Does this requirement actually apply to my product?

This is United States federal law: the Federal Food, Drug, and Cosmetic Act and FDA’s regulations under it. Those regulations have a habit worth knowing about. Part 111, the dietary supplement manufacturing rules, opens with a section titled “Who is subject to this part?” (21 CFR 111.1(a)). Part 211, the finished pharmaceutical rules, opens with one titled “Scope.” (21 CFR 211.1(a)). Part 117, the preventive controls rules for human food, splits the job in two: a section titled “Applicability and status” (21 CFR 117.1(a)), and a separate one titled “Exemptions” that runs to eleven lettered paragraphs (117.5(a) to 117.5(k)(2)).

Sections 111.1 and 211.1 each decide whether the rest of their part is addressed to you at all. Section 117.5 does something narrower and it is worth being exact about it from the start: it decides which subparts of part 117 fall away, and from whom. Every one of these sections writes somebody out of something, and none of them writes anybody out of everything.

Who is outside this page. It covers United States federal law only. If you sell nowhere in the United States, none of the sections below is your answer and the reading you need is in your own market’s law. It does not cover devices, and it does not cover tobacco products. It is written for products for people; a product for animals raises questions it does not answer. And if the requirement that landed on you came from a marketplace, a retailer, a distributor, a certification body or a payment processor rather than from a regulator, no scope section below decides it. That case is real, it is common, and it has an answer of its own further down.

Two questions get run together here, and pulling them apart is most of the work. One is whether a rule reaches you, which is settled by reading the part’s own applicability sections, its definitions and its exemptions. The other is what your product is, which is settled against the statutory definitions and is a different reading. A requirement can be perfectly real, correctly quoted, and aimed at somebody else.

The test takes one reading of the notice you were sent. If the demand names a part, and what you would dispute is whether you are the person that part is addressed to, your problem is scope and this page is the reading. If the demand assumes your product is a supplement, a drug, a cosmetic or a food, and that assumption is what you would dispute, your problem is category, and the reading that settles that one is on our page on how FDA decides whether a product is a cosmetic, a drug, a supplement or a food.

On this page: Start where the part starts · The exemption almost never removes the part · What “not enforced” means · The carve-out inside the definition · Where each part says who it reaches · When the demand is not a rule · What to put in writing

Start where the part starts

Three things get read before the requirement itself, in this order.

The scope or applicability section. It is usually the first section of the part and it usually says so in its own heading. Part 111’s is written as a question and answered in one sentence: you are subject to this part if you manufacture, package, label, or hold a dietary supplement. The section then names two cases inside that, so nobody has to argue about them. A dietary supplement you manufacture but that is packaged or labeled by another person is in. So is a dietary supplement imported or offered for import in any State or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico (21 CFR 111.1(a), 111.1(a)(1), 111.1(a)(2)).

Four verbs. The section does not turn on the size of your business, on whose brand is on the bottle, or on where you are established beyond the import limb it names. Whether you manufacture, package, label or hold is a fact about your own operation, not something the section settles for you, and it is the fact to establish before anything else.

Two arrangements are where that actually bites, and § 111.1 does not resolve either one on its face. The first is a brand owner whose contract manufacturer makes the product and applies a label the brand owner wrote: the section names labeling as one of the four acts that pull you in, and whether specifying label content is labeling within the meaning of these words is not answered in them. The second is stock sitting in a third party’s fulfilment center: paragraph (b) lifts the holding requirements only where you hold at a retail establishment for the sole purpose of direct retail sale to individual consumers, and it then says a warehouse or other storage facility for a retailer, or one that sells directly to individual consumers, is not a retail establishment (21 CFR 111.1(a), 111.1(b)). That tells you what such a facility is not, without telling you whose holding the stock inside it is. This page will not invent an answer to either. Both are the question to put in writing to whoever is applying the part to you, with the words of the section quoted back.

Read that second paragraph of § 111.1 to its end anyway, because it is narrow twice over. It reaches the holding requirements and nothing else in the part, and its own second sentence takes back most of what the first appears to give (21 CFR 111.1(b)).

