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Structure/function claims describe the role of a nutrient or dietary ingredient in affecting the normal structure or function of the human body. These claims focus on maintaining general health and wellness rather than diagnosing, treating, curing, or preventing a specific disease.
Examples of structure/function claims include:
- “Supports immune health.”
- “Promotes joint flexibility.”
- “Helps maintain cardiovascular health.”
These claims differ from health claims, which require FDA approval and involve a direct relationship between a nutrient and a reduced risk of a disease (e.g., “Calcium may reduce the risk of osteoporosis”).
Structure/function claims can be an important part of marketing dietary supplements, by allowing brands to communicate the potential benefits of their products to consumers.
Any label claim must be truthful and not misleading to consumers, but structure function claims have some specific substantiation and labeling criteria that must be met.
Substantiation involves using credible studies, research, or scientific reviews to support the claim being made. The evidence should relate directly to the nutrient or ingredient in the supplement, in the same form and dose as in the product. Any claim used should align with generally accepted scientific understanding of the ingredient’s effects on the body.
The FDA recommends maintaining a file of the substantiating evidence, including peer-reviewed studies, clinical trials, or other relevant research. Our regulatory team can assist by compiling or reviewing a substantiation package.
Notification to FDA about the structure/function claim you intend to make is required within 30 days of marketing the product.
A disclaimer must be used on the label of a dietary supplement making a structure/function claim, alerting consumers that the statement has not been evaluated by the FDA.
Accurate and substantiated structure/function claims build trust with consumers while ensuring compliance with FDA regulations. Non-compliance can lead to warning letters, fines, or even removal of products from the market.
Navigating the complexities of dietary supplement regulations can be challenging. SGS Nutrasource specializes in regulatory consulting, including label reviews, claim substantiation, and FDA notifications. Our team of experts ensures your structure/function claims are accurate, compliant, and backed by reliable scientific evidence.