QUIZ 1
What act are eggs regulated under the USDA?
Egg Product Act
Who regulates open-face sandwiches?
USDA
What is the Food Safety Inspection Services (FSIS) under and what is it responsible for?
USDA and responsible for food safety
Who regulates pepperoni pizza with over 10% pepperoni?
USDA, over 2% meat
Agencies are also allowed to prepare and publish......
non-binding general policy, guidance, and interpretive documents that describe how the Agency intends to exercise its discretionary authority and explains what a statute or regulation means.
FTC hearings are....
nonpublic and confidential
Cosmetics
• Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body ....for cleansing, beautifying, promoting attractiveness, or altering the appearance
Products FDA Regulates
-food -drugs -medical devices -biologics -animal feed and drugs -cosmetics -radiation-emitting products
FTC compromised of....
Commissioners appointed by the president and approved by the senate
Fair Packaging & Labeling Act
-Unfair and Deceptive Packaging and Labeling (nonconforming labels) -Requirements of Labeling (contents of label) -Rules and Regulations -Procedures for Promulgation of Regulations (Judicial review - hearings by Federal Trade Commission, cooperation with other departments and agencies, and returnable or reusable glass containers for beverages) -enforcement (misbranded consumer commodities, unfair or deceptive acts or practices in commerce, and imports) -defined consumer commodity, package, and label
Dietary Supplement
- A product (other than tobacco) intended to supplement the diet and bears or contains one or more of the following dietary ingredients: • Vitamins • Minerals • Herbs or other botanicals • Amino acids • Concentrate, metabolite, constituent, extract or combination of above listed ingredients - A substance used to increase total dietary intake - Concentrate, constituent, extract or combination of above - Must not be represented as a conventional food - Must not be represented as sole item of a diet - Must be labeled "dietary supplement"
Current FTC Health-Related Priorities
- Deceptive treatment or prevention claims for serious diseases - Misleading health claims in national advertising - Miracle weight loss claims - Privacy promises must be kept (doctors cannot share the data with the public, according to the FTC (trials with placebos and medicines are given to people and the data is collected))
Food Acts to know
- Federal Food, Drug, and Cosmetic Act - Federal Meat, Poultry and Egg Products Inspection Acts - Fair Packaging and Labeling Act - Federal Trade Commission Act - Lanham Act - trademarks
Does the Columbus Public Health Department have authority under the FD&C Act to perform inspections of dining halls and cafeterias at OSU?
-Columbus Public Health Department is in Columbus not under federal jurisdiction -does inspections, but no it does not get its authority under this act
The Infant Formula Act
-gave FDA authority to regulate labeling of infant formula and establish quality control rules and regulations governing formula manufacturing -defines adulteration -prescribes recall procedures -specifies inspection requirements -revised in 1985 based on recommendations from the Committee on Nutrition to include minimum concentrations of 29 nutrients and maximum concentrations of nine nutrients in infant formula -label must follow requirements under Nutrition Labeling and Education Act (requirements for act are found under the Federal Food, Drug, and Cosmetic Act, and must use GRAS products or approved food additives)
What does the USDA regulate?
-meat -poultry -egg products
Circle drawing
-outer circle: laws -inner circle: agencies (agencies are created to make sure that the laws work and that businesses comply with the laws)
How to create a law
1. A member of Congress proposes a bill (a document that when approved becomes a law) 2. If both houses of Congress approve a bill, it goes to the President who has the option to either approve it or veto it 3. If approved, the new law is called an act, and the text of the act is known as a public statute. 4. Once an act is passed, the House of Representatives standardizes the text of the law and publishes it in the US Code.
Zoonosis
An infectious disease that is transmissible from animals to humans.
APHIS
Animal and Plant Health Inspection Service
Who does the FDA work with on outbreaks?
CDC (If monitoring turns up problems that need to be corrected, FDA can ask the manufacturer to recall the product, withdraw approval (of a drug, for example), require labeling changes, send warnings to physicians or other health practitioners, have federal marshals seize products if a voluntary recall is not done, detain imports until problems are corrected and could ask the courts to issue injunctions or prosecute those that deliberately violate the law.)
