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History of US Food Regulation

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Introduction
Overview

Government "Players"
Requirements
Producer/Processor/Preparer Liability
Looking Forward/Future Issues

History of US Government Response

Concern about the safety of our food is not new, but it has received considerably more attention during the past century. This web page provides a brief historical perspective of food safety programs and laws.

  • Concerns about adulterated food can be traced back to as early a 200 BC (concerned that wine was being diluted with water).
  • European nations have wrestled with food safety concerns, and due to our extensive European heritage, have influenced our approach to food safety issues; e.g., cities enacted food laws, region in which wine was produced must be accurately represented; cannot mask spoiled grain with good grain; concern about what was being added to baked products, such as beans and peas to replace flour.
  • Food safety concerns were addressed in America's colonial times; e.g., Massachusetts and Virginia in 1641; e.g., bakers were required to place their identifying mark on their bread.
  • During the 19th century, industrialization, urbanization, reliance on purchased food, and food manufacturing expanded, and so did the concern over adulterated and misbranded food.

1800s

  • Roots of federal food law lie in the U.S. Patent office. Because many of the patents in the early 1800s dealt with advances in agricultural technologies, an Agriculture Division was established in the Patent Office in 1842.
  • US Department of Agriculture was established in 1862 with the staff of the Agriculture Division of the Patent Office; responsibilities of the new department included roles that have grown into today's food regulatory agencies.
  • Dr. Harvey Wiley (1880s) expanded food adulteration studies and campaigned for federal laws to address food safety issues; e.g., the Pure Food Congress in 1898.
  • "Poison Squad" -- volunteers tested the safety of food additives/preservatives.
  • First food laws in the United States were primarily state and local laws because the federal government was slower to respond; but variation among local laws made it difficult for an interstate business to comply with differing requirements.
    • Example - California enacted a food safety law in 1800s; North Dakota enacted a Pure Food Law in 1903.
  • Upton Sinclair's "The Jungle" (1905) described the conditions of the meat packing industry; this led to Congressional action.

1900s

  • The Pure Food and Drug Act regulated some food processing and food additives to protect consumers
    • Example -- 21 U.S.C. 331 "The following acts ... are prohibited:

      (a) The introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded.

      (b) The adulteration or misbranding of any food, drug, device, or cosmetic in interstate commerce.

      (c) The receipt in interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise."

  • Example -- 21 CFR 189.1 "Substances prohibited from use in human food. (a) The food ingredients listed in this section have been prohibited from use in human food by the Food and Drug Administration because of a determination that they present a potential risk to the public health or have not been shown by adequate scientific data to be safe for use in human food. Use of any of these substances in violation of this section causes the food involved to be adulterated in violation of the act."
  • Example -- 21 CFR 101.3(e) "Under ... the Federal Food, Drug, and Cosmetic Act, a food shall be deemed to be misbranded if it is an imitation of another food unless its label bears, in type of uniform size and prominence, the word "imitation" and, immediately thereafter, the name of the food imitated."
  • Example -- Oleomargarine (21 U.S.C. 347) led to some of the early food laws; arose over dairy industry concern about margarine and its competition with butter.

"No person shall sell, or offer for sale, colored oleomargarine or colored margarine unless (1) such oleomargarine or margarine is packaged, (2) the net weight of the contents of any package sold in a retail establishment is one pound or less, (3) there appears on the label of the package (A) the word "oleomargarine" or "margarine" in type or lettering at least as large as any other type or lettering on such label, and (B) a full and accurate statement of all the ingredients contained in such oleomargarine or margarine, and (4) each part of the contents of the package is contained in a wrapper which bears the word "oleomargarine" or "margarine" in type or lettering not smaller than 20-point type."

Is this "oleomargarine" law motivated by science or economics?

  • Meat Inspection Act
    • The Meat Inspection Act authorized USDA to assure meat products are safe, and not adulterated, misbranded or mislabeled.
    • USDA's responsibilities include inspecting meat-processing facilities, inspecting animals before and after slaughter (stamp with "US inspected and passed"), inspecting meat products, and approving processed meat product labels.
    • The Meat Inspection Act refers to Food and Drug Act for definitions of food additive, color additive and other terms thus establishing a close relationship between the Food and Drug Act and the Meat Inspection Act even though they are administered by different agencies.
  • Because federal law preempts state law, the focus of food law shifted from state to federal government as Congress began to address food safety issues. However, the role for state government in regulating food safety has not been eliminated, as is discussed on other pages in this site.

