FDA cosmetics regulations are the federal rules under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Fair Packaging and Labeling Act, and Title 21 of the Code of Federal Regulations (21 CFR Parts 700 to 740) that govern how cosmetic products are manufactured, labeled, and sold in the United States.
That sounds similar to Europe.
The resemblance ends with the list of statutes.
The US regulatory philosophy for cosmetics has historically been the opposite of the EU approach. No pre-market approval and no mandatory notification portal. Nothing requires a safety dossier to exist before sale.
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) shifted this architecture for the first time since 1938, but the underlying FD&C Act framework remains the baseline.
After 30 years in the hair and beauty sector, most recently in private label cosmetics, US market entry is where I watch European founders make the most assumptions, most of them wrong.
For the broader global compliance picture, see the pillar guide.
Important disclaimer: I am not a lawyer or US regulatory affairs professional. This is practical industry perspective, not legal advice. For specific questions, work with a qualified US regulatory consultant.
This guide covers the FD&C Act framework, cosmetic-versus-drug, 21 CFR labeling, MoCRA, state complexity, and international brand implications.
Before MoCRA, the US cosmetic regulatory environment ran on two simple principles.
The FD&C Act prohibits the distribution of cosmetics that are adulterated or misbranded.
These two concepts, defined at FD&C Act sections 601 and 602, drive essentially all federal enforcement.
Adulteration covers products that contain poisonous or deleterious substances, have been prepared under unsanitary conditions, contain unsafe color additives, or otherwise fail the safety standard.
Under MoCRA’s addition to Section 601(f), cosmetics that fail to follow future GMP requirements will also be considered adulterated.
Misbranding covers products whose labeling is false or misleading, whose required label statements are missing or inadequately prominent, or whose packaging does not conform to the labeling regulations.
Section 602(c) of the FD&C Act specifically requires that label information be placed with prominence and conspicuousness likely to be read and understood by ordinary consumers.
Most US cosmetic enforcement is triggered by the label rather than by a dangerous product, and the legal charge is misbranding. This is the single biggest divergence from European practice that international brands miss.
The pre-MoCRA framework had striking absences compared to the EU system.
No pre-market approval. The FDA does not approve cosmetic products before they are sold. Only color additives used in cosmetics require pre-market approval (under 21 CFR Parts 73, 74, 81, 82).
No mandatory registration. Before MoCRA, the Voluntary Cosmetic Registration Program (VCRP) existed, but participation was voluntary and most brands did not use it.
This changed under MoCRA.
No mandatory facility registration for cosmetic manufacturing. Before MoCRA, cosmetic facilities did not have to register with FDA.
No safety dossier requirement. There was no US equivalent of the PIF or CPSR. Safety substantiation was recommended but not legally required to be pre-compiled.
No responsible person requirement. There was no US equivalent of the EU Responsible Person legal entity.
Very limited banned ingredients list. Historically, the FDA has explicitly prohibited or restricted fewer than a dozen specific ingredients in cosmetics.
This compares to more than 1,700 Annex II entries prohibited under EU Regulation 1223/2009, counted at the May 1, 2026 consolidation. Annex II is counted in entries, not in substances: a single entry can cover a whole family.
Against the limited list of prohibitions, the FDA maintained and still maintains several baseline requirements.
Color additives. Any color additive used in a cosmetic must be approved by the FDA and listed in 21 CFR Parts 73, 74, 81, or 82. Straight colors in 21 CFR Part 74 must be batch-certified by FDA before use.
Labeling compliance under 21 CFR 701 and 740. Every cosmetic product sold in the US must meet the labeling requirements detailed in the next section.
Prohibition of specific ingredients. A small list of explicitly prohibited substances: bithionol, mercury compounds (with narrow exceptions for eye area products), vinyl chloride in aerosols, halogenated salicylanilides, zirconium-containing complexes in aerosols, chloroform, methylene chloride, chlorofluorocarbon propellants, and prohibited cattle-material ingredients related to BSE risk.
Hexachlorophene belongs in a separate line, because it is restricted rather than banned: it may be used as a preservative only, capped at 0.1 percent, only where no alternative has been shown to be effective, and never on mucous membranes (21 CFR 250.250). It is one of the rare points where the US is more permissive than the EU, which bans it outright under Annex II. A US-legal formula at 0.09 percent is a blocking violation in Europe.
This list has remained largely unchanged for decades.
