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Claims can be an important part of communicating the benefits and value of a dietary supplement, but each claim must be supported by appropriate scientific evidence and comply with applicable U.S. regulatory requirements. Understanding the distinction between claim types - and the requirements that apply to each - is essential for reducing regulatory risk and ensuring your messaging is truthful and not misleading.
The SGS Nutrasource team provides scientific and regulatory expertise to help companies evaluate, substantiate, and strategically develop claims for dietary supplements.
We work with you to:
- Strategically assess applicable U.S. regulations and claim requirements
- Review the scientific literature for supporting evidence
- Evaluate the strength, relevance, and quality of available evidence
- Assess proposed claims and identify potential regulatory concerns
- Develop appropriate claim language and substantiation strategies
- Identify evidence gaps and opportunities for additional research
- Design a clinical trial when additional evidence is needed
- Support applicable FDA notifications, petitions, and regulatory documentation
- Provide ongoing scientific and regulatory guidance throughout product development and commercialization
Structure/Function Claims
- Structure/function claims describe the role of a dietary ingredient in affecting or maintaining the normal structure or function of the body. Structure/function claims do not require FDA pre-approval, but notification to FDA is mandatory within 30 days of first marketing the product. Companies must have substantiation that the claims are truthful and not misleading.
- Our experts can evaluate proposed structure/function claims, assess the supporting evidence, and help develop a substantiation strategy that aligns with applicable requirements.
Health Claims
- Health claims describe a relationship between a substance and reduced risk of a disease or health-related condition. Unlike structure/function claims, each approved health claim is subject to specific criteria and new claims require authorization by the FDA prior to use.
- We can help assess proposed health claims, evaluate the scientific evidence, identify appropriate regulatory pathways, and develop the supporting scientific and regulatory documentation.
Nutrient Content Claims
- Nutrient content claims characterize the level of a nutrient in a dietary supplement, such as claims using terms like “high,” “low,” or “free.” These claims must meet specific regulatory criteria to be used appropriately.
- Our team can assess proposed nutrient content claims against applicable requirements and help ensure that the claim is supported by the product’s composition and meets relevant regulatory criteria.
Learn how we can help you substantiate your dietary supplement claims and communicate product benefits with confidence.