1. Food Law and Regulations FS 321 Friday, January 28, 2011 Lecture #5 Structure and Intro FFDCA

2. The Assignment A couple of updates A couple of updates Critical Thinking Critical Thinking Technical Writing Technical Writing

3. Critical Thinking Purposeful, self-regulatory judgment which gives consideration to the evidence, methods, concepts, and criteria upon which a judgment is based Purposeful, self-regulatory judgment which gives consideration to the evidence, methods, concepts, and criteria upon which a judgment is based

4. Technical Writing An appropriate type and format An appropriate type and format Well organized Well organized References must be cited References must be cited

5. Moving on Pure Food Act Pure Food Act Implications Implications Weaknesses Weaknesses Setting the stage for FDCA of 1938 Setting the stage for FDCA of 1938

6. Pure Food Act Implications Defined Adulteration and Misbranding Defined Adulteration and Misbranding Laid the ground work for the Federal Food, Drug and Cosmetic Act of 1938 Laid the ground work for the Federal Food, Drug and Cosmetic Act of 1938 At the same time: At the same time: –Meat Inspection Act –Poultry Products Inspection Act –Egg and Egg Products Inspection act

7. Global Intent The American consumer is entitled to safe food and the opportunity to make informed decisions based on accurate information in the market place The American consumer is entitled to safe food and the opportunity to make informed decisions based on accurate information in the market place In a nutshell it addressed fraud In a nutshell it addressed fraud

8. Regulatory Agencies Food Quality and Safety US Department of Agriculture US Department of Agriculture –Food Safety Food Safety and Inspection Service Food Safety and Inspection Service Agricultural Marketing Service Agricultural Marketing Service Department of Health and Human Services Department of Health and Human Services –Food and Drug Administration Center for Food Safety and Nutrition Center for Food Safety and Nutrition –Center for Disease Control and Prevention

9. Other Agencies Department of Treasury Department of Treasury –Bureau of Alcohol, Tobacco and Firearms Federal Trade Commission Federal Trade Commission –The Fair Trade Watch

10. Food Marketing to Children Food Composition Food Composition Also Under Consideration Also Under Consideration –Packaging –Typeface –Pictures

11. How to Find Information Government Accounting Office (GAO) Government Accounting Office (GAO) –Congressional Record Official record of proceedings and debates in Congress Official record of proceedings and debates in Congress –Code of Federal Regulations (CFR) –Federal Register Proposals Proposals Notices Notices –Individual websites of the agencies –Individual websites of the “voices”

12. Weaknesses Bureau of Chemistry Report 1917 Lack of legal standards (descriptions) of food Lack of legal standards (descriptions) of food Lack of authority to inspect food and drug warehouses Lack of authority to inspect food and drug warehouses Inability to restrict interstate shipments of food that naturally contained poison Inability to restrict interstate shipments of food that naturally contained poison Lack of jurisdiction over false or misleading claims made on foods Lack of jurisdiction over false or misleading claims made on foods Failure to address pesiticides Failure to address pesiticides

13. Food Drug and Cosmetic Act Grew from the zeitgeist of the times Grew from the zeitgeist of the times The Pure Food Act was narrow in focus The Pure Food Act was narrow in focus

14. What was happening? Lack of drug testing Lack of drug testing –Sulfanilamide prepared using diethylene glycol: 100 people died –Media Books of the 1930’s 100,000,000 Guinea Pigs: A Kallet Books of the 1930’s 100,000,000 Guinea Pigs: A Kallet American Chamber of Horror: R. Lamb American Chamber of Horror: R. Lamb Guinea Pigs No More: J. B. Matthews Guinea Pigs No More: J. B. Matthews

15. Food Drug Act of 1938 New Provisions Safe tolerances be set for unavoidable poisonous substances Safe tolerances be set for unavoidable poisonous substances Authorizing standards of identity, quality and fill-of-container for foods Authorizing standards of identity, quality and fill-of-container for foods Authorizing factory inspections Authorizing factory inspections Expanding definitions of adulteration and misbranding Expanding definitions of adulteration and misbranding Monday and Wednesday: the particulars Monday and Wednesday: the particulars