Housekeeping

1
Housekeeping

• Grading criteria
• Lecture Schedule / Spring Break
• No office hours today (Big meeting)
• Study Abroad Program

2
The Concept of Jurisdiction

• FSC-421

3
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

4
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

5
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

6
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

7
Definitions (Legal Mumbo-Jumbo)

• Food
• Adulteration
• Misbranding
• Jurisdiction
• Jurisdictional Prerequisites
• First section of the Act

8
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 bodys digestion of
  starch as an aid to controlling weight
• FDA alleges this is drug not foodand
  requested removal of product from market
• Stream of commerce / Commerce Clause
• Jurisdictional prerequisite

9
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)

10
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

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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

12
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)

13
Food

• Congressional intent
• Food is to be defined in terms of its 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 gt 7 (lt7 FDA)

14
Food

• Chewing gum
• Specifically defined as food
• Drug delivery device
• Snuff?
• Water
• EPA regulates drinking water
• FDA regulates bottled water

15
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

16
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 congresss intent

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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

18
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

19
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!

20
Tobacco and Cigarettes

• Food or Drug?
• Cigarette drug deliver device

21
Adulteration

• Next Time