The center is responsible for promoting and protecting the public's health and economic interest 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 center oversees a vast food industry that includes more than 30,000 U.S. food manufacturers and processors and over 20,000 food warehouses. 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.

In FY 1996, FDA spent over $221 million on food and cosmetic safety activities. The center's primary responsibilities include:

• the safety of food and color additives
• seafood Hazard Analysis Critical Point (HACCP) regulations
• regulatory and research programs to address health risks associated with foodborne chemical and microbiological contaminants
• regulations and activities dealing with the proper labeling of foods (e.g., ingredients, health claims)
• 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

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FDA is responsible for ensuring the safety and wholesomeness of all food sold in interstate commerce, except for meat and poultry, which are under the jurisdiction of the U.S. Department of Agriculture. 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. Since a growing proportion of the American food supply is imported, CFSAN also works 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 concernfor food safety are:

• microbiological pathogens (bacteria, viruses, parasites)
• natural 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
• potential allergens (e.g., sulfites, peanuts, eggs)
• nutrient concerns (e.g., vitamin D overdose, pediatric iron toxicity)
• dietary components (e.g., fat, cholesterol)
• radionuclides
• product tampering
• biotechnological changes

FDA's Tools for Ensuring Food Safety

• inspection of establishments
• collection and analysis of samples
• premarket approval review (food and color additives and animal drugs)
• regulation/agreement writing
• consumer education
• laboratory studies
  • develop/improve analytical methods
  • determine health effects of food contaminants
  • determine effects of processing on food composition
  • determine health effects of dietary factors
• pilot plant food processing and packaging and biotechnology studies
• cooperative activities/technical assistance
• collection and analysis of information

Microbiological Safety

A major food safety problem confronting the nation--which every American can help prevent through safe food-handling practices--is food contamination by microbial pathogens such as:

• Salmonella enteritidis
• Campylobacter jejuni
• Listeria monocytogenes
• Vibrio vulnificus
• Escherichia coli O157:H7
• Cyclospora cayetanensis

Escherichia coli is no longer considered a benign bacterial indicator of fecal contamination. Certain types of E. coli can be deadly. E. coli O157:H7 can cause hemolytic uremic syndrome, a life-threatening illness, particularly in children. Cyclospora cayetanensis is a parasitic protozoa that causes a long-lasting diarrhea. Outbreaks of cyclosporiasis are relatively recent occurrences in the United States and have been associated with imported fruit.

Recent Microbiological Safety Activities:

• FDA sponsored a Cyclospora workshop in August 1996, in response to a number of illness outbreaks in the United States and one in Canada caused by Cyclospora cayetanensis. Participants from FDA, USDA, EPA, CDC, state governments, and academia exchanged scientific information and discussed coordinated approaches to developing and improving analytical techniques for the rapid and sensitive detection of Cyclospora in foods and environmental samples, and identified areas of research needed to prepare for future outbreaks.
• Following an outbreak of E. coli O157:H7 in apple juice, FDA in conjunction with CDC, academia and industry held a two-day public meeting to receive public input on the safety of fruit and vegetable juices and to determine if FDA's regulatory program for fresh juice and juice products needs to be revised. Topics discussed included the details of juice-associated food-borne illnesses, farm-to-consumer production practices, methods to control the presence of pathogenic organisms in juices, and the economics of the juice industry.
• FDA conducted extensive ongoing research in the area of microbiological safety in 1996, including mechanisms of pathogenicity of food-borne microorganisms, immune responses to antigens of food-borne bacterial pathogens associated with post-infectious autoimmune conditions, adherence, invasion, and intracellular survival of Salmonella spp. in tissue cultures, detection and identification of novel forms of Vibrio and E. coli, detection methods to assess the presence of Listeria in food, pathogenesis of and detection methods for Campylobacter jejuni, food poisoning effects of staphylococcal enterotoxins using animal models, specific virulence gene sequences for Vibrio spp. and Salmonella enteritidis.