CFSAN
Center of Food Safety and Applied Nutrition
What department is The United States Department of Agriculture (USDA) under?
Department of Agriculture
What department is FDA under?
Department of Health and Human Services
Who regulates close-face sandwiches?
FDA
What role does FDA have with labeling?
FDA regulates what's on these labels to ensure that they are truthful and that they provide useable information that helps consumers make healthy, safe decisions when using the product.
Who regulates cheese pizza?
FDA, no meat
What act is red meat regulated under the USDA?
Federal Meat Inspection Act
FSIS (what does it stand for)
Food Safety and Inspection Service
How is the ORA divided?
Geographically, split up into entire country with specific regions of the U.S. (Ohio is in the Central Division with headquarters in Cincinnati)
ORA
Office of Regulatory Affairs
What act are poultry products regulated under the USDA?
Poultry Inspection Act
Food and Drug Administration
The FDA falls within the executive branch of the US government, under the Department of Health and Human Services (DHHS). FDA is headed by the Commissioner of Food and Drugs, who is appointed by the President of the United States, confirmed by the US Senate, and serves at the President's discretion. The Office of the Commissioner (OC) oversees all the Agency's components and is responsible for the efficient and effective implementation of FDA's mission.
Example that is drugs and cosmetics
antidandruff shampoo is both a cosmetic and a drug because it cleans the hair and treats the disease called dandruff
If it says this it's a cosmetic:
cleanse
Food Drug and Cosmetic Act
designed to protect consumer from regulated food, pharmaceutical, cosmetic and other products that are unsafe
What does FDA have jurisdiction over?
food plants that process products with <2% cooked meat and poultry, seafood and shell eggs (eggs broken and served) -responsible for monitoring pesticide tolerances on raw agricultural products Also, oversees drug use in animals and animal feeds, deeming them safe to eat or not
Adulteration
lowered quality and safety of a product caused by adding inferior ingredients that may be toxic (creates injurious products)
FTC is not in charge of
prescription drugs
Misbranding
the label is false or misleading
What role does FDA have with food from animal origin?
• Animal drugs (including drugs used in animal feeds), must gain FDA approval and proven safe and effective • Livestock drugs are evaluated for their safety to the environment and to the people who eat animal products • FDA ensures that any drug residues that remain in these foods are not harmful to the consumers.
Drugs
• Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals • Articles (other than food) intended to affect the structure or any function of the body of man or other animals
If it says this it's a drug:
treat, diagnose, cure, prevent, etc.
Federal Meat Inspection Act
• "Meat food product" means any product capable of use as human food which is made wholly or in part from any meat or other portion of the carcass of any cattle, sheep, swine, or goats.... • This term as applied to food products of equines shall have a meaning comparable to that provided in this paragraph with respect to cattle, sheep, swine, and goats. • The term "prepared' means slaughtered, canned, salted, rendered,boned, cut up, or otherwise manufactured or processed. • (m) The term "adulterated" shall apply to any carcass, part thereof, meat or meat food product under one or more of the following circumstances: • (2)(A) if it bears or contains (by reason of administration of any substance to the live animal or otherwise) any added poisonous or added deleterious substance (other than one which is (i) a pesticide chemical • Inspection requirements; adulteration and misbranding - Adulterated: If it bears or contains any poisonous or deleterious substance which may render it injurious to health - Misbranding: misleading label statements, etc. • Ante mortem inspection • Humane methods of slaughter • Post mortem inspection • Labeling and containers; standards • Sanitation • Prohibited acts - (2)(A) if it bears or contains (by reason of administration of any substance to the live animal or otherwise) any added poisonous or added deleterious substance (other than one which is (i) a pesticide chemical ..... - Irradiation must be under strict guidelines, etc. • Imports and exports • Registration
For the Federal Trade Commission Act, a communication is deceptive if it contains:
• A communication is deceptive if it contains: - A representation or omission likely to mislead consumers acting reasonably under the circumstances - In a material way, anything likely to affect a consumer's conduct or decisions regarding the product (main point: companies omit things because they think that this will make consumers not want to buy the product, but this is illegal)
What should a company do if their infant formula is recalled?
