Questions to ask a supplement manufacturer

Ask a supplement manufacturer which site will make your product and what certification it holds, how it meets the CGMP rule (specifications, identity testing of dietary ingredients, master and batch records, reserve samples), what its FDA inspection and recall history is, and the commercial terms: minimum order, lead time, who supplies ingredients and packaging, and who owns the formula.

Use this as a checklist for calls and emails with each manufacturer on your shortlist. Ask every manufacturer the same questions, in writing where you can, so you can compare the answers. Where a question relates to the US dietary supplement CGMP rule (21 CFR Part 111), the section is linked.

Certification and site

Which site will make my product, and what is its address?Why it matters: certifications, licences and FDA inspections apply to a specific site, not to a company as a whole.
Which certification or licence does that site hold, and what is the number?Why it matters: you can check it on the issuer’s public list, such as NSF’s NSF/ANSI 455 GMP listing.
Does the certification scope cover my dosage form and the work you will do?Why it matters: a site certified for packaging or warehousing is not certified to manufacture.
Will any of the work be done at another site or by a subcontractor?Why it matters: every site that handles your product is one you need to check.

How to verify a manufacturer’s certification shows how to check the answers.

Quality system under 21 CFR 111

What specifications will you set for my product, and can I see them?Why it matters: 21 CFR 111.70 requires specifications for components and for the finished batch, covering identity, purity, strength, composition and contaminant limits.
How do you verify the identity of each dietary ingredient?Why it matters: 21 CFR 111.75 requires at least one appropriate test or examination of every dietary ingredient, unless FDA grants an exemption.
For which other components do you rely on a supplier’s certificate of analysis, and how did you qualify those suppliers?Why it matters: 21 CFR 111.75 allows it for components other than dietary ingredients only after the supplier is qualified.
Will there be a master manufacturing record for my formula?Why it matters: 21 CFR 111.205 requires a written one for each unique formulation and batch size.
Can I see the batch production record for each of my batches?Why it matters: 21 CFR 111.255 requires one for every batch, with complete information on its production and control.
Will I get a certificate of analysis for each finished batch, and which tests does it report?Why it matters: it is how you see whether a batch met the finished-batch specifications you agreed.
Do you keep reserve samples of each lot, and for how long?Why it matters: 21 CFR 111.83 requires reserve samples of each lot distributed, held for one year past the shelf-life date or, without one, two years from distribution.
Who approves each batch for release, you or me?Why it matters: FDA has said a brand selling a contract-made supplement under its own label must know how it is made so it can decide whether to release it (72 FR 34790).

Inspection history and recalls

When did FDA last inspect this site, and how was the inspection classified?Why it matters: you can check final classifications (NAI, VAI or OAI) on the FDA Data Dashboard.
Has the company received an FDA warning letter, and has it been closed out?Why it matters: FDA’s warning letters page is searchable and shows response and closeout letters.
Has the company had a recall, and what was the cause?Why it matters: food recall enforcement reports are searchable through openFDA, and our profiles show matches.

Search under the legal name and address of the site, which may differ from the brand name. Are supplement manufacturers FDA approved? explains what these records mean.

Commercial terms

What is your minimum order quantity for this exact product?Why it matters: minimums vary by manufacturer, dosage form and formula, and we don’t verify them.
What is the lead time from approved order to shipment?Why it matters: it varies by manufacturer and product, and we don’t verify it.
Who supplies the ingredients and the packaging?Why it matters: it decides who chooses suppliers and who carries sourcing delays.
Who owns the formula and the specifications?Why it matters: it decides whether you can move production to another manufacturer, and only the contract settles it.
Who receives and investigates complaints and adverse event reports?Why it matters: the company named on the label must report serious adverse events to FDA within 15 business days (21 U.S.C. 379aa-1).

If you are deciding between a stock formula and your own, read private label vs custom formula supplements.

Red flags

“FDA approved” or “FDA certified” facility. FDA does not issue any certification of CGMP compliance, and a registration number does not mean FDA has approved or endorsed a facility.
A promise that your product will be “FDA approved”. FDA does not have the authority to approve dietary supplements before they are marketed.
Supplier certificates instead of identity tests for dietary ingredients. 21 CFR 111.75 requires at least one appropriate test or examination of each dietary ingredient.
A certification you can’t find on the issuer’s list, or no answer about which site will make your product.
No access to specifications or batch records for your own product. You need them to know what and how manufacturing is done, which FDA says is your obligation as the brand.

Next step

Build a shortlist from supplement manufacturers or NSF-certified supplement manufacturers, send each the same specification with the quote form, and work through these questions with each one that replies.

Common questions

What should I ask a supplement manufacturer first?

Which site will make your product, and which certification or licence that site holds, with the number. Certifications apply to specific sites, and you can check the answer on the issuer’s public list before you go further.

What is a master manufacturing record?

The written record a manufacturer must prepare and follow for each unique formulation and batch size of a dietary supplement under 21 CFR 111.205. Each batch made from it gets a batch production record under 21 CFR 111.255.

Can a manufacturer rely on a supplier’s certificate of analysis?

For dietary ingredients, no: 21 CFR 111.75 requires at least one appropriate test or examination to verify identity, unless FDA grants an exemption. For other components, a manufacturer may rely on a supplier’s certificate of analysis once it has qualified the supplier.

How long must a supplement manufacturer keep reserve samples?

Under 21 CFR 111.83, for one year past the shelf-life date if shelf-life dating is used, or otherwise for two years from distribution of the last batch associated with the sample.

What is a normal minimum order quantity?

There isn’t one: minimums vary by manufacturer, dosage form and formula, and our profiles list minimum order quantity as something we don’t verify. Ask each manufacturer for its minimum for your exact product.

Sources

Search the directory for certified or licensed manufacturers, or read how we verify each listing.