Is the Formula Shortage an Opportunity for Access to Better Quality Formula?

Rebecca Lancaster moved from England to live in Boston for three years while she was raising her two young children. Although she primarily breastfed her youngest, she wanted to introduce formula to him but learned from friends and brief research that the formula offered in the United States wasn't as clean as the formula she used in England—HiPP Organic.

"Every time we came back from visits to the U.K., we would bring back stock to last us until our next visit," Lancaster says. "When we moved back to England, I sold what formula we had left. There was lots of interest from people who wanted it."

But for most American families, these formulas manufactured abroad are difficult to come by because most of them aren't FDA approved. Despite the fact there are more than 50 different baby formulas available in the U.S., there is a growing number of parents opting for formulas manufactured outside of the country, which many consider cleaner and higher-quality nutrition for their babies. For example, unlike in the U.S., the European Union bans added sugars like corn syrup in baby formula and requires at least 30% of its carbohydrates come from lactose. There are even Facebook groups dedicated to helping parents learn more about and access formulas that haven't been approved in the States.

However, with the ever-continuing formula shortage saga, this could be a moment for change. Operation Fly Formula, President Joe Biden's answer to the shortage, facilitated at least 15 shipments of formula from other countries in a matter of months. Two European formulas, Aptamil (from the parent company Danone) and Kendamil, have been temporarily allowed in the U.S. under Operation Fly Formula. Another approved company is Aussie Bubs, an Australian formula manufacturer.

"The need to diversify and strengthen the U.S. infant formula supply is more important than ever," a July statement from the FDA read. "The recent shutdown of a major infant formula plant, compounded by unforeseen natural weather events, has shown just how vulnerable the supply chain has become."

To tackle the shortage, the FDA announced its intention to "temporarily exercise enforcement discretion with respect to certain requirements for infant formulas that may not comply with certain statutory and regulatory requirements..."

This might come as a relief to parents like Liz Fogarty, who also preferred European formula even before the shortage. "My priority is to use the cleanest formula for my children," says Fogarty, a Maryland mom with a 2-year-old and baby on the way. She wasn't thrilled with the ingredients she saw in some U.S. formulas, so Fogarty decided to give her first child the German formula Lebenswert Folgemilch and has chosen to feed her second child HiPP Dutch Stage 1. She buys them online and says they come with a high price tag—the first is currently $27.99 for a four-pack, while the latter is $46.99 per can. Not that prices in the U.S. are much better during the shortage. Analysis conducted by DataWeave found formula prices jumped 11% on average between March 2021 and May 2022.

Baby Formula and FDA Approval

The U.S. typically only imports about 2% of its formula—mainly from Mexico, Ireland, and the Netherlands. The other 98% of formula is manufactured in the States by four large producers: Abbott Nutrition (which takes up nearly half the market), Nestle USA, Mead Johnson Nutrition, and Perrio. Although safety concerns are always listed as the reason for limiting the import of baby formula from other countries, some argue it's just a way to monopolize the market, giving American brands the upper hand.

This new enforcement discretion has made FDA approval quicker, but it's not that simple to get FDA approval in normal times.

"To be sold in the U.S., companies need to register their formulas with the FDA and adhere to the Infant Formula Act, including providing clinical data to ensure that the protein in the formula is bioavailable and to ensure that the formula ensures adequate growth of infants," explains Anthony F. Porto, M.D., M.P.H., associate professor of pediatrics at Yale University School of Medicine. "This is a time-consuming and expensive process which may have been a deterrent for companies to follow and complete this process."

While there are differences between formulas, say between European and American ones, Dr. Porto found that when he compared the nutrient content of European formulas to the FDA requirements, nearly all the formulas contained nutrients that met those recommendations.

"The major differences in European and U.S. infant formulas are the iron content and that European formulas come in stages, so they are more tailored to the specific needs of younger and older infants," explains Dr. Porto. "And European formulas have guidelines that not only require docosahexaenoic acid (DHA), but also sets a minimum and maximum level. Though most U.S. formulas voluntarily contain DHA, levels vary and, for the most part, are below this minimum level set by the European Union."

Aussie Bubs' FDA application was one of the first to be filed with U.S. authorities after the FDA released its guidelines for issuing an enforcement discretion notice for the import of certain infant formula products. "It was the result of 18 months of preparation and investment in our U.S. market expansion strategy to meet the very stringent quality and safety nutrition requirements for FDA," says Kristy Carr, founder and CEO of Bubs Australia and Aussie Bubs.

In mid-June, Operation Fly Formula delivered 1.25 million cans of infant formula to the U.S. from Melbourne. Since then, there have been four other shipments.

"We had a long-term commitment to U.S. market before the current crisis, so we are always respectful of the local process for wanting safe and nutritious formula," Carr says. "The shortage allowed us to be assessed by the FDA to satisfy those requirements, and we look forward to continuing in this market with a more inclusive list of quality manufacturers that can prevent the shortage from happening again."

The Future of FDA Baby Formula Approval

If the FDA has made the decision to approve international formulas like Aussie Bubs, Aptamil, and Kendamil in light of the shortage, could this be the start of a more diverse selection of formula in years to come?

"I think of it as an opportunity," says Dr. Porto. "An opportunity to relook at the FDA Infant Formula Act requirements which has had few updates since 1980, while keeping infants safe."

Over the summer, the FDA said it would allow European formulas to be sold in the U.S. through November. In September, it was announced that the policy allowing importation was extended to January 2023. Companies can then ask to remain on the market for longer.

"Hopefully, this process will allow for opportunities for new manufacturers to enter the market while following the safety measure of the Infant Formula Act and address the current and prevent future shortages," adds Dr. Porto.