Who is supposed to build the label content, me or my manufacturer?

This is United States federal law, read for the four product classes covered here: dietary supplements, conventional food, cosmetics, and over-the-counter drugs. The question sounds like one question. It is two, and they have different answers.

Who has to do the work is left open in three of the four classes and answered in the fourth. Who answers for the result is settled in all four, and it runs to the name printed on the pack. That is usually yours.

So the honest version of the answer is this. Your manufacturer is required to run the line to a label its own records specify, and to be able to show the specified label went on. Nothing in that rule decides what the label should say. If you have not worked it out, and your agreement does not name who does, nobody has.

On this page: Which rule reaches you · What the rules do fix · What your maker’s own rule tells them · Cosmetics · Over-the-counter drugs · Which document decides it · The clause that is not there · Where the gap opens · Four things to check

Which rule reaches you, and which one does not

Start with the applicability clause, because for a brand owner this is where most of the internet’s advice stops being about you. Part 111, the dietary supplement manufacturing rule, opens by naming who it binds: except as provided by its own paragraph (b), you are subject to the part if you manufacture, package, label, or hold a dietary supplement (21 CFR 111.1(a)). Four verbs, and all four are physical operations. The narrow exception that follows removes the holding requirements from a retail establishment selling direct to consumers, and says a warehouse is not a retail establishment (111.1(b)).

If you own the brand, buy finished goods, and never touch the product, none of those four verbs describes you. Every label control clause in that part, the ones an article about supplement labels would otherwise walk you through, is written to somebody else. Being told your co-manufacturer is fully part 111 compliant is therefore true and beside the point at the same time.

Being outside part 111 is not being outside the law. The prohibition that reaches you is written against an act rather than a role, and it reaches whoever causes the act as well as whoever performs it. The statute states that the listed acts and the causing thereof are prohibited (21 U.S.C. 331), and the first act on the list is the introduction or delivery for introduction into interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded (331(a)). A food is misbranded if its labeling is false or misleading in any particular (343(a)). A cosmetic is misbranded on the same terms (362(a)). A dietary supplement is deemed to be a food within the meaning of the chapter, except for two named purposes that are not these (321(ff)).

Read those together and the shape of the thing appears. The manufacturing rule attaches to operations, so it lands on the plant. The misbranding rule attaches to the article and to the act of putting it into commerce, so it lands on you. Neither one contains an instruction to write anything.

What the rules do fix: the name on the pack

Every class has a provision that puts a company name on the label, and every one of them offers the same three-way choice. A food in package form must bear a label containing the name and place of business of the manufacturer, packer, or distributor (343(e)), and the regulation repeats it: the label shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5(a)). Cosmetics carry the same requirement in their own part (701.12(a)) and in the statute behind it (362(b)). The packaging and labeling statute that sits across consumer commodities asks for the identity of the commodity and the same name and place of business, though it works through regulations the promulgating authority establishes and binds only persons within its own prohibition (15 U.S.C. 1453(a)(1)).

Now read the sentence that settles the argument. Where the food is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such food, such as “Manufactured for ______”, “Distributed by ______”, or any other wording that expresses the facts (101.5(c)). Cosmetics carry the identical clause, word for word, with “cosmetic” in place of “food” (701.12(c)).

That clause exists because the regulator already knows you did not make the product. It does not treat that as a problem to be solved. It treats it as a fact to be disclosed, and then leaves your name on the front of the pack. “Distributed by” is not a disclaimer. It is a declaration of who to come to.

What your maker’s own rule tells them to do with your label

This is the part worth reading closely, because it is where the assumption breaks. Part 111 has a great deal to say about labels. Not one line of it is about wording.

You must establish specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, including specifications that ensure that you used the specified packaging and that you applied the specified label (21 CFR 111.70(g)). The master manufacturing record must include a description of packaging and a representative label, or a cross-reference to the physical location of the actual or representative label (111.210(g)). Before packaging and labeling operations run, labels for each batch must be examined to determine whether they conform to the master manufacturing record (111.410(c)). The operations themselves must be performed so that the supplement is packaged and labeled as specified in the master manufacturing record (111.415). Quality control personnel approve the packaging and labels for use in the manufacture of a dietary supplement and release them from quarantine (111.160(c)(3)), and review and approve all records for packaging and label operations (111.127(c)).

