Do I need FDA approval to sell cosmetics? What the rules actually say
There is no such thing as an FDA-approved cosmetic. That is not a loophole and it is not a technicality — it is how the framework was built. What does exist is a set of obligations that begin the moment a product is offered for sale in the United States, and most first-time brand owners meet them by accident.
The short answer
No. The FDA does not approve cosmetics, and it does not license the factories that make them. The agency’s own consumer guidance is blunt about it: a product being FDA-regulated does not make it FDA-approved, and the agency does not have the legal authority to approve a cosmetic before it goes on the market.
The single exception is colour additives. Those have to appear on a permitted list and, for most of them, come from batches the FDA has certified. That is a genuine pre-market approval — but it applies to the pigment supplier, not to your finished product, and it is the reason some people genuinely have seen an FDA certificate and concluded that the whole category works that way.
Ask what the document actually is. The FDA does not issue an approval certificate, a licence or a registration certificate for a cosmetic product or a cosmetic factory. What exists in the market are certificates issued by third-party certification bodies — Bureau Veritas, SGS, Intertek — stating that a facility was audited against a published standard. That is a real and useful thing. It is a different thing.
Five things people call “FDA approval”
Most of the confusion in this area comes from five different mechanisms being described with the same phrase. They are not interchangeable, they are not held by the same party, and only one of them is an approval.
| What it is often called | What it actually is | Who it belongs to |
|---|---|---|
| “FDA approved” | Does not exist for cosmetics. No pre-market review of a cosmetic formula takes place. | Nobody |
| Facility registration | A filing that tells the FDA which site manufactures the product. A notification, not a review. | The facility that makes or processes it |
| Product listing | A filing that records the product and its ingredients. Also a notification. | The responsible person, usually the brand |
| GMP compliance | Working to the FDA’s Cosmetic Good Manufacturing Practice Guidelines. The FDA certifies nobody against them. | The facility |
| Colour additive certification | A real FDA approval, granted batch by batch. | The pigment or dye supplier |
The distinction that matters is what a filing proves. Registration and listing tell the FDA that a facility and a product exist. They do not tell the FDA that either one is any good, and nobody at the agency signs off on your formula. A registration number is evidence that you filed. It is not evidence that anyone checked.
What MoCRA added — and what it did not
The Modernization of Cosmetics Regulation Act, passed at the end of 2022, is the largest change to American cosmetic law since 1938. It is also the main reason so many people now assume an approval exists: the law introduced registration, and registration sounds like approval.
What it added: mandatory facility registration and product listing, mandatory adverse event reporting with serious events reported within 15 business days, an explicit safety substantiation duty on the responsible person, a right of access to records, and recall authority. The registration and listing provisions became enforceable in 2024. Registration is renewed every two years, and changes have to be reported within 60 days.
What it did not add: pre-market approval. The FDA does not see your formula, does not assess your safety file before you sell, and does not issue a decision you can quote on a website.
Two practical consequences follow. First, the obligations sit on different parties — the facility registers itself, while the product listing is filed under the responsible person, which is usually the brand owner or a US agent acting for them. If nobody has been nominated as the responsible person, the listing has no owner. Second, the exemptions are narrow. Small businesses below the statutory sales threshold are exempt from GMP and from registration and listing, but not from adverse event reporting, and the exemption does not reach products that are injected, used internally, or intended to alter appearance for more than 24 hours.
Parts of MoCRA are still being written. Fragrance allergen labelling, and the testing methods for talc and PFAS, are being handled through rulemaking rather than settled in the statute. If your launch is more than a year out, the labelling rules you will have to meet may not be the ones in force today, and it is worth asking your factory how they are tracking that.
Our quality system is certified by Bureau Veritas to the FDA Cosmetic GMP Guidelines (2020), and separately to ISO 22716. Both are certifications of our factory against published standards. Neither is an FDA approval, and we do not describe them as one — a buyer who checks will not find us in an FDA approvals database, because that database does not exist. The certificates themselves are on our factory page.
What you actually have to get right
Because nobody is going to approve the product, the burden of getting it right stays with you and your factory. In practice five things decide whether a first shipment clears without being held, relabelled or destroyed. The permits that belong to you rather than the factory — company registration, resale certificate, importer status — are set out in whether you need a license to sell skincare.
The label
Ingredient declaration in INCI order, descending by weight down to 1%, with anything below 1% listed after those above it. Net quantity. The name and address of the manufacturer, packer or distributor. Country of origin for imports. Warnings where the product requires them. Fragrance may be declared as “fragrance” or “parfum” rather than broken out — which is exactly what the pending allergen rule would change.
Label errors are the most expensive kind of mistake in this business, because they are usually found at the border, after printing and after freight. The artwork should be reviewed line by line against the destination market’s requirements before the print run, not after.
Registration and listing, under the right name
Both filings have to exist before the product is offered for sale, and both have to be under the right party. A factory that has registered its own facility has done nothing about your product listing. Ask who is filing what, and get it in writing.
Safety substantiation
MoCRA makes the responsible person responsible for adequate safety substantiation. In the EU that is a formal Cosmetic Product Safety Report prepared by a qualified safety assessor. In the US the standard is “adequate” rather than a prescribed document — but adequate still means documented: toxicological assessment of the formula, stability data, and compatibility with the packaging it sits in.