The definition of the term the duty is addressed to. Requirements are written to defined words, and the definition is a second place the answer sits. This is covered below, because it is where the reading most often goes wrong.

What the exemption actually removes. Almost none of them removes a part, and across the four bodies of rules on this page none of them does.

The exemption almost never removes the part

Part 117 is the clearest case on the books, and it is worth reading both of its opening sections once from end to end. Start with § 117.1, because it is the applicability section and it does not answer the question in the shape § 111.1 does. It says the criteria and definitions in the part apply in determining whether a food is adulterated within two named limbs of section 402(a) of the Act, and in violation of section 361 of the Public Health Service Act (21 CFR 117.1(a)). It says that operating a facility that manufactures, processes, packs or holds food for sale in the United States, where the owner, operator or agent in charge is required to comply with and is not in compliance with section 418 of the Act or with subpart C, D, E, F or G of the part, is a prohibited act under section 301(uu) of the Act (117.1(b)). And it says food covered by specific current good manufacturing practice regulations is also subject to those (117.1(c)).

The subpart letters carry the whole payload of what follows, so here is what each one is, in the part’s own headings. Subpart B is Current Good Manufacturing Practice. Subpart C is Hazard Analysis and Risk-Based Preventive Controls. Subpart D is Modified Requirements. Subpart E is Withdrawal of a Qualified Facility Exemption. Subpart F is Requirements Applying to Records That Must Be Established and Maintained. Subpart G is Supply-Chain Program. Keep those in view through the next ten sentences, because every exemption below is stated in those letters and in nothing else.

Now § 117.5. Eleven paragraphs, and not one of them exempts anybody from part 117.

• Except as provided by subpart E, subparts C and G do not apply to a qualified facility, and the next sentence says qualified facilities are subject to the modified requirements in § 117.201 (21 CFR 117.5(a)). Two limits across two sentences: named subparts, and a named substitute. Both of the terms in that sentence are defined elsewhere in the part rather than in the exemption. A qualified facility is a very small business as the part defines that term, or a facility meeting two conditions: that over the three years before the applicable calendar year the average annual monetary value of food handled there and sold directly to qualified end-users exceeded the average annual value sold to all other purchasers, and that the average annual monetary value of all food sold in that period was under $500,000, adjusted for inflation (21 CFR 117.3). The modified requirements are attestations submitted to FDA: that the facility is a qualified facility as defined in § 117.3, and either that it has identified the potential hazards, is implementing preventive controls to address them and is monitoring their performance, or that it is in compliance with State, local, county, tribal or other applicable non-Federal food safety law (117.201(a), 117.201(a)(1), 117.201(a)(2)(i), 117.201(a)(2)(ii)). That is what the exemption hands you instead, and it is not nothing.
• Subparts C and G do not apply with respect to activities subject to the fish and fishery products part, the juice hazard analysis part, or the thermally processed low-acid foods part, at a facility, if you are required to comply with and are in compliance with that part with respect to those activities (117.5(b), 117.5(c), 117.5(d)(1)). Three conditions travel with each one: it reaches the activities rather than the facility, the other part has to actually cover you, and you have to actually be in compliance with it. The low-acid limb is then narrowed again, to the microbiological hazards that part regulates and no other (117.5(d)(2)).
• Subparts C and G do not apply to any facility with regard to the manufacturing, processing, packaging or holding of a dietary supplement that is in compliance with part 111 and the serious adverse event reporting section of the Act for dietary supplements (117.5(e)). This is the paragraph a supplement maker is usually looking for when a customer asks for a food safety plan. It is conditioned on part 111 compliance, so it is not free, and it leaves subpart B where it was. The paragraph does not say what establishes that you are in compliance with part 111, and nothing else in § 117.5 does either, so whoever is asking you for the plan is the party who decides what satisfies them.
• Subparts C and G do not apply to activities of a facility that are subject to the produce safety section of the Act (117.5(f)).
• Subparts C and G do not apply with respect to alcoholic beverages at a facility that meets two stated conditions, and to other food at such a facility only where that food is in prepackaged form that prevents any direct human contact and constitutes not more than five percent of the facility’s overall sales as determined by the Secretary of the Treasury (117.5(i)(1), 117.5(i)(2), 117.5(i)(2)(i), 117.5(i)(2)(ii)).
• Subparts C and G do not apply to facilities solely engaged in the storage of raw agricultural commodities other than fruits and vegetables, intended for further distribution or processing (117.5(j)). Solely, and not fruits and vegetables. Both are doing work.
• The last paragraph switches to a different subpart and a different list. Subpart B does not apply to farms as the regulations define them, to fishing vessels outside the registration requirement, to establishments solely engaged in holding or transporting one or more raw agricultural commodities, to activities of farm mixed-type facilities that fall within the farm definition, or to establishments solely engaged in hulling, shelling, drying, packing or holding nuts without additional manufacturing or processing (117.5(k)(1), 117.5(k)(1)(i) to 117.5(k)(1)(v)). And even that is taken back in part: where a farm or farm mixed-type facility dries raw agricultural commodities that are produce to create a distinct commodity, subpart B applies to the packaging, packing and holding of the dried commodities, and the same paragraph then says compliance with that requirement may be achieved either by complying with subpart B or by complying with the applicable packing and holding requirements in part 112 (117.5(k)(2)).

