Quick Answer
Cosmetic regulations in the USA are set by the FDA under the Federal Food, Drug, and Cosmetic Act, and they do not require premarket approval for cosmetics apart from color additives.
Since the Modernization of Cosmetics Regulation Act of 2022, most manufacturers must register facilities, list products, keep safety substantiation records, and report serious adverse events, though small businesses are exempt from several of these. The FDA bans only a short list of ingredients, leaving manufacturers legally responsible for the safety and correct labeling of everything they sell.
Introduction
Anyone trying to understand cosmetic regulations in the USA runs into the same confusing headline first. Cosmetics are not FDA-approved, yet they are firmly FDA-regulated, and mistaking the first fact for a lack of rules is how businesses get into trouble.
This guide explains the current FDA framework in plain terms, though it is general information rather than legal advice, so confirm specifics with the FDA or a qualified adviser before acting.
I have guided small makers through this system and watched the same misunderstanding repeat. They read that no approval is needed and assume freedom, then discover a real set of obligations around safety, labeling, and registration.
By the end, you will understand how the FDA regulates cosmetics, what MoCRA changed, which ingredients are restricted, and exactly which rules apply to your situation.
How the FDA Regulates Cosmetics
The FDA regulates cosmetics under two core laws, the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. Under these, cosmetics and their ingredients need no premarket approval, with the single exception of color additives.
The legal responsibility for safety sits with the manufacturer rather than the agency. A product must not be adulterated or misbranded, meaning it must be safe under normal use and labeled truthfully and completely.
The line between a cosmetic and a drug is decided by intended use, not marketing preference. A product claiming to treat or prevent a condition becomes a drug under the law and must meet drug requirements, including premarket approval, even if it also changes appearance.
Cosmetic Regulations USA After MoCRA
The biggest recent shift in cosmetic regulations in the USA came with the Modernization of Cosmetics Regulation Act of 2022, known as MoCRA. It represents the most significant expansion of FDA cosmetic authority since 1938, replacing a largely voluntary system with enforceable requirements.
Before MoCRA, registration and reporting were voluntary through the old Voluntary Cosmetic Registration Program, which the FDA sunset in March 2023. The table below shows what changed.
| Area | Before MoCRA | After MoCRA |
| Facility registration | Voluntary | Mandatory, renewed every two years |
| Product listing | Voluntary | Mandatory, updated annually |
| Safety substantiation | Advised, not required by statute | Required, with records kept |
| Adverse event reporting | Voluntary | Serious events reported within 15 business days |
| Recalls | Voluntary only | The FDA can order mandatory recalls |
| GMP | Non-binding guidance | Statutory rules are still pending |
These provisions moved cosmetics much closer to the oversight already applied to foods and drugs. The practical effect is that documentation and accountability now carry legal weight rather than being best practice.
FDA Facility Registration and Product Listing
Facility registration is now mandatory for most manufacturers and processors of cosmetics sold in the United States. Registration is submitted through the FDA’s Cosmetics Direct portal using Form 5066, and it must be renewed every two years.
Registration is based on where a product is manufactured, not where it is sold. A maker producing at home or in a studio has a facility, even when all sales happen online through a marketplace.
Product listing is the second requirement, submitted using Form 5067 and updated annually. Each listing includes the product and a full ingredient disclosure, giving the FDA visibility it never had under the old voluntary system.
Responsible Person, Safety Substantiation, and Adverse Events
Every cosmetic must have a Responsible Person, defined as the manufacturer, packer, or distributor whose name appears on the label. For most small makers, that is automatically the owner, with no separate registration step.
Safety substantiation applies to businesses of every size and has no small-business exemption. It means keeping records that show why each product is safe, such as ingredient safety data, supplier certificates, formulas, and batch records.
Adverse event duties are also significant. The Responsible Person must report serious adverse events to the FDA within 15 business days, and the FDA now holds mandatory recall authority when a product is likely to cause serious harm.
Small Business Exemptions
MoCRA recognizes that small makers cannot carry the same load as large manufacturers. A business with average annual US cosmetic sales under roughly one million dollars over the previous three years, adjusted for inflation, generally qualifies as a small business.
Qualifying small businesses are exempt from facility registration, product listing, and forthcoming GMP requirements. They still must meet safety substantiation and adverse event obligations, since those protect consumers directly.
The exemption has firm limits. It does not apply to certain higher-risk products, including those that contact the mucous membrane of the eye, are injected, are for internal use, or alter appearance for more than 24 hours without consumer removal.
Good Manufacturing Practice Under MoCRA
MoCRA directs the FDA to establish good manufacturing practice regulations for cosmetics. These will set minimum standards for how products are made, processed, packed, and held.
As of 2026, the final GMP rules are not yet in force, and the proposed rule has moved to the FDA’s longer-term agenda. The agency nonetheless expects manufacturers to maintain structured quality and safety controls in the meantime.
Building sound manufacturing habits now is the practical response. Clean processes, batch traceability, and documented controls prepare a business for the rules that are coming rather than scrambling later.
Banned and Restricted Cosmetic Ingredients in the USA
The USA restricts far fewer ingredients than the European Union, which surprises many formulators. Aside from color additives, manufacturers may use most raw materials without approval, provided the finished product is safe.