GMP
The FDA’s Cosmetic GMP Guidelines are guidance, and no certificate comes attached to them. ISO 22716 is the international standard most factories actually certify against, and the two overlap heavily. What you are looking for is not a logo on a wall but batch records, in-process checks, a validated water system, cleaning records and retained samples from previous runs.
Colour additives
Every colourant has to be permitted for the intended use, and most have to come from batches that the FDA has certified. Coal tar hair dyes are the standing exception. This is the one place where a supplier’s paperwork genuinely is an approval, so ask for the certified batch reference rather than a general statement that the pigment is compliant.
Where the cosmetic line ends and the drug line begins
The most common way a cosmetic becomes a drug is not the formula. It is a claim. “Moisturises” is a cosmetic claim. “Treats eczema”, “kills bacteria” or “reduces inflammation” are drug claims, and a product carrying one is regulated as a drug — which is the point at which pre-market requirements do appear.
Sun care is the clearest example and the one that catches the most people. In the United States a product carrying an SPF claim is an over-the-counter drug, not a cosmetic. It has to be made to an applicable OTC monograph, and the permitted UV filter list is short and has moved very slowly — which is why the same brand’s European and American sunscreens are frequently not the same formula.
In the European Union the same bottle is a cosmetic. Same product, same number on the front, two entirely different regulatory routes. If sun care is anywhere on your roadmap, that difference is worth understanding before a formula is briefed rather than after. We go through the testing and labelling side of it in sunscreen OEM manufacturing.
If you are selling in the EU or the UK instead
The EU does have a notification system — the Cosmetic Products Notification Portal — and it is the closest thing in this industry to a registration that gets mistaken for an approval. It is still a notification. Nobody reviews your formula before you place the product on the market.
What the EU does require: a Responsible Person established in the EU, a Cosmetic Product Safety Report prepared by a qualified safety assessor, a Product Information File kept for ten years after the last batch was made, GMP — in practice ISO 22716 — and CPNP notification before first placement. The UK mirrors the structure with its own Responsible Person, its own notification service and retained cosmetics regulation. A UK notification does not cover the EU, and an EU one does not cover Great Britain.
| United States | European Union | United Kingdom | |
|---|---|---|---|
| Pre-market approval of the formula | None | None | None |
| Filing before first sale | Facility registration and product listing | CPNP notification | SCPN notification |
| Responsible party | Responsible person, usually the brand or a US agent | Responsible Person established in the EU | Responsible Person established in the UK |
| Safety file | Adequate safety substantiation | CPSR plus a Product Information File | CPSR equivalent |
| Manufacturing standard | FDA Cosmetic GMP Guidelines (2020) | ISO 22716 | ISO 22716 |
| Sunscreen with an SPF claim | Over-the-counter drug | Cosmetic | Cosmetic |
What to ask a factory, in writing
Six questions separate a supplier who understands the framework from one who has learned the vocabulary without the substance. Send them by email, so the answers exist.
- Which registrations do you hold, in whose name, and can I see the document? A factory registration and a product listing are different filings held by different parties. A supplier who cannot tell you which one they mean has not done either.
- Who will be the responsible person for my product, and what do you need from me to support them? In the US this is usually you. In the EU it has to be an entity established there.
- Which laboratory will test this, is it accredited for the specific claim, and what is the lead time? For anything with a measured claim, the laboratory is the calendar.
- Can you supply the safety assessment, or the data I need to commission one? The formula, the ingredient percentages and the toxicological profile have to come from somewhere.
- What does your artwork review actually check? If the answer is “spelling and layout”, the compliance review is being done by you.
- Which markets do you already ship this category to, and who files the listing there? Experience shows up as a process, not as a claim.
One red flag is worth naming. A supplier who answers the first question with “we are FDA approved” has just told you they do not understand the framework they are working in. That is useful information, and it is much better to have it before a deposit than after a container has been held at a port.
What this does to your timeline
Regulatory work is rarely the long pole, and that surprises people who have been told to expect “FDA delays”. Registration and listing are administrative: days of form-filling rather than months of waiting, and no queue for a decision, because there is no decision to wait for.
The long poles are the familiar ones. Formula development and stability, which typically runs around three months and cannot be compressed by paying more. Any testing the claim requires, which depends on laboratory availability. And artwork approval, which depends mostly on how many people have to sign it off.
The sequencing that saves the most time is deciding two things in the brief: the destination markets, and the exact wording that will appear on the front of the pack. Both of them change the formula, the test plan and the label. Deciding them at the end of development instead of the beginning is how projects end up paying twice for the same work — and it is the single most common cause of a launch slipping a quarter. Our six-step process front-loads exactly those two decisions for that reason.
What to send us
If you are still working out whether you need FDA approval to sell cosmetics in your market, that is a reasonable place to start a conversation rather than a reason to wait. Send us:
- The countries the product will be sold in, including any market you plan to add later
- The exact wording you want on the front of the pack, not a description of it
- Whether any part of that wording could be read as a drug claim where you are selling
- The product type and format you have in mind, and whether packaging is already chosen
- Target quantity and the date you want to be on shelf
With those five answers we can tell you which route applies, which parts of the file we can prepare and which parts you will need to own — and what that does to the timeline for your specific combination. You can see the categories we manufacture under skincare OEM, and send a brief through the contact form.
Whatever the regulatory path, our perfume, skincare and haircare OEM/ODM pages show what each market expects from a manufacturer.
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Tell us where you plan to sell
Compliance questions are easier to answer with the destination market and the pack claim in front of us. Send both and we will tell you which route applies, what we can prepare and what you will need to own.