One line of label copy decides which regulatory route your private label sits in, and it is usually written last, by someone who will never see the consequence. In the US, a structure/function statement obliges the marketer to carry the disclaimer required by 21 CFR 101.93(b) and to notify FDA within 30 days of first marketing under 101.93(a). Move the same sentence one step further, into treating or preventing a condition, and the bottle is an unapproved drug. Move the formula instead — add an ingredient not marketed in a supplement in the US before 15 October 1994 — and you are in a new dietary ingredient notification under FDCA section 413, filed at least 75 days before the goods enter commerce. None of those three routes costs the same, and none of them is visible on a quotation. So settle the claim set and the ingredient list before anyone orders printed cartons. Print is the part you cannot re-cut, and the notification clock is the part you cannot compress.
What actually sits in the specification
A supplement quotation is a stack of decisions, and most of the money is in lines that never appear on a sales sheet. Ask for this filled in per SKU before you compare prices.
| Specification line | What to fix in writing | Why it moves the price |
|---|---|---|
| Format | Softgel, hard capsule, tablet, effervescent, powder in jar, stick pack, gummy | Each runs on different machinery with a different minimum run and a different scrap rate |
| Active and basis | Dose per unit, and whether that dose is stated as the raw material or as the active fraction | "1000 mg fish oil" and "1000 mg of EPA plus DHA" are different products at the same words |
| Overage | Declared overage at fill, and the shelf-life end specification | Overage is paid for at fill and is the quietest cost line in the category |
| Shell or carrier | Bovine, fish or plant-based capsule shell; excipient list with function | Shell choice carries both a cost and a market restriction |
| Potency and purity testing | Method and revision per analyte, plus heavy metals, microbiology and, for marine oils, oxidation values | Per-batch testing against a type test on file is a real price difference |
| Primary pack | Bottle resin and neck finish, induction seal, desiccant, blister foil, counts per pack | Bottle tooling and foil print run against their own minimums |
| Label and carton | Panel layout, language versions, number of colours, barcode ownership | Print is sold against a minimum run of material, not against your unit quantity |
| Shelf life | Months from manufacture, and the stability data that supports the number | A longer claim needs real-time data or a tighter specification; both cost |
Where two quotations for the same bottle differ
In rough order of money:
- Active basis and overage. The single biggest spread in the category, and it hides behind identical label copy.
- Testing scope. Per-batch identity, potency, heavy metals and microbiology, or a certificate recycled from an earlier lot.
- Shell and excipient grade. Gelatin source, carrier oils, flow agents and coatings are not one grade each.
- Pack components. Resin weight of the bottle, foil gauge, desiccant, tamper-evidence.
- Print minimums. Three language versions is three minimums, not one.
- Documentation depth. A named-method certificate of analysis with the revision printed on it takes lab time; a summary sheet does not.
RFQ fields, ordered by how much they move the number
- Destination market, and the exact claim set you intend to print on the pack.
- Dose per unit, stated on the active basis, plus the shelf-life end specification you will be held to.
- Format and count per pack, with the size split across your range.
- Shell or carrier restrictions driven by your market: plant-based, bovine-free, allergen-free.
- Test list per analyte with method and revision, and whether testing is per batch or type.
- Pack components: bottle, closure, seal, desiccant, carton, insert leaflet.
- Print: colours, bleed, language versions, barcode ownership, who signs the artwork.
- Inspection stage, who pays for it, and the annual volume and call-off pattern behind the first order.
