Nutraceuticals
21 CFR Part 111 cGMP, novel-food rules, and botanical provenance for dietary supplements.
Map a control once. Cite it everywhere.
What teams do with Traceage
Every card is a real job, framed for the person who owns it.
Quality Manager
21 CFR Part 111 cGMP records
Identity, purity, and potency testing logged per batch — supplement GMP, audit-ready.
Regulatory Specialist
Novel-food & DSHEA compliance
Ingredient status and structure/function claims checked against each market's rules.
Supply Chain Manager
Botanical ingredient provenance
Trace every botanical and active to its grower and certificate of analysis.
QA Analyst
Certificate-of-analysis control
Every incoming ingredient lot tied to its CoA before it touches a formulation.
Label Compliance Lead
Claim & label substantiation
Back potency and "clinically studied" claims with traceable test evidence.
Recall Coordinator
Adulteration-driven recall
Isolate affected lots fast when an ingredient supplier flags adulteration.
Every stage on one continuous record.
The nutraceuticalsworkflow — and where Traceage fits at each step.
- 01
Source ingredients
Botanicals and actives traced to grower and certificate of analysis.
- 02
Test & verify
Identity, purity, and potency results tied to each ingredient lot.
- 03
Formulate
Formulas checked against novel-food and DSHEA rules per market.
- 04
Manufacture
21 CFR Part 111 cGMP records captured per batch.
- 05
Label & claim
Potency and label claims backed by traceable test evidence.
What it delivers.
Proof of authenticity & quality
Potency and purity proven by test evidence tied to each batch.
Verified ethical & sustainable sourcing
Botanicals and actives traced to grower and certificate of analysis.
Real-time visibility & convenience
Retailers and consumers verify what's in the bottle.
Fast, painless issue resolution
An adulteration flag isolates the affected lots immediately.
The regulations, in plain terms.
Every framework Traceage maps for nutraceuticals.
- FDA DSHEA
- US Dietary Supplement Health and Education Act — the regulatory basis for dietary supplements.
- 21 CFR Part 111
- Title 21 of the US Code of Federal Regulations, Part 111 — the FDA current Good Manufacturing Practice for dietary supplements.
- NSF/ANSI 173
- The American National Standard for dietary supplements — content, purity, and labelling verification.
- EFSA
- European Food Safety Authority — the EU body for risk assessment on food and feed.
- EU Novel Food
- EU Regulation 2015/2283 — pre-market authorisation for foods without a history of consumption in the EU.
See it on your own data.
Stand up a working setup in days. No rip-and-replace.