Dietary Supplement Handbook: Part 9 - Authorized and Qualified Health Claims

Health claims are regulatory organization and medical industry marketing terms that refer to qualified or approved claims that a food and/or supplement reduces the risk of diseases or health-related conditions. There are two types of health claims.

An authorized health claim for a food or supplement having a marketing relationship with disease and health-related condition risk reduction is when there is significant scientific agreement in a substance/disease connection, that includes the sole-discretion of review by the FDA, for approval in marketing disease and health-related conditions using food and supplements.

A qualified health claim for a food or supplement having a marketing relationship with disease and health-related condition risk reduction is when agreement of scientific evidence is insufficient or entirely lacking in the substance/disease connection, thereby requiring private medical consensus or evidence-based review of applicable experts on any science available, that includes the sole-discretion of review by the FDA, for qualification in marketing disease and health-related conditions using food and supplements.