Review dietary supplement labels with cited findings

ArcheSync reviews supported dietary supplement label elements, including Supplement Facts, ingredients, identity, and claims. Findings identify relevant provisions and questions needing further review. Checking label wording does not establish scientific substantiation, verify that a notification was submitted, or settle whether a product is lawfully marketed as a supplement.

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Demonstration render of a fictional omega-3 fish oil softgel bottle. — Demonstration artwork. Fictional brand, not a customer label.

What a supplement review covers.

Supplement labels share most food-label rules and add their own panel and claim requirements.

Statement of identity
The term "dietary supplement" as part of the statement of identity.
21 CFR 101.3(g)
Supplement Facts
Serving size, servings per container, dietary ingredients with %DV or the "Daily Value not established" mark, and footnotes.
21 CFR 101.36
Other ingredients
Listed immediately below the panel when sources are named inside it.
21 CFR 101.4(g)
Structure/function claims
Claim wording, the linking symbol and the disclaimer on the same panel.
21 CFR 101.93
Disease claims
Wording that implies the product treats or mitigates a disease is marked for review.
21 CFR 101.93(g)(2)
Major food allergens
Fish, shellfish and tree nut sources named by species.
FD&C Act §403(w)(1), (2)
Name and place of business
Manufacturer, packer or distributor with a qualifying phrase.
21 CFR 101.5
Adverse event contact
A domestic address or phone number for serious adverse event reports.
FD&C Act §761

An annotated example.

The demonstration fish oil bottle claims it "helps reduce high triglycerides". The wording names a disease state, so the finding comes back as Review.

Flat label artwork for a fictional omega-3 fish oil dietary supplement with a Supplement Facts panel and a boxed disclaimer. — Demonstration artwork. Fictional brand, not a customer label.

Evidence: The label prints "Helps reduce high triglycerides.*" with the asterisk linking it to the boxed disclaimer.
Why: "High triglycerides" names a disease state, so the claim may imply that the product treats or mitigates a disease (21 CFR 101.93(g)(2)). The disclaimer does not make a disease claim acceptable. The regulation does not list this exact phrase, which is why the status is Review rather than Flag.
Next step: Consider wording limited to normal structure or function, for example "Helps maintain healthy triglyceride levels already within the normal range," and have a qualified reviewer confirm the claim.

fish_oil_label.pdf

Food, dietary supplement. Illustrative sample

Uploaded5 elements extractedFindings with clauses

No issue"Dietary supplement" in the statement of identity21 CFR 101.3(g)
No issueSupplement Facts with serving size, saturated fat and footnotes21 CFR 101.36(b)(2)
No issueDSHEA disclaimer, boxed, on the panel with the claims21 CFR 101.93(c)(2), (d)
No issueFish allergen declared with speciesFD&C Act §403(w)(2)
Review"Helps reduce high triglycerides" names a disease state; may be a disease claim21 CFR 101.93(g)(2)

5 elements checked: 1 to review, 4 with no issue foundIn the sample report

What the artwork can and cannot show.

Read from the label artwork

Whether "dietary supplement" appears in the statement of identity.
The structure and footnotes of the Supplement Facts panel.
Claim wording, the linking symbol and the disclaimer placement.
Allergen declarations and the business line.

Needs more than the artwork

Scientific substantiation for any claim.
Whether a structure/function notification was submitted to FDA.
Whether ingredient amounts match the formulation.
Whether the product qualifies as a dietary supplement at all.

Questions

Does ArcheSync review Supplement Facts?

The review checks the Supplement Facts panel as it appears on the label: serving size, servings per container, declared dietary ingredients and the footnotes. It does not verify ingredient amounts.

Can it verify claim substantiation?

No. ArcheSync reviews claim wording and the disclaimer that goes with it. Whether a claim is substantiated depends on evidence you hold, not on the artwork.

Does it submit structure/function notifications?

No. ArcheSync does not file anything with FDA and cannot confirm that a notification was submitted. It reviews the label artwork only.

Review your label before your next artwork revision.

Upload a PDF or image. Findings come back with the citation attached.

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