Is my product a cosmetic or a drug, a supplement, or a food?

This is United States federal law: the Federal Food, Drug, and Cosmetic Act and FDA’s regulations under it. Get it wrong and you may be selling, in FDA’s reading, a drug while your label says cosmetic. FDA states that drugs must generally either receive premarket approval through a New Drug Application or conform to a monograph for the drug category, the monograph route resting on sections 505(a) and (b) of the Act (FDA, “Is It a Cosmetic, a Drug, or Both?”). That is the agency describing the requirement; the requirement itself is statutory and this page does not cover it. This page is about which category you are in. What follows from the answer, meaning the approval route, the ingredient filing, and the duties that attach to a cosmetic, is a separate question each and is not covered here.

Before you change anything

If your claims are already live: If you are not deciding what to say, because you already said it months ago and something has just made you look at it again, do not start by deleting the page. You cannot assess a record you have already taken down, and neither can anyone advising you. The section on this is here, and the short version is: keep dated copies of what is live before you touch it.

What this page does not reach. It covers four categories: drug, cosmetic, dietary supplement and food. It does not cover devices, and the same statutory provisions that make drug requirements attach to a cosmetic reach a device on identical terms. It does not cover tobacco products. The food and drug definitions on their face reach articles for animals; everything below is written for products for people, and a pet or livestock product raises questions this page does not answer. If your product is one of those, the answer is not on this page.

Three words do heavy lifting below, so they are settled first.

• A monograph is a rule FDA publishes for a category of nonprescription drugs, stating what ingredients may be used and for what intended use. Acne medications, dandruff treatments and sunscreens are among the categories covered by one (FDA guidance).
• Compendial means recognized 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 (21 U.S.C. 321(g)(1), clause (A)). Those are the three publications the statute names, and the clause turns on recognition in one of them rather than on anything you claim. This page does not reproduce them and cannot tell you whether an article in your product is in one.
• Disease has a regulatory definition and it is narrower than the everyday one: damage to an organ, part, structure, or system of the body such that it does not function properly, for example cardiovascular disease, or a state of health leading to such dysfunctioning, for example hypertension. Diseases resulting from essential nutrient deficiencies, such as scurvy and pellagra, are expressly excluded from it. Read its opening words: that definition is given for purposes of 21 U.S.C. 343(r)(6) (21 CFR 101.93(g)(1)), which is the dietary supplement structure/function provision. It governs the supplement disease-claim analysis below and it does not, by its own terms, define “disease” for the drug definition generally. Where this page runs the supplement analysis, use it. Elsewhere the statute does not define the word, and that is a gap you should know about rather than one this page can fill.

On this page: The four definitions · How intended use is established · A working test, run on real sentences · Which door you are standing in · A cream is not a supplement · The supplement disclaimer · When the ingredient decides it · Soap · What does not decide your category · If the claims are already live · What clean looks like · Three things to check

The four definitions, and which ones turn on intended use

A drug is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals, or an article other than food intended to affect the structure or any function of the body of man or other animals. It also reaches anything compendial, a listing with nothing to do with what you claim, and it reaches an article intended for use as a component of any of those (321(g)(1)).

A cosmetic is an article 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, and, as with drugs, an article intended for use as a component of one. The definition carves soap out of itself (321(i)).

A food is an article used for food or drink for man or other animals, chewing gum, or a component of either (321(f)). Read that word. The food definition turns on use, not on what anyone intended, which is the first sign that “it all comes down to intended use” is too neat.

Hold on to the food definition anyway. A dietary supplement is deemed to be a food for the whole Act, with two exceptions, and the first of them is the drug definition itself (321(ff)). That exception is what puts a supplement’s structure-or-function claims inside the drug definition. Without it a supplement would be food, and food sits outside that prong by its own words.

Disease claims work differently. The disease clause carries no food exception of its own, so a claim to diagnose, cure, mitigate, treat or prevent disease reaches a food or a supplement without needing the deeming exception at all. But the section does not stop at that clause. Read to the end of it: a food or dietary supplement for which a claim subject to sections 343(r)(1)(B) and 343(r)(3), or 343(r)(1)(B) and 343(r)(5)(D), is made in accordance with the requirements of section 343(r) is not a drug solely because the label or the labeling contains that claim (321(g)(1)). That is the authorized health claim route, and it is a real carve-out for food and supplements. It is narrow, it is not automatic, and it is described below.

