Is setting the specification my manufacturer’s job, or mine?

This page is United States federal law for dietary supplements: 21 CFR part 111, the good manufacturing practice rule FDA issued under its authority to prescribe good manufacturing practices for dietary supplements (21 U.S.C. 342(g)(2)). If what you sell is a cosmetic, an over-the-counter drug, or a conventional food, none of the clauses below are yours. Part 111 reaches dietary supplements and nothing else, and the human-food preventive controls rule steps aside for them: subparts C and G of that part do not apply to a facility with regard to a dietary supplement that is in compliance with part 111 and section 761 of the Act (21 CFR 117.5(e)). If your product is not a supplement, your version of this question has a different answer and it is not on this page.

What this page does not answer. It settles who has to establish a specification. It does not tell you what to put in one, which is a separate question with its own answer. It does not settle whether a quality agreement or your supply contract is the document that records the split, which is answered here. And it is not a reading of your own contract, which we have not seen.

On this page: The short answer · What the rule means by “you” · Which specification is yours · The clause that lands on the brand owner · What the inspection record shows · Where it actually goes wrong · What you can hand over, and what you cannot · If the specification is wrong · Three things to check

The short answer

It is not one job held by one party. Part 111 puts seven separate specification duties in a single section, and most of them carry an operational condition on the face of the clause rather than naming a company (21 CFR 111.70(a) through (g)). Your manufacturer carries the ones covering the operations it performs. You carry the ones covering the operations you perform. If you take delivery of product from a supplier and put your label on it for your own distribution, some of those duties are expressly yours, and the fact that your manufacturer already wrote a specification does not discharge them.

What the contract does is record the split and set what each of you owes the other. What it cannot do is move a duty the rule attached to an operation you are the one performing.

What the rule means by “you”

Every requirement in part 111 is written at “you,” and the rule defines the word rather than leaving it to the reader. You means a person who manufactures, packages, labels, or holds dietary supplements (21 CFR 111.3). The coverage clause says the same thing from the other side: you are subject to the part if you manufacture, package, label, or hold a dietary supplement, including one you manufacture that is packaged or labeled by another person (21 CFR 111.1(a), (a)(1)).

Read those two together and the question answers itself. Nothing in either turns on whose brand is on the bottle, who paid for the batch, or who signed what. They turn on activity. FDA states the position plainly in its own guidance on the rule: if you package, label, or distribute a dietary supplement manufactured by another firm, you are subject to the rule, and it requires you to comply with the provisions directly applicable to the operations you perform (FDA Small Entity Compliance Guide on 21 CFR part 111). That guidance is FDA’s stated current thinking and it says of itself that it does not create or confer any rights and does not bind FDA or the public; the binding text is the regulation, and the regulation is what is quoted above.

There is one carve-out worth knowing, because it is narrower than people hope. The requirements about holding do not apply to you if you hold supplements at a retail establishment for the sole purpose of direct retail sale to individual consumers. A retail establishment does not include a warehouse or other storage facility for a retailer, and it does not include a warehouse or other storage facility that sells directly to individual consumers (21 CFR 111.1(b)). That second exclusion is the one that catches people: shipping to consumers out of your own warehouse is not the exempt case. And the carve-out exempts holding. It exempts nothing about specifications.

Which specification is yours

Take what you actually do with the product and read across.

One of the seven is written flat. Paragraph (d) requires specifications for dietary supplement labels and for packaging that may come in contact with the supplement, and unlike its neighbours it carries no condition tying it to manufacture (21 CFR 111.70(d)). It is addressed to “you,” and “you” includes a person who packages or labels. The consequence clause treats it the same way, listing (d) among the specifications whose failure requires quality control personnel to reject the package or label (21 CFR 111.77(a)). So a brand owner who labels received product holds (d) as well, which is the duty most often assumed to sit with the factory.

Two conditions have to hold together before the received-product clause fires, and dropping either one gets the answer wrong. The product has to be received for packaging or labeling, and it has to be for your distribution rather than for return to the supplier. FDA reads the second condition as a question about control: you are subject to those requirements if the product you will package or label has left the control of the firm that supplied it, for example because you purchased it, and you are not subject to them if you package or label under contract and return the product rather than distributing it yourself (FDA Small Entity Compliance Guide, discussing 21 CFR 111.70(f), 111.75(e) and 111.127(a)).

