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ProExport ColombiaProExport ColombiaTrade Training Seminar SeriesTrade Training Seminar Series

May 2012May 2012

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

Presented by: Presented by: Peter Quinter & Melissa GroismanPeter Quinter & Melissa Groisman

Customs and International Trade Law Group, Customs and International Trade Law Group, GrayRobinson Law Firm, GrayRobinson Law Firm,

Miami, FloridaMiami, Florida

www.gray-robinson.com 2

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


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; or3. 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 - Agreementto 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 commerce".


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

/RegulatoryProceduresManual/ucm179271.htm


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 isNOT a medical device?

1. Dental Floss

2. Lipstick

3. Eyeglasses

4. Pacemaker


What is a Medical Device?

Examples of Medical Devices:

• Pacemakers

• Contact Lenses

• Hearing Aids

• Dental Floss

• Thermometer


Federal Food, Drugand 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 ImportMedical 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/default.cfm


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/DeviceRegulationandGuidance/HowtoMarketYourDevice/Registroylistadodedispositivos/ucm257177.htm


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

www.gray-robinson.com

ProExport ColombiaProExport ColombiaTrade Training Seminar SeriesTrade Training Seminar Series

May 2012May 2012

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

Presented by: Presented by: Peter Quinter & Melissa GroismanPeter Quinter & Melissa Groisman

Customs and International Trade Law Group, Customs and International Trade Law Group, GrayRobinson Law Firm, GrayRobinson Law Firm,

Miami, FloridaMiami, Florida

www.gray-robinson.com proexport colombia trade training seminar series may 2012 u.s. customs and...

Documents

fda issues

entry bond slide

importer slide

nd notice of fda action

florida slide

fda import requirements

agenda fda laws

fda district office