Food and Drug Administration Chapter 6 Graded A+
History of FDA - Answers butter v. oleo
moving from local to mass-produced
Spanish-American War and The Jungle publicized need for change
Pure Food and Drug Act (1906) - Answers aka Wiley Act
forbids commerce of misbranded food and drugs
must a...
Spanish-American War and The Jungle publicized need for change
Pure Food and Drug Act (1906) - Answers aka Wiley Act
forbids commerce of misbranded food and drugs
must abide by standards
variations must be disclosed on label
Food and Drug Administration - Answers created by FDA
started as Bureau of Chemistry
Food, Drug, and Cosmetic Act of 1938 - Answers Manufactures must prove that drug is safe before it can
be used; requires FDA approval; distinguishes prescription drugs from over-the-couter
Extended power of FDA to cosmetics and therapeutic devices
Exempt: Meat (under dep. of Ag.)
Kefauver-Harris Amendments - Answers FDA had to approve drugs based on effectiveness
gave greater powers to FDA (including advertising)
Food Regulation - Answers Originally over just canned food (quality, quantity in can)
Delaney Clause (1958) - Answers FDA assumed control over food additives;
Banned carcinogenics (causes cancer)
Structure of FDA - Answers Under Dep. of Health and Human Serivces
Enforcement by the FDA - Answers Recalls; Injuctions; Seizure of the subject product; Fines; Consent
decree; Criminal investigation
Food Additives - Answers Delaney Clause: no additives execpt for GRAS; manfacturer has burden of
proof (ex: Red Dye No 2 and M&Ms)
Food Quality Protection Act: food additives must have reasonable certainty of no harm - expands FDA to
include pesticides
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller TutorJosh. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $7.99. You're not tied to anything after your purchase.