After 1906

  • Despite these two pieces of legislation, food safety issues continued to arise and attempts were made to revise the legislation, especially the Pure Food and Drug Act. A major issue was the continuing concerns about safety of substances in food supply.
    • Example - USDA raised concern in the early 1900s about nonnutritive sweeteners but President Teddy Roosevelt was using saccharin rather than sugar. Frustration that the safety of the product was being challenged led to an investigation of those who raised the concerns about the sweeteners.
  • Affirmative labeling (a 1913 amendment) required information about content and container size.
  • Adulteration and misbranding were being interpreted by the courts because they were not defined in the 1906 statute; e.g., 1924 Supreme Court decision.
  • There were unsuccessful attempts to legislatively address issues of "no significant risk level" (e.g., a chemical that poses no significant risk to an average person, but may pose a risk to a weaker person (perhaps young, elderly, ill) is prohibited by the statute), "slack fill," "foreign grown," "FDA authority to establish standards of identity" and "FDA authority to inspect processing plants."
  • Tragedy - Jamaican Ginger, an over-the-counter drug, was used during prohibition for an "alcoholic kick;" to reduce the cost of the Ginger, an untested but lethal substance was added.
  • Tragedy -- sulfa drug was useful but it required the person to also take a solvent to dissolve the drug; the safety of the solvent was not tested and caused death.
  • These tragedies led to major legislative revision in 1938.

Food, Drug, and Cosmetic Act of 1938

  • The legislation replaced the Pure Food and Drug Act of 1906
    • Story of the Laws Behind the Labels Part II: 1938 Federal Food, Drug, and Cosmetic Act
    • Federal Food, Drug, and Cosmetic Act can be found at 21 U.S.C. 301 et. seq.
    • Food subchapter within Act is 21 U.S.C. 341 to 350b
    • The Food, Drug and Cosmetic Act (FDCA) is administered by Food and Drug Administration (FDA)
    • Some provisions of the FDCA:
      • authorized FDA to established identity standards for food.
      • broadened adulteration laws -- rather than FDA having to prove the food was adulterated, the industry now had the burden of proving an additive is safe.
      • authorized FDA to inspect processing facility anytime during normal working hours.
      • prohibited false statements about the food item.
      • addressed labeling of imitation food (e.g, margarine/butter issue); if product imitated another food product, the label had to clearly state that fact.
      • mandated affirmative labeling - product name, quantity, contents, and manufacturer.
      • required additional label information for dietary food.
      • prohibited misleading containers.

After 1938

  • Food, Drug and Cosmetic Act (FDCA with its amendments) and Meat Inspection Act remain the primary food laws, but additional issues have been addressed with subsequent enactments.
  • Food Additives, 1958

"The Food Additives Amendment (of 1958) exempted two groups of substances from the food additive regulation process. All substances that FDA or the U.S. Department of Agriculture (USDA) had determined were safe for use in specific food prior to the 1958 amendment were designated as prior-sanctioned substances. Examples of prior-sanctioned substances are sodium nitrite and potassium nitrite used to preserve luncheon meats.

"A second category of substances excluded from the food additive regulation process are generally recognized as safe or GRAS substances. GRAS substances are those whose use is generally recognized by experts as safe, based on their extensive history of use in food before 1958 or based on publish scientific evidence. Salt, sugar, spices, vitamins and monosodium glutamate are classified as GRAS substances, along with several hundred other substances. Manufacturers may also request FDA to review the use of a substance to determine if it is GRAS.

"Both the Food Additives and Color Additives Amendments include a provision which prohibits the approval of an additive if it is found to cause cancer in humans or animals. This clause is often referred to as the Delaney Clause, named for its Congressional sponsor, Rep. James Delaney (D-N.Y.)."

Taken from http://www.cfsan.fda.gov/~dms/qa-adf16.html

Also see Frequently Asked Questions About GRAS

"Delaney Clause" -- a known carcinogen cannot be added to food in detectable quantities if the substance is shown to cause cancer in test animals; implementing this standard became more rigorous as analytical technologies advanced so that significantly smaller quantities can now be detected; there was no provision that if a low level of the substance poses "no significant risk," it would be tolerated; instead, any detectable presence of a carcinogen was prohibited.

