US Import Requirements Overview for Japan-Origin Products

US cosmetics: MoCRA changed the landscape

The Modernization of Cosmetics Regulation Act (MoCRA), enacted in 2022, materially expanded FDA authority over cosmetics for the first time since 1938. For overseas brand owners exporting Japanese OEM cosmetics to the US, the practical impacts:

• Facility registration. The Japanese OEM factory manufacturing cosmetics for the US market must register with FDA. Registration is by facility, not by product.
• Product listing. Each cosmetic product placed on the US market must be listed with FDA. The Responsible Person — the entity whose name is on the product label — files the listing. The Responsible Person may be the foreign brand if it lists a foreign address, but a US Agent is typically required for FDA communications.
• Safety substantiation.The Responsible Person must hold records substantiating the safety of the product. The form of the substantiation is not prescribed but must be adequate to the product's risk profile.
• Adverse event reporting. Serious adverse events must be reported to FDA within 15 business days, and a 6-year retention requirement applies.
• Good Manufacturing Practice. FDA is developing cosmetic GMP regulations under MoCRA authority. ISO 22716 alignment is commonly the practical baseline ahead of final FDA GMP rules.

US food: FDA registration, FSMA, and Prior Notice

Most food and dietary supplement imports go through the FDA framework. Three foundational pieces:

• Food Facility Registration. Required for facilities producing, packing, or holding food for consumption in the US. Includes Japanese OEM factories. Registration must be renewed every two years.
• FSMA Foreign Supplier Verification Program (FSVP).The US importer must verify that the foreign supplier produces food meeting US safety standards. Documentation requirements scale with risk category.
• Prior Notice. For each shipment of food into the US, the importer (or another authorised party) must submit Prior Notice to FDA before arrival. Failure to file results in shipment refusal.
• US Agent. A US-domiciled agent must be designated for FDA communications.

USDA scope and FTC labelling

• USDA. Most cosmetics, ordinary food, and supplements are outside USDA scope. USDA jurisdiction covers meat, poultry, and processed egg products, plus organic certification under the National Organic Program. Japan equivalents (JAS Organic) are not automatically recognised in the US — separate USDA Organic certification through an accredited certifier is required for the US Organic mark.
• FTC.Federal Trade Commission jurisdiction covers advertising and labelling claims (including online). Claims must be truthful, non-deceptive, and substantiated. Country-of-origin claims under the "Made in USA" framework are heavily enforced — "Made in Japan" is generally straightforward as long as the production is actually in Japan.

Customs and origin

• HTSUS classification. 10-digit US tariff schedule. Same first 6 digits as the WCO HS; US-specific extensions.
• US–Japan trade agreements. The US-Japan Trade Agreement (USJTA, 2019) and the US-Japan Digital Trade Agreement (2019) provide preferential tariffs for some categories. Coverage is narrower than US-Japan negotiations for a full FTA. Origin self-certification accepted where the agreement applies.
• Section 301 tariffs. Some Japan-origin goods have at times been affected by US trade actions; check current tariff schedules. Most cosmetics, food, and supplements are not currently affected.
• Customs broker. Most overseas buyers use a US customs broker to file the CBP entry. The broker may also file the FDA Prior Notice and coordinate any FDA hold or examination.

Practical sequencing for Japan-origin US launch

1. Confirm the Japanese OEM factory has registered (or will register) with FDA for Food Facility Registration (food / supplements) or MoCRA facility registration (cosmetics).
2. Identify the Responsible Person (cosmetics) or US importer (food / supplements) and ensure US Agent designation is in place.
3. File the MoCRA product listing (cosmetics) or prepare FSMA documentation and Prior Notice procedures (food / supplements).
4. Design US-compliant English labels including required statements (net contents, ingredient list, distributor / importer name and address, country of origin, allergen declaration).
5. Engage a US customs broker for CBP entry filing.
6. On arrival, CBP entry and (for food / supplements) FDA Prior Notice processed; goods released after admissibility confirmed.