US Federal and State Cosmetics Regulation Under MoCRA: What Importers Must Know

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA), signed into law on December 29, 2022 as part of the Consolidated Appropriations Act, 2023, represents the most significant update to US federal cosmetics regulation since the original Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938. MoCRA adds new Sections 607 through 614 to the FD&C Act, creating mandatory cosmetic facility registration, product listing, safety substantiation, adverse event reporting, and cosmetic product recall authority for the FDA for the first time. Prior to MoCRA, cosmetics were one of the least regulated product categories in the US federal regulatory framework, with no pre-market approval and no mandatory registration. MoCRA significantly increases the regulatory burden on cosmetics importers and creates substantial new compliance obligations for Taiwan brands selling cosmetics in the US.

MoCRA's initial compliance deadlines have now passed: facility registration and product listing were required by December 29, 2023 for cosmetics facilities and products already on the market. New cosmetics facilities and products introduced after December 29, 2023 must be registered and listed before the cosmetic is first marketed. Taiwan cosmetics manufacturers and importers that are not yet registered under MoCRA are in violation of the FD&C Act and subject to FDA enforcement action, including Warning Letters, injunctions, and product seizures. If you have not yet registered your Taiwan cosmetics facility or listed your US cosmetics products under MoCRA, do so immediately through FDA's Cosmetics Direct submission portal at cosmeticsdirect.fda.gov.

FDA's Cosmetics Direct portal is the online system for MoCRA facility registration and product listing submissions. Registration requires: the name and address of the facility, the name and address of the responsible person (US-based importer or distributor for foreign manufacturers), a description of the cosmetic product categories manufactured or processed at the facility, and contact information for a US agent if the registrant is outside the US. Registration must be renewed every 2 years. Product listing requires: the name of the product and brand name, the list of ingredients, the responsible person's name and address, and a product listing number (assigned by FDA upon submission). Product listings must be updated within 180 days of any change to the product formulation, responsible person, or product name.

The "responsible person" (RP) under MoCRA is the manufacturer, packer, or distributor whose name appears on the cosmetic product label. For Taiwan cosmetics brands, the RP is typically the US importer or distributor named on the US label. The RP is legally responsible for MoCRA compliance including facility registration, product listing, safety substantiation, and adverse event reporting. If a Taiwan brand sells cosmetics to a US distributor who becomes the "responsible person" by putting their name on the label, the distributor assumes MoCRA compliance responsibility. If the Taiwan brand retains its own name on the US label, the brand must comply with all MoCRA obligations as the RP, including maintaining a US agent for FDA communications and filing adverse event reports with FDA within 15 business days of receiving information about a serious adverse event.

Cosmetic manufacturing and processing facilities under MoCRA include facilities that manufacture or process cosmetic products for distribution in the US. "Manufacturing or processing" includes blending, filling, packaging, and labeling operations. Taiwan cosmetics manufacturers whose products are sold in the US must register their Taiwan facility with FDA through the Cosmetics Direct portal, regardless of whether the products are sold under a Taiwan brand name or US-brand-name products that the Taiwan manufacturer supplies as a contract manufacturer. The only exemption from facility registration is for contract laboratories that only perform testing or quality control activities without manufacturing or processing cosmetic products.

Product listing under MoCRA requires that for each unique cosmetic product (distinguished by formulation, not by product name or size variant), the responsible person must submit a product listing that includes the complete ingredient list in descending order of predominance. FDA has clarified that trade secret protection is not available for ingredient information submitted in MoCRA product listings: the complete ingredient list is required for all listed cosmetic products. However, FDA may apply confidentiality protections to certain information in product listings under the Trade Secrets Act if the information meets the statutory criteria for a trade secret. For Taiwan cosmetics brands concerned about formula disclosure, consult a US regulatory attorney about strategies for protecting proprietary formulation information within the MoCRA compliance framework.

Fragrance and flavor ingredient disclosure in MoCRA product listings is a key issue for Taiwan cosmetics brands. MoCRA requires product listings to include the complete ingredient list, which FDA has interpreted to include fragrance and flavor ingredients that are currently declared on consumer labels as "fragrance" or "flavor" (collective terms). However, the FDA's implementing regulations allow for fragrance and flavor ingredient disclosure at the IFRA (International Fragrance Association) material level rather than at the individual chemical constituent level in the product listing, provided the responsible person maintains the detailed ingredient information in their safety substantiation file. This compromise preserves some fragrance formula confidentiality while enabling FDA's safety surveillance objectives under MoCRA.

Product listing updates are required within 180 days of any change to: the product formulation (addition, removal, or change in concentration of any ingredient), the brand name or product name under which the product is marketed, or the responsible person. This 180-day update window is significantly shorter than the annual update cycle that many companies previously applied to internal product documentation. Establish a product change tracking system that automatically triggers a MoCRA product listing update whenever a formulation change, supplier change, or brand name change is approved. Failure to update product listings within 180 days of a change is a separate violation of MoCRA, independent of the underlying product compliance status.

MoCRA Section 606 requires that the responsible person (importer or brand) maintain records demonstrating that a cosmetic product is safe when used as intended. "Safe" under MoCRA means that the cosmetic does not contain any poisonous or deleterious substance that may render it injurious to users under conditions of customary use, considering the full ingredient list and intended use. FDA has not yet published detailed guidance on what specific safety testing is required to constitute "adequate substantiation of safety," but the agency has indicated that it will apply a risk-based approach where the required substantiation level depends on the specific ingredients, their concentrations, and the intended use (for example, rinse-off products require less stringent substantiation than leave-on products; products for children or damaged skin require more substantiation than products for healthy adult skin).

