This crisis is NOT the FDA’s fault. Their job is to make sure the products are SAFE. They didn’t cause any of this, and are acting as quickly as they reasonably can now to solve a problem created by others.
As mentioned above, Trump’s trade policies intentionally blocked formula from our closest neighbors.
And we have policies that are supposedly protecting the industry by imposing 17.5% tariffs on imported formula.
Also, it’s not like the FDA just decided, on their own, to regulate baby formula. Congress did that. And… I think it’s a good idea if you care about the safety of babies.
Summary of H.R.6940 - 96th Congress (1979-1980): An act to amend the Federal Food, Drug, and Cosmetic Act to strengthen the authority under that Act to assure the safety and nutrition of infant formulas, and for other purposes.
www.congress.gov
There are many factors to this crisis. Blaming the FDA doesn’t fix anything. Long-term, we need to possibly create a stockpile, reduce tariffs, find a way to encourage foreign countries to create products that meet the FDA standards (it’s mainly labeling, but with 17.5% tariffs, they just don’t bother), and maybe think twice before we rubber-stamp every single corporate merger in America.
Here are some more facts on the causes of the problem, and what’s being done.
A shortage of baby formula has provoked misleading partisan claims that suggest President Joe Biden is responsible for the "bare shelves." But the shortage has been caused by a recall and plant shutdown by a major manufacturer and ongoing supply-chain issues due to the pandemic.
www.factcheck.org
Finally, part of this is the same problem we had when stores ran out of toilet paper. People are hoarding.
Define fault- no they did not create contaminated formula but they allowed this situation to get completely out of hand.
Excuse me, but where did I say the FDA should not regulate baby formula? And I never said anything about “bare shelves Biden” or alluded to such. I said he should have pressured the FDA weeks ago to come up with a solution.
If you care about the safety of babies, then maybe you should consider having the FDA do their job in an efficient and effective manner.
And for the record European formula has been illegal in the US for decades as the US and European nutritional requirements do not align. I don’t know anything about the Trump-Formula situation, but I suspect it probably has a lot to do with the 3 major formula manufactures and farmers lobbying against it. Where the formula comes from is irrelevant and FDA fulfilling their responsibility is not a political issue.
First, why did the FDA go a full
2 years without inspecting Abbott’s facility? Especially one known to have issues.
Why is it that the FDA received a 34 page whistle blower report in October 2021 alleging:
- Falsification of records
- Distributing untested formula
- Staff celebrated the FDA not finding known problems in their 2019 audit
- Improper aseptic technique
- Failing to take action to reduce defects consistent with Good Manufacturing Practices policy
- Failing to properly trace products
The facility did not have an on-site until February 2022, nearly
4.5 months later.
Also in September 2021 the FDA was made aware of an infant death possibly linked to the formula and again, did nothing for months.
And even when the bacteria was confirmed to be in the factory, it took them
weeks to inform the public.
And then when the the FDA told Abbott to recall their formula and shut down the factory, they evidently had zero plan of where 30% or whatever of the country would get its formula. And this is on top of a pre-existing supply chain problem.
Now two months later the situation becomes desperate and so then the FDA realizes it needs to find a solution to this that’s faster than the months required to restart the Sturgis factory.
According to Scott Gottlieb, the former FDA head, this factory was known to have “persistent problems” that were “poorly handled” and that the FDA didn’t exert all the oversight that they could have”.
Just about every media source in the country is flabbergasted by the FDA’s repeated failures.
And if the FDA did such a good job, why have they started an investigation into themselves? Why is Congress hounding them for explanations?
This is not a controversial opinion on the slightest.
This crisis obviously stems from negligence from Abbott. But this wouldn’t have happened in the FDA provided the correct level of oversight to begin with (ie not going 2 years without an inspection). Based on other reporting, the inspections that did occur in the past were not particularly thorough. Maybe that promotes a culture of “we can get away not doing x y z”. Maybe better oversight would have caught this problem earlier and maybe the situation would be easier to mitigate.
We’re well past that point though. When the FDA was made aware of problems, they sat on their hands for months. And when the decision was made to close the factory, they evidently made zero plan deal with the consequences- in fact failed to even foresee the potential conflict (watch the CNN interview with the current FDA chief).
This performance should be absolutely unacceptable to Americans. I’m not sure why you’re trying to defend the blatant failures of this agency. If you ignore such circumstances, they are bound to repeat themselves. As I alluded to in my previous post, these shortcomings are nothing new but they never get mainstream media attention because the consequences aren’t felt by a large swath of the country. So many the silver lining is there will be improvements.
www.huffpost.com
