Claims on Foods and Dietary Supplements

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When referencing food and health products, there are three types of claims: health claims, structure/function claims, and nutrient content claims. The following are explanations of each:

Health claims require premarket approval by the U.S. Food and Drug Administration (FDA) for the U.S. market and by the European Commission and the European Food Safety Authority (EFSA) in the EU if they are intended for use on the label of foods or dietary supplements. Health claims must meet the FDA's standard of significant scientific agreement; that is, experts qualified to assess the substance-disease relationship agree that the scientific evidence in support of the claim is valid and substantive. These thorough assessments must include the definition of the substance(s), diseases, or health-related conditions; a summary of the scientific data, both positive and negative; and any data regarding adverse effects. In the EU, an evaluation of the data provided to substantiate a health claim is undertaken by EFSA to determine whether typical intake of a particular nutrient or ingredient provides the effect claimed. In the EU, health claims cannot be associated with disease reduction or prevention.
Structure/function claims describe the relationship between a nutrient deficiency and disease, the effect of a nutrient or dietary ingredient on a structure or function in the human body, or how the dietary ingredient maintains structure or function. These claims must be focused on the maintenance of healthy metabolic function, not preventing disease, and the manufacturer is responsible for ensuring the accuracy and truthfulness of the claims. Examples include such claims as 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, e.g., terms like "good source," "high in," or "free from." Nutrient content claims are typically made for substances that have an established daily value, such as vitamins and minerals.

Services

For 50+ years, we’ve thrived on solving unstructured problems that require bespoke solutions. Some of our services include:

• Literature searches to identify all relevant scientific data and critical reviews to develop weight-of-evidence assessments

• Regulatory strategies to determine the type of health claim that can be supported by current scientific evidence, to identify future data requirements, and to plan and coordinate research activities

• Independent evidence-based reviews of scientific data for proposed health claims employing FDA’s Evidence-Based Review System for the Scientific Evaluation of Health Claims or benchmarking against EFSA’s data requirements for health claims

• Document preparation, including structure/function claims substantiation dossiers

• Regulatory submission and monitoring of health claim petitions to the FDA, EFSA, or national agencies such as the U.K. FSA, including, where appropriate, meeting and corresponding with the agencies and resolving scientific and regulatory issues raised

• Secondary data analyses of dietary and nutritional factors as they relate to a variety of health outcomes, such as cardiovascular disease, cancer, infant allergies, childhood and adult obesity, and behavior and lifestyle patterns

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