US product compliance for importers
Children's products, lithium batteries, wireless electronics, food contact and California Prop 65. What each one actually requires, why the certificate your factory sent probably is not the document you need, and the one scheduling mistake that turns a compliance problem into a whole new production run.
What the product is decides this, not where it was made
Importers tend to think about compliance as a China problem. It is not. The requirements attach to what the product is and who uses it, and they would be identical if it were made in Ohio. What manufacturing overseas changes is only how far away the person is who has to actually do the thing.
The second thing worth knowing early: for goods entering the United States, the obligation sits with the importer. Not the factory. Your supplier agreement can allocate cost and blame between you privately, and it does not move the duty. The regulator's counterparty is whoever brought the goods in.
This is a plain-language summary to help you ask better questions before you commit money. It is not legal or regulatory advice, requirements change, and for anything high-risk a regulatory consultant is genuinely worth the fee.
Five regimes small importers actually hit
Pick the one that matches your product. Many products hit more than one: a children's tablet is CPSIA and FCC and UN 38.3 at the same time.
Anything designed or intended primarily for children 12 and under. Toys, furniture, clothing, feeding items, and a great deal that people do not think of as a children's product until the CPSC does.
A Children's Product Certificate, plus third-party testing that supports it.
This is the part that surprises people. Domestic manufacturers and importers issue the CPC. A certificate the factory hands you is not the document the law asks for, and the obligation stays with you whatever they said.
Not the factory's in-house lab and not a certificate with an unfamiliar logo. The list of accepted labs is published, and it is worth checking the name on any report you are handed against it.
Product identification; each safety rule it is certified to; the manufacturer or importer's name, address and phone; contact details for whoever holds the test records; the month, year and place of manufacture; the dates and places of testing; and the testing lab's name, address and phone. In English.
Because it carries the month and place of manufacture, a new run needs its own. A certificate from last year's batch does not cover this year's.
What CPSIA compliance actually involves, in order
Identify which children's product safety rules apply to your article: lead content and lead in paint apply to nearly everything, and then category rules stack on top for toys, cribs, bunk beds, bicycles, clothing with drawstrings, small parts, and a long list besides. Have the product tested by a CPSC-accepted laboratory against each one. Issue the Children's Product Certificate yourself, as importer, listing every rule. Then apply tracking labels.
Tracking labels are separate from the certificate and get forgotten
CPSIA requires a distinguishing permanent mark on the product and its packaging, where practicable, carrying the manufacturer, the location and date of production, and enough detail to identify the batch. It exists so a recall can be narrowed to one run instead of everything you have ever sold. It is a factory instruction and belongs in the purchase order.
Retesting is triggered by change, not by the calendar
A material change to the product, its materials or its manufacturing process requires retesting and a new certificate. Changing resin supplier, changing paint, moving to a second factory: all are material changes. This is why a certificate from last year's run does not carry forward.
Amazon and the major retailers ask for it before they ask anything else
Practically, a children's product listing that cannot produce a CPC and lab reports on request is a listing that gets suppressed. Product testing for Amazon in this category is the same testing the law already required; the platform simply enforces it faster than a regulator would.
Power banks, anything rechargeable, anything with a coin cell. Including products where the battery is a minor feature nobody thinks about.
UN 38.3 test summary, correct packing instruction, and state-of-charge control for air freight.
The 30 percent state-of-charge limit for air transport now applies mandatorily to cells and batteries packed WITH equipment under packing instruction 966, where it had previously been a recommendation. Loose cells were already capped at 30 percent. Batteries installed inside a device are still permitted at up to 100 percent.
If your product ships as a device with a separate battery in the box, the charge level has to be right when it is packed. That is a production instruction, and discovering it at the airport means the shipment does not fly.
UN 38.3 testing is done once per cell or battery design, and the summary must be made available. Ask for it by name at the quotation stage. A supplier who cannot produce it for the exact cell they are using has not done it.
Lithium batteries are dangerous goods by sea as well as by air. The declaration, packing and labeling differ, and undeclared batteries in an ocean container is a serious matter rather than a paperwork slip.
