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January 28, 2025 18 mins

Dive into the fascinating world of GRAS—"Generally Recognized as Safe"—in this eye-opening episode! From decoding the regulatory twists of GRAS to navigating the booming market of natural extracts like cannabinoids and psilocybin, we unpack what "safe" really means in food, drinks, and supplements. Learn to spot red flags, ask the right questions, and make informed choices about the products you consume. Empower yourself with the knowledge to protect your health in a world filled with bold claims and evolving science. Stay curious and join us for this essential conversation!

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Episode Transcript

Available transcripts are automatically generated. Complete accuracy is not guaranteed.
(00:00):
All right, jumping right in.

(00:01):
Today, we're doing a deep dive into, well,
the world of Gre-Assets.
So Gre-Assets, yeah, Gre-Assets,
which is generally recognized as safe.
Right.
A designation that really plays a huge role
in what we eat, what we drink,
and the medications that we take.

(00:21):
Absolutely.
You might not even realize it, but-
It's everywhere.
Gre-Assets is everywhere, so think about it,
especially in a market that's just overflowing
with all these products, making all these crazy claims,
especially those natural ones.
Especially the natural ones.
Yeah, how do you know what's truly safe?
That's what we're gonna uncover today.
Yeah, and I think it's so fascinating how much

(00:43):
we kinda just take for granted when it comes to safety.
Well, still-
Of the things that we consume, right?
And the GRS designation is really like
the perfect example of that.
It allows certain substances to bypass
the full FDA approval process for use in food and drugs
because they're already widely considered safe.
So, okay, so that means if something has
the GRS stamp of approval, we can trust

(01:06):
that it's been kinda thoroughly vetted and looked at.
Well, not quite.
Oh.
You see, the concept of general recognition of safety
is really where things get interesting.
Okay.
It's not about one study or just a quick check.
Right.
It's about a whole body of evidence built up over time.

(01:26):
Oh.
Like a historical record,
combined with scientific consensus.
So it's not just about rigorous testing in the lab,
but it's also about how these substances
have been used and understood historically.
Exactly.
A substance might gain GRS status because
it's been safely used in food for generations.
Right.
Even if it hasn't undergone the same

(01:47):
clinical trials as a new drug.
Oh, so it's a different kind of a different pathway
to demonstrating safety.
Yeah, exactly.
Okay, that makes sense.
Yeah.
Who actually decides what gets that GRS designation?
Is it the FDA who has that final say?
So this is where it gets a little more complex.
You might be surprised to learn that
it's actually the manufacturers.
Oh, wow.

(02:08):
Not the FDA, who initially determine the GRS status.
Really?
For their ingredients.
Yeah.
They're responsible for gathering the evidence
and making the case for why their substance
should be considered safe.
Hold on, so companies get to decide for themselves
if their ingredients are safe.
Right.

(02:29):
That seems a little bit like a fox guarding
the hen house situation, doesn't it?
Well, it's a valid concern, right?
Yeah.
There are definitely checks and balances in place, though.
Okay.
While manufacturers make that initial GRS determination,
they can choose to notify the FDA.
Right.
And they can submit their evidence for review.
Oh, okay.

(02:49):
So that adds a layer of scrutiny.
Gotcha.
It's not a mandatory step.
Okay, so there's an option for FDA oversight.
Right.
But it's not actually a requirement.
Right.
That definitely raises some questions
about how consistent that whole process is.
Does this apply to all substances used in food and drugs?
Well, it's important to differentiate GRS

(03:10):
from other categories, like nutraceuticals
and approved pharmaceutical ingredients,
which are also called APIs.
So while a GRS substance can be used in both foods and drugs,
nutraceuticals are a different beast altogether.
You know, you hear the word nutraceutical
thrown around a lot these days,
especially with the rise of all these

(03:31):
natural health products.
Absolutely.
What exactly makes them different
from something that's GRAS?
Think of it this way.
Okay.
GRS substances are generally used as ingredients in foods
or as inactive components of drugs.
Right.
Nutraceuticals, on the other hand,
are marketed specifically for their supposed health benefits.
Okay.
The catch is they don't have to go through

(03:51):
the same rigorous approval process as pharmaceuticals.
Ah, so that natural label doesn't necessarily mean
a product has been proven safe or effective.
Exactly.
And that's where a lot of the confusion
and potential risk lies.
Manufacturers can make all sorts of claims
about the benefits of their natural products
without having to provide the same level
of scientific backing as a drug company would.

