Food Law


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Food System Overview

This page introduces the food system, forces that influence food safety practices of food businesses, and some history of U.S. food law.



The food industry, both domestically and internationally, has evolved into a system of businesses extending from agricultural production, through processing and onto retail distribution.  U.S. food law defines the food industry as several sectors:  production agriculture, food processing, retail/food service sector, businesses that supply inputs to production agriculture, and consumers.  These sectors or categories probably were not intended, but arose over time as society, through government, responded to concerns about the safety of food.

  • A food safety concern can arise at any point in the food system (e.g., during processing, during transportation or storage, during final preparation) even though a food safety problem may not be recognized until a consumer becomes ill.  At that time, it may be difficult to recognize that the consumer's illness is related to unsafe food and, if the illness is identified as arising from unsafe food, it may be difficult to trace the contamination to its source in the complex food system.  The extensive commingling of foods and the extensive movement of food, domestically and internationally, exacerbates the challenge of identifying the source of an unsafe food product.  For example, think about all the different ingredients used to prepare a frozen pizza that contains several types of meat and a variety of cheese and vegetable toppings.  Also consider all the different businesses that are involved in the production of this common food:  a variety of farms, storage facilities, modes of transportation, processing facilities, distribution system, and more.
  • Food safety is not the same as food quality.  Food quality considers the taste, texture, and other characteristics of food, whereas food safety focuses on whether the food will harm the consumer.  Food businesses often simultaneously address safety and quality considerations, but from a regulatory perspective, safety and quality are two distinct considerations.  The focus of this discussion is on food safety.
  • Food safety is not the same as food security.  Food security considers the availability of food to meet the nutritional needs of consumers.  There is no question that some regions of the world are concerned about the reliability of an adequate food supply.  Of course, there are other regions that enjoy abundant food supplies.  This discussion does not emphasize the concern over food security.
  • Food defense refers to protecting food from intentional attacks or contamination.  It may be reasonable to consider food defense as a subset of food safety in that both concepts are directed towards reducing the risk of unsafe food.  They are different, however, in that food defense addresses only intentional attacks, whereas food safety could be described as a broader concept that addresses ALL causes of unsafe food.
  • There is no way to guarantee safe food; the best that can be done is to reduce the risk of unsafe food.
    • Assessing the risk that food is unsafe will be based on scientific analysis, rather than emotions, assumptions, and personal objectives.
  • Each sector -- or more correctly, each firm -- of the food industry must do what it can to reduce the risk of unsafe food; food safety must be pursued from "farm to fork".
  • Food must meet the regulations of the jurisdiction where the food is located; thus as food moves from nation to nation, or from state to state, the laws regulating the food will vary and the practices that the food industry needs to follow must be altered accordingly.  For example, food processed in Iowa must comply with Iowa state law and U.S. federal law.  As that food moves to Canada through Minnesota, it will need to temporarily comply with Minnesota state law and then Canadian law.  If there are extensive differences among the laws of these jurisdictions, the food company may find it difficult to comply with all of the various requirements.
    • Variation in the laws and standards among jurisdictions can restrict the movement of food.  Harmonizing food laws and standards among jurisdictions is a strategy to regulate food without unreasonably restricting the movement of food.
    • Drivers for Global Harmonization of Food Safety Legislation

      "There is no question that the more the avenues of global trade widen, the higher the probability of “traffic jams” in worldwide commerce. Barriers to trade in the form of differing—and sometimes, conflicting—country-by-country import/export rules and requirements, can and do make it difficult for food businesses to get traction in overseas markets. Food safety concerns are frequently cited by individual nations as underpinning the justification for their legislative acts and rulemaking—and for erecting trade barriers and other measures that have the impact of curtailing free trade. Unfortunately, in some cases, the science used to inform and bolster food safety policymaking is insufficient, inconsistent or contradictory, creating a roadblock to the promulgation of laws that have a clear and evident benefit to protecting public health. Differences between countries in food safety regulations and laws also trigger a red light to the advances offered by science and technology. Though many food companies throughout the world have contributed significantly to research and development (R&D) efforts and costs of food safety technology, industry is understandably hesitant to apply newly-developed capabilities on an international scale in an uncertain, maze-like regulatory environment." Excerpt from Global Harmonization Initiative (GHI) at, visited March 15, 2011.


