FDA registered facility. That is not FDA approved
TS LAB d.o.o. makes dietary supplements in capsules in Komenda, Slovenia, and operates an FDA registered food facility. Registration is an administrative filing under US law, not a quality verdict, and this page states the difference before anything else.
Is TS LAB FDA approved?
No, and neither is any other supplement manufacturer. Under DSHEA, FDA has no authority to approve dietary supplements before they are marketed, and FDA does not approve the facilities that make them either. What TS LAB has is a registered food facility, which is a different thing and a legal requirement for the US market.
What the law requires
Section 415 of the US Federal Food, Drug, and Cosmetic Act, implemented by 21 CFR Part 1 Subpart H, requires domestic and foreign food facilities within its scope to register with FDA before manufacturing, processing, packing or holding food for US consumption, unless an exemption applies. Dietary supplements and dietary ingredients are food for this purpose.
What FDA says about the number
FDA guidance states that assignment of a registration number means the facility is registered and does not in any way convey approval or endorsement of a facility or its products. So FDA registered is not FDA approved, not FDA certified and not FDA endorsed. Those three phrases are never used about TS LAB or about a product made here.
The sentence that closes the objection
FDA registration is a filing requirement under 21 CFR Part 1 Subpart H. It is not FDA approval, and FDA does not approve dietary supplements. Registration must be renewed every two years, in the window from 1 October to 31 December of each even numbered year, and updated within 60 days of any change to the registered information.
What does it cover, and what does it not cover?
Registration is a record that the site exists, is reachable and can be inspected. Everything about whether a product may be sold sits outside it.
What it covers
That the facility has filed its registration with FDA, that FDA knows the site exists and can inspect it, and that a foreign facility is reachable through a US agent.
What it does not cover
Product safety, product efficacy, label claims, formula legality, and compliance with the US cGMP rule for dietary supplements, 21 CFR Part 111, which is a separate obligation enforced by inspection rather than by registration. Responsibility for a supplement not being adulterated or misbranded stays with the manufacturer and the distributor.
Why do brand buyers ask about FDA registration?
For a product intended for the United States, buyers need to check the facility’s registration status alongside the separate product and import requirements. Agree the evidence needed for your order with the manufacturer and your importer.
Brands selling into the United States
A supplier without a registered facility is a non starter, because registration is required before the facility operates for the US market. This is the first question a US importer asks and the fastest one to answer.
Amazon sellers
Marketplace requirements are separate from facility registration. Check the current request in your seller account, including the marketplace, product and any approved testing provider required. Facility registration alone does not establish that a listing meets those requirements.
Buyers checking the production site
Check that the registration evidence refers to the manufacturer and production site handling your order. Discuss any further verification or site visit you need before placing the order.
How do I verify an FDA facility registration?
Ask for appropriate evidence of the facility’s current registration and check the legal entity and site details. Food facility registration information is not a public FDA register, and FDA does not require a facility to share its registration number with third parties. Any information needed for an import should be handled through the agreed import process.
| Field | What TS LAB publishes today |
|---|---|
| Facility registration number | Request appropriate registration evidence for your order |
| Next biennial renewal window | 1 October to 31 December 2026 |
| Verification route | Current registration evidence matched to the legal entity and site, with any information for import handled through the agreed import process. |
| What the registered address must match | Obrtna cona Potok pri Komendi 14, 1218 Komenda, Slovenia |
Read the wording on any FDA document you are shown
A document that says approved, certified or endorsed by FDA for a dietary supplement or a supplement facility is wrong on its face, whoever issued it. The correct wording is registered. If a supplier uses the other three words about themselves, that is the finding, not a detail.
What does TS LAB publish with your order?
Registration answers for the site. Your batch is answered by batch documents. A Certificate of Analysis, or COA, is the laboratory result sheet for one production batch, read against the specification that batch was released to.
Agree the documents for your order
- Finished-batch Certificate of Analysis, where included in the agreed testing scope
- Product specification the batch is released against
- Traceability documentation for the incoming raw materials
- Copy of the FDA registration confirmation, with the registered site address
- Site visit or customer audit in Komenda, by prior arrangement
Where to read more
For the US market the separate question is 21 CFR Part 111, which is a manufacturing rule and not a registration. Read the GMP page for what the European certificate covers, and the page on ISO 22000, IFS Food and BRCGS for retailer standards.
The full document pack, all certificates, what we make in capsules.
Questions buyers ask about FDA registration
Is TS LAB FDA approved?
No, and neither is any supplement manufacturer. FDA does not approve dietary supplements or the facilities that make them, and under DSHEA it has no authority to approve a supplement before it is marketed. The TS LAB facility is registered with FDA, which is a filing requirement under 21 CFR Part 1 Subpart H.
What does FDA registered facility actually mean?
It means the facility has filed its food facility registration with FDA. US registration rules apply to facilities that manufacture, process, pack or hold food for US consumption, unless exempt. Registration does not mean FDA has approved the facility or its products.
Does FDA registration mean my product can be sold in the United States?
No. The product still has to comply with US labelling and composition rules, and the distributor named on the label carries the responsibility to FDA. Registration is a precondition for the facility, not a clearance for the product.
Is FDA registration the same as 21 CFR 111 cGMP?
No. 21 CFR Part 111 is the US current good manufacturing practice rule for dietary supplements, and it is a separate obligation. It is verified by inspection or by third party certification, not by the act of registering a facility.
Does FDA registration expire?
Registration must be renewed every two years, in the window from 1 October to 31 December of each even numbered year, and updated within 60 days of any change to the registered information.
Ask for the registration document with your offer
Send the product and the quantity, and receive an offer within 1 to 3 business days.
Registered company since 2011, credit rating AA+ (2026), registered data on the proof page.