Center for Food Safety and Applied Nutrition ΓΈ Calorie Counter
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Center for Food Safety and Applied Nutrition

The Center for Food Safety and Applied Nutrition (CFSAN) is the branch of the Food and Drug Administration (FDA) which regulates food, dietary supplements, and cosmetics.

"Food" within the context of FDA is a very broad term with some limitations. Products that contain meat are regulated by the USDA's Food Safety and Inspection Service, 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 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). 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.


Consumers spend twenty-five cents of every consumer dollar on products regulated by the FDA. Of this amount, approximately 75 percent is spent on foods. The Center regulates $240 billion worth of domestic food, $15 billion worth of imported foods, and $15 billion worth of cosmetics sold across state lines. This regulation takes place from the products' point of U.S. entry or processing to their point of sale, with approximately 50,000 food establishments (includes more than 30,000 U.S. food manufacturers and processors and over 20,000 food warehouses) and 3,500 cosmetic firms. These figures do not include the roughly 600,000 restaurants and institutional food service establishments and the 235,000 supermarkets, grocery stores, and other food outlets regulated by state and local authorities that receive guidance, model codes, and other technical assistance from FDA. FDA enhances its programs by supporting state and local authorities with training and guidance to ensure uniform coverage of food establishments and retailers.

The economic importance of the American food industry is enormous. It contributes about 20 percent of the U.S. Gross National Product, employs about 14 million individuals, and provides an additional 4 million jobs in related industries.

The Center's primary responsibilities include:

  • The safety of substances added to food, e.g., food additives (including ionizing radiation) and color additives
  • The safety of foods and ingredients developed through biotechnology
  • Seafood Hazard Analysis and Critical Control Point (HACCP) regulations
  • Regulatory and research programs to address health risks associated with foodborne chemical, and biological contaminants
  • Regulations and activities dealing with the proper labeling of foods (e.g., ingredients, nutrition health claims) and cosmetics
  • Regulations and policy governing the safety of dietary supplements, infant formulas, and medical foods
  • Safe and properly labeled cosmetic ingredients and products
  • Food industry postmarket surveillance and compliance
  • Consumer education and industry outreach
  • Cooperative programs with state and local governments
  • International food standard and safety harmonization efforts
Although the U.S. food supply is among the world's safest, the increase in variety of foods and the convenience items available has brought with it public health concerns. The complexity of the food industry, and the technologies used in food production and packaging, is increasing. Because a growing proportion of the American food supply is imported, CFSAN also works with international organizations (WHO, FAO, Codex) and occasionally directly with foreign governments to ensure their understanding of U.S. requirements and to harmonize international food standards.

Sources of food contamination are almost as numerous and varied as the contaminants themselves. These include everything from preharvest conditions to contamination introduced during processing, packaging, transportation, and preparation. Some of CFSAN's current areas of food safety concern are:

  • Biological pathogens (e.g., bacteria, viruses, parasites)
  • Naturally occurring toxins (e.g., mycotoxins, ciguatera toxin, paralytic shellfish poison)
  • Dietary supplements (e.g., ephedra)
  • Pesticide residues
  • Toxic metals (e.g., lead, mercury)
  • Decomposition and filth (e.g., insect fragments)
  • Food allergens (e.g., eggs, peanuts, wheat, milk)
  • Nutrient concerns (e.g., vitamin D overdose, pediatric iron toxicity)
  • Dietary components (e.g., fat, cholesterol)
  • Radionuclides
  • TSE-type diseases (e.g., chronic wasting disease in elk)
  • Product tampering

FDA's Tools for Ensuring Food Safety

  • Inspection of establishments
  • Collection and analysis of samples
  • Monitoring of imports
  • Premarket review (e.g., food and color additives)
  • Notification programs (e.g., food contact substances, infant formula)
  • Regulations/agreements (e.g., memoranda of understanding)
  • Consumer studies, focus groups
  • Laboratory research
  • Develop/improve methods for detecting pathogens and chemical contaminants in food
  • Determine health effects of food contaminants
  • Determine effects of processing on food composition
  • Determine health effects of dietary factors
  • Investigate factors that contribute to virulence of biological contaminants
  • Pilot plant for food processing and packaging and biotechnology studies
  • Cooperative activities/technical assistance
  • Collection and analysis of information
  • Stakeholder awareness through education and public meetings
  • Information and outreach on Center activities


The Center has over 800 employees, who range from secretaries and other support staff to highly specialized professionals - such as chemists, microbiologists, toxicologists, food technologists, pathologists, molecular biologists, pharmacologists, nutritionists, epidemiologists, mathematicians, and sanitarians.

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