Forces Influencing Response to Food Safety Concerns

Government regulation often is mentioned as a force or factor that causes food firms to take steps to reduce the risk of unsafe food.  But government regulation is not the only force that impacts the activities of food businesses.  Product liability laws and buyer preferences (market forces) also influence the practices of food businesses.


Product Liability

A consumer who becomes ill from food is entitled to be compensated by the food company for the injuries or damages suffered by the sickened consumer.  For example, an ill consumer is entitled to be compensated for medical expenses and lost salary following a food-borne illness.  "Product liability" is the legal concept that defines the consumer's right to seek compensation from the firm that allowed the food to become unsafe.

As numerous firms are involved in providing a food product, one challenge is to identify which firm is responsible for the unsafe food:  was it the firm that provided the beef for the frozen pizza, or the firm that provided the flour for the crust, or one of the firms that provided the tomato sauce, cheese, green peppers, olives, or some other ingredient?  Of course, each firm will attempt to establish that it was not the cause of the unsafe food.  As discussed in another section, records is one way to help prove that the firm's product did not cause the consumer's illness.

No business wants to bear the risk of having to compensate for a consumer's illness or death; nor does any business want its reputation harmed by having distributed an unsafe food product.


Business Reputation

Associated with product liability is the risk of a damaged reputation for the business that is identified as the cause of the problem; if it was the olives from Firm A that caused the consumer of the pizza to become ill, the reputation of Firm A has been tarnished, for example.  The frozen pizza manufacturer may now decide to purchase olives from another firm.  No business wants to bear the burden of having a reputation of providing unsafe food.


Market Forces

Another force influencing the food industry are the firms/businesses that purchase food products.  For example, a food retailer may refuse to sell the product from Firm M unless Firm M can verify that its food manufacturing processes minimize the risk of unsafe food.  Restated, businesses in the food industry are imposing expectations on their suppliers to take steps to reduce the risk of unsafe food.  Walmart and McDonalds are two well-known food retailers (and there are many more firms) that are imposing expectations on their suppliers to reduce the risk of unsafe food.  These market forces are shaping practices in the food industry.

  • Will market forces be the "driving force" for the food industry in the 21st century?

These market expectations often are imposed as terms in the purchase agreement/contract; they could be paraphrased as "I will purchase these food items from your supply firm only if the food and the production practices meet the following standards ..."  To make it easier to assure the supplier is meeting these standards, the food industry is organizing itself to develop standards for food firms to adopt or follow, rather than having each firm develop its own standards.  To implement these industry standards, the industry also is developing mechanisms to monitor food firms that want to follow such industry standards. These organizations offer the service of inspecting/auditing/certifying that the food firms are operating according to the standards.  The following list identifies several non-government organizations that provide certification services for the food industry:

