Center for Food Safety and Applied Nutrition
Encyclopedia
The Center for Food Safety and Applied Nutrition (CFSAN, pronounced sif'-san) is the branch of the United States Food and Drug Administration (FDA) that regulates food, dietary supplement
s, and cosmetics .
, with the exception of seafood and some exotic meats. The regulation of eggs is similarly complicated by shared responsibilities between the two agencies.
Many other federal and state agencies have some overlapping or conflicting requirements for regulation of food products. For example, the United States Environmental Protection Agency
(EPA) regulates levels of allowable contaminants in public drinking water, where the FDA regulates bottled water.
Regulation of food also includes food additives such as preservatives and artificial sweeteners. Controversies over preservatives were very important in the early days of the FDA, where volunteers participated in experimental meals with high doses of the chemicals to determine their toxicity. Levels of undesirable food additives, such as methyl mercury in canned tuna, are the responsibility of the FDA.
FDA maintains a list of additives that are used in food in the United States as well as a list of additives Generally Recognized as Safe
(GRAS, pronounced grass). Products that contain ingredients that are not GRAS are usually dietary supplements (for example, many energy drinks contain stimulants which are not GRAS).
Food products may make health claims, such as the "Heart Healthy" labels on foods high in fiber. Each specific claim must be submitted and is based on the content of the food, it is not an approval of a specific product. Dietary supplements may make "structure or function" claims but cannot legally claim to cure or prevent disease unless they meet an approved health claim as a food product.
CFSAN is also responsible for food labeling, specifically the "Nutrition Facts" panel typically seen on packaged foods. Ingredient declarations are also required, and this is important for consumers with food allergies
Regulation of food includes evaluations of products which are used in food handling and storage, referred to as "food contact surfaces." Problems in this area include lead
based glazes that are used to decorate ceramic
dishes.
Here is the definition directly from Section 1 . [21 U.S.C. 301] of the Federal Food, Drug, and Cosmetic Act
.
The Center regulates approximately $240 billion worth of domestic food while simultaneously regulating $15 billion worth of imported foods and $15 billion worth of cosmetics
sold domestically. The center controls domestically with approximately 50,000 food establishments and 3,500 cosmetic firms. The services of the center are trained and enhanced by the FDA.
Most of the power for the CFSAN stems from congressional power given to the FDA through Acts and Regulations. The power to enforce the Acts and Regulations is then delegated from the FDA to the CFSAN as well as the other 5 product oriented centers. The congressional power can be traced to various acts and regulations such as:
The Center for Food Safety and Applied Nutrition has over 800 employees with a wide range of job titles. From secretary to molecular chemist
, the Center has an extensive staff that covers every possible aspect of food and nutrition science. In the past, most of the Center's work force was stationed at their headquarters in Washington, D.C., but in 2001 most of the headquarters staff was moved to its new location in College Park, Maryland
.
reads "CFSAN, in conjunction with the Agency's field staff, is responsible for promoting and protecting the public's health
by ensuring that the nation's food supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic products
are safe and properly labeled."
The Joint Institute for Food Safety and Applied Nutrition (JIFSAN) is a partnership between the FDA (specifically, the CFSAN and Center for Veterinary Medicine
(CVM)) and the University of Maryland
. JIFSAN was created in 1996 to "provide the scientific basis for ensuring a safe, wholesome food supply as well as provide the infrastructure for contributions to national food safety programs and international food standards." Currently JIFSAN is working on such research as Risk Analysis
, Microbial Pathogens and Toxins, Food Composition and Applied Nutrition, and Animal Health Sciences and Food Safety
.
The National Center for Food Safety and Technology (NCFST) is a research group between CFSAN, the Illinois Institute of Technology
(IIT) and members of the food industry
. NCFST is important because it is "the only center where industry can work collaboratively on projects with FDA scientists on food safety and technology research. Membership in the NCFST allows companies to gain an early insight into emerging food safety issues from the CFSAN perspective to assess the safety of new technologies which may be important for innovation
."
