Do I need FDA approval to sell makeup in the US?

Generally no — cosmetics (other than color additives, which must be approved for their intended use) do not require FDA pre-market approval. However, cosmetics must be safe, properly labeled, and compliant with the Modernization of Cosmetics Regulation Act (MoCRA), which introduced requirements including facility registration, product listing, and adverse event reporting.

The Modernization of Cosmetics Regulation Act of 2022 is the most significant expansion of US cosmetics regulation since 1938. It introduced requirements for facility registration, product listing with the FDA, safety substantiation, adverse event recordkeeping and reporting, and designation of a responsible person for each product.

Do You Need FDA Approval to Sell Makeup? A Compliance Guide for Creator Launches

Q: If I launch through a platform, who handles compliance?

It depends on how the platform structures manufacturing and branding responsibilities. Creators should confirm with any platform or supplier who handles facility registration, product listing, safety substantiation, and labeling requirements before launching. Ask the question explicitly — responsibility does not disappear just because production is outsourced.

It's one of the most common questions from first-time beauty founders, and the answer surprises most of them: in the United States, cosmetics generally do not require FDA approval before they're sold. But "no pre-market approval" is not the same as "no rules" — and since the Modernization of Cosmetics Regulation Act (MoCRA), the rules are more substantial than they've been in nearly a century.

Here's what an independent creator actually needs to know before launching a palette, in plain language. (This is an educational overview, not legal advice — for your specific launch, consult a regulatory professional.)

The baseline: no approval, but real obligations

The FDA does not approve cosmetic products or ingredients before they go to market, with one important exception: color additives (other than coal-tar hair dyes) must be approved by the FDA for their intended use^[1] — a detail that matters for makeup more than almost any other category, since pigment is the product. What the law requires instead of approval is that cosmetics not be "adulterated" or "misbranded": they must be safe for consumers when used according to label directions or in the customary way, and they must be properly labeled.^[2] The FDA's authority here is post-market — it can act against a product already on the market if there is reliable information showing it is adulterated or misbranded.^[1]

What MoCRA changed

MoCRA, enacted in December 2022, is — in the FDA's own framing — the most significant expansion of its authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act was passed in 1938.^[3] For a creator launching a product, the relevant pillars are:

Facility registration. Facilities that manufacture or process cosmetic products distributed in the United States must register with the FDA, update registration content within 60 days of changes, and renew registration every two years.^[4]

Product listing. A responsible person must list each marketed cosmetic product with the FDA, including product ingredients, and provide updates annually.^[4]

Responsible person. Under MoCRA, the responsible person is the manufacturer, packer, or distributor of a cosmetic product whose name appears on the product's label.^[5] That entity bears obligations including safety substantiation and adverse event reporting.

Safety substantiation. MoCRA explicitly requires the responsible person to ensure — and maintain records supporting — that there is adequate substantiation of the safety of the product.^[4]

Adverse event reporting. Responsible persons must report serious adverse events to the FDA and maintain related records.^[6] MoCRA also gave the FDA new authorities including mandatory recall and records access.^[4]

A warning on the small-business exemption — read this twice if you make eye makeup. MoCRA exempts certain small businesses from facility registration and product listing.^[3] But the exemption does not apply to facilities or responsible persons for certain product categories — including products that regularly come into contact with the mucus membrane of the eye under customary conditions of use.^[5] For a creator whose palette includes eye-area products, the small-business exemption may simply not be available. Do not assume exemption; check the specific criteria for your products.

Labeling: where most first launches go wrong

Labeling is regulated regardless of business size, and it's the compliance area a first-time creator is most likely to get wrong. Under the Fair Packaging and Labeling Act, the FDA requires an ingredient list for cosmetics marketed on a retail basis to consumers, and cosmetics that fail to comply are considered misbranded.^[7] Labels also carry the name that anchors the responsible-person obligations above — under MoCRA, the responsible person is defined as the manufacturer, packer, or distributor whose name appears on the label^[5] — and packaging and labeling must not be deceptive.^[8]

For a palette specifically, note that the shade names you create in a design tool like MiPalette's are the marketing layer — the regulatory layer underneath (ingredient declarations for the formulas in each pan) still has to be complete and accurate on the physical product.

Launching through a platform: who holds what?

Here's the question that matters most for a creator launching on any platform or through any supplier, and the one too few creators ask before their first order: who is the responsible person, and who handles registration, listing, and safety substantiation?

Responsibility doesn't evaporate because production is outsourced. When you launch through a platform like MiPalette, the formulas, manufacturing, and clean standard sit on the platform side — every pan is produced within MiPalette's formulation system, which means you're not sourcing untested formulas from an unknown factory. For the specific allocation of regulatory responsibilities on your launch — registration, listing, labeling, and adverse event contacts — confirm the details with the platform before your campaign goes live. It's a standard question, and any credible partner will have a standard answer.

The practical takeaway: a creator's compliance burden is dramatically different depending on the launch route. Sourcing your own formulas from an overseas manufacturer puts you closest to the full obligation set. Launching through an established platform whose formulas already sit within a defined system puts substantial parts of that burden on infrastructure that exists before you arrive.

Beyond the US

If you sell into other markets, different regimes apply — the EU's cosmetics regulation, for instance, has its own responsible person, notification, and safety assessment requirements that are generally more demanding than the US system. Selling internationally is a deliberate step, not a default; take it with advice.

Frequently asked questions

Do I need FDA approval to sell makeup?

Generally no — except color additives, which must be approved for their intended use. Products must still be safe, properly labeled, and MoCRA-compliant.

What is MoCRA?

The 2022 Modernization of Cosmetics Regulation Act — introducing facility registration, product listing, safety substantiation, responsible-person designation, and adverse event reporting to US cosmetics law.

Who handles compliance if I launch through a platform?

It depends on the platform's structure. Ask explicitly who holds registration, listing, labeling, and adverse-event responsibilities before you launch — and expect a clear answer.

References

U.S. Food & Drug Administration, "Does the FDA approve cosmetics before they go on the market?" — fda.gov ↩ ↩
U.S. Food & Drug Administration, "Cosmetics Q&A: Why are cosmetics not FDA-approved?" — fda.gov ↩
U.S. Food & Drug Administration, "Modernization of Cosmetics Regulation Act of 2022 (MoCRA)" — fda.gov ↩ ↩
U.S. Food & Drug Administration, "Cosmetics & U.S. Law" — fda.gov ↩ ↩ ↩ ↩
U.S. Food & Drug Administration, "Registration & Listing of Cosmetic Product Facilities and Products" — fda.gov ↩ ↩ ↩
U.S. Food & Drug Administration, "How FDA is Implementing Landmark Cosmetics Legislation to Positively Impact Public Health" — fda.gov ↩
U.S. Food & Drug Administration, "FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated" — fda.gov ↩
U.S. Food & Drug Administration, "Small Businesses & Homemade Cosmetics: Fact Sheet" — fda.gov ↩