Food Law and Policy
Negowetti
Fall 2012
1. Name 4 agencies responsible for food regulation and briefly explain their responsibilities.
· Food and Drug Administration (FDA)
o Enforces the Federal Food, Drug and Cosmetic Act (FDC &A)
§ Brought cosmetics and medical devices under government control;
§ Required that drugs be labeled with adequate directions for safe use;
§ Mandated pre-market approval of all new drugs;
§ Prohibited false therapeutic claims for drugs;
§ Mandated legally enforceable food standards;
§ Addressed tolerances for certain poisonous substances;
§ Authorized factory inspections
o FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.
o FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health. FDA also has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.
o Finally, FDA plays a significant role in the Nation’s counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.
o FDA regulates:
§ Foods
– safety of all food products
– (except for most meat and poultry products, which are regulated by the U.S. Department of Agriculture)
– labeling
– bottled water
– food additives
– infant formulas
§ Dietary Supplements
§ Human Drugs
– product approvals
– OTC and prescription drug labeling
– drug manufacturing standards
§ Vaccines, Blood Products, and Other Biologics
– product and manufacturing establishment licensing
– safety of the nation’s blood supply
– research to establish product standards and develop improved testing methods
§ Medical Devices
– from simple items like tongue depressors, to complex technologies such as heart pacemakers
– premarket approval of new devices
– manufacturing and performance standards
– tracking reports of device malfunctioning and serious adverse reactions
§ Electronic Products
– products that give off radiation, such as microwave ovens and X-ray equipment
– radiation safety performance standards for microwave ovens, television receivers, diagnostic
– x-ray equipment, cabinet x-ray systems (such as baggage x-rays at airports), laser products,
– ultrasonic therapy equipment, mercury vapor lamps, and sunlamps
– accrediting and inspecting mammography facilities
§ Cosmetics
– safety
– labeling
§ Veterinary Products
– livestock feeds
– pet foods
– veterinary drugs and devices
– veterinary biologics not regulated by USDA are considered new animal drugs
§ Tobacco Products
· U.S. Department of Agriculture (USDA)
o The USDA administers programs to help American farmers and ensure food safety for consumers. USDA aid includes distributing price supports and other subsidies to farmers, inspecting food processed at agricultural facilities, working to expand overseas markets for U.S. agricultural products, providing financing to expand job opportunities and improve housing, utilities, and infrastructure in rural America, and providing food assistance and nutrition education.
· USDA, Food Safety and Inspections Service (FSIS)
o The Food Safety and Inspection Service (FSIS) is the public health agency in the U.S. Department of Agriculture responsible for ensuring that the nation’s commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged.
o FSIS has intensified efforts to combat foodborne pathogens; for example, testing meat and poultry products for Listeria monocytogenes, implementing stricter Salmonella and new Campylobacter performance standards for poultry products, and declaring that six additional serogroups of pathogenic E. coli (in addition to E. coli O157:H7) are adulterants in non-intact raw beef.
o FSIS has a responsibility to ensure that while in commerce, these products are not adulterated, processed, or mishandled in a way that could render them injurious to health.
o FSIS works with federal, state and local food safety partners to address emerging pathogens, to detect foodborne hazards, and to prevent foodborne illness.
o There are four primary laws that provide FSIS the authority to issue regulations regarding the inspection of meat, poultry, and processed egg products. These include the Federal Meat Inspection Act (FMIA), Poultry Products Inspection Act (PPIA), Egg Products Inspection Act (EPIA), and Humane Methods of Slaughter Act (HMSA). Together, these statutes authorize FSIS to inspect all meat, poultry, and processed egg products, as well as certain exotic species, and provide FSIS the authority to ensure equivalence of foreign country systems for imports and re-inspect imported products. The HMSA specifically requires that the handling and slaughtering of livestock be carried out by humane methods.
· USDA, Animal and Plant Health Inspection Service (APHIS)
o Responsible for protecting animal health, animal welfare, and plant health.
o APHIS aims to protect American animals, plants, and the agricultural industry by offering:
§ 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
o Achievements
§ Brought cosmetics and medical devices under government control;
§ Required that drugs be labeled with adequate directions for safe use;
§ Mandated pre-market approval of all new drugs;
§ Prohibited false therapeutic claims for drugs;
§ Mandated legally enforceable food standards;
§ Addressed tolerances for certain poisonous substances;
§ Authorized factory inspections,
§ Added injunctions to the agency’s enforcement tools.
o The FD&C Act considers the legal use of a product to determine whether or not it is a cosmetic, food, or a drug. Cosmetics are deemed to be “articles intended to be rubbed, poured, sprinkled or sprayed, introduced into, or otherwise applied to the human body . . . for cleansing, beautifying, promoting attractiveness, or altering the appearance.” The FD&C Act classifies toothpaste and deodorant as well as cosmetics. The FD&C also defines certain soaps as drugs if they have a therapeutic function. Over-the-counter nonprescription drugs are also regulated by the FD&C, and the agency publishes rules for these products.
o Article used for food or drink for man or other animals, chewing gum and articles used for components of any other such article
§ Additives: includes wrappers, dyes, etc.
o Drug?
§ Articles intended for use in diagnosis, cure mitigation, treatment or prevention of disease in man or other animal and articles (other than food) intended to affect the structure or any function of body of man or other animals…
o What is food? *TEST*
§ First ask if the product is a commonly considered a food?
§ If not, is the product consumed primarily taste, aroma or nutritive value?
§ If not, probably not a food.
§ Intent doesn’t matter in determining if it’s a food, but it does matter in looking at a drug
· Hazard Analysis & Critical Control Points (HACCP)
o systematic preventive approach to food safety and pharmaceutical safety that identifies physical, allergenic, chemical, and biological hazards in production processes that can cause the finished product to be unsafe, and designs measurements to reduce these risks to a safe level. In this manner, HACCP is referred as the prevention of hazards rather than finished product inspection. The HACCP system can be used at all stages of a food chain, from food production and preparation processes including packaging, distribution, etc