1 · Soap is a narrow legal carve-out
The statute defines "cosmetic" and then takes soap out of it. A cosmetic is an article "intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body … for cleansing, beautifying, promoting attractiveness, or altering the appearance" — "except that such term shall not include soap."[1]
And then the statute stops. The regulation that fills the gap says so in its own words: "The term soap is nowhere defined in the act. In administering the act, the Food and Drug Administration interprets the term 'soap' to apply only to articles that meet the following conditions".[2]
⚠️ That word "interprets" is doing real work, and it is in the regulation itself. What follows is FDA's reading of an undefined statutory term, not a definition Congress wrote. Everything downstream — the conditions, the agency pages restating them, the maker advice restating those — inherits that.
So four kinds of document get quoted in this area, and they do not carry equal weight. This guide keeps them apart:
Statute — 21 U.S.C. § 321(i), § 364(2)
Regulation — 21 CFR § 701.20
Agency interpretation — FDA's soap pages, CPSC's soap guidance
Secondary — the maker press, quoted only as evidence of what makers
are being told
FDA's own explainer cites the definition correctly, at "[FD&C Act, sec. 201(i)]", and points at the two halves of it: section 201(i)(1) includes "articles…for cleansing" and section 201(i)(2) "excludes soap from the definition of a cosmetic."[3] Section 4 is about the one place where that page's citations stop being reliable.
2 · The test is the finished product
The regulation has two conditions, and they are short enough to read whole:
(1) "The bulk of the nonvolatile matter in the product consists of
an alkali salt of fatty acids and the detergent properties of the article are due to
the alkali-fatty acid compounds; and"
(2) "The product is labeled, sold, and represented only as
soap."[2]
Both agencies restate that as three conditions, splitting the first into what the product is made of and what causes its cleaning action. CPSC lists "ALL of the following conditions" in three numbered parts;[4] FDA's soap FAQ says "FDA's regulatory definition of soap includes the following three conditions; all three conditions must be met".[5]
⚠️ Two in the regulation, three on the agency pages. The three-part version is a restatement, not a different rule — but if you are citing something, cite the regulation for the test and the agency page for the explanation, and don't write that the CFR lists three.
What the test is about is the finished product and how it is offered — composition, what does the cleaning, and what it is represented as. Three things it is not about:
Not the word on the label. Both agencies say so in almost the same breath: synthetic detergents can make a product a cosmetic "although the product may be labeled as 'soap'",[4] and FDA's FAQ twice adds "You can still use the word 'soap' on the label."[5]
Not the method. Nothing in the regulation mentions cold process, hot process or melt-and-pour. A melt-and-pour bar is judged on the same two conditions as any other bar — which is why making soap is a separate guide from this one. The method decides what you have to handle; it does not decide what you are allowed to call the result.
Not the size of your operation. Classification and exemptions are different questions, and section 7 keeps them apart.
⚠️ One widely repeated figure is about the market, not about artisan soap. FDA writes "Today there are very few true soaps on the market. Most body cleansers, both liquid and solid, are synthetic detergent products."[5] That is a statement about body cleansers on sale, largely industrial ones. It is not a census of handmade soap, and it does not tell you which side of the line your bar is on.
3 · The scent trap
The third condition is where a scented bar gets interesting, because both agencies name smell directly. CPSC: "Making claims such as moisturizing skin, making the user smell nice, or deodorizing the body could classify the product as a cosmetic."[4] FDA: "If it is intended for purposes such as moisturizing the skin, making the user smell nice, or deodorizing the user's body, it's a cosmetic."[5]
⚠️ Read what the test actually is: a claim, or an intended purpose. Not the presence of fragrance oil. Neither agency says a scented soap is a cosmetic. Both say that representing the product as doing something to the user — moisturising, making them smell nice, deodorising them — could classify it as one.
The distinction a maker has to work with is between describing the product and describing an effect on the person. "Lavender-scented soap" is a description of the bar. "Leaves your skin beautifully scented" is a claim about the user.
⚠️ That pair of examples is ours, not either agency's. It is an illustration of the wording quoted above. Neither CPSC nor FDA has published a bright line between the two, and where your own copy sits is not something a guide can settle for you.
What follows from that is narrower than the alarm usually attached to it. Your recipe does not decide this. Your product page, your product names, your Etsy listing and your market-stall sign do — and they are the cheapest part of the business to change.
