Table 7.
Types of claims allowed about the Efficacy of Bioactives in Foods and Dietary Supplements in the USA
| Allowed In: | Comments | ||
|---|---|---|---|
| Food | Dietary Supplements | ||
| Claim and Description | |||
|
Nutrient Content Claims |
√ | √ | The content of a bioactive in can be provided but standardized terms and units are required for nutrients but no other bioactives |
|
Dietary Guidance Statements (based on consensus recommendations from reports such as the Dietary Guidelines for Americans to suggest that ingredient helps maintain a nutritious dietary pattern) |
√ | . | FDA premarket review not required Not encouraged on supplements because authoritative sources recommend that consumers meet their nutrient needs from whole food sources |
|
Authorized Health Claims (sometimes referred to as unqualified health claims, are based on “significant scientific agreement” (SSA or unqualified health claims). Approved by FDA for use based on strong scientific consensus on the evidence. |
√ | √ | Authorized health claims communicate more specific information on the relationship between a food substance such as a bioactive ingredient and reduced risk of a disease or condition |
|
Qualified Health Claims Describe the role of a bioactive in maintaining normal healthy bodily structures or functions Refer specifically to how an ingredient impacts a disease or condition |
√ | √ | Used when evidence is less than that needed to support the SSA standard. Supported by some scientific evidence, but the quality and amount of science are less definitive, FDA conditionally permits their use only after premarket review and when specific wording is applied. |
|
Structure Function Claims In the United States, when the botanicals label states how they might help a bodily function, they are regulated as dietary supplements, but if they claim to treat a disease or illness, they are regulated as drugs (Dwyer et al., 2021 and Dwyer et al., 2018). |
√ (only for claims based on nutrients | √ | Must be truthful, not misleading, and include a disclaimer that the claim has not been evaluated by FDA (Burdock Group, 2021. |
Key: √= yes