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A health claim that cannot be defended is a regulatory and reputational risk. FDA requires that substantiation exists before a claim appears on a label, not after. QSS works with your team to assess the evidentiary basis for your claims, identify what the science supports, and build a substantiation package that holds up under scrutiny.
FDA distinguishes between three types of claims on food and supplement labels. Authorized health claims characterize a relationship between a nutrient and a disease and require an FDA-approved regulation based on significant scientific agreement.
Qualified health claims are not based on promising evidence alone. FDA must review the science and issue a Letter of Enforcement Discretion specifying the qualifying language and conditions for use. Structure/function claims, available for dietary supplements, describe a nutrient's role in normal body structure or function. They do not require FDA pre-approval, but must be substantiated before appearing on a label and reported to FDA within 30 days of first use.
A claim that outpaces its evidence, or crosses into disease claim territory, creates enforcement exposure. QSS assesses your claims against the applicable framework before you commit to label language.
QSS classifies your proposed claims, identifies which regulatory framework applies, and advises on whether the language needs to be modified to stay within permissible boundaries.
QSS conducts a systematic review of the published scientific literature relevant to your ingredient and proposed claim, evaluating study quality, consistency, and the overall weight of evidence to assess whether the science supports the claim as worded.
QSS prepares a complete substantiation package documenting the scientific basis for your claim, structured to demonstrate that competent and reliable scientific evidence supports it.
Where your evidence supports a qualified health claim, QSS prepares and supports the petition to FDA, including proposed claim language and supporting scientific evidence.
For structure/function claims on dietary supplements, QSS prepares your 30-day notification under 21 CFR 101.93 and advises on the mandatory disclaimer language.
QSS reviews your existing or proposed label copy and marketing materials for claims that may not be adequately substantiated or that risk crossing into disease claim territory, and advises on how to modify language to reduce regulatory exposure.
Explore articles, blogs, and videos on health claim substantiation, FDA labeling requirements, and food ingredient compliance.
An authorized health claim characterizes a relationship between a nutrient and a disease or health condition and can only be used if FDA has issued a regulation approving it based on significant scientific agreement. A qualified health claim is permitted where the science does not yet meet that standard but is sufficient to support the claim with an appropriate qualifying disclaimer. A structure/function claim describes the role of a nutrient or ingredient in affecting normal body structure or function, does not require FDA pre-approval, but must be substantiated before it appears on a label and requires FDA notification within 30 days of first marketing. QSS assesses your proposed claim and confirms which framework applies.
Substantiation means having competent and reliable scientific evidence that your claim is truthful and not misleading before you use it. FDA has not specified a precise minimum standard for structure/function claim substantiation, but the standard is generally understood to require credible scientific evidence consistent with the nature and scope of the claim. For authorized and qualified health claims, the evidentiary bar is higher and more precisely defined. QSS assesses your evidence against the applicable standard and advises on whether it is sufficient to support the claim as worded.
A disease claim is a statement that implies your product can diagnose, cure, mitigate, treat, or prevent a specific disease or class of diseases. Disease claims require prior FDA approval and can only be made for products approved as drugs or under specific health claim regulations. A structure/function claim that crosses into disease claim territory creates enforcement exposure, including warning letters, injunctions, or seizure. QSS reviews your proposed claim language and advises on how to stay within the permissible structure/function boundary.
You are not required to notify FDA before using the claim, but you must have substantiation in place before the claim appears on your label. You are required to notify FDA no later than 30 days after first marketing the product with the claim, using the process under 21 CFR 101.93. The notification must include the text of the claim and a certification that the firm has substantiation that the statement is truthful and not misleading. QSS prepares your notification and ensures it meets all requirements.
The regulatory framework for claims differs between conventional foods and dietary supplements. Structure/function claims are available for both, but the procedural requirements, including notification and disclaimer obligations, apply specifically to dietary supplements under DSHEA. Claims on conventional food products are subject to different rules under 21 CFR Part 101. QSS advises on the applicable framework for your specific product type and claim.
If FDA determines that a claim is not adequately substantiated, makes a disease claim, or is otherwise non-compliant, it may issue a warning letter requiring the claim to be removed or modified. In more serious cases, enforcement action may follow. QSS reviews existing label claims and marketing materials to identify exposure before FDA does, and advises on how to bring non-compliant claims into line.