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 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 Personal Jurisdiction

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. “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 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 (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

18. 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

19. 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!

20. Tobacco and Cigarettes Food or Drug? Cigarette = “drug deliver device”

21. Adulteration Next Time