Chemical Safety

The mission of chemical safety projects in CFSAN is to ensure the safe and proper use of food and color additives, and to ensure that consumers are protected against any potential health risk posed by pesticides, chemical contaminants, and natural toxins in the food supply. Major activities include food and color additive petition review, the monitoring of pesticide residues and the regulation of industrial chemicals and natural toxins in foods, and the evaluation of risk associated with hazardous substances in the food supply.

Food and Color Additive Petitions

The Food Additive Amendment of 1958 to the Food, Drug, and Cosmetic Act requires the premarket clearance of food ingredients whose safety is not generally recognized or whose regulatory status was not sanctioned by FDA or USDA prior to 1958. The use of a new food additive is prohibited until its sponsor establishes its safety and FDA issues a regulation specifying conditions of use. The law also created a generally recognized as safe (GRAS) category to free FDA and industry from the burden of testing numerous substances that had been used extensively over many years with no known harmful effects. Because GRAS items are not legally food additives, they do not require food additive approval from FDA. Manufacturers, however, may petition FDA to affirm a substance as GRAS.

The Color Additive Amendments of 1960 require the premarket clearance of color additives in foods, drugs, cosmetics, and some devices. Similar to food additives, the use of a new color additive in a food, drug, or cosmetic is prohibited until the sponsor establishes safety for intended use and FDA issues a regulation specifying conditions of use.

Any interested party may request an authorizing regulation establishing safe conditions of use for a food or color additive by submitting a petition to FDA with the data showing that use of the substance is safe. Each petition is evaluated for adequacy of the data submitted by the petitioner. FDA then announces in the Federal Register that a food or color additive petition has been filed. If a petition establishes an adequate basis for finding that use of a substance is safe, the agency publishes a regulation prescribing safe conditions of use in the Federal Register. CFSAN also will reassess the safety of a previously approved additive if new scientific evidence raises questions about its safety. These substances are removed from the market if they are shown to be unsafe.

Recent food and color additives actions include:

• January 1996, FDA approved Olestra, a fat-based substitute for conventional fats developed by Procter and Gamble, Co. Olestra has properties similar to those of naturally occurring fat. However, it provides no calories or saturated fat.
• FDA continued reforms to the premarket approval process for food and color additives, including modernizing electronic information processing and initiating extramural contracts. Two of these contracts were for third-party reviews of scientific studies submitted in support of petitions.

Research and Monitoring for Pesticides and Contaminants

FDA conducts an active research and monitoring program to ensure the safety of the food we eat. FDA uses a "Total Diet Study" to assess daily dietary intakes of pesticides, PCBs, toxic elements, and radionuclides, and develops databases and computer programs to provide reports of pesticide and contaminant monitoring.

Examples of ongoing research conducted in 1996 include methods for detecting the presence of pesticides in food and toxic elements in tableware; improvements in thermal processing technology; methods for analyzing processed dairy products for antibiotic residues, mycotoxins, and biogenic amines; development of more efficient and practical approaches to monitor dioxin and furan residues in food; studies on the safety of packaging materials and the effects of processing temperature and time on the safety of processed foods.

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Diet plays a major role in certain diseases of public health importance. Consequently, the nutritional quality of the U.S. diet, including conventional foods, dietary supplements, and other special nutritional products, must be viewed as an important food safety and public health issue. Special nutritional foods, such as infant formula and medical foods, are particularly significant because they are consumed by highly vulnerable populations. CFSAN helps promote public health by ensuring food labeling is informative, honest and accurate, promoting improved nutrient quality of foods and developing information on improved dietary practices.

Food Labeling

The accuracy of nutrition information on food labels has increased over the past two years. A recent FDA survey compared label information with

FDA has taken several steps to improve the quality and usefulness of food product information, including:

• regulations requiring that restaurants have a reasonable basis for nutritional claims on menus.
• a March 1996 final rule authorizing the use of a health claim associating an adequate dietary intake of folic acid and the reduced
• a final rule authorizing food label of health claims on the association between sugar alcohols and the non-promotion of dental ca
• a final rule on the association between soluble fiber from rolled oats and oat bran and a reduced risk of coronary heart disease
• a proposed rule to permit digestibility factors to be used in estimating the amount of available fat as a basis for a health claim.

