The United States offers enormous potential for international beauty brands, but successful expansion requires more than an attractive product and a strong marketing strategy. Companies must also understand the regulatory framework administered by the U.S. Food and Drug Administration (FDA).
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) introduced the most significant changes to federal cosmetics legislation in decades. It expanded the FDA’s authority and placed additional responsibilities on manufacturers, processors, distributors and the companies named on cosmetic labels.
What MoCRA Means for Beauty Brands
MoCRA did not create a general premarket approval process for cosmetic products. With limited exceptions, such as certain color additives, cosmetics do not need individual FDA approval before being sold.
However, companies must be able to demonstrate that their products are safe, properly labelled and manufactured under controlled conditions. MoCRA also introduced or strengthened requirements involving facility registration, product listing, adverse event reporting and safety documentation.
The FDA now has greater authority to inspect records and, under specific circumstances, order a mandatory product recall when a company does not act voluntarily.
Determine How the Product Is Regulated
Before preparing a launch, brands should confirm whether the product is legally considered a cosmetic. This depends partly on its intended use and the claims used to promote it.
Products presented as cleansing, beautifying or changing appearance generally fall within the cosmetic category. Claims that a product treats disease or affects the body’s structure or function may cause it to be classified as a drug.
This distinction must be considered across the entire marketing ecosystem, including:
- Product packaging and instructions
- Company websites and online stores
- Social media posts
- Advertising campaigns
- Distributor materials
- Influencer communication
Even a compliant cosmetic formula can create regulatory problems if its marketing promises cross into therapeutic territory.
Identify the Responsible Person
Under MoCRA, the responsible person is the manufacturer, packer or distributor whose name appears on the product label.
This party is responsible for several important activities, including maintaining safety substantiation, managing cosmetic product listings and reporting serious adverse events. International brands should clearly define these responsibilities in agreements with manufacturers, importers, distributors and regulatory partners.
Unclear ownership can result in missed submissions, inconsistent records or delays when an incident requires immediate action.
Register Facilities and Submit Product Listings
Facilities that manufacture or process cosmetics for distribution in the United States generally need to register with the FDA and renew their registration every two years. The responsible person must also submit information about marketed cosmetic products and keep those listings current through the required updates.
Certain small businesses may qualify for exemptions. However, these exemptions do not apply to every product category, particularly some products used around the eyes, injected products, internal-use products and products designed to alter appearance for more than 24 hours.
Companies should confirm eligibility instead of automatically assuming that an exemption applies.
Create Defensible Safety Documentation
MoCRA requires the responsible person to ensure that adequate safety substantiation exists for each cosmetic product. The FDA does not prescribe one universal testing programme for every formula, but the supporting evidence must be scientifically reliable.
A safety file may include:
- Ingredient toxicology and exposure assessments
- Raw-material specifications and certificates
- Stability and packaging compatibility studies
- Microbiological testing
- Preservative effectiveness data
- Finished-product specifications
- Manufacturing and batch records
- Relevant published scientific literature
Animal testing is not automatically required. Companies may use existing information and scientifically robust alternative methods where appropriate. The objective is to demonstrate why the product is safe under its labelled and reasonably foreseeable conditions of use. FDA’s MoCRA overview provides additional details.
Establish an Adverse Event Procedure
Beauty brands need a documented system for receiving, evaluating and escalating consumer complaints. Serious adverse events must generally be reported to the FDA within 15 business days.
Product labels must provide a domestic address, domestic telephone number or electronic contact method through which consumers can submit adverse event information.
Internal teams should know how to distinguish an ordinary complaint from a potentially serious incident. Distributors and customer-service providers should also understand when information must be forwarded to the responsible person.
Review Labels Before Printing
A U.S. label review should cover the product identity, net quantity, ingredient declaration, business information, warnings and required contact details. Claims must be truthful and supported by suitable evidence.
Brands should avoid statements suggesting that a cosmetic has been “FDA approved.” They should also monitor future federal requirements concerning fragrance-allergen disclosure and other labelling changes.
Build Quality Systems for Long-Term Compliance
The FDA is developing cosmetic Good Manufacturing Practice regulations as required by MoCRA. Companies entering the market should already operate with documented quality controls rather than waiting for every rulemaking process to conclude.
A practical system should address supplier qualification, traceability, hygiene, batch documentation, deviations, complaints, corrective actions and recalls. Federal compliance must also be reviewed alongside relevant state-level restrictions and disclosure obligations.
Because requirements continue to evolve, companies benefit from treating compliance as an ongoing operational process. Specialist support with U.S. cosmetic regulations can help brands evaluate their formulas, claims, labels, registrations and technical documentation before launch.
A well-prepared regulatory strategy does more than reduce enforcement risk. It creates a reliable foundation for distribution, retailer relationships and sustainable growth in the American beauty market.
