The Food And Drug Administration
The U.S. Food and Drug Administration is the federal agency with the authority to regulate food safety. The United States Federal Food, Drug, and Cosmetic Act created the FDA in 1938. Congress passed the U.S. Federal Food, Drug and Cosmetic Act in reaction to the death of 100 people from a medicine. The Act defines food, dietary supplements and food additives and then creates laws that govern activities related to food. It creates both civil and criminal penalties for violations of federal food laws. In addition, the Act creates a naming system for food color additives. The FDA also regulates cosmetics and drugs. Their office provides information about how to start a food-related business.
The FDA sees their organization as a protector of food safety in the United States. In addition to protecting the public from natural diseases that can occur in food production and distribution, the FDA must also take measures to protect the public from bio terrorism and other intentional attacks on the food supply. The Administration also works to facilitate the development of new technology that makes food production safer and more affordable for the public.
I Want To Start My Own Food Business Now What
Determine which agency regulates the type of business you want to start:
- Restaurants, including catering operations, are regulated by county health departments.
- Meat and meat-containing products are regulated by the N.C. Department of Agriculture and Consumer Services’ Meat and Poultry Inspection Service.
- Packaged foods other than meat products are regulated by the NCDA& CS Food and Drug Protection Division. Some can be produced in a home setting. No license required, but inspections can be made.
- Seafood is regulated by the NCDA& CS Food and Drug Protection Division. Wholesale seafood dealers must fulfill training requirements.
- Dairy products, including milk, frozen dessert, cheese and butter, are regulated by the NCDA& CS Food and Drug Protection Division. Licensing is required.
- Wineries are regulated by several agencies, including the Federal Tax and Trade Bureau. Consult the Starting a Commercial Winery guide for more information.
- Farmers do/do not need a business license to sell commodities grown on their farm.
Food and Drug Protection Division links
My business will be:
Other resources
What Is Food Law
Food law is the collection of laws and regulations that govern food production, distribution and consumption. Food laws aim to protect consumers and provide for the efficient growth and use of food in the United States. Food attorneys focus their careers on helping clients comply with food laws and regulations. In addition, they work on behalf of government agencies making or enforcing food laws and policies.
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Wage And Hour Laws: Tipped Employees Minimum Wage Overtime
The federal Fair Labor Standards Act as well as many state and local laws and regulations impact how tipped employees must be paid, how tips must be accounted for, and how overtime and other payroll issues must be handled. This means that food service managers have an extra layer of regulations that affect their payroll management procedures.
Even if your restaurant does not have tipped employees, minimum wage regulations may be a concern. Restaurants and quick-serve restaurants operating in multiple states or municipalities must be aware of potential varying minimum wage rates and ensure that all employees are paid in compliance with applicable rate. If local, state, and federal minimum wage rates differ and an employee is covered by all, the employee must be paid the highest of the three.
There are also overtime regulations at the federal level under the Fair Labor Standards Act . State and local laws may provide for additional requirements and/or coverage. For example, according to the FLSA, overtime must be paid to a non-exempt employee for all hours worked over 40 hours in the same workweek. In certain states, however, employers may also be required to pay certain employees an overtime rate for hours worked over 8 in one workday.
Importing Food Into The United States
Importing food into the United States is more complex than exporting from the United States . Importing into the United States will likely involve several U.S. federal agencies.
- The U.S. Department of Commerce enforces trade agreements see
- U.S. Department of Homeland Security Customs and Border Protection applies FDA and USDA FSIS food standards as CBP inspects food imports.
- Protecting Agriculture at
- Product code for the purpose of importing food — aids traceability
An import agent is a firm or individual who helps coordinate the import activity.
This section focused on the importation of food it does not address the issues of importing animals or plants .
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Why Become A Food Lawyer
Food law is a large component of operations for any food-related business. Food attorneys are valued by their clients. Attorneys who work in private practice and attorneys who work for a government entity have the opportunity to serve the public good by protecting the interest of their clients. Food regulations in the United States are sizable and significant. Theres a lot of work to do for knowledgeable attorneys who specialize in the field.
Government Roles And Responsibilities For Food Safety In Ontario
All levels of government – federal, provincial and municipal – have distinct but interconnecting roles in maximizing food safety in Ontario.
Inspection:
The Federal Role:The Canadian Food Inspection Agency administers and enforces all federal legislation related to food inspection, agricultural inputs and animal and plant health. The CFIA performs this role on behalf of Health Canada, Agriculture and Agri-Food Canada and Fisheries and Oceans Canada. The CFIA is responsible for inspecting and regulating federally registered establishments .
The Provincial Role:In Ontario, the Ministry of Health and Long-Term Care is responsible for the protection of public health. The ministry sets food safety standards and policies for food premises. MOHLTC’s role in food safety inspection is delegated to the province’s 37 local public health units.
MOHLTC has broad powers to take action to protect public health, including the ability to: – condemn food – issue tickets under the Provincial Offences Act – lay charges – order an establishment closed and – issue a recall.
