Last week FDA took another step to combat the nation’s ongoing shortage of infant formula by unveiling a proposal for a streamlined pathway to allow foreign manufacturers currently selling formula on a temporary basis to do so on a permanent basis.  In a statement entitled “FDA Developing New Framework for Continued, Expanded Access to Infant Formula Options for U.S. Parents and Caregivers”, FDA outlines the various elements of its proposed program.  Emphasizing how "the recent shutdown of a major infant formula plant, compounded by unforeseen natural weather events, has shown just how vulnerable the supply chain has become," the Agency took this action to close the gap between what is annually produced and needed.

The newly introduced proposal is meant to supplement and expand upon on its earlier May 2022 “Guidance for Industry: Infant Formula Enforcement Discretion Policy,” which allows for the temporary marketing and sale of infant formula that does not meet all applicable statutory and regulatory requirements.  The draft guidance describes the factors FDA considers when exercising enforcement discretion with respect to foreign noncompliant infant products.

Under the proposal announced last week, FDA will take the following steps to lower the existing hurdles to the long-term marketing of infant formula in the U.S.:

  • Designate a single Agency technical representative whose job it will be to make it easier for foreign manufacturers to navigate the infant formula regulatory review process.
  • Host meetings with companies currently selling infant formula under the FDA’s temporary enforcement discretion policy and those planning to enter the U.S. market to identify any additional steps needed for long-term marketing. 
  • Develop and provide an expedited pathway for companies that import, sell, and/or distribute formula under the FDA’s May 2022 guidelines to continue to do so on a long-term basis.

FDA believes that these steps will help to maintain a sufficient supply of infant formula in the market and prevent similar shortages in the future.