Put your brand on a proven oral strip. Qualified private-label projects start at 500 boxes with branded sachets and cartons, lot testing and a reorder spec.
What private label means on a supplement label
21 CFR 101.5 requires the label to name the manufacturer, packer or distributor, and if that company did not make the product the name must be qualified: "Manufactured for" or "Distributed by." That line is the legal shape of private label. Costco's Kirkland Signature vitamins are the familiar case: Costco writes the specification, contract manufacturers produce to it, and the bottle carries Costco's name, not the maker's.
Responsibility does not move with the manufacturing. FDA's compliance guide to 21 CFR Part 111 says a firm that contracts out production and then distributes the product is responsible for what it releases and must know what was done and how. A 2023 warning letter to a distributor cited missing quality-control procedures for products "contract manufactured for your firm's own label."
Private label, white label and OEM
White label: one formula sold to several brands, artwork changed. Private label: a proven formula with some adjustment, usually flavor, sweetness, count or carton format. OEM: we manufacture to the buyer's specification. None changes the film. The scope should say who supplies actives and packaging, how far the formula may move, who reviews claims, who tests what, and who signs the release.
Checking fit, then building the package
A stock concept fits when customer, dose, flavor, count and price point match a film we already know how to make. Representative development targets from our library: melatonin at a 5 mg adult benchmark, caffeine up to 80 mg, KSM-66 ashwagandha up to 250 mg. A different active or dose goes to custom feasibility, 3–5 business days.
Each strip is sealed in its own lot-coded PET/aluminum/PE sachet; sachets go into a printed carton. Retail counts cluster: Listerine PocketPaks sell as 24-strip packs, and most melatonin strips on Amazon and brand sites are 30-count boxes. Our pilot standard is 20- or 30-count, with 10- to 60-count, wallet, sample and AM/PM cartons at pilot scale. Printed components have converter minimums and lead times, so we scope them with the pilot.
A worked example: 500 boxes of a melatonin strip
Take a 3 mg melatonin strip in a 30-count carton. Five hundred boxes is 15,000 strips and 15,000 sachets. Decide before production where they go: say 300 boxes to ecommerce, 100 to a clinic or wholesale account, 60 for sampling and seeding, 40 held as retained units and returns cover. Decide what would justify a reorder: sell-through in the first 60 days, return reasons, whether any sensory complaint repeats. Model 1,000, 3,000 and 5,000 boxes while the pilot is selling; formula, sachet and artwork stay fixed and only purchasing changes. A written allocation produces a decision. Without one, a pilot produces inventory.
Quality responsibilities, in writing
The scope should assign duties under 21 CFR Part 111: 111.13 (qualified supervisors), 111.35 (equipment and calibration records), 111.70 (specifications), 111.75 (ingredient identity and finished-batch testing), 111.210 and 111.255 (master manufacturing record and batch record). Ours: every lot made to an approved specification with standard release controls, third-party analysis through ILS Lab, a Lot Release Packet per released lot, a retained batch record. The brand's: label and claims review, the complaint file Subpart O requires, and the release decision. StripWorks holds no cGMP, FDA registration, ISO or NSF certification today and does not claim one.
Common questions
Yes, when concept, ingredients, packaging and production setup are confirmed workable at that quantity; component minimums can move the number.
Yes. Artwork carries your brand and "Distributed by" line; print method, minimums and proofs are confirmed per project.
It moves to custom feasibility: a 3–5 business day review of what development would need to prove.
White label changes only artwork; private label allows adjustment within a proven base.
You are, under FDA's reading of 21 CFR Part 111. Our release controls and Lot Release Packet document it.
Primary sources
- 21 CFR 101.5, name and place of business of manufacturer, packer, or distributor (Cornell LII)
- FDA Small Entity Compliance Guide: cGMP for dietary supplements (own-label distributor responsibility)
- FDA Warning Letter: Healthtex Distributors, Inc., June 15, 2023
- SupplySide SJ: Own-label distributors of dietary supplements have cGMP obligations
- AllAmerican.org: Where are Kirkland vitamins made?
- 21 CFR 111.70, specifications (Cornell LII)
- 21 CFR 111.75, testing and examination (Cornell LII)
- Listerine Cool Mint PocketPaks, 24-strip pack (Walmart listing)
- Solves Strips melatonin, 30 strips per box (product page)
Build the next step around facts.
Tell us the active ingredients, target amount, flavor direction, formula status, pack count, first-run quantity, launch market, timing, and anything already decided. StripWorks will use the brief to map the most practical next step.
Start the project brief