Because CFSAN regulates food safety and labeling, many food industry groups have an interest in their policies. Some of these groups include:
CFSAN is also a partner in the Partnership for Food Safety Education (PFSE), an organization dedicated to educating the public about food safety. The PFSE comprises some federal agencies, such as the CDC
and the EPA
, with many members from the food industry.
Dietary supplement
A dietary supplement, also known as food supplement or nutritional supplement, is a preparation intended to supplement the diet and provide nutrients, such as vitamins, minerals, fiber, fatty acids, or amino acids, that may be missing or may not be consumed in sufficient quantities in a person's diet...
s, and cosmetics .
Area of regulation
"Food" within the context of FDA is a very broad term with some limitations. Products that contain meat are regulated by the U.S. Department of Agriculture's Food Safety and Inspection ServiceFood Safety and Inspection Service
The Food Safety and Inspection Service , an agency of the United States Department of Agriculture , is the public health agency responsible for ensuring that the nation's commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged...
, with the exception of seafood and some exotic meats. The regulation of eggs is similarly complicated by shared responsibilities between the two agencies.
Many other federal and state agencies have some overlapping or conflicting requirements for regulation of food products. For example, the United States Environmental Protection Agency
United States Environmental Protection Agency
The U.S. Environmental Protection Agency is an agency of the federal government of the United States charged with protecting human health and the environment, by writing and enforcing regulations based on laws passed by Congress...
(EPA) regulates levels of allowable contaminants in public drinking water, where the FDA regulates bottled water.
Regulation of food also includes food additives such as preservatives and artificial sweeteners. Controversies over preservatives were very important in the early days of the FDA, where volunteers participated in experimental meals with high doses of the chemicals to determine their toxicity. Levels of undesirable food additives, such as methyl mercury in canned tuna, are the responsibility of the FDA.
FDA maintains a list of additives that are used in food in the United States as well as a list of additives Generally Recognized as Safe
Generally recognized as safe
Generally recognized as safe is an American Food and Drug Administration designation that a chemical or substance added to food is considered safe by experts, and so is exempted from the usual Federal Food, Drug, and Cosmetic Act food additive tolerance requirements.-History:On January 1, 1958,...
(GRAS, pronounced grass). Products that contain ingredients that are not GRAS are usually dietary supplements (for example, many energy drinks contain stimulants which are not GRAS).
Food products may make health claims, such as the "Heart Healthy" labels on foods high in fiber. Each specific claim must be submitted and is based on the content of the food, it is not an approval of a specific product. Dietary supplements may make "structure or function" claims but cannot legally claim to cure or prevent disease unless they meet an approved health claim as a food product.
CFSAN is also responsible for food labeling, specifically the "Nutrition Facts" panel typically seen on packaged foods. Ingredient declarations are also required, and this is important for consumers with food allergies
Regulation of food includes evaluations of products which are used in food handling and storage, referred to as "food contact surfaces." Problems in this area include lead
Lead
Lead is a main-group element in the carbon group with the symbol Pb and atomic number 82. Lead is a soft, malleable poor metal. It is also counted as one of the heavy metals. Metallic lead has a bluish-white color after being freshly cut, but it soon tarnishes to a dull grayish color when exposed...
based glazes that are used to decorate ceramic
Ceramic
A ceramic is an inorganic, nonmetallic solid prepared by the action of heat and subsequent cooling. Ceramic materials may have a crystalline or partly crystalline structure, or may be amorphous...
dishes.
Areas of concern
- Biological Pathogens
- Dietary SupplementsDietary supplementA dietary supplement, also known as food supplement or nutritional supplement, is a preparation intended to supplement the diet and provide nutrients, such as vitamins, minerals, fiber, fatty acids, or amino acids, that may be missing or may not be consumed in sufficient quantities in a person's diet...
