Health Claims

What Are Health Claims?

Health claims describe the relationship between a substance (e.g., food, food component, dietary supplement) and a disease or health-related condition such as cancer or hypertension. There are three categories of claims:

  1. Health claims (including qualified health claims)
  2. Structure/function claims
  3. Nutrient content claims.
Health Claims – Require premarket approval by the U.S. Food and Drug Administration (FDA) if they are intended for use on the label of foods or dietary supplements. Health claims must meet FDA’s standard of significant scientific agreement; that is, experts qualified to assess the substance-disease relationship would agree that the scientific evidence in support of the claim is valid and substantive. Qualified health claims are based on less scientific evidence than authorized health claims and require disclaimers or qualified wording. Health claim submissions require significant amounts of published data and undergo an extensive evidence-based scientific review by FDA personnel. Information/data requirements include the definition of the substance(s), diseases, or health-related conditions; a summary of the scientific data, both positive and negative; copies of all literature searches; copies of all published information/literature; and any data regarding adverse effects.

Structure/Function Claims– Describe the relationship between a nutrient deficiency and disease, the effect of a nutrient or dietary ingredient on a structure of function in humans, or how the dietary ingredient maintains structure or function. They are focused on the maintenance of healthy metabolic function, not preventing disease. The manufacturer is responsible for ensuring the accuracy and truthfulness of the claims, and they are not evaluated/approved by FDA. Examples include such claims as drinking milk builds strong bones, calcium builds strong bones, fiber maintains bowel regularity, and antioxidants maintain cell integrity.

Nutrient Content Claims – Describe the level of a nutrient or food substance in a product, using terms like “good source,” “high in,” or “free.” Nutrient content claims are typically made for substances that have an established daily value, such as vitamins and minerals.

How Can Exponent Help You with Health Claims?

Literature Search/Compilation – Conduct computerized literature searches aimed at identifying all relevant scientific data, both positive and negative to the identified substance-disease relationship.

Regulatory Strategy – Assist in determining the type of health claim that can be supported by current scientific evidence, identifying future data requirements for the desired health claim, and planning and coordinating research activities, including manuscript preparation and publication.

Independent Evidence-Based Review – Review the scientific data in support of proposed health claims employing FDA’s Evidence-Based Ranking System for Scientific Data. Independent reviews and rankings are compiled to provide composite rankings of the supporting studies and data. Study design inadequacies, confounders, and data gaps, if any, are identified for each study and considered in the study ranking process. An estimate of the probability of success of a future health claim petition can be provided.

Document/Petition Preparation – Prepare health claim petitions, including weight-of-evidence assessments of efficacy and safety.

Regulatory Submission/Monitoring – Submit health claim petition to FDA, meet and correspond with FDA as required, and resolve scientific and regulatory issues raised by FDA.

Meta-Analysis – Perform a meta-analysis that is, a systematic review of the literature, extraction of relevant data, and quantitative analyses of data across multiple studies. Exponent’s personnel have expertise in statistical computing, using a wide variety of software packages, including SAS, SPSS, Comprehensive Meta-Analysis, Meta-Analysis MIX, and Episheet. Exponent’s epidemiologists, biostatisticians, and other scientists are well versed in conducting meta-analyses and pooled analyses of observational and clinical data. For example, we can determine an exposure/response relation across a body of scientific literature, identify sources of variation across study groups, evaluate successful intervention strategies and effective treatment options, plan and coordinate research activities, and assist with project proposal writing and feasibility assessments.

Nutritional Epidemiology – Conduct large-scale critical reviews and primary data analyses of dietary and nutritional factors as they relate to a variety of health outcomes, such as cardiovascular disease, cancer, infant allergy, childhood and adult obesity, and behavior and lifestyle patterns. When examining the role that diet plays in health outcomes, Exponent relies on the expertise of staff from a broad range of health-and food-related disciplines.

Sample Projects

  • Conducted an expert panel review of scientific data in support of a proposed qualified health claim for an infant formula product and prepared a scientific-based strength of the evidence report in support of the proposed qualified health claim using current FDA guidance.
  • Critically reviewed the scientific databases (composed of clinical, animal, and in vitro studies) in support of proposed structure/function claims for a carbonated beverage product and a nutritionally enhanced food commodity, and prepared reports reviewing the scientifically-based strength of evidence supporting the claims using current FDA guidance.
  • For a proposed anti-aging skin product, systematically reviewed published clinical trial studies and assessed both the quality and strength of the scientific data in support of desired structure/function claims. Review adhered to FDA’s Guidance for Substantiation of Dietary Supplement Claims and FDA’s Evidence-Based Ranking System.
  • Conducted feasibility and data gap assessments for a cholesterol reduction claim on a dietary supplement and for a cardiovascular risk reduction claim on a natural beverage.