The US buyer wants an FDA certificate: food and cosmetics usually have no such paper

Bottom line:

When a US buyer asks for an FDA certificate or “FDA Approved”, split the category first. For food and cosmetics the box is usually facility registration and product listing, not an agency diploma. FDA has said it does not issue a registration certificate.
A foreign food facility must name a US-resident agent. FDA will not confirm the registration or give a number until that agent agrees. Device registration and listing are not approval. Some devices still need a 510(k) or PMA you can check in the public databases.
Opening a Hong Kong store does not run this registration. A broker PDF with the agency seal is not an official paper. Agent fees and lab work sit in the contract. There is no official US-dollar price.

The inquiry says: “Need FDA certificate before PO.” Sales staples a CE, a factory inspection and a Trade Assurance screenshot. The buyer replies that none of that is FDA. The shop floor asks whether to print “FDA” on the carton or buy a certificate.

How radio equipment is authorised is on FCC. How a California warning is written is on Prop 65. Who stands as importer at CBP is on IOR. This page is only the FDA box: whether a certificate exists, whose name the registration sits on, and whether a Hong Kong company can be the US agent.

1. The certificate they want is not issued for food or cosmetics

The phrase in the email often stacks four paths onto one sheet. FDA’s food-facility FAQ says the agency does not honor or issue a certificate as proof of registration; a copy of a valid registration is the proof. The device consumer page says a facility that registers does not receive a certificate, and FDA does not “certify” the listing. A handsome PDF with the agency seal is usually a broker’s letterhead.

What they say	What it is	Issued with a Hong Kong store?
FDA certificate / FDA Certified	No such paper on the food, cosmetic or most device paths	No. A broker PDF will not match
Food facility registration	A foreign facility that makes, packs or holds food for the US must register and name a US agent	No. The registration sits on the facility, not the store account
Cosmetic registration / listing	MoCRA facility registration and product listing through Cosmetics Direct	No. A food number will not fill that box
FDA Approved / 510(k)	Premarket clearance or approval for some devices; registration alone is not that	No. The number must match the public database
CE / Trade Assurance / Verified audit	EU safety, an order clause, a factory system	Will not fill the FDA box

Ask whether this shipment is food, a cosmetic, a device or only a food-contact material. The four answers differ. Sending a food registration number into a device inquiry gets you a 510(k) request in the next mail.

2. Food: registration plus a US agent, not product approval

From 21 CFR 1.225: facilities that make food for the US, at home or abroad, must register unless a rule exempts them. Farms and some retailers are not in that sentence. A foreign facility must name a US agent — a person who lives or keeps a place of business in the United States and is physically there. FDA will not confirm the registration or issue a number until that agent agrees.

Registration puts the facility on the official inventory so the agency can find you and inspect. It does not mean the product is approved, the label reviewed or the formula safe. Low-acid canned and acidified foods still need FCE / SID. Importers have a separate Foreign Supplier Verification Program. A registration number will not fix a label or an additive.

Renewal follows FDA’s calendar that year; the usual window is 1 October to 31 December in even-numbered years. An expired registration can hold a shipment. Read Registration of Food Facilities that day. Do not copy last year’s group chat.

3. Cosmetics and devices use other doors

After MoCRA, cosmetic facility registration and product listing are duties, through Cosmetics Direct. FDA has said it will not issue a certificate, letter of good standing or verification email for those filings. Keep your own submission receipt and screenshots. A food-facility number and an EU Responsible Person address will not fill that box.

Devices: establishments that make or distribute devices intended for the US usually register annually and list. The FDA consumer page says registration and listing do not mean the establishment or the device is approved, cleared or authorised. Most class I devices skip premarket review; class II often needs a 510(k); class III takes PMA. When the buyer says “FDA Approved”, send the 510(k) or PMA number they can check in the FDA databases. That beats a homemade certificate.

Food-contact materials are often called “FDA” in chat. That box is the substance’s conditions of use or an FCN, not food-facility registration. Match the substance and the intended use. Do not send a plant registration number as a material approval.