A dietary supplement is a product, other than tobacco, intended to supplement the diet, bearing or containing at least one of six things: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract or combination of any of those (321(ff)(1)).

Three further conditions all have to hold, and they are three, not two.

1. Form. It is intended for ingestion in tablet, capsule, powder, softgel, gelcap or liquid form. “Liquid form” is itself defined and the definition is narrow: a food is considered intended for ingestion in liquid form only if it is formulated in a fluid carrier and is intended for ingestion in daily quantities measured in drops or similar small units of measure (21 U.S.C. 350(c)(2)). A bottled drink or a shot is not that. If the product is not in one of the listed forms, the alternative branch applies instead: it is not represented as conventional food and is not represented for use as a sole item of a meal or of the diet (350(c)(1)(B)(i) and (ii); 321(ff)(2)(A)).
2. Representation. It is not represented for use as a conventional food or as a sole item of a meal or the diet. This one applies whatever form the product takes, so it is a separate hurdle from the first and not the same test repeated. It is where the supplement-versus-beverage line gets drawn (321(ff)(2)(B)).
3. Labeling. It is labeled as a dietary supplement (321(ff)(2)(C)). This is why the label matters and why it is not enough on its own.

So three of the four definitions turn on intent and one does not. That matters more than it sounds, because two of the ways you can land in a category have nothing to do with what you say: compendial recognition (321(g)(1), clause (A)), and the order in which an article was first approved or marketed (321(ff)(3)(B)). Neither is a claim problem, and rewriting copy does not touch either.

How intended use is established

Intended use is not what you meant by it. FDA has published how it establishes intended use. What follows is FDA’s stated position on its own page rather than regulatory text, which cuts both ways: it is how the agency says it decides, and it is not a rule you can hold it to. It says intended use may be established in a number of ways, and gives three examples (FDA, “Is It a Cosmetic, a Drug, or Both?”).

Claims stated on the product labeling, in advertising, on the internet, or in other promotional materials. FDA’s own examples of claims that establish a product as a drug are restoring hair growth, reducing cellulite, treating varicose veins, increasing or decreasing melanin production, and regenerating cells. Note how FDA files them: it says such claims establish the product as a drug because the intended use is to treat or prevent disease or otherwise affect the structure or functions of the body. The five are not a list of structure-or-function examples, and the test below shows which is which.

Consumer perception, which FDA says may be established through the product’s reputation, meaning asking why the consumer is buying it and what the consumer expects it to do.

Ingredients that have a well-known therapeutic use, well-known to the public and industry. FDA’s example is fluoride in toothpaste. No claim needed. FDA gives one example and no test, so this is a category you can be placed in without a way to check yourself out of it.

Labeling is a term of art here and it is wider than the sticker on the jar. The regulations treat labeling as including material like pamphlets and catalogs (101.93(d)), and FDA’s own position, above, reaches advertising and the internet. When a rule below says “the labeling bears” something, do not read it as “the jar says.”

FDA works the same principle through an example you may recognize. A fragrance marketed for promoting attractiveness is a cosmetic; the same fragrance marketed with aromatherapy claims, that the scent will help you sleep or help you quit smoking, meets the drug definition. A massage oil that lubricates the skin and imparts fragrance is a cosmetic; one intended to relieve muscle pain is a drug (FDA guidance).

There is a drug labeling regulation on the meaning of intended use, and it gets quoted at cosmetics and supplements. Read its opening line first. It defines the term as used in a short list of enumerated sections: 201.5, 201.115, 201.117, 201.119, 201.120, 201.122 and 1100.5. None of the six in part 201 governs cosmetics or dietary supplements.

Inside that scope it says objective intent may be shown by the responsible persons’ expressions, by the design or composition of the article, or by the circumstances surrounding its distribution, including a purpose the article is offered or used for, with their knowledge, that it is neither labeled nor advertised for. It carries a proviso that a firm is not regarded as intending an unapproved new use for an approved drug based solely on knowing that health care providers are prescribing or using it that way. And it carries one line aimed at private label: where a packer, distributor or seller intends an article for a different use than the person they received it from intended, they are required to supply adequate labeling for the new intended use (21 CFR 201.128). Useful reading. Not authority for your cream.

