UT%20Conference%20for%20Guidance%20Counselors

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

• History
• Who enforces them?
• How are they enforced?
• Specific examples
• GMPs, additives, labeling, dietary supplements
• Whats in it for you the Food Code
• Do you need an attorney to understand?

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History

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

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History

• 1842 Agriculture Division established
• 1862 President Lincoln establishes Bureau of
  Chemistry in Dept. of Agriculture
• 1880 Proposed national food drug law
• Defeated - gt 100 bills over next 25 years

• 1883 Dr. Harvey Wiley
• Crusading Chemist,Father of Pure Food and
  Drugs Act

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History

• 1902 Harvey Wiley studied preservatives and
  colors
• 1903 Wileys Poison Squad
• 1906 a busy year
• Upton Sinclairs The Jungle
• Pure Food and Drugs Act
• Meat Inspection Act
• 1912 - Harvey Wiley retires

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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

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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

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History

• 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
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Enforcement

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

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Enforcement

• USDA 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)

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Enforcement - FDA

• Inspection
• Food processing facilities
• Periodic (gt45,000 annually)
• Focuses on GMPs
• Snapshot
• Warning letters
• Seizures
• Injunction

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Enforcement - FDA

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

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Enforcement - FDA
Except Infant Formula
RECALLS
FDA has no authorityto mandate recalls!
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Enforcement - USDA

• Generally, same as FDA except
• Inspection
• Continuous
• Pre- and Post-slaughter
• No snapshot
• Focuses on HACCP

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Enforcement - USDA

• Generally, same as FDA except
• Suspension of inspection
• Not stamped Inspected and Passed

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Enforcement - USDA
RECALLS
Like FDA, USDAhas no authorityto mandate
recalls!
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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

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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.

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Examples

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

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Examples

• Food additives
• Must be approved by FDA (even if for meat)
• Chemical preservatives
• Irradiation

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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

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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

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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

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Examples

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

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Whats 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

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Whats in it for you??

• Educate yourself
• Be an enforcer - play a role in food safety
• Understand nutrition labeling make informed
  decisions
• Dont blame the government put responsibility
  where it lies

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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

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Understanding LabelsHow much juice is really
there?
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Understanding LabelsHow much juice is really
there?
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Understanding Labels Who regulates the
product?
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Understanding Labels Who regulates the
product?
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ThankYou!!