Thousands of products regulated by the U.S.
Food and Drug Administration, or FDA,
are imported into the United States every single
day.
The FDA is responsible for most of the nation's food
supply, human and animal drugs, medical devices,
and many other products, such as biologics,
cosmetics, tobacco products, and products
that emit radiation.
If you want to import a product regulated by the
FDA, it's important that you understand the FDA's
import process and what importers are required to
do.
Here's why.
Working with your suppliers up-front to
ensure that your FDA-regulated imports meet
all FDA requirements is not only good for
business, it's the law.
And the FDA works with all parties throughout the
supply chain to ensure that imported goods are
safe for American consumers.
Products must comply with the FDA's requirements.
If they don't, they may be refused entry.
There are five major phases to the FDA's import
process: One - Preparing to import.
Two - Entry submission.
Three - Entry review.
Four - Examination and sampling.
And five - Compliance review.
If, at any point after entry submission the
FDA determines that your products do not need
further review or examination, they'll be
released.
Otherwise, the agency will continue to review until a
final admissibility decision can be made.
Let's look at these five import phases in more
detail.
Phase One: Preparing to Import.
This first phase starts with the importer who
holds legal responsibility for the products they
intend to import into the United States.
Well-prepared importers will ensure - ahead of
time - that the products in their shipments comply
with the FDA's laws and regulations.
They'll also need to gather information about
the products in the shipment.
This includes information about the manufacturer and
related firms, the product, and any
applicable FDA requirements, such as
registration, listing, and clearance or approval
information, based on the product and intended use.
For more information on this process, refer to the
website on your screen.
Phase 2: Entry Submission.
Information about products arriving by ship, truck,
rail, or airplane at one of the many U.S.
ports of entry must be submitted, or declared, to
U.S.
Customs and Border Protection, more simply
known as "Customs." For FDA-regulated products,
Customs forwards the information to the FDA for
a product-specific admissibility review.
Your shipment is referred to as an "entry" and each
unique product in that shipment is called a
"line" in the entry.
You will need to submit or "file" specific data
elements for each product line, which will be
reviewed by the FDA.
Some importers prefer to hire a customs broker to
file their entries.
Brokers are individuals licensed by Customs to act
on behalf of importers.
Your broker will file your entry electronically in a
portal called the Automated Commercial
Environment, or "ACE." ACE allows brokers to send and
receive information to Customs and other agencies
like the FDA, in real-time.
Customs conducts the initial review of your
entry to assess compliance with Customs laws, and
collects duties, tariffs, and fees, depending on the
product and its country of origin.
Customs may issue a "Conditional Release,"
which allows the importer to move the shipment from
the port of entry - generally to a nearby
location in case the FDA requests an exam.
The importer must hold the shipment intact until the
FDA issues a final admissibility decision.
Phase 3: Entry Review.
Once the FDA has received information about your
shipment from Customs, your products will undergo
an automated electronic review using a risk-based
analytics tool.
Products that are flagged for additional FDA review
must be held intact until the FDA makes a final
admissibility decision.
The FDA's entry review system will forward
information about your products to the local FDA
import office where your shipment entered the
United States.
An FDA entry reviewer will assess the information to
determine if any products can be released or appear
to be violative, or if additional information is
needed, such as entry documents from the
importer or broker.
The entry documents consist of Customs forms,
invoices, bills of lading, and any other
documentation that would be helpful for the
reviewer to determine if your products are
admissible.
For example, you may consider providing
additional documentation such as an end-use letter,
product label, ingredients list, certificates, or
processing records.
The information contained in these documents can
help fill in information gaps and help the FDA
verify the product's compliance, resulting in
the FDA's release of your products.
If the reviewer still needs more information
beyond what is available in the documents, they may
request that your shipment be physically examined.
If that happens, you will be notified that the FDA
needs the location of your products.
If information indicates that any product in the
shipment may be in violation of FDA
requirements, the product will continue to be held
for a compliance review.
We'll discuss that a bit later.
Importers and brokers can monitor real-time status
of the shipment, submit entry documents and
locations for exam, and receive Notices of FDA
Action via an online portal called the Import
Trade Auxiliary Communications Systems, or
"ITACS" for short.
A link to the portal can be found at itacs.fda.gov.
Phase 4: Examination and Sampling.
If the FDA requests to examine your products,
it's your responsibility to notify the local FDA
office when your products are available for
examination.
Once you provide the location, the FDA will
arrange to examine the products.
During the exam, the investigator will
physically examine the products and may collect
one or more samples to be tested at an FDA
laboratory.
How the product is examined and whether a
sample is collected for testing depends on what
the product is, the known hazards for the product
type, and any other information the FDA has
gathered during the review process.
Products that appear to be compliant after the
physical exam which have no other concerns may be
released by the FDA.
If the physical exam suggests the product
appears to be violative, or if a sample was
collected, the results will be forwarded to the
FDA's local Compliance Branch to determine
whether the product can be released or should be
detained.
Phase 5: Compliance Review.
The Compliance Branch will review the evidence
gathered from documents, the physical exam, or
laboratory results to determine if the product
is in violation of any FDA laws or regulations.
If the product appears to be compliant, it will be
released.
If the product appears to be violative, it will be
detained, and a Notice of FDA Action will be issued
to the importer and broker with a list of the
violations observed by FDA staff.
The importer is then given a "detention and hearing
period" to present evidence or testimony to
demonstrate that the product is not violative.
If the evidence or testimony successfully
overcomes the appearance of violation, the product
can be released.
If the importer cannot overcome the appearance of
violation, the product will be refused entry into
the United States.
The Compliance Branch will issue a Notice of FDA
Action explaining the reasons for the FDA's
refusal decision and notify Customs.
The importer will then apply to either export the
refused product or have it destroyed, a process that
must be completed within 90 days after the date of
refusal.
As you've learned, there are five potential phases
of the import process.
Importers who are in full compliance with the FDA's
requirements are unlikely to see the last few phases
four or five.
To learn more about the FDA import process and
product-specific requirements, consult the
FDA's website.
Remember, you can find the real-time status of an
active shipment, submit entry documents and
locations for exam, and retrieve Notices of FDA
Action via the ITACS system at the website on
your screen.
We look forward to working with you and bringing safe
and secure products to the American people.