U.S. FDA and Customs Import Requirements Seminar

ProExport Colombia
Trade Training Seminar Series
May 2012

U.S. Customs and U.S. FDA Import Requirements
for Medical Devices & Cosmetics

Presented by:
Peter Quinter & Melissa Groisman
Customs and International Trade Law Group,
GrayRobinson Law Firm,
Miami, Florida www.gray-robinson.com

Agenda
• FDA Laws and Regulations
• FDA Import Process
• FDA Detentions (DWPE) and Refusals
• FDA Import Alerts
• U.S. Customs Liquidated Damages
• Medical Devices
• Cosmetics
• Food

www.gray-robinson.com 2

Detention Process

• The Food, Drug, and Cosmetic Act
authorizes the FDA to detain a
regulated product that “appears” to be
out of compliance.
• The FDA District Office will then issue a
"Notice of FDA Action“ specifying the
nature of the violation to the owner or
importer.

Detention Without Physical Examination
(DWPE)
• Detention without physical
examination, is appropriate when there
exists a history of the importation of
violative products, or products that
may appear violative
• Detention without physical examination
properly places the responsibility for
ensuring compliance with the law on
the importer

Notice of FDA Action #1

• Products that appear (from
examination or otherwise) to be
violative may be detained and
ultimately refused entry into the U.S.

• Detention is permissible without actual
observation of a product or its labeling.


Informal Hearing
• The owner or importer is entitled to an
informal hearing in order to provide
testimony regarding the admissibility
of the product.
• "You have the right to provide oral or
written testimony to the FDA, regarding
the admissibility of the article(s) or the
manner in which the article(s) can be
brought into compliance."

Question
• The U.S. importer has the right to provide
oral or written testimony to the FDA
regarding the admissibility of the article(s)
or the manner in which the article(s) can
be brought into compliance
• True or false?


Conditional Release
19 C.F.R. 141.113 - Food, drugs, devices, and cosmetics
• For purposes of determining the admissibility of any
food, drug, device, or cosmetic, the release from
CBP custody of any such product will be deemed
conditional.
• The conditional release period will terminate upon
the earliest occurring of the following events:
1. The date that FDA issues a notice of refusal of
admission;
2. The date that FDA issues a notice that the
merchandise may proceed; or
3. Upon the end of the 30-day period following the date
of release.


Notice to Redeliver
• "A request has been made to Customs
to order redeliver for all the above
product(s), in accordance with 19 CFR
141.113, which were conditionally
released to you under terms of the
entry bond. Failure to redeliver into
Customs custody will result in a claim
for liquidated damages under the
provisions of the entry bond"


Entry Bond - Agreement
to Redeliver Merchandise
• § 113.62 Basic importation and entry bond conditions
— A bond for basic importation and entry shall contain the conditions listed
in this section and may be either a single entry or a continuous bond.
(d) Agreement to Redeliver Merchandise.
— If merchandise is released conditionally from Customs custody to the principal
before all required evidence is produced, before its quantity and value are
determined, or before its right of admission into the United States is
determined, the principal agrees to redeliver timely, on demand by Customs,
the merchandise released if it:
(1) Fails to comply with the laws or regulations governing admission into the
United States;
(2) Must be examined, inspected, or appraised as required by 19 U.S.C. 1499;
or
(3) Must be marked with the country of origin as required by law or regulation. It is
understood that any demand for redelivery will be made no later than 30 days
after the date that the merchandise was released or 30 days after the end of the
conditional release period (whichever is later). (See §§ 141.113(4 12.73(b)(2),
and 12.80 of this chapter.)


2nd Notice of FDA Action
If the owner fails to submit evidence that
the product is in compliance or fails to
submit a plan to bring the product into
compliance, FDA will issue another
"Notice of FDA Action“ Refusing
admission of the product.


Final Notice FDA Action
• Subject: NO LOCATION RECEIVED
"You have been previously notified that
this shipment is to be held intact for
FDA examination and/or sampling. You
have not advised us of the status or
location of the lot represented by the
referenced entry number. A written
release from FDA is required before
moving your goods in domestic

Notice of Refusal
• The following products are subject to
refusal pursuant to the Federal Food
Drug and Cosmetic Act in that they
appear to be adulterated misbranded or
otherwise in violation.


Refusal
• The product then has to be exported or
destroyed within 90 days otherwise
subject to Liquidated Damages.
• Failure to do so may result in
destruction of the products.
• Distribution of the products may result
in their seizure and/or injunction or
criminal prosecution of persons
responsible for their distribution .