  • Color Additives, 1960

"In 1960, amendments to the Food, Drug, and Cosmetic Act of 1938 added the so-called Delaney anti-cancer clause to FDA's legal mandate. Among other things, the clause prohibits marketing any color additive the agency has found to cause cancer in animals or humans, regardless of amount.

"In recent years, regulators have faced a dilemma in light of technological advances that enable scientists to identify smaller and smaller concentrations of a substance and conduct more sensitive toxicological tests. Are such tiny amounts a health threat?"

Taken from http://www.cfsan.fda.gov/~dms/cos-221.html

Are some colors additives likely to lead to allergic reactions when consumed?

Also see Story of the Laws Behind the Labels Part III: 1962 Drug Amendments

  • Fair Packaging and Labeling Act, 1966
    • Requires processors to list ingredients on label by prominence (weight or volume) in product.
  • Fortification Restriction Amendment, 1976
    • Congressional action to limit FDA's attempt to regulate level of "fortification" in food products; FDA is authorized to determine "safe level" for additives (based on the assumption that too much of an additive may be dangerous) but industry (according to Congress) should decide how much it wants to add to a product within the "safe" level.  Thus FDA cannot prohibit the sale of a supplement that provides more nutrient than the consumer needs (as long as the level of the supplement is not so great as to injure the consumer).
  • Nutrition Labeling and Education Act, 1990
    • Mandated nutrition labeling; no longer voluntary; applies to imported food products as well as domestic products; such labeling is becoming a global trend.
    • Nutrition information must be presented on the basis of serving size, rather than size of package.
    • State enforcement authority; FDA sets the standards and perhaps identifies violations, but states agencies enforce the law.
    • Federal preemption for misbranding; replaced extensive state food laws in some jurisdictions but simplified compliance for interstate companies -- one standard rather than a different standard in each state.
      • Preemption -- legal concept that if there is a conflict between federal and state law, federal law prevails (unless Congress allows state law to be applied).
    • More detailed declaration of ingredients, to include colors, peanut, and juice content; defined difference between butter, margarine and spread; defined difference between fruit drink and fruit juice; allows combination of food ingredients that may have been prohibited by some state laws (but the ingredients must be accurately labeled), e.g., canola oil added to butter.

     

  • Food Quality Protection Act, 1996
    • Summary of FQPA Amendments to FIFRA and FDCA at http://www.epa.gov/oppfead1/fqpa/fqpa-iss.htm
    • Mandates a single, health-based standard for all pesticides in all foods
    • Provides special protections for infants and children in determining pesticide tolerances in food

    "This legislation eliminates the Delaney Paradox. The Delaney clause no longer applies to any tolerances set for pesticide residues in food. Rather, the EPA must determine that tolerances are "safe," defined as "a reasonable certainty that no harm will result from aggregate exposure" to the pesticide. EPA and others will be able to devote resources that have been consumed by Delaney-related activities to higher priority public health and environmental protection issues."

  • FDA Modernization Act of 1997
    • "The act eliminates the requirement of FDA's premarket approval for most packaging and other substances that come in contact with food and may migrate into it. Instead, the law establishes a process whereby the manufacturer can notify the agency about its intent to use certain food contact substances and, unless FDA objects within 120 days, may proceed with the marketing of the new product. Implementation of the notification process is contingent on additional appropriations to cover its cost to the agency. The act also expands procedures under which FDA can authorize health claims and nutrient content claims without reducing the statutory standard."

