Chapter 2: U.S. Import Regulations and Policies

Updated: 2026-10-21 — This chapter was rewritten for U.S. importers. It now explains how product rules, classification, origin, duties and documents fit together, and the tariff and de minimis statements are checked against official sources.

Import compliance starts before a supplier quotes. The importer must identify the product, its intended use, the materials and components, the country of origin, the users and the sales channels. Those facts determine which agencies, product rules, entry requirements and duties may apply. A supplier’s past shipment or a marketplace badge does not establish compliance for your product.

Start with the product, not a certificate name

There is no universal certificate that makes every product legal to import into the United States. Requirements change by product and use. Food, cosmetics, medical devices, children’s products, electrical products, chemicals, wireless devices, vehicles and agricultural goods can each involve different agencies and evidence.

“FDA certification” is often used too loosely. FDA oversight is product-specific. A registration, listing, clearance, approval or facility requirement is not interchangeable with a general quality certificate. Ask which rule applies to the exact product and which party must complete each action. Do not accept a document simply because its filename contains “FDA.”

CE marking is sometimes listed as if it were a U.S. import requirement. It is not. CE marking is an EU requirement for products covered by EU rules that call for it (Your Europe: CE marking), and it does not replace U.S. compliance. If the same product will be sold in both markets, maintain separate market-specific compliance files.

Build a U.S. compliance map before ordering

Write a short regulatory profile and have the appropriate regulator, customs broker, laboratory or specialist review it. Include:

the product’s plain-language description and commercial use;
the intended user, including whether children may use it;
materials, ingredients, coatings, batteries, radio functions and power supply;
claims that will appear on the product, packaging and listing;
the likely HTSUS classification and country of origin;
the federal agency or agencies that may regulate it;
state requirements and sales-channel requirements that may also apply;
the tests, records, labels and certificates that must be complete before shipment.

Keep regulatory requirements separate from buyer preferences. A retailer may demand a test or audit that is not a legal import requirement. Conversely, a platform accepting a listing does not prove that the product meets federal or state law.

Classify the goods and confirm origin

The HTSUS classification controls the normal duty rate and can also determine whether additional duties, restrictions or reporting requirements apply. Classification depends on the product’s material, construction, function and sometimes how it is packaged. A vague description such as “accessories,” “parts” or “samples” is not enough.

Use the current HTSUS and review relevant CBP rulings, but do not copy a competitor’s code without comparing the facts. Give your broker drawings, photographs, material breakdowns, technical sheets and the proposed use. For an uncertain or high-value classification, ask about obtaining a binding ruling before regular shipments begin.

Country of origin is not always the same as the country of shipment. Simple repacking or routing through another country does not automatically change origin. If components and processing span multiple countries, ask a qualified adviser to review the production facts. Keep the supplier’s origin support in the import file.

Understand the current U.S. duty stack

As of 2026-10-21, the duties on goods of China can include the HTSUS normal trade relations rate, the continuing China Section 301 duties, the additional Section 301 duty that began on July 24, 2026 subject to its exemptions, Section 232 duties where applicable, antidumping or countervailing duties where applicable, and customs user fees. Do not estimate landed cost from one headline tariff rate.

As of 2026-10-21, the China technology-transfer Section 301 actions remain in effect (USTR notice, October 7, 2026): 25 percent on Lists 1 to 3, 7.5 percent on List 4A, and the higher rates set in 2024 for specific products. A separate 12.5 percent Section 301 duty on products of China applies to goods entered on or after 12:01 a.m. eastern time on July 24, 2026, except products listed in the notice’s exemption annexes (USTR notice, 91 FR 47318). Whether a list or an exemption covers your product depends on its HTSUS code, so check the annexes for that code with your broker.

As of 2026-10-21, do not use the old $800 de minimis exemption in a U.S. cost model. It ended for goods from China and Hong Kong on May 2, 2025 (Executive Order 14256) and was suspended for all countries from August 29, 2025 (Executive Order 14324). CBP has since made the suspension indefinite for every mode except mail from June 24, 2026 (91 FR 37789) and for mail from July 24, 2026 (91 FR 37801). Ask the broker or carrier which entry type and fees apply to each shipment.

Duty is based on classification, origin, customs value and the programs that apply to that combination. Antidumping and countervailing duty exposure deserves separate attention because a scope decision can depend on technical product details and producer or exporter information. A sourcing quote should never promise a final U.S. duty result.

Assign the importer role clearly

The commercial agreement should identify who will act as importer of record and who will give instructions to the customs broker. Delivered pricing does not remove the need to understand the declaration made to CBP. Avoid arrangements where the seller will not disclose the broker, declared value, classification or importer identity.

The importer should give the broker accurate product and transaction information, review entry summaries, keep supporting records and correct discovered errors through the proper process. A broker can prepare an entry, but the importer should not treat brokerage as a transfer of all responsibility.

Prepare the core shipment documents

Document requirements vary, but a commercial shipment commonly uses a commercial invoice, packing list and transport document. Regulated goods may require permits, declarations, test evidence or agency filings. The document set must agree on the parties, product description, quantities, weights, value, currency, origin and shipping terms.

Document or record	Buyer check
Commercial invoice	Complete product description, buyer and seller, quantity, price, currency, origin and terms of sale
Packing list	Package count, contents, net and gross weight, dimensions and marks
Bill of lading or air waybill	Correct shipper, consignee, routing, package count and cargo description
Classification file	Product facts, HTSUS rationale, rulings reviewed and broker confirmation
Compliance file	Applicable rules, test reports, labels, declarations and responsible parties

Describe the product accurately. Calling commercial goods a gift, sample or part does not replace the real description or value. If assists, tooling, commissions, packing or related-party pricing could affect customs value, raise them with the broker before entry.

Control supplier-provided compliance evidence

Ask for reports and certificates early enough to review them before production. Match the company name, factory, model, materials, photographs, standards, test dates and laboratory details to the goods you are buying. A genuine report for a different model is not evidence for your order.

Put compliance into the purchase order. State which materials may not change, which labels must be applied, which documents must be delivered and which tests require passing results. Require written approval for substitutions. If a component changes after testing, determine whether the existing evidence still covers the final construction.

Verify labels, claims and packaging

Review the physical product, retail package, manual and online listing together. Origin marking, warnings, tracking information, ingredient or identity statements and responsible-party details may depend on the product. Marketing claims can create additional obligations, especially claims about safety, health, performance or environmental benefits.

Wood packaging, batteries, liquids and other restricted cargo also affect the shipping plan. Tell the forwarder what the shipment contains and ask what packing, declarations and carrier approvals are needed. Regulatory review and transport acceptance are related but separate checks.

Use a release gate before shipment

Do not make final payment or authorize loading merely because production is complete. Use a release checklist:

Confirm the final product matches the approved specification and compliance evidence.
Review inspection results and any corrective action.
Check labels, manuals, carton marks and packaging.
Reconcile the invoice, packing list and booking information.
Have the broker confirm classification, origin, value, current duties and agency filings.
Confirm the importer of record, bond and entry arrangements.
Release the shipment only after material exceptions are resolved in writing.

Rules can change between product development and entry. Re-check the tariff notices, agency requirements and product-specific rules shortly before each shipment, not only when the order is placed.

Import from China 101 – Chapter 2: U.S. Import Regulations and Policies