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INTRODUCTION TO FOOD INTRODUCTION TO FOOD REGULATIONSREGULATIONS

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Steven C SeidemanSteven C SeidemanExtension Food Processing SpecialistExtension Food Processing Specialist

Cooperative Extension ServiceCooperative Extension ServiceUniversity of ArkansasUniversity of Arkansas

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INTRODUCTIONINTRODUCTION

This module is an overview of food This module is an overview of food regulations to include the history of food regulations to include the history of food law, agencies responsible and where to law, agencies responsible and where to find various food regulations in the Code find various food regulations in the Code of Federal Regulations.of Federal Regulations.

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FOOD LAWS ARE NECESSARYFOOD LAWS ARE NECESSARY

Food Safety- The U.S. government sets The U.S. government sets standards to protect consumers from problems standards to protect consumers from problems associated with toxins from molds, rodent associated with toxins from molds, rodent remains, toxic dyes and preservatives, remains, toxic dyes and preservatives, insecticides and pesticides and certain food-insecticides and pesticides and certain food-borne pathogens.borne pathogens.

Quality or Standards of Acceptance- Foods must Foods must conform to standards for a particular food conform to standards for a particular food product to prevent consumer deception. product to prevent consumer deception.

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Why are Foods RegulatedWhy are Foods Regulated??

To ensure To ensure safetysafety and and wholesomenesswholesomeness

To prevent To prevent fraud and deceptionfraud and deception

To To inform consumersinform consumers about the nutritional about the nutritional content of foodscontent of foods

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HISTORY OF FOOD LAWSHISTORY OF FOOD LAWS

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HistoryHistory

Food laws began with Egyptian and Food laws began with Egyptian and Hebrew cultures.Hebrew cultures.

Hebrew or “Kosher” laws are in the Old Hebrew or “Kosher” laws are in the Old Testament of the Bible;Testament of the Bible;

Leviticus 11 and 22Leviticus 11 and 22

Deuteronomy 12 and 14Deuteronomy 12 and 14

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Examples of Old Testament Food Examples of Old Testament Food LawsLaws

Could eat only cloven-hooved, cud-chewing animals Could eat only cloven-hooved, cud-chewing animals (Leviticus 11;2).(Leviticus 11;2).Could not eat or touch pork (Leviticus 11;7)Could not eat or touch pork (Leviticus 11;7)Could not eat an animal which died of a disease Could not eat an animal which died of a disease (Leviticus 11;39)(Leviticus 11;39)Could not eat blood ( Deuteronomy 12:15 & 22)Could not eat blood ( Deuteronomy 12:15 & 22)Could not eat animals that died a natural death Could not eat animals that died a natural death (Deuteronomy 14;21)(Deuteronomy 14;21)Could not eat meat cooked with milk (Deuteronomy Could not eat meat cooked with milk (Deuteronomy 14;21)14;21)Could not eat the sciatic nerve ( Genesis 32:32)Could not eat the sciatic nerve ( Genesis 32:32)Christens believe in Peter’s vision ( Acts 10) to negate Christens believe in Peter’s vision ( Acts 10) to negate many of the Old Testament Laws.many of the Old Testament Laws.

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ADULTERATION OF FOODADULTERATION OF FOOD- Toxic colors, lead, poisonous preservatives, filth, animal remains- Toxic colors, lead, poisonous preservatives, filth, animal remains

MISBRANDING OF FOODMISBRANDING OF FOOD - - Misleading labels - “fruit jelly” ( water, glucose, grass seed, Misleading labels - “fruit jelly” ( water, glucose, grass seed,

color)color) - - no weight marked on the labelsno weight marked on the labels

FALSE ADVERTISINGFALSE ADVERTISING- - Phony patent cures, false claimsPhony patent cures, false claims

3 Problems at Beginning of 3 Problems at Beginning of Twentieth CenturyTwentieth Century

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Major Food LegislationMajor Food Legislation

