FDA Prior Notice – Everything You Need To Know
The Food and Drug Administration (FDA) of the United States has been directed to become the food regulations agency representing the Department of Health and Human Services by the Public Health Security and the Bioterrorism Act of 2002 (Bioterrorism Preparedness and Response Act). The FDA is responsible for taking all the necessary steps to ensure that public health is safe from a threatened or actual terrorist attack on the food supply of the United States.
Now, according to this Act, the FDA should be given a notice on the import shipment known as the prior notice. In this article, we are going to unleash everything there is to know regarding the FDA’s prior notice. Plus, if you’re wondering whether you need prior notice for importing tea or not, we’ve got you covered for that as well. So, stay tuned.
What is an FDA Prior Notice?
FDA prior notice is a notification that is given to the Food and Drug Administration (FDA) of the United States that informs about the imported food shipments before they arrive in the country. The FDA prior notice contains information regarding the product, say tea, its quality, quantity, and packaging. It also gives details about the related facilities of the products, such as the product’s manufacturer, owner, shipper, and most importantly, the consignee.
Why does the FDA require a Prior Notice?
FDA requires prior notice for three main reasons:
- It helps to buy them some time to review and evaluate the product information given in the prior notice.
- It helps to deploy better resources to conduct all the necessary inspections.
- It aids in intercepting the contaminated products from the imported food shipment.
All of this is done before the arrival of your imported goods.
Which of the industrial sectors are affected by the Prior Notice?
The prior notice affects about five industry sectors that include:
- Foreigner and domestic importers
- Foreign and domestic brokers and filers
- Foreign and domestic exporters
- Foreign and domestic growers and manufacturers
- Foreign and domestic cross-border transporters (truck, air, rail, ship)
It is obligatory to provide FDA prior notice if you want to import, export, transport food through/into the United States.
Do you require Prior Notice for importing tea?
Yes, you do require prior notice for importing tea to the United States or transshipping it through the US to the rest of the world. However, there are some exemptions that may apply to particular tea imports.
Tea imports that require Prior Notice
- Tea that is being imported for distribution, storage, or use in the United States (these imports also include gifts, market research samples, trade samples, and quality control/quality assurance samples)
- Tea transshipped to any other country via the United States
- Tea imported for use in a Foreign Trade Zone or for exports in the future unless some exemption applies.
Some Exemptions on the Tea Imports
- Tea that is brought into the country by an individual for that individual’s personal use. It is not for sale and distributive purposes. It involves the consumption of this tea by that individual, individual’s family, and friends.
- Tea leaves refined or modified by a person in their own residence and sent as a gift to a person who lives in the United States
- Tea that is being exported without leaving the arrival port until its export
- According to the authority in The Vienna Convention on Diplomatic Relations’ Article 27(3), tea in diplomatic pouches or bags is exempted.
What information is required for FDA Prior Notice?
Although brokers or the importers themselves provide all the necessary information to CBP (Customs and Border Protection) of the United States for the prior notice upon the arrival of tea, the FDA requires the below mentioned details before the imported goods enter the premises of the United States and you must provide this information.
Let’s take a closer look at what these details are:
- Name, telephone number, address of your business, and email of the person who submits the prior notice. If required, you also need to provide the name and address of your firm.
- Name, telephone number, email, and business address of the individual who transmits the prior notice on the behalf of the submitter. If required, the transmitter will also need to provide the name and address of the firm.
- Type of Entry. If an identifier is available, you need to provide a CBP identifier
- Identification of each food article present in the import shipment
- FDA Code of tea
- The market or common name of the tea
- The estimated quantity of the product
- Code number, lot, or any other identifier (if your imported food product has one)
- If the imported tea is in its natural condition, you need to give the name and location of the manufacturer
- If the tea is not in its natural state, you need to give the name of the manufacturer and either 1) the manufacturer’s country, city, and the registration number, or 2) both the manufacturer’s full address along with the reason why the registration number isn’t given (you can choose the reason from the ones listed in the Compliance Policy Guide for Prior Notice of Imported Food)
- FDA Production Country
- The name and full address of the shipper
- Country from where you’re importing your tea. However, if you import your tea leaves via international mail, you will need to provide the anticipated mailing date along with the name of the country from where the food is mailed
- Anticipated information of the arrival of your imported tea (time, location, and date). However, if you import tea by international mail, you will provide the name and address of the U.S. recipient
- Name and address of the consignee, importer, and owner. However, you will need to provide the name and full address of the U.S. recipient if you’re importing for transshipment via the U.S.
- Carrier and transportation mode (except for the products that are imported by international mail)
- Planned information of the shipment (except for the products that are imported by international mail)
- The name of the country for which the article refuses entry (2011 IFR)
If you want to import tea to the United States, you will need to fulfill all of these aforementioned requirements.
If you want to know more about FDA prior notice requirements, click here.
Who can give the FDA a Prior Notice for importing tea?
Any person who has all the necessary information regarding tea along with the manufacturer of tea can submit the prior notice. The person can be the importer, exporter, agent of the United States, manufacturer, and broker.
When should you give the FDA a Prior Notice for importing tea?
Prior notice for importing tea must be submitted before the import shipment arrives at the first port in the U.S. – the port of arrival. The deadline for the submission of the prior notice depends upon the transportation mode you choose for importing tea.
However, in the case of the shipment arriving by international mail, you must submit the prior notice: 1) 30 days before the arrival of your tea if you submit your notice via ACS/ABI, or 2) 15 days before the arrival of your shipment if you submit your notice via PNSI of FDA.
Take a look at this picture below to know the deadlines.
How to Give an FDA Prior Notice?
You need to electronically submit your prior notice through any one of the below-mentioned systems:
- The Automated Commercial System (ACS) of the CBP
- The FDA Prior Notice System Interface (PNSI)
Both of these systems allow you to submit your notice as a part of the entry process to avoid any kind of duplication of your information. If the ACS doesn’t work, you need to submit the prior notice via the FDA’s PNSI that is ready to be at your service 24 hours a day, 7 days a week.
If the FDA’s PNSI isn’t also working, the FDA will provide an official notice along with the instructions to submit your prior notice on the webpage of the system’s website.
Do you need some help with your FDA Prior Notice?
If everything is a little tricky for you, you can take some help from the online tutorials provided by the FDA on the PNSI. This system interface also has interactive feedback and Help features that can assist you every step of the way. With the help of these features, the submitter will be able to minimize omissions and spelling mistakes.
If you want to import goods, particularly tea or tea leaves, to the United States or transship them through this country, you must provide a Prior Notice to the Food and Drug Administration (FDA) of the United States.
We hope this guide proves to be helpful and answers your every query regarding the FDA Prior Notice and prior notice for importing tea. However, there are certain things you need to take care of before submitting a prior notice.
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