Health Claims

What Is a Health Claim? A health claim is a statement on a food, dietary supplement, or beverage label that connects a substance to a reduced risk of a specific disease or health condition, such as "calcium may reduce the risk of osteoporosis." Because health claims make a direct connection to disease risk, they require a much higher level of scientific substantiation than most other types of label language, and in the United States they must be either authorized by the FDA or qualified with specific disclaimer language. A brand can't create its own health claim from scratch; it must use language that fits within an existing authorized or qualified category. What Are the Different Types of Health Claims? The main categories of health claims recognized under U.S. regulations are authorized health claims, which are based on significant scientific agreement and have gone through a formal FDA review process, and qualified health claims, which are supported by emerging but less conclusive evidence and must include a disclaimer describing the limited nature of that evidence. A related but distinct category, nutrient content claims, describes the level of a nutrient in a product, such as "low fat" or "excellent source of fiber," without making a disease-risk connection. Structure/function claims, which describe how an ingredient affects the body's normal structure or function, such as "supports bone health," are also distinct from health claims and don't require the same disease-risk substantiation. Health Claims vs. Structure/Function Claims Health claims and structure/function claims are frequently confused, but the distinction matters enormously for compliance. A health claim explicitly links a product to reduced disease risk and requires FDA authorization or a qualifying disclaimer, while a structure/function claim describes a normal, non-disease-related effect on the body and doesn't require pre-approval, though it still must be truthful and substantiated. A supplement brand that wants to say its product "may reduce the risk of heart disease" is making a health claim and needs to meet that category's requirements, while a brand that says its product "supports heart health" is making a structure/function claim, which carries a different, generally lower substantiation bar. Why Are Health Claims So Tightly Regulated? Health claims are tightly regulated because they speak directly to disease risk, a category of statement regulators treat with the same scrutiny as drug claims, given the potential for a false or misleading health claim to influence a consumer's medical decisions. The FTC also plays a role alongside the FDA, since health claims used in advertising and marketing, not just on package labels, must meet a truth-in-advertising standard backed by competent and reliable scientific evidence. A brand that uses health claim language without proper authorization or substantiation risks warning letters, forced reformulation of its marketing, or FTC enforcement action. Common Examples of Health Claims in Consumer Health Marketing A supplement brand uses an FDA-authorized health claim connecting calcium intake to reduced osteoporosis risk on its packaging.A functional food brand adds a qualified health claim about an ingredient's association with reduced cardiovascular risk, along with the required disclaimer language.A CPG brand works with regulatory counsel to confirm that a proposed claim is a structure/function claim rather than an unauthorized health claim.A beverage brand revises its marketing copy after realizing a phrase implied a disease-risk connection that its clinical data didn't support. What Health Claims Mean for Your Brand Understanding exactly which category a proposed claim falls into, health claim, qualified health claim, structure/function claim, or nutrient content claim, is one of the most important steps in building compliant, defensible marketing for a consumer health product. Getting this distinction right from the start protects a brand from regulatory risk while still allowing it to communicate real, evidence-backed benefits to customers. Frequently Asked Questions What is a health claim? A health claim is a regulated statement that describes a relationship between a food, ingredient, or supplement and a reduced risk of a specific disease or health condition. What is the difference between a health claim and a structure/function claim? A health claim links a product to reduced disease risk and requires FDA authorization or a qualifying disclaimer, while a structure/function claim describes a normal effect on the body's structure or function without that same disease-risk connection. What is a qualified health claim? A qualified health claim is a health claim supported by emerging but not yet conclusive scientific evidence, which must include a disclaimer describing the limited strength of that evidence. Can a brand create its own health claim? No, a brand cannot create an original health claim; it must use language that fits within an FDA-authorized or FDA-qualified health claim category, since these claims require formal regulatory review. Are health claims regulated by the FDA or the FTC? Health claims fall under both agencies: the FDA regulates health claims on product labels, while the FTC regulates health claims made in advertising and marketing, both requiring adequate scientific substantiation. What happens if a brand uses an unauthorized health claim? A brand that uses an unauthorized or unsubstantiated health claim risks FDA warning letters, forced changes to its labeling or marketing, and potential FTC enforcement action. Ready to build health claims that are both compliant and compelling? Talk to Citruslabs.