4 · Where CPSC and FDA don't give one answer
This is the part of the subject maker-facing summaries often leave out, and it is a disagreement between primary agency sources rather than between blogs.
CPSC's soap page draws an inference from MoCRA — the Modernization of Cosmetics Regulation Act of 2022 — and states it as guidance:
"the Modernization of Cosmetics Regulation Act of 2022 amended the Federal Food, Drug, and Cosmetic Act by including the definition of a 'cosmetic product' as 'a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product,' 21 U.S.C. § 364(2); therefore, inclusion of ingredients commonly recognized as having cosmetic properties may classify the product as a cosmetic even if no cosmetic claims are made."[4]
Read that against the framework FDA still leads with. FDA's soap pages set out the composition, cleaning-action and intended-use conditions, and its explainer keeps the statutory position intact: section 201(i)(2) excludes soap from the definition of a cosmetic.[3][5] Neither FDA page addresses what CPSC's sentence implies: that ingredients alone might classify a product with no claims at all.
⚠️ Two different terms are in play, and they are not interchangeable. MoCRA's "cosmetic product" is defined for the cosmetics subchapter it amends.[6] "Cosmetic" is defined at 21 U.S.C. § 321(i), and that definition still excludes soap.[1] MoCRA did not rewrite the soap exclusion. Whether a "preparation of cosmetic ingredients" can be a cosmetic product without being a cosmetic is exactly the question CPSC's sentence leaves open.
CPSC's own next sentence gives the practical direction: "Firms may wish to contact the FDA for guidance whether their products fall under FDA's jurisdiction."[4]
This guide does not resolve the tension. It cannot: one agency has published an inference the other agency's pages do not address, and only FDA can say what FDA will do. What the guide can do is show you that the disagreement is real, in both agencies' own words, so that a maker who has been told "MoCRA doesn't touch true soap" knows the published materials don't give a clean answer.
⚠️ And one citation on FDA's own page is wrong, which is worth knowing before you rely on it. FDA's explainer gives MoCRA's "cosmetic product" definition and pins it to "[FD&C Act, sec. 361]".[3] The Code puts that definition at 21 U.S.C. § 364(2), which is FD&C Act § 604, added by MoCRA;[6] 21 U.S.C. § 361 is "Adulterated cosmetics", a different provision. CPSC's pin at § 364(2) is the correct one.[4] The definition FDA quotes is the right definition; only the section number is wrong.
5 · Claims that move the product
Classification follows intended use, and intended use can be established by what you say. FDA reads it from labelling, advertising and other material, and in some cases from ingredients with a well-known therapeutic use.[3] The same bar can sit in three places depending on the sentence attached to it.
| What the marketing says | What it may make the product |
|---|---|
| Only that it is soap, for washing | Soap — CPSC's, if the composition conditions are met[2] |
| Moisturises skin · makes the user smell nice · deodorises the body | A cosmetic[4][5] |
| Treats acne or eczema · kills germs · prevents disease | A drug — and possibly a cosmetic as well[4][5] |
"Aromatherapy" is not a legal category, and some aromatherapy claims are drug claims. FDA's example: "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."[3] The test is the claim, not the word.
⚠️ The product may be both. FDA says so plainly — "The product may be both a cosmetic and a drug"[5] — and the drug route is a different regulatory regime: drugs generally need premarket approval or must conform to an over-the-counter monograph.[3]
One exception to "cosmetics aren't pre-approved" matters to anyone colouring a bar. FDA: "cosmetic products and ingredients, with the exception of color additives, do not require FDA approval before they go on the market."[3] Colour additives are the carve-out inside the carve-out — approved for particular uses, and some subject to batch certification.
6 · If it's true soap
Then it is generally CPSC's rather than FDA's — and CPSC says "generally" for a reason. Its soap FAQ: "Generally speaking, true soaps that fall under CPSC's jurisdiction do not need to follow FDA's requirements because they would not be considered cosmetics or drugs; however, the applicable requirements for each product must be assessed individually."[7] The guidance page puts the split the same way: "CPSC regulates true soaps, while cosmetics or drugs are regulated by FDA. To that end, CPSC does not have specific requirements for soaps. In general, soaps would be subject to the Federal Hazardous Substances Act (FHSA) and the Consumer Product Safety Act (CPSA)."[4]
The FHSA question is whether the product is a hazardous substance. If it is, precautionary labelling follows — and CPSC says how rare that is for soap: "such labeling for standard soap is uncommon and usually reserved for strong degreasing soaps that could cause eye irritation."[4]
⚠️ "CPSC does not have specific requirements for soaps" is not "nothing applies." It means there is no soap rule. The general product-safety framework still applies, and if the bar is for children, section 8 is not optional.
