The milk industry is questioning the Food and Drug Administration's continued approval of infant formula imports from foreign manufacturers, even as the crisis begins to ease.
On Wednesday, FDA approved two new foreign importers of general infant formula – Danone of Ireland and the a2 Milk Company of New Zealand – to boost U.S. supplies of formula.
Reports indicate stocking rates of baby formula have been slowly improving. The national in-stock rate now at 82.24%, but that's still below the 89% registered before the crisis began in February.
The U.S. Census Bureau’s Household Pulse Survey reported in October that 52% of households with babies or infants under a year old were affected by the infant formula shortage and 34% had issues finding infant formula in the last seven days.
However, the situation is no longer an emergency, say those representing the milk industry, who want FDA to begin to focus on long-term solutions.
“It certainly seems like we're in a very, very different situation right now, thankfully, than we were six months or so ago at the height of the crisis. For us, that means it makes an awful lot of sense to be looking at a different set of tools than were needed at the height of the crisis when availability was such a huge concern,” said Shawna Morris, National Milk Producers Federation senior vice president of trade policy.
She added that NMPF has “strong concerns with the approach FDA has taken with enforcement discretion and the focus on expediting access or significantly expanding access for imported products as the long-term solution.”
Companies that have a letter of enforcement discretion issued by FDA by Nov. 14 can submit a letter of intent to pursue completion of all regulatory requirements. The letter of intent is due to FDA by Dec. 5 and triggers a years-long process during which the company can keep selling product in the U.S., even as it takes the needed steps to fully register and comply with FDA requirements.
This process has been created not just for certain specialty formulas but for all types of formula, despite the fact that the consequences of not having specialty formulas are the most acute for those who need them.
Morris said it will be interesting to see how many more foreign supplier approvals are granted in the next couple of weeks ahead of the Nov. 14 cut-off and how much product ends up arriving before the end of the year.
In an Oct. 17 letter to White House Domestic Policy Adviser Susan Rice and National Economic Council Director Brian Deese, NMPF President and CEO Jim Mulhern said “there is absolutely no basis for continuing to not enforce U.S. regulations as U.S. formula supplies return to normal levels and the crisis draws to a close.
“It is additionally concerning that FDA has chosen to issue such a sweeping change in policy with significant impacts on U.S. manufacturing and American jobs without first issuing it as a proposed rule for public comment. In contrast to the decision to implement enforcement discretion earlier this year, at present no emergency justifies bypassing this critical transparency and public consultation step. Rather, U.S. infant formula production has continued to recover,” the letter added.
Morris explained, “Really, the solution here to ensuring that the U.S. formula sector is as resilient as possible seems to have been placed on the wrong spot. Increasing U.S. reliance on imported products and continuing to have a formula supply for the just the right amount to fit demands here isn’t the solution to ensuring that we never end up in a spot that we were in last spring again.”
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NMPF has been taking a thorough look at what makes it more difficult to produce formula domestically compared to Europe and other countries that are also major dairy producers and exporters. “There needs to be a much more careful look at how do we deal with some of the regulations and policies that make it more difficult to use the U.S. as an export hub for formula,” Morris said.
NMPF’s letter stated, “FDA’s newly announced multi-year regulatory exemption policy runs directly counter to this administration’s professed goals of strengthening U.S. manufacturing capacity, American jobs, and onshoring critical supplies.”
The letter added if U.S. formula production had been at levels sufficient to not only meet U.S. demand but to also supply significant quantities to various foreign markets, the upheaval experienced by American families this year would have been mitigated by the ability to draw on that additional foreign-bound product. Prior to this year, the U.S. was able to meet 98% of its infant formula needs with American-made product.
NMPF is evaluating both policy and regulatory measures to increase domestic supplies of infant formula.
Steven Abrams, a professor of pediatrics in the Dell Medical School at the University of Texas at Austin, said importing formula using FDA’s temporary rules has “not led to any meaningful long-term solutions and has only marginally improved the situation in Texas and other states where the shortage has been severe.”
“In other words, we keep putting a Band-Aid on a big bleed and keep forcing families – especially low-income ones – to suffer,” he said, advocating for allowing foreign infant formula manufacturers to “permanently market in the U.S. without the need for excessive and unneeded research or paperwork. Factories and formulas used in Europe, Australia and New Zealand, for example, are already tightly regulated. We don’t need added layers of regulation in the U.S. other than ensuring safe means of transportation to the U.S.”
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