So the test is not the job title on the invoice, and it is not brand ownership on its own. A pure reseller who buys goods already packaged and labeled, and never packages or labels anything, is outside that clause. What the same guidance names for that party is different: a distributor who purchases a packaged and labeled dietary supplement and then holds it in a warehouse for distribution has to comply with the requirements for holding and distributing, and with other applicable requirements such as personnel and the physical plant (FDA Small Entity Compliance Guide).

The clause that lands on the brand owner

Here is the clause in its own words. If you receive a product from a supplier for packaging or labeling as a dietary supplement, and for distribution rather than for return to the supplier, you must establish specifications to provide sufficient assurance that the product you receive is adequately identified and is consistent with your purchase order (21 CFR 111.70(f)).

It does not stop at writing one. Before you package or label that product, you must visually examine it and have documentation to determine whether the specifications you established are met (21 CFR 111.75(e)). Your quality control personnel must review the results of that examination and documentation to ensure the specifications are met (21 CFR 111.127(a)), and must approve and release from quarantine every such product before it is used for packaging or labeling (21 CFR 111.127(b)). If the specifications are not met, quality control personnel must reject the product, and it may not be packaged or labeled for distribution as a dietary supplement (21 CFR 111.77(c)).

Notice what this specification is for. It is not a second copy of your manufacturer’s finished-product specification, and writing one does not make you responsible for running an assay. It is the specification that lets you tell, on receipt, that what arrived is the thing you ordered. Identity, the purchase order it is supposed to match, and whatever else you need in order to say yes or no before your name goes on it.

The finished-product specification is a different duty and it sits with whoever manufactures: for each dietary supplement you manufacture you must establish product specifications for identity, purity, strength and composition of the finished batch, and limits on contamination (21 CFR 111.70(e)). If your manufacturer is doing its job, that specification exists and it is theirs.

What is yours, if you package or label, is the release decision at the end: quality control personnel must approve for release, or reject, any packaged and labeled dietary supplement for distribution (21 CFR 111.127(h)). Making that call on a product built to somebody else’s specification is difficult if you have never read it, and FDA says as much, though in guidance rather than in the rule: a distributor who contracts with a manufacturer to make a dietary supplement it then distributes under its own label has an obligation to know what and how manufacturing activities are performed, so that the distributor can make decisions about whether the packaged and labeled product conforms to its established specifications and whether to approve and release the product for distribution (FDA Small Entity Compliance Guide). That is FDA’s stated expectation and not an enforceable clause. Note the possessive in it, though: FDA says its established specifications, meaning the distributor’s own.

What the inspection record shows

These are not dormant clauses. Counting FDA’s published inspectional observations, the specification duties of section 111.70 have been written up 3,570 times. The three the argument turns on look like this.

Counted 18 August 2026 across FDA’s published inspectional observation records for fiscal years 2009 to 2026, filtered on the cited clause. The middle column paraphrases what the observations say; every observation citing 111.70(f) carries one of two closely similar wordings, both tracking the clause.

What these numbers do not show. They count observations FDA issued and firms that received them. They do not count how many firms hold the duty, and they are not a compliance rate: an observation exists only where FDA inspected, so a small number can mean the duty is rarely breached or that the firms carrying it are rarely visited, and the count cannot tell you which. What they do establish is that this is a live citation an investigator writes, against real firms, in the current fiscal year.

Where it actually goes wrong

The failure here is not somebody refusing to write a specification. It is two parties each assuming the other holds a step, and a scope that stops short of what the party relying on it assumed it contained.

It runs like this. Your manufacturer has specifications, because it needs them to run. You have seen them, or you have seen a certificate of analysis written against them, and you concluded that specifications exist for your product. They do. They are the manufacturer’s, written for the operations the manufacturer performs, and they do not include the one thing part 111 asked you to write: the basis on which you decide that the pallet that arrived is the product you ordered, before your label goes on it. Nobody wrote that specification because each side could point at a document and see specifications. The gap is not in either document. It is in the space between them, and it is exactly the space the received-product clause was written to cover.

What good looks like is unglamorous. A short document, yours, naming the product and the supplier, the identity attributes you will confirm on receipt, what you check the delivery against, what documentation has to come with it, and what happens when it does not match. A dated record each time you run it. Quality control personnel named, and a signature approving or rejecting. That is not a manufacturing specification and it is not meant to be. It is the record that answers an investigator who asks how you knew.

