When something goes wrong with the product, who is actually on the hook — the brand or the manufacturer that made it?

This is United States federal law, read for four product classes: dietary supplements, human food, over-the-counter drugs and cosmetics. It answers who the law reaches. It does not answer who ends up paying for the destroyed stock, the recall and the customer claims, which is decided by your contract, your indemnities and your insurance. Those are questions for your own attorney and your broker, and they are worth putting to them separately, because the answer to this page changes none of them. For cosmetics the statute says as much on its own face: nothing in the 2022 amendments, nor any standard, rule, requirement, regulation or adverse event report, is to be construed to modify, preempt or displace any action for damages or the liability of any person under the law of any State, statutory or common law (21 U.S.C. 364j(c)).

Three notes on how to read the page. The statutes below say “the Secretary,” which the Act defines as the Secretary of Health and Human Services, the Department being Health and Human Services (21 U.S.C. 321(c), 321(d)); FDA is the agency inside that Department that inspects and acts, and where this page says one it means the same actor. Second, “interstate commerce” is a defined term meaning commerce between any State or Territory and any place outside it, and commerce within the District of Columbia or an unorganized Territory (321(b)); whether a particular sale is inside it is a question this page does not settle for you, and a single-state operation should not assume it sits outside. Third, the page is written to a brand owner as “you,” because that is who asks this question, but nothing in it depends on that. If you are the contract manufacturer reading this, every “you” and “your maker” swaps and the answer comes out the same, which is the point.

If it has already gone wrong. This page is a map of who the law reaches, not an incident procedure. Two things on it are time-bound and may already be running: the adverse event clock in the section below, and the two-business-day hearing that follows a registration suspension. If you are in that position, get your own counsel involved before you work through this, keep every record as it stands rather than tidying it, and establish which of you performed which acts, because that is what everything below turns on.

Read this before the map below. Some of the rules named here do not reach some of the people reading this, and being outside one of them is not being outside all of them. By class:

• Dietary supplements. The manufacturing part addresses a person who manufactures, packages, labels or holds a supplement, and defines its own “you” as exactly that person. The only exception it states is for holding at a retail establishment for the sole purpose of direct retail sale to individual consumers, and it says a warehouse or storage facility is not a retail establishment (21 CFR 111.1(a), 111.1(b), 111.3). So if your maker manufactures, packs and labels and ships direct to your customers, and you never take the goods, that part is not addressed to you. It expressly does reach a supplement you import or offer for import, and the part tells you itself that it is not the whole of what applies to you (111.1(a)(2), 111.5).
• Human food. The preventive controls subparts exempt a qualified facility, which is a defined term turning on a very small business threshold or on a second stated test, and a facility solely storing unexposed packaged food. Neither exemption is into nothing: the first substitutes the modified requirements at section 117.201 and the second those at 117.206 for food needing time or temperature control (21 CFR 117.5(a), 117.7(a), 117.7(b)). Read the definition at section 117.3 against your own sales figures rather than assuming that small means qualified.
• Over-the-counter drugs. The finished pharmaceuticals part is, pending consideration of a proposed exemption published in 1978 and until further notice, not enforced against over-the-counter drug products where the products and all their ingredients are ordinarily marketed and consumed as human foods, with parts 110 and 117, and where applicable 113 through 129, applied instead. That is a stated enforcement posture on a named part rather than a settled exclusion from drug requirements generally (21 CFR 211.1(c)).
• Cosmetics. Two exemptions sit on top of much of what follows. A responsible person, or an owner or operator of a facility, whose average gross annual United States cosmetic sales for the previous three-year period are less than $1,000,000 adjusted for inflation, and who does not make or process the four listed product types, is a small business outside the good manufacturing practice section and the registration and listing section. The four types are products that regularly contact the mucus membrane of the eye in customary use, products that are injected, products intended for internal use, and products intended to alter appearance for more than twenty-four hours where removal by the consumer is not part of customary use (21 U.S.C. 364h(a), 364h(b)). Separately, a cosmetic product or facility also subject to the drugs subchapter is exempt from seven named sections including adverse event reporting, good manufacturing practice, registration and listing, safety substantiation and records access, with the second limb taking that back for the facility’s cosmetic products which are not subject to that subchapter (364i(a), 364i(b)).

