The U S. Food and Drug Administration is a scientific, regulatory, and public health agency that oversees items accounting for 25 cents of every dollar spent by consumers. Its jurisdiction encompasses most food products (other than meat and poultry), human and animal drugs, therapeutic agents of biological origin, medical devices, radiation-emitting products for consumer, medical, and occupational use, cosmetics, and animal feed.
The agency grew from a single chemist in the U.S. Department of Agriculture in 1862 to a current staff of over 9,000 employees and a budget exceeding of $1 billion. The agency now employs chemists, pharmacologists, physicians, microbiologists, veterinarians, pharmacists, lawyers, and many others. About one-third of the agency's employees are stationed outside of the Washington, D. C. area, staffing over 150 field offices and laboratories, including five regional offices and 20 district offices.
Agency scientists evaluate applications for new human drugs and biologics, complex medical devices, food and color additives, infant formulas, and animal drugs. Also, the FDA monitors the manufacture, import, transport, storage, and sale of about $1 trillion worth of products annually at a cost to taxpayers of about $3 per person. Investigators and inspectors visit more than 16,000 facilities a year, and arrange with state governments to help increase the number of facilities checked.
The FDA works with state and local agencies to establish food safety standards for food products produced within state borders and to stop the sale of unsafe products made within the 50 states. State and local agencies assist in recalls for food products produced within state borders and inspect local retail and manufacturing facilities. State and local governments also monitor retail food stores and restaurants.
FDA recalls are categorized into one of three classes according to the level of hazard involved.
- Class I recalls are for dangerous or defective products that predictably could cause serious health problems or death. Examples of products that could fall into this category are a food found to contain botulinal toxin, food with undeclared allergens, a label mix-up on a life saving drug, or a defective artificial heart valve.
- Class II recalls are for products that might cause a temporary health problem, or pose only a slight threat of a serious nature. One example is a drug that is under-strength but that is not used to treat life-threatening situations.
- Class III recalls are for products that are unlikely to cause any adverse health reactions but still violate Federal safety regulations. Examples might be a container defect (plastic material delaminating or a lid that does not seal); off-taste, color, or leaks in a bottled drink, and lack of English labeling in a retail food.