If you did not formulate the product. Nothing above depends on you having made it. If you import, relabel, private-label or resell, the claims that establish intended use are the ones on your listing, your site and your ads, whoever wrote them, and the ingredient history is your product’s history whether or not you chose it. The difference is that you may have to ask someone else for the facts, and the last section says what to ask.

A working test for “affects the structure or any function of the body”

This is the hinge of the whole page. The cosmetic definition gives you four limbs and no more: cleansing, beautifying, promoting attractiveness, and altering the appearance (321(i)). Those are four separate things. Cleansing is not appearance. Promoting attractiveness is not appearance. A claim does not become cosmetic because you can argue it ends in someone looking better.

The drug prong sits next to it: an article other than food intended to affect the structure or any function of the body of man or other animals (321(g)(1), clause (C)). Three questions separate them.

1. Does the claim act on the body, or on how the body reads? Removing oil, adding color, adding scent, covering, smoothing the surface, making someone more attractive: those are the cosmetic limbs. Changing what tissue does, what a gland produces, how a cell behaves, or what a system regulates is the structure-or-function prong.
2. Does the claim name a mechanism? If so you are inside the prong. A sentence saying how the product acts on the body is a sentence about what it does to the structure or function of the body, which is the prong in its own words (321(g)(1), clause (C)). For dietary supplements the statute says so outright: it treats a statement that “characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function” as a structure/function statement in terms (343(r)(6)(A); 21 CFR 101.93(f)). Those two provisions govern nutrients and dietary ingredients on supplement labeling rather than cosmetics, so on a cream they show how the statute reads mechanism language rather than deciding your case. For an ingested supplement that statement is permitted, on conditions. For a cosmetic it is not, because the exemption reaches a food, a dietary ingredient or a dietary supplement, and a cosmetic is none of those (321(g)(1)).
3. Does the claim name a disease, or its characteristic signs or symptoms? Then you are in the disease prong, which is a different clause. On an ingested supplement, the regulatory definition of disease above governs that analysis directly. Elsewhere it is a useful reference point rather than a controlling definition, because the statute does not define the word for the drug definition generally.

The test, run on FDA’s own five examples. FDA lists these five together as claims that make a product a drug, and files them disjunctively, so they do not all land in the same place. FDA does not say which of the five goes to which prong. The allocations below are our reading of the five against the test, not FDA’s.

• “Treats varicose veins.” Question 3 answers it. Varicose veins are damage to a structure of the body such that it does not function properly. Disease prong.
• “Regenerates cells.” Question 1 answers it. Regenerating a cell is not cleansing, beautifying, promoting attractiveness or altering appearance; it is a change to what tissue does. Structure or function.
• “Restores hair growth.” Question 1. Growing hair is a function of the body, not an alteration of appearance. Structure or function.
• “Increases melanin production.” Questions 1 and 2 both. Melanin production is what a cell does, and the claim names the mechanism outright. Structure or function, and not a close case.
• “Reduces cellulite.” The one that needs care. If the claim is that the skin looks smoother, that is altering the appearance. If the claim explains that it breaks down subcutaneous fat, question 2 has been answered and you are in the prong. The same product, two sentences, two categories.

Now run your own sentence through the three questions in that order and write down which one caught it. If none of the three catches it, that is not yet a cosmetic result. The cosmetic definition is an affirmative test, so ask the fourth question: is the claim’s intended use one of the four named limbs, cleansing, beautifying, promoting attractiveness, or altering the appearance (321(i))? If it is, you are inside the cosmetic limbs on the claims test. If it is not, and none of the three drug questions caught it either, the claim sits in neither and the result is unresolved, exactly as the last row of the table below is unresolved. Either way the two non-claim routes still have to be checked.

If you are testing one sentence rather than the whole record, the same test runs claim by claim here: which clause of the drug definition your claim lands in, and why the structure/function relief reaches only one of them.

Which door you are standing in

These rows are not exclusive, and they are not read top to bottom until one matches. A product can satisfy several at once, and “both” is an ordinary outcome rather than an edge case. Read all of them against your product.

Product category by the route that decides it. Each row states what you do, the condition that applies, and the category that follows.

