US History (Ch. 1) Flashcards
What are the three branches of the US Government?
- The Legislative Branch
- The Executive Branch
- The Judicial Branch
What branch of the US government is responsible for making laws?
Legislative
What branch of the US government is responsible for executing laws?
Executive
What branch of the US government is responsible for evaluating laws?
Judicial
What does FDA stand for?
The US Food and Drug Administration
How do the three branches of US government affect the FDA?
They guide the regulations for products that are under the FDA’s jurisdiction
What are the two parts of Congress?
- The House of Representatives
2. The Senate
How does Congress affect the FDA?
Congress uses its authority to 1) regulate interstate commerce, and 2) legislate federal statutes on food/drugs
What is the process for a bill to become a statute?
Bill / Joint Resolution > Subject matter committees / public hearings > House/Senate votes > Signed by President > Statute
What is a statute?
An enacted law
What is a public law?
A law that affects society as a whole (e.g. food, drugs)
What is a private law?
A law that affects an individual or a small group
What is a slip law?
The first official publication of a statute (published separately)
What is the NARA, and what do they do?
National Archives and Records Administration (NARA),(Office of the Federal Register), prepares slip laws and adds marginal notes with explanatory info
What is the US Statutes at Large?
A permanent collection of all laws enacted during each session of Congress (prepared by the Office of the Federal Register)
What is the United States Code (U.S.C.)?
Statutes are published, or “codified” in the U.S.C. (e.g. Title 21 is federal statutes on food and drugs), prepared by the Law Revision Council of the House of Representatives
What is the HHS?
Department of Health and Human Services (HHS)
What branch of the government is the FDA under?
Executive branch, HHS
What is the purpose of the FDA?
To implement statutes through regulations, the mission is to protect public health by ensuring the safety of 1) food, 2) drugs, and 3) cosmetics
What are regulations?
interpret laws and describe how they will be enforced
What is rulemaking?
A process the FDA uses to propose and establish regulations
What is the Administrative Procedure Act (APA) of 1946?
Administrative Procedure Act (APA) of 1946:
Requires agencies to keep the public informed, and gives the public the right to participate in the rulemaking process by commenting on proposed regulations
What is the Government in the Sunshine Act of 1976?
Government in the Sunshine Act of 1976:
Requires advanced notice of rulemaking meetings, and that those meetings are open to the public (Unified Agenda provides regulatory agenda with planned rulemaking activities for 6 months)
What is the Federal Register (FR)?
Where new regulations, or changes to existing regulations are published (similar to US Statutes at Large)
What is the Code of Federal Regulations (CFR)?
Where regulations are published (similar to U.S. Code), organized into 50 titles
What is the CFR formatting?
Title #, “CFR”, Part #, “.”, Section # (e.g. 21 CFR 10.3)
What are FDA guidance documents?
Used to convey the FDA’s “current thinking” or enforcement priorities to establish regulatory principles and practices aligned with that thinking (not legally binding)
What is a treaty?
A written agreement between sovereign states (or other international bodies) dictating terms binding the parties to the agreement, becoming international law once signed
What is a trade agreement?
Establishes terms between parties regarding tariffs/trade restrictions
What is case law?
Law based on judicial opinions (as opposed to legislative law), judicial decisions set precedents that influence food and drug laws/regulations
What is the United States Reports?
The official record of the proceedings of the Supreme Court
How have judicial opinions influenced food/drug regulations?
Regulating false claims, chemicals in the food supply, labeling, ability to prosecute responsible individuals of a corporation, drug efficacy, scope of drug/devices
Who is Harvey Wiley?
(1902) Had concerns about the safety of food preservation chemicals (Poison Squad experiments)
What was Upton Sinclair’s book?
“The Jungle”, described the unsanitary conditions in the meat packing industry