Short answer: a published study is a scientific record, not a marketing permission. In the United States, a dietary supplement may carry structure/function statements about how an ingredient affects normal structure or function of the body, but it may not be marketed as affecting a named disease — no matter how much peer-reviewed research exists on that disease. This page explains where that line sits, gives a worked example, and lists the identity and documentation data a formulator should hold before a claim review.
The distinction, in one table
| Aspect | Structure/function statement | Disease claim |
|---|---|---|
| What it addresses | Normal structure or function of the body | A named disease or its symptoms |
| Regulatory position (US dietary supplement) | Permitted, subject to conditions | Renders the product an unapproved new drug |
| Disclaimer required | Yes — see 21 CFR 101.93 | Not curable by a disclaimer |
| FDA notification | Notification within 30 days of first marketing (21 CFR 101.93) | Not applicable |
| Substantiation held by | The finished-product marketer | — |
| Ingredient supplier’s role | Supply identity, purity and documentation | None |
The relevant section is 21 CFR 101.93, “Certain types of statements for dietary supplements.” It sets out both the notification requirement and the disclaimer that must accompany a structure/function statement: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
Two points are widely misunderstood by sourcing teams. First, the disclaimer does not convert a disease claim into a permitted one — it accompanies permitted statements, it does not rescue impermissible ones. Second, the boundary is drawn on what the marketing says, not on what the ingredient is. The same well-characterised compound can be sold compliantly or non-compliantly depending entirely on the finished-product copy.
A worked example: research volume does not create claim room
A 2025 review in Nutrients surveyed a range of nutraceutical compounds that have been studied in relation to fibromyalgia (Antonelli A., Bianchi M., Fear E., Nutrients 2025;17(3):530, doi:10.3390/nu17030530). It is a real, citable, peer-reviewed paper, and it is exactly the kind of source a formulator will bring to a sourcing conversation.
It still creates no claim room. Fibromyalgia is a named disease. A US dietary supplement may not be marketed for fibromyalgia, for its symptoms, or as an alternative to a prescription medicine indicated for it — regardless of how many studies exist, how favourable they are, or how carefully the sentence is worded. Citing the paper on a product page does not change that; naming the disease alongside the product is itself the problem.
This is the general rule, and it is worth stating plainly because it is where most compliance failures begin: a disease-associated research literature is a reason to characterise an ingredient carefully, not a licence to position a product against the disease. The same logic applies to any indication-linked literature — metabolic, cognitive, hepatic or otherwise.
What a supplier can properly contribute is the part that is verifiable: identity, standardisation, purity, analytical method and documentation. That is the subject of the rest of this page.
Identity data to hold before any claim review
A claim discussion that begins before identity is settled tends to go in circles. Fix the substance first. Every value below is taken from PubChem’s compound records and can be checked independently against the CID given.
| Active | CAS | Formula | MW | PubChem CID | InChIKey |
|---|---|---|---|---|---|
| Palmitoylethanolamide (PEA) | 544-31-0 | C18H37NO2 | 299.5 | 4671 | HXYVTAGFYLMHSO-UHFFFAOYSA-N |
| Alpha-lipoic acid (racemic) | 1077-28-7 | C8H14O2S2 | 206.3 | 864 | AGBQKNBQESQNJD-UHFFFAOYSA-N |
| R-(+)-alpha-lipoic acid | see note below | C8H14O2S2 | 206.3 | 6112 | AGBQKNBQESQNJD-SSDOTTSWSA-N |
| Curcumin | 458-37-7 | C21H20O6 | 368.4 | 969516 | VFLDPWHFBUODDF-FCXRPNKRSA-N |
| Quercetin | 117-39-5 | C15H10O7 | 302.23 | 5280343 | REFJWTPEDVJJIY-UHFFFAOYSA-N |
| Luteolin | 491-70-3 | C15H10O6 | 286.24 | 5280445 | IQPNAANSBPBGFQ-UHFFFAOYSA-N |
| Withaferin A | 5119-48-2 | C28H38O6 | 470.6 | 265237 | DBRXOUCRJQVYJQ-CKNDUULBSA-N |
Why the alpha-lipoic acid rows matter
Racemic alpha-lipoic acid and the R-(+)-enantiomer share a molecular formula and a molecular weight. A specification that states only “alpha-lipoic acid, C8H14O2S2, 206.3” therefore does not distinguish them, and neither does a purity figure — a 99% racemate is 99% pure and still approximately half S-enantiomer.
