Structure/Function Claim

Understanding Structure/Function Claims

Structure/Function Claims are statements that describe how a nutrient or dietary ingredient affects the normal structure or function of the human body. These claims are regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA) in the United States. For example, a claim that 'calcium builds strong bones' is a structure/function claim because it describes the role of calcium in maintaining normal bone structure without suggesting it treats any disease.

According to the U.S. Food and Drug Administration (FDA), manufacturers must notify the FDA within 30 days of marketing a dietary supplement with a structure/function claim. These claims must be truthful and not misleading, and they must include a disclaimer stating that the product has not been evaluated by the FDA and is not intended to diagnose, treat, cure, or prevent any disease.

Practical Compliance for Food Brands

For food brands, understanding and correctly using structure/function claims can help in marketing products effectively while staying within regulatory guidelines. Brands must ensure that these claims do not suggest any disease prevention or treatment and must be supported by scientific evidence. Misuse can lead to regulatory actions from the FDA, including warning letters or product seizures.

To assist in compliance, NutriCalcPro offers a nutrition label generator that can help brands accurately reflect nutrient content and ensure their claims are within legal boundaries. By using reliable tools and staying informed about regulations, brands can confidently market their products while maintaining consumer trust.