The Importation The Importation and Exportation and Exportation

of Foodsof FoodsFood LawFood Law

FSC-421FSC-421

ImportatImportationion

FDA and US Customs share jurisdiction FDA and US Customs share jurisdiction over imported food productsover imported food products

Foods may be imported into the Foods may be imported into the US so long as they meet the US so long as they meet the same standards as foods same standards as foods produced in US.produced in US.

USDA – Jurisdiction over imported USDA – Jurisdiction over imported meat productsmeat products Pursuant to 1906 Meat Inspection ActPursuant to 1906 Meat Inspection Act

US Customs ServiceUS Customs Service

Sub unit of the US Department of the Sub unit of the US Department of the TreasuryTreasury

Charged with assessing duties, fees, Charged with assessing duties, fees, etcetc

Required to notify the FDA of the Required to notify the FDA of the entry of any food products into the USentry of any food products into the US

Non-conforming food shipments will Non-conforming food shipments will be seized by Customs and released be seized by Customs and released only after written approval from FDAonly after written approval from FDA. .

RegistrationRegistration

Food products which are imported Food products which are imported into the United States are require into the United States are require to meet all applicable to meet all applicable requirements requirements at the time of at the time of importationimportation

Must be conforming at the time Must be conforming at the time they are offered for entry into the they are offered for entry into the USUS

Not adulterated or misbrandedNot adulterated or misbranded

ImportatImportationion

Certain types of foods must Certain types of foods must comply with registration comply with registration requirements:requirements: Specified dairy products Specified dairy products

(acidified milks, yogurts, cultured (acidified milks, yogurts, cultured productsproducts

Low acid foodsLow acid foods Acidified foodsAcidified foods Meat processing facilitiesMeat processing facilities

Must be manufactured according Must be manufactured according to specific processesto specific processes

Entry and Entry and SamplingSampling

Shipment must be filed with Shipment must be filed with Customs within 5 daysCustoms within 5 days

Customs notifies FDA if food Customs notifies FDA if food productproduct

Notice to proceed or, Notice of Notice to proceed or, Notice of SamplingSampling

Registered foods almost certain to Registered foods almost certain to be sampledbe sampled

Entry and Entry and SamplingSampling

Notice of Detention if Notice of Detention if nonconformingnonconforming

Notice of Refusal if Notice of Refusal if nonconforming after samplingnonconforming after sampling

Shipment destroyed unless Shipment destroyed unless exported within specified timeexported within specified time

Importer’s Options if Importer’s Options if RefusedRefused Request hearing, within 10 days, to Request hearing, within 10 days, to

defend acceptabilitydefend acceptability Permission to re-label or re-Permission to re-label or re-

condition (IBP)condition (IBP) Export shipmentExport shipment Request judicial review of Notice of Request judicial review of Notice of

RefusalRefusal

EnforcemeEnforcementnt

FDA may order destruction of FDA may order destruction of nonconforming goods if not nonconforming goods if not reconditionedreconditioned

FDA may declare a bond violation if FDA may declare a bond violation if shipment distributed without Notice shipment distributed without Notice of Acceptanceof Acceptance

FDA may order seizure and FDA may order seizure and condemnation of nonconforming condemnation of nonconforming goodsgoods

Export Export OptionOption

Shipper has option after FDA Shipper has option after FDA condemnation of exporting the condemnation of exporting the nonconforming goods as alternative to nonconforming goods as alternative to destruction if:destruction if: Adulteration (or misbranding) did not Adulteration (or misbranding) did not

occur occur afterafter importation importation Importer had no Importer had no knowledgeknowledge of the of the

nonconformitynonconformity Shipment is not otherwise in Shipment is not otherwise in violationviolation of of

US lawUS law

ExportatioExportationn Goods intended for export need not Goods intended for export need not

meet FDA requirements if:meet FDA requirements if: Products meets specs of importing Products meets specs of importing

countrycountry Not in conflict with laws of importing Not in conflict with laws of importing

countrycountry Labeling of shipment clearly indicates Labeling of shipment clearly indicates

that it is for exportthat it is for export Export ExemptionExport Exemption

Export Export ExemptionExemption Is US “less concerned” with safety of Is US “less concerned” with safety of

products intended for export?products intended for export? Exempts exports from jurisdiction of Exempts exports from jurisdiction of

FDA?FDA? Distribution into interstate commerce, Distribution into interstate commerce,

nullifies the exemptionnullifies the exemption Referred to as the “Referred to as the “commodity commodity

dumpingdumping” provision (” provision (Thalidimide, Thalidimide, DES, CyclamatesDES, Cyclamates))

Export Export ExemptionExemption

How does exporter prove How does exporter prove shipment complies with shipment complies with exemption requirements?exemption requirements?

Export CertificateExport Certificate issued by issued by “Official” in importing country“Official” in importing country

ExamplExampleses

Exporter wants to ship dried figs to Australian importer who uses them in coffee flavors. FDA seizes shipment because contaminated by worms and therefore “Adulterated”.

