May 27, 2022

Baby Formula Theater Hits Congress

A congressional hearing makes clear that the FDA is responsible for the shortage’s exacerbation.

Four companies supply America’s most popular baby formulas: Abbott, Perrigo, Nestle, and Mead Johnson. These companies are huge and hold a monopoly because of how difficult the Food and Drug Administration (FDA) has made it for other companies to break into the industry.

It’s both a good thing and a bad thing.

As Ron Belldegrun, cofounder of ByHeart baby formula (the first new company to be approved by the FDA in 15 years), said: “Infant formula is — appropriately — the most regulated food in the world. The road to providing babies with sole-source nutrition should be met with the highest rigor. But for the benefit of babies, and their parents, there need to be more incentives for new brands to rise to the challenge. We need more support for infant formula manufacturing and product innovation at the state and federal levels.”

This lack of competition is why a shortage turned into a crisis when, in February, Abbott’s factory in Sturgis, Michigan, shut down and recalled its baby formula products. This plant produces as much as one-fifth of all baby formula in the U.S. As bad as this news was for moms and dads, the shortage has been going on much longer than the recall would suggest, prompting a deeper look into FDA policies.

During a congressional hearing this week, the most troubling aspect that came to light is that the FDA has been aware of the baby formula trouble since September, particularly regarding potential issues with the Sturgis plant. Babies had gotten sick from bacteria and a few died. It was thought that Abbott’s formula was contaminated, though an investigation determined this was not the case. The bacteria in question was found at the plant but was genetically different than the strain that hurt those babies. The FDA was slow to even investigate — a period of four months passed between the reports and the shutdown of the Sturgis plant.

The current FDA commissioner, Robert Califf, has only been in his position since February 15, and he was not immediately made aware of the shortage. Ergo, he did not respond in a timely manner to bring about an uptick in imports and/or implement other methods that could alleviate the formula shortage.

President Joe Biden has invoked the Defense Production Act to ensure that the producers of the raw materials used to make baby formula ship them first to formula manufacturing plants. Babies need the formula, but the DPA trigger will slow other manufacturing and cause additional supply issues. Furthermore, it probably won’t solve the problem. To reiterate, the plant that produces one-fifth of all baby formula has been out of commission.

The president has also enlisted the Department of Defense to fly baby formula over from Europe, but it will be weeks until parents see these cans on the shelves. Plus, each load is only enough for a week’s worth of food for 9,000 infants and 18,000 toddlers. This is hardly going to make a dent. Moreover, as our Nate Jackson pointed out: “Democrats are the party running the protection racket that is the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) for low-income mothers. Long story short, food stamp regulations dictate a lot of what formula ends up on store shelves — or, in this case, doesn’t end up on shelves.” Babies who are not on WIC may not benefit from these flights of food.

Getting the formula from Europe is also not being done in the most efficient way. Besides not being nearly enough to satiate demand, importing formula from Europe is marred with all sorts of red tape and comes with a heavy tariff (18%). Senator Rand Paul has proposed the Freedom to Import Infant Formula Act. Should it pass, this act would lift the tariff on the European formula and also prevent the government from confiscating formula being brought in privately from certain approved countries.

In the meantime, House Speaker Nancy Pelosi has said: “When it comes to babies, it’s the here and now and in this moment. I think that when all of this is done — I’m not associating my politics with what I’m going to say right now — I’m just saying it myself, I think there might be a need for indictment.”

Sadly, she is referring to the Abbott plant owner and other businesses that are producing baby formula as the villains of this fiasco. They do have a role to play in this shortage, but it is the government — specifically the bureaucratic rigmarole that is the FDA — that is ultimately to blame. Now with the Defense Production Act, there will potentially be more bad supply chain shortages on top of not actually solving the problem. The government is primarily responsible for gumming up the works.

This finger-pointing does no good for those precious babies who need formula. Practical solutions are in order, but it seems those are out of the purview of this administration.

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