What no exemption from a manufacturing rule touches is the rest of this page: the prohibited acts, the duties written to the name on the label, and the registration your maker holds. Those are addressed to persons and to acts, and they do not read a contract.

On this page: The law has no word for the brand · The acts belong to whoever performs them · What lands on the name on the label · What lands on the plant · When their status stops your product · Where the mistake actually is · What the inspection record shows · The map · What a sound arrangement looks like · Four things to check

The law has no word for “the brand”

The question assumes there is a line somewhere with your name on one side of it and your manufacturer’s on the other. There is no such line, because there is no provision that names the two roles and divides anything between them. What the rules name instead is an activity, and then they address whoever performs it.

The dietary supplement part is the plainest case. Its own definition of the word it is written in says that “you” means a person who manufactures, packages, labels, or holds dietary supplements (21 CFR 111.3). Read that against the applicability clause and the shape appears: if your maker manufactures the batch and you label and warehouse it, you are each independently a “you” that the part addresses, for the operations each of you carries out, at the same time, on the same lot (111.1(a)). The part does not then allocate between you. It says the same things to both of you about your own operations.

The drug regulations say it as a rule rather than leaving it to be inferred. Where a person engages in only some of the operations the regulations cover and not others, that person need only comply with the regulations applicable to the operations that person is engaged in (21 CFR 210.2(b)). And when a drug is adulterated by a failure to comply, the drug, as well as the person responsible for the failure to comply, is subject to regulatory action (210.1(b)). That is a fact about who did the work. It is not a fact about who signed what.

The cosmetics statute draws the same distinction as a definition. The term facility includes any establishment, including an establishment of an importer, that manufactures or processes cosmetic products distributed in the United States, and the definition then names what a facility is not: an establishment that solely performs labeling, relabeling, packaging, repackaging, holding or distributing is outside the term, with filling a container excluded from what “packaging” means there (21 U.S.C. 364(3)(A), 364(3)(B)(viii), 364(3)(C)). Alongside it sits a second term, the responsible person, which is the manufacturer, packer or distributor whose name appears on the label (364(4)). Two terms, two different sets of duties, and in a contract manufacturing arrangement they are usually two different companies.

Two words on this page mean less than they sound like they mean. “Responsible person” is a statutory label for whoever is named on the pack. It does not mean the party at fault, and reading it that way turns this page upside down. And “facility” is not one word across the four classes: in cosmetics an establishment that only labels, packs, holds or distributes is expressly outside the term, while in food the same activities put an establishment inside it, because the food definitions count labeling and packaging as manufacturing or processing. Both statements below are correct and they are not in conflict. They are two statutes using one word differently, and you have to carry the right one into your own class.

The acts belong to whoever performs them

Underneath the manufacturing rules sits the list of prohibited acts, and it is written as a list of things done rather than a list of parties. Two words carry it, and neither means in law what it means in conversation. Adulterated is not confined to somebody putting something bad in the product: a supplement is adulterated if it was prepared, packed or held under conditions that do not meet the manufacturing regulations, and a cosmetic is adulterated if it was prepared, packed or held under insanitary conditions of a described kind, whatever is or is not in the bottle (21 U.S.C. 342(g)(1), 361(c)). Misbranded is likewise a status the article carries, not an accusation that somebody lied. So do not read past this section on the ground that you did not adulterate anything. It is a condition of the goods, and it can arrive without anyone deciding anything.

Now read the four acts that describe this relationship and notice which of you each one is about.

The introduction or delivery for introduction into interstate commerce of any adulterated or misbranded food, drug, device, tobacco product or cosmetic is prohibited (21 U.S.C. 331(a)). So is the adulteration or misbranding of such an article in interstate commerce (331(b)). So is the receipt of such an article in interstate commerce and its delivery or proffered delivery, for pay or otherwise (331(c)). And so is the doing of any act with respect to such an article, while it is held for sale after shipment in interstate commerce, that results in the article being adulterated or misbranded (331(k)).