What result?

FDA alleges contaminated figs = “impure material” under Australian law.

What result?

US v Catz American 53 F. US v Catz American 53 F. 2d. 4252d. 425

Importer has options of Importer has options of re-re-conditioningconditioning goods to make them goods to make them conform to Australian law or can conform to Australian law or can divert them to some divert them to some permitted permitted use.use.

So long as it is So long as it is possiblepossible for the for the goods to comply with importers goods to comply with importers laws, US will allow exportationlaws, US will allow exportation

Query:Query:

Agents Scully and Mulder tipped off Agents Scully and Mulder tipped off about Progressive Inc., who is discounting about Progressive Inc., who is discounting

nonconforming nonconforming ““alien frog legs”alien frog legs” which which were refused entry into US, to salvage were refused entry into US, to salvage purchaserspurchasers

Salvage purchasers selling frog legs in Salvage purchasers selling frog legs in interstate commerceinterstate commerce at premium prices at premium prices

FDA wants to seize and condemn shipmentFDA wants to seize and condemn shipment Progressive asserts export exemption as Progressive asserts export exemption as

defensedefense What result?What result?

US v. 76,552 Pounds of Frog Legs

Banana WarsBanana Wars

1980 Bananas big business1980 Bananas big business 1993 EU introduce preference for 1993 EU introduce preference for

bananas from former colonies (404/93 bananas from former colonies (404/93 Regime)Regime)

Latin America countries protested Latin America countries protested and negotiations began but not and negotiations began but not bindingbinding

1995 WTO established (rulings 1995 WTO established (rulings binding on members)binding on members)

Bananas Bananas ProducersProducers

Banana WarsBanana Wars 1996 Chiquita, Dole, Del Monte gave $5 1996 Chiquita, Dole, Del Monte gave $5

Million in contributions to Democrats and Million in contributions to Democrats and RepublicansRepublicans

Same year US rep challenged EU preference Same year US rep challenged EU preference for bananas from former EU coloniesfor bananas from former EU colonies

Bananas from former EU colonies allowed Bananas from former EU colonies allowed into EU into EU tariff freetariff free

Preference established as reparations Preference established as reparations for ills of European colonization of for ills of European colonization of Africa and othersAfrica and others

Banana WarsBanana Wars

US alleged this was US alleged this was “barrier to free “barrier to free trade”trade”

Costing US market $520 million/yearCosting US market $520 million/year Chiquita and Dole accustom to Chiquita and Dole accustom to

monopoly (term “Banana Republic”)monopoly (term “Banana Republic”) Caribbean countries started growing Caribbean countries started growing

“pot” as opposition to US banana “pot” as opposition to US banana policiespolicies

Banana WarsBanana Wars

1997 WTO (under US pressure) ruled 1997 WTO (under US pressure) ruled in favor of USin favor of US

Said EU preference was “violation of Said EU preference was “violation of international law”international law”

Chiquita’s right to make a profit Chiquita’s right to make a profit superseded preference for former superseded preference for former EU colonies farmsEU colonies farms

WTO appellate body upheld decision WTO appellate body upheld decision against the EUagainst the EU

Banana WarsBanana Wars

EU responded by establishing a “new EU responded by establishing a “new scheme” which tried to get around scheme” which tried to get around WTO problems with preference (first WTO problems with preference (first come/first serve policy)come/first serve policy)

1999 - US responded by imposing 100% 1999 - US responded by imposing 100% tariff (tariff (worth 1 billion dollars to EU worth 1 billion dollars to EU marketsmarkets) on a list of EU exports to US) on a list of EU exports to US

Mostly EU luxury items Mostly EU luxury items

Banana War TariffsBanana War Tariffs

Pecorino CheesePecorino Cheese Sweet biscuits, Sweet biscuits,

waffleswaffles Bath preparations Bath preparations

and saltsand salts Candles Candles Handbags, and Handbags, and

plastic coated items plastic coated items normally carried in normally carried in handbags handbags

Greeting cardsGreeting cards Cashmere clothesCashmere clothes Paper boxes and Paper boxes and

cartonscartons Cotton bed linenCotton bed linen Metal chandeliers Metal chandeliers

and other light and other light fixturesfixtures

Danish hamsDanish hams

Banana WarsBanana Wars April 2001 Banana Wars resolvedApril 2001 Banana Wars resolved US agreed to drop tariffs on EU exportsUS agreed to drop tariffs on EU exports EU agreed to drop preferenceEU agreed to drop preference

Quota for bananas from former colonies Quota for bananas from former colonies decreaseddecreased

Quota for US produced bananas Quota for US produced bananas increasedincreased

Almost forced Chiquita into bankruptcyAlmost forced Chiquita into bankruptcy Lost 40% of its share of EU marketLost 40% of its share of EU market