- Toxic MetalsToxic metalToxic metals are metals that form poisonous soluble compounds and have no biological role, i.e. are not essential minerals, or are in the wrong form. Often heavy metals are thought as synonymous, but lighter metals also have toxicity, such as beryllium, and not all heavy metals are particularly...
- Food AllergensFood allergyA food allergy is an adverse immune response to a food protein. They are distinct from other adverse responses to food, such as food intolerance, pharmacological reactions, and toxin-mediated reactions....
- Nutrient Concerns
- Pesticide residuePesticide residuePesticide residue refers to the pesticides that may remain on or in food after they are applied to food crops. The levels of these residues in foods is often stipulated by regulatory bodies in many countries...
- Naturally occurring toxins
- Decomposition and Filth
- Dietary Components
- Radionuclides
- TSE-type diseasesTransmissible spongiform encephalopathyTransmissible spongiform encephalopathies , also known as prion diseases, are a group of progressive conditions that affect the brain and nervous system of many animals, including humans. According to the most widespread hypothesis they are transmitted by prions, though some other data suggest an...
- Product tampering
Definitions
Before any product that classifies as a food/drug/cosmetic enters our markets, the FDA tests it to make sure it's not "harmful" to consumers. The FDA's mission to be the shield of consumers against dangerous and harmful Food, Drug, or Cosmetic products.Here is the definition directly from Section 1 . [21 U.S.C. 301] of the Federal Food, Drug, and Cosmetic Act
Federal Food, Drug, and Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act , is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration to oversee the safety of food, drugs, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from...
.
- (f) 1 The term "food" means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
- (g)(1) The term "drugDrugA drug, broadly speaking, is any substance that, when absorbed into the body of a living organism, alters normal bodily function. There is no single, precise definition, as there are different meanings in drug control law, government regulations, medicine, and colloquial usage.In pharmacology, a...
" means (A) articles recognized in the official United States PharmacopeiaUnited States PharmacopeiaThe United States Pharmacopeia is the official pharmacopeia of the United States, published dually with the National Formulary as the USP-NF. The United States Pharmacopeial Convention is the nonprofit organization that owns the trademark and copyright to the USP-NF and publishes it every year...
, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseaseDiseaseA disease is an abnormal condition affecting the body of an organism. It is often construed to be a medical condition associated with specific symptoms and signs. It may be caused by external factors, such as infectious disease, or it may be caused by internal dysfunctions, such as autoimmune...
in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 403(r)(1)(B) and 403(r)(3) or sections 403(r)(1)(B) and 403(r)(5)(D), is made in accordance with the requirements of section 403(r) is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 403(r)(6) is not a drug under clause (C) solely because the label or the labeling contains such a statement. (2) The term "counterfeit drug" means a drug which, or the containerPackaging and labellingPackaging is the science, art, and technology of enclosing or protecting products for distribution, storage, sale, and use. Packaging also refers to the process of design, evaluation, and production of packages. Packaging can be described as a coordinated system of preparing goods for transport,...
or labeling of which, without authorization, bears the trademarkTrademarkA trademark, trade mark, or trade-mark is a distinctive sign or indicator used by an individual, business organization, or other legal entity to identify that the products or services to consumers with which the trademark appears originate from a unique source, and to distinguish its products or...
, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other drug manufacturer, processor, packer, or distributor.
- (i) The term "cosmeticCosmeticsCosmetics are substances used to enhance the appearance or odor of the human body. Cosmetics include skin-care creams, lotions, powders, perfumes, lipsticks, fingernail and toe nail polish, eye and facial makeup, towelettes, permanent waves, colored contact lenses, hair colors, hair sprays and...
" means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soapSoapIn chemistry, soap is a salt of a fatty acid.IUPAC. "" Compendium of Chemical Terminology, 2nd ed. . Compiled by A. D. McNaught and A. Wilkinson. Blackwell Scientific Publications, Oxford . XML on-line corrected version: created by M. Nic, J. Jirat, B. Kosata; updates compiled by A. Jenkins. ISBN...
.
