In the United States, the FDA is the agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices, as well as food supply, cosmetics, and products that emit radiation.
Objective:
To ensure the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.
To regulate the production and distribution of tobacco products and monitor their effects on public health.
To protect public health by ensuring that foods are safe, wholesome, sanitary, and properly labeled.
To advance public health by helping to speed innovations in the food, drug, and cosmetic industries.
Functions:
1. Regulatory Oversight:
Oversees the manufacturing, marketing, and distribution of food products (excluding certain meat, poultry, and processed egg products, which are under USDA jurisdiction).
Ensures that food products are safe, sanitary, and correctly labeled according to federal standards.
2. Food Safety Modernization:
Implements the Food Safety Modernization Act (FSMA) to focus on preventing contamination rather than just responding to it.
Requires food facilities to implement preventive controls and increases the frequency of inspections.
3. Evaluation and Approval:
Evaluates and approves new food additives, packaging materials, and drugs before they enter the market.
Regulates genetically engineered foods to ensure they are safe for consumption.
4. Monitoring and Enforcement:
Monitors the safety of the current food and drug supply.
Conducts inspections of food processing facilities.
Takes enforcement actions against facilities or products that violate laws, including initiating recalls of unsafe or mislabeled products.
5. Research and Development:
Conducts and supports research to improve safety standards.
Develops new testing methods for food safety and nutrition.
Specialized Program Centers
The FDA is organized into several specialized program centers responsible for safeguarding public health:
1. Office of Regulatory Affairs
Enforces the FDA's laws and regulations to protect consumers and enhance public health.
2. Center for Food Safety and Applied Nutrition (CFSAN)
Focuses on ensuring the safety and nutritional quality of the food supply.
3. Center for Drug Evaluation and Research (CDER)
Evaluates new drugs before they can be sold and monitors drugs' safety after they are on the market.
4. Center for Biologics Evaluation and Research (CBER)
Responsible for regulating biological products, including vaccines, blood products, and gene therapies.
5. Center for Veterinary Medicine (CVM)
Ensures the safety of animal drugs, feeds, and related products.
6. National Center for Toxicological Research (NCTR)
Conducts research to support the FDA's mission, focusing on the toxicological aspects of products regulated by the FDA.