FDA Announces Guidance Outlining ‘Increased Flexibilities’ on Importation of Safe Baby Formula
The U.S. Food and Drug Administration announced on May 16 that it will issue guidelines with “increased flexibilities” regarding the importation of certain infant formula products. The FDA aims to increase the supply of infant formula nationwide while ensuring health and safety. The agency is also encouraging formula manufacturers worldwide to take advantage of these increased flexibilities.
“The FDA is leaving no stone unturned to further increase the availability of infant formula. We are doing everything in our power as part of the all-of-government efforts to ensure there’s adequate product available wherever and whenever parents and caregivers need it,” said FDA Commissioner Robert M. Califf, M.D.
“With these flexibilities in place, we anticipate that those products that can quickly meet safety and nutrition standards could hit U.S. stores in a matter of weeks,” Califf added.
Interested companies can submit information to the FDA for quick evaluation. The agency is already speaking with some manufacturers and suppliers regarding the additional supply of formula.
On May 13, Speaker Nancy Pelosi said the House would take steps to address the baby formula shortage. In a letter to lawmakers, Pelosi wrote that she would expedite a bill to grant emergency authority to the federal food assistance program for women and children to ease restrictions on the types of formula that can be purchased, The New York Times reported.
Baby formula maker Abbott has reached an agreement with the FDA to reopen the company’s manufacturing plant in Michigan after the facility was closed due to bacterial contamination in February, according to CNBC.
Under the conditions of the agreement, Abbott will adjust unsanitary conditions that led to the contamination.
The agreement was approved by the U.S. District Court for the Western District of Michigan on May 16. However, it could take six to eight weeks from the start of production for formula to arrive on shelves.
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