Jurisdiction and Fed.. - Michigan State University

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The Concept of Jurisdiction and Federalism

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Jurisdiction

Jurisdiction over persons

Police Authority

Jurisdictional prerequisite for exercise of authority over an individual

Habeas Corpus

Jurisdiction over subject Matter

Foods and drugs

Jurisdictional prerequisite for exercise of authority over an individual

Definitions

Compelling governmental interest

Jurisdictional

Prerequisites

Personal Jurisdiction

Minimum contacts with locality

Residence / Domicile

Benefits and protections of society

Some nexus between the activity, the person and the regulation

International Shoe v. Washington

Jurisdictional

Prerequisites

Exercise of authority over a thing

Compelling National interest

Health and welfare of inviduals

Protection of the environment

Food safety

Definition as basis for a violation

Jurisdictional Prerequisites

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

Definitions

(

Legal Mumbo-Jumbo

)

Food

Adulteration

Misbranding

Jurisdiction

Jurisdictional Prerequisites

First section of the “Act”

Nutrilabs v. Schweiker (1983)

Plantiff manufactures “starch blockers” and sells them as “food” for weight control

Alpha amylase inhibitor derived from food source

Claim: “Blocks the human body’s digestion of starch as an aid to controlling weight”

FDA alleges this is “drug” not “food”and requested removal of product from market

Stream of commerce / Commerce Clause

Jurisdictional prerequisite

Nutrilabs

Starch blocker contained protein extracted from kidney beans

Protein inhibits production of amylase

Undigested CHO passes through body

FDA says kidney bean dangerous if eaten raw

75 reports of injury

Marketed as a food so avoided rigorous drug testing procedure (Benecol)

Drug

Section 321(g)(1):

(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals

(C)

articles (other than foods) intended to affect the structure or any function of

the body of man or other animals………

“Food”

Section 321(f):|

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

(2) chewing gum,

(3) articles used for components of any such article

Food

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

Classification can determine the product

legality

of

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

“Food”

Congressional intent:

Food is to be defined in terms of it’s function as food rather than in terms of its source, composition or ingestibility.

What about vitamins and minerals?

Food unless therapeutic claims are made

Wine and Alchol

BATC

Wine if > 7% (<7% = FDA)

“Food”

Chewing gum

Specifically defined as “food”

Drug delivery device

Snuff?

Water

EPA regulates drinking water

FDA regulates bottled water

Nutrilabs

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

Definitions not mutually exclusive

Nutraceuticals/Dietary supplements

Food defined as “

articles used as food

Plantiffs (Nutrilabs)

Starch blockers are food because derived from food (kidney beans)

Bullshit! What about penicillin, caffeine, insulin, botulism toxin, influenza vaccine

Congress intended foods for “special dietary uses” to come within definition of a food

Bullshit! What about anti-fat drugs and slenderizers.

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

-not congress’s intent

Court

(7 th

Circuit Ct of Appeals)

No clear guidance from congress

Definition of food intended to be broad because includes chewing gum and food additives

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

Court

(7 th

Circuit Ct of Appeals)

Too narrow to restrict foods to just those that taste, smell or have nutritive value

What about prune juice and coffee (not consumed for taste)

Drugs intended to be something “other than food”

Food affects “function and structure” of man also

Court

(7 th

Circuit Ct of Appeals)

Starch blockers not food in any sense of definition

Not consumed for taste

Taken only to control weight

Not chewing gum, not food additive

Starch blocker is “article, other than food, intended to affect structure and function so is DRUG!

Federalism

The Separation of the Powers between the States and the Federal Government

Federalism

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

Individual states, surrendered certain governmental powers to the Federal

Government

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

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

Federalism

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

Amendment)

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

Federalism

States are free to operate in any arena that has not been preempted by federal law

Federalism provides opportunities for expression of a wide range of conservative, moderate and liberal positions within a national forum

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

Federalism

States may pass additional, restrictive or stringent more food safety laws or regulations than those promulgated at the federal level

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

Federalism Example

A small retailer in

Cascadia

bought a large bottle of nutritional supplements from an

interstate wholesaler

who had purchased them form an out of state supplier.

The bottle contained an

unapproved food additive

.

The label form the manufacturer had clearly listed that this additive was present in the product.

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

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

Holding:

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

FDA’s role in promoting food and drug safety is national in scope

.

This permits the federal government to regulate entirely local sales of goods simply because they had crossed a single state line sometime during production and final sale

Separation of Powers

Federal Government divided into three branches:

Legislative

Executive

Judicial

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

States have same system

Legislative Branch

Congress

Two houses

Senate

House of Representatives

“I’m just a bill”

Congress passes “laws”

Executive Branch

President is head of Executive Branch

Enforces laws passed by the Legislature

Federal agencies who are created by congress through “enabling Legislation”

Agency heads serve at “the pleasure of president”

DOJ is only agency that can bring criminal charges

Judicial Branch

Supreme and lower courts

Federal District Courts

Federal criminal cases

Courts of Appeal

Appeals from District Courts

Supreme Court hears only “certain” cases

Appeals from lower federal courts

State decisions regarding US Constitution

States vs. States

Interstate Commerce

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

Interstate = between any State and anyplace outside thereof…

Commerce = any form of commercial activity involving goods

Example

:

Michiganer goes to Wisconsin, buys cheese for personal consumption and returns to Mich.

Wis. seller had no reason to know

Michiganer returning to Mich. with cheese

This NOT interstate commerce b/c:

Wis. seller didn’t know or intend

Mich. Buyer did not resell cheese, personal use

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