New Dietary Ingredient

This glossary term is part of the SG Systems Global regulatory & operations guide library.

Updated January 2026 • Dietary Supplements & Regulatory Control • new dietary ingredient (NDI), NDI determination workflow, identity/specification discipline, historical use evidence, supply chain consistency, manufacturing process definition, ingredient standardization, change control triggers, NDI notification readiness, traceability-backed scope control, complaint/adverse event linkage, audit trail defensibility • Supplement Brands, Private Label, Contract Manufacturing (QA/QC, regulatory, R&D, sourcing, leadership)

New dietary ingredient (NDI) is a dietary ingredient that is considered “new” under the regulatory framework governing dietary supplements and therefore may trigger additional premarket compliance expectations before being marketed. Operationally, NDI is not a marketing adjective. It is a control classification that forces a business to answer hard questions: What exactly is this ingredient? How do we prove identity and consistency? What is the intended use and exposure? What evidence exists for safe use? And—most importantly—can we keep the ingredient we sell aligned to the ingredient we evaluated, even as suppliers, processes, and products change?

The hard truth is that “NDI” decisions are often made too loosely. Companies talk about an ingredient category (“mushroom extract,” “ashwagandha,” “fermented metabolite”) while procurement buys a specific material with a specific process, impurity profile, and standardization approach. If the decision record is conceptual but operations are physical, the business will drift without noticing. Drift is where risk grows—because your safety rationale may no longer describe what you sell.

Tell it like it is: an NDI determination is a business risk decision. It affects what you can market, how you can market it, and how quickly you must act when new information appears. If the determination is not integrated into your quality system—supplier qualification, identity testing, specifications, and change control—it becomes a one-time memo that decays the moment operations move. Strong companies treat NDI as a living control state: the ingredient is controlled, changes are governed, and traceability can prove scope fast when complaints or adverse events appear.

“NDI isn’t about novelty. It’s about evidence and control: can you prove what it is, and can you keep it that way?”

1) What “new dietary ingredient” represents

“New dietary ingredient” represents a regulatory risk boundary. It distinguishes ingredients that are treated as having a different premarket compliance posture from ingredients with well-established historical use under certain conditions. Operationally, the classification exists because ingredient variability and novelty can create safety uncertainty. The NDI label therefore forces documentation, scientific rationale, and—in high-performing organizations—real operational controls.

NDI is also a governance trigger. It changes how sourcing is allowed to behave (approved suppliers only), changes what QC must verify (identity and critical attributes), and changes how R&D must manage formulations (dose changes and new populations must trigger review). If those controls are not in place, “NDI” becomes a label without force.

2) NDI determination as a controlled decision record

NDI determination should be treated like any other high-impact compliance decision: documented, reviewable, and change-controlled. The determination record should capture: the ingredient definition, intended use conditions, the evidence reviewed (including historical use evidence where relevant), assumptions, uncertainties, and the final conclusion. It should also define what would cause re-evaluation (supplier change, process change, spec change, dose change, new population).

Tell it like it is: undocumented determinations don’t exist when you need them. They exist only in memory, and memory is not defensible.

3) Defining the ingredient: what counts as “the same”

“The same ingredient” is where most teams get trapped. Identity is not just a botanical name or a CAS number. It includes how the ingredient is produced and standardized. Two materials can share a name and be materially different in active content, impurity profile, solvent residues, and bioavailability. If your NDI determination is anchored to a loose definition, procurement can buy something that technically “matches” but operationally differs.

Strong definition includes: source material, processing method, extraction solvent or purification approach, standardization targets, and key impurity boundaries. Those attributes then become part of supplier qualification and part of incoming verification. That’s how you keep “new” from quietly becoming “different.”

4) Historical use evidence and why it must map to identity

Historical use evidence is only useful when it matches the ingredient you intend to sell. If historical evidence describes whole herb use, and you sell a high-potency extract, you cannot pretend the evidence is interchangeable. If historical evidence describes one preparation method, and you use another, you must reconcile the difference.

Operationally, this means the historical use evidence review should be paired with identity definition. The team should be able to answer: “Does the evidence describe this ingredient as produced, standardized, and dosed?” If the answer is uncertain, treat the uncertainty as real risk and route it for scientific review.

5) Identity testing and specifications that make control real

Identity and specs are where NDI becomes enforceable. A defensible NDI posture requires that the ingredient you buy is verified (identity) and bounded (specifications). This means internal testing programs that detect substitution and meaningful drift, not just “accept the CoA.” It also means specs that behave as decision gates: pass, hold, investigate, reject.

In practice, NDI-relevant specifications often include: identity confirmation method(s), active or marker content ranges, micro limits where relevant, heavy metals where relevant, and critical impurity boundaries. The exact panel depends on ingredient risk, but the governance logic is stable: the ingredient is released only if it matches the defined identity and falls within bounds consistent with the evidence base.

Tell it like it is: if you can’t stop a wrong or drifting ingredient at receiving, you don’t control NDI risk.

6) Supplier qualification and drift prevention

Supplier qualification is the mechanism that keeps ingredient identity stable across time. For NDI-classified ingredients, supplier controls should be stricter: approved supplier lists, defined change notification expectations, periodic verification testing, and trend monitoring by supplier lot.

Drift prevention means you don’t wait for a hard failure. If assay values trend upward or impurity values trend toward action thresholds, that triggers review. Trend review should be linked to supplier performance, not treated as lab trivia. When drift becomes visible, the goal is to contain it early—before it affects multiple SKUs and forces broad actions.