• A manufacturer should recall a formula is it is adulterated or misbranded • Shall notify FDA of the recall • Allow FDA to supervise the recall • Keep records of the recall
What is a new infant formula company required to do?
• All manufacturers of infant formula must register with FDA • FDA must be informed at least 90 days before marketing any new formula into interstate commerce • Major changes to an existing infant formula must be approved by FDA • Results of tests on the new formula must be submitted to FDA after its first manufacture and before it is introduced into interstate commerce
Unfairness of Federal Trade Commission Act
• An activity is unfair if: - It causes substantial injury - The injury is not outweighed by countervailing benefits - The injury cannot be reasonably avoided - The product poses a risk of injury but "safe" or "no risk'" claims made, or where a company unilaterally modifies the terms of a contract
FSIS
• Ensure that meat, poultry, and egg products are safe, wholesome, and accurately labeled. • This includes all raw beef, pork, lamb, chicken, and turkey, as well as processed hams, sausage, soups, stews, pizzas, and frozen dinners (generally, products that contain ≥2% cooked meat and poultry or ≥ 3% raw meat and poultry • Performs anti-mortem and post-mortem inspections in plants that do slaughtering • Inspections eggs before and after breaking, and eggs intended for further processing. • FSIS sets requirements for slaughter and processing activities, such as plant sanitation and thermal processing. • Performs microbiological, chemical, and other test for contaminations and collaborates with the CDC if necessary • Maintains a comprehensive system of import inspection and controls. • Assesses whether State inspection programs for meat and poultry products are equal to the Federal program. • Can assume responsibility for inspection if a State chooses to end its inspection program or cannot maintain the equivalent standard. • FSIS draws its authority from the Federal Meat Inspection Act of 1906, the Poultry Products Inspection Act of 1957 and the Egg Products Inspection Act of 1970.
FDA's role in food production
• FDA approves new food additives before they can be used in foods • FDA also monitors the safety of dietary supplements, the content of infant formulas and medical foods • Ensures that all ingredients used in foods are safe
What role does the FDA have in food production?
• FDA approves new food additives before they can be used in foods • FDA also monitors the safety of dietary supplements, the content of infant formulas and medical foods • Ensures that all ingredients used in foods are safe, and food is free of contaminants -- like disease-causing organisms, chemicals, or other harmful substances
How FDA Enforces the Law
• FDA uses a system of premarket approval before specific products could be manufactured and distributed into interstate commerce • FDA acts through the Department of Justice and the court to prevent future violations by seeking injunctions or punishment (seizures, fines, Product quarantine, etc.)
FTC Material Omissions
• Failure to adequately disclose information that is material to the purchaser's decision • But it must be more than material - it must be necessary to prevent deception - Example: An advertisement promotes the benefits of Saw Palmetto in preventing prostate cancer. FTC alleged that the ad suggested that S.P. is okay for most men but failed to disclose the importance of consulting with a doctor. - The FTC ruled that future ads must warn that S.P. consumption is not for everybody and that individuals should also consult with a doctor
Creating a Regulation
• First, an authorized agency decides that a regulation may be needed and proposes it. • The proposal is listed in the Federal Register so that members of the public can consider it and send their comments to the agency. • The agency considers all the comments, revises the regulation accordingly and issues a final rule. At each stage in the process, the agency publishes a notice in the Federal Register. • Once a regulation is completed and has been printed in the Federal Register as a final rule, it is "codified" by being published in the Code of Federal Regulations (CFR) • The CFR is the official record of all regulations created by the federal government
What are the main functions of FSIS?
