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Housekeeping

Housekeeping. 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

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Housekeeping

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  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 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

  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………

  11. 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”

  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 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)

  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 congress’s intent

  17. 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

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