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The FDA Was Making It Difficult For Moms To Get Baby Formula Long Before The Supply Chain Imploded

bottle formula in grassy field
Image CreditJayne Freeman

The formula shortage is finally bringing attention to the FDA’s labeling games that have angered many moms for years.


Months after distressed moms have been vocally upset and concerned about the baby formula shortage, the media is finally starting to ask, how could this happen? The short answer is lockdown supply chains and the shutdown of one of the country’s largest formula plants in Michigan over an alleged bacterial outbreak.

The long answer is that, unlike the problem of sky-rocketing lumber prices or your West Elm furniture stuck on cargo ships, this crisis is intertwined with an already highly regulated industry and a bureaucratic agency that has been the enemy of postpartum moms well before the pandemic.  

As the Food and Drug Administration (FDA) is quick to point out, they do not “approve” infant formula, but they do require manufacturers to meet certain requirements to be considered “FDA-registered.” The nutrition and quality control requirements for formulas are implemented by statute, the Infant Formula Act of 1980, and it’s the FDA’s job to enforce those federal law requirements, including the verification of imported European formulas that don’t meet their often-debated standards.

This is an important distinction because it’s also the smokescreen the FDA will likely hide behind as they are pressed to loosen restrictions on importing formulas amidst the ongoing crisis of mothers staring down empty shelves in the supermarket. When angry moms ask why their European formula orders were seized by U.S. Customs and Border Patrol, experts and FDA defenders point to the federal statute as a “their hands are tied” excuse.

It is not illegal to import formulas into the United States, but any formula imported must be from a manufacturer that is FDA-registered, which entails meeting their strict rules for products and labels. Despite what media or some American doctors say, European formulas are not unsafe, and are preferred by many American moms.

For a variety of reasons, many mothers prefer formulas manufactured in Europe. Some perceive European brands to be higher quality than American formulas, although medical experts disagree on whether this is true. The European equivalent of the FDA does not allow any amount of trace pesticides to be present in their milk, so the foundation of the formula is coming from cows producing a higher quality of milk, which appeals to today’s American customers often in search of “clean” ingredients.

The other main difference is the level of iron required by the FDA, which again, doctors and experts disagree on. A simplified explanation of the argument comes down to Americans perceiving Europeans as putting too little iron in their formula, while the Europeans think Americans put too much.

“They’re not hugely different, because babies are babies whether in the United States or Europe,” Dr. Steven Abrams, chair of the Committee on Nutrition at the American Academy of Pediatrics, told The Federalist. “But they’re slightly different and so the FDA is concerned about labeling for certain rules like their iron content.”

Two of the popular European brands sought out by American moms are HiPP and Holle, neither of which meet FDA requirements but are approved by the European Commission, which many parents argue has even higher standards than the FDA.

“So the problem becomes not so much that these formulas are dangerous, they’re not, but that if we allow companies to bring in formulas that the FDA doesn’t supervise, then anybody can start bringing in making whatever they want,” Abrams said.

This is true, but there are solutions for this the FDA should consider, especially in the emergency shortage we are currently facing, Jayne Freeman, a childbirth educator and breastfeeding counselor in Jersey City, told The Federalist.

Freeman said her clients and industry contacts began noticing an FDA crackdown on European formulas in the last few years, before the lockdowns, but an even greater spike since last August, well before the Abbott recall and plant shutdown that many are pointing to as the source of the shortage.

A private Facebook Group that functions as a support group for parents trying European formulas for children with specific nutrition needs is flooded with posts from frustrated moms whose orders are held up in customs for weeks or months, and in some cases, destroyed.

“My contention is that because we’re having this crisis, they need to let the guard down right now,” Freeman said. “An easy way to make this work for everybody would be to simply have an FDA disclaimer. Let HiPP and Holle in, but they all have to come with a label that states that the iron levels of this formula do not match the FDA minimum requirements.”

In some ways, the FDA seems more concerned about labeling than the nutrients themselves. In an FDA “Import Alert,” which is cited by Customs and Border Patrol agents when seizing or destroying imports, every product listed as “subject to detention” is dinged for “labeling that is false or misleading” or being “not labeled as required.” None of the products listed are noted as having insufficient iron levels.

After watching the FDA authorize vaccines for “emergency use” for two years, many American moms and dads are wondering when feeding their babies will be considered an “emergency”?

Update: When reached for comment, an FDA spokeswoman referred to a recent press release addressing the shortage that included their plan to expedite “the necessary certificates to allow for flexibility in the movement of already permitted products from abroad into the U.S.”