FDA to Extend Infant Formula Import Enforcement Discretion Policy
FDA will extend until Jan. 6 its policy of enforcement discretion allowing infant formula imports that don’t meet all regulatory requirements to address recent infant formula shortages, and also will provide a pathway for individual manufacturers to request a continuation of the policy on a case-by-case basis after that date, the agency said in a notice released Oct. 5.
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Set forth in a recently issued guidance document, the extension “aims to balance the need to ensure that manufacturers of infant formulas sold in the United States demonstrate that their products meet the minimum requirements for specified quality factors with the need to help ensure the existence of a more resilient infant formula supply and to minimize disruptions in the availability of formulas that have become an essential source of infant nutrition during recent periods of supply disruption,” FDA said.
The enforcement discretion policy, announced by FDA in May (see 2205170035), will now continue until Jan. 6, though FDA will require that manufacturers take steps toward compliance with the normal regulatory scheme if they want to continue importing under the policy past that date.
Manufacturers that want a further extension will have to submit a letter of intent by Dec. 5, followed by a plan for meeting regular infant formula requirements that’s due by Feb. 28, 2023. Further deadlines culminate in a requirement to submit a new infant formula submission or proof of exempt status by 2024, or in some cases 2025.
Some infant formula manufacturers have already submitted information as part of a new infant formula submission to FDA, and those “manufacturers do not need to resubmit this information unless updated information is available,” the agency said.