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The Concept of Jurisdiction
and Federalism
FSC-421
Jurisdiction
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Jurisdiction over persons
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Police Authority
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Habeas Corpus
Jurisdiction over subject Matter
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Foods and drugs
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Jurisdictional prerequisite for exercise of authority
over an individual
Jurisdictional prerequisite for exercise of authority
over an individual
Definitions
Compelling governmental interest
Jurisdictional
Prerequisites
Personal Jurisdiction
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Minimum contacts with locality
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Residence / Domicile
Benefits and protections of society
Some nexus between the activity,
the person and the regulation
International Shoe v. Washington
Jurisdictional
Prerequisites
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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
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Jurisdictional prerequisite to the
exercise of authority in area of
foods is a finding that the
product has been either
adulterated or misbranded
Definitions
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(Legal Mumbo-Jumbo)
Food
Adulteration
Misbranding
Jurisdiction
Jurisdictional Prerequisites
First section of the “Act”
Nutrilabs v. Schweiker (1983)
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Plantiff manufactures “starch blockers”
and sells them as “food” for weight control
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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
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Stream of commerce / Commerce Clause
Jurisdictional prerequisite
Nutrilabs
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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
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Section 321(g)(1):
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(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
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Statutory requirements for food differ
from drugs or other FDA regulated
products
Classification can determine legality of
the product
Use to which a product is put will
determine the category into which it
falls (fruits/veggies)
“Food”
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Congressional intent:
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What about vitamins and minerals?
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Food is to be defined in terms of it’s function as
food rather than in terms of its source,
composition or ingestibility.
Food unless therapeutic claims are made
Wine and Alchol
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BATC
Wine if > 7% (<7% = FDA)
“Food”
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Chewing gum
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Specifically defined as “food”
Drug delivery device
Snuff?
Water
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EPA regulates drinking water
FDA regulates bottled water
Nutrilabs
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“Articles (other than foods)”
expressly excluded from definition of a
drug
Definitions not mutually exclusive
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Nutraceuticals/Dietary supplements
Food defined as “articles used as
food”
Plantiffs (Nutrilabs)
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Starch blockers are food because derived from
food (kidney beans)
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Bullshit! What about penicillin, caffeine, insulin,
botulism toxin, influenza vaccine
Congress intended foods for “special dietary
uses” to come within definition of a food
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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
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(7th 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
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Too narrow to restrict foods to just those
that taste, smell or have nutritive value
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(7th Circuit Ct of Appeals)
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
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(7th 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
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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
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Issues, such as education, family, or social
matters, are retained by the states (10th
Amendment)
The 10th amendment created an enclave
of state autonomy that the federal
government may not enter through
exercise of legislative or regulatory power.
Federalism
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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
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States may pass additional, more
restrictive or stringent 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
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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:
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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
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Federal Government divided into three
branches:
Legislative
 Executive
 Judicial
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Act as “checks and balances” to prevent any
branch from dominating the government
States have same system
Legislative Branch
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Congress
Two houses
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Senate
House of Representatives
“I’m just a bill”
Congress passes “laws”
Executive Branch
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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
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Supreme and lower courts
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Federal District Courts
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Courts of Appeal
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Federal criminal cases
Appeals from District Courts
Supreme Court hears only “certain”
cases
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Appeals from lower federal courts
State decisions regarding US Constitution
States vs. States
Interstate Commerce
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Congress’ power to regulate foods limited
to foods that move in interstate
commerce
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Interstate = between any State and
anyplace outside thereof…
Commerce = any form of commercial
activity involving goods
Example
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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:
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Wis. seller didn’t know or intend
Mich. Buyer did not resell cheese, personal
use