U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
January 1998

Inside FDA:
Center for Food Safety and Applied Nutrition

The Center for Food Safety and Applied Nutrition (CFSAN), 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.

CFSAN is one of six centers within FDA. With a work force of about 800, the center promotes and protects the public health and economic interest by ensuring that:

• Food is safe, nutritious and wholesome, and cosmetics are safe.
• Food and cosmetics are honestly, accurately and informatively labeled.

Recent center activities demonstrate the center's commitment. For example, in approving olestra as the first synthetic fat-based fat substitute, the center's scientific staff evaluated more than 150 studies on olestra's safety. Concerned about olestra's potential ability to reduce nutrient absorption in the body, the center approved olestra on the conditions that vitamins A, D, E, and K be added to olestra-containing foods and that a statement appear on such foods to inform consumers of possible nutrient losses and thus the reason for the addition of the fat-soluble vitamins. The center also requires the statement to warn consumers about the possible side effects of abdominal cramping and loose stools.

A Sampling of Highlights

Examples of other more recent center actions include:

• revamping food labels to make it easier for consumers to get nutrition information about the foods they eat
• approving certain health claims supported by scientific evidence showing a link between a food or nutrient and a disease or health condition. These health claims can be used in food labeling.
• requiring warning labels on iron-containing drugs and dietary supplements and individual-dose packaging for products with 30 milligrams or more of iron per unit to protect children from accidental iron poisoning, a leading cause of death in children under 6
• establishing new regulations based on modern food safety techniques to improve seafood safety
• issuing regulations calling for folic acid fortification of enriched grain products by 1998 to reduce the chances of certain birth defects in infants
• signing an agreement with the University of Maryland to form the Joint Institute for Food Safety and Applied Nutrition, paving the way for both organizations to pool specialized knowledge, equipment and facilities.

Employees ranging from secretaries and other support staff to highly specialized professionals--such as chemists, microbiologists, toxicologists, food technologists, pathologists, pharmacologists, nutritionists, epidemiologists, mathematicians, and sanitarians--carry out the center's mission.

The center is divided into seven offices dealing with:

• cosmetics and colors
• food labeling
• plant and dairy foods and beverages
• premarket approval
• seafood
• special nutritionals, such as dietary supplements and infant formula
• special research skills and support.

Most center staff members work out of the center's headquarters in Washington, D.C. The center also operates research facilities in Laurel, Md., and a fisheries research center in Dauphin Island, Ala., and helps staff the National Center for Food Safety and Technology in the Chicago area.

In Touch with Others

Much of the information evaluated by center personnel is gathered by FDA employees across the country. For example, FDA field investigators inspect food and cosmetic companies, examine food shipments from abroad, and collect samples. Laboratory scientists and technicians analyze samples. Compliance officers recommend legal action and follow through on enforcement issues.

Center personnel also work with other government agencies, such as the Centers for Disease Control and Prevention and state health departments, to resolve food safety concerns and economic fraud cases, for example.

The center is increasingly being called on to work with international organizations, such as the Codex Alimentarius Commission--an international food standard-setting organization of the Food and Agriculture Organization and World Health Organization--and foreign governments, to help establish internationally recognized safety standards, rules and regulations for imported foods.

In the past, most of the center's efforts dealt with U.S. products. But that's changing as a result of recent international treaties. Now, more and more food is traveling in international circles.

Future Considerations

Other areas that will increasingly draw the center's attention are:

• Foods derived from genetic engineering. The first of these on the market, the Flavr Savr tomato, can be shipped vine-ripened, thus improving texture and flavor. Future possibilities include insect-resistant apples, long-lasting raspberries, and potatoes that absorb less fat.
• New packaging materials. These include recycled products and those that prolong shelf life.
• The hazard analysis critical control point (HACCP) food safety system. HACCP is considered more effective than the current system because it focuses on preventing problems rather than reacting to them after they've occurred. FDA is considering whether to make HACCP mandatory for all of the food industry it regulates.
• Food adulteration for economic gain.
• The center is eyeing several proposals to see how to increase the pace of its review of new food additives without jeopardizing public safety.

Considering that almost 20 cents of every consumer dollar Americans spend goes to food and cosmetics, these and other concerns for the Center for Food Safety and Applied Nutrition eventually come to rest with American consumers. Center dealings that make news one day, such as the approval of olestra, usually make it to the marketplace another.

Computer users can keep up-to-date on CFSAN activities on the World Wide Web at http://www.cfsan.fda.gov/.

Center Director

While in the Commissioner's office, Levitt was instrumental in launching the nutrition labeling program and in speeding the availability of new drugs for desperately ill patients. At the Center for Radiological Health, he has had major responsibility for developing the Agency's mammography quality standards program and implementing the Safe Medical Devices Act of 1990.

Mr. Levitt is a magna cum laude graduate of Cornell University. He graduated cum laude with a J.D. from Boston University. He has received numerous awards including the Presidential Meritorious Executive Rank Award in 1992.

Additional background information on FDA's Center for Food Safety and Applied Nutrition

FDA Almanac: CFSAN or all of FDA