2/6/2017 Guide to Introduction US Food Laws and Regulations Early colonial food laws were written to SECONDEDITION protect consumers from economic fraud Chapter 4 PatriciaA.Curtis In the early 1900s,federal food laws Major Food Laws focused on food safety and prevention and Regulations of food adulteration This chapter will discuss federal food laws related to economic,aesthetic,and food safety expectations WILEY Blackwel Pure Food and Drug Act(1906) Pure Food and Drug Act(1906) Federal Meat Inspection Act(1906) Federal Meat Inspection Act(1906) 1906,Pres.Theodore Roosevelt signed PFDA made it unlawful to manufacture and distribute both acts into law into interstate or foreign commerce food or drugs that were adulterated or misbranded Regulatory responsibilities were divided PFDA gave the Bureau of Chemistry the authority to among 2 agencies within the USDA inspect food products and to turn violators over to -Bureau of Chemistry(later the FDA) the justice system enforced the PFDA Violators were brought to trial by the Secretary of Agriculture -Bureau of Animal Industry enforced FMIA If guilty,the violator was charged with a misdemeanor and fined up to 500 dollars,one year in prison,or both
2/6/2017 1 Chapter 4 Major Food Laws and Regulations Introduction • Early colonial food laws were written to protect consumers from economic fraud • In the early 1900s, federal food laws focused on food safety and prevention of food adulteration • This chapter will discuss federal food laws related to economic, aesthetic, and food safety expectations Pure Food and Drug Act (1906) Federal Meat Inspection Act (1906) • 1906, Pres. Theodore Roosevelt signed both acts into law • Regulatory responsibilities were divided among 2 agencies within the USDA - Bureau of Chemistry (later the FDA) enforced the PFDA - Bureau of Animal Industry enforced FMIA Pure Food and Drug Act (1906) Federal Meat Inspection Act (1906) • PFDA made it unlawful to manufacture and distribute into interstate or foreign commerce food or drugs that were adulterated or misbranded • PFDA gave the Bureau of Chemistry the authority to inspect food products and to turn violators over to the justice system • Violators were brought to trial by the Secretary of Agriculture • If guilty, the violator was charged with a misdemeanor and fined up to 500 dollars, one year in prison, or both
2/6/2017 Pure Food and Drug Act(1906) First produced with COCA-COLA Federal Meat Inspection Act(1906) two kev inaredients SYRUP&AND春EXTRACT cocaine and caffeine Deficiencies in the law made it hard to prosecute For Soda Water adoter Carbonated Beverages No legal standards for food were stated in the Cocaine was derived law making adulteration and misbranding de ToN from the coca leaf difficult to prove Caffeine was derived No legal authority was granted to an agency for 0 from kola nut inspecting warehouses storing food and drugs No legal authority was granted to restrict Thus,the name Coca- interstate commerce of food confaining a Cola naturally-occurring poison APFmberton. -No legal authority was granted over false or misleading statements made about a food Pure Food and Drug Act(1906) Pure Food and Drug Act(1906) Federal Meat Inspection Act(1906) Federal Meat Inspection Act(1906) PFDA defined adulteration and misbranding An adulterated food has one of the following as it relates to food and drugs mixed and packaged with a substance that Definition allowed FDA and USDA to include reduces or injuriously affects its quality foods processed in unsanitary environments or strength substituted in whole or part or subtracted PFDA was only 6 pages long but it paved the from in whole or part way for more stringent federal regulations mixed with a substance added to conceal inferior or damaged quality
2/6/2017 2 First produced with two key ingredients, cocaine and caffeine Cocaine was derived from the coca leaf Caffeine was derived from kola nut Thus, the name CocaCola Pure Food and Drug Act (1906) Federal Meat Inspection Act (1906) Deficiencies in the law made it hard to prosecute - No legal standards for food were stated in the law making adulteration and misbranding difficult to prove - No legal authority was granted to an agency for inspecting warehouses storing food and drugs - No legal authority was granted to restrict interstate commerce of food containing a naturally-occurring poison - No legal authority was granted over false or misleading statements made about a food Pure Food and Drug Act (1906) Federal Meat Inspection Act (1906) • PFDA defined adulteration and misbranding as it relates to food and drugs • Definition allowed FDA and USDA to include foods processed in unsanitary environments • PFDA was only 6 pages long but it paved the way for more stringent federal regulations Pure Food and Drug Act (1906) Federal Meat Inspection Act (1906) • An adulterated food has one of the following - mixed and packaged with a substance that reduces or injuriously affects its quality or strength - substituted in whole or part or subtracted from in whole or part - mixed with a substance added to conceal inferior or damaged quality
