1. All Those Laws and Regulations!!!
Who can keep up???
David A. Golden, Associate Professor Department of Food Science and Technology The University of Tennessee

2. Food Laws & Regulations
History
Who enforces them?
How are they enforced?
Specific examples
GMPs, additives, labeling, dietary supplements
What’s in it for you & the Food Code
Do you need an attorney to understand?

3. History Pre-1800 Early 1800’s No formal regulatory body
Economic adulteration/fraud
Bread and wine
Early 1800’s
Legislation focus on sale of fresh and processed foods

4. History 1842 – Agriculture Division established
1862 – President Lincoln establishes Bureau of Chemistry in Dept. of Agriculture
1880 – Proposed national food & drug law
Defeated - > 100 bills over next 25 years
1883 – Dr. Harvey Wiley
“Crusading Chemist,” “Father of Pure Food and Drugs Act”

5. History 1902 – Harvey Wiley studied preservatives and colors
1903 – Wiley’s “Poison Squad”
1906 – a busy year
Upton Sinclair’s “The Jungle”
Pure Food and Drugs Act
Meat Inspection Act
Harvey Wiley retires
Poison Squad’s dining room

6. History 1927 – Bureau of Chemistry - split
Regulatory - Food, Drug, and Insecticide Administration (FDIA)
1930 – FDIA name shortened to Food and Drug Administration (FDA)
1933 – FDA recommends revision of 1906 Food and Drugs Act
1938 – Federal Food, Drug, and Cosmetic Act
1958 – Food Additives Amendment
Delaney Clause
GRAS list

7. History 1960 – Color Additives Amendment
1971 – Saccharin removed from GRAS list
1973 – Low acid canned food regulations
1977 – Saccharin Study and Labeling Act
1988 – FDA established as agency in DHHS

8. History Laws vs. Regulations
1990 – Nutrition Labeling and Education Act
1994 – Dietary Supplement Health and Education Act
1997 – Saccharin Notice Repeal Act (warning label lifted, 2000)
Bioterrorism Act of 2002 – June 12, 2002 (Administrative detention provision)
Laws vs. Regulations

9. Enforcement USDA – Food Safety and Inspection Service
Meat and meat products
FDA
Non-meat products
Seafood

10. Enforcement USDA enforces: FDA enforces: Meat Products Inspection Act
Poultry Products Inspection Act
Egg Products Inspection Act
FDA enforces:
Federal Food Drug and Cosmetic Act, as Amended
Components of others (e.g., Title III, Bioterrorism Act)

11. Enforcement - FDA Inspection Warning letters Seizures Injunction
Food processing facilities
Periodic (>45,000 annually)
Focuses on GMPs
Snapshot
Warning letters
Seizures
Injunction

12. Enforcement - FDA Publicity Self-regulation Public warnings
Enforcement actions
Self-regulation
Public perception
Competition
Simple survival

13. FDA has no authority to mandate recalls!
Enforcement - FDA
Except…
Infant Formula
RECALLS
FDA has no authority to mandate recalls!

14. Enforcement - USDA Generally, same as FDA except: Inspection
Continuous
Pre- and Post-slaughter
No “snapshot”
Focuses on HACCP

15. Enforcement - USDA Generally, same as FDA except:
Suspension of inspection
Not stamped “Inspected and Passed”

16. Like FDA, USDA has no authority to mandate recalls!
Enforcement - USDA
RECALLS
Like FDA, USDA has no authority to mandate recalls!

17. Examples GMPs (Good manufacturing practices)
“Common sense” regulations
Broad instructions
Focus on food safety
Sanitation
Intended to prevent adulteration
Define minimum practices for safe food (e.g., temperatures)
Basis for FDA inspections

18. Examples HACCP (Hazard Analysis and Critical Control Points)
Preventive system
Seven principles
(1) hazard analysis, (2) critical control point identification, (3) establishment of critical limits, (4) monitoring procedures, (5) corrective actions, (6) record keeping, and (7) verification procedures.

19. Examples HACCP Basis for ALL USDA inspections
Basis for SOME FDA inspections
Seafood
Fresh juices

20. Treated With Irradiation or Treated by Irradiation
Examples
Treated With Irradiation or Treated by Irradiation
Food additives
Must be approved by FDA (even if for meat)
Chemical preservatives
Irradiation

21. Examples Nutrition Labeling most foods (~ 90% of processed foods)
distinctive, easy-to-read format
per serving information for saturated fat, cholesterol, dietary fiber, other nutrients
uniform definitions for various terms
e.g., low calorie, light, low-fat, reduced fat, high-fiber, low sodium

22. Examples
nutrient claims related to disease or health-related conditions
calcium and osteoporosis
fat and cancer
standardized serving sizes
serving size = "amount customarily eaten at one time"
Example

23. Examples Dietary Supplements Include (with some exceptions):
Vitamins (vitamin B, C, etc.)
Minerals (Iron, Calcium)
Herbs, botanicals, & plant-derived substances (ephedra, ginkgo, echinacea)
Amino acids and concentrates, metabolites, constituents, and extracts of these products

24. Examples Dietary Supplements Essentially UNREGULATED
Regulated through labeling
Dietary Supplements Health & Education Act
Authorizes establishment of GMPs

25. What’s in it for you?? State regulations Health Departments
Regulate retail food establishments
Use the “Food Code”
GMPs for restaurants
Hygiene, sanitation
Temperatures
Equipment
Restaurant Inspection Scores

26. What’s in it for you?? Educate yourself
Be an “enforcer” - play a role in food safety
Understand nutrition labeling – make informed decisions
Don’t blame the government – put responsibility where it lies

27. Do you need an attorney?
No – Federal agencies have become “consumer friendly”
Visit FDA and USDA websites
Browse “Consumer Advice”
FDA Consumer Magazine
Seniors – (info for those over 65)
Recall notices and safety alerts

28. Understanding Labels How much juice is really there?

29. Understanding Labels How much juice is really there?

30. Understanding Labels Who regulates the product?

31. Understanding Labels Who regulates the product?

32. Thank You!!