- Project Spotlight: FDA Commissioning
- What is the FDA State/Local Commissioning and Credentialing Program?
- What authorities are granted by an FDA commission?
- Why are commissions granted?
- How are commissions granted?
- How do I learn more about the commissioning program?
- Commissioning Program Fact Sheet (Version April 2023)
Project Spotlight: FDA Commissioning
What is the FDA State/Local Commissioning and Credentialing Program?
The Commissioning Program was developed to make inter-agency cooperation more effective and, hence, increase the amount of protection afforded to the American consumer. As authorized under the Federal Food, Drug, and Cosmetic Act (FDCA), state and local officials perform specifically designated functions on behalf of FDA and acting as FDA officials.
An officer or employee of a state, territory, tribe or a political subdivision thereof can be commissioned as an officer of the Department of Health and Human Services/FDA. For more information on Commissioning including the Commission application and renewal process see: Regulatory Procedures Manual, Chapter 3, Subchapter – Commissioning, Work Sharing, and Information Sharing.
What authorities are granted by an FDA Commission?
Authorized by 702(a) of the FDCA, an FDA Commission enables a state or local public health official to conduct inspections and examinations on behalf of FDA under the authority of the FDCA. This includes the receipt of FDA-owned non-public information for use for their work with the FDA, as well as disclose that information to other commissioned officials with a need to know the information and FDA employees in order to protect the public health. Although they may receive the information for situational awareness, commissioned officials are not allowed to use any non-public information received for state regulatory or enforcement actions. Commissioned officials are the nexus of the invaluable partnership between the FDA and our state and local counterparts.
Commissioned employees with credentials: May conduct inspections and collect samples under the FDCA even if the official’s own state/local laws do not provide such authority. Such inspections are generally in furtherance of a cooperative agreement or contract with FDA. When commissioned officials conduct inspections under the FDCA, they are acting as FDA officials and therefore any associated records are FDA rather than state records.
Employees with a certificate of commission only: May review and receive certain pieces of FDA information usually considered confidential and not releasable to the general public for their work with the FDA.
Why are commissions granted?
Commissions are primarily granted for the purposes of work sharing. To learn more about information sharing vehicles, contact the Division of Information Disclosure Programs at ORAinfoshare@fda.hhs.gov for most cases.
How are commissions Granted?
To seek a commission for tobacco retail compliance, contact FDA’s Center for Tobacco Products at CTPTrainer@fda.hhs.gov. To seek a commission for all other commodities, contact your FDA District Office and/or State Liaison.
How do I learn more about the Commissioning Program?
The specific operational details of the mechanics of the commissioning process may be found in the Regulatory Procedures Manual, Chapter 3, Subchapter – Commissioning, Work Sharing, and Information Sharing.
Contact the OP commissioning/credentialing program: Statecommissioning@fda.hhs.gov