History
The Center for Food Safety and Applied Nutrition is a member of one of the six product oriented centers that seeks to carry out the mission of the FDA. The CFSAN contributes to a nationwide field force centered around the ideals and motives of the FDA, under delegated power from the FDA.The Center regulates approximately $240 billion worth of domestic food while simultaneously regulating $15 billion worth of imported foods and $15 billion worth of cosmetics
Cosmetics
Cosmetics are substances used to enhance the appearance or odor of the human body. Cosmetics include skin-care creams, lotions, powders, perfumes, lipsticks, fingernail and toe nail polish, eye and facial makeup, towelettes, permanent waves, colored contact lenses, hair colors, hair sprays and...
sold domestically. The center controls domestically with approximately 50,000 food establishments and 3,500 cosmetic firms. The services of the center are trained and enhanced by the FDA.
Most of the power for the CFSAN stems from congressional power given to the FDA through Acts and Regulations. The power to enforce the Acts and Regulations is then delegated from the FDA to the CFSAN as well as the other 5 product oriented centers. The congressional power can be traced to various acts and regulations such as:
- Food and Drug act of 1906Pure Food and Drug ActThe Pure Food and Drug Act of June 30, 1906, is a United States federal law that provided federal inspection of meat products and forbade the manufacture, sale, or transportation of adulterated food products and poisonous patent medicines...
- The Federal Import Milk Act (1927)
- The Federal Food Drug and Cosmetic Act of 1938Federal Food, Drug, and Cosmetic ActThe United States Federal Food, Drug, and Cosmetic Act , is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration to oversee the safety of food, drugs, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from...
- The Public Health Service Act (1944)Public Health Service ActThe Public Health Service Act is a United States federal law enacted in 1944. The full act is captured under Title 42 of the United States Code "The Public Health and Welfare", Chapter 6A "Public Health Service"....
- The Fair Packaging and Labeling Act (1966)Fair Packaging and Labeling ActThe Fair Packaging and Labeling Act is a US law that applies to labels on many consumer products. It requires the label to state:*The identity of the product;*The name and place of business of the manufacturer, packer, or distributor; and...
- The Infant Formula Act of 1980
- The Nutrition Labeling and Education Act of 1990Nutrition Labeling and Education ActThe Nutrition Labeling and Education Act is a 1990 United States Federal law. It was signed into law on November 8, 1990 by President George H. W...
- The Dietary Supplement Health and Education Act of 1994
Structure
In 1992 the organization evaluated its structure and concluded that its 20 year old configuration was insufficient to provide proper service in current times. New legislative and budgetary obstacles also fueled the need for change. In response to all of this, the food program joined together its once disconnected scientific and regulatory policies. Rather than being a rigidly centralized organization they separated their various tasks and assigned each to a designated office. Strategic managers assigned issues facing multiple offices at once, while each office is headed by an Office Manager. This allows adequate management on both macro and micro scales.Organization
- Office of Food Labeling
- Office of Seafood
- Office of Cosmetics and Colors
- Office of Plant and Dairy Foods and Beverages
- Office of Special Nutritionals
- Office of Special Research Skills and Support
- Office of Premarket Approval
Personnel
- Executive OfficerExecutive officerAn executive officer is generally a person responsible for running an organization, although the exact nature of the role varies depending on the organization.-Administrative law:...
: Thomas D. Williams, M.B.A - Deputy Director: Charles Sabatos
- Safety Management Staff: Jim Zelinsky
- Division of Planning and Financial Resources Management: Grover G. Heiman III
- Division of Program Services Director: Charles Sabatos (Temporary)
Past directors
- Fred R. Shank, Ph.D.
- Joseph A. Levitt
- Robert E. Brackett, Ph.D.
The Center for Food Safety and Applied Nutrition has over 800 employees with a wide range of job titles. From secretary to molecular chemist
Chemistry
Chemistry is the science of matter, especially its chemical reactions, but also its composition, structure and properties. Chemistry is concerned with atoms and their interactions with other atoms, and particularly with the properties of chemical bonds....