7 · If it's a cosmetic
Then FDA's cosmetic requirements apply, and MoCRA's are the newest layer of them. The regulation that defines soap also says what happens when a body cleanser is not soap: such products "are 'cosmetics,' and accordingly they are subject to the requirements of the act and the regulations thereunder", and it gives the example of a bar having to bear "an accurate statement of the weight of the bar in avoirdupois pounds and ounces".[2]
MoCRA's duties, as FDA describes them:
| Duty | Whose | Off for a small business? |
|---|---|---|
| Facility registration, renewed every two years | The facility that manufactures or processes | Yes[8] |
| Product listing | The responsible person | Yes[8] |
| Good manufacturing practice | The facility | Yes[8] |
| Safety substantiation, with records kept | The responsible person | No[9] |
| Serious adverse event reporting | The responsible person | No[9] |
The responsible person and the facility are different parties, which matters if someone else pours for you. FDA defines the responsible person as "the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label"; registration is the facility's obligation.[9]
The small-business exemption is in the statute, with a number. Responsible persons and facility owners "whose average gross annual sales in the United States of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation", and who do not make the products listed in subsection (b), "shall be considered small businesses and not subject to the requirements of section 364b or 364c" — GMP, registration and listing.[8]
⚠️ The exemption has product-based exceptions. FDA lists the product types it does not cover, including products that regularly contact the mucous membrane of the eye, products that are injected, products intended for internal use, and products intended to alter appearance for more than 24 hours where removal is not part of customary use.[9] And "small business" is not "unregulated": safety substantiation and adverse event reporting do not switch off.
⚠️ Registration is not approval, and FDA says so in its own words: "Cosmetic product facility registration and cosmetic product listing is neither a cosmetic approval program nor a promotional tool. The assignment of a facility registration number or product listing number does not indicate FDA approval of the facility or its cosmetic products."[10] Nobody can hand you a certificate that proves compliance, and nothing about being registered is a marketing claim.
One MoCRA labelling duty is written but not yet operative. The statute requires the responsible person to "identify on the label of a cosmetic product each fragrance allergen included in such cosmetic product", with the allergens "determined by the Secretary by regulation" — a rulemaking the statute directs FDA to run.[11] FDA's current MoCRA page continues to list fragrance-allergen labeling among the rulemakings MoCRA requires; no operative rule is identified there.[9] A scented cosmetic soap is squarely in its path.
8 · If it's for children
A soap primarily intended for children 12 or under is a children's product, and this layer applies whether the bar is soap or a cosmetic. CPSC: soaps "primarily intended to be used by children 12 years of age or younger are classified as children's products. These products must bear a permanent tracking label and be tested for total lead content by a third-party, CPSC-accepted laboratory." A Children's Product Certificate is also required, "verifying compliance with the applicable children's product safety rules."[4]
⚠️ This is the layer most soap guides skip, and the FDA question does not touch it. Concluding "mine is true soap, so FDA's rules are not mine" says nothing about the tracking label, the lead test or the certificate.
9 · State and local
Clearing the federal question does not clear your own state's. Two examples, and they work differently.
California operates reporting regimes, not a permit regime — and there are two of them, with different triggers. Under the Safe Cosmetics Act, "the manufacturer of any cosmetic product subject to regulation by the federal Food and Drug Administration that is sold in this state" must give the state a list of its products sold there containing any ingredient "identified as causing cancer or reproductive toxicity", including a chemical "contained in the product for purposes of fragrance or flavoring."[12] Separately, since 1 January 2022, "a manufacturer of a cosmetic product sold in the state" must disclose fragrance and flavour ingredients that appear on a designated list, and fragrance allergens from Annex III of the EU Cosmetics Regulation above stated concentrations.[13]
⚠️ One of the two carries a small-seller exemption and the other was not checked for one. The Safe Cosmetics Act section says it "shall not apply to any manufacturer of cosmetic products with annual aggregate sales of cosmetic products, both within and outside of California, of less than one million dollars ($1,000,000), based on the manufacturer's most recent tax year filing."[12] That exemption is written into that section. This page makes no claim about an exemption in the fragrance-disclosure statute, which was read for its duty and not for its exceptions. Read both for your own sales volume.