(04:15):
This is especially relevant now, wouldn't you say?
Yeah.
We're seeing more and more products
popping up with extracts like,
like cannabinoids and psilocybin mushroom extracts.
Absolutely.
And things like that.
The consumer packaged goods market, or CPG,
is exploding with products that contain
these types of natural extracts.

(04:35):
Right.
And while some of these extracts might have,
you know, potential benefits,
the lack of regulation means there's a wide range
in quality and safety.
So we've got this interesting situation
where a product could contain a substance
as this technically GRAS.
Right.
But because it's being marketed as a nutraceutical

(04:58):
with specific health claims,
it falls into a kind of gray area.
Yeah, that's the crux of it.
Okay.
And it's why understanding GRAS
is so important for consumers.
You can't just assume that because something
is labeled as natural,
or because it contains a GRAS ingredient,
that it's automatically safe.
Or that it'll do with the label claims.

(05:19):
That's a really crucial point.
Yeah.
So how do we, how do we as consumers
start to navigate this complex landscape?
I mean, are there any red flags
we should be looking out for
when we see these kinds of products on the shelves?
Yeah, one of the biggest red flags
is a lack of transparency.

(05:40):
Okay.
When a product is making bold claims,
but doesn't clearly list its ingredients,
their concentrations, or any scientific evidence
to support those claims.
That's a major warning sign.
It's like that old saying,
if it sounds too good to be true, it probably is.
Exactly. Right.
Absolutely.
Another red flag is when a product claims

(06:02):
to cure or treat a serious medical condition,
the pharmaceuticals,
even those derived from natural sources.
Right.
Simply aren't subject to the same rigorous testing
and approval processes as pharmaceuticals.
Right, exactly.
So any promises of quick fixes or miracle cures.

(06:23):
Yes.
Should definitely raise some eyebrows.
Absolutely.
And remember, natural doesn't automatically equal safe.
Right.
Many substances found in nature can be potent
and even harmful.
Right.
If not used properly.
Or if they interact with other medications
they might be taking.
It's easy to get caught up in the hype,
especially when it comes to natural products.

(06:45):
We have this perception that they're inherently safer
and gentler than conventional medications.
Right.
But it sounds like that's not always the case.
That's a common misconception that we need
to kind of address.
Right.
Natural substances can have just as powerful
biological effects as synthetic compounds.

(07:07):
Right.
It's crucial to remember that they can interact
with medications or the other supplements.
Right.
And even pre-existing health conditions.
So before adding any new product,
especially those with natural extracts to our routine,
it's essential to talk to our doctor
or a qualified healthcare professional.

(07:27):
Right.
They can help us assess the risks and benefits
and figure out if a particular product is right for us.
That's a great point.
They can provide personalized guidance
based on your individual health history and needs
that can also help you kind of interpret
the scientific research.

(07:48):
Right.
And make informed decisions
about what's safe and effective.
It seems like knowledge really is power in this case.
Absolutely.
The more we understand about GRAS,
the better equipped we are to make informed choices
about the products that we choose.
Exactly.
Don't just blindly trust labels or marketing claims.

(08:10):
Right.
Do your own research.
Right.
Look for evidence-based information
from reputable sources.
Right.
Ask questions.
So it's a combination of doing our homework.
Yeah.
But also knowing when to seek expert advice.
Absolutely.
We've covered a lot of ground already.
I have.
But it feels like we're just scratching the surface.

(08:32):
There's so much more to explore.
You're absolutely right.
Right.
And that's why we're gonna continue our deep dive
into GRS in part two.
Okay.
We'll delve even deeper into the regulatory landscape,
examine some specific case studies.
Okay.
And provide you with even more tools
to navigate this complex world of natural product extracts.

