Private label probiotic supplements are capsules, powders or drops containing live microorganisms, made by a supplement manufacturer and sold under your brand. They’re harder to get right than most supplements because the ingredient is alive. The count of live bacteria falls over time, so the number on your label must still hold at the end of shelf life, not just on the day the batch was made. Minimums are manageable: US manufacturers publish starting points from 500 bottles.
I’ll cover manufacturers, what to ask them, how to label CFU counts, storage, and Amazon’s testing requirement.
Probiotic manufacturers and minimums
From each company’s own site, checked in October 2026:
| Manufacturer | Location | Published minimum |
|---|---|---|
| Aligen | Miramar, Florida | 500 bottles |
| Matsun Nutrition | United States | Liquid probiotic drops from 2,500 units |
| Private Label Express | Coral Springs, Florida | Custom runs from 150,000 capsules or tablets |
My take: start with a stock formula at a 500-bottle maker, choose well-documented strains, and spend your effort on positioning and label clarity. Don’t fund a custom run until a product earns repeat orders.
What to ask a probiotic manufacturer
- Which strains, exactly? Ask for genus, species and strain designation. Effects are strain-specific; the NIH’s Office of Dietary Supplements says recommendations for probiotic use need to be strain-specific.
- What CFU count is guaranteed at expiry? Not at manufacture. At expiry.
- How was shelf life tested, and under what storage conditions?
- Refrigerated or shelf-stable? Some probiotics need refrigeration; others can be kept at room temperature.
- cGMP compliance under 21 CFR Part 111, with a recent audit.
- Certificate of Analysis for each batch, including microbial counts and contaminant testing.
When you compare quotes, compare the guaranteed count at expiry. A cheap formula with a high count “at manufacture” can fall far below its label by the time a customer opens it.
How to label CFU counts
Federal rules require dietary supplements to list ingredient amounts by weight. Many probiotic brands also want to show colony forming units (CFU), which is what buyers understand. The FDA’s 2018 draft guidance (still a draft) says it intends to allow CFU declarations alongside weight, as long as:
- the quantity is first listed by weight;
- the CFU figure is clearly separate, for example in parentheses or a sub-line;
- CFU counts only live microorganisms, not dead or inactive ones;
- blends are listed in descending order of predominance by weight.
The NIH advises consumers to look for products labeled with the CFU count at the end of shelf life. Honestly, I’d treat that as the standard for your label too. It’s the honest number, and it’s the one reviewers test.
Typical doses, per the NIH, range from 1 to 10 billion CFU per dose. You don’t need the biggest number on the shelf; you need a number you can prove.
The other supplement rules
- No FDA pre-approval, but manufacturers must follow cGMP, and you’re responsible for your label.
- Structure/function claims (“supports digestive health”) need the FDA disclaimer and a notification to the FDA within 30 days of marketing. Disease claims are not allowed.
Our guide to private label supplements with no minimum order covers these rules in more depth, and contract manufacturing vs private label explains who is responsible for what.
Selling probiotics on Amazon
Since April 2, 2024, Amazon has required dietary supplements to be verified through a third-party testing, inspection and certification (TIC) organization, according to Amazon staff in the Seller Forums. Plan for:
- TIC verification before listing, with the costs built into your margin.
- Label images that match the physical product exactly.
- Storage: if your product needs refrigeration, think hard about FBA. Shelf-stable formulas are far simpler to sell through Amazon’s network.
If you’d like a team to vet manufacturers and manage production, that’s our complete sourcing management service. For a related supplement, see our guide to private label omega-3.
FAQ
What is the minimum order for private label probiotics?
Published minimums from US makers start at 500 bottles for stock formulas. Custom runs can require 150,000 capsules or more.
Can I put the CFU count on my probiotic label?
Under FDA draft guidance, yes, alongside the weight, as long as the CFU count covers only live microorganisms and is shown separately from the weight.
Should my label show CFU at manufacture or at expiry?
The NIH advises consumers to look for counts at the end of shelf life. Labeling that way is the safer, more honest choice.
Do private label probiotics need refrigeration?
Some strains do; others are shelf-stable. Shelf-stable formulas are simpler to store, ship and sell through FBA.
Do I need FDA approval for a probiotic supplement?
No. Supplements are not approved before sale, but manufacturers must follow cGMP and structure/function claims need a disclaimer and FDA notification.
Can I sell private label probiotics on Amazon?
Yes, after third-party verification through an Amazon-accepted testing, inspection and certification organization, which Amazon has required for supplements since April 2024.
Last updated: October 5, 2026. General information, not legal advice; confirm requirements with the FDA and Amazon. Sources: FDA, draft guidance on labeling live microbials (PDF); NIH ODS, probiotics fact sheet; 21 CFR 101.93; Amazon Seller Forums, supplement TIC verification; Aligen; Matsun Nutrition; Private Label Express.