What UN 38.3 testing covers
Eight tests, run on the cell or battery design rather than on your finished product: altitude simulation, thermal cycling, vibration, shock, external short circuit, impact or crush, overcharge, and forced discharge. They simulate what transport does to a cell. A design passes once, and the resulting test summary follows that design.
The test summary is a defined document you are entitled to receive
It has to identify the cell or battery, the manufacturer, the test lab, the test report reference and date, and confirm which tests were performed. Ask for it by name at quotation, and check the cell it names is the cell in your product. A summary for a similar cell from the same factory is not a summary for yours.
Which packing instruction applies changes everything
Lithium battery shipping rules split by whether cells travel alone, packed with equipment, or installed in equipment, and each route has its own packing instruction, labeling and documentation. Getting this wrong is not a paperwork correction: an incorrectly declared shipment is refused, and an undeclared one is a serious matter for the shipper of record, which is you.
Air and ocean both apply, with different paperwork
Air is stricter and moves faster; ocean is not an exemption. Both need the goods correctly classified, packed, marked, labeled and declared, and both need a shipper who knows they are handling dangerous goods before the container is stuffed.
Anything that emits radio frequency energy. Wi-Fi and Bluetooth obviously, and also a great many things that merely contain a clock circuit or a switching power supply.
Either Certification with an FCC ID, or a Supplier's Declaration of Conformity, depending on which kind of device it is.
If it deliberately transmits, which means Wi-Fi, Bluetooth, any radio, any remote control, it goes through the full Certification route and is issued an FCC ID that appears on the product.
Digital devices that emit RF energy as a side effect rather than on purpose can use the lighter SDoC route, holding test reports and a compliance information statement rather than obtaining an ID.
The responsible party named must be in the United States. An overseas factory cannot be it, which in practice means the importer is.
A pre-certified wireless module can carry its approval into your product, and only within the conditions of its grant: antenna, placement, enclosure, host. Changing any of those can require testing you were told you had avoided.
What FCC certification for imported electronics requires
For an intentional radiator, testing at an accredited laboratory, submission through a Telecommunication Certification Body, and a grant of certification carrying an FCC ID that must appear on the device or in its electronic label. For an unintentional radiator, testing and a Supplier's Declaration of Conformity that you hold rather than file.
The compliance information statement is a real deliverable
Under SDoC you must be able to produce, on request, the test report and a statement identifying the product and naming a responsible party located in the United States, with contact details. An overseas factory cannot be that party. In practice the importer is, and that is a role with obligations rather than a formality.
Using a pre-certified module does not automatically transfer its grant
A module carries its approval into a host product only within the conditions of its grant: the specified antenna, the antenna placement, the enclosure, and often the host category. Change the antenna or move it and you may need testing you were told you had avoided. Ask the module vendor for the grant conditions in writing before designing around it.
The marking has to be right on the goods
The FCC ID, or the SDoC compliance statement, has to be on the product where it can be found. Like every other marking requirement, it is cheap at the factory and expensive in a US warehouse.
Anything that touches food or drink in normal use. Bottles, tumblers, utensils, cookware, storage, packaging, and anything with a coating or gasket that touches the contents.
Materials that are lawful for food contact, and documentation showing which basis they are lawful on.
The FDA does not approve, certify or register drinkware. It regulates the substances. Any 'FDA certificate' for a finished article, and they circulate widely, is not the document it appears to be. This single misunderstanding causes more false confidence in this category than anything else.
Each substance in the food-contact layer has to be lawful: covered by a regulation, the subject of an effective food contact notification, generally recognized as safe, prior-sanctioned, or below the threshold of regulation. What you want from a supplier is a statement of which basis applies, with the material specified.
'Food grade silicone' is a marketing phrase. A named polymer, a grade, and a statement of the compliance basis is a document. The gap between those two is where the risk lives.
The lid seal, the interior coating, the printed inner surface. People specify the body of the product carefully and inherit whatever the factory uses for everything touching it.
What a 'food grade certificate from China' is actually worth
Usually very little on its own. There is no FDA registration, approval or certificate for a finished food-contact article, so a document titled that way is either a test report against some standard, a supplier's own declaration, or a certificate issued by a body with no US authority. Any of those can be useful evidence and none of them is the thing people believe they are receiving.