Specific warning statements required under 21 CFR 740 for certain categories: products whose safety has not been substantiated, aerosols and propellant inhalation, feminine deodorant sprays, foaming detergent bath products, coal-tar hair dyes, and suntanning products without sunscreen. Tampons carry a toxic shock syndrome warning too, but that duty sits in FDA’s medical device rules, not in the cosmetics part.
This is the single most important legal concept a founder needs to understand before entering the US market.
Under the FD&C Act, a product is a cosmetic if it is intended to cleanse, beautify, promote attractiveness, or alter the appearance, without affecting the body’s structure or function.
A product is a drug if it is intended to diagnose, cure, mitigate, treat, or prevent disease, or to affect the structure or function of the body.
Products can be both. Sunscreens, anti-dandruff shampoos, fluoride toothpastes, and anti-acne products are regulated as both cosmetics and over-the-counter (OTC) drugs. A "dual-purpose" product must comply with both regimes simultaneously.
The dangerous zone for international brands is when a claim pushes a cosmetic into drug territory without the founder realizing it. Claims like "reduces wrinkles by affecting collagen production," "treats rosacea," "prevents dandruff," or "relieves eczema symptoms" turn a cosmetic product into a drug and, outside an applicable OTC monograph, an unapproved one. An unapproved drug in the US market is subject to FDA seizure, warning letters, and import refusals.
Claims that stay cosmetic: "improves the appearance of fine lines," "softens dry skin," "smooths the hair," "cleanses." Claims that cross into drug: "repairs damage at the cellular level," "treats," "heals," "prevents," "cures," or anything implying a physiological effect on the body.
European brands launching in the US are particularly vulnerable here because EU cosmetic claims practice (under Commission Regulation (EU) 655/2013) and US practice treat the same claim differently.
Review your label through US eyes before shipping.
The labeling regime is where most US enforcement activity happens, and where international brands most frequently slip into misbranding.
Under 21 CFR Part 701, every cosmetic product label must carry specific information, correctly placed, in legible type.
Identity statement on the Principal Display Panel (PDP). The part of the label most likely to be seen under customary display conditions must carry the product’s common or usual name, descriptive name, or fanciful name if the product nature is obvious. The identity statement must be in bold type and in lines generally parallel to the base of the package (21 CFR 701.11).
Net quantity of contents on the PDP. The weight, measure, or count, placed in the lower 30 percent of the PDP, in lines generally parallel to the base. US customary units (ounces, fluid ounces) are the mandatory declaration on the PDP under 21 CFR 701.13(b), with a metric statement permitted alongside them under 701.13(r), and the FPLA statute itself (15 USC 1453(a)(2)) asks for both together. The only safe format is the dual one: "Net wt. 1.7 oz. (50 g)". A metric-only label in the European style fails outright.
Name and place of business on the information panel. The manufacturer, packer, or distributor must be identified by name along with city, state, and ZIP code (21 CFR 701.12). The street address can be omitted if the business is listed in a current telephone or city directory.
Ingredient declaration on the information panel. Ingredients listed in descending order of predominance, with ingredients at 1 percent or less listed in any order after those above 1 percent, using English common or usual names (FPLA requirement enforced under 21 CFR 701.3(c)). European INCI conventions are not substitutes for them: "Aqua", "Parfum", a CI number on its own or a Latin-only botanical name may appear in parentheses after the English name, as in "Water (Aqua)" or "Fragrance (Parfum)", but not instead of it. A European ingredient list carried over unconverted is the most common defect on labels exported from the EU.
Warnings and cautions. Where required under 21 CFR 740, the specific word-for-word warnings for flammable aerosols, foaming bath products, feminine deodorants, suntanning products without sunscreen, and other regulated categories.
English language requirement. All required labeling information must be in English. A product distributed solely in Puerto Rico can use Spanish as an alternative. If the label carries any information in a foreign language, all required FD&C Act information must also appear in that language (21 CFR 701.2(b)).
The FDA is explicit that label information must be legible under normal conditions of purchase and use.
Specific minimum type heights apply for required statements, typically 1/16 of an inch, though the exact requirement varies by statement type and package size.
Section 602(c) of the FD&C Act separately requires that required information be placed with prominence and conspicuousness likely to be read and understood by ordinary individuals.
A label that technically contains all required information but in type so small or in a location so obscure that consumers cannot reasonably read it is still misbranded.
This is enforced. Import refusals at US ports frequently cite illegible or inconspicuous label placement, even when the content is correct.