⚠️ Notice what that duty hangs on: being a cosmetic subject to FDA regulation. It mirrors the federal argument exactly — a bar that is true soap sits outside a rule written for cosmetics, and a bar that is a cosmetic does not. That is the same reasoning as section 4, arriving from the other direction.
Florida runs a permit regime rather than a reporting one, and it writes its exemption around the soap carve-out. Section 499.01(2)(p) of the Florida Statutes requires a permit to manufacture cosmetics, and exempts a manufacturer whose annual gross sales are $25,000 or less.[14] An exempt manufacturer must be able to produce written documentation of that figure on request, and the figure counts all cosmetic sales at any location — not the sales of one product or one shop.
The exemption carries four conditions, at subparagraphs 1.a to 1.d:
a. Prepackaged goods are labelled to FDA requirements
b. Only soaps, lotions, moisturizers and creams are made
c. Nothing is adulterated or misbranded under 21 U.S.C. §§ 361 and 362
d. Products are stored on the premises
And each unit has to say so, in contrasting colour and not less than 10-point type: "Made by a manufacturer exempt from Florida's cosmetic manufacturing permit requirements."[14]
⚠️ Subparagraph 1.b is the finding, and it is this guide's own argument in a state legislature's words. It lets an exempt manufacturer make "cosmetics that are soaps, not otherwise exempt from the definition of cosmetics".[14] Florida has used the federal soap carve-out as a condition of its own exemption.
Read it forward and the structure is the same as section 4: a bar that is true soap is outside the definition of a cosmetic, so it is outside a permit regime written for cosmetics, and none of this reaches it. The exemption exists for the bars that crossed into cosmetic territory — the ones that added a moisturising claim, or cleaned with a detergent. The classification question decides which paragraph you are reading.
⚠️ The exemption is from the state permit and nothing else. Subparagraph 4 says it does not relieve anyone of any county or municipal ordinance, or of any tax law.[14] A state exemption is not a local one, and it is not a tax position.
Two states, two mechanisms, one lesson. California asks who has to report; Florida asks who needs a permit. Both hang on whether the thing is a cosmetic — and neither is the whole of state law. Read the statute for the state you sell in.
10 · A decision tree
Four questions, in order. Each one is answered by a document, not by a preference.
1. Did you clean with alkali-saponified fat or oil, without a synthetic
detergent doing the cleaning?
This one is answered by the formula and the ingredient list, not by the word "soap".
No → it is not true soap; continue to the cosmetic or drug
classification below, and see section 7.
"I don't know" → treat it as a cosmetic until a composition document says
otherwise.
2. Is it labelled, sold and represented only as soap?
No → it is not true soap; continue to the cosmetic or drug
classification below, and see section 7.
3. Does anything you say about it claim to treat or prevent disease?
Yes → it is a drug, possibly as well as a cosmetic. Section 5.
4. Is it primarily intended for children 12 or under?
Yes → section 8 applies as well, whichever of the above it is.
If you answered "yes, only soap" to 1 and 2 and "no" to 3, it is true soap: section 6. And section 4 is the caveat on that answer — CPSC has published an inference that ingredients alone may classify a product as a cosmetic without any claim, and FDA's pages do not address it.
⚠️ Two answers the tree cannot give you. Whether your own marketing copy crosses the line in question 2 — that depends on sentences only you can read — and what FDA would say about your particular product. For the second, CPSC's own advice is to ask FDA.[4]
This guide is about classification, not about making soap. The making guide — lye safety, saponification, the three methods, cure and how fragrance behaves in an alkaline batter — is a separate page, and nothing here is a substitute for it.
⚠️ And 21 CFR 701.20 does not travel. The soap carve-out is a feature of US law. The EU Cosmetics Regulation defines a cosmetic product as "any substance or mixture intended to be placed in contact with the external parts of the human body … with a view exclusively or mainly to cleaning them", and its definition carries no soap exception.[15] A bar that is soap here is often a cosmetic product there.
What this guide won't decide: which side of the line your bar is on, whether your copy is a claim, whether MoCRA reaches a true soap with cosmetic-ish ingredients, or what your state requires. It tells you which document answers each of those, and which of them currently has no single answer.