What you do	Condition that applies	Category that follows
apply it to the body	the claims stay inside cleansing, beautifying, promoting attractiveness, or altering appearance	a cosmetic (321(i))
apply it to the body	the claims say it treats or prevents a disease, or affects the body’s structure or function	a drug (321(g)(1))
make something intended to supplement the diet, bearing at least one of the six listed dietary ingredients	all three conditions above hold: form, representation, and labeling	a dietary supplement (321(ff)(1); 321(ff)(2))
sell it as ordinary food or drink	it is used as food; no intent test applies to this one	a food (321(f))
market it as a dietary supplement	the labeling bears a disease claim that is not an authorized health claim the product qualifies for	regulated as a drug (21 CFR 101.93(f))
sell it as a conventional food	the claims say it diagnoses, mitigates, treats, cures or prevents a disease, outside the authorized health claim route	a drug (321(g)(1))
do a cosmetic thing and a drug thing at once	either	both. FDA says such products must comply with the requirements for both cosmetics and drugs, and the provisions carrying that reach a cosmetic which is also a drug or device or component of one (FDA guidance; 21 CFR 700.3(b); 21 U.S.C. 359)
use an article approved as a new drug, certified as an antibiotic, or licensed as a biologic, or one publicly under substantial clinical investigation	it was not marketed as a supplement or a food before that, and the Secretary has not issued a regulation, after notice and comment, finding the article would be lawful	not a dietary supplement, whatever you claim (321(ff)(3); 321(ff)(3)(B)). It is still whatever the other rows make it: a topical carrying it may be a cosmetic or a drug; an ingested product carrying it is a food or a drug, but not a supplement
none of the rows describes your product	either your product is outside the four categories entirely, or one of the two non-claim routes has caught it	unresolved. Devices, tobacco products and animal products are outside this page. Within the four, the compendial route (321(g)(1), clause (A)) and the ingredient-history route (321(ff)(3)(B)) are the two that catch products no claim analysis would flag

FDA is explicit that the Act does not recognize “cosmeceutical” as a category. A product is a drug, a cosmetic, or both, and the word has no meaning under the law (FDA guidance). Soap sits outside all of it and has its own section below.

What an authorized health claim is, and where it is settled. The term decides two rows above, so here it is exactly. The statute says a food or dietary supplement for which a claim subject to sections 343(r)(1)(B) and 343(r)(3), or 343(r)(1)(B) and 343(r)(5)(D), is made in accordance with the requirements of section 343(r) is not a drug solely because the label or the labeling contains that claim (321(g)(1)). Section 343(r)(1)(B) describes the claim as one characterizing the relationship of any nutrient which is of the type required by paragraph (q)(1) or (q)(2) to be in the label or labeling of the food to a disease or a health-related condition, unless the claim is made in accordance with subparagraph (3) or (5)(D) (343(r)(1)(B)). That nutrient-type condition is part of the clause and it bounds which claims the carve-out can reach. Which specific claims are authorized, and what qualifies a product to make one, is set by 343(r)(3) and 343(r)(5)(D) and the regulations under them. Those are the provisions to read; this page does not carry the list, and the phrase is not a general escape hatch.

A cream is not a supplement

You may have reached for the supplement rules on a topical because the structure/function allowance looks like a way to say more. It is not available, and the reason is the first line of the definition rather than anything about dosage forms: a dietary supplement is a product intended to supplement the diet (321(ff)(1)). A cream is not, whatever is printed on it.

So a topical has three doors. Its claims stay inside cleansing, beautifying, promoting attractiveness or altering appearance and it is a cosmetic. They go past that and it is a drug. And it can be both at once, which FDA treats as ordinary: it names an antidandruff shampoo, a deodorant that is also an antiperspirant, and a moisturizer or makeup sold with sun-protection claims, and says such products must comply with the requirements for both cosmetics and drugs (FDA guidance).

The regulation says the same of the word sunscreen, and says it twice. A product that includes the term in its labeling, or in any other way represents or suggests that it is intended to prevent, cure, treat or mitigate disease or to affect a structure or function of the body, comes within the drug definition. And, in the same subsection: use of the term or similar sun protection terminology in a product’s labeling generally causes the product to be subject to regulation as a drug (21 CFR 700.35(a)).