The safety substantiation file that Taiwan cosmetics brands should maintain for each product marketed in the US includes: a product safety assessment (PSA) evaluating each ingredient against its safety profile at the concentration used, human safety data from in vitro and in vivo toxicology studies for novel or high-risk ingredients, third-party dermatologist-tested or clinician-reviewed formulation safety opinion, adverse event tracking and resolution records, and a stability testing program confirming that the product's safety profile does not change over its declared shelf life. Preparing a complete safety substantiation file for a cosmetics product to EU Cosmetics Regulation (EC) 1223/2009 standards (which requires a full Product Safety Report) creates a document that is also sufficient for MoCRA purposes and is a globally recognized safety substantiation framework.

The EU Cosmetic Products Regulation (EC) 1223/2009 Product Safety Report (PSR) is the international benchmark for cosmetics safety substantiation. A PSR consists of two parts: Part A (Product Safety Information, covering ingredient profiles, specifications, microbiological quality criteria, impurities, packaging interaction, and stability data) and Part B (Product Safety Assessment, covering safety assessment of each ingredient at use concentration, exposure calculation, safety margin assessment, and assessor's declaration). Preparing a PSR for your Taiwan cosmetics product requires engagement of a qualified EU Responsible Person and Cosmetics Safety Assessor (CSA): fees range from EUR 2,000 to EUR 6,000 per product depending on formulation complexity. A US-equivalent safety assessment built to this standard is accepted by FDA as substantiation evidence under MoCRA.

Adverse event reporting under MoCRA requires the responsible person to submit a report to FDA within 15 business days of receiving information that a serious adverse event (SAE) in the US was associated with use of the cosmetic. SAEs include: serious illness, serious injury, or death requiring medical attention; significant disfigurement; or hospitalization. The reporting threshold is "receiving information" that an SAE occurred, not a confirmed causality determination: if a consumer contacts your brand reporting hospitalization after using your cosmetic product, you must file the SAE report within 15 business days regardless of whether you believe the product caused the event. Implement a customer complaint tracking system that flags any complaint mentioning hospitalization, emergency room visit, significant allergic reaction, or injury requiring medical attention, and route these flags to your regulatory affairs contact for MoCRA adverse event reporting assessment.

California has enacted the most comprehensive state-level cosmetics safety legislation in the US, which layers additional obligations on top of federal MoCRA requirements. The California Cosmetics Safety Act (SB 312, effective January 1, 2025) prohibits 56 specific chemicals in cosmetics sold in California, including several substances not banned under federal law: PFAS (per- and polyfluoroalkyl substances) as a class (effective 2025), formaldehyde above 0.001 percent (effective 2025), mercury above 1 ppm, and certain formaldehyde-releasing preservatives including methylene glycol. Taiwan cosmetics brands must audit their US product formulations against the California Cosmetics Safety Act prohibited list before selling in California, even if the same products are compliant with MoCRA at the federal level.

California's Proposition 65 (Safe Drinking Water and Toxic Enforcement Act) adds further complexity for cosmetics. Cosmetic products containing chemicals on California's Prop 65 list at levels above "no significant risk levels" (NSRL) must carry a Prop 65 warning. Common cosmetics chemicals that trigger Prop 65 include: titanium dioxide (inhalation exposure from powder cosmetics: NSRL of 1 mcg/day inhaled), formaldehyde (from formaldehyde-releasing preservatives), and lead (in lipstick and other colored cosmetics: no safe harbor level for oral-ingestion route). California cosmetics enforcement is active: the Environmental Defense Fund and other NGOs conduct cosmetics testing and file Prop 65 lawsuits against brands whose products contain regulated chemicals above NSRL. Budget USD 5,000 to USD 15,000 for a Proposition 65 compliance audit of your cosmetics product line before entering the California market.

New York's Cosmetic Safety legislation (NY S 2325-B, enacted 2023, effective 2026) requires cosmetics manufacturers to disclose all ingredients in their products to the New York State Department of Health (NYSDOH), including fragrance and flavor constituents at the individual chemical level (not just "fragrance" as a collective term). This New York disclosure requirement is stricter than both federal MoCRA (which allows fragrance to be declared collectively in product listings) and the EU CPC (which requires individual disclosure of certain fragrance allergens but not all fragrance constituents). Taiwan cosmetics brands selling in New York must provide complete fragrance ingredient disclosure to NYSDOH by the applicable disclosure deadline, which may require renegotiating confidentiality terms with your fragrance supplier.

Multi-state compliance strategy for Taiwan cosmetics brands requires a tiered approach. Tier 1: Comply with federal MoCRA requirements (facility registration, product listing, safety substantiation, adverse event reporting) as the national baseline. Tier 2: Comply with California Cosmetics Safety Act prohibited substance list by reformulating out any prohibited substances. Tier 3: Conduct California Prop 65 compliance screening and add required warnings where applicable. Tier 4: Prepare for New York fragrance disclosure by documenting complete fragrance ingredient lists from your fragrance supplier (under an NDA to protect supplier confidentiality). Given that California and New York together represent approximately 20 percent of US cosmetics sales, Tiers 1 through 3 compliance is non-negotiable for any Taiwan cosmetics brand seeking meaningful US market presence.