The Ontario Ministry of Agriculture and Food administers and enforces a number of provincial statutes designed to minimize food safety risks for the following:
In order to achieve compliance with its regulations, OMAF has the power to:
– suspend or revoke licences
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Orientation And Language Style
As it is important that regulations be understood, they must be written in clear, concise, and appropriate language and terminology. For example, directive terminology is used to describe required actions. The word, should, is used for recommendations or suggested actions.
Regulations are also written in an active language style which identifies the actor. The difference between active and passive writing can be seen in the following examples:
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ActiveFood employees shall wear clean outer clothing.
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PassiveThe outer clothing of food employees shall be clean.
Summary Findings: The Current Us System For Food Safety
- Has many of the attributes of an effective system
- is a complex, interrelated activity involving government at all levels, the food industry from farm and sea to table, universities, the media, and the consumer
- is moving toward a more science-based approach with HACCP and with risk-based assessment
- is limited by statute in implementing practices and enforcement that are based in science and
- is fragmented by having 12 primary federal agencies involved in key functions of safety: monitoring, surveillance, inspection, enforcement, outbreak management, research, and education.
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Who Regulates Food Operations
Food Safety in Florida is regulated by multiple agencies. The main three are: the Department of Health, the Department of Agriculture and Consumer Services, and the Department of Business and Professional Regulation. Additionally, the following agencies regulate food services for some of their licensed facilites: Department of Children and Families , Agency for Health Care Administration , Agency for Persons with Disabilities .
Generally, the Department of Health regulates food service establishments located in institutional settings , civic and fraternal organizations, bars and lounges that don’t prepare foods, and theaters that limit their food service to items customarily served at theaters . For info, contact one of our local health departments or call 245-4277. The Department of Agriculture and Consumer Services generally regulates whole-sale food operations, convenience stores, grocery stores, food processing operations, food storage/warehouse operation and non-alcoholic beverage operations . They can be reached by telephone at 245-5520. The Department of Business and Professional Regulation regulates restaurants, most mobile food vehicles, caterers, and most public food service events. You can reach their Customer Contact Center by calling 487-1395 or you can file a complaint online.
Is It Necessary To Get Fda Clearance Before Selling Food
Before distributing goods in the United States, food establishments are not required to acquire any kind of certification or permission. Food facilities must register with the FDA, but this does not imply that the facility or its products have been approved by the FDA. FDA clearance is required for new food additives.
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Who Practices Food Law
Food lawyers primarily work for food producers and government agencies. Any business thats involved in food production must comply with food laws. Food producers, distributors and retailers rely on attorneys to help them with the many bodies of law that might apply to their work. A business thats sizeable might employ an attorney as in-house counsel. Attorneys who specialize in food law may also work in private practice and work with their clients on specific matters as they arise.
Food law is largely administrative. It involves compliance. Food producers must ensure that they comply with the law as they conduct business. They must identify the laws and follow them. Food lawyers help their clients with all aspects of compliance. They help their clients react if theyre accused of violating a federal or state law. Lawyers may also work as lobbyists in order to present issues to legislators on behalf of their clients.
Attorneys who specialize in food law may work for the federal government. They may enforce regulations and work with inspectors. Federal food lawyers may take enforcement actions when they believe food producers violate federal laws. State governments also employ food lawyers to work on enforcement actions regarding state laws.
Protecting Public Health And Preventing Foodborne Illness
USDA continues to protect consumers from the dangers of E. coli contamination by adopting of a zero tolerance policy for six additional strains of the pathogen in raw beef products. Prohibiting them just like to E. coli O157:H7. Enforcement to detect these dangerous pathogens and prevent them from reaching consumers began in March 2012.
USDA expects to prevent as many as 25,000 foodborne illnesses annually thanks to tougher standards set for Salmonella and new standards for Campylobacter which will reduce the occurrence of these pathogens in poultry.
Implementation of a “test and hold” policy in December 2012 prevents the recall of unsafe foods. Facilities are now required to hold product until microbiological testing can determine it is safe to release meat, poultry and egg products into commerce. This policy will significantly reduce consumer exposure to unsafe meat products. The measure would have prevented 44 recalls of unsafe foods between 2007 and 2009.
USDA continues to enhance the Public Health Information System, a modernized, comprehensive database that allows the agency to identify public health trends and food safety violations more effectively at the nearly 6,200 plants where the Food Safety and Inspection Service ensures the wholesomeness of the products produced.
Learn how to Report a Problem with Food and what information to have available.
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Assessing And Monitoring Food Safety
To minimize health risks and ensure that you have access to safe and healthy food, we:
- conduct research on foodborne bacteria, viruses and parasites
- conduct surveillance and studies on chemical contaminants found in foods
- set maximum residue limits for veterinary drugs in food-producing animals
- assess the safety and effectiveness of new or improved food processing and handling methods
- conduct health risk assessments in support of food safety investigations undertaken by the Canadian Food Inspection Agency
We assess the safety of:
- all foods, including novel foods, such as genetically modified foods
- processing technologies, some of which are newly used in Canada, such as beef irradiation
Health Canada also keeps those with food allergies and dietary restrictions safe by requiring mandatory labelling of priority allergens. Priority allergens are:
- soy
Hazard Analysis Includes Intentional Attacks
As explicitly stated by Congress in the Food Safety Modernization Act, hazard analysis and food safety plans will need to consider the risk of intentional attacks on food businesses. Although FDA has not yet proposed any regulations on this topic, such a regulation can be anticipated in the future. Until then, FDA does offer some thoughts on this critical topic for example, see
- FDA’s Guidance for Industry: Food Producers, Processors, and Transporters: Food Security Preventive Measures Guidance at
- Food Defense Programs at .