Pure Food and Drug Act. Pure Food and Drug Act. (1906) The first (1906) The first federal food act. Developed by Dr Harvey Wiley federal food act. Developed by Dr Harvey Wiley (The father of FDA)(The father of FDA)Federal Meat Inspection ActFederal Meat Inspection Act (1906)-mandatory (1906)-mandatory inspection of animal, slaughtering conditions and inspection of animal, slaughtering conditions and processing facilities as a result of THE JUNGLE processing facilities as a result of THE JUNGLE by Upton Sinclair.by Upton Sinclair.Federal Food, Drug and Cosmetic Act Federal Food, Drug and Cosmetic Act (1938)- (1938)- Authorized the creation of the FDA for food Authorized the creation of the FDA for food regulation.regulation.Federal Poultry Products ActFederal Poultry Products Act (1957)- The first (1957)- The first poultry regulations.poultry regulations.

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Major Food Legislation -Major Food Legislation -ContinuedContinued

Federal Trade CommissionFederal Trade Commission (1938)- (1938)-regulations against false advertising.regulations against false advertising.

Nutritional Labeling and Education ActNutritional Labeling and Education Act (NLEA, 1990)- uniform and consistent (NLEA, 1990)- uniform and consistent nutritional labels.nutritional labels.

Food Quality Protection ActFood Quality Protection Act (FQPA)- (FQPA)-regulates pesticide use in foods.regulates pesticide use in foods.

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Food safety, interstate trade and foreign commerceFood safety, interstate trade and foreign commerce

Major weaknessesMajor weaknesses::1. Not applicable within state boundaries1. Not applicable within state boundaries2. Difficult to enforce - no QA methods2. Difficult to enforce - no QA methods

3. Had to show intent to fraud3. Had to show intent to fraud

Pure Food And Drug Law 1906Pure Food And Drug Law 1906

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New law as a result of food New law as a result of food scandalsscandals

AdvantagesAdvantages::1. Devices regulated 1. Devices regulated

2. No need to prove fraud2. No need to prove fraud3. Prove safety of products3. Prove safety of products4. Poisons prohibited4. Poisons prohibited5. Inspections5. Inspections6. Food standards6. Food standards7. Legal actions7. Legal actions

Federal Food, Drug and Cosmetic Federal Food, Drug and Cosmetic Act 1938Act 1938

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Regulatory Agencies Involved in Regulatory Agencies Involved in Food LawsFood Laws

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ConsumersConsumers

Demand food that is safeDemand food that is safe

IndustryIndustry

Need profit and good reputationNeed profit and good reputation

GovernmentGovernment

Must protect the consumer and foodMust protect the consumer and food

FORCES AFFECTING FORCES AFFECTING LEGISLATIONLEGISLATION

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Major U.S. Food Regulatory Major U.S. Food Regulatory AgenciesAgencies

Food and Drug AdministrationFood and Drug Administration (FDA)- (FDA)- oversees most foods.oversees most foods.United States Department of AgricultureUnited States Department of Agriculture (USDA)-Oversees most meat and poultry.(USDA)-Oversees most meat and poultry.Federal Trade CommissionFederal Trade Commission (FTC) – (FTC) – oversees advertising. oversees advertising. Bureau of Alcohol, Tobacco and FirearmsBureau of Alcohol, Tobacco and Firearms (ATF)-Alcohol(ATF)-AlcoholEnvironmental Protection AgencyEnvironmental Protection Agency(EPA)- (EPA)- pesticide regulation and waste waterpesticide regulation and waste water

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Role of GovernmentRole of Government CONGRESSCONGRESS: : legislative branch legislative branch

Pass laws- “STATUTORY LAW” Pass laws- “STATUTORY LAW” Called the “U.S. Code” Food is Title 21Called the “U.S. Code” Food is Title 21 PRESIDENTPRESIDENT: : executive branch executive branch