      Taken from http://www.fda.gov/opacom/backgrounders/modact.htm

  • Food Safety from Farm to Table:  A New Strategy for the 21st Century (1997)
    • "[Presidential initiative] to fund a nationwide early warning system for foodborne illness, enhance seafood safety inspections, and expand food safety research, risk assessment, training, and education."
    • "Sources of food contamination are almost as numerous and varied as the contaminants themselves. Bacteria and other infectious organisms are pervasive in the environment. Salmonella enteritidis enters eggs directly from the hen. Bacteria (occasionally pathogenic) inhabit the surfaces of fruits and vegetables in the field. Molds and their toxic byproducts can develop in grains during unusually wet or dry growing seasons, damage and stress during harvesting, or during improper storage. Seafood may become contaminated from agricultural and other runoff, as well as by sewage, microorganisms, and toxins present in marine environments. Many organisms that cause foodborne illness in humans can be part of the normal flora of the gastrointestinal tract of food-producing animals without any adverse effects to the animal. Milk, eggs, seafood, poultry, and meat from food-producing animals may become contaminated due to contaminated feed, misuse of veterinary drugs, or poor farming practices, including production and harvesting activities, or disposal of solid waste on land. Foods may become contaminated during processing due to malfunctioning or improperly sanitized equipment; misuse of cleaning materials; rodent and insect infestations; and improper storage. Foods may become contaminated in retail facilities and in the home through use of poor food handling practices."
    • Scope of challenge:  issues involve farm; food processing; transportation; importation; restaurants, supermarkets, and institutional food services; surveillance of foodborne illness; home; research; and education.
    • Strategies:  early warning system; coordination; risk assessment; research; revised inspections (HACCP); education.
    • Agencies that previously focused on commodity standards, promoting product utilization and market development, and similar concerns now found themselves becoming involved in assuring a safe food supply by working to minimize the risk of food contamination during the production (pre-harvest) stage.

 

The following Background is an excerpt from Food Safety Strategic Plan, January 19, 2001; note the description of the jurisdictions of the three agencies:

BACKGROUND

Today [written in 2001 ] seven statutes provide HHS [Department of Health and Human Services], USDA [US Department of Agriculture], and EPA [Environmental Protection Agency] with the primary tools to regulate food safety:

the Federal Food, Drug, and Cosmetic Act (FDCA);
the Public Health Service Act (PHSA);
the Federal Meat Inspection Act (FMIA);
the Poultry Products Inspection Act (PPIA);
the Egg Products Inspection Act (EPIA);
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); and
the Food Quality Protection Act (FQPA).

These statutes were enacted and amended over a span of 90 years, starting in 1906 and 1907 with the first Federal food safety statutes, the Food and Drugs Act and the Meat Inspection Act. From their inception, however, these laws focused on different areas of the food supply, and they take varying approaches to food safety.

The Meat Inspection Act and its successor, the FMIA, required continuous inspection of meat and meat food products, both ante- and post-mortem, to identify animal diseases. The Meat Inspection Act also created an inspection force, which is administered today by USDA's Food Safety and Inspection Service (FSIS). Over the years, FSIS was also given similar authority to oversee poultry and egg products inspection under the PPIA and EPIA. Under these laws, FSIS carries out its food safety activities and protects the public health by ensuring that meat, poultry, and egg products distributed to consumers are wholesome, not adulterated, and are properly marked, labeled, and packaged.

Under these statutes, FSIS is charged with preventing the preparation, distribution and shipment of adulterated meat, poultry, and egg products to consumers, and overseeing appropriate labeling and provision of other consumer information. Meat, poultry, and egg products are not to be sold or transported unless they bear the USDA mark of inspection - the signal that FSIS has, through premarket inspections, determined that a product is wholesome, and neither adulterated nor misbranded. The three statutes also require that any country wishing to export meat, poultry, or egg products to the U.S. maintain an inspection program that is equivalent to the U.S. inspection program. This equivalence requirement goes not just to a system of inspection, but also to the maintenance of that system and to the equivalence of the products that are produced within that system.

The Food and Drugs Act, as originally enacted, forbade adulteration and misbranding of foods in interstate commerce. Under this statute, the food industry is responsible for producing safe and wholesome food, with the government, in effect, policing the industry through marketplace surveillance rather than mandatory premarket inspection. In 1938, the FDCA was enacted. It added controls over food processing, but did not change the basic approach to food safety set out in the 1906 act. In the 1950s and early 1960s, HHS' Food and Drug Administration (FDA) was given additional authority over pesticides, contaminants, and food and color additives. Since then, with the exception of pesticides and dietary supplements, no fundamental changes have been made to the food safety provisions of the FDCA. Under the FDCA, FDA exercises jurisdiction over production, processing, packaging, storage, and holding of domestic and imported food except meat, poultry, and some egg products. FDA seeks under this authority to ensure that food products are safe, sanitary, nutritious, wholesome, and adequately labeled. FDA's jurisdiction also includes premarket approval and surveillance of new animal drugs, medicated feed, and all food additives (including coloring agents, preservatives, food packaging, and sanitizers) that can become part of food. FDA also has jurisdiction related to food safety under the PHSA, which gives FDA two valuable additional tools: very broad authority to adopt regulations to prevent the spread of communicable diseases, and the ability to both provide assistance to, and accept assistance from, state and local government counterparts in the regulation of communicable disease.