• Has ~7,800 inspection personnel assigned to ~6,200 federal slaughter, food processing, and import establishments in the US • Verify the safe processing meat, poultry and egg products • Perform antemortem inspections to prevent slaughter of diseased animals • Postmortem examinations to identify diseased carcasses not evident during antemortem inspections • Verify the rapid chilling, adequate trimming and sanitary washing of carcasses to reduce microbial contamination • Collect samples for residual testing to ensure that antibiotics, pesticides and other residues are within safe limits • Collect samples of the testing of specific animal diseases such as bovine spongiform encephalopathy (Mad Cow), Foot and Mouth Disease, etc • Ensure that HACCP requirements and standards of identity are met • Monitor the pasteurization of egg products • Monitor in plant sanitation, net weight and accurate labeling • Responsible for the inspection of imported food product at U.S. ports and borders, from countries determined to have inspection systems equivalent to US Federal inspection systems • Food, Conservation and Energy Act of 2008, also known as the 2008 Farm Bill give USDA jurisdiction to inspect catfish farms
When is infant formula deemed adulterated?
• If it does not provide nutrients required under the act • If it does not meet the quality requirements • If not manufactured under GMP
What is the history of the USDA?
• In 1862, President Abraham Lincoln established the Department of Agriculture to be headed by a Commissioner without Cabinet status • In 1889, President Grover Cleveland signed a bill into law elevating the Department of Agriculture to Cabinet level • In 1887, the Hatch Act provided for the federal funding of agricultural experiment stations in each state. The Smith-Lever Act of 1914 then funded cooperative extension services in each state to teach agriculture, home economics and related subjects to the public. With these and similar provisions, the USDA reached out to every county of every state. • During the Great Depression, the Department of Agriculture provided assistance to needed individuals to help them make it through this difficult period • The department helped to ensure that food continued to be produced and distributed to those in need, assisting with loans for small landowners, and contributing to the education of the rural youth
FTC Procedures and Remedies
• Investigationsarenonpublicandevidencecollected by the Commission is confidential except approved for public release or requested by Congress • Administrativeandfederalcourtlitigation • Ordersandinjunctionsto"ceaseanddesistfrom using unlawful methods of competition or acts or practices" • Consumerredressanddisgorgementofprofits • AllowsforthefilingofappealsintheUnitesStates Court of Appeals and to the Supreme Court • TheCommissionmayalsochoosetomodifyorset aside in whole or part, any order made or issued by it under section 15. • Corrective advertising • Civil penalties for violation of roles and orders; • Civil contempt - for continued violation of FTC order regarding unsubstantied claims • Examples of FTC concerns: - Health and safety claims, claims consumers cannot evaluate on their own, diet products, charges and consents involve corporations, officers, expert endorsers, and celebrities (sidenote: during the hearing, the company may have to explain trade secrets, such as ingredients and processing, which is why it is confidential, unless Congress says that it must be made public)
What is the Environmental Protection Agency (EPA) responsible for?
• Is responsible for food safety, water quality, and pesticide applicator training • Regulates the use of pesticides • Responsible for registration of new pesticides before they can be marketed and the re-registration of older pesticides to ensure that they meet current scientific standards -responsible for establishing tolerances for pesticides residue in foods
What is the mission of the USDA?
• Is responsible for the development and execution of the federal government's policy on farming, agriculture and food production • It mission is to meet the needs of farmers and ranchers, promote agricultural trade and production, assure food safety, protect natural resources, foster rural communities and end hunger in the United States and abroad.
Committee on Nutrition
• It continues to play an important role in pediatric nutrition by issuing policy statements as new information becomes available and publishing the Pediatric Nutrition Handbook • Recent policy statements from the committee have addressed iron fortification of infant formula (1979, 1989, 1999), the use of hypoallergenic infant formulas (2000), breastfeeding and the use of human milk (1997), soy-protein-based formulas (1998, 2001), and the use and misuse of fruit juice (2001)
What is ORA responsible for?
