The FDA’s baby formula fiasco continues


Offering a big-ticket “solution” to a problem his own agency created, Food and Drug Administration head Robert Califf suggests creating a national baby-formula stockpile in case of future shortages.

No: The FDA’s at fault for the nation having so few formula-makers, by setting up high barriers for new plants to open even as it fails to properly monitor the big players that dominate as a result.

Yes, fails: It got notification of bad safety protocols at that Sturgis, Mich., formula plant in October. Incredibly, this report — per senior officials — didn’t reach high command because of “mailroom issues.”

Four kids got sick and two died. “Mailroom issues” doesn’t cut it. 

The FDA did force the plant to shut down in February, after those deaths, although with no seeming plan to make up for lost capacity. When the actual shortages hit — as much as 40% — the Biden White House was left to its usual bumbling. 

Now Biden has arranged for formula to be flown in from Europe, but not nearly enough to make much of a difference, along with using the Defense Production Act to help get production back up. 

But why is European formula banned in this country in the first place? EU regulators are plenty finicky; the stuff is clearly safe; the FDA just doesn’t like the labelling. Which, per former FDA big Peter Pitts, is the major difference between US and EU formula.

As for the stockpile idea: Baby formula expires. The correct solution is to make sure the FDA doesn’t create any future shortages.

Ditch the absurd import ban, and the cockeyed barriers to entry. (Congress should end all tariffs on European formula, too.) Leaving the industry hyper-consolidated, with a few big players producing almost all the supply, is just asking for a crisis. 

The FDA’s bungling during COVID (insisting on devising its own tests, which didn’t work, for starters) already had us demanding reform. The current majorities in Washington may have no interest in that, but this new fiasco should put the issue top of the agenda for the folks who win in November. 

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