FDA /USDA produces rules to enforce statutory FDA /USDA produces rules to enforce statutory lawlaw REGULATIONS - “ADMINISTRATIVE LAW”REGULATIONS - “ADMINISTRATIVE LAW” Called the “Code of Federal Regulations”. Food are found Called the “Code of Federal Regulations”. Food are found

in Titles 9 (USDA) and 21(FDA).in Titles 9 (USDA) and 21(FDA). COURTSCOURTS : : judicial branchjudicial branch

IInterpret the lawnterpret the lawCASES - “CASE LAW”CASES - “CASE LAW”

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Regulatory AgenciesRegulatory Agencies

FDA - part of HHSFDA - part of HHS

Police the food industry in interstate trade:Police the food industry in interstate trade:

- processing procedures- processing procedures

- food adulteration- food adulteration

- misbranding- misbranding

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Regulatory Agencies Regulatory Agencies

Limitations of FDA:Limitations of FDA:

Restricted to interstate tradeRestricted to interstate trade Can not prevent sale of defective Can not prevent sale of defective

goodsgoods Cannot recall foodsCannot recall foods

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Regulatory AgenciesRegulatory Agencies

USDA:USDA: Regulate food with > 2% meatRegulate food with > 2% meat Food gradesFood grades Food and nutrition programsFood and nutrition programs

FTC:FTC: CConsumer protection - advertisingonsumer protection - advertising

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Regulatory AgenciesRegulatory Agencies

EPAEPA:: Pesticide regulationPesticide regulation Water treatmentWater treatment Environmental safetyEnvironmental safety Waste managementWaste management

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President

USDA Dept. of Commerce HHS

NIH

CSAN

NCI

FSISFNS

NMFS

FDA

NTIS

Congress

FTC

Treasury

BATF

EPA Labor CPSC

THE FEDERAL GOVERNMENT AND THE FOOD SUPPLYTHE FEDERAL GOVERNMENT AND THE FOOD SUPPLY

OSHA

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Legislative branchLegislative branch

Congress Congress - pass food law- pass food law

Executive branchExecutive branch

Presidency ( FDA) Presidency ( FDA) - enforce food laws- enforce food laws

Judicial branch Judicial branch

Courts Courts - interpret food laws- interpret food laws

ROLE OF GOVERNMENTROLE OF GOVERNMENT

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Role of Federal RegulationsRole of Federal Regulations

Ensure that foods areEnsure that foods are;;

*Safe*Safe

*Pure*Pure

*Wholesome*Wholesome

*Sanitary*Sanitary

*Honestly labeled*Honestly labeled

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Activities of Federal AgenciesActivities of Federal Agencies

Work with industry to Work with industry to interpretinterpret regulations. regulations.

Help industry establish Help industry establish controlcontrol measures. measures.

Make Make inspectionsinspections of food plants of food plants

ExamineExamine food from interstate shipments. food from interstate shipments.

Issue and enforce regulations on food Issue and enforce regulations on food additives.additives.

Approve and certify acceptable food Approve and certify acceptable food colors.colors.

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Activities of Federal Agencies-Activities of Federal Agencies-ContinuedContinued

Test for Test for pesticidepesticide residues residuesExamine Examine importedimported foods. foods.AdviseAdvise state and local inspection state and local inspection agencies.agencies.Work with state and local agencies in Work with state and local agencies in times of times of disasterdisaster to dispose of to dispose of contaminated foods.contaminated foods.Set up “Set up “standards of identitystandards of identity” to promote ” to promote honesty and value of food products.honesty and value of food products.

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Food LabelingFood Labeling

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Food LabelingFood Labeling

Types of food label informationTypes of food label information..

**MandatoryMandatory labeling information labeling information

**Optional Optional information which is regulated if information which is regulated if

present.present.

**VoluntaryVoluntary –unregulated information –unregulated information (recipes, preparation info etc)(recipes, preparation info etc)

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Required Label InformationRequired Label Information

1)Common food name without confusing 1)Common food name without confusing adjectives ( Standards of Identity).adjectives ( Standards of Identity).