That subsection then allows for something you may miss. Sunscreen ingredients may also be used for nontherapeutic, nonphysiologic purposes, and the regulation’s own examples are as a color additive, or to protect the color of the product. Where a cosmetic product contains a sunscreen ingredient and uses the term “sunscreen” or similar sun protection terminology anywhere in its labeling, the term must be qualified by describing the cosmetic benefit provided by the sunscreen ingredient (700.35(a)). That qualifying information must appear prominently and conspicuously at least once, in conjunction with the term. The regulation’s illustration is “Contains a sunscreen—to protect product color” (700.35(b)). What the regulation does not say is that satisfying the qualification keeps you a cosmetic. It states a labeling duty, and it states the general rule above.

The supplement disclaimer, and what it does not buy

For an ingested supplement, a structure/function statement is allowed. Four things come with it.

The statement has to be one of four kinds the statute describes (343(r)(6)(A)):

• a benefit related to a classical nutrient deficiency disease, with the prevalence of that disease in the United States disclosed;
• the role of a nutrient or dietary ingredient intended to affect structure or function in humans;
• the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function; or
• general well-being from consumption of a nutrient or dietary ingredient.

The manufacturer has to have substantiation that the statement is truthful and not misleading (343(r)(6)(B)). It has to carry the disclaimer, prominently displayed and in boldface type (343(r)(6)(C)). And the manufacturer has to notify the Secretary no later than 30 days after first marketing with the statement (343(r)(6)). The regulation extends that duty to the packer or distributor, on a notice signed by a responsible individual or by the person who can certify the accuracy of the information, certifying that the notice is complete and accurate and that the notifying firm has substantiation that the statement is truthful and not misleading (21 CFR 101.93(a)(1); 101.93(a)(3)). Somebody signs their name to that.

The disclaimer has a shape too. It sits adjacent to the statement with no intervening material, or is linked to it with a symbol such as an asterisk. It is set off in a box where it is not adjacent. It appears on each panel or page carrying such a statement (101.93(d)). And it is boldface at a typesize no smaller than one-sixteenth of an inch (101.93(e)).

What the whole scheme buys is narrow, and the regulation says where it comes from: the exemption is provided by compliance with the statute’s own structure/function provision, and the section’s requirements apply where a supplement bears such a statement and the manufacturer, packer or distributor wishes to take advantage of that exemption (101.93(b); 321(g)(1)). A cosmetic making a structure-or-function claim is inside that same prong, which is why the disclaimer looks tempting on a cream. It does not reach.

And it does not reach a disease claim. The statute says so in the same subparagraph that permits the statement: a statement under it may not claim to diagnose, mitigate, treat, cure or prevent a specific disease or class of diseases (343(r)(6)). The regulation says what happens then. A product marketed as a supplement whose labeling bears a disease claim will be subject to regulation as a drug unless the claim is an authorized health claim for which the product qualifies (101.93(f)).

The ten criteria, and the sentence above them. FDA will find that a statement claims to diagnose, mitigate, treat, cure or prevent disease, other than a classical nutrient deficiency disease, if it meets one or more of the criteria below. Before the list, the regulation says this: “These criteria are not intended to classify as disease claims statements that refer to the ability of a product to maintain healthy structure or function, unless the statement implies disease prevention or treatment.” It also says FDA will consider the context in which the claim is presented (101.93(g)(2)). That carve-out is aimed at exactly the copy a supplement brand writes, and reading the ten criteria without it makes them look wider than they are.

A statement is a disease claim if it claims, explicitly or implicitly, that the product:

1. has an effect on a specific disease or class of diseases;
2. has an effect on the characteristic signs or symptoms of a specific disease or class of diseases, using scientific or lay terminology;
3. has an effect on an abnormal condition associated with a natural state or process, if the abnormal condition is uncommon or can cause significant or permanent harm;
4. has an effect on a disease through one or more of the following factors:
   • the name of the product;
   • a statement about the formulation, including a claim that it contains an ingredient that FDA has regulated as a drug and that is well known to consumers for its use or claimed use in preventing or treating a disease, other than an ingredient that is an article included in the dietary supplement definition at 321(ff)(3);
   • citation of a publication or reference, if the citation refers to a disease use and, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease, for example through placement on the immediate product label or packaging, inappropriate prominence, or lack of relationship to the product’s express claims;
   • use of the term “disease” or “diseased”, except in general statements about disease prevention that do not refer explicitly or implicitly to a specific disease or class of diseases or to a specific product or ingredient; or
   • use of pictures, vignettes, symbols or other means;
5. belongs to a class of products intended to diagnose, mitigate, treat, cure or prevent a disease;
6. is a substitute for a product that is a therapy for a disease;
7. augments a particular therapy or drug action intended to diagnose, mitigate, treat, cure or prevent a disease or class of diseases;
8. has a role in the body’s response to a disease or to a vector of disease;
9. treats, prevents or mitigates adverse events associated with a therapy for a disease, if those adverse events constitute diseases; or
10. otherwise suggests an effect on a disease or diseases (101.93(g)(2)(i) to (x)).

