Food Law Exam 2

Why do food laws exist?

1) Public Health & Safety

2) Food Quality & Wholesomeness

3) Prevent Economic Adulteration

4) Fair Competition

Public Health & Safety

-Prevent food-borne illness

-Protect against contamination (intentional & unintentional)

-Example: CDC estimates

48 million illnesses/year

128,000 hospitalizations

3,000 deaths

Food Quality & Wholesomeness

• Ensures food is:

  • Nutritious

  • Not spoiled

  • Meets standards

• Includes:

  • Fortification (adding nutrients)

  • Labeling accuracy

  • Standards of identity

Prevent Economic Adulteration

• Fraud involving food value

• Examples:

  • Adding water to juice

  • Removing cream from milk

Fair Competition

-prevents misleading marketing

-ensures honest labeling and advertising

Adulteration

Food is unsafe because it:

-contains harmful substances

-is contaminated

-is produced in unsanitary conditions

Misbranding

When food labeling is:

-False

-Misleading

-Missed required info

Interstate Commerce

Food crossing state lines = under federal regulation

Laws

-created by Congress

-legally binding

Regulations

-created by agencies (FDA, USDA)

-explain how to follow laws

Policies/Guidance

-agency recommendations

-NOT legally binding

-Show “current thinking.”

FDCA

Federal Food, Drug, and Cosmetic Act

FSMA

Food Safety Modernization Act

FPLA

Fair Packaging and Labeling Act

FTCA

Federal Trade Commission Act

FMIA

Federal Meat Inspection Act

PPIA

Poultry Products Inspection Act

EPIA

Eggs Products Inspection Act

OFPA

Organic Foods Production Act

NLEA

Nutrition Labeling and Education Act

DSHEA

Dietary Supplement Health and Education Act

FALCPA

Food Allergen Labeling and Consumer Protection Act

FIFRA

Federal insecticide, Fungicide, and Rodenticide Act

FSQS

Food Safety and Quality Service (Former USDA agency)

Congress

Makes laws

President

Enforces Laws

Courts

Interpret laws

Example cases:

POM WONDERFUL vs. Coca-Cola (2014)

FDA (Food and Drug Administration)

-Under HHS (Health and Human Services)

-Regulates: 80% of food supply

-Covers: packaged foods, supplements, bottled water

CFSAN

Center for Food Safety and Applied Nutrition

Approach: Post-market (after product is sold)

USDA

United States Department of Agriculture

FSIS

Food Safety and Inspection Service

USDA Regulates

Meat

Poultry

Processed Eggs

Catfish

USDA Main Regulatory Branch

FSIS = Food Safety and Inspection Service

USDA Approach

-pre-market (before sale)

-continuous inspection

FTC

Federal Trade Commission

FTC regulates

advertising

prevents misleading claims

EPA

Environmental Protection Agency

EPA Regulates

Pesticides

Water Safety

Sets residue limits in food

TTB

Alcohol and Tobacco Tax and Trade Bureau

TTB Regulates

Alcohol labeling

Ingredients

Taxes

GRAS

Generally Recognized As Safe

Meaning: Ingredient does NOT need FDA pre-approval

Requirements: Must be accepted by experts

Pathways: scientific evidence, historical use (pre-1958)

DGA

Dietary Guidelines for Americas

Created by DGAC = Dietary Guidelines Advisory Committee

Purpose: Guide National Nutrition Policy

2026 Update

New “Inverted Pyramid”

TOP Priority: Protein, dairy, healthy fats

High: Fruits & Vegetables

Modern Food Issues

CRISPR (gene editing)

Lab-grown meat

CBD/cannabis foods

Ultra-processed foods

Edible Insects

Microbiome (probiotics/prebiotics)

Regulatory Process (APA)

APA = Administrative Procedure Act

Steps:

1) ANPRM = Advance Notice of Proposed Rulemaking

2) Proposed Rule

3) Public Comment

4) Final Rule

Enforcement Tools For FDA

FDA:

Inspections

Warning Letters

Recalls

Seizures

Criminal Penalties

Enforcement Tools For FSMA

Mandatory recalls

Facility shutdown

Enforcement Tools For USDA

Stop inspections

Condemn products

Withdraw approval

Food

used for taste, aroma, or nutrition

Drug

treats or prevents disease

Dietary Supplement

Adds nutrients (vitamins, herbs, etc)

Food Additive

Substance added to food

History (KEY DATES)

1906 —> Pure Food & Drug Act

1938 —> FDCA passed

1958 —> Food Additive Amendment

2010 —> FSMA

Current Issues & Lawsuits

Trends:

"Natural” Claims

Origin Claims (ex, “Italian Olive Oil”)

Sugar/sweetener claims

Ingredient transparency

Sustainability claims

Key Exam Takeaways

ALWAYS remember:

Adulteration = safety issue

Misbranding = labeling issue

FDA vs. USDA differences = VERY IMPORTANT

Know acronyms —> likely tested

4 purposes of food law = CORE QUESTION

Food Law touches…

ALL parts of the food system

Imports/exports

Ingredients

Nutrition Programs

Food Safety

Food Defense (Intentional contamination prevention)

Retail food protection

Labeling & marketing

International standards

Regulatory agencies

Public health policies

Even though food laws exist, companies still fail because:

Regulations are complex

Many agencies involved

Constant updates (ex: MAHA initiative)

Misunderstanding of rules

Poor compliance systems

Ex: Allergy Recalls

(undeclared allergens = about 50% of recalls)

Regulation

Agency enforcing laws

Policies

Internal agency approaches

Guidance

Recommendations (non-binding)

FAQs

Clarifications

MAHA Initiative

Major driver of current food regulatory landscape

MAHA’s Focus:

New regulations

New guidance

Food Recalls

Main cause:

Undeclared allergens

Examples:

Soy

Wheat

Sesame

Peanut

Tree nuts

Milk

Seafood (fish, crab, shrimp)

What Drives Food Innovation

Science

Technology

Data

Public Health Statistics

Consumer Demand

Economics

Politics

Environment

CFR

Code of Federal Regulations

Important Sections:

Title 21 —> Food & Drugs

Title 9 —> Animals & Animal Products

Early History:

1836 —> Patent Office created

1862 —> USDA established

1906 —> Pure & Food Drug Act

The Jungle (1906)

Exposed meat industry conditions

Led to food laws

USDA Agencies

FSIS = Food Safety and Inspection Service

AMS = Agricultural Marketing Service

APHIS = Animal and Plant Health Inspection Service

FNS = Food and Nutrition Service

CNPP = Center for Nutrition Policy and Promotion

State Role

States have similar laws to the federal

cannot conflict with federal law

Examples:

California Prop 65

GMO labeling lawa

Sugar taxes