As part of an effort to ensure adequate supply of infant formula, in May, FDA issued a guidance announcing the agency’s intention to temporarily exercise enforcement discretion, on a case-by-case basis, for certain requirements that apply to infant formula to address the temporary shortage. The agency prioritized review of requests from firms that can: 1) produce documentation to demonstrate the safety and nutritional adequacy of the product; 2) make the largest volume of product available; and/or 3) get product onto U.S. shelves quickly.
According to FDA, its flexibilities have enabled the agency to help dramatically increase infant formula supplies to address the shortage, while also protecting the health of infants. To date, it has resulted in an estimated quantity of more than 400 million, 8-ounce bottles worth of formula from nine countries for children in the U.S. The enforcement discretion described in the May guidance is set to remain in effect until Nov. 14, 2022.
Many of the companies providing these formula products have expressed interest in continuing to serve the American market permanently, says FDA. To allow for formula importers to continue to serve the U.S. market, FDA intends to:
Provide a single technical assistance contact at the FDA for any company aiming to enter the U.S. infant formula market, making it easier for potential newpractice commonly used by other FDA centers that has resulted in novel medical therapeutics entering the U.S. market in a more efficient manner. The FDA hopes to encourage more entrants into the market, including new domestic firms.
Host meetings this summer with companies that import, sell, and/or distribute formula under the FDA’s temporary enforcement discretion policy to determine what additional steps would be needed to provide a pathway to long-term, uninterrupted marketing for safe and nutritious formula.
Provide a pathway for companies that import, sell, and/or distribute formula under the FDA’s temporary enforcement discretion policy to continue to supply infant formula to the U.S. past November. In September, the FDA intends to issue further guidance on the topic of how companies that have already received temporary enforcement discretion could meet FDA requirements to continue to supply infant formula to the U.S. beyond that time.
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