There is a specification duty in there, and it is worth being exact about it, because that clause is the one people reach for when they say the plant owns the label. The plant does owe a specification. What the specification is for is stated inside the clause itself: specifications that ensure the specified packaging was used and the specified label was applied. The companion clause makes the reference point explicit, requiring a specification at any point where control is necessary to ensure the supplement is packaged and labeled as specified in the master manufacturing record (111.70(a)).

So the benchmark is the master record, and the master record is where a label that already exists gets filed. Every duty in that chain runs from an operation to its own records rather than from your maker to you. The part’s own definition of “you”, at 21 CFR 111.3, is a person who manufactures, packages, labels, or holds dietary supplements, which is the plant and not the brand. Nothing in the part decides what the label should say, and nothing in it asks whether the words on it are lawful.

You can see the same thing in what the regulator writes up. The standard observation under the examination clause reads: “You did not examine, before packaging and labeling operations, packaging and labels for each batch of dietary supplement to determine whether the packaging and labels conformed to the master manufacturing record.” That is a finding about conformance, and it is written to the establishment that was inspected. It asks whether the label matched the record. It does not ask whether the label was right.

Cosmetics: the one place a statute names the party

The cosmetics subchapter, as amended in 2022, does something none of the others do. It defines a role and then hands that role the label duties by name. The responsible person means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product, in accordance with the adverse event contact provision below or with the federal packaging and labeling statute (21 U.S.C. 364(4)).

What that person then owes is stated directly. Each cosmetic product shall bear a label that includes a domestic address, domestic phone number, or electronic contact information through which the responsible person can receive adverse event reports (364e(a)). The responsible person shall identify on the label each fragrance allergen included in the product, with the substances to be determined by the Secretary by regulation (364e(b)). And the responsible person shall ensure, and maintain records supporting, that there is adequate substantiation of safety of the product (364d(a)), with one carve-out: that duty does not apply to a coal-tar hair dye that otherwise complies with the adulteration provision, though the responsible person for one still keeps records related to its safety (364d(b)).

Read the allergen sentence again. It is the closest thing in United States law to a rule about who builds label content, and the party it names is the one on the label rather than the one at the plant. If your name is on the jar, that sentence is addressed to you.

One trap sits next to this. The small business relief in the same subchapter is real but narrow: a responsible person under the sales threshold, who does not make or process the four product types the following subsection names, is a small business and not subject to the good manufacturing practice section or the registration and listing section (364h(a)). Two sections, named. Labeling is not one of them, and neither is safety substantiation. Being small changes what you register. It does not change who the label belongs to.

Over-the-counter drugs: your labeler code, their filing

Drug registration and listing is the one regime that gives your situation a name. A private label distributor is, with respect to a particular drug, a person who did not manufacture, repack, relabel, or salvage the drug but under whose label or trade name the drug is commercially distributed. That definition is set out in the definitions section of the registration and listing part, at 21 CFR 207.1.

What follows from it is a split that catches people out. Private label distributors who do not also manufacture, repack, relabel, or salvage drugs are not required to register (21 CFR 207.17(b)). The part still covers them, and it says why in one line: because they must have labeler codes (207.9(a)(3)). Each registrant must then list each drug it manufactures, repacks, or relabels for commercial distribution under the trade name or label of a private label distributor using a National Drug Code that includes that distributor’s labeler code (207.41(c)(1)).

Be precise about where that code lives. Each person who engages in manufacturing, repacking, relabeling or private label distribution of a listed drug must apply for a labeler code (207.33(c)), so the code is issued to you. Whether the resulting National Drug Code has to be printed on the pack is a separate question, and the answer is no: the number is requested but not required to appear on drug labels and labeling (21 CFR 201.2).

So you hold the identifier, the plant makes the submission that ties the product to it, and nothing anywhere in the part says who writes the Drug Facts. The content sits between you.

Which document decides who writes it

What each class fixes, what it leaves open, and what actually settles the open part. This table covers United States federal requirements and the certification-scheme documents named here. It does not cover state law, import requirements, or what a particular retailer or marketplace will demand of you.

Read from the text of each clause named, on August 18, 2026. What this does not evidence: it is a reading of the provisions listed and not a complete statement of every obligation attaching to a label. It says nothing about state law, about private litigation, or about a customer’s own contractual demands, and a rule outside the authorities named here is not caught by it.

