The Basis of Structure/Function Claims of Nutraceuticals

Andrea T. Borchers, Carl L Keen, M. Eric Gershwin

Research output: Contribution to journalReview article

6 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)370-382
Number of pages13
JournalClinical Reviews in Allergy and Immunology
Volume51
Issue number3
DOIs
StatePublished - Dec 1 2016

Fingerprint

Dietary Supplements
Prescription Drugs
Poisons
United States Food and Drug Administration
Legislation
Human Body
Health Education
Prescriptions
Hypersensitivity
Placebos
Diet
Physicians
Weights and Measures
Health

Keywords

  • Alternative medicine
  • Dietary supplements
  • FDA
  • Immune booster
  • Integrative medicine
  • Nutraceuticals

ASJC Scopus subject areas

  • Immunology and Allergy

Cite this

The Basis of Structure/Function Claims of Nutraceuticals. / Borchers, Andrea T.; Keen, Carl L; Gershwin, M. Eric.

In: Clinical Reviews in Allergy and Immunology, Vol. 51, No. 3, 01.12.2016, p. 370-382.

Research output: Contribution to journalReview article

Borchers, Andrea T. ; Keen, Carl L ; Gershwin, M. Eric. / The Basis of Structure/Function Claims of Nutraceuticals. In: Clinical Reviews in Allergy and Immunology. 2016 ; Vol. 51, No. 3. pp. 370-382.
@article{58afcbfa0c6647f880b50b9910cbb437,
title = "The Basis of Structure/Function Claims of Nutraceuticals",
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.",
keywords = "Alternative medicine, Dietary supplements, FDA, Immune booster, Integrative medicine, Nutraceuticals",
author = "Borchers, {Andrea T.} and Keen, {Carl L} and Gershwin, {M. Eric}",
year = "2016",
month = "12",
day = "1",
doi = "10.1007/s12016-016-8536-9",
language = "English (US)",
volume = "51",
pages = "370--382",
journal = "Clinical Reviews in Allergy and Immunology",
issn = "1080-0549",
publisher = "Humana Press",
number = "3",

}

TY - JOUR

T1 - The Basis of Structure/Function Claims of Nutraceuticals

AU - Borchers, Andrea T.

AU - Keen, Carl L

AU - Gershwin, M. Eric

PY - 2016/12/1

Y1 - 2016/12/1

N2 - 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.

AB - 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.

KW - Alternative medicine

KW - Dietary supplements

KW - FDA

KW - Immune booster

KW - Integrative medicine

KW - Nutraceuticals

UR - http://www.scopus.com/inward/record.url?scp=84996486988&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84996486988&partnerID=8YFLogxK

U2 - 10.1007/s12016-016-8536-9

DO - 10.1007/s12016-016-8536-9

M3 - Review article

C2 - 27122022

AN - SCOPUS:84996486988

VL - 51

SP - 370

EP - 382

JO - Clinical Reviews in Allergy and Immunology

JF - Clinical Reviews in Allergy and Immunology

SN - 1080-0549

IS - 3

ER -