Unlike pharmaceuticals, cosmetics in the US have no federal requirement to display an expiration date or shelf life.
The FDA considers shelf-life determination to be the manufacturer’s responsibility, not a regulatory mandate. Products that qualify as both cosmetics and drugs (sunscreens, anti-dandruff shampoos, fluoride toothpastes) fall under drug GMP and normally carry an expiration date set by stability testing. But 21 CFR 211.137(h) says that requirement is not enforced for OTC drug products whose labeling bears no dosage limitations and which are stable for at least 3 years on appropriate stability data, which is why many US sunscreens ship without a printed expiry.
This is a practical divergence from the EU, where a minimum durability of 30 months or less means a date of minimum durability on the label, and more than 30 months means a period after opening (PAO) instead, except where durability after opening is not a relevant concept. US products sold in the EU must add this element to the label. European products shipped to the US do not need to add a US-specific equivalent.
Products manufactured outside the US must typically be labeled with the country of origin, under US Customs and Border Protection rules. Products claiming "Made in USA" are subject to FTC standards and must be "all or virtually all" made in the United States to avoid deceptive claims liability.
For European brands, this means the country of origin must appear on the label before the product clears US customs. This is a practical compliance layer that exists in parallel with FDA labeling.
MoCRA is the most significant change to US cosmetic regulation in eighty years. It amended the FD&C Act rather than replacing it, so the pre-MoCRA framework remains in force underneath the new requirements.
Mandatory facility registration. Every facility manufacturing or processing cosmetic products for the US market must register with FDA using Form FDA 5066, with renewal every two years counted from that facility’s own first registration rather than from one calendar date shared by everyone, unless it qualifies for the small-business exemption in Section 612 of the FD&C Act (average gross annual US cosmetic sales under 1,000,000 USD, adjusted for inflation, over the previous three years). That exemption does not cover products that regularly contact the mucous membrane of the eye, injected products, products for internal use, or products that alter appearance for more than 24 hours and that the consumer does not normally remove. Section 613 (21 U.S.C. 364i) adds a second exemption for a facility that is also subject to the drug requirements of subchapter V, but only for those products: a facility that also makes ordinary cosmetics stays in. Facilities registered by the July 1, 2024 deadline are in their first renewal cycle in 2026.
Mandatory product listing. Each cosmetic product sold in the US must be listed with FDA using Form FDA 5067, providing formulation information, product category coding, and the identity of the responsible person (the brand name on the label). The same Section 612 exemption covers the listing obligation, and Section 613 takes out cosmetic products that are also subject to subchapter V, that is over-the-counter drugs.
Adverse event reporting. Serious adverse events must be reported to FDA within fifteen business days of the responsible person receiving the report. Each cosmetic product sold in the US must also bear on the label one route through which the responsible person can receive adverse event reports, a domestic address, a domestic phone number or electronic contact information such as a website; a cosmetic product that is also subject to subchapter V, that is an over-the-counter drug, is exempt under Section 613 (21 U.S.C. 364i).
Safety substantiation records. The responsible person must maintain records supporting the safety of each product. These records are not submitted pre-market but must be producible on FDA request.
FDA enforcement powers. Mandatory recall authority for cosmetics, expanded records access powers, and suspension authority over facility registrations.
For a detailed guide to the MoCRA-specific requirements and current rulemaking status, see MoCRA cosmetics regulation.
MoCRA expanded FDA authority but did not create an EU-style pre-market assessment system.
There is still no pre-market approval for cosmetics, and no requirement that a PIF-style safety dossier be pre-compiled. Nothing in the US plays the role of the CPSR. Nor is there a CPNP-style central notification portal that ties into poison centre data (the FDA adverse event reporting system is separate).
MoCRA moves the US toward a mandatory facility-and-product registration model with FDA enforcement teeth, but the overall architecture remains post-market-oriented.
Three implementation points matter for any brand planning a 2026 US launch.
The GMP rule is delayed indefinitely. MoCRA required FDA to issue a proposed GMP rule by December 29, 2024 and a final rule by December 29, 2025. Both statutory deadlines passed. The FDA’s Spring 2025 Unified Agenda moved the GMP rulemaking to the "Long-Term Actions" list, signaling no Notice of Proposed Rulemaking within twelve months. In the interim, ISO 22716 serves as the de facto GMP reference standard.