The reliable machine-readable discriminator is the final block of the InChIKey: -UHFFFAOYSA-N denotes undefined or unspecified stereochemistry, while -SSDOTTSWSA-N denotes the defined R configuration. If enantiomeric form matters to your formulation, specify it by InChIKey and require a chiral assay method on the COA rather than relying on the product name. Our fuller treatment of these forms is in the alpha-lipoic acid sourcing guide.
Note on the R-enantiomer CAS: we do not publish a CAS number for R-(+)-alpha-lipoic acid here because we could not confirm one against a primary registry at the time of writing. The PubChem CID and InChIKey above are primary-sourced and unambiguous; use those. We would rather leave a cell marked than publish an identifier a buyer cannot verify.
Documentation checklist
Before a regulatory or claim review, assemble the following for each active. This is the same list we supply on request.
- Certificate of Analysis (COA) — batch-specific, with the assay method named, not just a result.
- Specification sheet — identity, assay basis, stereochemistry where applicable, particle size, residual solvents, heavy metals, microbiological limits.
- Analytical method — including a chiral method where enantiomeric form is specified.
- Allergen and GMO statements.
- Stability data — relevant to the intended format and shelf life.
- Botanical identity documentation — for plant-derived actives, the species, plant part and marker compound with its standardisation basis.
- Safety and regulatory status documentation for the intended market.
Our quality systems and certification position are set out on the Quality & Certifications page. Certificates are provided under buyer review on request.
What we do and do not supply
Nutrition BioTech supplies ingredients and the documentation that characterises them. We do not supply claim language, and we do not support disease positioning for any material we sell. Where a customer asks us to confirm an effect on a named condition, the answer is no — and the reason is the boundary described above, not reticence about our materials.
Frequently asked questions
Can we cite a peer-reviewed study on our product page?
Citing literature is not itself prohibited, but a citation does not expand what you may claim. If the cited study concerns a named disease, referencing it next to your product can create a disease claim by implication even when your own sentence is carefully worded. Treat the citation and the claim as one combined statement and review them together.
Does the FDA disclaimer make a disease claim acceptable?
No. The disclaimer in 21 CFR 101.93 accompanies permitted structure/function statements. It does not convert an impermissible disease claim into a permitted one.
Who holds the substantiation for a structure/function claim?
The finished-product marketer. An ingredient supplier can provide identity, purity, method and stability documentation, but substantiation for a claim made on a finished product sits with the company making that claim.
Can you put the claim we want on the COA?
No. A COA reports analytical results for a batch. Adding positioning language to it would compromise the document’s function and its value to your own auditors.
How do we specify enantiomeric form so there is no ambiguity?
Specify the InChIKey in the purchase specification and require a chiral analytical method on the COA. Product names and purity percentages do not distinguish a racemate from a single enantiomer.
What documents can we get before committing to a sample?
Specification sheet, a representative COA, allergen and GMO statements, and our certification summary. Request them through the contact page.
Request a specification, COA or sample
Tell us the active, the intended format and your target specification, and we will send the documentation set for review. Request a sample, COA or spec →
Related reading: Ingredient Selection Guides · Quality & Certifications
This page describes United States regulatory concepts for dietary supplements in general terms for sourcing and procurement purposes. It is not legal advice, and it does not describe requirements in other markets. Confirm your position with qualified regulatory counsel before finalising finished-product copy.