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.
Scope of Responsibility
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 $417 billion worth of domestic food, $49 billion worth of imported foods, and over $60 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. There are over 377,000 registered food facilities (including approximately 154,000 domestic facilities and 223,000 foreign facilities) that manufacture, process, pack, or hold food consumed by humans or animals in the United States and several thousand cosmetic firms. These figures do not include restaurants, institutional food service establishments, or supermarkets, grocery stores, and other food outlets regulated by state, local, and tribal authorities that receive guidance, model codes, and other technical assistance from FDA. FDA enhances its programs by supporting these authorities with training and guidance to direct 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.
FDA's responsibility in the food area generally covers all domestic and imported food except meat, poultry, and frozen, dried and liquid eggs, which are under the authority of the U.S. Department of Agriculture (USDA's Food Safety and Inspection Service (FSIS), the labeling of alcoholic beverages (above 7% alcohol) and tobacco, which are regulated by the U.S. Department of the Treasury's Alcohol and Tobacco Tax and Trade Bureau (TTB), and the U.S. Environmental Protection Agency (EPA), which establishes tolerances for pesticide residues in foods and requirements for drinking water.
FDA’s responsibility in the area of cosmetics covers all domestic and imported products.
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 and juice 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)
- regulations and policy governing the safety of dietary supplements, infant formulas, and medical foods
- food industry postmarket surveillance and compliance
- industry outreach and consumer education
- cooperative programs with state, local, and tribal governments
- international food standard and safety harmonization efforts
- regulations and policy governing the safety of cosmetic ingredients and finished products
- regulations, policy, and other activities dealing with proper labeling of cosmetics
- regulatory and research programs to address possible health risks associated with chemical or biological contaminants
- post-market surveillance and related compliance activities
- industry outreach and consumer education
- international standard-setting and harmonization efforts
Although the U.S. food supply is among the world's safest, the increase in variety of foods and 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.
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
- pesticide residues
- toxic metals (e.g., lead, mercury)
- decomposition (e.g. histamine formation) and filth (e.g., insect fragments)
- food allergens (e.g., milk, eggs, peanuts, tree nuts, soybeans, wheat, fish, shellfish)
- nutrient concerns (e.g., vitamin D overdose, pediatric iron toxicity)
- dietary components (e.g., fat, cholesterol)
- Transmissible Spongiform Encephalopathy-type diseases (e.g., chronic wasting disease in elk)
- product tampering
As with foods, the complexity of the cosmetic industry and the technologies and ingredients used in production of cosmetics is increasing. The increase in global trade of cosmetics has also increased the challenges in a number of areas, as products and ingredients are entering the U.S. from a wide variety of countries with different regulatory frameworks and safety standards. Some of the current areas of focus for cosmetics include:
- microbiological contaminants
- chemical contaminants
- drug vs. cosmetic products
- use of nanoscale materials as ingredients
- botanical ingredients
- alternatives to animal testing
FDA's regulatory authority for food and cosmetics comes from:
- The Federal Food and Drugs Act of 1906
- The Federal Import Milk Act (1927)
- The Federal Food, Drug, and Cosmetic Act of 1938, as amended
- The Public Health Service Act (1944)
- The Fair Packaging and Labeling Act (1966)
- The Infant Formula Act of 1980, as amended
- The Nutrition Labeling and Education Act of 1990
- The Dietary Supplement Health and Education Act of 1994
- Food Allergen Labeling and Consumer Protection Act of 2004
- Food and Drug Administration Amendments Act of 2007
- Other Related Statutes
FDA's Tools for Protecting the Food and Cosmetic Supplies
- inspection of establishments
- collection and analysis of samples
- monitoring of imports
- monitoring of adverse event reports and consumer complaints
- 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 and cosmetics
- determine health effects of food and cosmetic contaminants
- determine effects of processing on food composition and allergenicity
- determine health effects of dietary factors
- investigate factors that contribute to virulence of biological contaminants
- determine skin penetration of cosmetic ingredients and contaminants
- pilot plant for food processing and packaging and biotechnology studies
- cooperative activities/technical assistance
- issuance of model codes and guidance documents
- stakeholder awareness through education and public meetings
- information and outreach on Center activities
Because a growing proportion of the American food and cosmetic supplies is imported, CFSAN also works with international organizations (World Health Organization, Food and Agriculture Organization of the United Nations, Codex Alimentarius Commission, International Cooperation on Cosmetic Regulation) and occasionally directly with foreign governments to educate them on U.S. requirements and to harmonize international standards. The Center is increasingly 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 (FAO) and the World Health Organization (WHO)--and foreign governments, to help establish internationally recognized safety standards, rules and regulations for imported products. In the past, most of the Center's standard-setting efforts dealt with U.S. products, but that is changing as a result of recent international treaties and the increasing amount of food and cosmetics that is moving in international commerce.
Collaboration with Other Federal and Local Authorities
FDA maintains close communications with these and other federal agencies such as the U.S. Department of Commerce's National Marine Fisheries Service; the Centers for Disease Control and Prevention (CDC), the U.S. Department of Treasury's U.S. Customs and Border Protection; the Federal Trade Commission (FTC), the U.S. Department of Transportation (DoT), the Consumer Product Safety Commission (CPSC) and the U.S. Department of Justice (DoJ). In many instances, FDA has interagency agreements with them to delineate respective responsibilities.
FDA regulates food and cosmetic products sold in interstate commerce, whereas products made and sold entirely within a state are regulated by that state. Center personnel work with state agriculture and health departments, to resolve food or cosmetic safety concerns and economic fraud cases, for example.
Collaboration with Academia and Industry
The Center is actively involved in high-visibility endeavors with several academic institutions through its Centers of Excellence (COE) program. These collaborations yield critical information that enhances our on-going efforts to protect the food supply. CFSAN has four COEs, the National Center for Food Safety and Technology (NCFST) with the Illinois Institute of Technology; the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) with the University of Maryland; the FDA COE for Botanical Dietary Supplement Research at the National Center for Natural Products Research (NCNPR), University of Mississippi; and the Western Center for Food Safety (WCFS) with the University of California at UC, Davis. In addition, formal agreements with the states for conducting inspections enhance the Center's ability to meet its public health mission.