, the Center has an extensive staff that covers every possible aspect of food and nutrition science. In the past, most of the Center's work force was stationed at their headquarters in Washington, D.C., but in 2001 most of the headquarters staff was moved to its new location in College Park, Maryland
College Park, Maryland
College Park is a city in Prince George's County, Maryland, USA. The population was 30,413 at the 2010 census. It is best known as the home of the University of Maryland, College Park, and since 1994 the city has also been home to the "Archives II" facility of the U.S...
.
Mission statement
CFSAN's mission statementMission statement
A mission statement is a statement of the purpose of a company or organization. The mission statement should guide the actions of the organization, spell out its overall goal, provide a path, and guide decision-making...
reads "CFSAN, in conjunction with the Agency's field staff, is responsible for promoting and protecting the public's health
Public health
Public health is "the science and art of preventing disease, prolonging life and promoting health through the organized efforts and informed choices of society, organizations, public and private, communities and individuals" . It is concerned with threats to health based on population health...
by ensuring that the nation's food supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic products
Cosmetics
Cosmetics are substances used to enhance the appearance or odor of the human body. Cosmetics include skin-care creams, lotions, powders, perfumes, lipsticks, fingernail and toe nail polish, eye and facial makeup, towelettes, permanent waves, colored contact lenses, hair colors, hair sprays and...
are safe and properly labeled."
Important regulations established
The Center for Food Safety and Applied Nutrition or CFSAN imposes regulations mainly on corporate entities that create and market foods and drugs. These regulations usually have to deal with products in the pipeline for introduction into the American market. Here is an abbreviated list from the linked page that highlights the most important and influential actions regulation created by the FDA. It also deals with the expansion of the FDA's powers and the creation of the agency itself.- 1906- The original Food and Drug actPure Food and Drug ActThe Pure Food and Drug Act of June 30, 1906, is a United States federal law that provided federal inspection of meat products and forbade the manufacture, sale, or transportation of adulterated food products and poisonous patent medicines...
is passed that mandates strict health safety and testing policies be established mostly in response to the recently publicized meat packing plant scandals, as well as poisonous ingredients that were being added to other products for preservation and "health benefits". The act was a huge step forward in the overall health and safety of the consumer, and laid the groundwork for future consumer advocateConsumer protectionConsumer protection laws designed to ensure fair trade competition and the free flow of truthful information in the marketplace. The laws are designed to prevent businesses that engage in fraud or specified unfair practices from gaining an advantage over competitors and may provide additional...
success.
- 1912- The Shirley Amendment is passes that effectively prohibits false advertisingFalse advertisingFalse advertising or deceptive advertising is the use of false or misleading statements in advertising. As advertising has the potential to persuade people into commercial transactions that they might otherwise avoid, many governments around the world use regulations to control false, deceptive or...
of therapeutic benefits from the use of food/dietary supplement products
- 1958- Food additives Act passed that required companies to predetermine safety of additives and submit them to the FDA for testing
- 1990- Nutrition Labeling and Education ActNutrition Labeling and Education ActThe Nutrition Labeling and Education Act is a 1990 United States Federal law. It was signed into law on November 8, 1990 by President George H. W...
- establishes the modern guidelines for nutritional labeling and inspection
- 2004- Food allergy Labeling act requires companies to label foods with peanuts, soybeans, cows milk, eggs, fish, tree nuts, wheat, and shellfish
Organizations that influence CFSAN
There are two main research groups outside the FDA that have a direct impact on the CFSAN, the Joint Institute for Food Safety and Applied Nutrition, and the National Center for Food Safety and Technology. In addition, there are many interest groups who have a stake in CFSAN's policies.The Joint Institute for Food Safety and Applied Nutrition (JIFSAN) is a partnership between the FDA (specifically, the CFSAN and Center for Veterinary Medicine
Center for Veterinary Medicine
The Center for Veterinary Medicine is a branch of the U.S. Food and Drug Administration that regulates the manufacture and distribution of food, food additives, and drugs that will be given to animals. These include animals from which human foods are derived, as well as food additives and drugs...