• Managing and operating the field offices • Coordinating and managing all Agency field operations • Providing advice and assistance on regulations and compliance policy matters • Working with additional federal agencies on issues of compliance and evaluating proposed legal actions • Directing and conducting criminal investigative activities in coordination with FDA headquarters units and other federal, state, and local law enforcement agencies
Liaison with FDA
• Memorandum of understanding with FTC and FDA to regulate labeling of foods, prescription and OTC drugs, devices and cosmetics, while FTC regulates advertising for all except prescription drugs • Differences in procedures and approaches - FTC has prosecutors, FDA has regulators - FTC favors free markets, FDA regulates • Extremely close day-to-day relationship • FTC is made up mainly of lawyers and economists but they rely on FDA scientist for certain guidance
CFSAN definition
• Monitoring and inspection in conjunction with ORA • Analyzes samples collected by ORA • Cooperates with ORA and other centers in taking necessary corrective actions • Provides pre-market approval to food and color additives •Performs studies on packaging, processing, bio-technology and consumer responses to food safety issues • Provides educational outreach activities on selected food safety issues (main focus: Office of Regulatory Affairs, Office of Food Safety, and Office of Nutrition Labeling and Dietary Supplement)
Specific Products FDA Regulates
• Non-specified red meat - Bison, rabbit, game animals, zoo animals, deer, elk and moose • Shell eggs • Non-specified birds - Wild turkeys, wild ducks, wild geese and Emus • Products with <2% poultry on a wet basis • Closed-face sandwiches (35% cooked meat and poultry products between 2 slices of bread which are less than 50% of the weight of the product) not inspected by USDA • Otherproductssuchas: - Cheese pizza, onion and mushroom pizza, meat flavored spaghetti with <3% red meat, frozen fish dinners, alligator nuggets, shrimp flavored noodles, seafood (except catfish), etc.
Ohio State Food Regulatory Agencies
• Ohio Department of Health - Inspect restaurants and food service operations • Ohio Department of Agriculture - Inspect bulk food preparation (eg. Meals on wheels), food processing (both meat and non- meat processing) • Departments inspect food processing and food service operations that do not do interstate commerce
ORA's Commodity-based Programs
• Pharmaceutical quality (includes drugs and biologics regulated by CDER and veterinary drugs) • Food and feeds • Medical devices and radiological health • Products regulated by CBER • Tobacco • Bioresearch Monitoring (BIMO)
Provisions of The Food Drug and Cosmetic Act of 1938
• Prohibits interstate commerce of foods that are injurious to health • Prohibits the addition of poisonous substances to foods, except for unavoidable inclusions • Authorizes the use of an Emergency Permit if FDA determines that one is needed in order to protect the health of the public • Authorizes the labeling of foods, drugs, cosmetics, dietary supplements, etc. and the labeling of artificial colors, flavors, preservatives, etc. • Outlines limits on the use of packaging and packaging materials relative to the safety of foods • Outlines what could be described as deceptive packaging and prohibits its use • Authorizes factory inspections • Authorizes injunctive relief • Provides for a Standards of identity, for foods, drugs, cosmetics, medical devices, etc. • Outlines penalties for violations
Main programs of APHIS
• Protection from invasive non-native plants, animals, insects, and diseases • Monitoring and management of existing agricultural pests and diseases • Resolution and management of trade issues related to animal or plant health • Prevention or cessation of the inhumane treatment (of animals)
Specific Products USDA Regulates
• Red meat - Cattle, sheep, swine, goat, horse, mules, etc. • Poultry and poultry products - Domesticated chicken, turkey, duck, geese, guineas • Eggs - after shell is broken - Egg products of chicken, turkey, duck, geese or guinea - Washing, sorting, breaking and pasteurizing of eggs • Open sandwiches (bread is unhinged) with >3% meat and >2% poultry on a wet basis • Other products such as: - Pepperoni pizza, open face beef sandwich, hot dogs, corn dogs, beef/vegetable pot pie, chicken noodle soup, chicken sandwich , catfish
Selected Programs run by USDA
• Safe and wholesome food distribution to US citizens • Nutrition education to those in need under the USDA Food and Nutrition Service • Assistance to farmers and food producers with domestic and foreign sale of crops and food • It manages overseas aid programs to developing countries via USAID, foreign governments, international agencies such as World Food Program, or approved non profit organizations • The Agricultural Act of 1949, and Agricultural Trade Development and Assistance Act of 1954, also known as Public Law 480 or Food for Peace, provides the legal basis of such actions.