2/6/2017 Pure Food and Drug Act(1906) Pure Food and Drug Act(1906) Federal Meat Inspection Act(1906) Federal Meat Inspection Act(1906) An adulterated food has one of the following In layman's terms: (cont'd) An adulterated food or drug was one that manufactured to contain poisonous or was unfit for human consumption harmful ingredients which renders the produced under false pretenses food injurious to health contained ingredients that are unsafe manufactured to contain filth, decomposed or decaying material from o poisons plants or animals o filth manufactured to contain diseased animals o decomposed/decaying or diseased or animals dying before slaughter material Pure Food and Drug Act(1906) Pure Food and Drug Act(1906) Federal Meat Inspection Act(1906) Federal Meat Inspection Act(1906) PFDA is sometimes referred to as the Wiley FMIA required that Bureau Act since Dr.Harvey Wiley devoted his of Animal Industry verify Meat Inspection Bill Passes the Senate career to raising public awareness of that adulterated food meat-producing animals were not adulterated or misbranded meat producing animals were ITS ADOPTION slaughtered and processed UNEXPECTED under sanitary conditions NONE adulterated and misbranded were defined as in PFDA CAN EAT THE
2/6/2017 3 Pure Food and Drug Act (1906) Federal Meat Inspection Act (1906) • An adulterated food has one of the following (cont’d) - manufactured to contain poisonous or harmful ingredients which renders the food injurious to health - manufactured to contain filth, decomposed or decaying material from plants or animals - manufactured to contain diseased animals or animals dying before slaughter Pure Food and Drug Act (1906) Federal Meat Inspection Act (1906) In layman’s terms: • An adulterated food or drug was one that - was unfit for human consumption - produced under false pretenses - contained ingredients that are unsafe o poisons o filth o decomposed/decaying or diseased material Pure Food and Drug Act (1906) Federal Meat Inspection Act (1906) • PFDA is sometimes referred to as the Wiley Act since Dr. Harvey Wiley devoted his career to raising public awareness of adulterated food Pure Food and Drug Act (1906) Federal Meat Inspection Act (1906) • FMIA required that Bureau of Animal Industry verify that - meat-producing animals were not adulterated or misbranded - meat producing animals were slaughtered and processed under sanitary conditions - adulterated and misbranded were defined as in PFDA
2/6/2017 Pure Food and Drug Act(1906) Pure Food and Drug Act(1906) Federal Meat Inspection Act(1906) Federal Meat Inspection Act(1906) FMIA animal species included cattle,sheep FMIA was the direct result of swine,goats,horses,mules or other equine Upton Sinclair's reporting on Today species include additional livestock the Chicago's meat packing HENG图 considered appropriate by the Secretary of industry Agriculture Well-known Socialist FMIA tasks that are outlined are carried out ·Quoted by Food Safety Inspection Service within the USDA "I aimed a the heart of American society and struck 。 FSIS created as the Food Safety and Quality their stomachs" Service in 1977,renamed FSIS in 1981 Pure Food and Drug Act(1906) Pure Food and Drug Act(1906) Federal Meat Inspection Act(1906) Federal Meat Inspection Act(1906) Under FMIA,the Bureau of Animal Inspection FMIA has been amended many times to had 4 main responsibilities strengthen it 1.Mandatory inspection of livestock for Poultry Products Inspection Act(1957) evidence of disease before slaughter 2.Mandatory inspection of every livestock Wholesome Meat Act (1967) carcass after slaughter for disease Wholesome Poultry Products Act(1968) 3.Monitoring the slaughter and processing operation for cleanliness Bureau of Chemistry reorganized to Food, 4.Enforcement of the food safety Drug and Insecticide Administration(1927). which was renamed again in 1930 to Food and regulatory requirements in livestock slaughtering establishments Drug Administration
2/6/2017 4 Pure Food and Drug Act (1906) Federal Meat Inspection Act (1906) • FMIA animal species included cattle, sheep, swine, goats, horses, mules or other equine • Today species include additional livestock considered appropriate by the Secretary of Agriculture • FMIA tasks that are outlined are carried out by Food Safety Inspection Service within the USDA • FSIS created as the Food Safety and Quality Service in 1977, renamed FSIS in 1981 Pure Food and Drug Act (1906) Federal Meat Inspection Act (1906) • FMIA was the direct result of Upton Sinclair’s reporting on the Chicago’s meat packing industry • Well-known Socialist • Quoted “I aimed a the heart of American society and struck their stomachs” Pure Food and Drug Act (1906) Federal Meat Inspection Act (1906) • Under FMIA, the Bureau of Animal Inspection had 4 main responsibilities 1. Mandatory inspection of livestock for evidence of disease before slaughter 2. Mandatory inspection of every livestock carcass after slaughter for disease 3. Monitoring the slaughter and processing operation for cleanliness 4. Enforcement of the food safety regulatory requirements in livestock slaughtering establishments Pure Food and Drug Act (1906) Federal Meat Inspection Act (1906) • FMIA has been amended many times to strengthen it - Poultry Products Inspection Act (1957) - Wholesome Meat Act (1967) - Wholesome Poultry Products Act (1968) • Bureau of Chemistry reorganized to Food, Drug and Insecticide Administration (1927), which was renamed again in 1930 to Food and Drug Administration
