FSC-421

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

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

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Exercise of authority over a thing
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Compelling National interest
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Health and welfare of inviduals
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Protection of the environment
Food safety
Definition as basis for a violation

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Jurisdictional prerequisite to the exercise of authority in area of foods is a finding that the product has been either adulterated or misbranded

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

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Plantiff manufactures “starch blockers” and sells them as “food” for weight control
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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
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Stream of commerce / Commerce Clause
Jurisdictional prerequisite

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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)

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Section 321(g)(1):
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(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………

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

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

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Congressional intent:
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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?
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Food unless therapeutic claims are made
Wine and Alchol
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BATC
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Wine if > 7% (<7% = FDA)

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

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

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

(7 th Circuit Ct of Appeals)
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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

(7 th Circuit Ct of Appeals)
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Too narrow to restrict foods to just those that taste, smell or have nutritive value
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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

(7 th Circuit Ct of Appeals)
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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!

The Separation of the Powers between the States and the Federal Government

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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

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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.

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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.

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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

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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

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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

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

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

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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

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

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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

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