  • Global Food Safety Initiative (GFSI) --
    • "The Global Food Safety Initiative (GFSI) is an industry-driven initiative providing thought leadership and guidance on food safety management systems necessary for safety along the supply chain."
  • Global (Good Agricultural Practices) G.A.P. --
    • "GLOBALG.A.P.’s ... standards helped producers comply with Europe-wide accepted criteria for food safety, sustainable production methods, worker and animal welfare, and responsible use of water, compound feed and plant propagation materials. Harmonized certification also meant savings for producers, as they would no longer need to undergo several audits against different criteria every year"
  • Safe Quality Food Institute (SQFI) and the SQF Code --
    • "SQF is recognized by retailers and foodservice providers around the world who require a rigorous, credible food safety management system.  Using the SQF certification program will help reduce assessment inconsistencies and costs of multiple assessment standards. The SQF Program is recognized by the Global Food Safety Initiative (GFSI) and links primary production certification to food manufacturing, distribution and agent/broker management certification."
  • BRC Global Standards --
    • "... safety and quality certification programme, used by over 23,000 certificated suppliers in 123 countries, with certification issued through a worldwide network of accredited certification bodies."
    • "The BRC Global Standard for Food Safety Issue 7 was published in January 2015, setting benchmarks for best practice in food manufacture" --
  • International Organization for Standardization (ISO)  and ISO 22000 --
    • "ISO 22000 is a Food Safety Management System that can be applied to any organization in the food chain, farm to fork. Becoming certified to ISO 22000 allows a company to show their customers that they have a food safety management system in place. This provides customer confidence in the product.
    • "ISO 22000 is not a Global Food Safety Initiative (GFSI) benchmarked standard."
  • Food Safety System Certification (FSSC) and FSSC 22000 --
    • "FSSC 22000 is fully recognized by the Global Food Safety Initiative (GFSI) and is based on existing ISO Standards. It demonstrates your company has a robust Food Safety Management System in place that meets the requirements of your customers and consumers."

This short list illustrates that numerous non-government organizations are emerging globally to serve the food industry by establishing food safety and quality standards, and offering a service to audit and certify that participating food firms are complying with the standards.

Food businesses must adhere to government (mandatory) regulations and industry expectations.  Government regulations and industry standards often are similar, but not necessarily identical.


Government Regulation

Of course, government regulation also directs (mandates) practices of food businesses. Some key concepts are listed here.

    • U.S. law prohibits the sale of adulterated or misbranded food (21 U.S.C. 331).
      • Food is adulterated if, among other violations, it contains any poisonous or deleterious substance which may render it injurious to health; it consists of any filthy, putrid, or decomposed substance, or is otherwise unfit for food; it has been prepared, packed, or held under insanitary conditions; it is the product of a diseased animal or an animal which died other than by slaughter; or its container is composed of any poisonous or deleterious substance (21 U.S.C. 342).  Note that food is adulterated if it is stored or transported (i.e., held) in unsanitary conditions even if the food is NOT contaminated.
        • To understand the concept of adulterated food, it may be best to begin with the fundamental concept that "any food that has had anything added to the food (whether it was intentionally or unintentionally added to the food) is adulterated food."  The law then defines a huge exception:  substances can be added to food if there is a regulation that allows the substance to be added to the food or to be in contact with the food (such as processing equipment or packaging material).  Therefore, a food processing firm, for example, needs to identify the appropriate regulations that allow the firm to add the desired substances to its food products.
      • Food is misbranded if, among other violations, its label is false or misleading, its label does not accurately  present the required nutritional information, is sold under the name of another food, its container is made or filled to be misleading, or it is not labeled as an imitation food if it is an imitation (21 U.S.C. 343).  Food also is misbranded if its advertising is false or misleading.
    • Food firms must prove their food is in compliance with the law; that is, the firm must establish that its food product is not adulterated or misbranded.  It is not the government’s responsibility to prove food is unsafe, adulterated or misbranded.
    • The basic remedy when food is suspected of being adulterated or misbranded is to separate the food from consumers.  If the food firm does not take steps to remove the food, such as voluntarily recalling the food, law authorizes government agencies to take steps to recall, detain, seize or enjoin the movement of the food.  But before the agency proceeds to recall, detention, seizure or injuction, it begins by issuing advisory letters.
      • Untitled Letter and Warning Letter (see; visited November 10, 2016).
        • Warning Letter:  A Warning Letter is issued for violations that may lead to enforcement action if the problem is not promptly and adequately corrected.  A Warning Letter is intended to notify the firm and give it an opportunity to voluntarily and promptly correct a problem.  Warning Letters are based on the expectation that most firms will voluntarily comply with the law.  Warnings are the FDA's principal means of achieving prompt voluntary compliance before the FDA initiates an enforcement action.
        • Untitled Letter: An Untitled Letter cites violations that do not warrant a Warning Letter. The letter requests a written response from the firm within a reasonable amount of time (e.g., "Please respond within 30 days").
      • Recall (see; visited November 10, 2016):  Removing food from the market so it cannot be consumed is perhaps the most common remedy when food is suspected of being adulterated or misbranded.  Prior to 2011, U.S. federal agencies had limited authority to mandate a food recall, but with the enactment of the Food Safety Modernization Act, FDA is authorized to recall food.  
        • A manufacturer or distributor may voluntarily initiate a recall at any time...  The FDA may request a recall... Under certain authorities, FDA may mandate a recall.
        • An FDA recall request or recall mandate are directed to the food firm and the food firm is expected to initiate the product recall.  An FDA recall request or recall mandate is NOT directed to consumers or otherwise directs a recall.  Restated, the FDA directs the firm to initiate and conduct the recall.
        • The FDA may take appropriate regulatory action when: 1) a firm refuses to recall after being requested or ordered (mandated) to do so by the FDA; 2) a firm fails to complete a recall in a timely fashion; or, 3) the FDA has reason to believe that the firm’s recall strategy is not effective.
        • See; visited November 22, 2015
      • Detention (see; visited November 22, 2015).
        • A qualified employee of FDA may order the detention of any food article that is found during an inspection, examination, or investigation as presenting a threat of serious adverse health consequences or death to humans or animals. Detained food may not be transferred from the place where it has been ordered detained until an authorized FDA representative releases the food.

