Food and Drug Administration

US health officials have declared the largest cyclospora food poisoning outbreak in the country's history over.

The FDA says all recalled iceberg lettuce linked to the outbreak is off the market.

Nearly 13,000 cases were reported.

The outbreak affected 21 states, with Michigan hit the hardest.

That's never gonna change, ever, because the USDA has been captured by the corporations.

Now, what about the FDA? Well, maybe we could work on the FDA, and then they would come around and say, "Oh, gosh, you know, human beings for the last three and a half million years have been eating mostly fatty meat, eggs, and some vegetables, some fruits, some berries.

That's, that's the proper human diet." Well, guess what? There are these corporations by the name of Kellogg's, Kraft Heinz, Mondelez, General Mills, who say they got the same deal with the FDA as, as the other corporations do with the USDA.

And so the US, the FDA, you may not know this, they get anywhere from 45 to 50% of their funding from the profits of the big food manufacturers and the big pharmaceutical manufacturers.

So you work at the FDA for a few years, it's not a great salary, and then you get a promotion to the co-

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so that's why FDA can look at it and go, "Oh, we've nothing to see here." Yeah, there's a lot to see here.

Like, really a lot to see.

Um, I mean, all you have to do is go on the social media pages about these drugs, and I'm sorry, when they say, "Oh, we, we've only had, like, you know, 20,000 complaints," I'm like, "Well, there's 150,000 people on this one site complaining.

coding, reimbursement, adoption, and delivery.

You can have an FDA cleared or approved technology supported by evidence, but if coverage labels it investigational, reimbursement doesn't support it.

or administrative friction makes adoption impractical, it may never meaningfully reach patients.

So innovation that cannot traverse coverage and reimbursement is innovation a patient will never receive.

Memorials are ongoing as we're recording this, and we hope everyone can take a few minutes to remember those we lost on that terrible day.

First up is FDA leadership.

The agency announced this week that the directors of the Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research were no longer temporary leaders.

Sue, what do we know about this at this point?

Well, Kareem McHale and Mike Davis were named permanent directors of Center for Biologics and Center for Drugs, respectively.

So they have been in an acting capacity since mid-May when there was a whole bunch of personnel chaos at the FDA.

So one would think this is a good sign, a good indicator of some growing stability Within those two centers, after a very kind of rocky year and a half, which involved a lot of revolving leadership at both centers, I think we had counted last year, in 2025 alone, CEDAR had five directors or acting directors.

And I'm not sure what the numbers were for CBER.

We are pulling from a ton of industry intelligence.

We are talking about the National Restaurant Association's 2026 State of the Industry Projections, DoorDash's Q4 shareholder letter, these crazy new FDA compliance mandates that are like legitimately keeping supply chain managers up at night.

You have to,

because what we are seeing across all of these disparate reports from the tech side, the food safety side, the labor side is is this fundamental permanent shift.

And I saw a piece from Food Dive that warned operators that the next big recall risk isn't even the ingredients themselves.

Oh, really?

Yeah, the FDA is going to start cracking down on packaging data.

The physical materials touching the food have to be just as traceable as the food itself.

Listen, I don't want to insult my buddy, but Claude did a better job than my buddy did.

So I think where there is a fixed data set, FDA files and FDA guidelines and really depth of information on the FDA that says this is exactly what you need to do.

If you're not using a large language model to kind of short circuit things, keep costs down and to move faster, you're missing the boat.

And that's just one example of many things that I use that I use that for.

So let's say that we created a center of excellence for treating muscular dystrophies, and there are centers of excellence throughout the United States, about 90 different clinics.

But why don't we say, let's say one of those clinics is really, really good at cell therapy for muscular dystrophy.

Okay, well then have FDA validate their small scale manufacturing, their cellular manufacturing process, And then, you know, put together a program where you fly patients in and they get treated there.

You're flying to Thailand, you know, you shouldn't have to fly to Thailand.

You would absolutely have called it science fiction.

I mean, okay, sure, we can explain how you would die even without AI ever doing anything it can't already do, only by doing it all sufficiently faster and better and cheaper, if that's what you really want, like I need to get every move an AI makes past some sort of FDA-style approval process that always says no, but I don't see the point.

The head of YC, Gary Tan, illustrates how crazy this mindset now looks, as he expresses views well summarized by Ball and F. Quote Dean W.

Ball, I don't really care about science fiction.

He talked about his grandfather working in a factory there that he recently visited.

He said the Democrats today are not even the party, are not the party of FDA or JFK, FDR or JFK, and not even the party of Bill Clinton.

But then he made an argument that I don't understand politically.

He said again and again and again, the Democrats are the party of hatred.