What authority do states have over food safety?
• States may pass additional, more restrictive or stringent food safety laws or regulations than those promulgated at the federal level • Federal government may delegate part of its authority to state agencies, such as permitting a state agency to conduct food plant safety inspections on its behalf
Food
• Statutory Definition "Articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article" • Judicial Interpretation The courts have further defined foods as "articles used primarily for taste, aroma, or nutritive value"
Privacy and Security of Information
• Tell consumers what you collect & how you plan to use it • Statements about privacy and security must be true • Special rules apply for sites directed to children • Company must live up to their promises • Unintentional disclosures can be actionable - Example: A pharmaceutical company discloses personal information it collected on a group of patients during a drug trial study. FTC ruled that the company made an unauthorized disclosure of sensitive personal information
Quality factors for formulas
• Testing of each batch of infant formula for nutrient content • Regularly scheduled testing • In-process controls for continuous monitoring • Regular scheduled audits to ensure compliance
Food, Drugs, and Cosmetic Act of 1938
• The FD&C Act of 1938 replaced The Pure Food Act of 1906 and was passed after a legally marketed toxic elixir killed 107 people, including many children • This Act completely overhauled the public health system • The law authorized the FDA to demand evidence of safety for new drugs, issue standards for food, and conduct factory inspections • Only safe and wholesome foods must be in interstate commerce • Regulatory decision-making must be science- based • Enforcement responsibility is with government • Processors, distributors, importers, etc. are expected to comply or face liability for non- compliance • There must be fairness and transparency in the regulatory process • The process must be accessible to the public
Federal Trade Commission Act
• The Federal Trade Commission Act empowers the FTC to prevent unfair or deceptive acts or practices from affecting commerce • The FTC Act prohibits false advertisement as an inducement for the purchase of food, drugs, devices, services, or cosmetics • FTC has broad jurisdiction over the advertising of food, dietary supplements, OTC drugs, devices, alcohol, tobacco, gasoline, computer software, etc. Including virtually all products sold to consumers • Composed of five Commissioners, who shall be appointed by the President, by and with the advice and consent of the Senate • One commissioner is elected as the chair • Focus of the FTC - Promotion of export trade and prevention of unfair methods of competition
Office of Regulatory Affairs
• The Office of Regulatory Affairs (ORA) is the lead office for FDA's field activities • Headed by Associate Commissioner for Regulatory Affairs • ORA strives to achieve effective and efficient compliance of regulated products through high-quality, science-based work that maximizes consumer protection. • Surveys and inspects regulated firms in order to assess their compliance with public health laws • Compliance strategies include: - providing information to industry - highlighting areas of significant violations and impact on public health - prioritizing and targeting high-risk areas - cooperating with state and local public health authorities and regulators - focusing on covering products imported into the US through border coverage and foreign inspections
Poultry Products Inspection Act
• The term "poultry" means any domesticated bird, whether live or dead • poultry product" means any poultry carcass, or part thereof; or any product which is made wholly or in part from any poultry carcass or part thereof, excepting products which contain poultry ingredients only in a relatively small proportion .....
APHIS definition
•APHIS is responsible for protecting plant and animal health, and animal welfare • It collaborates with other agencies in protecting U.S. agriculture from invasive pests and diseases (airport or terrorist trying to introduce a foreign disease) •APHIS is the National Plant Protection Authority for the U.S. government • The agency's head of veterinary services is Chief Veterinary Officer of the United States (when customs check if you have fruit or fresh produce) (law enforced that animals must always be killed humanely)