Download FDA Presentation - Columbus Importers and Brokers Association

US FDA
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The Federal Food, Drug, & Cosmetic Act is a
multitude of laws that ensure the safety and
efficacy of foods, cosmetics, medical devices,
drugs, biological products, and radiation emitting
devices distributed in the United States
(www.fda.gov/opacom/laws/fdcact/fdctoc.htm).
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The US FDA is responsible for enforcing the laws
contained within the FD&C Act.
FD&C Act, Section 801
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Various sections within the FD&C Act, especially Section
801, require US CBP to deliver samples of FDA regulated
commodities, offered for import into the United States,
to the FDA.
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FDA relies on HTS codes to correctly classify commodities (FD0,
FD1, FD2, FD3, & FD4) to ensure FDA is aware of regulated
commodities offered for import.
As the amount and complexity of FDA regulated imports has
grown tremendously, FDA officers are responsible for examining
and sampling regulated commodities offered for import.
US FDA/US CBP & Liquidated
Damages
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During the process of examination and
sampling, FDA relies on US CBP to keep
the commodities from being distributed.
 US
CBP requires importation bonds for
regulated commodities of 3 times the entered
value to ensure the commodities are available
for FDA examination or returned to the sender
if refused entry by FDA (19 USC 1623).
US FDA/US CBP & Seizures
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If, during the process of examination, FDA
officers find regulated commodities that pose
immediate risk to public health, FDA will request
US CBP to exercise their authority to seize the
commodities.
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According to US CBP law, commodities may be seized
if their importation is subject to any restriction that is
imposed by law relating to health, safety, or
conservation (19 USC 1595a(c)(2)A).
US FDA/US CBP & Penalties
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FDA relies upon US CBP to issue monetary penalties
and/or restrictions to all parties involved in the
intentional/unintentional act of falsifying or omitting
materials used during the importation of regulated
commodities.
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US CBP can penalize for intentional (fraud) and unintentional
(negligence) acts to include monetary penalties and revocation
of broker license (19 USC 1592).
Penalties are an effective tool used by US CBP, at the request of
FDA, to ensure brokers exercise responsibility when supplying
information to FDA (19 USC 1641).
RADIATION EMITTING
PRODUCTS
Articles, under CDRH purview, (a) that are operated by an electrical
current and emit (with or without radiation shielding) electronic product
radiation (ionizing (X rays), non-ionizing (UV, visible, IR, microwaves,
radiowaves), sonic, infrasonic, and ultrasonic), (b) which are used as a
component of (a).
Affirmation of Compliance for Radiation Emitting Products (often on the
2877, but rarely legible):
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RAA (1=prior to standard, 2=exclude b/c, 3=personal(3units),
4=repair/return, 5=components (no diagnostic Xrays), 6=prototypes (QUAN
limited), 7=export only)
RAB (1=ACC, 2=unknown MAN)
RAC (1=research/training/investigation (TIB), 2=trade show (TIB))
RAD (1=approved petition (petition not uploaded but attached), 2=petition
request (TIB), 3=request to be submitted (TIB ).
MDL (product model number)
ACC (accession number)
WWW.FDA.GOV
COSMETICS
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Articles, under the purview of CFSAN, (a) intended to be rubbed, poured, …
or otherwise applied to the human body for cleansing, beautifying, … or
altering the appearance, (b) intended for use as a component of (a).
 Common types of import:
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Bulk ingredients
 CAS number is always helpful for identification of bulk ingredients.
 Color Additives:
 Subject to and exempt from batch certification
www.cfsan.fda.gov/~dms/opa-col2.html
Finished product
 Use the ~45 characters in the product description field to identify
product
WWW.FDA.GOV
HUMAN DRUGS
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Articles, under CDER purview, (a) recognized in USP-NF or HP, (b)
intended for use in the diagnosis, treatment, or prevention of disease, (c)
intended to affect (other than food) structure and function of the body,
(d) intended for the use as a component of (a), (b), or (c).