Line them up against a normal arrangement. Your maker ships you the finished goods: that is the first one, done by your maker. You receive them and ship them to your customers: that is the third one, done by you. A repacker or a warehouse does something to the goods after they were shipped and the goods end up adulterated: that is the fourth one, done by the repacker or the warehouse, whoever they belong to. Not one of these paragraphs excuses a party because another party is also caught. They are separate acts by separate people, and each person answers for the act that person did.

The goods themselves are a third target, and one that is not a person at all. An article of food, drug or cosmetic that is adulterated or misbranded when introduced into or while in interstate commerce, or while held for sale after shipment, is liable to be proceeded against and condemned in a district court (21 U.S.C. 334(a)(1)). That runs against the article wherever the article is, which means it can reach stock sitting in your maker’s building and stock sitting in yours, in the same week, for the same defect. What the document between you does to any of this is a separate question, and the sibling article on whether a quality agreement protects you when your manufacturer fails works it through provision by provision. Nothing on this page is a reading of the agreement you hold.

One provision does speak about the person rather than the act, and it is worth knowing because it is the point at which “who is on the hook” stops being abstract. Before a violation is reported to a United States attorney for a criminal proceeding, the person against whom that proceeding is contemplated is to be given appropriate notice and an opportunity to present his views, orally or in writing (21 U.S.C. 335). The section is procedural and it identifies a person, not a company role. Who that person turns out to be in any real case is a matter of case law, which this page does not read and does not pretend to. If that is the part you are worried about, it is a question for a lawyer rather than for a quality document, and it is worth asking one early rather than at the point somebody is asking you.

What lands on the name on the label

Some duties do attach to one named party, and the statute picks that party the same way in every class: by whose name is on the pack. A food label in package form must bear the name and place of business of the manufacturer, packer, or distributor (21 U.S.C. 343(e), clause (1)), and a drug label carries the identical requirement (352(b), clause (1)). Whose name that is, is a commercial decision the two of you make. What follows from it is not.

For a dietary supplement, the manufacturer, packer or distributor whose name appears on the label is the responsible person, and the responsible person must submit to the Secretary any report received of a serious adverse event associated with that supplement when used in the United States, with a copy of the label. The fifteen-business-day clock on that submission runs from receipt of the report through the address or phone number the Act requires on the label, rather than from receipt by any route; and the responsible person must keep the underlying records for six years and let an authorized officer or employee of the Department, duly designated and appropriately credentialed, have access to them during an inspection (21 U.S.C. 379aa-1, subsections (b)(1), (c)(1) and (e)). Over-the-counter drugs carry the same machinery in the same words, keyed to the name on that label and to that label’s own contact details (21 U.S.C. 379aa, subsections (b)(1), (c)(1) and (e)). For cosmetics the responsible person submits the serious adverse event report, and it is the responsible person, not the facility, who must submit the product listing for each cosmetic product or ensure that the submission is made (21 U.S.C. 364a(a), 364c(c)(1)). Read that second verb: the filing can be done by somebody else, and it is still owed by you.

Now the exception that shows how narrow the room to move is. The supplement adverse event section contains one express permission to hand a duty over, and it is drawn tightly: a retailer whose name appears on the label as a distributor may, by agreement, authorize the manufacturer or packer to submit the reports, so long as the retailer directs to them every adverse event reported to it through the contact details on the label (21 U.S.C. 379aa-1, subsection (b)(2)). The drug section carries the same permission for a retailer (21 U.S.C. 379aa, subsection (b)(2)). Our reading of that, and it is a reading rather than a rule: Congress knew how to let an agreement move a duty from one party to another, wrote the sentence that does it, limited it to a retailer, limited it to this one duty and attached a condition to it, and wrote no such sentence anywhere else in these sections. Drawing a general conclusion from where a provision stops is a recognized way of reading a statute and it is not the only one, so treat it as the argument it is.