- FSMA Rule to Protect Food Against Intentional Adulteration at
USDA FSIS also addresses food defense but not as part of the mandated HACCP plans for “official establishments” instead, FSIS expects meat & poultry processing firms to voluntarily prepare a food defense plan as part of its overall business operation, see “Food Defense — Plan Security Measures for Food Defense” at
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What Is A Temporary Event
For Department of Health regulated events, a temporary event is any event offering food service on the premises of a food service establishment under the licensing authority of the Department of Health. These events are at a fixed location for a temporary period of time not to exceed any combination of 18 days within a calendar year and in conjunction with a single event or celebration. You may access the Temporary Food Service Event Application using the following link: Form DH 8004
Following Restaurant Regulations And Maintaining Compliance
Despite all of the regulations involved, running a restaurant can be a fulfilling and lucrative experience. With the right preparation, you can make the dream a reality.
In most states, being properly licensed and insured is essential to operate a restaurant. NEXT Insurance offers customized restaurant insurance packages that make it easy to get the coverage you need to protect your small business. From general liability to workers compensation and more, you can mix and match policies to get the right-sized coverage.
You can see your policy options, buy coverage and get your certificate of insurance in less than 10 minutes, all online. If you have questions, our licensed, U.S.-based insurance professionals can help.
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Lessons Learned From Self
The history of food industry self-regulation is being written now. Much can be gained by reviewing the history of self-regulation in other industries to help avoid pitfalls and adopt practices that maximize chances for success. These accounts reveal critical factors that bear on such questions as whether industry can be trusted, whether regulatory control should be ceded to industry, how criteria for evaluating self-regulation might be established, and what the overall goals might be.
An important factor is motivation for change. Industries protecting a dwindling resource face the internal threat of overuse and exploitation of the environment. They have incentives to regulate effectively and can behave in ways that benefit the public . Governance, implementation, and basic strategy all present challenges, but the potential for good is considerable. Thus far, self-regulation by the food industry has not been motivated by concerns about dwindling resources, but it should be. Depleted and contaminated water resources, land loss, shrinking biodiversity, and the energy intensity of modern agriculture are serious problems that threaten basic business models and are likely to burst into public consciousness in ways that will pressure companies into selling products grown and raised, processed, and transported in sustainable ways.
Chemical Residues And Environmental Contaminants
Responsibility for monitoring chemical residues and environmental contaminants in food is dispersed among many agencies primary responsibility rests with FDA and several agencies in USDA, EPA, and NMFS. Frequently, one agency might be responsible for approving a chemical’s use, while another is responsible for monitoring residues of that chemical in the food supply. For example, EPA is responsible for approving uses of pesticides on food crops and for setting tolerances, but the testing of foods for pesticide residues is the responsibility of USDA and FDA . Brief descriptions of agency programs follow details can be found elsewhere .
Food and Drug Administration
FDA implements the Federal Food Drug and Cosmetic Act by monitoring foods to ensure that approved chemicals and environmental contaminants are within permissible levels. A wide variety of raw agricultural commodities, processed foods, and animal feeds are tested for pesticide residues, environmental contaminants , industrial chemicals, animal drugs, and other potential contaminants.
US Department of Agriculture
The FSIS is responsible for monitoring meat, poultry, and eggs for pesticides, animal drugs, and environmental contaminants.
The AMS has responsibility to maintain standards for shell egg surveillance and to ensure the proper disposal of restricted eggs, which are shell eggs that may be dirty, cracked, leaking, or otherwise unsuitable for consumer purchase.
Environmental Protection Agency
Industry
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Contact Surfaces Water And Air
U.S. law recognizes that other substances contact food during processing and that these contacts can adulterate the food. For example, materials used in constructing food-contact surfaces of food-processing equipment can migrate into food . Accordingly, all plant equipment and utensils must be designed and made of material to be cleanable. The design, construction, and use of equipment and utensils also must prevent lubricants, fuel, metal fragments, contaminated water, or other contaminants from adulterating the food. Food-contact surfaces should be corrosion-resistant and made of nontoxic materials and designed to withstand the environment of their intended use and the action of food, cleaning compounds and sanitizing agents. Holding, conveying, and manufacturing systems are required to be designed and constructed so they can be maintained in appropriate sanitary condition .
Compressed air or other gases mechanically introduced into food or used to clean food-contact surfaces or equipment shall be treated in such a way that food is not contaminated with unlawful indirect food additives. See 21 CFR 110.40
Any water that contacts food or food-contact surfaces shall be safe and of adequate sanitary quality. See 21 CFR 110.37
FDA regulation 21 CFR 117 includes the following points
