‘What are we supposed to feed our babies?’

Mama Lauren Galvin needed extra milk for her baby. He threw up so much after breastfeeding that he didn’t gain weight and had to be hospitalized twice.

But with the US suffering from a serious national shortage of infant formula, she couldn’t buy any.

So Lauren turned to the black market and ordered online a Dutch-made brand that’s banned from importing into the United States.

US authorities have repeatedly warned against buying milk that is not approved for export to the US.

Last year, customs officials seized $30,000 worth of European formulas, saying they lacked proper nutritional labeling and could not guarantee their safety. Two years earlier, they blocked $162,000 worth of formula at the border.

Lauren, a nurse in Missouri, consulted with her pediatrician and others about the risks, but she didn’t hesitate.

“If this is healthy enough for European babies, it’s no different for American babies,” she says.

Lauren says the rules don’t make sense to her. And she’s not the only one with questions.

The infant formula shortage, now in its fourth month, has shaken confidence in US food safety agencies, revealing a mix of weak oversight and rigid government regulations that analysts say has left the industry vulnerable to crises.

“I’m angry,” says Stephanie Esposito, a New Jersey mom. She spends her days finding formula for her nine-month-old son Dominic, who suffers from allergies and can only tolerate certain formulas. “What should we feed our babies?

“I don’t understand how they could have let it get to this point.”

Signs of the shortage first emerged last year after Covid-19-related supply shortages emerged. It reached full-blown crisis in February after formula maker Abbott Nutrition, the company behind the Similac brand, issued a major product recall. Authorities shut down one of the company’s factories citing bacterial contamination, shutting down much of US production.

Few dispute that conditions at the factory called for action, but the government’s handling of the situation drew widespread criticism, particularly after it was revealed that a whistleblower had alerted authorities to hygiene problems months before inspectors could react.

After the shutdown, analysts say the Food and Drug Administration (FDA), which oversees the formula industry, made matters worse by overestimating the ability of Abbott’s competitors to close the manufacturing gap, especially after parents panicked and sales had skyrocketed.

More than half of American infants receive at least some formula until three months of age. So the political pressure to find a solution is growing.

Last month, US President Joe Biden announced “Operation Fly Formula,” which allowed the FDA to temporarily relax its rules and authorized the use of military jets to ship formulas overseas.

More than two dozen companies have applied to bring formula to the US. The UK’s Kendamil, Bubs Australia and Nestle’s NAN are among the brands that have received exemptions valid until November.

Had such steps been taken sooner, the crisis could have been averted, says Morvarid Rahmani, a professor of operations management at Georgia Tech’s Scheller College of Business.

“There is obviously no global shortage,” she says. “All of this could have been prevented by timely action.”

But even before the shortage, doubts about the FDA were smoldering.

There has been a spate of reports warning of risky ingredients in products that the FDA monitors, including baby formula, sunscreen and cosmetics. And some parents are already turning to banned foreign baby milk products pulled by stricter rules in some overseas markets, such as a ban on corn syrup, an ingredient common in US mixes.

Instagram influencer Mallory Whitmore, a certified infant nutritionist known as “Formula Mom,” says parents “don’t care much about FDA guidelines anymore.”

“Especially now we’re seeing this very rapid approval of foreign imports… which is very exciting, but I think a lot of parents… are starting to wonder: Was the FDA actually concerned about what’s the safest and healthiest? for my child or were you concerned to protect the interests of American infant formula manufacturers?”

Once the foreign formula exemption expires, parents will stop believing they are unsafe, she stresses. “So the question is, ‘Are these formulas going to stick or not?'”

Analysts say increasing the number of formula suppliers in the US is crucial to prevent another crisis.

But right now, two big players, Abbott and Mead Johnson of Reckitt Benckiser, the makers of Enfamil, dominate the market and together account for about 80% of sales.

And it’s a difficult sector to penetrate.

Abbott and Reckitt Benckiser hold many of the government contracts to supply infant formula to low-income families participating in social assistance programs, which account for about half of all infant formula sales in the United States. And for newcomers, there are lengthy blend reviews, border taxes, and strict labeling rules to contend with.

Meanwhile, US infant formula sales are falling as birth rates fall and breastfeeding rates rise.

Thorben Nilewski is Managing Director of the US unit of the Swiss formula manufacturer Holle. It has applied to sell infant formula under the relaxed rules, but says regulatory hurdles to import are “very high”.

“Holle has observed this area for a long time, but has never finally applied for approval due to the immense cost and time involved,” he says.

Laura Modi argues it’s time to open up the market to competition. Her own start-up company, Bobbie, makes a “European-style” formula that was launched after she was dismayed at not having choices as a new mom.

“If you look at the reason for this lack, it’s inseparable from the fact that only two players own the majority of the market,” she says. “If one manufacturer fails, we should be able to turn to another.”

However, the FDA continues to describe the current exemptions for overseas imports as temporary.

At hearings in Washington last month, Commissioner Roger Califf admitted to problems with food regulators, saying the agency’s side needed a “shot in the arm” and calling for more resources and powers to monitor companies’ shipments. But he has generally defended the current rules as upholding safety standards.

Lauren says something has to change. “Make it better,” she says. “Our children’s lives are in danger”