The fragrance allergen labeling rule is still unproposed. The FDA’s proposed rule on fragrance allergen disclosure was originally due June 29, 2024. The Unified Agenda then targeted May 2026, and that passed with no proposed rule published, and the FDA now indicates an NPRM in November 2026, which means a final rule is unlikely before 2027.
The talc asbestos testing rule was withdrawn on November 28, 2025. The FDA proposed standardized detection methods for asbestos in talc-containing cosmetics in December 2024, then withdrew the proposal (Federal Register 2025-21407), saying it intends to reconsider the approach and republish. There is no pending proposal to track.
The absence of the GMP rule has opened a window. Brands whose manufacturers already operate to ISO 22716 are effectively ahead of whatever final rule arrives, and brands whose manufacturers do not are accumulating risk. Anyone reading the delay as a grace period will meet a steep adaptation curve when the rule lands.
The setup that works in 2026 is to treat ISO 22716 as the operating standard, maintain the MoCRA registrations, build safety substantiation records product by product, and monitor the FDA Unified Agenda each quarter.
Federal MoCRA is only half the US compliance picture. The other half is the fragmented state-level regulatory environment, led by California.
Proposition 65, officially the Safe Drinking Water and Toxic Enforcement Act of 1986, is California’s most far-reaching regulatory requirement for products sold in the state.
The law requires specific warnings on products that expose consumers to any of the substances California has listed as known to cause cancer or reproductive toxicity. The list is maintained by the Office of Environmental Health Hazard Assessment (OEHHA), part of the California Environmental Protection Agency, which puts it at around 900 substances and updates it at least once a year.
The reach into cosmetics is wide. Substances commonly present in fragrances, preservatives, and some natural extracts appear on the Prop 65 list. Titanium dioxide, for example, is listed when it meets certain particulate specifications, although the warning duty for it in cosmetics is currently suspended: in Personal Care Products Council v. Bonta the Eastern District of California held in August 2025 that the compelled cancer warning violates the First Amendment. The substance stays on the list and the state has appealed to the Ninth Circuit, so this is a pause under review rather than a settled position. Products sold in California without the required warning, when a listed substance is present above threshold, expose the brand to plaintiff-filed enforcement actions, which have been extensive.
Prop 65 is enforced primarily through private plaintiff litigation, and most of what a case costs never reaches the state. In the out-of-court settlements reported to the California Attorney General for 2024, the total was 27.08 million USD, of which 23.55 million was plaintiffs' attorney fees and 3.54 million civil penalties, at an average of about 24,600 USD per settlement. Cases in the millions exist, but they are outliers. For a small brand, most of the cost is the legal defense plus pulling or relabeling stock already sitting in the California channel; the penalty itself is the small part.
California Assembly Bill 496, signed into law in 2023, expands the state’s cosmetic ingredient prohibitions beyond earlier legislation.
Effective January 1, 2025 (earlier legislation, not AB 496): the Toxic-Free Cosmetics Act (AB 2762, signed in 2020) prohibits 24 intentionally added ingredients in cosmetics sold in California, including a closed list of thirteen named PFAS, two phthalates, formaldehyde and paraformaldehyde, mercury, and two parabens. A separate 2022 law, AB 2771, bans intentionally added PFAS as a class from the same date.
Effective January 1, 2027: the second list, in Health and Safety Code section 108980(b). AB 496 created it in 2023, and AB 60 of 2025, the Musk Reduction Act, took it to thirty numbered entries by adding musk ambrette, musk tibetene, musk moskene and musk xylene and capping musk ketone. Other entries include anthraquinone, malachite green, pyrogallol, trichloroacetic acid, vinyl acetate, sixteen boron-containing substances (boric acid, borates, perboric acids) and several dyes (Basic Green 1, Basic Blue 7, Basic Violet 4, Basic Blue 3, Basic Blue 9, C.I. Disperse Blue 1, C.I. Disperse Blue 3). Boric acid in vaginal suppository products is carved out: section 108980(f) requires a label warning from 2027 and bans those products from January 1, 2035.
For a brand with any California distribution, the 2027 list means formulation review now, not in December 2026. Reformulation timelines for most products run six to twelve months once affected ingredients are identified.
State-level rules extend well beyond California.
State PFAS bans. Colorado, Minnesota, Washington and Maine ban intentionally added PFAS as an entire class in cosmetics, as does California. Maryland differs in kind and not only in date: HB 643 bans a closed list of 24 ingredients, thirteen of them named PFAS and their salts, so a PFAS outside that list stays legal there. Minnesota’s 2025 ban covers eleven major product categories with particularly broad scope.