Certificates: what each one actually proves
This is where a sourcing file gets padded. A quality system certificate proves a system, not a product; a test report proves one lot, not a line.
| Document | What it proves | What it does not prove |
|---|---|---|
| 21 CFR Part 111 cGMP compliance | Production, process control and testing requirements for supplements apply to the site, domestic or foreign, and are confirmed through inspection | It is not a product approval and no agency issues a certificate for it |
| Third-party GMP audit (NSF, NPA, UL and similar) | An auditor visited and scored the site against a published scheme | Scope is the audited scope only; read the scope line, not the logo |
| Certificate of analysis | Results for one lot by one laboratory, against the methods printed on it | Nothing about the next lot, unless the method and limits are in your purchase order |
| NDI notification acknowledgement | FDA received a notification 75 days before marketing under FDCA 413 | Acknowledgement is not approval, and the file becomes public |
| EU health claim | The wording sits in the authorised list under Regulation (EC) No 1924/2006 and Regulation (EU) No 432/2012 | Nothing about whether your national authority accepts the rest of the panel |
The most common failure in a supplier file is a certificate whose scope line does not cover the format you are buying: a site audited for powders, quoting gummies. Read the scope, not the header.
Inspection, defect classes and the AQL question
Sampling is the uncontroversial part. Pull against ISO 2859-1, general inspection level II, with the lot defined as the production batch, a during-production check while the line is still running, and a pre-shipment inspection on the sealed pallets.
The acceptance number is where buyers drift. Supplements carry no statutory acceptance figure — the only category where a number is written into law is examination gloves, where the US applies AQL 2.5 under 21 CFR 800.20 and the EU applies AQL 1.5 under EN 455-1. A supplier who quotes "the usual AQL 1.5" for capsules is reading a glove standard at you. Define the classes yourself, with named examples: fill count short, cap not sealed, label misregistration or wrong language version, lot code missing or illegible, capsule defects per unit, carton crush. We accept the inspection company you nominate, or we use the inspection company we work with on a continuing basis.
Packing, cube and the tariff lines
Supplements are dense for their cube in bottles and light in powders, so the loading plan matters more than a rule of thumb. As planning figures, a 20ft box takes roughly 26–28 m³ of export cartons, a 40ft 55–58 m³ and a 40HQ 65–68 m³ — typical ranges in this trade, not a loading guarantee.
| Commercial term | What to fix in the purchase order |
|---|---|
| Packing hierarchy | Unit → bottle or blister → carton → shipper → pallet, with count at every level, carton dimensions and gross and net weight per SKU |
| Count reconciliation | Reconcile by unit, not by carton. A 60-count and a 90-count bottle at the same cartons-per-pallet is the most common invoice dispute here |
| Pallet configuration | Pallet type, cartons per tier, tiers per pallet, pallet-in or loose-loaded, and whether heat-treated pallets are required at your port |
| Incoterm and port of loading | State both. An EXW number, a FOB number and a DDP number are three different prices; compare only like with like. The port of loading is confirmed with each quotation. |
| HS lines | Heading 2106 carries most finished supplements in capsule, tablet and powder form, but a single-ingredient marine oil can be argued onto 1504.20 and a hydrolysed collagen powder onto 3504.00. Confirm each SKU against your own tariff before you compare a landed figure |
| Price basis | Indicative USD per carton against the current active and shell material costs, with a stated validity window rather than an open-ended price |
| Temperature in transit | Fish oils and probiotics are exposed in transit; agree whether a temperature logger travels with the load |
That HS row is where a private label order quietly goes wrong. A collagen powder, a fish oil softgel and a multivitamin tablet in one shipment can sit on three subheadings, and a packing list that calls the lot "health products" invites the broker to apply the least favourable line to the whole invoice. Split them on the commercial invoice before the goods move.
Price, minimum order quantity and lead time are confirmed with each quotation, against your specification and destination market. A figure handed over without your formula, pack and destination market behind it is a placeholder, whoever hands it to you.
