bildramer t1_j5hf7lw wrote on January 23, 2023 at 12:49 AM

Reply to comment by 8BitSk8r in US investigating baby formula plant after national shortage by nosotros_road_sodium

The FDA are the very ones responsible for the mess. Paying them more money is supposed to accomplish what, exactly?

DefinitelyNotAliens t1_j5i0p58 wrote on January 23, 2023 at 3:21 AM

The FDA is responsible for taking reports, investigating them, issuing multiple warning to a private company they are out of compliance, starting a plan to fix the issue, private company not complying and then shutting down a facility that killed babies due to unsafe food standards?

Timeline here. Pdf of the intitial complaints.

They had gotten a warning several months prior, and then sicknesses started. Of the batches of formula sampled, none actually turned up as positive for bacterial contamination. After several sicknesses they arranged a site visit to Abbott anyways. Abbott was notified of the visit due to COVID and then said they had an active outbreak. The visit was delayed. At this point, no formula from the homes of sick/ deceased infants had actually tested positive, just the children. But all their formula came from one facility.

When Abbott tried for a second delay, the FDA showed up anyways, found dilapidated equipment, roof leaks and multiple swabs came back positive for bacterial contamination. The facility had not made any changes since the prior warning but understaffing at the FDA had poor follow up. They confirmed bacterial contamination on Feb 13 and had a recall by the 17th after delaying voluntary recall. On Feb 17th the FDA issued a statement to not use those baby formula cans and the company finally recalled them.

Better funding for more frequent inspections and more follow up could have stopped them from having the facility get that bad and better enforcement of repairs once the issues are found.

bildramer t1_j5j9ilv wrote on January 23, 2023 at 11:59 AM

The FDA is also responsible for the insane regulations that don't let anyone import foreign baby food in the first place. Not because of any nutrition requirements, or safety, but labeling requirements. Why not temporarily suspend those? I guess babies don't matter that much after all.

The FDA is responsible for closing the plant two+ months after they had multiple reports about the same issue leading to baby deaths, relying on "maybe if we tell them they'll stop on their own" when they had less reports I guess, and for somehow not finding any of the clearly contaminated baby formula. Or maybe that means there wasn't any, and the contamination in the plant was confirmation bias and not significant? If they were trustworthy I wouldn't question that, but they aren't. The FDA is responsible for not responding quickly to the issue after the fact, taking entire months to sign paperwork and plan meetings when babies are potentially dying. The FDA is responsible for wanting increased control over the baby formula supply chain but having no sensible plan and communicating nothing to the public when a real crisis came. "Let's just kill the majority of the country's supply for months, and wait, maybe some day we'll reopen it" is not a plan.

I don't see how giving them more staff could fix the dumb decisionmaking.

I guess you're right in that it's not only them. The WIC contracts are responsible for Abbott having all this monopoly power, and the NAFTA is responsible for enormous tariffs on Canadian formula.

DefinitelyNotAliens t1_j5jt8zu wrote on January 23, 2023 at 2:53 PM

They did allow import other countries formula. We eased import regs almost immediately and the FDA is changing rules to make it a permanent shift and working with overseas suppliers to keep formula incoming, especially with our ongoing shortage.

They had four cases. Two illnesses, two deaths. They and the state department of health (Texas and Minnesota) and the CDC were all involved in testing and none of the formula tested was contaminated in testing. Some bacteria doesn't mean the entire can was evenly contaminated, especially since the infections weren't widespread. Unless you think multiple state departments of health and CDC were in on the grift, too. They also had the CDC sequence DNA of the bacteria and knew the cases were linked and it wasn't just environmental which is why they focused on formula without contaminated supply in any of the homes. They also sequenced DNA of bacteria in the plant.

Given the fact it wasn't a pattern at first - and four is bad without being a mass outbreak - the babies shouldn't be affected at all, but October to February given mass pandemic slowing everything at the Dept of Health in those States and the CDC and three days to shutdown after confirmation is downright fast. With the first few cases being in Minnesota, it was potentially environmental and not food related. The third case was Texas.

They did immediately start a plan to reopen the plant, and they shut down in February and the plant failed multiple reopening inspections because subsequent tests still had contamination on tested swabs. They did reopen in May, and shut in early June. It flooded due to storms, damaging supply again.

You're mad at the FDA over things they actually did do and are continuing to do. They didn't flood the factory immediately after opening. And they are permanently changing import rules.