The Concept of Jurisdiction The Concept of Jurisdiction and Federalismand Federalism

FSC-421FSC-421

JurisdictionJurisdiction

Jurisdiction over personsJurisdiction over persons Police Authority Police Authority

Jurisdictional prerequisite for exercise of Jurisdictional prerequisite for exercise of authority over an individualauthority over an individual

Habeas CorpusHabeas Corpus Jurisdiction over subject MatterJurisdiction over subject Matter

Foods and drugsFoods and drugs Jurisdictional prerequisite for exercise of Jurisdictional prerequisite for exercise of

authority over an individual authority over an individual DefinitionsDefinitions Compelling governmental interestCompelling governmental interest

Jurisdictional Jurisdictional PrerequisitesPrerequisites

Minimum contacts with localityMinimum contacts with locality Residence / DomicileResidence / Domicile

Benefits and protections of Benefits and protections of societysociety

Some nexus between the activity, Some nexus between the activity, the person and the regulationthe person and the regulation

International Shoe v. WashingtonInternational Shoe v. Washington

Personal Jurisdiction

Jurisdictional Jurisdictional PrerequisitesPrerequisites Exercise of authority over a thingExercise of authority over a thing Compelling National interestCompelling National interest Health and welfare of invidualsHealth and welfare of inviduals Protection of the environmentProtection of the environment Food safetyFood safety DefinitionDefinition as basis for a violation as basis for a violation

Jurisdictional PrerequisitesJurisdictional Prerequisites

Jurisdictional prerequisite to Jurisdictional prerequisite to the exercise of authority in the exercise of authority in area of foods is a finding that area of foods is a finding that the product has been either the product has been either adulteratedadulterated or or misbrandedmisbranded

DefinitionsDefinitions ((Legal Mumbo-JumboLegal Mumbo-Jumbo))

FoodFood AdulterationAdulteration MisbrandingMisbranding JurisdictionJurisdiction Jurisdictional PrerequisitesJurisdictional Prerequisites First section of the “Act”First section of the “Act”

Nutrilabs v. Schweiker Nutrilabs v. Schweiker (1983)(1983) Plantiff manufactures “starch blockers” Plantiff manufactures “starch blockers”

and sells them as “food” for weight and sells them as “food” for weight controlcontrol

Alpha amylase inhibitor derived from food sourceAlpha amylase inhibitor derived from food source Claim: “Blocks the human body’s digestion of Claim: “Blocks the human body’s digestion of

starch as an aid to controlling weight”starch as an aid to controlling weight” FDA alleges this is “drug” not “food”and FDA alleges this is “drug” not “food”and

requested removal of product from requested removal of product from marketmarket Stream of commerce / Commerce ClauseStream of commerce / Commerce Clause Jurisdictional prerequisiteJurisdictional prerequisite

NutrilabsNutrilabs

Starch blocker contained protein extracted Starch blocker contained protein extracted from from kidney beanskidney beans

Protein inhibits production of amylaseProtein inhibits production of amylase Undigested CHO passes through bodyUndigested CHO passes through body FDA says kidney bean dangerous if eaten FDA says kidney bean dangerous if eaten

rawraw 75 reports of injury75 reports of injury Marketed as a food so avoided rigorous Marketed as a food so avoided rigorous

drug testing procedure (Benecol)drug testing procedure (Benecol)

DrugDrug

Section 321(g)(1):Section 321(g)(1): (B) articles intended for use in the (B) articles intended for use in the

diagnosis, cure, mitigation, treatment, diagnosis, cure, mitigation, treatment, or prevention of disease in man or other or prevention of disease in man or other animalsanimals

(C) (C) articles (other than foods) articles (other than foods) intended to affect the structure or intended to affect the structure or any function of the body of man or any function of the body of man or other animalsother animals………………

““Food”Food”

Section 321(f):|Section 321(f):|

(1) articles used for food or (1) articles used for food or drink for man or other animals,drink for man or other animals,

(2) chewing gum,(2) chewing gum,

(3) articles used for (3) articles used for components of any such article components of any such article

FoodFood

Statutory requirements for food Statutory requirements for food differ from drugs or other FDA differ from drugs or other FDA regulated productsregulated products

Classification can determine Classification can determine legalitylegality of the product of the product

Use to which a product is put will Use to which a product is put will determine the category into which determine the category into which it falls (fruits/veggies)it falls (fruits/veggies)

““Food”Food”

Congressional intent:Congressional intent: Food is to be defined in terms of it’s Food is to be defined in terms of it’s

function as food rather than in terms of its function as food rather than in terms of its source, composition or ingestibility.source, composition or ingestibility.

