FDA rolls out new import guidelines, manufacturer flexibilities to boost infant formula supply


The Food and Drug Administration (FDA) on Monday announced a series of measures aimed at increasing the domestic U.S. supply of infant formula to counteract the current shortage, including temporary import guidelines and flexibilities for companies that don’t normally sell formula.

The FDA said it will temporarily “not object” to the importation of certain infant formula products or the distribution of formula products that are manufactured in the U.S. but are meant to be exported to foreign countries.

“We’ve set up a mechanism that streamlines the ability for companies that do not normally sell infant formula in this country to do so. And it provides other flexibilities to domestic distributors who can help increase availability,” FDA Commissioner Robert Califf said in a press call.

When asked if these measures could signal the FDA permanently opening the U.S. up to infant formula products that previously had not been allowed in, the officials stressed that these measures are meant to be temporary.

The new guidances announced on Monday are set to last for the next 180 days. Califf said the question over whether the U.S. needed more diversity in its product availability would be discussed when the supply chain is normalized and stable.

Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition, noted that there are regulatory differences between products that are permitted to be sold in the U.S. and those that are sold abroad.

“We’re casting a broad net. We are seeking manufacturers from around the globe who they have available product that could meet our regulatory standards for both nutrition and food safety — to reach out to us let us know what they have available and we can discuss with them what that might look like to get that product into the U.S.,” Mayne said.

Companies interested in taking advantage of these temporary flexibilities are asked to “quickly” submit information to the FDA for evaluation. Mayne noted that it is important that the labelling for these products be in English so that consumers in the U.S. are able to read the instructions.

News of these measures came shortly after it was announced that baby formula manufacturer Abbott Nutrition had reached an agreement with the FDA to restart operations at its plant in Michigan after three months of being shuttered.

Operations at the plant had been halted while the FDA investigated whether powdered infant formula made at the facility was linked to four cases of infants contracting rare bacterial infections.

Part of what contributed to the current shortage in the infant formula supply is due to the recall that was issued following the reports of bacterial infections in infants. Frank Yiannas, the FDA’s deputy commissioner for food policy and response, said discussions on how to boost supply began as soon as the recall was issued.

The FDA officials on Monday noted the “treachery” of trying to give exact timelines but referred to Abbott’s own estimations that it will be able restart operations within about two weeks and will be back to full capacity within two months.



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