State animal testing bans. California, New York, Virginia, Illinois, Nevada, Louisiana, Hawaii, Maryland, New Jersey, Oregon, Maine, and others now prohibit the sale of cosmetics tested on animals. The cumulative effect is that a nationally distributed brand must in practice operate to a no-animal-testing standard, because complying with the most restrictive state creates the operational floor.
State color additive and food color bills. Separately from cosmetic-specific legislation, several states have enacted restrictions on synthetic food colors (FD&C Red 3, Red 40, Yellow 5, Yellow 6, Blue 1, Blue 2, Green 3) that do not directly affect cosmetics but signal a broader legislative movement that may extend into cosmetic color additives in coming years.
Texas warning-label litigation. In early 2026, a federal court preliminarily enjoined portions of a Texas consumer warning-label law on First Amendment grounds. The injunction limits how far states can go in requiring specific warnings, but does not eliminate state-level ingredient bans, which operate on different legal grounds.
US state-level regulation in 2026 is not a patchwork you can ignore by picking the states you ship to. Major retailers and marketplaces operate nationally, and they enforce the strictest applicable standard across their entire network. A product acceptable under federal rules but non-compliant in California is, in practical effect, non-compliant for national distribution.
So the US regulatory environment for cosmetics in 2026 is more restrictive than the federal framework alone suggests, and the trajectory is toward further tightening at both the federal and state level.
The FD&C Act framework, MoCRA additions, and state-level layer combine into a specific set of practical considerations for brands launching in the US.
A first-time EU launch runs through formulation, PIF, CPSR, CPNP. In the US the order is different.
Manufacturer FDA facility registration confirmed. Before placing a US order, verify your manufacturer’s FDA facility registration is active and the FEI number is valid. For US-based manufacturers this is routine. For EU, Turkish, or Asian manufacturers supplying the US market, this is a specific check, not an assumption.
Product listing filed. The brand (as responsible person under MoCRA) or the manufacturer files the product listing on FDA Cosmetics Direct. Nobody approves the product at this step: the filing is a notification, and it generates a record that customs and FDA can reference.
Label designed for US compliance. A label designed for the EU does not automatically work in the US. The identity statement must be on the PDP in US-compliant format. The ingredient declaration must meet FPLA requirements. The label must give one route for MoCRA adverse event reports, a domestic address, a domestic phone number or electronic contact details, except for products that are also OTC drugs (Section 613). California Prop 65 warnings must be assessed and applied if a listed substance is present above threshold.
Claims reviewed against US drug-versus-cosmetic boundaries. Every claim on the label, in advertising, and on the website must be reviewed against the US cosmetic-versus-drug distinction. European claims that are acceptable under Regulation 655/2013 can easily cross the US drug line.
Safety substantiation records prepared. No PIF is required, but a US-style safety substantiation file should exist. The EU CPSR and supporting documentation are usually sufficient as the core of a US safety substantiation record.
For a line of three to five products launching in the US under MoCRA, the federal compliance cost is relatively modest: facility registration and product listing are free, and safety substantiation typically builds on the existing EU file.
The real cost centers are: US-specific label redesign (500 to 1,500 EUR/USD per product), US regulatory legal review (1,000 to 3,000 EUR/USD per product for the first launch, less for subsequent products), California Prop 65 assessment (500 to 1,500 EUR/USD per product when a listed substance is potentially present), and state-by-state ingredient compliance review for brands with nationwide ambitions (1,000 to 3,000 EUR/USD as a one-time portfolio review). (All cost figures in this article are indicative estimates that vary by manufacturer, region, and project scope.)
Total first-launch US compliance cost for a three-to-five product line: typically 5,000 to 15,000 euros, compared to the 3,000 to 5,000 euros range for a parallel EU launch. The US is not cheap, but it is different in structure rather than uniformly more expensive.
The mistakes I see most consistently in EU brands launching in the US.
Label not reworked for US requirements. EU labels often do not comply with US FPLA identity-statement rules, US ingredient-declaration conventions, or the FPLA requirement to give the name and place of business of the manufacturer, packer or distributor, which need not be a US address. Import refusals follow.