One more lands on the responsible person and not on the plant alone, and it is a records duty rather than a filing. Where the Secretary has a reasonable belief that a cosmetic product is likely to be adulterated such that use of it presents a threat of serious adverse health consequences or death, each responsible person and facility must, at the request of a duly designated officer or employee who presents credentials and a written notice, and at reasonable times, within reasonable limits and in a reasonable manner, permit access to and copying of the records relating to that product that are needed to help the Secretary determine whether it is adulterated and presents that threat. The subsection does not extend to recipes or formulas, financial or pricing data, most personnel data or most research data, and reaches sales data only as to shipment data regarding sales; safety substantiation data for the product and its ingredients is expressly carved back in (21 U.S.C. 364f(a)). Both parties are named side by side in one sentence. If the records live in your formulator’s building, the demand still arrives at your door, and what you are entitled to receive from them is a question about your own contract that this page does not answer.

What lands on the plant

The traffic runs the other way too, and this is the half that gets left out of the argument. A set of duties reaches the party that made the product and does not reach you at all, which is why the assurance that your maker is registered and inspected answers a smaller question than it sounds like it answers.

Start with food, and remember that a dietary supplement is deemed to be a food within the meaning of the Act except for two named purposes (21 U.S.C. 321(ff)). The statute directs the Secretary to require by regulation that any facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States be registered; for a domestic facility the owner, operator, or agent in charge submits that registration, and for a foreign facility the same parties submit it and must include the name of the United States agent for the facility (21 U.S.C. 350d(a)(1), 350d(a)(1)(A), 350d(a)(1)(B)). Facility there means a factory, warehouse or establishment that manufactures, processes, packs or holds food, and the term excludes farms, restaurants, other retail food establishments, nonprofit food establishments serving the consumer directly, and most fishing vessels (350d(c)(1)); the implementing regulation carries that list and adds two of its own, for a foreign facility whose food undergoes further manufacturing or processing abroad and for a facility regulated exclusively throughout by the Department of Agriculture, and it defines the facility as an establishment under one ownership at one general physical location (21 CFR 1.225(a), 1.226, 1.227).

Whether that is you turns almost entirely on the word “hold,” so read it before you rule yourself out. Holding means storage of the food, plus activities incidental to storage and activities performed as a practical necessity for distribution, and the definition says holding facilities could include warehouses, cold storage facilities, storage silos, grain elevators and liquid storage tanks. Manufacturing and processing, in the same definitions, expressly include labeling and packaging, and packing includes re-packing (21 CFR 1.227). Two consequences follow. If you own or operate a building where your finished goods sit, or a labeling line, you are looking at a facility on the same terms as the plant. And if your goods sit in a third party’s fulfilment center or warehouse under a contract, that establishment is doing the holding and is a facility in its own right; whether you are also one is a question about what you own or operate, not about who owns the stock. It is worth settling in writing with whoever runs that building rather than assuming either answer.

Over-the-counter drugs draw the line in one sentence, and it is the sharpest statement of this asymmetry anywhere in the four classes. Unless exempt under section 510(g) of the Act or under the part itself, all manufacturers, repackers, relabelers and salvagers must register each domestic establishment that performs those operations, and each foreign establishment that performs them on a drug imported or offered for import into the United States; private label distributors who do not also manufacture, repack, relabel or salvage drugs are not required to register at all, and the agency will accept a filing from one only where it is acting as authorized agent for an establishment that does (21 CFR 207.17(a), 207.17(b)). Then read what still lands on that unregistered distributor. It must obtain its own national drug code labeler code, because every person who engages in private label distribution of a drug subject to listing must apply for one (21 CFR 207.33(c)). And the registrant that made the product must list it under your labeler code, and separately under its own, and supply your name, address, telephone number and email in the submission (21 CFR 207.41(c)(1), 207.41(c)(2), 207.49(a)(16)(ii)). You are in the agency’s records under your own code, filed there by somebody else, holding no establishment registration of your own.