What about vitamins and minerals?What about vitamins and minerals? Food unless therapeutic claims are madeFood unless therapeutic claims are made

Wine and AlcholWine and Alchol BATC BATC Wine if > 7% (<7% = FDA) Wine if > 7% (<7% = FDA)

““FoodFood””

Chewing gumChewing gum Specifically defined as “food”Specifically defined as “food” Drug delivery deviceDrug delivery device Snuff?Snuff?

WaterWater EPA regulates drinking waterEPA regulates drinking water FDA regulates bottled waterFDA regulates bottled water

NutrilabsNutrilabs

““Articles (other than foods)”Articles (other than foods)” expressly expressly excluded from definition excluded from definition of a drugof a drug

Definitions not mutually exclusiveDefinitions not mutually exclusive Nutraceuticals/Dietary supplementsNutraceuticals/Dietary supplements

Food defined as “Food defined as “articles used as articles used as foodfood””

PlantiffsPlantiffs (Nutrilabs) (Nutrilabs) Starch blockers are food because derived Starch blockers are food because derived

from food (kidney beans)from food (kidney beans) Bullshit! What about penicillin, caffeine, Bullshit! What about penicillin, caffeine,

insulin, botulism toxin, influenza vaccineinsulin, botulism toxin, influenza vaccine Congress intended foods for “special Congress intended foods for “special

dietary uses” to come within definition of a dietary uses” to come within definition of a foodfood Bullshit! What about anti-fat drugs and Bullshit! What about anti-fat drugs and

slenderizers. If all products intended for slenderizers. If all products intended for weight control are foods then no diet products weight control are foods then no diet products could be regulated as drugs (no testing)could be regulated as drugs (no testing)

-not congress’s intent-not congress’s intent

CourtCourt (7(7thth Circuit Ct of Appeals) Circuit Ct of Appeals)

No clear guidance from congressNo clear guidance from congress Definition of food intended to be Definition of food intended to be

broad because includes chewing gum broad because includes chewing gum and food additivesand food additives

But, common sense definition But, common sense definition includes articles used by people in includes articles used by people in the ordinary way most people use the ordinary way most people use foodfood

CourtCourt (7(7thth Circuit Ct of Appeals) Circuit Ct of Appeals)

Too narrow to restrict foods to just Too narrow to restrict foods to just those that taste, smell or have those that taste, smell or have nutritive valuenutritive value What about prune juice and coffee (not What about prune juice and coffee (not

consumed for taste)consumed for taste) Drugs intended to be something Drugs intended to be something

“other than food”“other than food” Food affects “function and structure” Food affects “function and structure”

of man alsoof man also

CourtCourt (7(7thth Circuit Ct of Appeals) Circuit Ct of Appeals)

Starch blockers not food in any sense Starch blockers not food in any sense of definitionof definition

Not consumed for tasteNot consumed for taste Taken only to control weightTaken only to control weight Not chewing gum, not food additiveNot chewing gum, not food additive Starch blocker is “article, other Starch blocker is “article, other

than food, intended to affect than food, intended to affect structure and function so is structure and function so is DRUG!DRUG!

FederalismFederalismThe Separation of the Powers The Separation of the Powers between the States and the between the States and the

Federal GovernmentFederal Government

FederalismFederalism

Federalism provides for a separation of powers Federalism provides for a separation of powers between the state and federal governmentsbetween the state and federal governments

Individual states, surrendered certain Individual states, surrendered certain governmental powers to the Federal governmental powers to the Federal Government Government

States retain control over all legal issues not States retain control over all legal issues not specifically delegated to the federal governmentspecifically delegated to the federal government

Federal Government can regulate local activity Federal Government can regulate local activity that substantially affects interstate commerce if that substantially affects interstate commerce if national regulation is needed because states, on national regulation is needed because states, on their own, could not achieve the same objectivetheir own, could not achieve the same objective

FederalismFederalism

Issues, such as education, family, or Issues, such as education, family, or social matters, are retained by the social matters, are retained by the states (10states (10thth Amendment) Amendment)

The 10The 10thth amendment created an amendment created an enclave of state autonomy that the enclave of state autonomy that the federal government may not enter federal government may not enter through exercise of legislative or through exercise of legislative or regulatory power. regulatory power.

