FDA and State Counterparts (Food)
To help facilitate human and animal food safety programs, the FDA strives to maintain strong working relationships with state counterparts, thereby embodying the concept of domestic mutual reliance. This is accomplished through information sharing, reliance on state inspections and investigations, and compliance activities.
Multiple staff within FDA work with our partners to achieve domestic mutual reliance. Below are descriptions of some of those roles.
| FDA Employee Role | General Description |
|---|---|
| Program Division Director | Oversees all field operations within a Division |
| Director of Compliance | Oversees all compliance, enforcement and recall operations within a Division |
| Director of Investigations | Oversees all inspectional and investigational operations within a Division |
| Recall Coordinators | Manage firm recalls |
| Consumer Complaint Coordinators | Manage consumer complaints |
| State Liaisons | Serve as primary contact for state cooperative agreements, contracts, information sharing, general inquiries, AFPRS, MFRPS, Produce Safety Grant, and Tissue Residue Grant |
| Emergency Response Coordinators | Serve as primary contact for emergencies and outbreaks; work closely with FDA Coordinated Outbreak Response Network (CORE) |
| Compliance Officers | Review inspections, investigations, firm responses, and sample results to develop strategies that facilitate the oversight of corrective actions at firms that are deemed to be out of compliance |
| Investigators | Conduct inspections, investigations, and sample collections |
An establishment inspection is an official examination of a facility to determine its compliance with the laws and regulations administered by the FDA. The FDA investigator conducts the establishment inspection at any reasonable time and in a reasonable manner. The inspection covers the establishment’s facilities, equipment, processes, products, and records as necessary to determine compliance with the U.S. Code of Federal Regulations and the Federal Food, Drug, and Cosmetic Act. It may be initiated with or without notice and ordinarily is conducted during regular business hours. The investigators use the Investigations Operations Manual, or IOM, as a reference guide for procedures and inspectional activity information. The specific Compliance Programs, assignments, and the investigator’s supervisor define the scope of the investigation. FDA investigators conduct both domestic and international inspections.
Additional Resources
Recalls are actions taken by a firm to remove a product from the market. They may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority.
Additional Resources
- Recalls of Foods & Dietary Supplements
- Recalls (FDA Data Dashboard)
- OII Recall Coordinators
- Reportable Food Registry for Industry
- Recalls, Market Withdrawals, & Safety Alerts
- Recall Resources
The FDA welcomes reports from consumers alerting the agency to problems with FDA-regulated products. These reports help ensure that products on the market are safe and properly manufactured, labeled, and stored. Every report is important to FDA. In each case, the FDA evaluates the information the consumer provides to determine how serious the problem is and what follow-up is needed.
Additional Resources
- SmartHub Portal for reporting on an FDA-regulated product
- MedWatch: The FDA Safety Information and Adverse Event Reporting Program
- Consumer Products Complaint System
- How to Report Product Problems and Complaints to the FDA
Rapid Response Teams, or RRTs, are multi-agency, multi-disciplinary teams that operate using Incident Command System/National Incident Management System principles and a Unified Command structure to respond to human and animal food emergencies. RRTs work together to minimize the time between FDA notification of an emergency and implementation of control measures, and they are a key component of domestic mutual reliance.
The FDA works with states to bring non-compliant firms into compliance. States can immediately embargo product if FDA inspections finds adulterated product. States can act quickly when adulterated product is found using their own authorities such as embargoes, stop/sale powers, and/or licensing and registration suspension. FDA can seize adulterated product and enjoin firms when egregious conditions are found.
FDA contracts with states to perform inspections within the human and animal food industry. When doing so, state counterparts help complete annual workplan assignments. Their assistance helps alleviate the inspectional burden of FDA employees by leveraging resources.
State employees assisting with FDA workplan accomplishments are commissioned or credentialed. State liaisons monitor the status of commissioning or credentialing.