The italicized conditions are the ones that get dropped when this list is repeated second-hand: the harm qualifier in criterion three, and the three exceptions inside criterion four. Dropping them makes each criterion bigger than the regulation wrote it, and criterion four is where that bites hardest, because on its face it appears to catch any ingredient with a drug history and any footnote to a paper.

When the ingredient decides it before you write a word

A product is not a dietary supplement if its article was approved as a new drug, certified as an antibiotic, or licensed as a biologic (321(ff)(3)(B)(i)), or was authorized for investigation as a new drug, antibiotic or biological where substantial clinical investigations were instituted and the existence of those investigations was made public (321(ff)(3)(B)(ii)).

Two escapes sit in the closing text of that paragraph: the article was marketed as a dietary supplement or as a food before that approval, certification, licensing or authorization, or the Secretary, in the Secretary’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under the Act (321(ff)(3)).

The first escape carries a further condition. For an article approved as a new drug or licensed as a biologic, prior marketing holds unless the Secretary has issued a regulation, after notice and comment, finding the article unlawful under section 342(f) when used as or in a dietary supplement under the conditions of use and dosages set out in the labeling (321(ff)(3)(A)). How far that condition reaches is not clean on the face of the text: the clause opens by naming only new-drug approval and biologic licensure, and then refers to “such approval, certification, or license”, the word certification being the one the antibiotic limb uses. Read it before relying on it either way.

Order matters more than chemistry, because the question is which came first. No claim changes it.

Which category your product is in is one question. Whether an article in it is cleared for use is another: self-affirmed GRAS or an FDA-notified one, which your customers accept, and whether self-affirmed is going away.

Soap, which is nobody’s special case until it is yours

The cosmetic definition excludes soap (321(i)), and FDA’s own regulation states that the term soap is nowhere defined in the Act (21 CFR 701.20(a)). FDA reads it narrowly. The bulk of the nonvolatile matter has to be an alkali salt of fatty acids, the detergent properties of the article have to be due to those compounds (701.20(a)(1)), and the product has to be labeled, sold and represented only as soap (701.20(a)(2)). A product that clears all three is regulated by the Consumer Product Safety Commission, not FDA (FDA guidance). That is a different body of law than this page covers, so clearing the soap test is not clearing everything.

Fail it and the regulation says a product intended for cleansing the human body that is not soap is a cosmetic (701.20(b)). FDA’s guidance puts it wider: a cleanser that does not meet all the criteria is either a cosmetic or a drug. Both of the outcomes it then gives are conditioned on composition, so read that condition with them. A product that consists of detergents, or primarily of alkali salts of fatty acids, and is intended not only for cleansing but also for other cosmetic uses, such as deodorizing, imparting fragrance or moisturizing, is regulated as a cosmetic. The same product intended not only for cleansing but also to cure, treat or prevent disease, or to affect the structure or any function of the human body, meaning an antibacterial cleanser or an acne bar, is regulated as a drug, or possibly both a drug and a cosmetic. And a cleanser intended solely for cleansing the body, having the characteristics consumers generally associate with soap, that does not consist primarily of alkali salts of fatty acids, may still be identified in labeling as soap and is regulated as a cosmetic anyway (FDA guidance). So the word on the wrapper and the category are two separate questions, and the answer to one does not give you the other. “I make soap” was never a category. It was an exemption, and clearing it takes three tests.

What does not decide your category

Four beliefs come up, and none of them is stupid. Each is a normal response to a gap.

“It is a supplement because I am selling it as one.” Being labeled a supplement is one element of the definition, not the definition (321(ff)(2)(C)). Nobody hands you a category before you sell, so you assign your own, which is what happens anywhere a required decision is not written down.