Drug claims imported from EU language. Claims common on the EU market and defensible under the Regulation 655/2013 criteria when properly substantiated (like "supports the skin barrier function" or "helps regenerate the skin’s appearance") can read as drug claims in the US. Even in the EU, a regeneration claim remains a strong claim: it needs proportionate evidence and must refer to the skin’s appearance and condition, not to tissue regeneration. Warning letters and import holds follow.
Prop 65 ignored until after California sales begin. Private plaintiff litigation can begin within weeks of a non-compliant product entering the California market. The cost of retroactive Prop 65 compliance, including legal defense, is materially higher than pre-launch compliance.
Assumption that no pre-market notification means no compliance work. Brands assume the absence of a CPNP equivalent means the US is less demanding. The misbranding and adulteration doctrines generate substantial enforcement activity on exactly the kinds of details EU founders underestimate.
MoCRA facility registration not verified at the manufacturer. The brand files a product listing, but the manufacturer’s facility registration is lapsed or never completed. The listing references a non-compliant facility, generating enforcement exposure.
For a deeper dive on MoCRA implementation and on label requirements comparison across EU, US, and Great Britain, see the dedicated guides.
Do I need to register with the FDA to sell cosmetics in the US?
Yes, under MoCRA, unless one of two narrow exemptions applies. As of 2024-2025, every cosmetic product sold in the US must be listed with FDA through Cosmetics Direct using Form FDA 5067, and every manufacturing or processing facility supplying the US market must register with FDA using Form FDA 5066 (with biennial renewal). Section 612 of the FD&C Act exempts responsible persons and facilities whose average gross annual US cosmetic sales are under 1,000,000 USD, adjusted for inflation, over the previous three years from both duties, unless they handle products that regularly contact the mucous membrane of the eye, injected products, products for internal use, or products that alter appearance for more than 24 hours and that the consumer does not normally remove. Section 613 separately exempts cosmetic products that are also OTC drugs, and the facilities that handle only those products. Both the facility registration and the product listing are free. The brand acts as the "responsible person" for product listing purposes (the name on the label). Before MoCRA, only the Voluntary Cosmetic Registration Program existed and most brands did not participate; since MoCRA, participation is mandatory. Enforcement is FDA-led: failing to register the facility or to file the product listing is a prohibited act under section 301(hhh) of the FD&C Act, enforceable through the ordinary chain against prohibited acts, warning letters, injunction under section 302 and criminal liability under section 303; it does not by itself make the product adulterated or misbranded, and it is not among the grounds for refusing admission under section 801(a).
What is the difference between a cosmetic and a drug under FDA rules?
Under the Federal Food, Drug, and Cosmetic Act, a product is a cosmetic if intended to cleanse, beautify, promote attractiveness, or alter the appearance, without affecting the body’s structure or function. A product is a drug if intended to diagnose, cure, mitigate, treat, or prevent disease, or to affect the structure or function of the body. Products can be both: sunscreens, anti-dandruff shampoos, fluoride toothpastes, and anti-acne treatments are regulated as both cosmetics and over-the-counter drugs and must comply with both regimes. A cosmetic label or advertisement that claims a physiological effect (like treating acne, preventing dandruff, or reducing wrinkles by affecting collagen production) turns the product into a drug and, outside an applicable OTC monograph, an unapproved one, subject to FDA enforcement including warning letters and import refusals.
What are the main FDA labeling requirements for cosmetics?
Under 21 CFR Parts 701 and 740 and the Fair Packaging and Labeling Act, every cosmetic sold in the US must carry: the identity statement on the Principal Display Panel, the net quantity of contents in the lower 30 percent of the PDP, the name and place of business (manufacturer, packer, or distributor) on the information panel, the ingredient declaration in descending order of predominance (with ingredients at 1 percent or less listed in any order), and any category-specific warnings required under 21 CFR 740. All required information must be in English (with narrow exceptions), in legible type size, placed with sufficient prominence and conspicuousness to be read and understood by ordinary consumers. Under MoCRA, the label must also give one route for adverse event reports, a domestic address, a domestic phone number or electronic contact details, except for products that are also OTC drugs (Section 613). Unlike the EU, cosmetics do not require an expiration date or PAO symbol, and even a product that is also an OTC drug can ship without a printed expiry where its labeling bears no dosage limitations and stability data show it is stable for at least 3 years, under the 21 CFR 211.137(h) exemption.
How is the US different from the EU in cosmetic regulation?