Regulatory route, market by market
| Market | Route for a conventional supplement | What shifts the route |
|---|---|---|
| US | Dietary supplement under DSHEA: food facility registration, cGMP under 21 CFR Part 111, Supplement Facts labelling under 21 CFR 101.36, importer verification obligations under FSVP | A new dietary ingredient triggers a 75-day notification under FDCA 413; a disease claim moves the product into the drug column |
| EU | Food supplement under Directive 2002/46/EC, with only the vitamin and mineral sources in its annexes, labelled under Regulation (EU) No 1169/2011. Notification is national, not harmonised — there is no notify-once-sell-everywhere route | An ingredient without a history of significant consumption before 15 May 1997 falls under the novel food Regulation (EU) 2015/2283; claims must sit in the authorised list |
| UK | Mirrored national regime with its own notification and claim lists | Divergence from the EU claim list; check both before printing one bilingual pack |
Three fields belong in your supplier file whichever column you land in: the legal manufacturer named on the pack, the EU responsible person for the food information on the label, and the US agent of record where one applies. Ask every supplier on your list for all three in writing, with the entity name and address as they will appear. We confirm ours for your destination market with the quotation rather than printing it on a web page.
MOQ, samples and lead time — and the print trap
The minimum you are quoted is rarely set by the capsule. It is set by the printed components: labels, cartons and foil run against a minimum per design and per colour set. Buyers planning a six-market launch on one container learn this the hard way at the artwork stage, usually two weeks after the formula was signed off.
Stock samples and development samples are separate conversations. A stock sample settles capsule size, swallowability, odour and pack feel. A development sample answers "can you make my formula" across raw material sourcing, a trial batch, stability and any testing you asked for — and on a marine oil, the stability work is the long pole.
On printed goods, establish which stage the clock starts at — order date or artwork approval — and have it written into the order acknowledgement. Samples are supplied free of charge. The minimum order and the lead time are confirmed with the quotation for your formula and pack.
Change control and traceability
Change control is where the third order goes wrong, not the first. Ask for a written change notification policy covering a change of active supplier, shell source, excipient grade, bottle resin or production site. A change of active supplier is the one most often treated as internal — it is not, because it moves the impurity profile and the certificate of analysis your retail customer filed.
Ask for the lot code on the bottle and the shipper so a complaint traces to one batch, and for the lot-code key with the first shipment. We notify specification changes in writing; that notification is for your records — we do not hold production for a written approval from you. If your retail customer's quality system needs an approval gate, raise it at the purchase order stage so it sits in the terms rather than in an assumption. Ask also for the retention sample policy and the shelf-life basis; in practice a supplier who cannot say how long retention samples are kept cannot support a complaint two years out.
When private label is the wrong call
Below roughly a container a year per SKU, private label usually costs more than it returns: you pay the label and carton minimums, the artwork cycle and any notification work. Buy a neutral pack and apply your own outer label until the volume justifies the plates.
What to send us
Send your destination market, the claim set you plan to print, the dose on the active basis, the format and count, and your annual volume.
Start from the nutrition supplements OEM programme page, or take in the whole nutrition and pharma supplier range. Format-specific pages worth opening alongside a first brief: omega-3 fish oil softgels wholesale, multivitamin supplements supplier and collagen powder bulk. For the paperwork that travels with the container, see our import documentation checklist.
FAQ
How is the minimum first order set — by bottle, by batch or by print design?
Ask whether the minimum applies to the formula batch, the label or carton print run, or a combination, and ask for each minimum in finished-pack quantities. For a multi-language launch, ask whether a neutral pack with market-specific applied labels is an available alternative. Price, minimum order quantity and lead time are confirmed with each quotation, against your specification and destination market.
Can you send a sample before we commit to a development batch?
Samples are supplied free of charge. Ask for one in a format already in production — it settles capsule size, odour and pack feel before anyone pays for plates or tooling.
Which documents come with the shipment?
Ask for the invoice and packing list split by HS line, the certificate of analysis for the shipped lot with method and revision printed on it, the allergen and specification sheets, and the inspection report where agreed.
How is the price held, and against what?
In USD per carton against the current active and shell material costs, with a stated validity window. An open-ended price in this category usually means the overage or the test scope has room in it.