2/6/2017 Amendments to Federal Meat Inspection Amendments to Federal Meat Inspection Act(1906) Act(1906) Poultry Products Inspection Act of 1957 Poultry Products Inspection Act of 1957 -1800s:50%of US population earned 1940s,larger flocks reared on farms and sold to consumers as "New york Dressed"carcasses a living by farming New york Dressed meant blood and feathers were Backyard flocks furnished families missing with eggs and meat for dinner 1942,carcasses with intestines removed was approved for commercial use Early 1900s:poultry breed for -1949,chicken slaughter houses emerged plumage,increased egg and meat yield 1950s,USDA realized the same standards for and entertainment poultry as for meat were needed USDA assigned responsibility for monitoring processing operations Amendments to Federal Meat Inspection Act(1906) Food,Drug,and Cosmetic Act(1938) Wholesome Meat Act of 1967 PFDA provided no standards for Wholesome Poultry Act of 1968 determining the purity of food nor what extend federal standards to foreign could or could not be in food establishments that are importing products into the US PFDA only required that a statement on the food be truthful -extend federal standards to state-inspected establishments that are distributing meat Food labels were not required to state and poultry intrastate commerce content weight Also called "Equal-to Acts"as the amendments require that state,federal,and Many cases brought to court were thrown foreign meat and poultry establishments out for lack of proof of adulteration or have the same standards of inspection misbranding
2/6/2017 5 Amendments to Federal Meat Inspection Act (1906) • Poultry Products Inspection Act of 1957 - 1800s: 50% of US population earned a living by farming - Backyard flocks furnished families with eggs and meat for dinner - Early 1900s: poultry breed for plumage, increased egg and meat yield and entertainment Amendments to Federal Meat Inspection Act (1906) • Poultry Products Inspection Act of 1957 - 1940s, larger flocks reared on farms and sold to consumers as “New York Dressed” carcasses - New York Dressed meant blood and feathers were missing - 1942, carcasses with intestines removed was approved for commercial use - 1949, chicken slaughter houses emerged - 1950s, USDA realized the same standards for poultry as for meat were needed - USDA assigned responsibility for monitoring processing operations Amendments to Federal Meat Inspection Act (1906) • Wholesome Meat Act of 1967 • Wholesome Poultry Act of 1968 - extend federal standards to foreign establishments that are importing products into the US - extend federal standards to state-inspected establishments that are distributing meat and poultry intrastate commerce - Also called “Equal-to Acts” as the amendments require that state, federal, and foreign meat and poultry establishments have the same standards of inspection Food, Drug, and Cosmetic Act (1938) • PFDA provided no standards for determining the purity of food nor what could or could not be in food • PFDA only required that a statement on the food be truthful • Food labels were not required to state content weight • Many cases brought to court were thrown out for lack of proof of adulteration or misbranding
2/6/2017 Food,Drug,and Cosmetic Act(1938) Food,Drug,and Cosmetic Act(1938) 1917,the Bureau of Chemistry reported Congress blocked early that the PFDA lacked attempts to rewrite PFDA legal standards for foods 1930s,Great Depression assigned authority to inspect food and occurred drug warehouses created a market for -restrictions on poisons in drugs cheap products and stretching food limitations on naturally-occurring production adulterations -adulteration increased PFDA was difficult to enforce misbranding increased Food,Drug,and Cosmetic Act(1938) Food,Drug,and Cosmetic Act(1938) President Franklin Roosevelt,once elected, Most noteworthy attributes of FDCA called for a revision of PFDA gave FDA authority over 4 broad consumer -took 5 years of debate for a revision odus:food,drugs,cosmetics,and medical new law was FDCA included comprehensive listing of definitions FDCA is still considered the primary US to clearly communicate the law law regulating food,drugs,beverages, -included standards of identity cosmetics,and medical devices -required specific food labeling components Complete law can be found in the US Code Title 21(Food and Drugs),Chapter 9, More than 100 amendments to FDCA have been made just for new definitions as food sections 301-399d technology has advanced 6