(CVM)) and the University of Maryland
University of Maryland, College Park
The University of Maryland, College Park is a top-ranked public research university located in the city of College Park in Prince George's County, Maryland, just outside Washington, D.C...
. JIFSAN was created in 1996 to "provide the scientific basis for ensuring a safe, wholesome food supply as well as provide the infrastructure for contributions to national food safety programs and international food standards." Currently JIFSAN is working on such research as Risk Analysis
Risk analysis (engineering)
Risk analysis is the science of risks and their probability and evaluation.Probabilistic risk assessment is one analysis strategy usually employed in science and engineering.-Risk analysis and the risk workshop:...
, Microbial Pathogens and Toxins, Food Composition and Applied Nutrition, and Animal Health Sciences and Food Safety
Food safety
Food safety is a scientific discipline describing handling, preparation, and storage of food in ways that prevent foodborne illness. This includes a number of routines that should be followed to avoid potentially severe health hazards....
.
The National Center for Food Safety and Technology (NCFST) is a research group between CFSAN, the Illinois Institute of Technology
Illinois Institute of Technology
Illinois Institute of Technology, commonly called Illinois Tech or IIT, is a private Ph.D.-granting university located in Chicago, Illinois, with programs in engineering, science, psychology, architecture, business, communications, industrial technology, information technology, design, and law...
(IIT) and members of the food industry
Food industry
The food production is a complex, global collective of diverse businesses that together supply much of the food energy consumed by the world population...
. NCFST is important because it is "the only center where industry can work collaboratively on projects with FDA scientists on food safety and technology research. Membership in the NCFST allows companies to gain an early insight into emerging food safety issues from the CFSAN perspective to assess the safety of new technologies which may be important for innovation
Innovation
Innovation is the creation of better or more effective products, processes, technologies, or ideas that are accepted by markets, governments, and society...
."
Because CFSAN regulates food safety and labeling, many food industry groups have an interest in their policies. Some of these groups include:
- American Feed Industry Association
- The Association of Food & Drug Officials
- Food Marketing InstituteFood Marketing InstituteThe Food Marketing Institute is an organization that conducts food safety, public affairs, education, research, and industry relations programs for food retailers and wholesalers. FMI's membership consists of approximately 1,500 companies in 50 countries, ranging from large multi-chain stores to...
- Institute of Food TechnologistsInstitute of Food TechnologistsThe Institute of Food Technologists or IFT is an international, non-profit professional organization for the advancement of food science and technology. It is the largest of food science organizations in the world, encompassing 22,000 members worldwide as of 2006. It is referred to as "THE Society...
- National Chicken CouncilNational Chicken CouncilThe National Chicken Council , based in Washington, D.C., is the non-profit trade association representing the interests of the United States chicken industry to the United States Congress and United States federal agencies....
- National Pork Board
- National Turkey FederationNational Turkey FederationThe National Turkey Federation is the non-profit national trade association based in Washington, D.C. representing the turkey industry and its allies and affiliates. NTF advocates for all segments of the turkey industry, providing services and conducting activities which increase demand for its...
- United Fresh Fruit and Vegetable Association
CFSAN is also a partner in the Partnership for Food Safety Education (PFSE), an organization dedicated to educating the public about food safety. The PFSE comprises some federal agencies, such as the CDC
Centers for Disease Control and Prevention
The Centers for Disease Control and Prevention are a United States federal agency under the Department of Health and Human Services headquartered in Druid Hills, unincorporated DeKalb County, Georgia, in Greater Atlanta...
and the EPA
United States Environmental Protection Agency
The U.S. Environmental Protection Agency is an agency of the federal government of the United States charged with protecting human health and the environment, by writing and enforcing regulations based on laws passed by Congress...
, with many members from the food industry.