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

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?

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

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”

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 1912 - Harvey Wiley retires Poison Squad’s dining room

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

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

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

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

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)

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

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

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

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

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

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

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

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.

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

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

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

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

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

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

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

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

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

Understanding Labels How much juice is really there?

Understanding Labels How much juice is really there?

Understanding Labels Who regulates the product?

Understanding Labels Who regulates the product?

Thank You!!