Cosmetics wire the two parties together explicitly. The person who owns or operates a facility that manufactures or processes cosmetic products for distribution in the United States registers it, on a stated deadline for a facility already operating when the amendments were enacted and within sixty days of first engaging for one that starts later; and where a facility makes products on behalf of a responsible person only one registration is required for that facility, which may be submitted by the facility or by any responsible person whose products are made there (21 U.S.C. 364c(a)(1)(A), 364c(a)(1)(B), 364c(a)(3)). That registration must contain all brand names under which products made there are sold, and the product category and responsible person for each product (364c(b)(2)(D), 364c(b)(2)(E)). Your listing, going the other way, must contain the facility registration number of each facility where the product is made (364c(c)(4)(A)(i)). Each of you names the other, in a filing the other cannot make for you unless you let them.

Importing does not lighten any of this. The supplement part reaches a supplement you import or offer for import on its own terms (21 CFR 111.1(a)(2)), a foreign food facility registers through a United States agent it must name (21 U.S.C. 350d(a)(1)(B)), and a foreign drug establishment registers where the drug is imported or offered for import (21 CFR 207.17(a)). What an importer additionally owes by way of a verification program for its foreign suppliers is a subject of its own, and the sibling article on whether a quality agreement protects you when your manufacturer fails reads that subpart clause by clause. The short of it for this page: importing adds a party in another country whose registration you cannot make and whose plant you cannot inspect, and it moves nothing off you.

The cosmetic manufacturing rule itself is the one row of this map that is still empty. The statute directs the Secretary to establish good manufacturing practices for facilities by regulation and sets dates for a proposed and a final rule (21 U.S.C. 364b(a), 364b(c)). No such regulation is cited here at the read date at the foot of this page, which is a fact about what this page reads before it is a fact about the world. Check that rulemaking at its source rather than relying on this sentence, because it is the kind of gap that closes without notice.

When their status stops your product

Here is the mechanism that makes the plant’s problem your problem without a single word being addressed to you.

Where the Secretary determines that food manufactured, processed, packed, received, or held by a registered facility has a reasonable probability of causing serious adverse health consequences or death, the registration of that facility may be suspended by order (21 U.S.C. 350d(b)(1)). And then: if the registration of a facility is suspended, no person shall import or export food into the United States from that facility, offer to do so, or otherwise introduce food from that facility into interstate or intrastate commerce (350d(b)(4)). No person. On the face of that provision your supply from that facility would stop on an order that was served on somebody else, and nothing you signed with your maker appears anywhere in it. Cosmetics carry the same pair, with the suspension available where the Secretary also has reasonable belief that other products from the facility may be similarly affected, and with the same closing prohibition on introducing cosmetic products from that facility into commerce (21 U.S.C. 364c(f)(1), 364c(f)(6)).

Now read the food suspension provision to the end, because the second limb is about you. The order may suspend the registration of a facility that created, caused, or was otherwise responsible for that reasonable probability; or of a facility that knew of, or had reason to know of, it, and packed, received, or held such food (350d(b)(1)(A), 350d(b)(1)(B)(i), 350d(b)(1)(B)(ii)). The first limb is your maker. The second limb reaches a registered facility that held the goods and had reason to know, so if you hold your own goods and are registered on the terms set out above, it is written to reach you as well. That would be a suspension of your own registration, for a condition created in a building you do not own, on a state of knowledge rather than an act of manufacture.

The reinstatement route is the same for either of you, and it is short: an informal hearing no later than two business days after the order, unless the Secretary and the registrant agree another period, and a corrective action plan if the suspension stands, reviewed within fourteen days of submission or such other period as the Secretary determines (350d(b)(2), 350d(b)(3)(A)). Two business days is not much time to establish who did what, which is the practical argument for having the answer written down before anybody asks for it.

