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What is a co-packer? Co-packing, co-manufacturing and the FDA rules

A co-packer (contract packager) is a company that packages your product, and often makes it too, in its own facility under your brand. Founders use one to launch food, drinks, supplements or beauty products without building a plant. For food sold in the US, the co-packer's facility must be registered with the FDA unless an exemption applies, because packing and labeling count as manufacturing.

Also called: Copacker · Contract packager · Co-manufacturer (co-man) · Contract manufacturer

Published Last reviewed Fact-checked

Spec sheet
Co-packers at a glance
What they doPackage (fill, seal, label) your product, and often make it to your formula
Who uses themFood, beverage, supplement, cosmetic and household brands that do not own a plant
FormulaYours (co-packer or co-man) or theirs (private label)
FDA food facility registrationRequired for facilities that make, process, pack or hold food for US consumption (21 CFR 1.225), renewed every even-numbered year
Your labelYour name with "Manufactured for" or "Distributed by" (21 CFR 101.5)
SupplementscGMP rules (21 CFR 111) cover anyone who makes, packages, labels or holds them
Minimums and costSet by each co-packer per run; ask for the minimum batch, setup fees and the per-unit price

01Co-packer vs co-manufacturer vs private label

The words overlap, and the industry's own sources disagree. Blue Label Packaging defines a co-packer as a contract packager that packages a product you already made, and a co-manufacturer (co-man) as one that makes and packages it to your formula. Co-packing.org, a matchmaking site, says a co-packer both produces and packages. In practice, ask each one what it does, not what it calls itself.

Co-packer (contract packager)Co-manufacturer (co-man)Private label
Makes the productSometimes; often only fills and packsYes, to your formulaYes, to its own formula
Who owns the formulaYouYouThe manufacturer
PackagingFills, seals, labels and case-packsMakes and packsIts stock product in your packaging
Speed to marketFast if your product existsSlower: formula scale-up and trialsFastest
How uniqueAs unique as your productUniqueMay be shared with other brands

Private label in food works much like it does in apparel; see private label vs white label.

02When founders use a co-packer

  • You have a recipe or formula that works in a kitchen or lab, and need it made at volume without building a facility.
  • Your product needs a licensed facility. Cornell's Food Venture Center notes federal rules keep low-acid, acidified, meat and reduced-oxygen packaged foods out of home kitchens.
  • You want to test a market before committing capital to a plant, a use the University of Florida's extension guide to co-packers describes.
  • You need a packaging format you can't run yourself: canning, bottling, stick packs and sachets, pouches.
  • You want retail-ready output: labeled units, case-packed and palletized, ready for a distributor.

Co-packers can also kit: assembling variety packs and gift sets from your finished products. See kitting for how that works and how barcodes change for a kit.

03FDA food facility registration (21 CFR 1, Subpart H)

Under 21 CFR 1.225, the owner, operator or agent in charge of a domestic or foreign facility that manufactures or processes, packs, or holds food for consumption in the US must register it with the FDA, unless an exemption in 1.226 applies. A domestic facility registers whether or not its food crosses state lines. Registration comes before the facility starts.

  • Packing and labeling count. The definition of manufacturing/processing in 21 CFR 1.227 lists labeling and packaging among its examples, so a co-packer that only fills and labels your product still registers.
  • Renewal: every other year, between October 1 and December 31 of each even-numbered year (21 CFR 1.230). The FDA reminded facilities in September 2026 that registrations not renewed by December 31, 2026 are treated as expired, and that there is no fee to register or renew.
  • Identifier: registration needs a unique facility identifier (21 CFR 1.232), and the FDA accepts a DUNS number. It won't confirm a registration until it has verified the identifier and that its address matches (21 CFR 1.231).
  • Changes: updates are due within 60 calendar days of a change; a change of owner means the old registration is canceled and the new owner registers (21 CFR 1.234).
  • Foreign co-packers must name a US agent (21 CFR 1.232).
  • Exempt: farms, retail food establishments, restaurants, some nonprofits, some fishing vessels, and facilities regulated entirely by the USDA (meat, poultry and egg products) (21 CFR 1.226).

The registration is the facility's, not yours. As the brand, ask for the co-packer's FDA registration number and check it is current, especially in the last quarter of an even-numbered year. Meat and poultry go through USDA FSIS inspection instead: a meat plant needs written sanitation procedures, recall procedures and a HACCP plan before it is granted federal inspection (9 CFR 304.3).