2/6/2017 6 Food, Drug, and Cosmetic Act (1938) • 1917, the Bureau of Chemistry reported that the PFDA lacked - legal standards for foods - assigned authority to inspect food and drug warehouses - restrictions on poisons in drugs - limitations on naturally-occurring adulterations • PFDA was difficult to enforce Food, Drug, and Cosmetic Act (1938) • Congress blocked early attempts to rewrite PFDA • 1930s, Great Depression occurred - created a market for cheap products and stretching food production - adulteration increased - misbranding increased Food, Drug, and Cosmetic Act (1938) • President Franklin Roosevelt, once elected, called for a revision of PFDA - took 5 years of debate for a revision - new law was FDCA • FDCA is still considered the primary US law regulating food, drugs, beverages, cosmetics, and medical devices • Complete law can be found in the US Code Title 21(Food and Drugs), Chapter 9, sections 301-399d Food, Drug, and Cosmetic Act (1938) • Most noteworthy attributes of FDCA - gave FDA authority over 4 broad consumer products: food, drugs, cosmetics, and medical devices - included comprehensive listing of definitions to clearly communicate the law - included standards of identity - required specific food labeling components • More than 100 amendments to FDCA have been made just for new definitions as food technology has advanced
2/6/2017 Food,Drug,and Cosmetic Act(1938) Food,Drug,and Cosmetic Act(1938) Definition for food was one of the most Legally,food is defined by its intended critical.FDCA defined it as use articles used for food or drink for man or other animals food that is spoiled or decomposed is -chewing gum still considered food articles used chewing gum is considered food for components unless it contains nicotine or a of any other laxative then it is a drug Nicorette such articles Feen-a-mint Food,Drug,and Cosmetic Act(1938) Food,Drug,and Cosmetic Act(1938) FDCA strengthens definitions of adulteration A food shall be deemed to be adulterated and misbranding if… ."A food shall be deemed to be adulterated if... -it is handled under insanitary conditions it contains any poisonous or harmful where it may become contaminated or substances which may render it injurious to where it may be rendered injurious to health health it contains an added poisonous or harmful its container is composed of any substance which is unsafe poisonous or harmful substances which it contains any filth,putrid or decomposed may make the food injurious to health material that is unfit for food 1
2/6/2017 7 Food, Drug, and Cosmetic Act (1938) • Definition for food was one of the most critical. FDCA defined it as … - articles used for food or drink for man or other animals - chewing gum - articles used for components of any other such articles Food, Drug, and Cosmetic Act (1938) • Legally, food is defined by its intended use - food that is spoiled or decomposed is still considered food - chewing gum is considered food unless it contains nicotine or a laxative then it is a drug Food, Drug, and Cosmetic Act (1938) • FDCA strengthens definitions of adulteration and misbranding • “A food shall be deemed to be adulterated if ….. - it contains any poisonous or harmful substances which may render it injurious to health - it contains an added poisonous or harmful substance which is unsafe - it contains any filth, putrid or decomposed material that is unfit for food Food, Drug, and Cosmetic Act (1938) • A food shall be deemed to be adulterated if …… - it is handled under insanitary conditions where it may become contaminated or where it may be rendered injurious to health - its container is composed of any poisonous or harmful substances which may make the food injurious to health
2/6/2017 Food,Drug,and Cosmetic Act(1938) Food,Drug,and Cosmetic Act(1938) A food shall be deemed to be adulterated FDCA makes provisions for unavoidable if… substances that are naturally occurring or any valuable component of the food has are introduced during production, processing or handling been omitted or substituted,or if any FDCA requires safe tolerances are set damage or inferiority has been concealed,or if anything has been added Good Manufacturing Practices to increase its bulk weight or reduce its -Defect Action Levels quality/strength o covers unavoidable or natural it contains a color additive which is contaminates of food that are not unsafe harmful Food,Drug,and Cosmetic Act(1938) Food,Drug,and Cosmetic Act(1938) ·Defect Action Levels Established for substances such as Good Manufacturing Practices prohibits mixing of defective foods with o insects uncontaminated foods to reduce the o insect parts overall load o worm fragments o fly eggs FDA publishes online a defect action o rodent dropping level handbook entitled o mold "Levels of natural or unavoidable defects o foreign matter in foods that present no health hazards Informal standards set to warn of inadequate for humans" sanitation