Ask for the specific thing instead
For each material in contact with food: the polymer or alloy and its grade, the compliance basis (a citation to the regulation, an effective food contact notification number, GRAS, prior sanction, or below the threshold of regulation), and a test report against the relevant extraction conditions for how the product is actually used. Hot liquid, acidic food and repeated dishwasher cycles are different conditions with different results.
Every layer that touches food counts
The interior coating, the lid gasket, the printed inner surface, the valve, the straw, the adhesive. Brands specify the body of the product carefully and inherit whatever the factory uses for the parts they never asked about, which is usually where a problem starts.
California adds a second question
Food-contact articles are a common source of Prop 65 exposure claims, particularly around metals in ceramics, glazes and some alloys. Answering the FDA question does not answer the California one.
Effectively anyone selling to US consumers, because almost nobody excludes California. Applies across categories: metals, plastics, leather, cables, ceramics, cosmetics, food.
A clear and reasonable warning where a listed chemical exposure occurs, or evidence that it does not.
As of 1 January 2025 the short-form safe-harbor warning must name at least one chemical for each endpoint claimed. There is a three-year transition ending 31 December 2027: products manufactured on or after 1 January 2028 have to use the new format. Product already labeled before then can sell through without a time limit.
The practical consequence of the change is that a business cannot apply a generic warning as cheap insurance any more. Naming a chemical means testing or a supply-chain declaration that identifies it.
Prop 65 is enforced substantially through private actions, and the economics of that mean small importers do receive notices. The usual first contact is a letter, not a regulator.
Slapping a warning on everything used to be the standard defensive move. It is a weaker position under the new rules and it can hurt conversion. Knowing what is actually in your product is the durable answer.
Prop 65 warning requirements: what a compliant warning has to contain now
A warning symbol, the word WARNING, and text naming at least one listed chemical for each endpoint you are warning about, along with the P65Warnings website reference. The short-form option, which previously allowed a generic warning with no chemical named, now requires a chemical too. Food products have their own separate safe-harbor wording.
The deadline that matters
The amended rules took effect on 1 January 2025 with a three-year transition running to 31 December 2027. Products manufactured on or after 1 January 2028 must use the new format. Anything labeled before that can sell through with no time limit, so existing inventory is not stranded.
The warning has to reach the buyer before the purchase
Which for ecommerce means the listing page, not just the box. A warning that appears only when the product arrives has not done the thing the rule asks for.
Naming a chemical means knowing what is in your product
The practical effect of the amendment is that blanket warnings as cheap insurance no longer work. You need testing or a supply chain declaration specific enough to name the substance, which is a sourcing task with a lead time rather than a labeling decision at the end.
Where compliance goes wrong is when, not what
Most importers eventually find out what applies to them. The expensive ones find out in the wrong week.
The immovable fact is that certification has to rest on the goods you are actually selling. Sample testing tells you the design can pass. It is not a certificate for the run. So the test that matters happens on production units, which is after the deposit, after tooling, and usually while the freight is already booked.
Build it into the purchase order and the inspection schedule at the start, and it is a line item. Discover it at the end and it is a rework, a new run, or a container of goods you own and cannot lawfully sell.
- At RFQ, before you shortlistName the market and ask which regimes the supplier has produced to before. A factory that has never shipped a certified version of your product into the US is not disqualified, and it is a different project.
- Before toolingSome compliance outcomes are decided by material and geometry. Finding out after the mold is cut is the expensive version.
- On the golden sampleSample testing tells you whether the design can pass. It is not the certificate, because the certificate has to cover the goods you actually sell.
- On production units, before shipmentThis is the one people compress and it is the one that cannot be. Testing has to be done on units from the run. A failure found here is a rework or a new run; a failure found after the container lands is goods you own and cannot lawfully sell.
- Kept, for as long as it mattersCertificates, test reports, and the contact details of whoever holds the records. Retention obligations differ by regime and the practical rule is that you keep them for as long as the product is in the market, plus a sensible margin.
We are not a certification body
What we do is identify what applies to your product, write it into the purchase order so it becomes the factory's contractual obligation rather than a conversation, and coordinate third-party testing alongside the inspection program so it happens on production units at the right moment. We do not issue certificates and we are not a regulatory consultancy. For novel products, medical-adjacent claims or anything where a failure is a safety matter, get a specialist, and we will tell you when we think that is the case.
