Supplements × USA
Private label supplements for the US market
Nobody in the US approves a supplement before sale. The label, the claims and the factory records carry the burden, and they are tested when FDA, the FTC or a retailer asks.
Private label supplements in the USA: how the rules actually work
To launch private label supplements in the USA, you need a formula built from lawful dietary ingredients, a factory that follows dietary supplement cGMP under 21 CFR Part 111, a registered food facility, a label with a compliant Supplement Facts panel, and claims you can substantiate. FDA does not approve dietary supplements or their labelling before marketing.
Three federal clocks shape the timeline. An ingredient not marketed in the US before 15 October 1994 is a new dietary ingredient, and FDA must be notified at least 75 days before the product enters interstate commerce. A structure or function statement, must be notified to FDA no later than 30 days after first marketing and carry the disclaimer that FDA has not evaluated it and that the product is not intended to diagnose, treat, cure or prevent any disease. Serious adverse event reports received through the address or phone number on the label go to FDA within 15 business days.
Advertising is a separate front. The FTC’s Health Products Compliance Guidance expects competent and reliable scientific evidence for health claims. For the wider US picture see our US market guide, and for category logic across markets see private label supplements. This page is general orientation only: in a project, the formula, label and claims are reviewed by a licensed US regulatory specialist before release.
What applies to a private label supplement in the US
Federal rules in launch order.
| Requirement | What it means | Who is responsible | Timing or cost driver |
|---|---|---|---|
| Dietary supplement cGMP (21 CFR Part 111) | Specifications for components, identity testing, batch records, and specifications for labels and packaging | Anyone who manufactures, packages, labels or holds the product | Depth of the factory’s own testing; gaps get pushed back onto the brand |
| Food facility registration | Sites that make, pack or hold food for US consumption register before operating; a foreign site names a US agent | Each facility, including your contract manufacturer and any US warehouse | Renewal every other year from 1 October to 31 December of even-numbered years, so 2026 is a renewal window |
| New dietary ingredient notification | Needed for ingredients not marketed in the US before 15 October 1994 | Manufacturer or distributor | Filed at least 75 days before sale; the safety dossier is the real cost |
| Supplement Facts and label | Serving size, servings per container, each dietary ingredient with its amount, other ingredients listed below, US contact for adverse event reports | Company named on the label | Artwork reprints every time the formula or a claim changes |
| Structure or function claims | Truthful, substantiated, notified, and printed with the FDA disclaimer | Manufacturer, packer or distributor | Notice within 30 days of first marketing; an evidence file per claim |
Amazon and large retailers can add their own testing demands.
Checklist before the first US batch ships
If any line is still open, the release date is not real yet.
- Every ingredient confirmed as a lawful dietary ingredient, with new dietary ingredient status checked and any notification filed 75 days ahead
- Contract manufacturer assessed against 21 CFR Part 111, with specifications and a certificate of analysis for each batch
- Food facility registration for the producing site, and a named US agent if the site is outside the US
- FSVP importer identified and supplier verification documented before the first entry
- Supplement Facts panel, ingredient list, net quantity and a US address or phone number for adverse event reports
- Claims file with evidence for each structure or function statement, the FDA disclaimer on pack, and the 30-day notice in the calendar
- US trademark search and filing strategy, covered on our US trademark page
Launch sequence for a US supplement brand
Regulatory clocks are fixed by law.
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1
Claim and customer first
Decide what the product may honestly say before choosing the formula. A supplement may not claim to diagnose, treat, cure or prevent disease.
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2
Formula and ingredient screen
Check each ingredient’s status and dose, and choose a stock formula or a custom blend.
At least 75 days before sale if a new dietary ingredient notification is needed -
3
Factory selection
We shortlist selected contract manufacturers and review their Part 111 records, testing practice and facility registration. See our <a href="/services/private-label-manufacturing/">manufacturing stage</a>.
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4
Import set-up
Name the importer of record and FSVP importer, and model landed cost at the current duty rate. Duty-free de minimis treatment has been suspended for all countries since 29 August 2025.
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5
Launch and notify
Start selling, then file the claim notification.
No later than 30 days after first marketing
Frequently asked questions
Do private label supplements need FDA approval?
No. FDA does not approve dietary supplements or their labelling before they are sold. You still need a Part 111 compliant manufacturer, a registered facility, a compliant label and the claim and ingredient notifications.
Can I sell supplements in the US that are made abroad?
Yes, if the foreign site is registered with FDA and names a US agent, works to Part 111, and a US importer runs supplier verification under FSVP.
What is a structure or function claim on a supplement?
It describes how a nutrient or ingredient affects normal structure or function of the body, without claiming to treat or prevent disease. It must be substantiated, notified within 30 days of first marketing and carry the FDA disclaimer.
Who is liable if my contract manufacturer makes a mistake?
Your brand, in practice. The company named on the label handles serious adverse event reports, and whoever labels or holds the product falls under Part 111.
Have a product idea? Check it before you buy stock.
Send a short brief. We tell you what we think, including when we think you should not do it.
Tell us about your brand
A few lines are enough: what you want to sell, where and to whom. We reply with an honest view of feasibility, the stages you need and the next step.
- No obligation: the first review of your idea is free
- If we think the idea will not pay back, we say so
- Your idea stays confidential; we can sign an NDA
What happens next
- 1We review your briefand may ask a few questions
- 2A short callabout goals, budget and limits
- 3Written proposalstages, scope, fees and timing
- 4First stage startswith a decision gate at its end
- usually 300–1 000 units per product in a first order
- usually 6–12 months from brief to first sales
- EU company, contract under Polish law