The Concept of Jurisdiction and Federalism

1. The Concept of Jurisdiction and Federalism FSC-421

2. 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

3. 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

4. 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

5. 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

6. Definitions(Legal Mumbo-Jumbo) • Food • Adulteration • Misbranding • Jurisdiction • Jurisdictional Prerequisites • First section of the “Act”

7. 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

8. 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)

9. 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………

10. 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”

11. 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)

12. “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)

13. “Food” • Chewing gum • Specifically defined as “food” • Drug delivery device • Snuff? • Water • EPA regulates drinking water • FDA regulates bottled water

14. 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”

15. 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

16. 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

17. 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

18. 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!

19. Federalism The Separation of the Powers between the States and the Federal Government

20. Federalism • 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

21. Federalism • 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.

22. Federalism • 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.

23. Federalism • 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

24. Federalism Example • 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

25. Holding: • 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

26. Separation of Powers • Federal Government divided into three branches: • Legislative • Executive • Judicial • Act as “checks and balances” to prevent any branch from dominating the government • States have same system

27. Legislative Branch • Congress • Two houses • Senate • House of Representatives • “I’m just a bill” • Congress passes “laws”

28. Executive Branch • 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

29. Judicial Branch • Supreme and lower courts • Federal District Courts • Federal criminal cases • Courts of Appeal • Appeals from District Courts • Supreme Court hears only “certain” cases • Appeals from lower federal courts • State decisions regarding US Constitution • States vs. States

30. Interstate Commerce • Congress’ power to regulate foods limited to foods that move in interstate commerce • Interstate = between any State and anyplace outside thereof… • Commerce = any form of commercial activity involving goods

31. Example: • 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: • Wis. seller didn’t know or intend • Mich. Buyer did not resell cheese, personal use