

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Abstract

In the United States, as in most of the world, there are large numbers of nutraceuticals that are sold and which people take to boost their immune response. There are, in addition, almost an equal number of products sold to reduce allergies. However, very few consumers, and indeed physicians, are aware of what a structure/function claim is. Structure/function claims are labeling claims that can be used to describe the potential effects of a dietary ingredient or similar substance on the structure or function of the human body. This category of claims was created by legislation contained in the Dietary Supplement Health and Education Act. The intent was to supply consumers with reasonably substantiated information that would allow them to make educated choices about their diet and health. They were not intended to have the same weight and substantiation as the claims made for conventional prescription pharmaceuticals. Rather, they were proposed to fill the gap between consumer desire for over-the-counter supplements and foods, and rigorous and generally more potent and potentially “toxic” prescription medications. The legally mandated disclaimer, stating that the U.S. Food and Drug Administration has not evaluated the structure/function claim, often leads to misinterpretation. While there should be a biologic premise underlying the claim, there is not an absolute requirement for a conventional rigorous placebo-controlled dose response trial. While this may not be the clinical standard that a typical scientific oriented society might desire, it reflects the attempts of the FDA to find common grounds and to allow consumers to use products that are generally considered as safe based on historical use and biologic comparisons. The logic of, indeed need for, structure/function claims is straightforward; however, of equal importance is that nutraceuticals should be properly labeled, have accuracy in their ingredients, be free of contamination, be safe, and have a reasonable body of data that supports their efficacy.

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References

  1. Dickinson A, MacKay D (2014) Health habits and other characteristics of dietary supplement users: a review. Nutr J 13:14

    Article  PubMed  PubMed Central  Google Scholar 

  2. Bailey RL, Gahche JJ, Lentino CV et al (2011) Dietary supplement use in the United States, 2003–2006. J Nutr 141:261–266

    Article  CAS  PubMed  Google Scholar 

  3. Dickinson A, Blatman J, El-Dash N, Franco JC (2014) Consumer usage and reasons for using dietary supplements: report of a series of surveys. J Am Coll Nutr 33:176–182

    Article  CAS  PubMed  Google Scholar 

  4. Muth MK, Anderson DW, Domanico JL, Smith JB and Wendling B (1999) Economic characterization of the dietary supplement industry. Prepared for Clark Nardinelli, DHHS/Food and Drug Administration, Center for Economics Research, Research Triangle Institute, Research Triangle Park, NC

  5. Gershwin ME, Borchers AT, Keen CL, Hendler S, Hagie F, Greenwood MR (2010) Public safety and dietary supplementation. Ann N Y Acad Sci 1190:104–117

    Article  PubMed  Google Scholar 

  6. Taylor CL, Wilkening VL (2008) How the nutrition food label was developed, Part 2: the purpose and promise of nutrition claims. J Am Diet Assoc 108:618–623

    Article  PubMed  Google Scholar 

  7. Hegefeld HA (2000) Overview of federal regulation of dietary supplements: past, present and future trends. http://nrs.harvard.edu/urn-2013:HUL.InstRepos:8846738. Accessed 1/23/2016

  8. Department of Health and Human Services (1994) Food labeling: general requirements for health claims for dietary Supplements. Final rule. Fed Regist 59. http://www.gpo.gov. Accessed 1/14/16

  9. U.S. Department of Health and Human Services and Food and Drug Administration (2003) Guidance for industry: interim procedures for qualified health claims in the labeling of conventional human food and human dietary supplements. http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm053832.htm. Accessed 1/23/2016

  10. U.S. Department of Health and Human Services and Food and Drug Administration (2003) Guidance for industry: interim evidence-based ranking system for scientific data. http://www.fda.gov/ohrms/dockets/dockets/2004q0072/2004q-0072-pdn0001-2005-FDA-vol2015.pdf. Accessed 12/13/2015

  11. U.S. Department of Health and Human Services and Food and Drug Administration (2006) Guidance for industry: FDA’s implementation of “qualified health claims”: questions and answers. Final guidance. http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm053843.htm. Accessed 12/13/2015

  12. U.S. Department of Health and Human Services and Food and Drug Administration (2013) A food labeling guide. Guidance for industry. http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/labelingnutrition/ucm2006828.htm. Accessed 12/13/2015

  13. FDA and Department of Health and Human Services (2000) Regulations on statements made for dietary supplements concerning the effect of the product on the structure or function of the body. Final rule. Fed Regist 65:1000–1050

    Google Scholar 

  14. Office of Inspector General and Department of Health and Human Services (2003) Dietary supplement labels: an assessment. March 2003, OEI-01-01-00121

  15. Office of Inspector General and Department of Health and Human Services (2012) Dietary supplements: structure/function claims fail to meet federal requirements. October 2012, OEI-01-11-00210