Where the mistake actually is

The failure underneath this question is not that people misread a statute. Almost nobody reads it. The failure is the ordinary one that runs wherever somebody relies on a check performed for someone else: a scope narrower than the party relying on it assumes it contains. Your maker is registered, audited and certified, and the conclusion drawn from that is that the product is covered. What was actually examined was that plant’s operations, on a date, against a scope the certifier wrote down.

The schemes themselves are blunter about this than their customers are. NSF’s certification guideline for its sport program treats a product carrying somebody else’s name as a separate matter needing separate authorization. If NSF authorizes it, the certified product may be labeled with another company’s name under one of two stated provisions: a marking route, on which the label and the advertising must identify both companies to a specified standard of prominence; or an official listing route, under which a separate listing is issued by NSF in the private label company’s name, supported by the original company’s certified product. Additional fees and terms attach (NSF Certification Guideline 306, clause GP-13). The mark does not travel to your name on its own, and the scheme wrote two routes to make it travel precisely because it does not.

The cosmetic manufacturing standard goes further and makes the registration duty turn on which of you is which. It requires manufacturers, packers and distributors of cosmetic products in commercial distribution to be registered with the regulatory agency in the country of manufacture or sale where the jurisdiction requires it, and adds a second clause for where those parties are the responsible party, or are so under a contractual agreement, in which case those products are to be registered with that agency, as the relevant jurisdictions require (NSF/ANSI 455-3, clauses 4.1.1 and 4.1.2). A scheme auditor will ask which of you that is. The answer will come from your arrangement, and the arrangement is the thing most of these relationships have never written down in a form anyone can read back.

These are certification-scheme documents rather than law, and they are copyrighted works of their publisher. They are described here rather than reproduced, and they bind you if you hold the certification and not otherwise.

What the inspection record shows

The clearest evidence that federal requirements reach the party that did not make the product is that the agency writes findings against that party, under clauses that could not apply to anyone else.

Four places in the dietary supplement part are written only about a person who receives a product from a supplier for packaging or labeling as a dietary supplement, and for distribution rather than for return to the supplier. That person must establish specifications giving sufficient assurance that what arrives is adequately identified and consistent with the purchase order (21 CFR 111.70(f)). A whole section governs the received product, requiring visual examination of the containers and of the supplier’s invoice, guarantee or certification, quarantine until representative samples are taken and quality control personnel review the documentation and approve the product out of quarantine, lot identification traceable to the supplier, and holding under conditions that protect against contamination, deterioration and mix-ups (21 CFR 111.165(a), 111.165(b), 111.165(c), 111.165(d)(1), 111.165(e)). Quality control personnel must review the results of that visual examination and documentation against the specifications, and must approve and release the received product from quarantine before it is used (111.127(a), 111.127(b)). And they must not approve and release for distribution any product so received for which sufficient assurance is not provided to identify it and determine that it is consistent with the purchase order (111.123(b)(4)). None of that is written to a manufacturer about its own batch. It is written to whoever puts their packaging or their label on somebody else’s finished product.

Across the published FDA inspection observation records, fiscal years 2009 to 2026, those provisions carry 232 observations, written against 171 distinct firms across 194 inspections. The whole of the dietary supplement part carries 23,440 observations against 2,507 firms in the same set. Read August 20, 2026. The count takes section 111.165 whole, because every paragraph of that section is written to the received-product case and its own heading says so, together with the three paragraph-level provisions named above: 111.70(f), 111.127(a) and (b), and 111.123(b)(4). Section 111.127 is not taken whole, because its other paragraphs reach any packager including the one that made the batch.

Reading a sample of the records rather than the total: the observations are ordinary and they are recent. One firm in Texas in April 2026 did not establish specifications to assure that product it received for packaging or labeling was adequately identified and consistent with its purchase order. One firm in Arizona in June 2026 had quality control personnel approve and release for distribution product received from a supplier for labeling, for which sufficient assurance was not provided. One firm in Michigan in February 2026 had quality control personnel who did not review and approve documentation to determine whether quarantined received product met specifications. Each of those is a finding written to a company that did not make what was in the bottle.

