Will this claim make my product a drug?

This is United States federal law: the Federal Food, Drug, and Cosmetic Act and FDA’s regulations under it. Start with the part most writing on this subject leaves until the end. The allowance people mean when they say “structure/function claim” is one provision of the Act, it is written for dietary supplements, and the sentence that ties it back to the drug definition names exactly three things it protects: a food, a dietary ingredient, and a dietary supplement (21 U.S.C. 321(g)(1)). A cosmetic is none of the three. If what you make is a cream, a serum, a deodorant, a shampoo or a fragrance, that allowance does not reach you. You are better off knowing that in the first paragraph than in the last.

What this page answers. The claim question, and only that: the sentence you are about to publish, and whether publishing it moves your product. Whether your product is a cosmetic, a supplement, a food or a drug to begin with is the wider question, and it is answered on our page on how FDA sets the category, which also carries the full conditions attached to the supplement allowance. This page is written for products for people. It does not reach devices, tobacco products, or products for animals.

Two clauses, and the structure/function way out reaches only one

A claim can put you in one of two places. The drug definition is built in four clauses, and the two that turn on what you say are these. Clause (B): “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.” Clause (C): “articles (other than food) intended to affect the structure or any function of the body of man or other animals” (321(g)(1)). The other two are not about your marketing at all: clause (A) turns on recognition in the official United States Pharmacopoeia, the official Homoeopathic Pharmacopoeia of the United States or the official National Formulary, or any supplement to any of them, and clause (D) on being a component of an article in (A), (B) or (C).

Now read the way out you are probably reaching for, in the statute’s own words. At the end of that same definition: “A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 343(r)(6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a statement” (321(g)(1)).

Three words carry the whole thing: under clause (C). That relief is clause-specific, and it says nothing about clause (B). The provision it points at says the same in its own voice: “A statement under this subparagraph may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases” (343(r)(6)). The regulation names it more plainly than either. Its requirements apply where a dietary supplement bears such a statement and the manufacturer, packer, or distributor “wishes to take advantage of the exemption to section 201(g)(1)(C) of the act that is provided by compliance with section 403(r)(6) of the act” (21 CFR 101.93(b)). Section 201(g)(1) of the Act is the definition above. One clause is named, and it is (C).

That is not the same as saying clause (B) has no route at all, and this is where a lot of writing on the subject goes wrong. The sentence immediately before it, in the same definition, is not clause-limited: “A food or dietary supplement for which a claim, subject to sections 343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in accordance with the requirements of section 343(r) of this title is not a drug solely because the label or the labeling contains such a claim” (321(g)(1)). That is the authorized health claim route. It reaches a claim characterizing the relationship of a nutrient to a disease or a health-related condition (343(r)(1)(B)), and it runs through its own gate (343(r)(3)(A); 343(r)(5)(D)).

So there are two routes and they are not interchangeable. Nothing you attach to a structure/function statement, no disclaimer, no substantiation file and no notification, converts a disease claim into a permitted one. Those conditions buy relief from clause (C). A disease relationship goes through the health claim route or it does not go at all, and that is a different application with a different standard.

Why a supplement is not a food here, and what that changes

Look at clause (C) again. It reaches “articles (other than food).” A conventional food sits outside that clause by the clause’s own words, because food means “articles used for food or drink for man or other animals”, chewing gum, and articles used for components of any such article (321(f)).

You would expect a dietary supplement to get the same free ride, since supplements are treated as food almost everywhere else in the Act. They do not, and the reason is one sentence at the end of the supplement definition: “Except for purposes of paragraph (g) and section 350f of this title, a dietary supplement shall be deemed to be a food within the meaning of this chapter” (321(ff)). That sentence names two exceptions to the deeming rule. The one that matters here is the first: paragraph (g) is the drug definition, so the place where a supplement is not deemed a food is the exact place where the words “other than food” are printed.

That is why the carve-out sentence had to be written at all, and it is why the two protections fail in different ways. A conventional food’s position under clause (C) comes from the text of the clause, and no paperwork is attached to it. A supplement’s comes from complying with the supplement provision, which carries conditions: the statement has to be one of the kinds the provision describes (343(r)(6)(A)), the manufacturer has to hold substantiation that it is truthful and not misleading (343(r)(6)(B)), it has to carry the prescribed disclaimer (343(r)(6)(C)), and the Secretary has to be notified no later than 30 days after the first marketing of the supplement with the statement (343(r)(6)). Miss one and the statement was not made in accordance with the provision, which is the only thing the carve-out asks of it.

A cosmetic is on neither footing. The cosmetic definition names four intended uses: articles intended to be rubbed, poured, sprinkled or sprayed on, introduced into, or otherwise applied to the human body or any part of it “for cleansing, beautifying, promoting attractiveness, or altering the appearance”. It then adds articles intended for use as a component of such articles, and it excludes soap outright (321(i)). What it does not carry is any permitted-claim provision of the kind written for supplements, and the carve-out sentence in the drug definition does not name cosmetics (321(g)(1)). So the boundary gets drawn from what the category next door is allowed to say, and the category next door is working from a provision that does not name you.

