Nara Organics recalls baby formula sold at Target after multistate infant botulism outbreak

The first thing to know is that the baby is all right now. She’s coming up on her second birthday, playful and curious. She chases the family dog around the house, trying to give him kisses, and mimics her dad by wiggling her hips as he shows her how to hula hoop.

But her home holds a few clues to her past. An oddly huggable orange stuffed animal shaped like Clostridium botulinum, the bacteria that causes botulism. And enshrined in plexiglass, a bottle of BabyBIG, the antitoxin treatment that saved her life when she was 7 months old.

Katie Connolly’s daughter, M., was among the dozens of babies who became sick with infant botulism after drinking contaminated infant formula from ByHeart last year. (The children in this story are identified by their first initials in order to keep their health records private.) Last weekend, another formula brand, Nara Organics, was linked to three new cases of infant botulism by the Food and Drug Administration.

“You buy a product that you think is going to be safe for them, and it ends up putting them in the hospital,” said Connolly. She initially chose ByHeart because she was drawn to its “organic, natural direction.” But one morning, her daughter woke up unable to lift her head or move her arms and legs — a sign of the encroaching paralysis caused by botulism, which can leave infants unable to breathe as it progresses. M. spent nearly a week in the hospital.

Today, Connolly is pregnant with her second child and anxious about the possibility she could have to use formula again. “I definitely operate with extra caution,” she said.

While infant formula in the U.S. has a good overall safety record, the stakes are incredibly high if something goes wrong. Food safety experts who spoke with STAT say they want regulators and the industry to take even stronger measures to prevent disease outbreaks that put babies’ lives at risk. And they want consumers to be wary of marketing from newer, high-end formula companies like ByHeart and Nara that position their products as safer than other options.

“I think a lot of parents can be confused and think that if they spend more money on a formula, it’s safer,” said Steven Abrams, a professor of pediatrics at Dell Medical School at the University of Texas at Austin. In fact, formulas are remarkably similar to one another because they’re required to use a blend of 30 ingredients necessary to give babies the nutrition they need. All formulas are also subject to annual FDA inspections and requirements to test for the pathogens salmonella and Cronobacter.

Of designations like organic, GMO-free, or added probiotics and prebiotics, Abrams said, there’s no evidence that such features “have the slightest health effect on babies.”

Nara and ByHeart were both manufacturers “claiming to produce a healthier type of infant formula because they were using whole milk,” said Frank Yiannas, a former deputy commissioner for food policy and response at the FDA. The fact that both brands have been linked with infant botulism, he said, suggests that “reformulating powdered infant formula should be done with extreme due diligence and caution.”

The FDA told STAT that its investigation into the Nara outbreak is underway, and it’s still investigating the root cause of the ByHeart outbreak, assessing the supply chain and production environment as well as dairy-based ingredients. So far it has matched Clostridium botulinum, or C. bot, isolates from the organic whole milk powder supplied to ByHeart with samples from closed cans of formula and affected infants. It’s not clear how the contamination of ByHeart’s whole milk powder, made by Organic West Milk and processed by a Dairy Farmers of America plant, occurred.

“The FDA is also working with a range of partners all over the world to better understand the risks associated with Clostridium botulinum in infant formula to inform future monitoring and mitigation measures,” a spokesperson for the agency told STAT. Understanding the latest science on spore-forming pathogens like C. bot is “a priority for the FDA.”

Yiannas said it’s important for the FDA to determine the root cause so it can  provide guidance to manufacturers on what steps to take to minimize the risk of C. bot. Historically, C. bot has been rarely found in formula, and companies are not currently required to test for it. “It might be a combination of things like formulation, but there might be other on-farm interventions that can be taken to minimize [risk], or in the manufacturing of the product itself,” he said.

But the FDA may not be in a good position to get to the bottom of the outbreaks, according to Sarah Sorscher, director of regulatory affairs at the Center for Science in the Public Interest. She said that over the past year , the agency has been “pummeled by a hostile administration that cut support staff, pushed out veteran experts, and eliminated advisory committees that could have provided the agency’s access to outside scientific…