Two long paragraphs in the middle of the section do the same job for on-farm packing, holding and manufacturing by small and very small businesses, and they do it by naming particular activity-and-food combinations one at a time, in numbered lists. The on-farm packing and holding list runs to twenty-three entries, among them baked goods such as bread and cookies, roasted coffee beans, pasteurized honey, milled grain products, and other grain products such as dried pasta and popcorn (117.5(g)(3), 117.5(g)(3)(i), 117.5(g)(3)(v), 117.5(g)(3)(viii), 117.5(g)(3)(x), 117.5(g)(3)(xiv)). The on-farm manufacturing and processing list runs to twenty-seven entries and is built the same way (117.5(h)(3)).

Read the condition those two paragraphs hang on, because it is not the per-item test it looks like. Each applies only if the listed combinations are the only activities of that kind, subject to section 418 of the Act, that the business conducts. One covered activity off the list and the paragraph is unavailable to that business for all of them. And the relief inside each paragraph is split: subparts C and G fall away for a small or a very small business, while § 117.201 falls away only for a very small business (117.5(g)(3), 117.5(h)(3)). Five examples cannot stand in for a list of twenty-three, either: if this limb is yours, the entries have to be read at the source, and the section is linked throughout this page.

Read the section together and it says one thing repeatedly. An exemption names the subparts it switches off, and something else stays on. “We are exempt from part 117” is a sentence that no paragraph of the exemptions section supports. The version that survives contact with a reader names two things: which subparts fall away, and what applies in their place.

What “not enforced” means, and what it does not

Part 211’s scope section is three paragraphs. The first says what the part covers: the minimum current good manufacturing practice for preparation of drug products, excluding positron emission tomography drugs and medical gases as defined in § 213.3(b)(12) of that chapter, for administration to humans or animals (21 CFR 211.1(a)). Note what that paragraph does not do while you are in it: it draws no line between a drug marketed under an approved application and one marketed under a monograph. Two exclusions, both named, and neither is that one. The second paragraph settles precedence, saying the other current good manufacturing practice regulations supplement and do not supersede this part unless they explicitly provide otherwise, and that where two applicable regulations conflict, the one specifically applicable to the drug product in question supersedes the more general (211.1(b)).