“My competitor sells it, so it must be fine.” A departure that passes without consequence stops being read as a departure. The shortcut becomes the standard, the next person learns it as the way the work is done, and each accepted departure sets the baseline for the next. A category nobody has challenged is not a category anyone has cleared.

“My contract manufacturer said the label is compliant.” An informal assurance is not a determination, and on a structure/function statement an individual signs a certification that the notice is complete and accurate and that the notifying firm has substantiation that the statement is truthful and not misleading (21 CFR 101.93(a)(3)). There is a formal instrument that does more than an assurance, and it is not the same thing as somebody telling you it is fine: a signed guaranty under 333(c), described below, is a named statutory route and it has to be signed, has to carry the name and address of a person residing in the United States, and has to say the specific things the statute requires.

“Worst case is a warning letter.” A letter is a step and the statute says what sits above it. Introducing, or delivering for introduction, into interstate commerce any food, drug, device, tobacco product or cosmetic that is adulterated or misbranded is a prohibited act (21 U.S.C. 331(a)). 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 in interstate commerce, whether or not it is the first sale, is liable to be proceeded against and condemned (334(a)(1)). And a person who violates a prohibited act shall be imprisoned for not more than one year or fined not more than $1,000, or both (333(a)(1)), rising to not more than three years or not more than $10,000, or both, in two named circumstances: a violation committed after a conviction under that section has become final, or a violation committed with the intent to defraud or mislead (333(a)(2)).

Two limits on that, close to this page’s subject. Food misbranded solely because of its advertising is carved out twice. No person is subject to the paragraph (1) penalties for a violation involving misbranded food if the violation exists solely because the food is misbranded under section 343(a)(2) because of its advertising (333(d)). And no libel for condemnation may be instituted against food misbranded under 343(a)(2) because of its advertising while it is held for sale to the ultimate consumer in an establishment not owned or operated by the food’s manufacturer, packer or distributor, unless the advertising was disseminated in that establishment, or by or under the direction of its owner or operator, or the owner or operator paid all or part of the cost of it, and the owner or operator used it in the establishment to promote the sale of the food (334(a)(3)). Neither carve-out reaches a drug or a cosmetic, and neither reaches misbranding on the label itself.

The relief provision has six routes. A page that describes only the first two leaves out the one that catches cosmetics. Section 333(c) says a person is not subject to the paragraph (1) penalties (333(c)):

1. for having received an article in interstate commerce and delivered or offered to deliver it, if that delivery or offer was made in good faith, unless he refuses to furnish, on request of an officer or employee duly designated by the Secretary, the name and address of the person from whom he purchased or received the article and copies of all documents pertaining to its delivery to him;
2. for having violated section 331(a) or (d), if he establishes a guaranty or undertaking signed by, and containing the name and address of, a person residing in the United States from whom he received the article in good faith. The guaranty has to say different things depending on the branch: for an alleged 331(a) violation, that the article is not adulterated or misbranded within the meaning of the chapter, designating this chapter; for an alleged 331(d) violation, that the article is not one which may not, under sections 344 or 355, be introduced into interstate commerce;
3. for having violated 331(a) where the article is adulterated by containing a color additive not from a batch certified under the Secretary’s regulations, if he establishes a guaranty signed by, and containing the name and address of, the manufacturer of the color additive, to the effect that the additive was from a certified batch. This is the color-additive guaranty. The statute gives uncertified color additives a relief route of their own, which no other adulteration ground on this list gets;
4. for having violated section 331(b), (c) or (k) by failure to comply with section 352(f) in respect of an article received in interstate commerce to which neither section 353(a) nor 353(b)(1) is applicable, if the delivery or proffered delivery was made in good faith and the labeling at the time carried the same directions for use and warning statements as the labeling carried when the article was received;
5. for the counterfeit drug provisions at 331(i)(2) and (i)(3), where the person acted in good faith and had no reason to believe the article or the thing used would result in a counterfeit drug; and
6. for the counterfeit device provisions at 331(fff)(2) and (fff)(3), on the same good-faith terms.

Read all six in full before relying on any of them.

If the claims are already live

The record is not only your label. FDA says intended use may be established by claims stated on the product labeling, in advertising, on the internet, or in other promotional materials, and by consumer perception established through the product’s reputation, meaning why the consumer is buying it and what they expect it to do (FDA guidance). Two things follow from that sentence.

