The FDA issued Notice 2023-06249, proposing amendments to infant formula requirements.

This information collection supports FDA regulations, and associated Agency forms and guidance, pertaining to infant formula requirements. Statutory provisions for infant formula under the Federal Food, Drug, and Cosmetic Act (FD&C Act) were enacted to protect the health of infants and include specific current good manufacturing practice (CGMP), labeling (disclosure), and a number of reporting and recordkeeping requirements. Section 412 of the FD&C Act (21 U.S.C. 350a) requires manufacturers of infant formula to establish and document the adherence to quality control procedures, notify FDA when a batch of infant formula that has left the manufacturers’ control may be adulterated or misbranded, and keep records of infant formula distribution. Notification requirements are also included in the regulations regarding the quantitative formulation of the infant formula; a description of any reformulation or change in processing; assurances that the formula will not be marketed until regulatory requirements are met as demonstrated by specific testing; and assurances that manufacturing processes comply with the regulations.

The notice was published in the Federal Register on March 27, 2023. There is a 30-day comment period.

Learn more via: https://public-inspection.federalregister.gov/2023-06249.pdf

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