04The other rules a co-packed product meets

Checked October 22, 2026 on eCFR, FDA and the US Code. Not legal advice: confirm with the FDA or a regulatory consultant.
RuleWhat it saysWhat to ask the co-packer
21 CFR 117 (FSMA preventive controls)Unless exempt, facilities that make, process, pack or hold food follow current good manufacturing practice (Subpart B) and hazard analysis and risk-based preventive controls (Subpart C); Subpart G requires a written supply-chain program where an ingredient hazard is controlled by a supplierTheir preventive controls, latest third-party audit (SQF, BRCGS, FSSC 22000 or similar) and who approves your ingredient suppliers
21 CFR 101.5 (label name and address)The label names the manufacturer, packer or distributor; if it is not the maker, the name is qualified, such as "Manufactured for" or "Distributed by"Approve the label wording before printing
21 CFR 111 (dietary supplements)Covers anyone who manufactures, packages, labels or holds a dietary supplement, including a maker whose supplement another company packages or labelsTheir cGMP compliance for supplements, and batch records
MoCRA (cosmetics, FD&C Act 604 and 607)Cosmetic manufacturers and processors register their facilities (some small businesses are exempt); a site that only labels, packages or holds is excluded, and filling a container does not count as packagingTheir FDA cosmetic facility registration, and who lists your products

Notice the flip between food and cosmetics: under the food rule, a site that only packs or labels must register; under the cosmetics law, a site that only labels or packages is excluded, unless it fills the containers.

05How to find and vet a co-packer

  • Start with directories: university food venture centers (Cornell keeps a state-by-state list of co-packers and commercial kitchens) and trade association matchmaking sites.
  • Match on process first (hot fill, cold fill, baking, canning, powder blending), then on minimum run size.
  • Ask for the facility's FDA registration number and its latest third-party audit before you share your formula, and sign an NDA.
  • Run a paid trial batch before a full run, and taste or test against your reference sample.

The Vault in the Product Sourcing Secrets course lists manufacturers across categories, including skincare and cosmetics and private label factories. For packaging alone, see our packaging manufacturer list.

06How to spec it with a supplier

Send the same brief to every co-packer so the quotes compare. Keep the formula under NDA until you have shortlisted.

Lines for the packaging spec
No.FieldWhat to write
01Product and processWhat it is, and the process it needs (for example hot fill, baking, powder blending, filling)
02FormulaYours (under NDA), or theirs to adapt
03PackagingContainer, closure, label, case pack, and who supplies each
04Run sizeUnits per run at launch and at reorder
05ComplianceFDA registration number, food safety plan, audit certificate, allergen handling
06DocumentsCertificate of analysis, batch records, label approval

Questions to ask the supplier

  • What is your minimum batch size, and the per-unit price at two run sizes?
  • What setup, trial batch or line change fees apply?
  • Is your facility's FDA registration current, and when was your last third-party audit?
  • Who sources ingredients and packaging, and who owns leftover stock?

07FAQ

Q01What is a co-packer?

A contract packager: a company that packages your product, and often makes it, in its own facility under your brand.

Q02What is the difference between a co-packer and a contract manufacturer?

Strictly, a co-packer packages and a contract manufacturer (co-man) makes and packages to your formula. Many companies do both and use the words loosely, so ask what each one does.

Q03What is the difference between a co-packer and private label?

With a co-packer the formula is yours. With private label the manufacturer's own product goes into your packaging, and other brands may sell the same product.

Q04Does a co-packer need FDA registration?

For food sold in the US, yes, unless an exemption applies: 21 CFR 1.225 covers facilities that manufacture or process, pack or hold food, and packaging and labeling count as manufacturing. Registration is renewed between October 1 and December 31 of every even-numbered year.

Q05How much does a co-packer cost?

There is no public price list. Co-packers price per unit or per case with setup fees and a minimum run, so ask several for the same brief at two run sizes.

08Sources

  1. 21 CFR 1.225, Who must register under this subpart?eCFR (U.S. Government Publishing Office)
  2. 21 CFR 1.226, Who does not have to register?eCFR (U.S. Government Publishing Office)
  3. 21 CFR 1.227, DefinitionseCFR (U.S. Government Publishing Office)
  4. 21 CFR 1.230, When must you register or renew?eCFR (U.S. Government Publishing Office)
  5. 21 CFR 1.231, How and where do you register or renew?eCFR (U.S. Government Publishing Office)
  6. 21 CFR 1.232, What information is required?eCFR (U.S. Government Publishing Office)
  7. 21 CFR 1.234, How and when do you update your registration?eCFR (U.S. Government Publishing Office)
  8. FDA reminds food facilities of biennial renewal requirements (September 29, 2026)U.S. Food and Drug Administration
  9. 21 CFR 101.5, Food; name and place of businesseCFR (U.S. Government Publishing Office)
  10. 21 CFR 117, Current good manufacturing practice and preventive controls for human foodeCFR (U.S. Government Publishing Office)
  11. 21 CFR 111.1, Who is subject to this part?eCFR (U.S. Government Publishing Office)
  12. 21 U.S.C. 364, Definitions (cosmetics facility)Legal Information Institute, Cornell Law School
  13. Registration and listing of cosmetic product facilities and productsU.S. Food and Drug Administration
  14. 9 CFR 304.3, Conditions for receiving inspectioneCFR (U.S. Government Publishing Office)
  15. Kitchens and co-packersCornell Food Venture Center
  16. Finding and using a co-packer (FS380)UF/IFAS Extension
  17. What is a co-packer and how do you find the right oneBlue Label Packaging