2/6/2017 8 Food, Drug, and Cosmetic Act (1938) • A food shall be deemed to be adulterated if …… - any valuable component of the food has been omitted or substituted, or if any damage or inferiority has been concealed, or if anything has been added to increase its bulk weight or reduce its quality/strength - it contains a color additive which is unsafe Food, Drug, and Cosmetic Act (1938) • FDCA makes provisions for unavoidable substances that are naturally occurring or are introduced during production, processing or handling • FDCA requires safe tolerances are set • Good Manufacturing Practices - Defect Action Levels o covers unavoidable or natural contaminates of food that are not harmful Food, Drug, and Cosmetic Act (1938) • Defect Action Levels - Established for substances such as o insects o insect parts o worm fragments o fly eggs o rodent dropping o mold o foreign matter • Informal standards set to warn of inadequate sanitation Food, Drug, and Cosmetic Act (1938) • Good Manufacturing Practices prohibits mixing of defective foods with uncontaminated foods to reduce the overall load • FDA publishes online a defect action level handbook entitled “Levels of natural or unavoidable defects in foods that present no health hazards for humans
2/6/2017 Amendments to the Food,Drug,and Amendments to the Food,Drug,and Cosmetic Act (1938) Cosmetic Act (1938) Most notable amendments altered the authority of the FDA or extended coverage of the law First 3 amendments were written after WWII Amendments discussed here: Miller Pesticide Amendment Food production increased to feed troops Food Additive Amendment People began to move off the farm into the Color Additive Amendment city Dietary Supplement Health Education Act Many new ingredients and packaging -Public Health Security and Bioterrorism materials that did not require preapproval Preparedness Response Act by the FDA FDA Food Safety and Modernization Act Patient Protection and Affordable Care Act aches spread MORE MEAT MORE MILK MORE EGGS PESTROY 通 司 默T 9
2/6/2017 9 Amendments to the Food, Drug, and Cosmetic Act (1938) • Most notable amendments altered the authority of the FDA or extended coverage of the law • Amendments discussed here: - Miller Pesticide Amendment - Food Additive Amendment - Color Additive Amendment - Dietary Supplement Health Education Act - Public Health Security and Bioterrorism Preparedness Response Act - FDA Food Safety and Modernization Act - Patient Protection and Affordable Care Act Amendments to the Food, Drug, and Cosmetic Act (1938) • First 3 amendments were written after WWII • Food production increased to feed troops • People began to move off the farm into the city • Many new ingredients and packaging materials that did not require preapproval by the FDA
2/6/2017 Phasing out trans fats Amendments to the Food,Drug,and Cosmetic Act(1938) Low trans fat■■== 1949,Select House Committee-Delaney Committee investigated use of pesticides,chemicals, and insecticides in or associated with foods -paved the path for FDCA to be amended amendments passed by Delaney's committee ensured that ingredients added did not compromise the safety of the food Amendments to the Food,Drug,and Amendments to the Food,Drug,and Cosmetic Act (1938) Cosmetic Act (1938) Miller Pesticide Amendment,1954 Food Additive Amendment,1958 EPA not yet formed(1970) pesticides regulated by the FDA Congress realized it needed proof that a regulation began,1910-Federal Insecticide Act food additive was poisonous to block it from Miller Act reguired safe tolerances for being added to food pesticides in food be set Congress also noted that food technology Miller Act instructed FDA to "protect the was providing food with longer shelf-life, public"but also to consider "the necessity for increased flavor,and added nutrients the production of adequate,wholesome and economical food supply" Congress was concerned that the legal Don't be so strict that you keep manufacturers system would hinder these advances from making food 10
2/6/2017 10 Amendments to the Food, Drug, and Cosmetic Act (1938) • 1949, Select House Committee –Delaney Committee - investigated use of pesticides, chemicals, and insecticides in or associated with foods - paved the path for FDCA to be amended - amendments passed by Delaney’s committee ensured that ingredients added did not compromise the safety of the food Amendments to the Food, Drug, and Cosmetic Act (1938) • Miller Pesticide Amendment, 1954 - EPA not yet formed (1970) - pesticides regulated by the FDA - regulation began, 1910 – Federal Insecticide Act - Miller Act required safe tolerances for pesticides in food be set - Miller Act instructed FDA to “protect the public” but also to consider “the necessity for the production of adequate, wholesome and economical food supply” - Don’t be so strict that you keep manufacturers from making food Amendments to the Food, Drug, and Cosmetic Act (1938) • Food Additive Amendment, 1958 - Congress realized it needed proof that a food additive was poisonous to block it from being added to food - Congress also noted that food technology was providing food with longer shelf-life, increased flavor, and added nutrients - Congress was concerned that the legal system would hinder these advances