What this does not evidence. It says nothing about whether any of these firms had a quality agreement, or what one said. It does not tell you the firm was a brand owner rather than a contract packer doing the same work for somebody else, and that distinction is exactly the point: the clause attaches to the act of receiving and labeling, not to a commercial role, so it catches whoever performs it. It is FDA’s published observation data, not the whole of the agency’s record, and an observation is an investigator’s finding rather than a final determination.

The map

Which duties reach the party that made the product, which reach the party whose name is on it, and which reach both, by what your product legally is. Two cautions before you use it. The rows turn on what your product is in law, which is not always what you call it commercially, and this page does not settle that question — a sunscreen, an anti-dandruff shampoo, an antiperspirant or a fortified food can sit in two rows at once, and the page states two such overlaps above. Settle the category first, with your own counsel or a classification opinion, or you will read the wrong row confidently. And most readers appear in more than one column, because the columns are acts rather than companies: if you label and you hold, the left column is describing you as well. This is the federal position read from the provisions cited on this page. It does not cover state law, your contract, or what a customer or certification scheme demands of you separately. Read August 20, 2026.

What a sound arrangement looks like

Almost everything above is written as reach and exposure, which is how the statutes are written. It is worth saying plainly what the other side of it looks like, because a reader with a well-run arrangement should be able to finish this page and stop rather than worry. Four things, and if all four hold, this page has nothing further for you.

You can name, in writing, which of the four acts each party performs, and both parties would give the same answer. Whoever is named on the label is the party actually running the adverse event channel printed on that label and holding those records. You hold the registration numbers for every establishment your product passes through, you know which of them you are, and you know what a suspension of any of them would do to your stock. And you have read the certificate your maker holds for its scope, and you know on what terms, if any, the scheme lets that certification appear against your name.

None of that requires a lawyer, a consultant or a purchase. It requires somebody to sit down and write four things down. The reason it so rarely exists is that nobody is asked for it until the day it matters, and by then two business days is the window.

Four things to check before you decide who carries what

1. Write down which of the four acts each of you performs. Manufacture, package, label, hold. Not who is responsible for them in the agreement. Who physically does them. That list is the input to the third column of the map above and to the section on why the law has no word for the brand: the supplement part defines its own reader by exactly those four verbs (21 CFR 111.3) and the drug regulations say a person complies with the regulations applicable to the operations that person is engaged in (210.2(b)). Take the verbs that came out as yours and read the manufacturing part for your class against those and no others. Most arrangements have never been written out this way, and the surprises are usually in “hold.”
2. Read your own label for whose name is on it, and treat that as a duty list. In supplements and over-the-counter drugs the name and place of business on the pack is what the adverse event sections key the responsible person to, and in cosmetics it is what the responsible person definition keys to (21 U.S.C. 343(e), 364(4)). In plain human food no separate duty set follows from the name alone, so this check is short for you. Where it is not, the reports, the clock and the six years of records are yours, and the next step is to find out who is answering the phone number printed on your pack and whether anyone is keeping what they are told.
3. Ask which registrations exist, in whose name, and what happens to your stock if one is suspended. Get the number, not the assurance. A suspension of your maker’s registration would, on the face of the provision, stop any person introducing product from that facility into commerce, which reaches inventory you already own (21 U.S.C. 350d(b)(4), 364c(f)(6)). Qualifying a second source is the usual answer and it carries a long lead time, so the step this week is to price and schedule it rather than to decide it.
4. Read the certificate for its scope, then ask the scheme what it says about your name. A certification is of a facility’s operations against a standard on a date. Where a scheme permits a certified product to be sold under another company’s name it says so in its own clause and attaches conditions, up to a separate listing in your name (NSF Certification Guideline 306, clause GP-13). Ask your maker for the clause number and the certificate’s stated scope in writing. If nobody can produce either, the mark on your maker’s wall is not on your product, and your own marketing should not be using it.

If the prior question for you is whether you need a separate quality document at all, that is answered in the sibling article on whether your supply contract already covers quality.