A supplement co-packer, more often called a contract manufacturer, encapsulates, tablets, powders or bottles a dietary supplement for a brand. The rules are heavier than for most foods: anyone who manufactures, packages, labels or holds a dietary supplement follows FDA's dietary supplement current good manufacturing practice, with specifications for every ingredient, identity testing, and a master manufacturing record. That's a big reason small supplement brands use contract manufacturers at all. In the example below, a noni powder capsule maker selling 600 bottles a month pays $5.26 a bottle encapsulating it itself, $5.20 with a small contract manufacturer, and $4.06 with a larger one whose minimum is eight months of sales. Below is what the rules ask, what the manufacturer needs from you, the label, three quotes, and a free calculator.
The short version
- Dietary supplement cGMP applies to anyone who makes, packages, labels or holds a supplement.
- Each ingredient needs specifications, including its identity, and testing to confirm it.
- The manufacturer works from a master manufacturing record and keeps a batch record for each run.
- The label carries a Supplement Facts panel, not Nutrition Facts.
- Claims to treat or prevent disease make a product a drug; structure-and-function claims follow their own rules.
- Testing and documents are part of the setup cost, which is why minimums are high.
- TaroStack keeps track of your powder and bottles at the manufacturer, by lot, as a site of its own. More below.
What the rules ask
FDA's dietary supplement cGMP applies to anyone who manufactures, packages, labels or holds a dietary supplement, including a supplement made by one company and packaged or labeled by another (21 CFR 111.1). Under it, the manufacturer establishes specifications wherever control is needed, and for every component, starting with an identity specification (21 CFR 111.70): your noni powder has to be shown to be noni powder, lot by lot. The product is made to a master manufacturing record, and each batch gets a batch record. Encapsulating at home with a hand-cranked machine doesn't escape any of this; the rules apply to the activity, not the size. This is general information, not legal advice. How a master record differs from a batch record is in master batch record vs batch record.
The label
A dietary supplement's label carries nutrition labeling in the Supplement Facts format (21 CFR 101.36), with the serving size, the amount of each dietary ingredient per serving, and the other ingredients, such as the capsule shell, listed below it. Claims about treating, curing or preventing a disease make it a drug; structure-and-function claims, the kind that describe a role in the body, come with their own disclaimer and notification rules. A contract manufacturer may ask to see your label and claims before it runs.
What a supplement contract manufacturer will ask you for
- The formula: each ingredient, its amount per serving, its form and its supplier.
- Specifications and certificates for each ingredient you supply, and agreement on the identity testing they'll do.
- The finished product specs: capsule size and type, fill weight, count per bottle, the tests on the finished product.
- Packaging and labels, or approval for them to source them.
- A forecast, a deposit and time: first runs take weeks for the testing and the documents.
Three quotes compared
Noni Grove, a made-up noni fruit powder capsule maker on Hawaiʻi I use in these examples, sells about 600 bottles of 90 capsules a month, each holding 45 grams of its own powder, $1.35 a bottle:
| Encapsulate it yourself | Small contract manufacturer | Larger contract manufacturer | |
|---|---|---|---|
| Run you'd order | 300 | 1,000 | 5,000 |
| Minimum run | none | 1,000 | 5,000 |
| Good bottles, after the loss | 291 | 980 | 4,950 |
| Setup: cleaning, testing, records | $300 | $600 | $1,200 |
| Fee, or your own labor, a bottle | $1.00 | $1.20 | $0.70 |
| Noni powder, a bottle | $1.35 | $1.35 | $1.35 |
| Capsules, bottle, cap, desiccant, label | $1.75 | $1.60 | $1.40 |
| Freight a run | $0 | $350 | $800 |
| Run cost | $1,530 | $5,100 | $19,250 |
| Months to sell the run | 0.5 | 1.6 | 8.3 |
| Storage while it sells | $0 | $0 | $870 |
| Cost a good bottle | $5.26 | $5.20 | $4.06 |
Encapsulating itself, Noni Grove's setup includes the identity test on each lot of powder, and the cGMP records that come with doing it in-house. The small contract manufacturer costs about the same a bottle and takes the cGMP work off its hands. The larger one saves $1.14 a bottle, but its 5,000-bottle run is eight months of sales and $19,250 out. Capsules keep for a long time in sealed bottles, so the larger run is a cash question. How supplement makers keep their stock is in supplement inventory software.
Get the calculator
Download the supplement co-packer quote calculator. One column for each quote and one for doing it yourself: type the run you'd order, the minimum, the loss, the setup, the fee or your labor, ingredients, packaging, freight and storage, and the run's cost, the months it takes to sell at your sales a month, the storage while it sells, the cost of each good bottle and the cash out before it sells fill in. It's an ordinary Excel file with no macros, and it works in Google Sheets, LibreOffice and Numbers.
Where this stops working
Powder from your own drying, sent to the manufacturer with its certificate, bottles made in runs with their own lots and test results, cases at the manufacturer and at home, and bottles going to shops and online. A spreadsheet can't keep each powder lot's certificate with the runs that used it, or show which shops got a lot if a test comes back late.
How TaroStack does it
TaroStack keeps track of your powder and bottles at the manufacturer, by lot, as a site of its own.
Lots with their certificates. Each lot of powder is received with its lot code and fields of your own, such as the identity test result and certificate number, so the test behind every run is on record.
The manufacturer as a site. The manufacturer's premises can be a site, so the powder you send is a transfer, shown in transit until it arrives, and the finished bottles there are counted as yours. More than one site is on Standard at $99 a month.
Runs, holds and recalls. Each run is a batch with a lot that records the powder lots it used; a lot waiting on its test can be held, kept out of what can be sold, and a recall report shows which customers got each lot. How lot tracking works is in what is lot tracking.
| The job | Spreadsheet | In TaroStack |
|---|---|---|
| A powder lot's identity test | A PDF in an inbox | A field on the lot |
| Bottles at the manufacturer | Ask them | Stock at their site |
| A run waiting on its test | Set aside, maybe | Held from sale |
| Which shops got lot NC-1015 | Search the invoices | One recall report |
Lots, holds, sites, transfers and recalls are on Standard at $99 a month for more than one site. The first 30 days are free, with no credit card. If you'd like a hand setting up, ask, and we'll do it with you.