When a seller puts its label on someone else's supplement

A category the rules name outright

Not every company that sells a supplement made it. Some buy finished product and put their own label on it, and the regulations have a specific name for that.

The phrase is a product received for packaging or labeling as a dietary supplement. It carries a parenthetical that decides which rules apply: for distribution rather than for return to the supplier.

That distinction is the hinge. Material passing through on its way back to whoever sent it is a different situation from material about to be sold under a new name.

Once it is the second one, the receiving company inherits duties. It does not simply resell somebody else's work.

Two examinations, on arrival

The first duties are physical and documentary, and both are described as visual.

The containers are checked. Each immediate container, or grouping of them, is examined "for appropriate content label, container damage, or broken seals."

The purpose is stated: "to determine whether the container condition may have resulted in contamination or deterioration of the received product." So the examination is about what the damage implies, not about tidiness.

The paperwork is checked too. The supplier's "invoice, guarantee, or certification" is examined to make sure the received product is consistent with the purchase order.

Quarantine until three things happen

Arrival does not mean availability. The received product is quarantined until a short sequence completes.

Samples come first. Representative samples are collected "of each unique shipment, and of each unique lot within each unique shipment, of received product."

Then a review. Quality control personnel "review and approve the documentation to determine whether the received product meets the specifications" established for it.

Then a release. Those same personnel approve the product for packaging or labeling and release it from quarantine. Until that happens, it stays where it is.

An identifier that reaches back to the supplier

The traceability requirement is the most useful thing in this section, because it defines what the receiving company has to be able to answer.

Each unique lot within each unique shipment has to be identified so it can be traced to five things. Those are the supplier, the date received, the name of the received product, its status, and the finished product distributed from it.

The regulation even gives its own examples of status, listing "quarantined, approved, or rejected." Status is a tracked field, not a state of mind.

And the identifier gets reused. It has to be used "whenever you record the disposition of each unique lot within each unique shipment of the received product."

Packaging and labels arrive the same way

Empty containers and printed labels get their own section, and it mirrors the one above almost exactly.

They are visually examined on arrival, and the supplier's invoice, guarantee or certification is checked against the purchase order.

They are quarantined until representative samples are collected and, "at a minimum," a visual identification of the immediate containers and closures is conducted.

Quality control personnel then review and approve any test results and release them from quarantine. Labels are treated as a material with a lot number, which is exactly what they are.

What happens to what is rejected

The rejection section is one sentence, and it is written to prevent a specific failure.

Anything rejected and unsuitable for use has to be clearly identified, held, and controlled "under a quarantine system for appropriate disposition."

That applies to components, packaging, labels and received product alike. Rejected material does not sit in a corner waiting for someone to remember it.

The word disposition matters. Something has to be decided and recorded about the material, rather than the rejection itself being the end of the story.

The laboratory behind all of it

Every approval above rests on a test or an examination, and a separate subpart governs how those are done.

A company must "use adequate laboratory facilities" to perform whatever testing is necessary to determine whether components, in-process material and finished supplements meet specifications.

The control processes are approved rather than assumed. Laboratory control processes have to be "reviewed and approved by quality control personnel."

They cover criteria for setting specifications, sampling plans for representative samples, criteria for selecting test methods, and criteria for selecting standard reference materials.

A valid method for each specification

Two short sentences carry most of the weight in the laboratory subpart.

The first is about fit: "You must verify that the laboratory examination and testing methodologies are appropriate for their intended use."

The second is about coverage. A company must "identify and use an appropriate scientifically valid method for each established specification for which testing or examination is required."

Read together, that is a method-per-specification rule. A single general assay does not satisfy a set of specifications it was not chosen for.

What the receiving record has to hold

The records requirement names its documents by example, which makes it unusually concrete.

Receiving records are kept, "including records such as certificates of analysis, suppliers' invoices, and suppliers' guarantees."

The person who performs a required operation documents it at the time of performance. The record carries the date the material was received and "The initials of the person performing the required operation."

It also carries the results of any tests or examinations, and any material review and disposition decision made about the material.

What this changes when reading a product page

None of these records is published, and nothing in either subpart requires any of them to reach a buyer.

What the sections do is describe a real and common arrangement without euphemism. A company can sell a supplement it did not make, and the rules assign it duties anyway.

That reframes a familiar sentence. A claim that a product is third-party tested says nothing about who received it, who approved its release, or whether a method was chosen for each specification.

It also puts a certificate of analysis in its place. In these subparts a certificate is named as a receiving record, filed alongside an invoice, rather than as the thing that settles whether a batch may be used.

Sources

Each document below is named as it names itself, with the date printed on that document rather than the day it was read.

1. Title 21 Code of Federal Regulations section 111.165, What requirements apply to a product received for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier) — the visual examination of containers at (a) and of the supplier's invoice, guarantee or certification at (b), the quarantine until sampling, quality control review against specifications and release at (c), the unique lot identifier traceable to the supplier, receipt date, name and status at (d), and the holding conditions at (e) — Electronic Code of Federal Regulations, Office of the Federal Register, June 2007
2. Title 21 Code of Federal Regulations section 111.160, What requirements apply to packaging and labels received — the visual examination on arrival, the check against the purchase order, the quarantine until representative samples are collected and a visual identification of immediate containers and closures is conducted, the quality control review and release, and the unique lot identifier — Electronic Code of Federal Regulations, Office of the Federal Register, June 2007
3. Title 21 Code of Federal Regulations section 111.315, What are the requirements for laboratory control processes — the requirement that laboratory control processes be reviewed and approved by quality control personnel, and the listed elements including criteria for establishing specifications, sampling plans for representative samples of components, in-process materials, finished batches and received product, criteria for selecting examination and testing methods, and criteria for selecting standard reference materials — Electronic Code of Federal Regulations, Office of the Federal Register, June 2007
4. Title 21 Code of Federal Regulations section 111.320, What requirements apply to laboratory methods for testing and examination — the verification that examination and testing methodologies are appropriate for their intended use at (a), and the requirement to identify and use an appropriate scientifically valid method for each established specification for which testing or examination is required at (b) — Electronic Code of Federal Regulations, Office of the Federal Register, June 2007
5. Title 21 Code of Federal Regulations section 111.180, Under this subpart G, what records must you make and keep — the written procedures at (b)(1), the receiving records including certificates of analysis, suppliers' invoices and suppliers' guarantees at (b)(2), and the documentation at the time of performance carrying the receipt date, the initials of the person performing the operation, any test or examination results, and any material review and disposition decision at (b)(3) — Electronic Code of Federal Regulations, Office of the Federal Register, June 2007
6. Title 21 Code of Federal Regulations section 111.170, What requirements apply to rejected components, packaging, and labels, and to rejected products that are received for packaging or labeling as a dietary supplement — the requirement to clearly identify, hold and control rejected material under a quarantine system for appropriate disposition — Electronic Code of Federal Regulations, Office of the Federal Register, June 2007
7. Title 21 Code of Federal Regulations section 111.310, What are the requirements for the laboratory facilities that you use — the requirement to use adequate laboratory facilities to perform the testing and examinations necessary to determine whether components meet specifications, whether in-process specifications in the master manufacturing record are met, and whether finished dietary supplements meet specifications — Electronic Code of Federal Regulations, Office of the Federal Register, June 2007