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Selling cosmetics and beauty products in the US

In the US, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the largest expansion of the FDA's authority over cosmetics since 1938. Facilities that make or process cosmetics register with the FDA, the responsible person lists each product with its ingredients, keeps records substantiating its safety, and reports serious adverse events within 15 business days.

Updated · Each section links to the official source it comes from

Main law
MoCRA, amending the FD&C Act
Who answers
The responsible person: the name on the label
Facilities
Registered with the FDA, renewed every two years
Products
Listed with ingredients, updated annually
Serious adverse events
Reported within 15 business days

Before a product goes on sale

The questions to answer, in the order they usually come up.

  1. 1Who is the responsible person, whose name is on the label? Read more
  2. 2Is the facility that makes or processes it registered? Read more
  3. 3Is the product listed with its ingredients? Read more
  4. 4Are there records that substantiate its safety? Read more
  5. 5Is there a way to report serious adverse events? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

The responsible person

Who answers for a cosmetic product under MoCRA.

  • The responsible person is the manufacturer, packer or distributor whose name appears on the label.
  • The responsible person reports serious adverse events in the US to the FDA within 15 business days, with a copy of the label, and sends new medical information received within a year within 15 business days.
  • If the FDA finds a reasonable probability that a cosmetic is adulterated or misbranded and will cause serious harm, it can order a recall if the responsible person refuses to recall voluntarily.

How we help: Compliant Always keeps the responsible person's records for each product in one place, including the label version an adverse event report needs. Ask about this

Facility registration and product listing

Telling the FDA where cosmetics are made and what is sold.

  • Manufacturers and processors register their facilities with the FDA and renew every two years.
  • The responsible person lists each marketed cosmetic product with the FDA, including its ingredients, and updates the listing annually.
  • The FDA can suspend a facility's registration in set circumstances, after which its cosmetics may not be distributed in the US.

How we help: Compliant Always keeps each product's ingredient list and listing details current, so the annual update is drawn from the record. Ask about this

Safety substantiation and records

The evidence that a product is safe.

  • Companies and individuals who make or market cosmetics are responsible for the safety of their products. The law does not require specific tests for individual products or ingredients.
  • The responsible person keeps records supporting adequate safety substantiation, and may use relevant safety data that is already available.
  • Animal testing is not a requirement for marketing a cosmetic product.
  • The FDA can access and copy certain records, including safety records, when conditions are met. MoCRA also provides for good manufacturing practice rules and fragrance allergen labelling.

How we help: Compliant Always keeps the safety substantiation and test reports with each product, dated, ready when the FDA or a retailer asks. Ask about this

Who answers for what

WhoWhat they answer forHow we help
Responsible personListing, safety substantiation records and serious adverse event reports.Listing data, safety records and labels kept together and dated.
Manufacturer or processorFacility registration, renewed every two years.Registration and certificates kept current, with renewals in view.
Brand or distributorThe responsible person's duties where its name is on the label.Formula and label checked, with the paperwork behind them.

Federal and state

Federal agencies set the national rules. States can add their own: California's Proposition 65, for example, can call for a warning on a product sold there.

Retailers and marketplaces often ask for more than the law does, such as test reports by lot or third party certificates.

Questions businesses ask

What is MoCRA?
The Modernization of Cosmetics Regulation Act of 2022, the most significant expansion of the FDA's authority to regulate cosmetics since the FD&C Act was passed in 1938.
Who is the responsible person for a US cosmetic?
The manufacturer, packer or distributor whose name appears on the cosmetic product's label.
Do cosmetic facilities register with the FDA?
Yes. Manufacturers and processors register their facilities with the FDA and renew the registration every two years.
Do cosmetic products have to be listed with the FDA?
Yes. The responsible person lists each marketed cosmetic product, including its ingredients, and provides updates annually.
Does a cosmetic need specific safety tests in the US?
Neither the law nor FDA regulations require specific tests. The responsible person keeps records supporting adequate safety substantiation, and may use relevant safety data already available.
Is animal testing required for US cosmetics?
No. Animal testing is not a requirement for marketing a cosmetic product, and the data used should come from scientifically robust methods.
When are adverse events reported?
Serious adverse events associated with use in the US are reported to the FDA within 15 business days, with a copy of the label.
Can the FDA recall a cosmetic?
Yes. If there is a reasonable probability a cosmetic is adulterated or misbranded and will cause serious adverse health consequences, the FDA can order a recall when the responsible person refuses to recall voluntarily.
How does Compliant Always help with selling in the US?
Our team reads the rules for the markets you sell in. Compliant Always shows which apply to your product, keeps the documents behind each one ready, and watches federal sources for changes. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

Tell us what you make, and we will show you the rules for it.

Name the product and the markets you sell in. We will come back to you with what applies in the US and what your paperwork needs to show.

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