Revisiting the Definition of ‘Healthy’ Participants in Substantiation of Structure/Function Claims for Dietary Supplements

Figures & data

Table 1. Defining populations for dietary reference intakes National (National Academies of Sciences 2022). Summarized for the purposes of this perspective.

Q1: Who should be included in the ‘healthy population’ definition to adequately characterize the population covered by the DRIs? The phrase “apparently healthy population” (or “general population” or “healthy population”) has been used by DRI committees to define the population covered by the DRIs as mentioned above in the text.

Q2: Is it assumed that subpopulations with risk factors for chronic diseases (such as overweight or obesity, high blood pressure, hypercholesterolemia, or prediabetes) are considered to meet the current definition since they do not meet the exclusion criteria listed above? Unless there is reason to specifically exclude certain subpopulations, those at risk of chronic disease should be included. Individuals within subpopulations that are at risk for, or who have, a chronic disease and are also taking medications that alter the absorption should be evaluated in light of their specific condition.

Q3: Should a different term be considered other than “apparently healthy” population since the DRIs are developed to determine the recommended intake of nutrients to meet the needs of the majority of the general population and the health status of this population has shifted? The term “exception” should be used in place of “exclusion” to describe the characteristics in the subgroups not to be included in the general population for the DRIs.

Q4: How should overweight and obesity be considered given the high prevalence of obesity? Recommendation is to include populations who are overweight or with obesity because they sometimes represent a large segment of the population. However, when these individuals also have severe comorbidities and other metabolic disorders, they may be excluded from the population if there is evidence that their condition or medications alter their energy or other nutrient requirements.

Q5: How should this definition inform the use of the DRIs for their various purposes? Specific exceptions to the general population should be determined on a nutrient-by-nutrient basis. Exceptions would be based on evidence that a particular disease, health condition, disability, or medication is likely to alter the requirement for the nutrient under review.

Table 2. Criteria to determine if a claim is a structure/function claim or a disease claim FDA 2017: Ten criteria to assist in deciding whether a claim is or isn’t a disease claim, the new regulation contains a definition for disease (National Academies of Sciences 2022): Summarized for the purposes of this perspective.

Disease claims should, explicitly or implicitly, state that the dietary supplement has an effect on the following:
1	A specific disease(s)
2	Symptoms characteristic to a specific disease(s)
3	Consequence of a natural state of symptoms constituting a health abnormality,
4	Disease through the dietary supplement, the formulation including the claim that the product contains an ingredient that is regulated as a drug by FDA for preventing or treating a disease, citations that refer to its use for disease, use of the term disease, use of visuals
5	Belongs to a class of products intended to diagnose, mitigate, treat, cure, or prevent a disease
6	Is a substitute for a disease therapy
7	Augments a therapeutic action
8	A role in the body’s response to a disease
9	Treats, prevents, or mitigates adverse events associated with a therapy for a disease with symptoms
10	Otherwise suggests an effect on a disease(s)

National Academies of Sciences, Engineering, and Medicine. 2022. Defining populations for dietary reference intake recommendations: A letter report. Washington, DC: The National Academies Press; p. 50. https://nap.nationalacademies.org/catalog/26733/defining-populations-for-dietary-reference-intake-recommendations-a-letter-report.

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FDA. 2017. Small entity compliance guide on structure/function claims. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/small-entity-compliance-guide-structurefunction-claims

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