(08:54):
I can't wait.
Until then, stay curious.
Absolutely.
And keep asking those important questions.
Absolutely.
Welcome back to our deep dive into the world of GRS.
Yeah.
It's clear that you're really interested
in taking control of your health
and making informed decisions.
Right.
And that's exactly what we want to empower you to do.
Absolutely.

(09:15):
You know, something that really struck me in the last part
was how certain products, like some herbal teas
or even cough drops, really blur the lines
between what we think of as food and drugs.
Right, yeah.
It's interesting.
Yeah, it highlights a key point that we've been discussing.
Which is that the regulatory landscape
for substances that we ingest is far more intricate

(09:38):
than most people realize.
Right, so how do we as consumers
start to make sense of it all?
I mean, what are some things we should watch out for
when we see products, especially those with natural extracts
making these bold claims?
Yeah, I think one of the biggest red flags
is a lack of scientific evidence to back up those claims.
Okay.
If a product boasts miraculous benefits

(09:59):
but doesn't cite any reputable studies or research,
that's a huge warning sign.
It's like that old saying,
if it sounds too good to be true, it probably is.
Exactly.
Another red flag is when a product claims to cure
or treat a serious medical condition.
Okay.
Remember, nutraceuticals,

(10:20):
even those derived from natural sources,
they aren't subject to the same rigorous testing
and approval processes as pharmaceuticals.
Right, so we should be wary of anything
that promises to be a quick fix or a miracle cure.
Absolutely, and always remember that,
that natural doesn't automatically equal safe.

(10:41):
Right.
Many substances found in nature can be pertinent
and even harmful if not used properly.
I think it's easy to get caught up in the hype,
especially when it comes to natural products.
Right.
There's this perception that they're inherently safer
and gentler than conventional medications.
Right.

(11:01):
But it sounds like that's not always the case.
That's a misconception that we need to address.
Okay.
Natural substances can have powerful biological effects,
just like synthetic compounds,
and they can interact with medications, other supplements,
and even preexisting health conditions.
So it's crucial to talk to our doctor
or a qualified healthcare professional

(11:22):
before adding anything new to our routine.
Right, precisely.
Okay.
They can help you assess the risks and benefits
and determine if a particular product is right for you.
Okay, so we've talked about the red flags,
but what about the green flags?
What are some things that suggest a product
might be more trustworthy?
Well, I think a good sign is when a product

(11:44):
clearly lists its ingredients.
Okay.
Including the specific extracts and their concentrations.
Right.
Transparency is key.
Right, because even if a product contains
a beneficial natural extract,
the amount present might be too low.
Exactly.
To have any real effects.
You're getting it.
Right.

(12:05):
Another positive indicator is when a manufacturer
provides information about their quality control processes.
Okay.
Do they follow good manufacturing practices?
Do they test their products for purity and potency?
That makes sense, yeah.
It's reassuring to know that,
that a company takes quality seriously
and is committed to producing safe and effective products.

(12:25):
Right, and of course, always look for products
that are backed by scientific evidence.
Are there any reputable studies
that support the claims being made?
That's where things can get a little tricky.
Sure.
For the average consumer.
Absolutely.
You know, it's not always easy
to decipher scientific research.
You're right.
That's why it's so important to consult with your doctor

(12:47):
or a healthcare professional who can, you know,
who can help you interpret the evidence
and make informed decisions.
So it's about doing our homework,
but also knowing when to seek expert advice.
Exactly.
It's a powerful combination.
And remember, it's an ongoing process.
Right.
The world of natural product extracts
is constantly evolving.

(13:08):
Right.
New research is emerging all the time.
Right.
So staying informed is key.
This all makes me think about those products
with cannabinoids and psilocybin mushroom extracts
that we were talking about earlier.
Sure.
It seems like there's a lot of excitement,
but also a lot of uncertainty.
Right.
Surrounding those ingredients.
Yeah.

(13:29):
You've hit on a really crucial point.
Yeah.
These are substances that have shown
potential therapeutic benefits.
Right.
But there's still a lot we don't know
about their long-term effects and potential risks.
And because they're often marketed as nutraceuticals.
Right.
They're not subject to the same level
of scrutiny as pharmaceuticals, right?