2)Net quantity of contents2)Net quantity of contents 3)Ingredients –list of ingredients in descending 3)Ingredients –list of ingredients in descending

order by weight.order by weight. 4)Company name and address.4)Company name and address. 5)Nutritional information5)Nutritional information 6) Establishment number and USDA seal (Meat 6) Establishment number and USDA seal (Meat

products only).products only).

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Label ClaimsLabel Claims

Every adjective has a well-defined definitionEvery adjective has a well-defined definition;;

**Fat freeFat free- <0.5 gram fat per serving- <0.5 gram fat per serving

**Low-fatLow-fat- have less than 3 gram fat per - have less than 3 gram fat per

serving.serving.

**LightLight- product to have 33% fewer calories - product to have 33% fewer calories

than a standard reference product.than a standard reference product.

*Other examples include “fresh”, “good source of *Other examples include “fresh”, “good source of ___.” “Organic” etc.___.” “Organic” etc.

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Nutritional LabelingNutritional Labeling

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NUTRITIONAL LABELINGNUTRITIONAL LABELING

The Nutritional Labeling and Education Act The Nutritional Labeling and Education Act (NLEA) of 1990 provided for a mandate for (NLEA) of 1990 provided for a mandate for the food industry to provide food nutrient the food industry to provide food nutrient data on food packages. data on food packages.

Detailed information on the NLEA Detailed information on the NLEA regulations can be found in ”A Food regulations can be found in ”A Food Labeling Guide” at Labeling Guide” at http://vm.cfsan.fda.gov/~dms/flg-toc.htmlhttp://vm.cfsan.fda.gov/~dms/flg-toc.html. .

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Parts of a Nutritional LabelParts of a Nutritional Label

Serving SizeServing Size- Serving size is based on a - Serving size is based on a reference amount which is defined in the reference amount which is defined in the regulations. In most cases, if a retail unit’s regulations. In most cases, if a retail unit’s contents are less than 200% of the contents are less than 200% of the reference amount, the container would be reference amount, the container would be labeled as 1 serving. There are many labeled as 1 serving. There are many other rules and exemptions in the other rules and exemptions in the calculation of a serving size.calculation of a serving size.

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Parts of the Nutritional LabelParts of the Nutritional Label

Required nutrientsRequired nutrients- There are fourteen - There are fourteen (14) nutrients or nutrient facts that must be (14) nutrients or nutrient facts that must be specified on all nutritional labels.specified on all nutritional labels.

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Fourteen Required NutrientsFourteen Required Nutrients

CaloriesCalories

Calories from FatCalories from Fat

Total FatTotal Fat

Saturated FatSaturated Fat

CholesterolCholesterol

SodiumSodium

Dietary fiberDietary fiber

Total CarbohydratesTotal Carbohydrates

SugarSugar

ProteinProtein

Vitamin AVitamin A

Vitamin CVitamin C

Calcium Calcium

IronIron

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Nutritional LabelNutritional Label

The nutritional label may be located on The nutritional label may be located on either the principle display panel or on the either the principle display panel or on the information panel of the package.information panel of the package.

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FOOD REGULATIONSFOOD REGULATIONS

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FOOD LAW LITERATUREFOOD LAW LITERATURE

Statutory Law-Statutory Law- Laws passed by Congress Laws passed by Congress go into the U.S. Code which is divided into go into the U.S. Code which is divided into titles.titles.

Title 21 deals with all food regulationsTitle 21 deals with all food regulations

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FOOD LAW LITERATUREFOOD LAW LITERATURE

Administrative Law-Administrative Law- These are regulations and practical These are regulations and practical instructions found in the Code of Federal Regulations instructions found in the Code of Federal Regulations (CFR).(CFR).The CFR shows how to comply with the U.S. Code.The CFR shows how to comply with the U.S. Code.Titles; Titles;

Title 7 Food and Nutrition ServiceTitle 7 Food and Nutrition Service Title 9; USDA/ Food Safety and Inspection Title 9; USDA/ Food Safety and Inspection Service. Deals with meat and poultry food Service. Deals with meat and poultry food

items.items. Title 21; Food & Drug Administration (FDA). Deals with Title 21; Food & Drug Administration (FDA). Deals with all non-meat food itemsall non-meat food items