Import Alert
• Import Alert # 12-10, May 25, 2012 (Cheese
due to microbiological contamination)

• Import Alert #53-06, May 25, 2012 (cosmetics
containing illegal colors)ished Date: 8/9/2010

• Green List v. Red List


Import Alert Example
• Import Alert # 16-81
• Published Date: 05/13/2010
• Type: DWPE (Detention Without Physical Examination)
• Import Alert Name:
• — "Detention Without Physical Examination of Seafood
Products Due to the Presence of Salmonella"
• Reason for Alert: Division of Import Operations and Policy has
received recommendations from districts for detention without
physical examination of seafood products due to Salmonella
contamination from specific manufacturers/shippers. This
import alert has been developed for seafood products from
firms/countries which do not readily fit into previously existing
import alerts.


Removal from Import Alert List
• FDA's Regulatory Procedures Manual
– Ch. 9 - Import Operations And Actions
• 9-6 Detention without Physical
• Examination (DWPE)
– http://www.fda.gov/ICECI/ComplianceManuals/R


Removal from Import Alert List
• FDA's Regulatory Procedures Manual provides
guidance to those who wish to get off the Import
Alert list.
• Generally, one would need:
– A minimum of five consecutive non-violative
commercial shipments must enter the U.S.,
– At least one of the five non-violative entries should be
audited by the FDA to ensure compliance.
– The five shipments must be over a reasonable time
period, not one day.
– A Petition must be filed with the FDA requesting that
the importer be removed from the automatic detention
list.

Entry Bond -
Consequence of Default
• § 113.62 Basic importation and entry
bond conditions.
– (m) Consequence of default.
• (1) If the principal defaults on agreements in
this condition ... the obligors agree to pay
liquidated damages equal to the value of the
merchandise involved in the default, or three
times the value of the merchandise involved in
the default if the merchandise is restricted or
prohibited merchandise ...


CBP Form 301 Customs Bond


Liquidated Damages Claim
• In accordance with 19 C.F.R. 141.113
– Redelivery Notice (date)
– Redelivery Required (date)
– "Described merchandise not redelivered into
Customs custody after refused admission by the
FDA"
– "Failure to comply with a demand for redelivery...
will result in the assessment of liquidated
damages equal to three times the value of the
merchandise..."


Liquidated Damage Claim
• The provisions of 21 C.F.R. 1.97 require
that Customs and FDA agree about the
amount to cancel the claim for
liquidated damages.
• All Petitions for relief received by
Customs in FDA cases must be
referred to FDA for recommendation.
• With few exceptions, Customs must
follow the recommendation of FDA.

Cosmetic Labeling
• It is illegal to introduce a misbranded
cosmetic into interstate commerce, and
such products are subject to FDA action.
• Some of the ways a cosmetic can become
misbranded are:
– labeling is false or misleading
– label fails to provide required information
– required label information is not properly
displayed

Labeling Terms
• Labeling. This term refers to all labels and other written,
printed, or graphic matter on or accompanying a product

• Principal Display Panel (PDP). This is the part of the
label most likely displayed or examined under customary
conditions of display for sale

• Information Panel. Generally, this term refers to a panel
other than the PDP that can accommodate label
information where the consumer is likely to see it. The
information must be prominently and conspicuously
displayed.


Required Label Information
• An identity statement, indicating the nature and use of the product, by means of either the common or usual
name, a descriptive name, a fanciful name understood by the public, or an illustration

• An accurate statement of the net quantity of contents, in terms of weight, measure, numerical count or a
combination of numerical count and weight or measure The following information must appear on an information
panel.

• Name and place of business. This may be the manufacturer, packer, or distributor.

• Distributor statement. If the name and address are not those of the manufacturer, the label must say
"Manufactured for..." or "Distributed by..."

• Material facts. Failure to reveal material facts is one form of misleading labeling and therefore makes a product
misbranded. An example is directions for safe use, if a product could be unsafe if used incorrectly.

• Warning and caution statements. Cosmetics that may be hazardous to consumers must bear appropriate label
warnings. Flammable cosmetics are an example.

• Ingredients. If the product is marketed on a retail basis to consumers, even it it is labeled "For professional use
only" or words to that effect, the ingredients must appear on an information panel, in descending order of
predominance.


• All required labeling information must be in
English

• It is not permitted to label cosmetics "FDA
Approved“. As part of the prohibition against
false or misleading information, no cosmetic may
be labeled or advertised with statements
suggesting that FDA has approved the product.

• False or misleading statements on labeling
make a cosmetic misbranded.


Anti-Aging Creams
• Import Alert # 66-38 Published Date: 03/27/2012
• "Skin Care Products Labeled As Anti-Aging Creams"
•
There are numerous skin care products on the market
with exaggerated "anti aging" claims which cause the
products to be unapproved new drugs.