  16. Morris CA, Avorn J (2003) Internet marketing of herbal products. JAMA 290:1505–1509

    Article  CAS  PubMed  Google Scholar 

  17. Chung EP, Hwang HJ, Kim M-K (2007) Evaluation of non-English dietary supplement advertisements in an ethnic minority community in America. Public Health Nutr 10:834–837

    Article  PubMed  Google Scholar 

  18. Legault L, Brandt MB, McCabe N, Adler C, Brown AM, Brecher S (2004) 2000–2001 food label and package survey: an update on prevalence of nutrition labeling and claims on processed, packaged foods. J Am Diet Assoc 104:952–958

    Article  PubMed  Google Scholar 

  19. Shimakawa T, Ferguson M (2015) Prevalence of structure function claims: 2006–2007 food label and package survey. 38th National Nutrient Databank Conference. Procedia Food Sci 4:133–137

    Article  Google Scholar 

  20. Brandt MB, Moss J, Ellwood K, Ferguson M, Asefa A (2010) Tracking label claims. Food Technol 64:34–40

    Google Scholar 

  21. Parker BJ (2003) Food for health: the use of nutrient content, health, and structure/function claims in food advertising. J Advert 32:47–55

    Article  Google Scholar 

  22. Choi H, Yoo K, Baek TH, Reid LN, Macias W (2013) Presence and effects of health and nutrition-related (HNR) claims with benefit-seeking and risk-avoidance appeals in female-orientated magazine food advertisements. Int J Advert 32:587–616

    Article  Google Scholar 

  23. Nan X, Briones R, Shen H, Jiang H, Zhang A (2013) A current appraisal of health- and nutrition-related claims in magazine food advertisements. J Health Commun 18:263–277

    Article  PubMed  Google Scholar 

  24. Yoon HJ, Paek H-J, Ahn H, Choi H (2009) Are food ads healthy? Examination of television food advertising on health claims and persuasion strategies. Health Commun Res 1:65–90

    Google Scholar 

  25. U.S. Department of Health and Human Services and Food and Drug Administration (2008) Guidance for industry: substantiation for dietary supplement claims made under section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act. http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm073200.htm. Accessed 12/13/2015

  26. GAO (U.S. Government Accountability Office) (2011) Food labeling: FDA needs to reassess its approach to protecting consumers from false or misleading claims. GAO-11-102

  27. Pomeranz JL (2013) A comprehensive strategy to overhaul FDA authority for misleading food labels. Am J Law Med 39:617–647

    PubMed  Google Scholar 

  28. GAO (U.S. Government Accountability Office) (2009) Dietary supplements: FDA should take further actions to improve oversight and consumer understanding. GAO-09-250

  29. Springer J (2013) The success of the citizen suit: protecting consumers from inaccurate food labeling by amending the Federal Food, Drug, and Cosmetic Act. Food Drug Law J 68:401–422, i-ii

    PubMed  Google Scholar 

  30. Rutkow L, Vernick JS, Edwards DM, Rodman SO, Barry CL (2015) Legal action against health claims on foods and beverages marketed to youth. Am J Public Health 105:450–456

    Article  PubMed  Google Scholar 

  31. Kapsak WR, Schmidt D, Childs NM, Meunier J, White C (2008) Consumer perceptions of graded, graphic and text label presentations for qualified health claims. Crit Rev Food Sci Nutr 48:248–256

    Article  PubMed  Google Scholar 

  32. GAO (U.S. Government Accountability Office) (2000) Food safety: improvements needed in overseeing the safety of dietary supplements and “functional foods”. GAO-00-156

  33. France KR, Bone PF (2005) Policy makers’ paradigms and evidence from consumer interpretations of dietary supplement labels. J Consum Aff 39:27–51

    Article  Google Scholar 

  34. Roe B, Levy AS, Derby BM (1999) The impact of health claims on consumer search and product evaluation outcomes: results from FDA experimental data. J Public Policy Mark 18:89–105

    Google Scholar 

  35. Wansink B, Sonka ST, Hasler CM (2004) Front-label health claims: when less is more. Food Policy 29:659–667

    Article  Google Scholar 

  36. Aschemann-Witzel J, Grunert KG (2015) Influence of ‘soft’ versus ‘scientific’ health information framing and contradictory information on consumers’ health inferences and attitudes towards a food supplement. Food Qual Prefer 42:90–99

    Article  Google Scholar 

  37. Pothoulaki M, Chryssochoidis G (2009) Health claims: consumers’ matters. J Funct Foods 1:222–228

    Article  Google Scholar 

  38. Lähteenmäki L (2013) Claiming health in food products. Food Qual Prefer 27:196–201

    Article  Google Scholar 

  39. Wong CL, Arcand J, Mendoza J et al (2013) Consumer attitudes and understanding of low-sodium claims on food: an analysis of healthy and hypertensive individuals. Am J Clin Nutr 97:1288–1298

