Chapter 1-12 Flashcards
Historical Food Law Issues
toxic colors and preservatives, quack medicines
Pure Food and Drug Act 1906
Prohibited interstate commerce in misbranded and adulterated foods, drinks, and drugs.
Revisions to 1938 Food, Drug and Cosmetic Act
-1907 First Certifed Color Regulations
-1913 Gould Amendment
-1914 US vs. Lexington Mill case (flour
-1924 US vs. Barrels Alleged Cider Vinegar
-1927 Bureau of Chemistry spilt
-1930 McNary-Mapes Amendment
New Provisions to 1938 Food, Drug, and Cosmetic Act
- Authorizing SOI, SOQ, and fill of the container
- Authorizing factory inspection
- Providing that safe tolerances be set for unavoidable poisonous substances
- Included cosmetic and therapeutic devices
- Premarket safety testing of drugs
- Toxic substances prohibited in foods unless unavoidable or required in processing
- Authority for factory inspections
- Proof of fraud no longer required to stop false claims
- Previously only the maker had to believe efficacy
- Safe tolerances were authorized for pesticides residues
- Standards were developed for many foods
GRAS list
Generally Recognized as Safe
Delany Clause
zero tolerance on carcinogenic substances
What abolished the Delany Clause for pesticides?
Food Quality Protection Act 1996
8 Major Allergens
Milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans
FSMA Prevention Controls
-Mandatory preventive controls for food facilities
-Mandatory produce safety standards
-Authority to prevent intentional contamination
FSMA Inspection and Compliance Tools
-Mandated Inspection Frequency
-Records access
-Testing by accredited laboratories
FSMA Responses
-Mandatory recall
-Expanded administrative detention
-Suspension of registration
-Enhanced product tracing abilities
-Additional recordkeeping for high-risk foods
FSMA Imports
-Importer accountability
-Third-Party Certification
-Certification for high risk foods
-Voluntary qualified importer program
-Authority to deny entry
FSMA Enhanced Partnerships
-State and Local
-Foreign
-Other agencies
3 Federal Agencies that have enforcement auth
- FDA
- Meat Inspection Division
- Poultry Services
Standard
is a measure used to compare quality
Regulation
is a government control with the force of law
Ordinance, law, statue
gives the legal authority for governmental agencies to publicize and put regulations into effect
Code
often equals a regulation or statue and is a collection of regulations, statues, and procedures
Duties of FDA
- New Product Review
- Keeping Watch
- Standards and Regulations
- Research
- Enforcement-Correcting Problems
Where is FDA housed?
Department of Health and Human Services
adulteration
- filthy, putrid, decomposed
- Produced under unsanitary conditions
- Contains substances deleterious to health
- Economic value decreased without notification
misbranded
- Standard of identity fails
- Wrongly labeled
- Standard of fill fails
What 2 laws do FDA operate under?
- Food Drug and Cosmetic Act (FDCA)
- Public Health Services Act (PHS Act)
USDA regulates what food?
- Meat and products containing more than 3% w/w
- Poultry and products containing more than 2 w/w
- Eggs
- Certain dairy products
