By Kelli Pierce, R Street
What would you do if your premature baby could not get the formula they desperately needed?
This frightening scenario may soon become a real question that parents, doctors, and hospitals start asking. That is because at least one of the only two manufacturers of formulas for extremely premature babies in American neonatal intensive care units (NICUs) might stop making those formulas due to lawsuits and low profit margins.
Situations like these are why U.S. government policies around baby formula need to change, and the Food and Drug Administration (FDA) should more quickly approve items that have a long track record of safety in other countries.
Formula is crucial for severely premature infants to survive.
Premature infants in NICUs need specialized formulas that are higher in protein, vitamins, and minerals. Children’s Hospital Los Angeles says those proteins and fats are easier to digest, while the fats themselves tend to have a higher amount of medium-chain triglycerides (MCTs). MCTs help infants with immature digestive systems. Other formulas used in NICUs have higher amounts of long-chain triglycerides (LCTs), which doctors believe help infants with central nervous system development and visual function.
Additionally, breastfeeding or supplementation with breastmilk is not always possible. Though the exact numbers are unclear, a significant percentage of babies who end up in the NICU each year are exposed to substances like opioids and alcohol in utero, making mom’s breastmilk essentially unusable. In the cases of foster or adoptive parents, they are usually not nursing.
European formula could help during shortages, if we let it.
If Abbott or Reckitt Benckiser stopped production tomorrow, there would be no existing channels for hospitals to acquire equivalent European formulas for preemies, even though there are perfectly safe alternatives on the other side of the pond.
Unfortunately, if those formulas are on the FDA’s Red List, they could be seized by U.S. Customs and Border Patrol. Like parents and retail stores, hospitals can only legally import and give their patients formula if the FDA approves it.
Making barriers to foreign medications and baby formulas insanely high is completely unnecessary and counterproductive when a potential shortage looms. Babies were not harmed en masse when more European formulas were allowed. The FDA also allowed more specialty formulas for infants with medical needs to be imported during the 2022 formula crisis with no negative health outcomes.
Yet, legislation that could help fix the problem has stalled while special interests have consistently opposed reforms, even during the high-profile 2022 formula shortages.
We have to trust American parents and doctors to make informed choices.
American parents and doctors are fully capable of making the best decisions for their families and patients when given the opportunity. The FDA agrees.
While we need to remember the lessons of thalidomide, the regulatory barriers in the United States are so high for safe, effective medications from other countries that companies refuse to manufacture them for the American market. The Biden administration recognized this in 2022 and sped up approvals of formulas during the crisis.
For a better infant formula supply that would not be subject to supply shocks, the FDA must approve products with a long safety track record in other advanced economies more quickly.
Congress should also rethink dairy tariffs. Restricting foreign products has only deepened formula shortages, failing to help family farms stay afloat.
Ultimately, allowing more European formulas on American shelves will have no negative effects on infant health.
Kelli Pierce manages content on R Street’s website and assists with digital communications.