Importing Wet Wipes into the USA: Customs & FDA Guide

Short answer

To import wet wipes into the USA, first fix the product’s regulatory category: cleansing wipes are cosmetics (MoCRA product listing by the company on the label), antiseptic hand wipes are OTC drugs, and surface disinfecting wipes are EPA-registered pesticides that also need an EPA Notice of Arrival. Then handle customs: for ocean freight, an Importer Security Filing at least 24 hours before loading in China, a customs bond, entry through a licensed customs broker with FDA data, and “Made in China” origin marking. Check state “Do Not Flush” labelling laws before printing.

Which US regulator applies to your wet wipes?

Product	Category	Before you import
Baby, facial, makeup, personal care wipes (cleansing only)	Cosmetic (FDA)	MoCRA product listing by the responsible person; facility registration by the manufacturing facility; safety substantiation; FDA-compliant labelling
Hand wipes claiming to kill germs	OTC drug (FDA)	Drug establishment registration and listing; compliant Drug Facts label
Surface disinfecting or sanitizing wipes	Pesticide (EPA)	EPA-registered product made in an EPA-registered establishment; Notice of Arrival before arrival
Cleaning wipes without germ claims	General consumer product	Labelling under consumer product rules where hazardous

The difference between cosmetic, drug and pesticide claims is explained in antibacterial vs disinfecting wipes, and MoCRA duties in wet wipes regulations by market. FDA lists facility registration and product listing requirements on its MoCRA registration page (FDA).

What are the customs steps for an ocean shipment?

Appoint a customs broker and decide who is the importer of record (usually your US company).
Customs bond. An Importer Security Filing must be secured by a bond, and formal entries need one too; your broker can arrange a single-transaction or continuous bond.
Importer Security Filing (ISF, “10+2”). For vessel cargo, seller, buyer, importer and consignee numbers, manufacturer, ship-to party, country of origin and HTSUS number must be filed no later than 24 hours before the cargo is loaded at the foreign port (19 CFR 149.2). CBP warns that non-compliance can lead to penalties, more inspections and delays (CBP).
Entry filing with the HTSUS classification, value and FDA data for FDA-regulated products.
FDA entry review (see below), duty payment and release.

Your supplier’s job is to provide accurate commercial documents early: commercial invoice, packing list, manufacturer name and address, and any product codes your broker asks for. Duty rates and any additional tariffs on goods from China change; ask your broker for the current rate for your classification rather than relying on old quotes.

How does FDA review imported wet wipes?

When a shipment contains FDA-regulated products, CBP sends the entry data to FDA. FDA screens every entry electronically; complete and accurate data can lead to release without further review, while higher-risk or incomplete entries go to human review, document requests, examination or sampling (FDA).

FDA lists common reasons cosmetics are refused entry, including unsafe ingredients or contaminants, colour additive violations, microbial contamination, labelling deficiencies such as missing English information, and claims that make a cosmetic a drug (FDA). If a product is detained, FDA issues a Notice of Detention and Hearing; if the violation cannot be overcome, the product is refused and must be destroyed or exported (FDA).

Do imported wet wipes need “Made in China” marking?

Yes. Unless an exception applies, every imported article or its container must be marked legibly, indelibly and permanently with the English name of the country of origin, so the ultimate purchaser can see it (19 CFR 134.11). For retail packs, the retail buyer is the ultimate purchaser, so print “Made in China” on each consumer pack, not only on the export carton. CBP’s guidance adds that marking must be easy to find with casual handling and not covered by later additions (CBP).

What extra steps apply to disinfecting wipes?

Imported pesticides, including disinfecting wipes, need an EPA Notice of Arrival (EPA Form 3540-1, or its electronic equivalent) submitted before the shipment arrives, and the product must match its EPA registration, label and producing establishment (EPA). If you sell a registered product under your own brand, that is usually done as a supplemental distributor of the registrant. Without registration, do not make germ-killing claims at all.

Which state rules should you check?

Several states, including California, Washington, Oregon, Illinois, Colorado, Michigan and New Jersey, require non-flushable wipes such as baby wipes to carry a “Do Not Flush” symbol with set size and placement. Plan this on the artwork before printing (see Do Not Flush labeling laws by state). If you sell through Amazon, also prepare for expiration-date and FBA rules (see Amazon FBA prep for wet wipes).

What is the US import checklist?

Regulatory category confirmed: cosmetic, OTC drug, pesticide or general product.
MoCRA listing / drug listing / EPA registration in place as needed.
English label with required elements, “Made in China” and state symbols.
Customs broker, importer of record and bond arranged.
ISF filed 24 hours before loading; EPA Notice of Arrival for pesticides.
Commercial invoice, packing list and manufacturer details accurate and consistent.

This is a buyer summary, not legal or customs advice. Your customs broker and compliance adviser should confirm the details for your product.

Plan your first US shipment

Tell us your product type and port. We agree US-compliant labelling with the partner factory and prepare the documents your customs broker needs.

Get a quote for US delivery Regulations by market

Frequently asked questions

Do I need FDA approval to import wet wipes?

Not for cosmetic wipes: FDA does not approve cosmetics before sale. MoCRA requires product listing by the responsible person and facility registration, and FDA reviews imports at entry. Antiseptic hand wipes are OTC drugs with drug requirements.

When must the ISF be filed for wet wipes shipped by sea?

The main Importer Security Filing elements must be filed no later than 24 hours before the cargo is loaded onto the vessel at the foreign port.

Do wet wipes need “Made in China” on each pack?

Yes, unless an exception applies. Country of origin must be marked so the ultimate purchaser, the retail buyer for consumer packs, can see it.

What extra import step applies to disinfecting wipes?

An EPA Notice of Arrival must be submitted before the shipment arrives, and the product must match its EPA registration and be produced in an EPA-registered establishment.

Can LX Wipe ship wet wipes to the USA?

Yes. LX Wipe supplies wipes from partner factories with US-compliant labelling agreed in the specification, and provides the commercial documents your customs broker needs. Terms such as FOB, CIF or DDP are agreed in the quotation.

Sources

Regulatory information is a summary for buyers and is not legal advice. Check the official sources and your own compliance adviser before launch. Last reviewed 18 October 2026.