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Common types of import:
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BULK API
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BULK FINISHED
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Affirmations of Compliance for bulk entries:
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DLS (drug listing number)
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NDA (new drug application number)
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ANDA (abbreviated new drug application number)
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IND (investigational new drug)
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IFE
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PERSONAL IMPORTATION OF MEDICINES
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Two routes:
1.
Medical necessity, under physician care, for treatment that cannot be obtained
in US.
2.
Continuation of treatment that began in another country.
WWW.FDA.GOV
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MEDICAL DEVICES
Medical devices, under CDRH purview, are instruments, ... in vitro
reagents, ... components, parts, or accessories which are (a) intended for
use in the diagnosis/treatment of disease or (b) intended to affect the
structure or function of the body.
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Common types of import:
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Affirmations of Compliance:
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Components for further manufacture
Finished devices (class I to III)
Miscellaneous (investigational, R&D, personal use)
DEV (facility registration)
LST (product listing)
PMN (pre-market notification aka 510k)
PMA (pre-market approval)
IDE (investigational device exemption)
IRC (impact resistance certificate for pesky sunglass entries)
IFE
WWW.FDA.GOV
BIOLOGICAL PRODUCTS
Biological products, under CBER purview, consist of viruses, serums, (anti)
toxins, vaccines, blood, blood components/derivatives, human tissue, and
allergenic products used to diagnose, treat, prevent disease in humans.
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Common types of import:
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Affirmations of Compliance:
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Licensed products (blood, plasma, vaccines, allergenic products)
Combination biologic/drug (anticoagulants in blood collection bags)
Combination biologic/devices (systems that test blood or aid in blood collection)
Miscellaneous (products in short supply, autologous blood, R&D)
BFL (Biological Establishment License)
OR
BPL (Biological Product License Number)
Combination bio/drug :IND or NDA and DLS
Combination bio/device :IDE or PMN and LST
IFE
WWW.FDA.GOV
ALL THINGS FOOD
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Articles, under CFSAN purview, used for food or drink, chewing gum, and all components used
to manufacture such articles (food and composing ingredients).
Any substance, under CFSAN purview, which results … directly or indirectly … in it becoming a
component … of any food (food contact substances).
A dye, pigment, or other substance, under CFSAN purview, … when applied to a food … is
capable of imparting color (color additives).
Problem areas for filers:
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Low Acid or Acidified
 Affirmations of Compliance:
 FCE (food canning establishment number)
 SID (schedule identifier number)
Seafood:
 HACCP (MOU or accompanying documentation)
Food Contact Substances:
 www.cfsan.fda.gov/~dms/opa-indt.html
Food Additives:
 www.cfsan.fda.gov/~dms/eafus.html
Color Additives:
 Subject to and exempt from batch certification
 www.cfsan.fda.gov/~dms/opa-col2.html
WWW.FDA.GOV
Animal Friendly
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Almost all products used to feed and treat animals are under
CVM purview.
Most imported products for animal use must be submitted to
FDA for review, but import regulations are often not the same
for commodities intended for humans versus commodities
intended for animals .
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Devices for veterinary use will not be approved and listed and
manufacturers will not be registered (radiation emitting devices must have
valid product reports).
Generally, bulk animal drugs will need to be listed and approved, while
personal importation of unapproved drugs are reviewed on a case-by-case
basis by CVM.
Most animal biologics are regulated by USDA.
Animal cosmetics are not subject to FDA.
Animal feeds are subject to Prior Notice.
Prior Notice of Imported Foods
• According to the Bioterrorism Act, FDA must be
notified in advance of any shipments of food for
humans and other animals that are imported into
the United States.
• Exclusions include:
• Food carried or otherwise accompanying an individual arriving
in the U.S. for that individual’s personal use.
• Food made by an individual in his/her residence and sent by
that individual as a personal gift to an individual in the U.S.
• Food that is exported without leaving the port of arrival until
exported.
• Meat, poultry, & egg products subject to USDA jurisdiction.
Foods
• Food, as defined by the FD&C Act, is (a) any
article used for food or drink for man or other
animals, (b) chewing gum, (c) any article used as
a component of (a) or (b) to exclude food contact
substances and pesticides.
