The FDA hasn’t exactly been providing people with a lot of confidence lately. We’ve seen how they’ve been quick to approve COVID vaccines even though there’s been a long list of side effects. We’ve also seen how they’ve approved COVID tests only for them to offer false positives and false negatives.
Money talks – and someone’s been collecting lots of money to keep approving things without sufficient testing.
The FDA hasn’t just been failing when it comes to COVID, though. The Food and Drug Administration is responsible for protecting the overall public health when it comes to the safety and efficacy of drugs (for humans and animals) as well as medical supplies, cosmetics, and let’s not forget – our food supply as a country.
If we see the FDA seal of approval, we’re supposed to be able to let out a sigh of relief.
Don’t sigh too quickly.
Abbott Nutrition formula has faced a massive recall from the FDA because a baby became sick from a rare bacterium that was discovered in the formula being produced at the Sturgis, Michigan plant.
The bacterial infection should have been caught. In fact, an FDA inspector was at the Abbott Nutrition formula plant in September of last year – the same day that the FDA found out about a baby getting sick. What did the inspectors find? Nothing that would warrant regulatory action.
That is, the inspectors didn’t find what they should have. They failed. And they failed parents all around the nation as a result of their insufficient inspections.
As if that’s not enough to make you sick, it had been two years since the FDA visited the Abbott Nutrition formula plant. That’s a long gap. Infants face more health vulnerabilities than virtually any other population, which means that formula manufacturers are supposed to be inspected by the FDA at least once a year.
According to the FDA, the Sturgis plant was inspected at least once a year from 2012 to 2019. Due to COVID and other unspecified reasons, the inspections were paused because they weren’t “mission critical.”
Hmmm. Inspecting infant formula isn’t considered critical? Literally every mother who has ever wondered if their baby’s formula is safe would disagree with that assessment.
When the FDA finally did make it to the Abbott Nutrition manufacturing plant last September, they were there for five days. They didn’t find anything more than a few food safety issues. They most certainly didn’t find the Cronobacter sakazakii, which is a rare bacteria that can lead to deadly infections in infants.
In the coming months, four infants would be hospitalized with bacterial infections – and two would die.
It took FDA inspectors another four months to return to the plant. When they finally got around to the inspection, they found over five different strains of Cronobacter on plant equipment that would eventually come into contact with the infant formula.
Here’s the real problem, as identified by Sarah Sorcher, the deputy director of regulatory affairs at the Center for Science in the Public Interest: “One of the lessons from this seems to be that FDA’s formula inspections could be a lot more rigorous. It’s clear that FDA caught a lot of things in [the most recent inspection] that they missed last fall because they weren’t looking closely enough.”
It kind of makes you wonder what else they haven’t looked at closely enough – you know, COVID vaccines, COVID tests, the food that we eat day in and day out.
Suddenly, “FDA approved” doesn’t provide us with the confidence that it once did.