Structurally very different. The EU operates a pre-market assessment system: no product can be sold without a complete Product Information File, a signed Cosmetic Product Safety Report, an EU-based Responsible Person, and a CPNP notification. The US operates a post-market surveillance system: no pre-market approval, no notification portal, no equivalent of the CPSR, no responsible person in the EU sense. MoCRA added mandatory facility and product registration plus adverse event reporting, but did not move the US to EU-style pre-market assessment. The EU prohibits more than 1,700 Annex II entries at the May 1, 2026 consolidation, and a single entry can cover a whole substance family; the FDA explicitly prohibits fewer than a dozen substances. The US relies on the FD&C Act’s adulteration and misbranding doctrines plus state-level regulation (especially California) to create enforcement pressure, whereas the EU relies on pre-market documentation, so a product compliant in one market does not automatically meet the other’s requirements.
What is California Proposition 65 and does it apply to my cosmetic product?
California Proposition 65 (the Safe Drinking Water and Toxic Enforcement Act of 1986) requires specific warnings on products sold in California that expose consumers to any of the substances California has listed as known to cause cancer or reproductive toxicity, around 900 of them on OEHHA’s own count, with the list updated at least once a year. The list includes substances commonly present in fragrances, preservatives, certain natural extracts, and specific forms of titanium dioxide and other ingredients. If your cosmetic contains a listed substance above the applicable threshold and you do not carry the required warning, you face private plaintiff litigation exposure. Prop 65 is enforced primarily through private lawsuits, and most of the money in a settlement is the plaintiff’s attorney fees rather than a penalty: the out-of-court settlements reported to the California Attorney General for 2024 totaled 27.08 million USD, 23.55 million of it attorney fees, at an average of about 24,600 USD per settlement. The bigger hit for a small brand is the legal defense plus pulling or relabeling stock already in California. For any brand selling into California (including online sales to California consumers), Prop 65 assessment before launch is non-optional.
What is California Assembly Bill 496 and how does it affect my formulations?
California AB 496, signed in 2023, adds to prohibitions the state already had. The January 1, 2025 layer is not AB 496: it is the Toxic-Free Cosmetics Act (AB 2762, 2020), which bans 24 intentionally added ingredients including thirteen named PFAS, two phthalates, formaldehyde and paraformaldehyde, mercury, and two parabens, together with AB 2771 (2022), which bans intentionally added PFAS as a class from the same date. The AB 496 list takes effect January 1, 2027, and AB 60 of 2025, the Musk Reduction Act, extended it with musk ambrette, musk tibetene, musk moskene and musk xylene plus concentration limits for musk ketone, so Health and Safety Code section 108980(b) now runs to thirty numbered entries: anthraquinone, malachite green, pyrogallol, trichloroacetic acid, sixteen boron-containing substances, the four musks, and several dye substances (Basic Green 1, Basic Blue 7, Basic Violet 4, Basic Blue 3, Basic Blue 9, and others). Products containing any of these substances cannot be manufactured, distributed, or sold in California after the effective dates, with boric acid in vaginal suppository products carved out to January 1, 2035 under section 108980(f). For a brand with California distribution or nationwide retail through partners who operate California distribution centers, reformulation review should be completed in 2026 to allow time for any needed formulation change before January 2027.
Is the US cheaper or more expensive for regulatory compliance than the EU?
Neither, exactly; the cost structure is different. Federal US compliance under MoCRA is relatively modest in direct filing fees (facility registration and product listing are free). EU compliance has higher direct documentation costs (PIF 500 to 1,800 euros per product, CPSR 300 to 800 euros per product, Responsible Person service 500 to 2,000 euros per year). However, the US carries significant compliance costs that the EU does not: US-specific label redesign, drug-versus-cosmetic claims legal review, California Prop 65 assessment, and state-level ingredient compliance review. For a three-to-five product launch, total EU compliance typically runs 3,000 to 5,000 euros, and total US compliance typically runs 5,000 to 15,000 euros including the state-level work. The US is more expensive once state-level complexity is properly accounted for, but the spread is narrower than the federal-only comparison suggests.
Keep reading
Complete independent guide to cosmetics import/export documentation in 2026. EU, USA, and Great Britain customs requirements, HS codes, certificates of free sale, IOSS changes, MoCRA obligations, and the operational traps that cost founders the most. From 30 years in the industry.
Complete independent guide to cosmetic brand trademark protection in 2026. EUIPO, USPTO, UKIPO, and the Madrid System compared, Nice classes 3 and 5 explained, costs and timelines. From 30 years in the industry. Not legal advice.
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