In the expanding market of dietary supplements, consumers are bombarded with various claims on product labels promising numerous health benefits.
Understanding the distinctions between these claims is critical to ensuring compliance with FDA rules. This article will assist you in making informed decisions.
The three primary categories of claims used on dietary supplements are health claims, nutrient content claims, and structure/function claims. Each serves a unique purpose and is regulated differently by the FDA.
- Health Claims
Definition: Health claims describe the relationship between a dietary supplement ingredient and the reduction of risk for a disease or health-related condition. These claims are specific in linking a nutrient or ingredient to the prevention or mitigation of a disease.
Regulation: Health claims must be substantiated by scientific evidence and approved by the FDA. This process involves rigorous scientific review to ensure the claim is backed by significant scientific agreement among qualified experts. There are two types of health claims:
Authorized Health Claims: These claims are based on significant scientific agreement and must undergo a pre-approval process by the FDA. The scientific evidence supporting these claims is robust and generally accepted by the medical community.
Qualified Health Claims: When the scientific evidence does not meet the rigorous standards for an authorized health claim but still suggests a potential benefit, a qualified health claim may be used. These claims must include a disclaimer or qualifying language to indicate the level of scientific evidence.
Example:
- “Calcium may reduce the risk of osteoporosis.”
Importance: Health claims are powerful marketing tools because they directly link a supplement to disease prevention. However, the stringent regulatory requirements ensure that only scientifically proven claims are made, protecting consumers from false or misleading information.
- Nutrient Content Claims
Definition: Nutrient content claims describe the level of a nutrient or dietary substance in the product, using terms such as “free,” “high,” and “low,” or they compare the level of a nutrient in a food to that of another food, using terms such as “more,” “reduced,” and “lite.”
Regulation: These claims must comply with FDA regulations that define specific terms. For example, for a product to be labeled as “high in vitamin C,” it must contain at least 20% of the Daily Value (DV) per serving. These claims do not require pre-approval but must be truthful and not misleading.
Example:
- “High in vitamin D”
- “Low in sodium”
Importance: Nutrient content claims help consumers quickly understand the nutritional value of a supplement. By adhering to FDA definitions, these claims provide a standardized way of communicating nutrient levels, making it easier for consumers to compare products and make informed choices.
Structure/Function Claims
Definition: Structure/function claims describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body, or they characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function. Unlike health claims, structure/function claims do not reference disease prevention or risk reduction.
Regulation: Structure/function claims do not require pre-approval by the FDA. However, manufacturers must have substantiation that the claim is truthful and not misleading. Additionally, products with these claims must include a disclaimer stating that the FDA has not evaluated the claim and that the product is not intended to diagnose, treat, cure, or prevent any disease. The FDA must be notified within 30 days of marketing the supplement with a structure/function claim.
Example:
- “Supports immune health”
- “Helps maintain healthy joint function”
- “Promotes relaxation”
Importance: Structure/function claims are the most common type of claim on dietary supplements. They allow manufacturers to communicate the benefits of their products without the stringent scientific evidence required for health claims. The disclaimer ensures that consumers understand the scope of the claim, promoting transparency.
Key Differences
Pre-Approval:
- Health Claims: Require FDA pre-approval based on substantial scientific evidence.
- Nutrient Content Claims: Must adhere to FDA-defined terms but do not require pre-approval.
- Structure/Function Claims: Do not require pre-approval but must be substantiated and include a disclaimer.
Scientific Evidence:
- Health Claims: Need significant scientific agreement or authoritative statements.
- Nutrient Content Claims: Rely on established FDA definitions.
- Structure/Function Claims: Require substantiation by the manufacturer but are not subjected to the same level of scientific scrutiny as health claims.
Purpose:
- Health Claims: Link a nutrient to a disease risk reduction.
- Nutrient Content Claims: Describe the amount of a nutrient in the product.
- Structure/Function Claims: Describe the role of a nutrient in maintaining normal body function.
Conclusion
Understanding the distinctions between the three categories of claims used on dietary supplements is essential for regulatory compliance and consumer protection. Health claims require rigorous scientific evidence and FDA approval, ensuring only proven benefits are advertised. Nutrient content claims provide clear information about the nutrient levels in a product, helping consumers make informed choices. Structure/function claims, while not requiring pre-approval, must be truthful and include disclaimers to maintain transparency.
To ensuring these claims are accurately represented and compliant with FDA regulations is crucial for maintaining product integrity and consumer trust. By navigating these regulations effectively, manufacturers can promote their products' benefits responsibly while safeguarding public health.
Reference:
- U.S. Food & Drug Administration. (2013). Guidance for Industry: A Food Labeling Guide (14. Appendix A: Definitions of Nutrient Content Claims). Retrieved from FDA.gov
- U.S. Food & Drug Administration. (2018). Structure/Function Claims. Retrieved from FDA.gov
- U.S. Food & Drug Administration. (2019). Dietary Supplement Current Good Manufacturing Practices (CGMPs) and Interim Final Rule (IFR) Facts. Retrieved from FDA.gov