Capture before you change anything. Take dated copies of what is live: the product pages, the ad copy, the product name, the packaging artwork, the affiliate and influencer material, and the review and Q&A text. Dated PDFs or full-page captures with the URL and the date visible, kept in one place, are the artifact. A folder of undated screenshots is not. Taking a page down removes the page; it does not remove what was published, what was archived, or what a customer now expects the product to do.

Removal is not resolution. Consumer perception is named by FDA as a way intended use is established, and it is the one input an edit does not reach directly. That is a statement about what you can change, not about what you can see: reviews, affiliate posts, marketplace Q&A and your own listing history are all readable, and reading them is how you find out what the product is understood to do. Do not confuse an input you cannot control with an input you cannot examine.

What resolves a category is a determination on the whole record, made against the definitions. That is different work from writing better claims.

Once the category is settled, the next document the rule asks you for is the specification, and it has the same shape of problem: 21 CFR 111.70 tells you to establish specifications and gives you no numbers.

Specimen drawn from the Document Control™ case — skincare claims that crossed into drug territory

What clean looks like, and when to stop

There is a version of this where the answer is that you are a cosmetic, or a supplement, and always were. It looks like all four of these coming back the same way:

• Claims. Every claim across the whole record, not the label alone, stays inside the four cosmetic limbs, or inside the permitted structure/function kinds for an ingested supplement with the substantiation, disclaimer and notice in place. You can check this yourself with the three-question test above.
• Definition conditions. If the route is dietary supplement, the form, the representation and the labeling all satisfy the definition, not just the label statement. You can check this yourself against the three conditions above.
• Compendial status. Nothing in the product is recognized in the USP, the HPUS or the NF in a way that engages 321(g)(1), clause (A). You cannot check this from this page. The statute names the three publications and this page reproduces none of them; the answer is in the compendia themselves, and where each is published and how it is searched is a question to put to the body that maintains it.
• Ingredient history. No article in it was approved as a new drug, certified as an antibiotic, licensed as a biologic, or publicly under substantial clinical investigation before it was marketed as a supplement or a food. You cannot check this from this page either. It is a question about the regulatory history of each article, and the answer lives in FDA’s own approval, licensure and investigational records rather than in any rule reproduced here.

Two of the four are self-assessable and two are not. That is worth stating plainly rather than leaving you to discover it: this page can carry you all the way through the claims analysis and cannot carry you through the ingredient analysis, because the ingredient analysis is a records search, not a reading of a rule.

If all four come back clean, you are done with this question. You do not need what follows, and you do not need to buy anything. Being a cosmetic is a category rather than a clearance, and duties attach to it, but which duties is a separate question from which category, and this page settles neither for your specific product.

Which duties, once you know the category, is the next page rather than this one. If the answer came back cosmetic, the duty that follows is the safety file: whether you have to hold safety substantiation, and whether the small business exemption removes it. If it came back dietary supplement, it is the label: what has to be on the panel, and what FDA writes up instead.

Three things to check before you spend

1. Audit every claim, everywhere. Not the label alone. The site, the ads, the posts, the product name, your photography and packaging artwork, and what your reviewers say it fixed. FDA’s own criteria name pictures, vignettes and symbols as a way a product claims an effect on disease, alongside the words, for a supplement disease claim (21 CFR 101.93(g)(2)(iv)(E)). FDA says intended use may be established by claims in advertising and on the internet, and by consumer perception through the product’s reputation (FDA guidance).
2. Check each article’s history before its benefits. An article approved as a new drug, certified as an antibiotic or licensed as a biologic first, or authorized for investigation as one where substantial clinical investigations were instituted and made public, is not a dietary supplement no matter what you claim. Two escapes exist, both in the closing text of that paragraph and both narrower than they sound (321(ff)(3); 321(ff)(3)(B)). If you did not formulate the product, this is the question to put to whoever did, in writing, article by article.
3. Ask your manufacturer one question. If any part of this is a drug, is it made in a facility run to drug requirements. Failure to comply with the drug manufacturing regulations renders the drug adulterated, and the person responsible for the failure is subject to regulatory action along with it (21 CFR 210.1(b)). A drug on paper has to be a drug in the plant.

If the answer to that last one is that a quality agreement covers it, that is the next question rather than the end of this one: whether a quality agreement actually protects you when your manufacturer fails.