Generally recognized as safe

And that is what some refer to as This regulatory gap that's often referred to as a GRAS loophole, G-R-A-S loophole.

What does that stand for? Well, that stands for Generally Recognized as Safe.

So as we know, the vast majority of things that become toxic become toxic either inherently they're toxic or they're toxic in a particular dose.

So toxicity, doctors will tell you toxicity is in the dose.

And the woman died from... just too much water, which is not an easy thing to do, I imagine.

So toxicity is always going to be in the dose.

But what we're looking at as these generally recognized as safe, this kind of regulatory gap is tightening that up and finding out what's in there.

And I think these sweeteners are going to end up being some of the first things.

Um, but okay, so I'm just gonna get right into the news that we have for you today.

So first up in news, FDA has proposed a significant change to the generally recognized as safe, or GRAS, framework that would require companies to notify the agency when they independently conclude that a substance used in human or animal food is GRAS.

So the new proposed rule would amend 21 CFR Parts 170 and 570 and largely end the existing voluntary notification system.

It would apply to substances that are introduced into interstate commerce under the GRAS provision of the Federal Food, Drug, and Cosmetic Act, including ingredients added directly to food and substances added indirectly, such as those that migrate from food packaging.

So of note, mandatory notification would not turn GRAS into a pre-market review and approval program.

Companies would still independently determine whether a substance is GRAS, and then market it before notifying FDA or while FDA evaluates the notice.

So instead, FDA said mandatory notification would improve post-market oversight by giving the agency greater visibility into substances entering the food supply and helping it identify uses that may actually require food additive approval.

So under the current system, FDA says it doesn't know how many substances are marketed based solely on independent GRAS conclusions.

It's been going on since 1958.

It stands for Generally Recognized as Safe.

So this was initially created just for household ingredients like salt and vinegar.

Of course, over time, corporate capture came in and the system changed completely.

People weren't dying on the spot.

So by the late 1950s, they determined that the additives that had been around for a long time, um, were generally recognized as safe or GRAS, G-R-A-S, GRAS.

And they were out in the food supply, and the idea was if anybody could find anything wrong with them, they would take them out.

Otherwise, they were in.

Yeah

... could you help me to understand that?

What the FDA is able to do is to revoke the GRAS status, and it did that for trans fats.

That is partially hydrogenated, uh, salad oils that have fatty acids in a specific configuration that's different from the natural one, and they revoked.

So you might be surprised at my thoughts on this.

I'm breaking down today what it is to be a generally recognized as safe ingredient, what it means and what the new proposal coming from the FDA, what it could change and why I'm not convinced that government regulation is really the answer here.

Stay with me until the end because I'm going to share what I believe is actually the most powerful thing you and I can do to truly change the broken food system.

And it's something that you can start doing today right in your own pantry.

Okay, so my head is spinning with so many things that I want to cover in this episode.

So first, I want to start by backtracking.

Before we get too far into this episode, we've actually talked about the history behind ingredients being considered generally recognized as safe.

We did a full episode quite a while back, episode 131.