• Examples of such claims are that the products
"counteract," "retard," or "control" the aging process.
Claims that the product will "rejuvenate," "repair," or
"restructure" the skin may also be drug claims.


Voluntary Cosmetic Registration Program
• FDA Form 2511 -
Registration of Cosmetic Product
Establishment

• FDA Form FDA 2512 -
Cosmetic Product Ingredient Statement
(CPIS)


What is a Medical Device?
• The term "device" means an instrument, apparatus,
implement, machine, implant, or other similar or
related article…which is:

– recognized in the official National Formulary, or the
United States Pharmacopeia, or any supplement to
them,
– intended for use in the diagnosis of disease or other
conditions, or in the cure, mitigation, treatment, or
prevention of disease, in man or other animals, or
– intended to affect the structure or any function of the
body….


Which of the following products is
NOT a medical device?

• Dental Floss
• Lipstick
• Eyeglasses
• Pacemaker


What is a Medical Device?
Examples of Medical Devices:
• Pacemakers
• Contact Lenses
• Hearing Aids
• Dental Floss
• Thermometer


Federal Food, Drug
and Cosmetic Act

Imported medical devices must fully
comply with the Act before the device is
released by U.S. Customs into the United
States.


Medical Device Import Alert
• Import Alert # 89-16 Published Date: 03/13/2012

• Detention Without Physical Examination of Products from Medical Device Firms
Refusing FDA Foreign Establishment Inspection

• The FDA often conducts establishment inspections of foreign manufacturers who
produce FDA-regulated articles intended for sale in the US.
As part of this inspection process, FDA may contact the foreign manufacturer and
schedule the establishment inspection.
If a manufacturer who offers devices for import into the United States refuses to
permit or allow the completion of an FDA inspection of the foreign facility, it will be
assumed that the methods and controls used for the design, manufacture, packaging,
labeling, storage, installation, or servicing of any devices produced at such facility do
not conform to the U.S. requirements, and that the devices manufactured at that
facility are considered to be “adulterated”. They will be refused entry into the United
States.


Checklist To Import
Medical Devices
• Premarket Notification (510(k)), unless
exempt, or Premarket Approval (PMA)
• Establishment Registration on Form
FDA-2891
• Device Listing on Form FDA-2892
• Quality System Regulation (QSR) (sometimes
referred to as good manufacturing practices
or GMPs)
• Labeling Requirements
• U.S. Designated Agent (for imported devices)


Medical Devices Classes
The class to which your device is
assigned determines, among other
things, the type of premarket
submission or application required for
FDA clearance to sell the device.


Medical Devices Classes
• CLASS I most are exempt from Premarket
Notification
• CLASS II most require a Premarket Notification
• Most Class I devices and some Class II devices are
exempt from 510(k) submission. A list of exempt
devices is located at:
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm

• CLASS III those that support or sustain human life,
most require a Premarket Approval (PMA)


DUE DILIGENCE
• Does the foreign manufacturer, and
initial importer or distributor have a
current Establishment Registration?
• Check FDA Website:
http://
www.accessdata.fda.gov/scripts/cder/drls/d


DUE DILIGENCE --
U.S. Agent
• Cualquier establecimiento extranjero que se dedica a la
producción, preparación, distribución, combinación o
procesamiento de dispositivos importados a los Estados
Unidos debe identificar a un agente en Estados Unidos
(agente estadounidense) para tal establecimiento.
• Information on U.S. Agents can be found at (en
español):
• http://www.fda.gov/MedicalDevices/DeviceRegulationand


Responsabilidades de un agente
estadounidense
• El agente estadounidense debe, ya sea residir en EE.UU. o contar con un
espacio comercial en EE.UU. El agente estadounidense no puede utilizar
una casilla de correo postal como dirección. El agente estadounidense no
puede utilizar simplemente un servicio de respuesta. Deben estar
disponibles para responder llamadas telefónicas o contar con un empleado
disponible para responder llamados telefónicos durante el horario comercial
normal.
• Las responsabilidades del agente estadounidense son limitadas e incluyen:
• asesorar a la FDA en comunicaciones con el establecimiento extranjero,
• responder preguntas relacionadas con los dispositivos de establecimiento
extranjeros que son importados u ofrecidos para importación a los Estados
Unidos.
• asesorar a la FDA en la coordinación de inspecciones a los
establecimientos extranjeros y
• si la FDA no puede contactar al establecimiento extranjero directa o
rápidamente, la FDA puede suministrar información o documentos al agente
estadounidense y tal acción será considerada equivalente a proporcionar la
misma información o documentos al establecimiento extranjero


Questions


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