Does your product need FDA compliance to import into the US?

Status by product family

Registration-required (no pre-market approval, but you must register/comply before import): dietary supplements, most cosmetics, and the facility side of food. Cosmetics changed materially under MoCRA — facility registration and per-product listing are now required, with a designated responsible person maintaining safety substantiation. This catches a lot of small beauty sellers who assumed cosmetics were unregulated because FDA doesn't 'approve' them.

Prior-notice / declaration required (per-shipment action): food (Prior Notice before arrival) and radiation-emitting electronics (Form FDA-2877 at entry). Clearance-required (authorization before you can sell at all): medical devices and drugs — these are professional-review territory, not a checkout-speed compliance step.

What happens at the border if you're not compliant

CBP refers every FDA-regulated entry to FDA. FDA screens the entry data and issues 'May Proceed', or a Notice of Detention and Hearing (you get about 10 business days to respond), then Refusal — at which point the goods must be destroyed or exported within 90 days under CBP supervision, at your cost. A refused shipment is a total loss plus fees.

The practical order for a seller: identify whether your product is FDA-regulated, get the registration/listing/notice done before you ship, and for devices/drugs get the authorization confirmed by a regulatory professional before ordering inventory. This page tells you which gate applies; it is not legal or regulatory advice.

Common questions

I sell cosmetics from overseas on Amazon. Do I really need MoCRA registration?

If you're the responsible person placing cosmetics on the US market, MoCRA facility registration and product listing apply — FDA began enforcement in 2024. Marketplaces increasingly ask for compliance too. Confirm your responsible-person status for your setup.

Are supplements easier because FDA doesn't approve them?

Easier than drugs, not exempt: facility registration applies, new dietary ingredients need a 75-day notification, and labeling/claims rules are enforced. 'No approval' is not 'no rules.'

Official sources behind these numbers

• Prior Notice must be submitted to FDA before human or animal food is imported or offered for import into the US (mandated by the 2002 Bioterrorism Act, in effect since Dec 12, 2003). Filed via CBP ABI/ACE or FDA's Prior Notice System Interface (PNSI); no FDA fee. FDA · verified 2026-07-24 · effective 2003-12-12
• Domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the US must register with FDA (Section 415 FD&C Act; Bioterrorism Act 2002, amended by FSMA). Registration must be renewed every even-numbered year between Oct 1 and Dec 31. No fee. FDA · verified 2026-07-24
• Under DSHEA, FDA does NOT approve dietary supplements before they are marketed. Facilities must register (food facility registration), and marketers wishing to use a New Dietary Ingredient (NDI) must submit an NDI notification to FDA at least 75 days before introducing the product into interstate commerce. FDA · verified 2026-07-24
• Under MoCRA (Modernization of Cosmetics Regulation Act of 2022), facilities that manufacture or process cosmetic products for US distribution must register with FDA and renew every two years. Statutory deadline was Dec 29, 2023; FDA delayed enforcement until July 1, 2024. FDA · verified 2026-07-24 · effective 2024-07-01
• Under MoCRA, the 'responsible person' must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually. Same July 1, 2024 enforcement date as facility registration. FDA · verified 2026-07-24 · effective 2024-07-01
• Under MoCRA, the responsible person must ensure and maintain records supporting adequate substantiation of safety of the cosmetic product, and must report serious adverse events to FDA within 15 business days. FDA · verified 2026-07-24
• Establishments producing/distributing medical devices for US commercial distribution must register annually with FDA and list their devices. Foreign device establishments must comply before/during/after import. FDA · verified 2026-07-24
• Many medical devices require FDA marketing authorization before US sale/import (e.g., 510(k) clearance, De Novo, or PMA approval). At import the owner/operator provides the premarket submission number (510(k)/De Novo/PMA/PDP/HDE). FDA · verified 2026-07-24
• Radiation-emitting electronic products (e.g., lasers, and many products with electronic emissions) subject to a US Federal Performance Standard require Form FDA-2877 (Declaration for Imported Electronic Products Subject to Radiation Control Standards) at time of entry; FDA verifies the declaration. FDA · verified 2026-07-24
• CBP refers all FDA-regulated products to FDA for review. FDA screens entry data; compliant entries may receive a lower risk score and 'May Proceed' release. Apparent violations get a Notice of Detention and Hearing (respond-by typically 10 business days, up to 20 calendar days); unresolved shipments are refused admission. FDA · verified 2026-07-24
• FDA determines admissibility, but CBP physically enforces FDA import decisions: refused/detained shipments must be destroyed or exported under CBP (and FDA) supervision. FDA does not 'approve' most cosmetics or supplements pre-market, yet products must still comply at the border. FDA · verified 2026-07-24