1. The Concept of Jurisdiction and Federalism FSC-421

2. Jurisdiction Jurisdiction over persons Jurisdiction over persons Police Authority Police Authority Jurisdictional prerequisite for exercise of authority over an individual Jurisdictional prerequisite for exercise of authority over an individual Habeas Corpus Habeas Corpus Jurisdiction over subject Matter Jurisdiction over subject Matter Foods and drugs Foods and drugs Jurisdictional prerequisite for exercise of authority over an individual Jurisdictional prerequisite for exercise of authority over an individual Definitions Definitions Compelling governmental interest Compelling governmental interest

3. Jurisdictional Prerequisites Minimum contacts with locality Minimum contacts with locality Residence / Domicile Residence / Domicile Benefits and protections of society Benefits and protections of society Some nexus between the activity, the person and the regulation Some nexus between the activity, the person and the regulation International Shoe v. Washington International Shoe v. Washington Personal Jurisdiction

4. Jurisdictional Prerequisites Exercise of authority over a thing Exercise of authority over a thing Compelling National interest Compelling National interest Health and welfare of inviduals Health and welfare of inviduals Protection of the environment Protection of the environment Food safety Food safety Definition as basis for a violation 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 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 Food Adulteration Adulteration Misbranding Misbranding Jurisdiction Jurisdiction Jurisdictional Prerequisites Jurisdictional Prerequisites First section of the “Act” First section of the “Act”

7. Nutrilabs v. Schweiker (1983) Plantiff manufactures “starch blockers” and sells them as “food” for weight control Plantiff manufactures “starch blockers” and sells them as “food” for weight control Alpha amylase inhibitor derived from food source Alpha amylase inhibitor derived from food source Claim: “Blocks the human body’s digestion of starch as an aid to controlling weight” 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 FDA alleges this is “drug” not “food”and requested removal of product from market Stream of commerce / Commerce Clause Stream of commerce / Commerce Clause Jurisdictional prerequisite Jurisdictional prerequisite

8. Nutrilabs Starch blocker contained protein extracted from kidney beans Starch blocker contained protein extracted from kidney beans Protein inhibits production of amylase Protein inhibits production of amylase Undigested CHO passes through body Undigested CHO passes through body FDA says kidney bean dangerous if eaten raw FDA says kidney bean dangerous if eaten raw 75 reports of injury 75 reports of injury Marketed as a food so avoided rigorous drug testing procedure (Benecol) Marketed as a food so avoided rigorous drug testing procedure (Benecol)

9. Drug Section 321(g)(1): Section 321(g)(1): (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals (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……… (C) articles (other than foods) intended to affect the structure or any function of the body of man or other animals………

10. “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

11. Food Statutory requirements for food differ from drugs or other FDA regulated products Statutory requirements for food differ from drugs or other FDA regulated products Classification can determine legality of the product Classification can determine legality of the product Use to which a product is put will determine the category into which it falls (fruits/veggies) Use to which a product is put will determine the category into which it falls (fruits/veggies)

12. “Food” Congressional intent: 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. 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? What about vitamins and minerals? Food unless therapeutic claims are made Food unless therapeutic claims are made Wine and Alchol Wine and Alchol BATC BATC Wine if > 7% ( 7% (<7% = FDA)

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

14. Nutrilabs “Articles (other than foods)” expressly excluded from definition of a drug “Articles (other than foods)” expressly excluded from definition of a drug Definitions not mutually exclusive Definitions not mutually exclusive Nutraceuticals/Dietary supplements Nutraceuticals/Dietary supplements Food defined as “articles used as food” Food defined as “articles used as food”

15. Plantiffs (Nutrilabs) Starch blockers are food because derived from food (kidney beans) Starch blockers are food because derived from food (kidney beans) Bullshit! What about penicillin, caffeine, insulin, botulism toxin, influenza vaccine Bullshit! What about penicillin, caffeine, insulin, botulism toxin, influenza vaccine Congress intended foods for “special dietary uses” to come within definition of a food 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) 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 -not congress’s intent

16. Court (7 th Circuit Ct of Appeals) No clear guidance from congress No clear guidance from congress Definition of food intended to be broad because includes chewing gum and food additives 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 But, common sense definition includes articles used by people in the ordinary way most people use food

17. Court (7 th Circuit Ct of Appeals) Too narrow to restrict foods to just those that taste, smell or have nutritive value 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) What about prune juice and coffee (not consumed for taste) Drugs intended to be something “other than food” Drugs intended to be something “other than food” Food affects “function and structure” of man also Food affects “function and structure” of man also

18. Court (7 th Circuit Ct of Appeals) Starch blockers not food in any sense of definition Starch blockers not food in any sense of definition Not consumed for taste Not consumed for taste Taken only to control weight Taken only to control weight Not chewing gum, not food additive Not chewing gum, not food additive Starch blocker is “article, other than food, intended to affect structure and function so is DRUG! 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 Federalism provides for a separation of powers between the state and federal governments Individual states, surrendered certain governmental powers to the Federal Government Individual states, surrendered certain governmental powers to the Federal Government States retain control over all legal issues not specifically delegated 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 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 (10 th Amendment) Issues, such as education, family, or social matters, are retained by the states (10 th Amendment) The 10 th amendment created an enclave of state autonomy that the federal government may not enter through exercise of legislative or regulatory power. The 10 th 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 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 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. 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 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 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. 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 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. 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 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. 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 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: Federal Government divided into three branches: Legislative Legislative Executive Executive Judicial Judicial Act as “checks and balances” to prevent any branch from dominating the government Act as “checks and balances” to prevent any branch from dominating the government States have same system States have same system

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

28. Executive Branch President is head of Executive Branch President is head of Executive Branch Enforces laws passed by the Legislature Enforces laws passed by the Legislature Federal agencies who are created by congress through “enabling Legislation” Federal agencies who are created by congress through “enabling Legislation” Agency heads serve at “the pleasure of president” Agency heads serve at “the pleasure of president” DOJ is only agency that can bring criminal charges DOJ is only agency that can bring criminal charges

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

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

31. Example : Michiganer goes to Wisconsin, buys cheese for personal consumption and returns to Mich. 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 Wis. seller had no reason to know Michiganer returning to Mich. with cheese This NOT interstate commerce b/c: This NOT interstate commerce b/c: Wis. seller didn’t know or intend Wis. seller didn’t know or intend Mich. Buyer did not resell cheese, personal use Mich. Buyer did not resell cheese, personal use