Transcript Jurisdiction

Housekeeping
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Grading criteria
Lecture Schedule / Spring Break
No office hours today (Big meeting)
Study Abroad Program
The Concept of Jurisdiction
FSC-421
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
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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
• 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)
• 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 legality of the
product
• 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
(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
(7th 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
(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!
Tobacco and Cigarettes
• Food or Drug?
• Cigarette = “drug deliver device”
Adulteration
Next Time