FederalismFederalism States are free to operate in any arena that States are free to operate in any arena that

has not been preempted by federal lawhas not been preempted by federal law Federalism provides opportunities for Federalism provides opportunities for

expression of a wide range of conservative, expression of a wide range of conservative, moderate and liberal positions within a moderate and liberal positions within a national forumnational forum

Separation of federal and state authority Separation of federal and state authority provides different groups with a stake in provides different groups with a stake in the political system and discourages the political system and discourages separatist movements.separatist movements.

FederalismFederalism States may pass additional, States may pass additional, more more

restrictive or stringentrestrictive or stringent food safety food safety laws or regulations than those laws or regulations than those promulgated at the federal levelpromulgated at the federal level

Federal government may Federal government may delegatedelegate part of its authority to state part of its authority to state agencies, such as permitting a state agencies, such as permitting a state agency to conduct food plant safety agency to conduct food plant safety inspections on its behalfinspections on its behalf

Federalism ExampleFederalism Example

A small retailer in A small retailer in CascadiaCascadia bought a large bottle bought a large bottle of nutritional supplements from an of nutritional supplements from an interstate interstate wholesalerwholesaler who had purchased them form an who had purchased them form an out of state supplier. out of state supplier.

The bottle contained an The bottle contained an unapproved food unapproved food additiveadditive. The label form the manufacturer had . The label form the manufacturer had clearly listed that this additive was present in the clearly listed that this additive was present in the product. product.

The retailer transferred 12 pill to a smaller The retailer transferred 12 pill to a smaller container and sold them in Cascadia. container and sold them in Cascadia.

Defendant charged with violating provisions of Defendant charged with violating provisions of the federal Food, Drug and Cosmetics Actthe federal Food, Drug and Cosmetics Act

Holding:Holding:

Extension of federal jurisdiction to Extension of federal jurisdiction to this apparently in-state matter is this apparently in-state matter is valid. valid.

FDA’s role in promoting food and FDA’s role in promoting food and drug safety is national in scopedrug safety is national in scope.. This permits the federal government This permits the federal government to regulate entirely local sales of to regulate entirely local sales of goods simply because they had goods simply because they had crossed a single state line sometime crossed a single state line sometime during production and final saleduring production and final sale

Separation of PowersSeparation of Powers

Federal Government divided into three Federal Government divided into three branches:branches:

LegislativeLegislative Executive Executive JudicialJudicial

Act as “checks and balances” to prevent Act as “checks and balances” to prevent any branch from dominating the any branch from dominating the governmentgovernment

States have same systemStates have same system

Legislative BranchLegislative Branch

CongressCongress Two housesTwo houses

SenateSenate House of House of

RepresentativesRepresentatives ““I’m just a bill”I’m just a bill” Congress passes “laws”Congress passes “laws”

Executive BranchExecutive Branch

President is head of Executive BranchPresident is head of Executive Branch Enforces lawsEnforces laws passed by the Legislature passed by the Legislature Federal agencies who are created by Federal agencies who are created by

congress through “enabling Legislation”congress through “enabling Legislation” Agency heads serve at “the pleasure of Agency heads serve at “the pleasure of

president”president” DOJ is only agency that can bring DOJ is only agency that can bring

criminal chargescriminal charges

Judicial BranchJudicial Branch

Supreme and lower courtsSupreme and lower courts Federal District CourtsFederal District Courts

Federal criminal casesFederal criminal cases Courts of AppealCourts of Appeal

Appeals from District CourtsAppeals from District Courts

Supreme Court hears only Supreme Court hears only “certain” cases“certain” cases Appeals from lower federal courtsAppeals from lower federal courts State decisions regarding US ConstitutionState decisions regarding US Constitution States vs. StatesStates vs. States

Interstate CommerceInterstate Commerce

Congress’ power to regulate foods Congress’ power to regulate foods limited to foods that move in limited to foods that move in interstate commerceinterstate commerce

Interstate = between any State and Interstate = between any State and anyplace outside thereof…anyplace outside thereof…

Commerce = any form of Commerce = any form of commercial activity involving goodscommercial activity involving goods

ExampleExample:: Michiganer goes to Wisconsin, buys Michiganer goes to Wisconsin, buys

cheese for personal consumption cheese for personal consumption and returns to Mich.and returns to Mich.

Wis. seller had no reason to know Wis. seller had no reason to know Michiganer returning to Mich. with Michiganer returning to Mich. with cheesecheese

This NOT interstate commerce b/c:This NOT interstate commerce b/c: Wis. seller didn’t know or intend Wis. seller didn’t know or intend Mich. Buyer did not resell cheese, Mich. Buyer did not resell cheese,

personal usepersonal use