The clause that is not there

We went looking for it properly rather than assuming. The full text of the statutes, regulations and certification-scheme documents read here was searched for any provision that names who writes, drafts, prepares, authors or creates the content of a product label. Read on August 18, 2026, there is not one. The hits the search returns are definitions of what a label is, rules about what must appear on it, and controls on how printed labels are stored, issued and reconciled.

What the search does return is the arrangement running the other way, and it is the nearest thing anywhere to an acknowledgment of how this actually works. Two good manufacturing practice certification standards address label controls to the plant, and both of them name label copy provided by customers as something those controls may be extended to reach, alongside labels printed in-house and labels printed externally. The dietary supplement standard puts it as an expectation, at its clause 4.5.54.6; the over-the-counter drug standard states the same control at its clause 4.5.37.7. In both, the extension to customer-supplied copy is written as permitted rather than required (NSF/ANSI 455-2 and NSF/ANSI 455-4, certification schemes rather than law).

Read that from where you sit. The standard that governs your manufacturer already anticipates that label copy arrives from the customer, and treats controlling it as something the plant may extend its checks to cover. It does not tell them to write it, and it does not ask them to judge whether it is lawful. If you are relying on that check, read your maker’s own procedure to see whether they took the option.

There is one place a scheme does dictate label content directly, and it is worth knowing if a certification mark is going on your pack. Private labeling a certified product happens only if the certifier authorizes it, and the program then offers three routes rather than one. On the first, the marking has to name the company the private labeling is for and also prominently identify the original manufacturer, carrying that company’s name and address and listed trade designation on the label and in all advertising, close to each mark and in a font at least as large as the private label name. The other two routes work through the listing instead and put nothing extra on the pack (NSF Certification Guideline 306, Certified for Sport, a certification scheme rather than law). Which route you are on is a question for whoever holds the certificate, and on the first one a scheme you joined can put words on your label that no regulation asks for.

Method: a full-text search of the provisions named here for authorship verbs appearing near a label term, then a reading of each hit. What this does not evidence: it is a search of the authorities named here, not of every authority in the United States, and it is a search for a form of words. A rule could require the substance of an authorship duty without using any of those verbs, and nothing here reaches state law or contract law.

Where the gap actually opens

This is not really a question about labels. It is an instance of a failure that turns up wherever two organizations meet: at the edge of a scope, who holds the work, and what falls into the space between. The pattern we have seen is that each party writes its own version of the shared step, so the allocation is agreed by neither and gets settled on the spot by whoever is present. Alongside it sits a scope that stops short of what those relying on it assume it contains.

Both halves show up here in the same conversation. Your manufacturer’s scope is the operation. Your designer’s scope is the layout. Yours, by default, is everything neither of them named, and nobody says so out loud because each party is looking at their own half and seeing it complete.

The second pattern is the one that costs money. A separate checker is assumed to take the maker off the hook, and the check turns out to be narrower than the people relying on it believed. Quality control personnel do approve labels. What they approve is the packaging and labels for use in the manufacture of the supplement, releasing them from quarantine (111.160(c)(3)), and that the records of the packaging and label operation have been reviewed (111.127(c)). The examination they perform before the run asks whether the label conforms to the master manufacturing record (111.410(c)). Every one of those is a check that the right approved label went on. None of them is an opinion that the words on it are lawful. A perfectly executed label control system will apply a misbranded label with complete accuracy, batch after batch, and the record will show it doing so correctly.

Four things to check before your next print run

1. Find the sentence in your agreement that names the label. Not the sentence about compliance in general. The one that says who supplies the artwork, who supplies the regulated content inside it, who approves a change, and who carries the cost of a reprint when it changes. A clause that says the label shall be compliant, without naming who makes it so, has allocated nothing.
2. Ask what your manufacturer holds as the master label. The master manufacturing record has to carry a representative label or a cross-reference to where the real one is kept (111.210(g)). Ask to see the version they are running to. It should be the version you last approved, and the two drift more often than anyone expects.
3. Read your own footer. If it says “Distributed by” or “Manufactured for” and then your company name, you have already made a declaration under 101.5(c) or its cosmetic twin 701.12(c). Decide whether the content behind that name was ever actually built by anyone.
4. Separate typesetting from authorship, in writing. A designer who lays out a panel is not deciding whether the claim is a structure and function claim, whether the daily values reconcile, or whether an ingredient may lawfully be declared. Somebody has to. Name them.