The third paragraph is the one that gets misquoted, and it is the one an over-the-counter seller is usually pointed at. Because this is the paragraph worth quoting rather than summarising, here it is in the regulation’s own words: “Pending consideration of a proposed exemption, published in the Federal Register of September 29, 1978, the requirements in this part shall not be enforced for OTC drug products if the products and all their ingredients are ordinarily marketed and consumed as human foods, and which products may also fall within the legal definition of drugs by virtue of their intended use. Therefore, until further notice, regulations under parts 110 and 117 of this chapter, and where applicable, parts 113 through 129 of this chapter, shall be applied in determining whether these OTC drug products that are also foods are manufactured, processed, packed, or held under current good manufacturing practice.” (21 CFR 211.1(c))

Three things in that paragraph fall out when it is repeated second hand. It is a statement about enforcement rather than about scope, and it sits inside the part rather than removing anything from it. Its condition reaches the ingredients as well as the product, so one ingredient that is not ordinarily marketed and consumed as human food takes the paragraph away. And it does not leave you standing in open air: it names the food manufacturing regulations to be applied instead. Anyone relying on this paragraph should be able to say which of those parts they are being measured against, because that is the question the paragraph hands them.

The paragraph also still opens with “pending” and still says “until further notice” in the text the eCFR serves today, forty-eight years after the notice it is pending on. That is not a mistake in your reading of it. The paragraph has been amended since, and now names part 117, which did not exist until 2015. That language survived every amendment.

The carve-out is often in the definition, not the exemption

A requirement is written to a defined word, and the definition is where a whole class of reader is sometimes removed without any section headed “exemptions” being involved.

The cosmetics subchapter of the Act is the clean example, and one thing has to be said before it is opened, because it is the belief that sends most readers to the wrong page. The duty below is a registration duty. Registration is something an operator owes; it is not a clearance a government grants, and nothing on this page turns on anyone having approved anything. Registering a facility is not FDA approving a product, and being unable to point to an approval is not evidence that no rule reaches you. Which products need a premarket application, and which do not, is a separate question and it is answered against the definitions rather than here.

Now the duty. Every person that, on December 29, 2022, owned or operated a facility engaged in manufacturing or processing a cosmetic product for distribution in the United States had to register that facility within a year of that date, and every person that first engages in that activity after December 29, 2022 has to register within sixty days of first engaging in it, or sixty days after that first deadline, whichever is later (21 U.S.C. 364c(a)(1)(A), 364c(a)(1)(B)). The duty is addressed to a facility, and the subchapter defines that word. A facility includes any establishment, including an establishment of an importer, that manufactures or processes cosmetic products distributed in the United States (364(3)(A)). The same definition then names what the term does not include (364(3)(B)), and the list is long.

• Beauty shops and salons, unless the establishment manufactures or processes cosmetic products at that location (364(3)(B)(i)).
• Cosmetic product retailers, including individual sales representatives, direct sellers, retail distribution facilities and pharmacies, unless the establishment manufactures or processes cosmetic products that are not sold directly to consumers at that location (364(3)(B)(ii)).
• Hospitals, physicians’ offices and health care clinics (364(3)(B)(iii)), and public health agencies and other nonprofit entities that provide cosmetic products directly to the consumer (364(3)(B)(iv)).
• Entities such as hotels and airlines that provide complimentary cosmetic products to customers incidental to other services (364(3)(B)(v)), and trade shows and other venues where samples are provided free of charge (364(3)(B)(vi)).
• An establishment that manufactures or processes cosmetic products solely for use in research or evaluation, including for production testing, and not offered for retail sale (364(3)(B)(vii)).
• An establishment that solely labels, relabels, packages, repackages, holds or distributes (364(3)(B)(viii)). That one carries its own definition on the end: for its purposes, packaging and repackaging do not include filling a product container with a cosmetic product (364(3)(C)), so a contract filler is not sitting inside it.

None of that is in a section headed “exemptions.” It is in the definition of one word, three sections away from the duty it governs, and a reader who searched for the exemption section would not find it. The word “solely” is the hinge of the last two entries, and it runs in one direction: doing anything else at that location takes the establishment off the not-a-facility list, and the registration duty is back on.

