Ann: Upgrade to FY22 Market Guidance, page-102

The FDA plan

The FDA plan unveiled this week has three parts, according to Califf and Mayne. The agency intends to:

• Create a single technical assistance contact for companies wanting to market their infant formula in the US
• Meet with companies that have already imported, sold or distributed their formula here the FDA’s temporary authorization to discuss what they would have to do so they can continue on a more permanent basis once the formula shortage ends.
• Create a pathway to make that happen. The agency promises that it will issue guidance in September to help those who have temporary authorization so they can continue submitting formula.

“Ensuring that the youngest and most vulnerable individuals have access to safe and nutritious formula products are a top priority for the FDA,” read the statement from Califf and Mayne. “The FDA expects that our continued efforts will help infant formula manufacturers who are new entrants to the US market better understand their options to continue producing and submitting formula to the US in the weeks, months and years ahead.”
The temporary authorizations that simplify bringing in outside formula during the baby formula shortage are slated to expire in November, though the Biden administration says it will extend them, if needed. The FDA plan could make that unnecessary.