    Article  CAS  PubMed  Google Scholar 

  40. Chrysochou P, Grunert KG (2014) Health-related ad information and health motivation effects on product evaluations. J Bus Res 67:1209–1217

    Article  Google Scholar 

  41. Mason MJ, Scammon DL (2011) Unintended consequences of health supplement information regulations: the importance of recognizing consumer motivations. J Consum Aff 45:201–223

    Article  Google Scholar 

  42. Murphy RD and FTC (2005) Consumer perceptions of qualified health claims in advertising, Washington DC

  43. Lähteenmäki L, Lampila P, Gruner KG et al (2010) Impact of health-related claims on the perception of other product attributes. Food Policy 35:230–239

    Article  Google Scholar 

  44. Orquin JL, Scholderer J (2015) Consumer judgments of explicit and implied health claims on foods: misguided but not misled. Food Policy 51:144–157

    Article  Google Scholar 

  45. Choi H, Springston JK (2014) How to use health and nutrition-related claims correctly on food advertising: comparison of benefit-seeking, risk-avoidance, and taste appeals on different food categories. J Health Commun 19:1047–1063

    Article  PubMed  Google Scholar 

  46. Paek H-J, Yoon HJ, Hove T (2011) Not all nutrition claims are perceived equal: anchoring effects and moderating mechanisms in food advertising. Health Commun 26:159–170

    Article  PubMed  Google Scholar 

  47. Meer M, Misner S, Meer R (2004) Labeling of dietary supplements: consumer awareness and industry compliance. J Nutraceuticals Funct Med Foods 4:29–44

    Article  Google Scholar 

  48. Dodge T, Kaufman A (2007) What makes consumers think dietary supplements are safe and effective? The role of disclaimers and FDA approval. Health Psychol 26:513–517

    Article  PubMed  Google Scholar 

  49. Mason MJ, Scammon DL, Fang X (2007) The impact of warnings, disclaimers, and product experience on consumers’ perception of dietary supplements. J Consum Aff 41:74–99

    Article  Google Scholar 

  50. Andrews JC (2011) Waring and disclosures. In: Communicating risks and benefits: an evidence-based user’s guide. B Fischhoff, NT Brewer and JS Downs. U.S. Food and Drug Administration, Silver Spring, MD

  51. Pillitteri JL, Shiffman S, Rohay JM, Harkins AM, Burton SL, Wadden TA (2008) Use of dietary supplements for weight loss in the United States: results of a national survey. Obesity (Silver Spring) 16:790–796

    Article  CAS  Google Scholar 

  52. Miller CK, Russell T (2004) Knowledge of dietary supplement label information among female supplement users. Patient Educ Couns 52:291–296

    Article  PubMed  Google Scholar 

  53. DeLorme DE, Huh J, Reid LN, An S (2012) Dietary supplement advertising in the US: a review and research agenda. Int J Advert 31:547–577

    Article  Google Scholar 

  54. Kesselheim AS, Connolly J, Rogers J, Avorn J (2015) Mandatory disclaimers on dietary supplements do not reliably communicate the intended issues. Health Aff (Millwood) 34:438–446

    Article  Google Scholar 

  55. Dodge T, Litt D, Kaufman A (2011) Influence of the Dietary Supplement Health and Education Act on consumer beliefs about the safety and effectiveness of dietary supplements. J Health Commun 16:230–244

    Article  PubMed  Google Scholar 

  56. Ashar BH, Miller RG, Pichard CP, Levine R, Wright SM (2008) Patients’ understanding of the regulation of dietary supplements. J Community Health 33:22–30

    Article  PubMed  Google Scholar 

  57. Heller IR (2001) Functional foods: regulatory and marketing developments. Food Drug Law J 56:197–225

    CAS  PubMed  Google Scholar 

  58. U.S. Department of Health and Human Services and Food and Drug Administration (2010) Guidance for industry: current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements; small entity compliance guide. http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm238182.htm. Accessed 12/13/2015

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Authors and Affiliations

  1. Division of Rheumatology, Allergy and Clinical Immunology, University of California at Davis School of Medicine, 451 Health Sciences Drive, Suite 6510, Davis, CA, 95616, USA

    Andrea T. Borchers & M. Eric Gershwin

  2. Department of Nutrition, University of California at Davis, Davis, CA, USA

    Carl L. Keen

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  1. Andrea T. Borchers
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  2. Carl L. Keen
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  3. M. Eric Gershwin
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Correspondence to M. Eric Gershwin.

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Borchers, A.T., Keen, C.L. & Gershwin, M.E. The Basis of Structure/Function Claims of Nutraceuticals. Clinic Rev Allerg Immunol 51, 370–382 (2016). https://doi.org/10.1007/s12016-016-8536-9

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