Sources
- US Code, 21 U.S.C. § 321(i) (FD&C Act § 201(i)), definitions: a cosmetic is "(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap." Statute. Read at the House US Code site, 17 September 2026. ↩
- 21 CFR § 701.20, Detergent substances, other than soap, intended for use in cleansing the body: "In its definition of the term cosmetic, the Federal Food, Drug, and Cosmetic Act specifically excludes soap. The term soap is nowhere defined in the act. In administering the act, the Food and Drug Administration interprets the term 'soap' to apply only to articles that meet the following conditions: (1) The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the detergent properties of the article are due to the alkali-fatty acid compounds; and (2) The product is labeled, sold, and represented only as soap." Paragraph (b): products for cleansing the body that are not soap "are 'cosmetics,'… subject to the requirements of the act", with the avoirdupois weight example. Regulation — and note it describes itself as an interpretation. ⚠️ eCFR returned only site furniture to an automated request; read at Cornell LII, 17 September 2026. ↩
- FDA, Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?), page updated 11 September 2024. Cites the cosmetic definition at "[FD&C Act, sec. 201(i)]"; "Section 201(i)(1) of the act includes 'articles…for cleansing' in the definition of a cosmetic-Section 201(i)(2) excludes soap from the definition of a cosmetic"; aromatherapy claims "meets the definition of a drug because of its intended use"; "cosmetic products and ingredients, with the exception of color additives, do not require FDA approval before they go on the market". ⚠️ Agency interpretation. ⚠️ And this page misprints one citation: it gives MoCRA's "cosmetic product" definition as "[FD&C Act, sec. 361]", where the Code puts it at 21 U.S.C. § 364(2) (source 6). Read through a rendering reader, 17 September 2026. ↩
- US Consumer Product Safety Commission, Soap Business Guidance: the three restated conditions ("ALL of the following"); "Making claims such as moisturizing skin, making the user smell nice, or deodorizing the body could classify the product as a cosmetic; making claims such as intending to treat skin conditions (like acne or eczema) or killing germs could classify the product as a drug"; the MoCRA inference quoted in section 4, pinned to 21 U.S.C. § 364(2); "Firms may wish to contact the FDA for guidance whether their products fall under FDA's jurisdiction"; "CPSC regulates true soaps… In general, soaps would be subject to the Federal Hazardous Substances Act (FHSA) and the Consumer Product Safety Act (CPSA)"; precautionary labelling "uncommon and usually reserved for strong degreasing soaps"; and the children's-product paragraph (tracking label, third-party total lead test, Children's Product Certificate). ⚠️ Agency interpretation, and the source of the tension in section 4. Read through a rendering reader, 17 September 2026. ↩
- FDA, Frequently Asked Questions on Soap: "FDA's regulatory definition of soap includes the following three conditions; all three conditions must be met"; "If the product contains synthetic detergents, it's a cosmetic, not a soap. You can still use the word 'soap' on the label."; "If it is intended for purposes such as moisturizing the skin, making the user smell nice, or deodorizing the user's body, it's a cosmetic."; "The product may be both a cosmetic and a drug."; "Today there are very few true soaps on the market. Most body cleansers, both liquid and solid, are synthetic detergent products." ⚠️ Agency interpretation, and the "very few true soaps" sentence is about body cleansers on the market, not about handmade soap. Read through a rendering reader, 17 September 2026. ↩
- 21 U.S.C. § 364, definitions for the cosmetics subchapter: "(2) Cosmetic product The term 'cosmetic product' means a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product". The credit line dates it "June 25, 1938, ch. 675, § 604, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022" — so 21 U.S.C. § 364 is FD&C Act § 604, added by MoCRA. Statute. By contrast 21 U.S.C. § 361 is "Adulterated cosmetics". Read at Cornell LII, 17 September 2026. ↩
- US Consumer Product Safety Commission, Soap (FAQ): "Generally speaking, true soaps that fall under CPSC's jurisdiction do not need to follow FDA's requirements because they would not be considered cosmetics or drugs; however, the applicable requirements for each product must be assessed individually." ⚠️ Agency interpretation, and the qualification is the agency's own. Read through a rendering reader, 17 September 2026. ↩
- 21 U.S.C. § 364h, Small businesses: responsible persons and facility owners and operators "whose average gross annual sales in the United States of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation, and who do not engage in the manufacturing or processing of the cosmetic products described in subsection (b), shall be considered small businesses and not subject to the requirements of section 364b or 364c of this title" — GMP, and registration and listing. Statute, which is where the $1,000,000 figure belongs: it is quoted here from the Code rather than from any secondary summary. Read at Cornell LII, 17 September 2026. ↩
