FDA under fire as baby formula shortage grows

The FDA is defending its handling of the baby formula shortage, as prominent Republicans say the Biden administration has allowed the situation to spiral into a full-blown crisis.

Why it matters: Parents are scrambling to find formula with retailers reporting about 40% of their supplies out of stock and actively limiting purchases. About 3 in 4 parents of young babies rely on it.

• Parents who adopted their children or had babies through surrogates — including, in some cases, LGBTQ parents — or people who gave birth to twins are particularly hard hit.
• In many cases, "they don't have breastmilk as an option for that baby, and those are the ones that are most concerned about the formula shortage," Victoria Regan, pediatrician at Children’s Memorial Hermann Pediatrics in Houston, tells Axios.

What they’re saying: Republicans including Sen. Mitt Romney of Utah and Sen. Tom Cotton of Arkansas are demanding answers from the FDA, which essentially shut down Abbott Nutrition's Sturgis, Michigan, facility in February after the agency found evidence of a food-borne pathogen there and flagged several baby illnesses.

• The company issued a voluntary recall that has exacerbated shortages that had already begun months earlier due to industry-wide supply chain issues.
• “I hope that the FDA understands the extraordinary strain this crisis has placed on parents and children alike and is doing everything in its power to re-open the Abbott plant,” Cotton said in a statement.
• “This formula shortage is terrifying," Republican Minnesota State Sen. Julia Coleman, a mother of newborns, said on Twitter. "Haven't been able to find it in stores for weeks. Amazon sold out too. Where is the president on this?!”

The other side: FDA spokesperson Tara Rabin said the agency “did recognize that this recall would result in supply chain implications” but noted that the FDA has taken a series of steps to bolster supplies of infant formula:

• It’s “meeting regularly with major infant formula manufacturers,” “expediting review" processes to jolt production and speeding “already permitted” foreign imports, the FDA said in a statement.
• "They are working around the clock to address any possible shortage," White House Press Secretary Jen Psaki said Monday.

Details: Abbott Nutrition said Wednesday in a statement that it’s made physical improvements to its plant and updated safety protocols, though it maintained that “no evidence” has not been found linking Cronobacter sakazakii found at its plant and the infant illnesses, including two babies who died.

• “We understand the situation is urgent – getting Sturgis up and running will help alleviate this shortage,” Abbott said. “Subject to FDA approval, we could restart the site within two weeks.”
• From then it will take six to eight more weeks before product is available on shelves, the company said.

Of note: It’s not easy to quickly ramp up production of baby formula at alternative locations. And parents have to be careful about substituting one formula for another due to health concerns and babies’ preferences.

• “Only facilities experienced in and already making essentially complete nutrition products are in the position to produce infant formula product that would not pose significant health risks to consumers,” the FDA said.