The second version of the same failure is quieter. You put your manufacturer’s specification on your own letterhead, unchanged, and now you hold a document you cannot explain, because you do not know why any number in it is what it is. The people you designate as quality control personnel have to approve specifications that may affect identity, purity, strength or composition (21 CFR 111.105(a)), and an approval nobody in your company can account for is what an investigator finds. Whether you can rely on a supplier’s certificate of analysis is a separate question, and the rule answers it only for components, with conditions attached (21 CFR 111.75(a)(2)(ii)).

What you can hand over, and what you cannot

You can hire the work out. The rule anticipates it in the definition it gives the people who do it: quality control personnel means any person, persons, or group, within or outside of your organization, who you designate to be responsible for your quality control operations (21 CFR 111.3). Outside your organization is expressly allowed. So a consultant can write your received-product specification, and a laboratory can run whatever testing you decide to do, and none of that is a departure from the rule.

What does not move is the designation and the duty behind it. You must implement a system of production and process controls covering all stages of manufacturing, packaging, labeling and holding of the supplement (21 CFR 111.55), you must implement quality control operations (21 CFR 111.65), and the personnel you designate must approve or reject all processes, specifications, written procedures, controls, tests and examinations that may affect identity, purity, strength or composition (21 CFR 111.105(a)). Someone else can draft. The approval is an act performed on your behalf, by people you named, and the operation stays yours.

FDA offers a worked example of hired work, and it is written about a manufacturer rather than about a brand owner: a manufacturer who hires a contractor to perform specific operations within the scope of the manufacturer’s own responsibilities under the rule is responsible for complying with the requirements related to that contracted operation, even though the contractor is the one performing the task (FDA Small Entity Compliance Guide). It is one of three examples FDA gives, and FDA says plainly that it is not practical to list every contractual relationship. Read it for the shape rather than the coverage, because the shape is what the regulation already carries on its own terms: the duties follow the operations, and paying somebody to perform an operation you are subject to does not move the requirement off you.

If the specification is wrong, whose problem is it

This is where the contract stops helping. A dietary supplement is adulterated if it has been prepared, packed, or held under conditions that do not meet the good manufacturing practice regulations (21 U.S.C. 342(g)(1)). Introducing or delivering for introduction into interstate commerce any food that is adulterated or misbranded is a prohibited act (21 U.S.C. 331(a)), and so is receiving such an article in interstate commerce and delivering it for pay (21 U.S.C. 331(c)). Any person who violates a provision of section 331 is subject to the penalties the statute sets (21 U.S.C. 333(a)(1)).

The prohibited act attaches to the person who introduces the article into commerce. That is you, on your own product, whoever made it.

The statute then names six situations in which a person is not subject to those penalties, and two of them are worth knowing precisely, because they are the real version of the protection people believe their contract gives them (21 U.S.C. 333(c)).

The first covers the receipt-and-delivery exposure. A person is not subject to those penalties for having received an article in interstate commerce and delivered it, or offered to deliver it, if the delivery was made in good faith, unless he refuses to furnish, on request of an officer or employee the Secretary designates, the name and address of the person he bought or received the article from, together with copies of the documents pertaining to its delivery to him. That relief turns on good faith and on being able to produce your supply records when asked. It is the reason a brand owner who cannot say where a lot came from is in a materially worse position than one who can.

The second is the guaranty. A person is not subject to those penalties for having violated section 331(a) if he establishes a guaranty or undertaking, signed by and containing the name and address of the person residing in the United States from whom he received the article in good faith, to the effect that the article is not adulterated or misbranded within the meaning of the chapter, designating the chapter. Note the shape of it: a signed instrument from your supplier, in the statute’s own terms including that designation, held by you before you need it. An indemnity clause is not that instrument, and a clause in a supply agreement saying quality is the manufacturer’s responsibility is not that instrument either. Both routes run to the penalties named in that subsection. Neither is a general shield, and neither makes the product any less adulterated.

Three things to check before you spend

1. Ask which of the seven you hold. Go through 111.70(a) to (g) against what your company physically does with the product. A brand owner who takes delivery and labels usually finds it holds (d), (f) and (g), and has never written any of them. That is a short, cheap gap to close and it is the one an investigator asks about first.
2. Read your manufacturer’s specification before you put it on your letterhead. If you cannot say where a limit came from, you cannot account for approving it, and the document carrying your name does not change that. Ask for the basis, in writing, per attribute.
3. Find out whether you hold a guaranty, not an indemnity, and whether you can produce your supply records. Those are the two things the statute actually names. If nobody in your company can produce a signed guaranty carrying a US name and address, you do not have one.