The FDA specifically prohibits or restricts a short list of ingredients in cosmetics:
- Bithionol, mercury compounds, and vinyl chloride
- Halogenated salicylanilides and hexachlorophene
- Chloroform, methylene chloride, and chlorofluorocarbon propellants
- Zirconium-containing complexes in aerosol products
Color additives are the notable exception to the no-approval rule. They must be approved by the FDA for their intended use, and some may only be used from batches the FDA has tested and certified.
State law increasingly goes further than federal rules. California and a growing number of states have banned intentionally added PFAS in cosmetics on staggered timelines, so a product legal federally can still be barred in specific states.
FDA Rules on Cosmetic Labeling and Claims
Labeling is where many small brands slip, since the FDA enforces specific requirements. Labels must carry an accurate ingredient declaration, identity, net quantity, and any warnings, and they must not mislead the consumer.
Claims are the fastest route to reclassifying a cosmetic as a drug. Saying a product treats acne, heals skin, or reduces inflammation implies a therapeutic effect and can trigger drug requirements, so cosmetic claims must describe appearance and feel rather than medical outcomes.
Several popular marketing terms carry no legal FDA definition. Words like natural, hypoallergenic, and cruelty-free are not regulated standards, so using them does not exempt a product from any rule, a point that resources like Formula Chemistry stress to new brands.
Common Mistakes in US Cosmetic Compliance
Compliance tends to fail in predictable ways, and each mistake below has a clear fix. Avoiding them keeps a business on the right side of FDA enforcement.
The first mistake is believing cosmetics are FDA-approved. They are regulated, not approved, so never imply approval and instead focus on meeting the actual requirements.
Assuming no premarket approval means no rules is a second error. The absence of approval does not remove safety, labeling, or MoCRA duties, so treat compliance as mandatory from the first sale.
Neglecting safety substantiation records is a third mistake. Makers assume it applies only to large firms, yet it binds every size, so keep ingredient and safety documentation organized and current.
Making drug-like claims unknowingly is a fourth error. Wording that promises to treat or cure reclassifies a product as a drug, so review every claim and keep the language cosmetic.
Using unapproved color additives is a fifth mistake. Color is the one ingredient category needing FDA approval, so verify every colorant is listed for cosmetic use and certified where required.
The sixth error is overlooking state law. Several states restrict ingredients that the FDA still permits, so check the rules of every state you sell into, not just the federal baseline.
Which Rules Apply to You
A small US maker under the sales threshold carries the lightest load. Safety substantiation and compliant labeling always apply, while facility registration, product listing, and GMP are usually exempt.
Larger brands and those selling higher-risk products face the full framework. Facility registration, annual product listing, and complete Responsible Person duties apply without exemption.
Importers have added obligations, since foreign facilities must register and designate a US agent. Anyone selling into states with extra ingredient bans must meet the strictest applicable state rule, not merely the federal one.
Whatever your size, map your obligations before you sell rather than after. To start, confirm whether you meet the small business threshold, then build the safety and labeling records that every US cosmetic seller needs, regardless of size.
Frequently Asked Questions
Are cosmetics FDA-approved in the USA?
No, cosmetics do not receive FDA approval before going on the market, except for color additives. The FDA regulates cosmetics but does not pre-approve them. Manufacturers hold legal responsibility for product safety and labeling.
What is MoCRA in cosmetics?
MoCRA is the Modernization of Cosmetics Regulation Act of 2022, the largest expansion of FDA cosmetic authority since 1938. It introduced mandatory facility registration, product listing, safety substantiation, and adverse event reporting. It replaced the previous voluntary registration system.
Do I need to register with the FDA?
Most manufacturers must register their facility and list products under MoCRA. However, small businesses under roughly one million dollars in average annual US cosmetic sales are often exempt. Registration is based on where you manufacture, not where you sell.
What ingredients are banned in US cosmetics?
The FDA prohibits or restricts a short list, including bithionol, mercury compounds, vinyl chloride, chloroform, methylene chloride, and several others. Color additives require FDA approval for cosmetic use. Some states ban additional ingredients, such as intentionally added PFAS.
Does the FDA regulate cosmetic claims?
Yes, claims determine whether a product is a cosmetic or a drug. Statements about treating or curing conditions can make a product a drug requiring approval. Cosmetic claims should describe appearance and feel rather than medical effects.
What are the FDA rules for selling cosmetics?
You must ensure products are safe, properly labeled, and not misbranded, and keep safety substantiation records. Depending on size, you may also need facility registration and product listing under MoCRA. Color additives must be FDA-approved.
Are small businesses exempt from MoCRA?
Qualifying small businesses are exempt from facility registration, product listing, and forthcoming GMP rules. They remain subject to safety substantiation and adverse event reporting. The exemption excludes certain higher-risk product types.
Are PFAS banned in US cosmetics?
There is currently no federal ban on intentionally added PFAS in cosmetics. The FDA reported to Congress on PFAS in December 2025, but has not prohibited them. Several states, including California, have enacted their own PFAS bans.
Key Takeaways
Cosmetic regulations in the USA rest on FDA oversight without premarket approval, apart from color additives, leaving safety responsibility with the manufacturer. MoCRA added mandatory registration, listing, safety substantiation, and adverse event reporting, with exemptions for small businesses.
The FDA bans only a short ingredient list, so state laws increasingly set stricter limits, especially on PFAS. Labeling accuracy and careful claims are essential, since a therapeutic claim can turn a cosmetic into a regulated drug.
Identify your obligations by size and product type before selling. To act now, confirm your small business status, keep organized safety and labeling records, and check the specific rules of every state you sell into.