Food Safety Registration for Importing Tea into the United States

Food Safety Registration for Importing Tea into the United States

Since the U.S. imports around 15 percent of its food supply, it needs a safety system in place. This gives Americans security in the food they can access, not only in terms of diversity and abundance but in quality as well. So if you want to import something like green tea from Japan, you must be well-versed in American safety and quality standards.

The U.S. Food and Drug Administration

The Food and Drug Administration (FDA) is a regulatory agency under the U.S. Department of Health. It is mandated to ensure the quality, safety, and efficacy of various health products, including drugs, food, cosmetics, and even health or medical devices and equipment.

It also works with foreign governments, the World Trade Organization and other international science-based standard-setting agencies to establish and harmonize global food safety standards and controls. Tea importers must fall within these arrangements to bring their products abroad.

The FDA Food Safety Modernization Act

In 2011, Congress enacted the Food Safety Modernization Act (FSMA). It provides that facilities that manufacture, process, pack, or store food products for U.S. consumption should ensure that their goods are sanitary, safe, and properly labeled according to American requirements.

These facilities are required to register with the FDA and give the assurance that the agency is allowed to inspect the facility at any time and in any manner permitted by law. Registration must be renewed every other year, and it can be suspended if the FDA finds a reasonable probability of the food manufactured, processed, packed, received, or stored by the facility being substandard and unsafe.

Tea importers may note that they don’t actually have to get prior sanction from the FDA to bring their product into the U.S. for trade. As long as the facilities that produce, hold, or generally handle the tea they’re importing are registered with the FDA, and they file prior notice of import shipment, they’re good to bring their product into the country.

Food Facility Registration

As implied above, the FDA has been directed to take measures to shield the public from terrorist threats or attacks on the country’s food supply. One of the steps the agency chose to take is to

require the registration of facilities used in the importation of food. If you’re a tea importer who wants to have your facility registered, what can you expect concerning the process?

First, you must have an account with the FDA Industry Systems (FIS). This is necessary for anybody who wishes to make electronic submissions to the FDA, something the agency encourages as it’s faster, more convenient, and generally more efficient.

With your account, log into the FIS and choose “Food Facility Registration” from the choices provided on the FDA Unified Registration Listing Systems. When you get to the Food Facility Registration Module, you’ll see 12 sections presented:

1. Type of Registration
2. Facility Information (name, address, etc.)
3. Optional: Mailing Address
4. Parent Company Information
5. Facility Emergency Contact Details
6. Trade Names
7. United States Agent
8. Optional: Facility Dates of Operation (Seasonal)
9. General Product Categories (For consumption of human, animal, or both)
10. Owner/Operator/Agent-in-Charge Information
11. Inspection Statement
12. Certification Statement

You get a chance to review your submission. Understandably, there are some fields you cannot alter, such as the type of registration, and if you change the facility location, you’d have to start the process over. However, if everything is correct, you can click “Submit.” If there are no problems, you will receive a message indicating that your registration submission was successful. It will also include your registration number and PIN. You may then view your complete registration and, if you wish to, print it out.

Importing Tea into the U.S.

Once you have registered your facility with the FDA through their website, there are other steps you expect to have to take to be able to import. One of them is to designate a U.S. agent to act as your liaison for all your communications with the FDA. The FDA will inform you through your agent regarding inspection schedules and confirmation of met safety requirements.

There is a company called Registrar Corp., which is endorsed on the FDA website in case you don’t have a stateside agent who can perform the following services for you:

• Registration Renewal
• Issuance of registration certificate
• Registration updates
• Prior notice filings
• Assistance in case of detained shipment
• Mock FDA inspection
• Assistance in obtaining and updating DUNS record
• FDA compliance monitoring

Another step you have to take as an importer is to obtain a complete set of required permits, including health certificates. You must also file a Prior Notice with the FDA to inform them of an incoming shipment. Once received at the port of entry, it will undergo a thorough inspection to ensure that it passes all food safety requirements. It goes without saying, of course, that you must be familiar with the FDA requirements for the food product category under which tea falls and ensure that you comply with each one.

The final step is making sure that your product is appropriately labeled. For example, tea that has been canned or packed must bear information on the country of origin, ingredients, and nutrients. The FDA permits different labeling formats. Find ones that fit your product packaging.

Summary

While there’s no need to register the actual tea you’re importing for safety, there is a need to register the facility that handles it. There’s also no need to get prior sanction from the FDA before bringing in the tea, but there is a need to file prior notice about its shipment. The United States government is very serious about ensuring the quality and safety of its food supply. So make sure that, besides meeting these requirements, you also go through every hoop to ascertain that your tea is eligible for import.

Food Safety Registration for Importing Tea — Frequently Asked Questions

What is FDA Food Safety Registration? What is the FDA Food Safety Modernization Act? Do tea importers need FDA approval before importing? How do I register a tea facility with the FDA? How often must FDA Food Facility Registration be renewed?

What is FDA Food Safety Registration?

FDA Food Safety Registration is the process by which any facility that manufactures, processes, packs, or stores food products for U.S. consumption — including imported Japanese tea — must register with the U.S. Food and Drug Administration. The requirement was established under the 2011 Food Safety Modernization Act (FSMA). Registration confirms that the facility meets federal sanitation and labeling standards and gives the FDA the right to inspect the facility at any time, in any manner permitted by law.

FDA Prior Notice - Everything You Need To Know

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What Is TRACES for Tea Importing?

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What is the FDA Food Safety Modernization Act?

The Food Safety Modernization Act (FSMA) was enacted by Congress in 2011 to strengthen U.S. food safety standards in response to growing import volumes — the U.S. now sources roughly 15% of its food supply from abroad. Under FSMA, facilities handling food for U.S. consumption must register with the FDA, maintain sanitary operations, and submit to FDA inspection on demand. The registration must be renewed every other year, and the FDA can suspend it if there is reasonable probability that the facility's food is substandard or unsafe.

Do tea importers need FDA approval before importing?

No — tea importers do not need to obtain prior FDA approval to bring tea into the United States. However, two conditions must be met: the facilities that produce, hold, or generally handle the tea must be registered with the FDA, and a prior notice of import must be filed for each shipment. Once both are in place, the tea can enter the U.S. market for trade. Failure to register the facility or file prior notice can result in shipment detention or rejection at the border.

FDA Prior Notice - Everything You Need To Know

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How do I register a tea facility with the FDA?

Start by creating an account on the FDA Industry Systems (FIS) — the digital portal for electronic submissions. Log in, navigate to the Unified Registration Listing System, and select "Food Facility Registration." The form has 12 sections to complete: type of registration, facility information, optional mailing address, parent company details, facility emergency contact, trade names, U.S. agent, optional seasonal operation dates, general product categories, owner/operator/agent-in-charge information, inspection statement, and certification statement. Review carefully — some fields cannot be edited after submission.

How often must FDA Food Facility Registration be renewed?

FDA Food Facility Registration must be renewed every two years. The renewal happens between October 1 and December 31 in even-numbered years. Missing the renewal window can cause the facility's registration to be cancelled, which in turn blocks imports from that facility. Registrants should set calendar reminders well in advance — the FDA also sends renewal notifications to the U.S. agent on file for the facility. Maintaining current registration is one of the simplest but most important compliance steps for any tea importer.

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