FDA MoCRA Compliance for Taiwan Cosmetics Exporters: What Changed and What to Do

The Modernization of Cosmetics Regulation Act (MoCRA), signed into US law in December 2022, is the most significant overhaul of US cosmetics regulation since 1938. For 85 years, US cosmetics were largely self-regulated — companies could sell cosmetics without notifying the FDA unless a product was a drug-cosmetic hybrid.

MoCRA changed this fundamentally. For the first time, all US cosmetics manufacturers and importers — including Taiwan brands — must register their facilities with the FDA, submit product listings, maintain safety records, and report serious adverse events.

For Taiwan cosmetics brands selling or planning to sell in the US market, MoCRA compliance is now a legal requirement, not a voluntary quality measure. Non-compliant brands face FDA warning letters, import alerts, and potential import bans.

Amazon began enforcing MoCRA compliance documentation in 2024. Sellers in the Beauty category may be asked to provide FDA facility registration numbers and product listing confirmation as part of Amazon's ongoing compliance audits.

Every facility that manufactures or processes cosmetic products for distribution in the United States must register with the FDA under MoCRA — including overseas facilities. If your Taiwan factory manufactures cosmetics shipped to the US, that factory must register.

Registration deadline: The initial registration deadline was December 29, 2023. If your facility is already manufacturing for the US market and has not registered, you are currently non-compliant. Register immediately at FDA's Cosmetics Direct portal (free registration, no fee).

What you need to register: facility name and address, facility type (manufacturer, processor, packer, or labeler), owner/operator contact information, US agent information (required for foreign facilities — a US-based person or company designated to receive FDA communications on your behalf), and the broad categories of cosmetic products manufactured.

US agent requirement: every foreign facility must designate a US agent — an individual or company physically located in the United States available to receive FDA communications during business hours. This can be your US distributor, a compliance consultant, or a professional registered agent service. The US agent does not need to be a lawyer.

Registration renewal: facilities must renew registration every two years (odd-numbered years: 2025, 2027, etc.). The FDA will send renewal reminders to registered facilities.

In addition to facility registration, each cosmetic product line must be listed with the FDA. Product listing must be submitted within 60 days of first marketing a product in the US, and updated annually thereafter.

Information required for each product listing: product name, cosmetic category (FDA provides a standard list of categories), list of ingredients (in descending order of predominance, using INCI names), the name and contact information of the responsible party, and the facility registration numbers of all facilities where the product is manufactured or processed.

INCI names: International Nomenclature of Cosmetic Ingredients names are standardized ingredient names used globally. If you already sell in the EU (which also requires INCI ingredient lists on cosmetics labels), you likely already have this information. Use the exact INCI names — do not substitute trade names or proprietary names.

Responsible party: the entity that markets the cosmetic product in the US. For a Taiwan brand selling directly to US consumers via Amazon, the responsible party is typically the Taiwan company. For a brand working through a US distributor, the distributor may take on the responsible party role.

Submitting product listings: use FDA's Cosmetics Direct electronic portal. The portal accepts bulk uploads for companies with large product portfolios. Keep copies of all submission confirmations.

Safety substantiation: MoCRA requires that all cosmetics are safe when used as intended, and that manufacturers have documentation to support this. You must maintain safety records — but the law does not specify exactly what form these records must take.

Practical approach to safety substantiation: maintain records of all safety assessments, toxicology reviews, dermatologist testing results, and relevant scientific literature supporting your ingredient formulations. For cosmetics already sold in the EU (which has stricter pre-market safety requirements), your existing EU Cosmetic Product Safety Report (CPSR) provides strong evidence of safety substantiation for MoCRA purposes.

Serious Adverse Event Reporting (SAER): MoCRA requires manufacturers and importers to report "serious adverse events" to the FDA within 15 business days of receiving the report. A serious adverse event is one that results in hospitalization, a disability or permanent damage, birth defect, or death, or that requires medical intervention.

You must also keep records of all adverse events (not just serious ones) for 6 years. This means setting up a consumer complaint management system that captures, categorizes, and tracks all product-related health complaints from US customers.

Practical recommendation: add a product safety complaint tracking process to your US market operations. Designate a person responsible for reviewing Amazon customer messages and reviews for health-related complaints and escalating potential serious adverse events for FDA reporting.

MoCRA added two new labeling requirements that apply to all cosmetics sold in the US:

Allergen labeling: products that contain any fragrance allergens on the FDA's designated list must list those allergens on the product label. The FDA published its initial list of fragrance allergens in 2024. This affects virtually all fragranced products — perfumes, scented lotions, shampoos, body washes.

Professional-use cosmetics labeling: cosmetics intended for professional use only (salon products, medical aesthetics products) must bear a "For professional use only" label. This is a new requirement under MoCRA.

Existing FD&C Act labeling requirements (still in effect): product identity statement, net quantity of contents, ingredient list in INCI names in descending order of predominance, name and address of the responsible party, and directions for safe use.

Label review before market entry: if you are preparing to enter the US cosmetics market, have your labels reviewed by a US regulatory attorney or compliance consultant before printing. Relabeling 10,000 units of product because of a labeling error costs far more than a one-time label review.