The claim is not only the words on the label

Labeling is a defined term and it is wider than the label: “all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article” (321(m)).

FDA’s regulation on what “intended uses” means is the clearest written account of what the agency is actually looking at. Read its scope first, because it is easy to over-read: by its own opening words it defines the term as used in seven named sections of that chapter, not for every appearance of the word in the Act. Within that scope it says intended uses “refer to the objective intent of the persons legally responsible for the labeling of an article (or their representatives). The intent may be shown by such persons’ expressions, the design or composition of the article, or by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives” (21 CFR 201.128).

Three things in that sentence are not the label. The design or composition of the article. The circumstances surrounding its distribution. Oral statements. FDA’s own account on its cosmetic-drug page runs wider still: claims “stated on the product labeling, in advertising, on the Internet, or in other promotional materials”; consumer perception, “which may be established through the product’s reputation”, which it explains as “asking why the consumer is buying it and what the consumer expects it to do”; and ingredients that carry a well-known therapeutic use, for which its example is fluoride in toothpaste (FDA, “Is It a Cosmetic, a Drug, or Both?”). Mark the standing of that source: it is the agency describing how it reads the definitions. The definitions themselves are in the statute, and the statute is what a court reads.

The same page makes the point concrete on one product. “A fragrance marketed for promoting attractiveness is a cosmetic. But a fragrance marketed with certain ‘aromatherapy’ claims, such as assertions that the scent will help the consumer sleep or quit smoking, meets the definition of a drug because of its intended use. Similarly, a massage oil that is simply intended to lubricate the skin and impart fragrance is a cosmetic, but if the product is intended for a therapeutic use, such as relieving muscle pain, it’s a drug” (FDA guidance). Same oil in the bottle. The sentence moved it.

So a review of your claims that stops at the carton is not a review of your claims. The product page, the paid ad set, the wholesale line sheet, the packaging insert, the interview, and the ingredient you chose because of what buyers already believe it does are all in scope.

The claim you did not make

The sentence that moves a product is often written by somebody else. The same regulation ends with two lines that brands rarely read: “The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he or she received the article, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses” (21 CFR 201.128). The scope note above travels with that duty: it is written for the sections the regulation names.

This is a gap between parties rather than a mistake inside one. Your label is clean, your site is clean, and a marketplace listing your distributor built carries a bullet you have never read. Each side wrote its own version of the same step, so the claim set nobody agreed on is the one in front of buyers. A scope that stops short of what the people relying on it assume it contains is a failure mode in its own right, and it is what makes this one hard to see from inside the brand: you are auditing the surfaces you control, and the exposure is on the ones you do not.

The practical consequence is simple. If you wholesale, license, or let anyone else list the product, the set of sentences a partner may use is either written into the agreement or it is being written by the partner.

Which clause your sentence lands in

Run your own sentence down the first column. The rows read claims, not products.

What lands the moment the claim does

A product that becomes a drug because of what you said has no approval behind it, because you were never seeking one. What the approval provision turns on is one step further in. It binds a new drug, and a new drug is one whose composition is such that it “is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof” (321(p)(1)). Where the product is generally recognized as safe and effective for the conditions its own labeling states, it is not a new drug and this provision does not reach it. Where it is, the statute is short: “No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug” (21 U.S.C. 355(a)). FDA describes the other door as the monograph: once it has made a final determination on the status of an over-the-counter drug category, such products must either be the subject of an approved application or comply with the appropriate monograph, and a monograph specifies “conditions whereby OTC drug ingredients are generally recognized as safe and effective (GRASE), and not misbranded” (FDA guidance).

It may also be misbranded, for a reason that has nothing to do with the claim itself. A drug is misbranded unless its labeling bears “adequate directions for use” and “such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application” (352(f)). The directions limb is not absolute: the same paragraph directs the Secretary to exempt a drug from it by regulation where the requirement is not necessary for the protection of the public health (352(f)). Absent an exemption, a cosmetic carton does not carry drug directions, because nobody wrote it as a drug. The category changed and the label did not.

Introducing a misbranded article into interstate commerce is a prohibited act (331(a)). Against that act the district courts have jurisdiction, for cause shown, to restrain the violation (332(a)); a person who violates a provision of section 331 is liable to imprisonment or a fine or both (333(a)(1)); and the article itself is liable to be proceeded against and condemned (334(a)(1)). None of those three provisions conditions its remedy on a letter having been sent first.

That is the whole reason a sentence is worth an afternoon before it publishes rather than a quarter after. The claim is the cheapest thing on the product to change, right up until the moment it is live.