7) Change control triggers that protect the evidence base

Change control is the “NDI insurance policy.” After determination (and possibly after notification), changes will happen. The risk is silent drift: small changes that gradually move the ingredient away from the evaluated profile. Strong programs define NDI-impacting triggers that automatically require review:

• Supplier change or new site of manufacture.
• Process change (extraction/purification/fermentation parameters).
• Spec changes that broaden acceptance ranges.
• Method changes that affect comparability of results.
• Formula or dose changes that change exposure.
• New target populations or new conditions of use.

Tell it like it is: if your change control system can’t recognize NDI-impacting changes, your NDI decision decays over time.

8) NDI notification readiness: what operations must support

When NDI notification is required, operations must support it by producing consistent evidence. That means your internal controls must generate artifacts: identity results, spec conformance, supplier qualification records, process descriptions, and traceability. A notification narrative that cannot be supported by operational records is fragile, because it cannot survive scrutiny when something changes or when a safety signal appears.

Operational readiness also means repeatability: if you file a notification based on one supplier and later use a different supplier, you must be able to evaluate whether the ingredient is still materially the same. That evaluation depends on the discipline above: identity definition, specs, supplier controls, and change control triggers.

9) Post-market signals: complaints, adverse events, and scope

Once the product is in market, post-market signals become part of your evidence base. Complaints and adverse events should be captured as structured data, linked to product and lot identity, and trended. If an NDI ingredient is associated with repeated signals, you need scope and speed: which lots, which suppliers, which SKUs, which shipments?

This is where traceability and retains become critical. When a signal arrives, you should be able to map the ingredient lot into finished lots using lot genealogy, pull retain samples under controlled workflows, and execute targeted investigations. The goal is to avoid either denial (“one-off”) or panic (“everything is affected”) by making scope solvable.

10) Inspection-ready NDI decision evidence pack

A credible NDI posture is demonstrated through an evidence pack that is current and coherent:

• NDI determination record with identity definition, conditions of use, evidence reviewed, and conclusion.
• Ingredient specification set including identity methods and critical attributes.
• Supplier qualification records and approved supplier list controls.
• Incoming verification and CoA verification strategy and results.
• Change control history showing reviews for NDI-impacting changes.
• Traceability capability to map ingredient lots into finished lots and shipments.
• Post-market linkage to complaints/adverse events and CAPA when patterns exist.
• Audit trail proving who approved what, and when.

Tell it like it is: if you can’t assemble this quickly, you don’t control it—you store it.

11) Copy/paste readiness scorecard

12) Common failure modes

• Loose ingredient definitions that don’t constrain procurement decisions.
• Historical evidence mismatch (evidence doesn’t match the ingredient as sold).
• CoA dependency without internal verification or trend control.
• Silent supplier changes that alter the ingredient profile without review.
• Spec creep that broadens variability beyond what the evidence supports.
• Traceability gaps that make scope unclear during safety signals.
• Binder syndrome (policy exists, controls don’t).

Tell it like it is: NDI failures are rarely about intent. They’re about unmanaged drift.

13) How this maps to V5 by SG Systems Global

V5 makes NDI governance executable by turning ingredient definition and control requirements into enforced system behavior. In practice, V5 can represent an NDI ingredient as controlled master data with locked specifications, required identity tests, and an approved supplier list—so purchasing and receiving can’t quietly substitute “similar” materials without triggering change control. At receipt, V5 can enforce quarantine until required verification is completed, bind CoA data to the exact incoming lot, and preserve an audit trail for approvals and overrides. The decisive advantage is scope: when complaints or adverse events arise, V5 can traverse end-to-end lot genealogy to identify which finished lots consumed the ingredient, which shipments those lots went to, and which other SKUs share the same ingredient lots or suppliers—so containment can be narrow when evidence allows and broad only when necessary. V5 also supports “NDI stays true” operations by linking supplier qualification, formula versioning, and post-market signals into one evidence chain, enabling targeted investigations and CAPA when patterns emerge. Put bluntly: V5 reduces NDI risk by preventing silent drift and making scope solvable under pressure.

• Platform overview: V5 Solution Overview
• Quality governance: Quality Management System (QMS)
• Warehouse controls: Warehouse Management System (WMS)
• Traceability: V5 Traceability
• Integration layer: V5 Connect (API)

14) Extended FAQ

Q1. Why does “NDI” matter operationally?
Because it changes what you must prove: ingredient identity, consistent supply chain control, and disciplined change governance so the ingredient evaluated remains the ingredient marketed.

Q2. What is the most common NDI mistake?
Treating the decision as conceptual (“this type of ingredient”) instead of physical (this defined ingredient with this process/spec profile), which allows silent drift.

Q3. How do we keep an NDI decision true over time?
Lock identity and specs, restrict to approved suppliers, verify CoAs, trend drift by supplier lot, and route NDI-impacting changes through change control.

Q4. Why is traceability part of NDI risk control?
Because safety signals require fast scope definition. Genealogy and shipment mapping keep actions narrow and defensible rather than broad and costly.

Q5. What should be in an inspection-ready NDI evidence pack?
The NDI determination record, ingredient definition and specs, supplier qualification and verification strategy, change control history, traceability scope capability, post-market signal linkage, and audit trails.

Related Reading
Prepare operationally with NDI Notification, strengthen controls with Supplier Qualification and Change Control, and reduce scope risk using End-to-End Lot Genealogy.