Special Nutritionals

A major part of CFSAN's public health mission is the assurance of the safety of foods for special nutritional products such as infant formulas and medical foods. The Dietary Supplement Health and Education Act of 1994 (DSHEA) altered significantly the way FDA regulated dietary supplements. DSHEA defines a "new dietary ingredient" and establishes circumstances under which such products can be safely used in dietary supplements. The DSHEA places the burden on FDA to prove that a product presents a significant or unreasonable risk of illness or injury under the label's conditions of use before it can be removed from the marketplace.

Examples of recent activities in this area include:

• a proposed rule on Infant Formula Good Manufacturing Practices
• a warning to consumers not to purchase or consume ephedrine-containing dietary supplements with labels portraying the products as apparent alternatives to illegal street drugs such as "Ecstasy," because these products pose a significant health risk to consumers.

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FDA estimates that over 40,000 cosmetic product formulators are being produced in more than 1,600 domestic manufacturing and repacking establishments. Consumer expenditures for cosmetic products exceed $20 billion annually. The cosmetics industry uses about 7,500 different cosmetic ingredients and about 4,000 fragrance ingredients.

CFSAN is responsible for the safety and proper labeling of domestically manufactured and imported cosmetics. Activities to support this responsibility include:

• evaluation of cosmetic-related adverse reactions
• dermal tests for toxicity and absorption of colors and cosmetics
• safety research on photo effects of cosmetic ingredients
• safety research on cosmetic ingredients and contaminants
• safely research and analytical methods development for cosmetic ingredients and preservative systems.

Current work in the area of cosmetics include adverse reaction monitoring, drug-cosmetics enforcement, use of alpha hydroxy acids (AHA)

The Center has also launched a toll-free Cosmetic Automated Information Line where consumers may obtain information about cosmetics 24 hours

In addition, CFSAN is responsible for the certification of colors and to assure that certified colors are used in FDA regulated commodities

• proposed permanent listing for color additive lakes in the Federal Register
• certified over 12 million pounds of color during FY 1996
• analyzed over 4,500 certification and surveillance samples
• developed new methods for the analysis of certified colors
• collected and analyzed audit samples
• analyzed samples to assure the integrity of certification analyses.

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The agency is beginning to develop and implement new and innovative strategies to reduce food-borne illness and improve the safety of the food supply that are efficient and effective, but less resource intensive. These strategies will include federal, state, and local public health and regulatory officials, food processors and manufacturers, retail food service, academic scientists, and consumer representatives. Recent collaborative activities include:

• A letter of agreement in March 1996 with the University of Maryland's Center for Marine Biotechnology, to create a new molecular biology and seafood safety research facility at the Columbus Center, Baltimore, Md. Research at this new facility is expected to result in the development of advanced methods for the detection of pathogens in the food supply.
• Signed a Memorandum of Understanding (MOU) in April 1996 with the University of Maryland, establishing the Joint Institute for Food Safety and Applied Nutrition, a partnership committed to the pursuit of high quality research, education, and outreach in support of food science. The institute will combine the resources and expertise of academia and government and function as a jointly administered, multidisciplinary research program. Through this program, internationally renowned scientists from both organizations will share their specialized knowledge, equipment and facilities to promote scientific advances in the fields of food safety, nutrition and regulation. Included will be studies on food pathogens, contaminants, risk assessment, nutritional analyses, food labeling, consumer behavior and other research to expand the scientific bases of FDA's food programs. A groundbreaking ceremony was held on Sept. 24, 1996 for FDA's $84 million facility to consolidate CFSAN and Center for Veterinary Medicine staff now scattered at numerous sites around the region. The facility is expected to be open by the year 2001.
• Aseptic processing is a food industry tool currently used to control the growth of hazardous microorganisms and to increase shelf life and freshness of packaged food products. In 1996, the agency held workshops on aseptic processing with technical experts from more than 23 different food industries, 16 universities, FDA, the National Food Processors trade association, and the U.S. Army identified methods to scientifically establish the effectiveness of this food processing technology.

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