• Food imported for use, storage, or distribution in U.S. to
include gifts and trade (not manufactured in residence),
QA/QC, and research samples.
• Food transshipped through U.S. to another country (i.e.
port of entry in U.S. and trucked across border to MX).
• Food imported for future export, or food for use in a
FTZ.
Submission of PN
• PN may accompany the entry
electronically ( ABI/ACS → OASIS ) or
as a hardcopy generated from FDA’s
PNSI.
• PN will only be accepted by e-mail or fax
when ABI/ACS/OASIS and PNSI are not
functional.
PN Timeframe
By land via road
Between 5 days and 2 hours
before arrival
By land via rail
Between 5 days and 4 hours
before arrival
By air
Between 5 days and 4 hours
before arrival
By water
Between 5 days and 8 hours
before arrival
By international mail
Before the food is sent
Accompanying an individual
Within timeframe for
applicable mode of
transportation
WHO should submit PN
• Any individual with knowledge of the
required information to include
manufacturers, exporters, brokers,
importers, and designated U.S. agents.
• WWW.FDA.GOV
FDA Product Coding
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When importing FDA-regulated commodities, five data elements
must be accurately submitted to FDA.
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Commercial Description
FDA Manufacturer (actual manufacturer of goods)
FDA Shipper
FDA Country of Origin (country in which FDA manufacturer is located)
Product Code
These five elements are critical in determining the amount of time
FDA will allocate to the review of the proposed entry (i.e.
automated proceed via OASIS versus FDA officer proceed).
As FDA is moving toward a more risk-based approach to import
regulation, the product code will be the greatest indicator of risk
and thus the most important data element used in the
determination of FDA review time.
Product Code Structure
•
•
The product code is seven characters divided into the following
five fields:
– Industry: (2) determines the broadest area into which a product falls
(i.e. ’05’ cereal prep/breakfast food)
– Class: (1) designates the food group, source, product, use,
pharmacological action, category or animal species of the product (i.e.
‘A’ breakfast food RTE)
– Subclass: (1) represents the container type, method of application, use,
market class, or type of product (i.e. ‘M’ multiple container)
– Process Indicator Code: (1) specifies either the process, storage or
dosage form depending on the type of product (i.e. ‘ T ’ packaged NCS)
– Product: (2) relates directly to a particular Industry/Class combination
(i.e. ’05’ mixed flake RTE)
WWW.FDA.GOV
Filer Evaluations
• Purpose:
– To assure a filer can recognize FDA-regulated
commodities in the FD1 category.
– To assure a filer can correctly input data into ACS.
– To assure the data entered accurately reflects the
information known by the filer at the time of entry.
• Method:
– Stage 1: Filers will be evaluated by an initial ‘dual’ filing
state that will require paper documentation to
accompany electronic submission of all FD2 and FD1
imported products (at least 3 weeks an 50 entries)
• If filer evaluation is ≤ 10%, filer moves to ‘paperless’ state.
• If filer evaluation is > 10%, problems are identified and
discussed and at least another 4 weeks is completed in
‘dual’ state.
– Stage 2: Filers will be evaluated through periodic
evaluations (not more that nine month intervals) to
determine if the recognition, correct data input, and
accuracy of information known at the time of entry is still
being performed at a reasonable level (≤ 10%).
Filer Evaluations
•
Required data elements:
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Commercial Description
FDA Manufacturer (actual manufacturer of goods)
FDA Shipper
FDA Country of Origin (country in which FDA manufacturer is
located)
– Product Code
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Optional data elements
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Affirmations of Compliance
Quantity
Value
Consignee
Discrepancies between data elements contained in paper
documentation and electronic submission may be
considered a filing error when encountered.
Q: Why submit optional data elements when I can be
penalized for incorrect submission?
– A: Correctly transmitted optional data elements greatly reduce
FDA review time.
FDA IMPORT CONTACT
Patricia Cochran, Import Manager
Cincinnati District Office, Cincinnati, OH
513-679-2700