- FDA, Modernization of Cosmetics Regulation Act of 2022 (MoCRA): "Manufacturers and processors must register their facilities with FDA and renew their registration every two years"; "A responsible person is required to ensure and maintain records supporting adequate safety substantiation of their cosmetic products"; the responsible person is "the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label"; "MoCRA exempts certain small businesses from GMP, registration, and product listing requirements. However, such exemptions do not apply to manufacturers or facilities that manufacture or process the following cosmetic products", followed by the carve-out list (eye mucous membrane contact, injected, internal use, altering appearance beyond 24 hours where removal is not customary). ⚠️ Agency interpretation of the statute; the threshold itself is in source 7. Read through a rendering reader, 17 September 2026. ↩
- FDA, Registration & Listing of Cosmetic Product Facilities and Products: "Cosmetic product facility registration and cosmetic product listing is neither a cosmetic approval program nor a promotional tool. The assignment of a facility registration number or product listing number does not indicate FDA approval of the facility or its cosmetic products." Read through a rendering reader, 17 September 2026. ↩
- 21 U.S.C. § 364e, Labeling, subsection (b), fragrance allergens: "The responsible person shall identify on the label of a cosmetic product each fragrance allergen included in such cosmetic product. Substances that are fragrance allergens for purposes of this subsection shall be determined by the Secretary by regulation." Statute. ⚠️ The duty depends on that rulemaking; this page does not state its status, which was not checked. Read at Cornell LII, 17 September 2026. ↩
- California Health and Safety Code § 111792 (Safe Cosmetics Act, Article 3.5, Chronic Health Effects of Cosmetics, §§ 111791–111793.5): "The manufacturer of any cosmetic product subject to regulation by the federal Food and Drug Administration that is sold in this state shall… provide the division with a complete and accurate list of its cosmetic products that… are sold in the state and that contain any ingredient that is a chemical identified as causing cancer or reproductive toxicity", including "(1) A chemical contained in the product for purposes of fragrance or flavoring." State statute. The defined terms are at § 111791.5. Read at the California Legislative Information site, 17 September 2026. ↩
- California Health and Safety Code § 111792.6: "Commencing January 1, 2022, a manufacturer of a cosmetic product sold in the state shall disclose" to the state "(A) A list of each fragrance ingredient or flavor ingredient that is included on a designated list … and present in the cosmetic product" and "(B) A list of each fragrance allergen included in Annex III of the EU C[osmetics Regulation]" above the stated concentrations. State statute, separate from source 12 and with its own definition of "cosmetic product". ⚠️ Read for the duty; not read for exceptions, so this page claims none. Read at the California Legislative Information site, 17 September 2026. ↩
- Florida Statutes, § 499.01(2)(p): a permit is required to manufacture cosmetics, with an exemption for a manufacturer whose annual gross sales are $25,000 or less, who "must provide written documentation of annual gross sales" on request, that figure including all cosmetic sales at any location. The conditions at 1.a–d are FDA-compliant labelling of prepackaged goods; manufacture limited to "cosmetics that are soaps, not otherwise exempt from the definition of cosmetics", lotions, moisturizers and creams; no adulteration or misbranding under 21 U.S.C. §§ 361 and 362; and storage on the premises. Each unit must carry, in contrasting colour and not less than 10-point type: "Made by a manufacturer exempt from Florida's cosmetic manufacturing permit requirements." Subparagraph 4 provides that the exemption does not relieve a person of any county or municipal ordinance or any tax law. ⚠️ Read from leg.state.fl.us by the site's author, 18 September 2026, which closes the open item recorded here on 17 September, when that site returned navigation only. ⚠️ Worth noticing: this statute cites 21 U.S.C. § 361 for adulteration, which is the same provision FDA's own explainer misprints as the home of the MoCRA "cosmetic product" definition — see section 4 and source 7. Florida's citation is the correct use of it. ↩
- Regulation (EC) No 1223/2009 on cosmetic products, Article 2(1)(a): a "cosmetic product" means "any substance or mixture intended to be placed in contact with the external parts of the human body … with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours". EU statute, cited only for the absence of a soap exclusion in that definition. ⚠️ Read in the EU text as it stands on legislation.gov.uk, 17 September 2026; no claim is made here about GB divergence since exit. ↩