This subchapter also has a conventional exemption, four sections past the duty, and a reading that stopped at the definition would miss it. Responsible persons, and owners and operators of facilities, whose average gross annual United States sales of cosmetic products over the previous three-year period is less than $1,000,000, adjusted for inflation, and who do not make or process the products described in the next subsection, are considered small businesses and are not subject to the requirements of the good manufacturing practice section or the registration and listing section (21 U.S.C. 364h(a), 364b(a)). That subsection names four product kinds that take the exemption back: products regularly coming into contact with the mucus membrane of the eye under customary or usual conditions of use, products that are injected, products intended for internal use, and products intended to alter appearance for more than twenty-four hours under customary or usual conditions of use where removal by the consumer is not part of them (364h(b), 364h(b)(1), 364h(b)(2), 364h(b)(3), 364h(b)(4)). So this duty is carved at both ends, once in a definition and once in an exemption section, and the two are read together or not at all.

The same move runs through the Act at a higher level. A dietary supplement is deemed to be a food within the meaning of the chapter, except for the purposes of paragraph (g) and one other section (21 U.S.C. 321(ff)). Paragraph (g) is the drug definition (321(g)(1)), and the other is section 350f. That one sentence is why the food rules reach a supplement at all, and the drug definition is one of the two places the deeming stops. When somebody applies a food rule to your supplement, this is the sentence behind it, and it is usually right. When somebody applies the drug definition, this sentence is the reason the argument is available to them at all.

Where each part says who it reaches

Where the applicability answer is written, for four bodies of rules a maker of regulated consumer goods is most often handed. Each row states the section that decides, what it says, and what an exemption in it takes away. Read from the clause text on August 20, 2026. It is a way of reading four sections, not a classification of your operation.

The rules	The section that decides	Who it says it reaches	What comes off, and from what
21 CFR part 111, dietary supplement manufacturing	§ 111.1, titled “Who is subject to this part?”	You, if you manufacture, package, label or hold a dietary supplement, including one you manufacture that another person packages or labels, and one imported or offered for import (111.1(a), 111.1(a)(1), 111.1(a)(2))	The requirements pertaining to holding, and only where you hold at a retail establishment for the sole purpose of direct retail sale to individual consumers. A warehouse for a retailer, or one that sells directly to consumers, is not a retail establishment (111.1(b))
21 CFR part 117, preventive controls for human food	Two sections. § 117.1, titled “Applicability and status,” and § 117.5, titled “Exemptions,” which runs to eleven paragraphs	§ 117.1 states what the part’s criteria and definitions are used to determine, and makes operating a covered facility out of compliance with section 418 of the Act or with subparts C, D, E, F or G a prohibited act (117.1(a), 117.1(b)). § 117.5 states only the departures	Named subparts, never the part. Subparts C (preventive controls) and G (supply-chain program) from a qualified facility, which takes the attestations of § 117.201 instead (117.5(a), 117.201(a)); C and G for activities under the seafood, juice and low-acid canned rules, and only where you are required to comply and are in compliance (117.5(b), 117.5(c), 117.5(d)(1)); C and G for a dietary supplement in compliance with part 111 (117.5(e)); subpart B (good manufacturing practice) from farms and from establishments solely holding or transporting raw agricultural commodities (117.5(k)(1))
21 CFR part 211, finished pharmaceuticals	§ 211.1, titled “Scope.”	Preparation of drug products for administration to humans or animals, excluding positron emission tomography drugs and medical gases as the chapter defines them. No distinction drawn between an approved-application product and a monograph one (211.1(a))	Nothing, by exemption. The section carries a non-enforcement statement instead, for over-the-counter drug products where the products and all their ingredients are ordinarily marketed and consumed as human foods, and it names the food manufacturing parts to be applied in their place (211.1(c))
21 U.S.C. subchapter VI, cosmetics	The definition of “facility” at 364(3), three sections before the registration duty at 364c, and the small business section at 364h, four sections after it	Any establishment, including an importer’s, that manufactures or processes cosmetic products distributed in the United States (364(3)(A))	Two carve-outs, in two different places. Eight kinds of establishment written out of the definition itself: salons, retailers and pharmacies, hospitals and clinics, nonprofits supplying consumers directly, hotels and airlines, trade shows, research-only establishments, and one that solely labels, packages, holds or distributes (364(3)(B)(i) to 364(3)(B)(viii)). And small businesses under the sales threshold, taken out of the good manufacturing practice and registration sections, except where they make the four product kinds the next subsection names back in (364h(a), 364h(b))

