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PACKIQ · Compliance · 3 credits

Supplement Label Guard

Check every supplement label against FDA 21 CFR 101 and EFSA rules — before print

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What it does

Submit your supplement label draft. The Supplement Label Guard checks mandatory elements (Supplement Facts panel, daily values, allergen statement, net quantity, manufacturer address), validates every structure/function claim for the mandatory FDA disclaimer and EFSA approved claim register, flags illegal disease claims, and produces a market-readiness verdict for US, Canada, EU, and UK.

Example use case

A supplement brand's label states 'Boosts immune function and fights inflammation' and 'Clinically proven to increase energy.' The Label Guard flags both as FDA non-compliant disease/drug claims, rewrites them as compliant structure/function claims ('Supports normal immune function' / 'Contributes to normal energy-yielding metabolism'), and checks the Supplement Facts panel against 2022 updated Daily Values — identifying three incorrect DV percentages using pre-2022 values.

Frequently asked questions

What is a disease claim vs structure/function claim?
A disease claim implies the product treats, cures, or prevents a disease — illegal without FDA drug approval. A structure/function claim describes normal body function — legal with the mandatory FDA disclaimer.
Which EU health claims are approved?
Only claims on the EU Register of Authorised Health Claims (Regulation 432/2012) are legal. 'Boosts immunity', 'detoxifies', 'anti-aging' are NOT on the register.
Does the agent cover Canadian NPN requirements?
Yes — it flags that a Natural Product Number is required for sale in Canada and checks for the mandatory bilingual label.

Related searches

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Run Supplement Label Guard on PACKIQ

3 credits per run · Grounded in live PackIndex data · Result in under 2 minutes

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