The Environmental Protection Agency (EPA) also plays a role in food safety through its authorities to protect water and regulate pesticide products used in this country. EPA's regulation of pesticides under the FDCA and FIFRA has historically focused on determining whether a pesticide should be licensed for use on designated crops and establishing maximum allowable residue levels (so-called "tolerances") in/on food. This authority was further strengthened by the Food Quality Protection Act of 1996 (FQPA) which establishes a health-based standard for pesticide residues and mandates that EPA look, among other things, at aggregate exposure, cumulative risk, and the potential need for an additional safety factor to protect infants and children.

End of Excerpt

 

  • The Public Health Security And Bioterrorism Preparedness And Response Act Of 2002
    • Summary of provisions intended to protect our food supply
    • Food Safety and Security Strategy provisions of the Public Health Security And Bioterrorism Preparedness And Response Act
    • Protection Against Adulteration of Food
      • priority is to increase number of inspections of imported food to detect intentional adulteration.
      • research to develop tests to rapidly detect intentionally adulterated food
    • Administrative Detention
      • authorizes FDA to detain food that presents a threat of serious adverse health consequences or death to humans or animals.
    • Debarment for Repeated or Serious Food Import Violations
      • debars (prohibited from importing) persons convicted of importing food that presents a threat of serious adverse health consequences or death to humans or animals.
    • Registration of Food Facilities
      • requires the owner, operator, or agent in charge of a domestic or foreign facility to register facility
      • defines facility as any factory, warehouse, or establishment of an importer that manufactures, processes, packs, or holds food. Specifically excludes farms, restaurants, other retail food establishments, nonprofit food establishments in which food is prepared for or served directly to the consumer; and fishing vessels. Limits foreign facilities to those that manufacture, process, pack, or hold food only if food from such facility is exported to the U.S. without further processing or packaging outside the U.S.
      • makes failure to register a prohibited act.
        • Does this suggest that a third category of "prohibited acts" been added to the two historical categories of "adulterated" and "misbranded?"
    • Maintenance and Inspection of Records for Foods
      • authorizes Secretary to access records when there is a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals. It applies to all records relating to the manufacture, processing, packing, distribution, receipt, holding, or importation of the food. It excludes farms and restaurants. It excludes information such as recipes, financial data, personnel data, research data, and sales data (other than shipment data regarding sales).
    •  

    • Prior Notice of Imported Food Shipments
      • requires prior notice of imported food shipments. The notice is required to provide the article, the manufacturer and shipper, the grower (if known within the specified time in which notice is required), the country of origin, the country from which the article is shipped, and the anticipated port of entry. States that, if notice is not provided, the article shall be refused admission.
      • makes it a prohibited act to import an article of food in violation of these requirements.

       

    • Authority to Mark Articles Refused Admission into United States
      • requires marking food that has been refused for import (other than food required to be destroyed).
      • defines food as misbranded if it fails to bear the required label when the Secretary has found that the food presents a threat of serious adverse health consequences or death to humans and animals and the Secretary has notified the owner that the label is required.

       

    • Prohibition Against Port Shopping
      • deems food adulterated if it offered for import after it has been previously refused admission, unless the person reoffering the food establishes that the article is in compliance.

       

    • Notices to States Regarding Imported Food
      • requires Secretary to notify States when there is credible evidence or information indicating that a shipment, or portions of shipment, of imported food presents a threat of serious adverse health consequences or death to humans or animals.

       

    • Grants to States for Inspections
      • authorizes Secretary to make grants to States that undertake examinations, inspections, and investigations

       

    • Authority to Commission Other Federal Officials to Conduct Inspections
      • authorizes Secretary to commission other Federal employees to conduct examinations and inspections. Requires a memorandum of understanding (MOU) between the Secretary and the head of the other Federal agency. The MOU must address training and reimbursement. It is restricted to facilities or other locations that are jointly regulated by the Secretary and the other department or agency.

This page provided an overview of US federal food laws. The next page introduces/reviews the general strategies developed by government in response to concerns over food safety.

Last updated January 5, 2008

   
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