When the demand is not a rule

Now the case none of the sections above touches, and the one behind a lot of the traffic on this question. A marketplace, a retailer, a distributor, a certification body, a customer’s supplier program and a payment processor can each impose a requirement on your product, and none of them is a regulator. The requirement is real. It can cost you the listing, the account, or the purchase order. And the question “does this apply to my product” still has an answer, it is just not in the Code of Federal Regulations. It is in the published policy and in the agreement you are on, and that document has a scope section too, read the same way as any other.

Two things follow, and both are worth knowing before you spend a week on the wrong argument. A federal reading does not answer a private demand: showing that a part does not reach you says nothing about whether a company will carry your listing. And a private requirement does not answer the federal question either. They run in parallel, and neither is evidence about the other.

A certification scheme is where people most expect one to answer the other, and the standards themselves are direct about it. NSF/ANSI 527-2025, the personal care products standard, carries a clause setting out what its scope excludes from the program, and evaluation of regulatory compliance is one of the things named in it (NSF/ANSI 527-2025, § 1.4). NSF/ANSI 173-2025, the dietary supplements standard, carries a conflicts clause inside its own scope section, which sets a regulatory requirement of a country of distribution above a conflicting requirement of the standard, and which treats a standard requirement that is merely stricter, without being a violation of the regulation, as no conflict at all (NSF/ANSI 173-2025, § 1.2.1). Two registers, kept apart by the standards themselves, in the first pages of each.

So a certificate is evidence that a body assessed you against that standard’s scope. Where that scope says it does not evaluate regulatory compliance, the certificate is not evidence about the law, and treating it as though it were is one of the more expensive readings a competent operator makes.

Specimen drawn from the High Desert Botanical Extracts™ case, a constructed teaching case and not a real company — a quality system scoped to the wrong boundary, and a certification read as proof of legal status

What to put in writing

Answering a demand well is short, and it runs in the same four steps every time.

1. Name the source the demand rests on: the part and section, or the clause of the policy. If the demand names none, that is the first thing to ask for, because a requirement nobody can locate in a document is a requirement nobody has read.
2. Quote what that source says about who it reaches, in its own words rather than yours.
3. Say which limb you are inside or outside, and why, in one sentence tied to a fact about your own operation.
4. Say what applies instead. If you are relying on an exemption, name the subparts that fall away and the requirement that stands in their place. An exemption relied on without naming the substitute is an answer with a hole in the middle of it, and the hole is what a customer’s auditor asks about first.

Here is what that looks like finished, for a reader who is outside part of a rule. A supplement manufacturer has been asked by a customer for a food safety plan under part 117. The answer: the requirement sits in subpart C of part 117; section 117.5(e) says subparts C and G do not apply to a facility with regard to manufacturing a dietary supplement that is in compliance with part 111 and the Act’s serious adverse event reporting section for dietary supplements; this facility manufactures dietary supplements and holds its part 111 system, and here is the evidence of it; subpart B still applies and is answered separately. Four sentences, each one traceable, and it names what is still on rather than only what came off.

And for a reader who is inside, which is the more common result: the requirement sits in this part; the applicability section reaches me on this limb, for this reason; no exemption in the part names my situation; so what is owed is this. That is a shorter answer and a more expensive one, and it is still better written down than argued in an email thread.

One boundary on all of this. Reading a scope section tells you whether a rule reaches you. It does not tell you what your product is, and where the demand assumes a category, the category is the thing under argument rather than the requirement. If you can name the section, the limb and the substitute, this reading is finished and you do not need anything else on this site. If it stalled because you cannot settle what the product is, the reading that settles that is the other half of the same afternoon.