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FOOD LAW LITERATUREFOOD LAW LITERATURE

www.gpoaccess.gov/topics/food.htmlwww.gpoaccess.gov/topics/food.html..The above website is the location to find The above website is the location to find both the both the U.S. CodeU.S. Code and the and the Code of Code of Federal Regulations.Federal Regulations.U.S. CodeU.S. Code is half way down the page in is half way down the page in the section entitled Federal Food & Drug the section entitled Federal Food & Drug Legislation. Click on Title 21 for all food Legislation. Click on Title 21 for all food (including meat ). These are laws passed (including meat ). These are laws passed by Congress.by Congress.

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Federal Food and Drug Federal Food and Drug RegulationsRegulations

Federal Food and Drug RegulationsFederal Food and Drug Regulations are found in are found in the Code of Federal Regulations also in the the Code of Federal Regulations also in the same website.same website.These are the most utilized sources of These are the most utilized sources of information for food processors.information for food processors.We will now spend some more time on where to We will now spend some more time on where to find specific information within the CFR.find specific information within the CFR.Go to; Go to; www.gpoaccess.gov/topics/food.htmlwww.gpoaccess.gov/topics/food.html..Go to the second division entitled “ Federal Food Go to the second division entitled “ Federal Food & Drug Regulations”.& Drug Regulations”.

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CFR Title 7CFR Title 7

This has some information that may be of This has some information that may be of assistance to food processors but mainly assistance to food processors but mainly covers the covers the National School Lunch National School Lunch Program and the Nutritional Education and Program and the Nutritional Education and Training ProgramTraining Program and similar other and similar other programs but little on food regulations.programs but little on food regulations.

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CFR Title 9CFR Title 9

This title has to do with meat, poultry and This title has to do with meat, poultry and egg regulations. egg regulations.

Go to Chapter III Parts 300-599 (Food Go to Chapter III Parts 300-599 (Food Safety and Inspection Service; USDA).Safety and Inspection Service; USDA).

This Chapter has almost all the regulations This Chapter has almost all the regulations food processors need to know about food processors need to know about USDA inspection for meat, poultry and egg USDA inspection for meat, poultry and egg products.products.

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CFR Title 9CFR Title 9

PartPart Topics CoveredTopics Covered317 Labeling, marking devices and 317 Labeling, marking devices and containers. All about labels and containers. All about labels and nutritional labelingnutritional labeling319 Definitions and standards of identity or 319 Definitions and standards of identity or composition. List of meat items with composition. List of meat items with standards of identitystandards of identity416 Sanitation416 Sanitation417 HACCP417 HACCP

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CFR Title 21CFR Title 21

This title covers all foods except for meat, This title covers all foods except for meat, poultry and eggs.poultry and eggs.

Go to Go to ww.gpoaccess.gov/topics/food.htmlww.gpoaccess.gov/topics/food.html - Go to the second division entitled - Go to the second division entitled

“Federal Food & Drug Regulations”“Federal Food & Drug Regulations” - Click on “Food and Drug Administration” –- Click on “Food and Drug Administration” –

Title 21,I. Title 21,I.

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CFR Title 21CFR Title 21

PartsParts Topics CoveredTopics Covered

100-169 All about food labeling, standards 100-169 All about food labeling, standards

of identity, GMPs, HACCP. Most of identity, GMPs, HACCP. Most

food information are in these partsfood information are in these parts

170-199 Deals with food additives and 170-199 Deals with food additives and

irradiation of foodsirradiation of foods

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SUMMARYSUMMARY

This module has briefly covered the This module has briefly covered the history of food laws, agencies responsible history of food laws, agencies responsible and where to find the regulations in the and where to find the regulations in the Code of Federal Regulations.Code of Federal Regulations.

We encourage you to go through the We encourage you to go through the gpoaccess website and become familiar gpoaccess website and become familiar with where to find those food regulation with where to find those food regulation topics that you may be interested in.topics that you may be interested in.

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