4. A Hong Kong company cannot be the US agent

The food-path US agent must be in the United States. A Hong Kong registered office, a forwarder mailbox or a buyer’s purchasing inbox is not a name you type in. The agent can be the importer, a law firm or a specialist service — in writing. FDA emails that person to check. If they reply that they never agreed, the registration stops there.

Opening the store does not give you an agent or a number. DDP and “duty paid” only say who pays — see IOR. The importer can also be the agent, but write two contracts. Do not take a forwarder’s “we cover it” as both.

5. How to answer the inquiry

They ask	You can say	Do not say
Send FDA certificate.	Please confirm food, cosmetic or device. FDA does not issue a registration certificate for food or cosmetics. We can send the registration confirmation or listing receipt. If a device needs 510(k) / PMA, we will send a number you can check in the FDA databases.	Forward a broker PDF as an official certificate.
You are FDA approved.	Facility registration is not product approval. The food path is registration plus a US agent. Device approval is a 510(k) or PMA, not the registration number.	Write FDA Approved on the showcase.
Use our US office as your FDA.	The food agent must agree in writing and pass FDA’s check. We can talk about your office. We cannot type it into a Hong Kong seller showcase as already registered.	We will borrow your address for now.
CE / HACCP is the same as FDA.	CE is EU product safety. HACCP is a system. The US food box before import is facility registration and an agent. Three files.	CE means we can sell into US grocery.

Do not write “FDA passed” or “FDA certified” on the showcase. You can say the seller is a Hong Kong company, food follows facility registration and a US agent, cosmetics follow MoCRA listing, devices follow registration and the premarket path, and papers follow the category.

6. If you already wrote “we have FDA”

Tell sales the same day: stop sending prices that say “ready for the US / FDA certified”.
Ask of this US order: food, cosmetic, device or contact material; whether they want a registration number, a listing or a 510(k).
Keep FCC, Prop 65 and IOR in their own files. Do not retitle one PDF.
If you need to register: use the FDA portal and a written US-agent consent. Do not hand the master account to a broker. If you need a 510(k): match the public database. Do not buy an “urgent certificate”.
If the cargo is already moving: send the registration or premarket file that matches. Do not invent a registration number to clear the dock.

The membership still only buys the file and the showcases. Wire it to ALIBABA.COM HONG KONG LIMITED. Corpable does not file FDA, sit as the US agent or pay the registration or lab. Whether the agency inspects or releases a shipment follows their process that day. Do not write a penalty figure into the contract.

Questions teams actually ask

Do we need an FDA certificate before food can enter the US?

FDA does not issue a food-facility registration certificate. A foreign facility that makes, packs or holds food for the US must register and name a US-resident agent. A copy of a valid registration is the proof. A “FDA Certified” PDF with the agency seal is not what the agency issues.

Does opening Alibaba.com on a Hong Kong company give us FDA?

No. The membership buys showcases. It does not register a food facility or clear a device. A Hong Kong address cannot be the US agent.

Are cosmetics the same registration as food?

No. Cosmetics take facility registration and product listing under MoCRA, through Cosmetics Direct. FDA also issues no cosmetic registration certificate. A food-facility number will not fill that box.

If a medical device is registered, is it FDA Approved?

No. FDA says establishment registration and device listing do not mean approval, clearance or authorisation. Some devices still need a 510(k) or PMA, which you can check in the public databases. Writing “FDA Approved” against a registration number alone is treated as misleading.

Can the showcase say “FDA passed / ready for the US”?

Not without a matching registration, listing or premarket file. Agent fees and lab work sit in the contract. There is no site-wide official US-dollar price. Writing “certified” will be screenshotted back at you.

Can Corpable file FDA for us, or guarantee a US order will clear?

No. An advisor can help you see whether the buyer wants food registration, a cosmetic listing or a device 510(k). We do not sit as the US agent, file with FDA or promise a customs or buyer review. Membership fees still wire to ALIBABA.COM HONG KONG LIMITED.