Launching a cosmetic product in the United States

A company launching a cosmetic in the United States needs to know more than whether the formula was accepted in another market. Its claims determine how it is regulated, while separate US requirements apply to the product’s safety, the manufacturing facility and the company named on the label.

This guide focuses on ordinary cosmetics and selected federal requirements. Products with sunscreen or therapeutic claims, and state and import requirements, need separate assessment. For a comparison with other markets, see launching a cosmetic product across eight markets. Sources were checked on 3 November 2026.

This article was generated with AI and checked against the sources linked below. It has not been independently reviewed by a local regulatory professional.

Classify the complete product

FDA regulates products according to their intended use. A moisturiser may be a cosmetic; a product marketed with claims to treat a disease or affect the body’s structure or function may also be a drug. A sunscreen, for example, can be both a cosmetic and a drug in the United States. Check the actual label, online claims, ingredients and intended use before deciding which requirements apply. FDA: cosmetics, drugs or both.

For most cosmetics, FDA does not approve the product or its ingredients before sale, with important exceptions such as the rules for colour additives. The company remains responsible for legal, safe products. Neither registration nor listing changes a product into an FDA-approved cosmetic.

Identify the responsible person and safety evidence

Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the responsible person is the manufacturer, packer or distributor whose name appears on the cosmetic label under the applicable law. It must ensure adequate safety substantiation and maintain supporting records. The law describes a standard of evidence sufficient, in the judgement of appropriately qualified experts, to support reasonable certainty that the product is safe under labelled or customary use.

Connect the safety substantiation to the formula version, concentrations, intended users and exposure. Organise ingredient safety data, finished-product information and the reasoning supporting the conclusion. FDA does not prescribe the same test for every cosmetic; determine what evidence is appropriate to the actual product. Keep the evidence available for review when a formula or package changes. FDA: MoCRA.

Separate the facility from the product

MoCRA generally requires owners or operators of facilities manufacturing or processing cosmetics for US distribution to register with FDA and renew every two years. The responsible person generally must list each marketed cosmetic product, including its ingredients, and provide any updates annually. Some small businesses are exempt from registration and listing, but the exemption has conditions and does not apply to certain product categories. Exemptions also exist for certain products and facilities subject to drug or device requirements. Determine eligibility for the actual entity and products before relying on an exemption. FDA: registration and listing.

Registration and listing have different subjects and owners. The facility may be a contract manufacturer while a brand, manufacturer, packer or distributor is the responsible person. A foreign facility that must register needs a US agent for registration purposes; that agent’s role should not be confused with the product’s responsible person.

For a facility that first began manufacturing or processing cosmetics for US distribution after 29 December 2022, FDA describes a registration deadline of 60 days after that activity begins or 27 February 2024, whichever is later. FDA’s guidance expects listing of a product first marketed after 29 December 2022 within 120 days of marketing in interstate commerce or by 27 April 2024, whichever is later. Existing facilities and products had different initial deadlines. Check applicable exemptions and the current guidance for the business’s circumstances rather than treating either step as a universal pre-sale approval. FDA: registration and listing guidance.

Prepare the label and launch records

Review the applicable federal labelling requirements for product identity, net contents, name and place of business, ingredients and any necessary warnings. FDA identifies different requirements for particular panels, packages and uses. MoCRA also adds contact information requirements for adverse-event reporting. Check the final artwork and the distribution model against FDA’s labelling guidance, rather than assuming an EU or Canadian label can be reused unchanged.

Assign someone to receive complaints and identify potentially serious adverse events. MoCRA requires the responsible person to report qualifying serious adverse events associated with use in the United States to FDA no later than 15 business days after receiving the report, and describes obligations for certain additional information received later. Put the reporting route in place before the product reaches customers.

What the responsible person remains accountable for

The responsible person must ensure adequate safety substantiation and maintain supporting records. Unless an exemption applies, it also submits the product listing and provides any updates annually. For qualifying serious adverse events, it reports to FDA no later than 15 business days after receiving the report. The statute also requires submission, within 15 business days of receipt, of new and material medical information received within one year of the initial report to FDA. FDA’s overview describes the follow-up information more broadly as medical or other information. FDA describes separate record-retention requirements for adverse-event records, including a shorter period for qualifying small businesses. These duties are not replaced by a contract manufacturer’s facility registration. 21 USC 364a: adverse events; FDA: MoCRA; FDA: draft records-access guidance.

FDA has enforcement powers that depend on the applicable facts. For example, it can order a mandatory recall if the statutory serious health-risk threshold and other conditions are met and the responsible person fails to voluntarily cease distribution and recall the product when given the opportunity. Adulterated or misbranded cosmetics may also be subject to seizure under the conditions set out in the law. The responsible person’s statutory duties, the facility’s duties and any civil claims are different questions; contracts do not decide FDA’s powers or automatically establish who is liable for damages. FDA: mandatory cosmetics recalls; 21 USC 334: seizure.

Record the formula, supplier, manufacturer, label and listing versions together. If a preservative changes or the label is revised, the team can assess whether the safety substantiation and other records need updating. Check state requirements and import arrangements separately; this article does not establish compliance for an individual launch.

Sources

• FDA: Modernization of Cosmetics Regulation Act of 2022.
• FDA: Registration and listing of cosmetic product facilities and products, guidance.
• FDA: Is it a cosmetic, a drug, or both?.
• FDA: Cosmetics Labeling Guide.