The U.S. Food & Drug Administration (FDA) hosted Part 1 of a 4-part webinar series on Friday, October 21, 2022 at 2 pm ET to provide more in-depth information about the details outlined in the Infant Formula Transition Plan for Exercise of Enforcement Discretion and address questions.
The guidance outlines a pathway for manufacturers of infant formula under enforcement discretion to market infant formula products that may not currently comply with specific FDA requirements while they work toward meeting those requirements. Under the new guidance, the period of enforcement discretion for those products identified in the letters of enforcement discretion will be extended until Jan. 6, 2023, with further extensions possible for firms that express interest in and take steps toward the lawful marketing of such products in the United States. The guidance balances the need to ensure that infant formula products meet regulatory requirements with the need for a more resilient infant formula supply.
Register to Webinar Series - [ Ссылка ].
Links:
Guidance for Industry: Infant Formula Transition Plan for Exercise of Enforcement Discretion - [ Ссылка ]
Guidance for Industry: Frequently Asked Questions about FDA’s Regulation of Infant Formula - [ Ссылка ]
Guidance for Industry: Exempt Infant Formula Production - [ Ссылка ]
Guidance for Industry: Labeling of Infant Formula - [ Ссылка ]
Questions & Answers Concerning Infant Formula - [ Ссылка ]
Infant Formula Guidance Documents & Regulatory Information - [ Ссылка ]