(13:49):
Exactly.
That means consumers need to be, you know, extra cautious
and do their due diligence before trying these products.
So what kind of questions should we be asking ourselves
when we encounter a product containing, you know,
a cannabinoid or a psilocybin mushroom extract?
First and foremost, what are the specific claims being made?

(14:11):
Okay.
Are they backed by scientific evidence
or are they just hype?
Secondly, what's the source of the extract?
Yeah.
Is it coming from a reputable supplier
with high quality control standards?
Those are really important questions to consider.
Yeah.
It's easy to get, you know, swept up in the marketing.
Absolutely.
But we need to be critical thinkers.

(14:33):
Yeah.
And look beyond those flashy labels.
I couldn't agree more.
Right.
We need to remember that our health is precious.
Right.
And we shouldn't take, you know,
risks with unproven products.
So while there's a lot of potential
in these natural extracts,
it's crucial to proceed with caution

(14:54):
and make informed choices.
Absolutely.
We need to be our own advocates
and seek out reliable information.
Absolutely.
And that's what we're trying to equip you to do here today.
We want you to feel empowered to navigate the complexities
of the GRES landscape.
Right.
And make decisions that support your wellbeing.
This has been a really eye-opening conversation so far.

(15:15):
I feel like I'm starting to understand the nuances
of RIS in a way I never have before.
That's fantastic to hear.
And we're not done yet.
Okay.
In part three, we're gonna delve even deeper
into specific case studies
and explore the future of GRES
in the context of this rapidly evolving CPG market.
I can't wait to continue this journey with you.

(15:37):
Me too.
Until then, stay curious
and keep those critical thinking skills sharp.
Absolutely.
Welcome back to the Deep Dive.
It's been quite a journey, really.
It has.
Discovering all the intricacies of GRES.
We've explored its regulatory twists and turns,
tackled those tricky natural product claims.

(15:58):
Right.
And even ventured into the wild west of extracts
in the CPG market.
The wild west, that's a great way to put it.
Yeah, it's pretty wild out there.
It is.
When we started this Deep Dive,
I thought GRES was a pretty black and white concept.
A substance is either safe or it isn't.
With a heart.
Turns out there's a lot of gray areas,

(16:18):
especially when you consider how GRES interacts
with the world of nutraceuticals.
Yeah.
And those unregulated players in the CPG market.
Yeah, you're absolutely right.
There's a real tension between the flexibility
that GRES allows.
Right.
And the need for consumer protection,
particularly in a market that's constantly evolving

(16:39):
with new ingredients and products emerging all the time.
Thinking back to our discussion about those products
with cannabinoids and psilocybin mushroom extracts.
Right.
It seems like those are prime examples
of that tension playing out in real time.
Absolutely.
Those extracts are creating a whole new set of challenges

(17:00):
for regulators and consumers alike.
Right.
On the one hand, there's growing interest
in their potential therapeutic benefits.
Right.
But on the other hand, there's still so much we don't know
about their long-term effects and how they interact
with other substances.
It feels like we're in this transition period

(17:20):
where science is trying to catch up with the market.
And consumers are left to navigate a lot of uncertainty.
That's a great way to put it.
Yeah.
And that's precisely why understanding GRES is so crucial.
Right.
It's not just about knowing what's safe.
It's about understanding the limitations
of that designation.

(17:41):
Right.
The potential loopholes and the importance
of critical thinking when evaluating product claims.
So as we wrap up our deep dive into the world of GRES,
what's the one key takeaway you want our listener to remember?
I'd say it's this.
Empower yourself with knowledge.
Thank you.
Don't just blindly trust labels or marketing hype,

(18:04):
especially when it comes to products
containing natural extracts.
Right.
Do your research.
OK.
Ask questions.
OK.
When in doubt, consult with a qualified health care
professional.
Right.
Your health is your most valuable asset.
Protect it wisely.
Beautifully said.
Thank you.
And on that note, we've reached the end of our GRES deep dive.

(18:26):
We hope you found it enlightening.
Yeah.
Maybe even a little bit empowering.
Absolutely.
Remember, keep learning, keep questioning, and stay curious.
Stay curious.
We'll catch you in our next deep dive.
Sounds good.
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