Frequently asked
My factory says the product is already certified. Is that enough?
Almost never on its own, and the question to ask back is: certified to what standard, by which laboratory, for which market, on what date, and against which production run. A certificate for a similar product, for the EU rather than the US, or for a batch made two years ago is a real document that does not cover your goods. For children's products specifically, the certificate the law wants is one the importer issues, not one the factory hands over.
Who is legally responsible, me or the factory?
For goods entering the United States, the importer carries the obligation. That is uncomfortable and it is also the entire point: an overseas factory is difficult for a US regulator to reach, so the duty attaches to the party who brought the goods in. Whatever your supplier agreement says about indemnities, the regulator's counterparty is you.
What is the most expensive mistake?
Leaving testing until the goods are made. Compliance testing has to be done on production units, so a failure discovered at that point is either a rework or an entire new run, and either way it lands after you have paid a deposit and booked freight. The second most expensive is assuming an 'FDA certificate' for a finished food-contact product means something. It does not; the FDA regulates the substances, not the object.
Do I need to test if I am just reselling someone else's product?
If you are importing it, you are generally the party with the obligation, even if the product is not yours in any design sense. Private label and straight resale both put you in the chain. What changes is that you may be able to rely on documentation from further up it, provided it actually covers your goods and you hold it.
What does compliance testing cost?
It depends entirely on the regime, the number of tests, the number of materials and colors, and the lab. We are not publishing a range for the same reason there are no freight rates on this site: it would be wrong for most people reading it. What is worth knowing is that testing is almost always small next to a failed production run, which is what it is insuring against.
Is labeling part of compliance?
Overlapping but not the same thing. Compliance decides whether the product may lawfully be sold; labeling decides whether it can be identified, scanned and imported. Country of origin marking is a legal requirement in its own right, and marketplace identifiers are a commercial one. We cover those separately in barcodes, labeling and packaging, and both belong in the same purchase order.
Does this cover the EU or UK?
No. This page is about importing into the United States. CE and UKCA marking are separate regimes with their own conformity routes, their own documentation and their own responsible-person requirements, and treating a US clearance as evidence for either is a mistake in both directions.
Can you handle this for us?
We identify what applies, get it written into the purchase order so it is the factory's obligation rather than a hope, and coordinate testing with a third-party laboratory as part of the inspection program. We are not a certification body, we do not issue certificates, and for anything unusual or high-risk a regulatory consultant is worth the money and we will say so.
What is a CPC, or Children's Product Certificate?
The certificate a US importer issues for a children's product, declaring it complies with every applicable children's product safety rule, based on testing at a CPSC-accepted third-party laboratory. You issue it, not the factory, and it has to identify the rules, the lab, the testing date and the place of manufacture. It must accompany the shipment and be furnished to distributors and retailers on request.
What is a UN 38.3 test summary?
The document proving lithium cells and batteries have passed the UN Manual of Tests and Criteria section 38.3 tests, which cover altitude, thermal, vibration, shock, short circuit and overcharge. Manufacturers and distributors have to make the summary available, and a freight forwarder or airline will ask for it before anything containing a lithium battery moves. Get it from the cell manufacturer at sampling, not at booking.
FCC ID or SDoC, which does my product need?
It depends on whether the product deliberately transmits. Intentional radiators, anything with WiFi, Bluetooth or a radio, generally need certification through a Telecommunication Certification Body and carry an FCC ID. Unintentional radiators, which is most powered electronics that merely emit interference as a side effect, generally take a Supplier's Declaration of Conformity instead. Get this settled before tooling, because it can change the enclosure.
Send us the product
What it is, who uses it, whether it has a battery, whether it transmits, and whether anything touches food. That is enough to tell you what you are walking into.
- Requirements written into the PO, so they are the factory's obligation.
- Testing scheduled on production units, not on a sample and a hope.
- Third-party labs engaged on your behalf, with the quote shown to you.
Tell us about your project
We'll come back with a scope and a quote. If we're not the right fit, we'll say so.