FDA is authorized to detain meat, poultry and egg products and shell eggs when they are no longer within the authority of the USDA.

    • Seizure and Injunction (see; visited November 22, 2015)
      • Seizure: FDA initiates a lawsuit (i.e., a court proceeding) against a product (not the product owner) requesting that the court order the U.S. Marshal to seize control of the suspect food product.
      • Injunction:  FDA initiates a lawsuit requesting a court order that the suspect food not be moved.
      • Note that both a seizure and injunction involves a court proceeding to assure that the FDA's action does violate the Constitutional prohibition against unlawful government seizure of private property.
    • Fines and other criminal penalties also can be imposed on food businesses that do not take steps to resolve a food safety problem, but these remedies are often considered the "last resort" and imposed on "uncooperative businesses."


    Food law has evolved in response to problems

    U.S. food laws often are enacted in response to a food-related problem.  For example, the Meat Inspection Act of 1906 (one of the first two U.S. federal food safety laws) was enacted only after an outcry about the processing practices of the meat industry.  More recently, concerns over food color additives in the 1950s, botulism in canned foods in the 1960s, infant formula in the 1970s, fruit juice in the 1990s, and seafood in 1990s each led to a government response of expanded legislation or regulation.  For example,


    Not all public pressure for food regulations has been based on confirmed safety considerations, but may have been a guise for shielding economic concerns.  The outcry for regulating margarine, for example, may have been based more on concerns of the dairy industry about competition from soybeans or other oil crops than on the safety of margarine.


    There are exceptions to every general statement, and in this case, there are examples of U.S. food law that are in response to a vision, rather than a problem.  An example is the idea that consumers should decide what food they will eat, but that they should be provided information about the food so they can make an informed decision.  This fundamental value was expressed (reiterated?) by President Kennedy in the early 1960s and continues to politically support labeling legislation and consumer education programs.  For example, see "Get to Know Your Basic Consumer Rights: How Do They Work for You?" at, visited November 22, 2015.



    Food businesses recognize that consumers, other food businesses, and society, through government, expect each business in the food industry to adopt practices that reduce the risk of unsafe food, and that a business that allows food to become unsafe will be held accountable.  This accountability is motivating most firms to adopt risk-minimizing practices.  Historically, however, U.S. food law has generally been reactive, that is, many food laws have been enacted in response to a food-related problem that caught the attention of society and government leaders.




    This material is intended for educational purposes only. It is not a substitute for competent legal counsel. Seek appropriate professional advice for answers to your specific questions.

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