U.S. FDA EXPORT REGULATIONS – Part 3: Food Labeling, Prior Notice, U.S. Agent Requirements


There are lots of things that your buyers
may tell you they want. But there’s, again, a difference between what
are legal requirements and requirements of the FDA, and what maybe additional requirements
placed on you by your buyer in the United States. So, requirements to focus on, food, drug and
cosmetic act as I said earlier, is the overriding regulation, but within that law, which has
been amended many times, will focus on the Bio Terrorism Act, labeling and other areas
of importance such as low acid can food regulations, HAACP, and good manufacturing principle, practices
requirements. So firstly, the U.S. Bioterrorism Act. This came about in 2002. It required that effective October of 2003,
that companies Register their facility with FDA. A facility being a factory or a warehouse. So, a site where you’re producing the product
or storing the product. In an essence, this registration requirement
allow the FDA to gather information about the products being shipped to the United States. So, you’re providing to FDA in the registration. Information about who, what, where, when. All about your company about the products
that you’re producing and that you intend to export to the United States. The registration is done through what’s called
a Food Facility Registration module or an FFRM. This can be done directly with the FDA or
you can have a third party assist you actually in completing the registration. It is a one time registration. However, it must be updated within sixty days
Of any change in your data. So, if you’ve indicated to FDA that you’re
producing seafood and then you launch into a produce line as well or some other type
of processed foods, you need to update your registration. If the contact details for your facility have
changed and your production manager who’s listed in your registration as your emergency
contact is not longer in that location, then that information needs be updated as well. Now once you’ve registered, you are assigned
an eleven digit number and this number, again, is given by the US Food and Drug Administration,
but that is all you will receive from FDA. You’ll receive this 11 digit number. Register our corp as a private company. We do assist with registrations and we will
issue a Certificate of Registration that is a third party verification. It serves as evidence to potential or current
customers of yours that you have registered with the FDA and you’ve complied with those
registration requirements. Within the registration requirement, you are
required to designate a US agent for FDA Communications. The US agent must have a physical presence
in the United States, must be available to communicate with the FDA twenty fours a day,
seven days a week. It’s very important that whoever you choose
to be your US agent, whether it is a private company such as ourselves, or whether it is
a customer or even a relative that they are available to answer FDA, if FDA contacts them
with questions about your facility or a particular shift. The essence of an agent, the entire role of
the agent, is the agent speaks for you as a registered firm. When the agent speaks to the FDA, it is as
though you are speaking with FDA yourself. You may have many customers in the United
States You may have customers out on the west coast or the east coast, but only one agent
for FDA communications is designated in your registration with FDA. And that is, again, is the company or the
individual that FDA will contact if they have a question about your shipment. Now let’s take a quick look at how many companies
are actually registered with FDA. There are approximately 370,000 companies
worldwide that are registered. About 150,000 of those companies are here
in the United States, and approximately 250, 260 thousand are registered all over in about
another 150 countries around the world. We can see here some of the statistics that
will give you an idea and for the countries, your countries, that interest us today. Cambodia: 28, Laos: 27, we have the Philippines
at fifteen hundred and sixty-one, and Vietnam at five thousand, five hundred and fifty-one
companies. Those numbers give you a little bit of an
idea as well of how active those countries are in exporting certainly to the United States. Now another part of the Bioterrorism Act is
something called Prior Notice. So once you have registered your facility
with the FDA and you’re ready to begin shipping to the United States. You’re required to file something called Prior
Notice which is, in essence, a notification, submission of information, that you give to
FDA for each and every shipment of food or beverages that will arrive in the United States. It is a time-sensitive submission where you
must tell FDA details about the shipment. Where it is coming from, how many cases, how
many cartons, who’s the manufacturer, who it’s going to, what the product is, when it
will arrive. These are all of the different details that
you provide to FDA in the submission called Prior Notice. Prior notice is not an approval. You don’t submit the data and then FDA says,
“Okay. It’s approved.” Go ahead and ship it, it won’t be stopped. What prior notice allows FDA to do, it allows
them to look at the approximately 20,000 shipments of food that arrives into the United States
everyday and it allows them to target their resources and target their inspections by
deciding which shipments they would like to take a closer look at. It’s impossible for them to look at everything. And in fact, FDA only inspects less than 2%
of all shipments of food products arriving into the United States. So, it’s actually a very, very small number
of shipments that physically are looked at by FDA. Part of that again goes back to the information
that’s submitted in the prior notice. It allows FDA to focus their resources on
what they consider to be the highest risk shipments. Now Talk briefly about food labeling. Again, I could spend a lot of time, an hour
even, two hours just on food labeling. But let me give you some very basic guidelines
on food labeling. All labeling must be in English. However, bilingual labels, trilingual, as
many languages as you would like are permitted, and the only rule you need to focus on is
that if you have any foreign language on your label, the entire label will need to be translated. So, in other words, you have to have certain
things said about your product in English and if you choose to translate it, then you
must translate everything that’s said in English. You must translate it entirely as well into
Vietnamese. This again is to prevent companies from making
certain very specific statements or claims about their product in their native language
in hopes that perhaps someone here in the United States, the Vietnamese Population will
see that product and maybe there’s claims on there in Vietnamese, but those same claims
are not made in English. So, again English, but any other language
is fine as long as it’s translating what is said, the mandatory information, that is said
in English. There are very strict guidelines, regulation,
concerning the formatting of the nutrition fact chart, which is what I have up here in
the little picture. Also regulations and requirements on the font
size of the lettering, there are requirements regarding what ingredients are permitted and
also, there are ingredients that are not permitted non-grass ingredients. And an area where companies often have a lot
of difficulties is with health claims. There are certain claims that you may be able
to make about your product with regards to health benefits, but those are very closely
regulated by FDA. So, if you have a product that you want to
make claim, So you’ll need to be very cautious about that.

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