CNCCurrency
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What makes this relevant to you?exploitedworkerbee said:
Even a stopped clock shows the correct time twice daily.GTS97 said:
And people say he’s ssSssSsssSssooOooOooOO HORRIBLE
RFK Announces Reclassification of Several Peptides
- Thread starter mybodyisasewer
- Start date
ltjltj
Explorer
That's no different from any other medication — so why should peptides be exempt from at least having safety data?CNCCurrency said:
What do you mean? After they are rescheduled, compounders will be permitted to produce them once more! A doctor's prescription is still required.ltjltj said:
Peptides are simply drugs. Why would they all be made available automatically to everyone through compounding, without regard to what the data says about their safety and efficacy?CNCCurrency said:
Wait, what? This guy backs peptides! He takes them himselfltjltj said:
The filter keeps flagging most of what I wanted to say as prohibited content, and I honestly can't work out why
I'm not convinced health is the real motive here. We'll find out soon enough who sits on the panel that signs off on this, and whether things like Melanotan 2 end up getting "approved". I have no desire to return to the days of pre-FDA snake oil and poison peddlers.
With far less pharma and far more of him, GLP-1 drugs and vaccines wouldn't exist — and I want both of those very much.
(As for efficacy, that's arguable, but since I'm quite open to off-label use, I'm far less worried about proof of efficacy in this area than I am about safety.)
I also don't see any reason why peptides should be reviewed by a separate panel compared with other kinds of drugs.
Broadly speaking, I'm very open to a pathway that assesses drugs backed by substantial data — particularly ones already approved elsewhere — without a sponsoring company driving them through. That fits a couple of the peptides on the list, but not the majority. So, as I said above, let's see who ends up on this panel, and what safety justification is given for the ones that pass and get approved. It's still early.
CNCCurrency
Explorer
I don't get what your problem is with this. At the moment, where do you actually source your GLP-1 and your other peptides?ltjltj said:
That's no different from any other medication — so why should peptides be exempt from at least having safety data?CNCCurrency said:
What do you mean? After they are rescheduled, compounders will be permitted to produce them once more! A doctor's prescription is still required.ltjltj said:
Peptides are simply drugs. Why would they all be made available automatically to everyone through compounding, without regard to what the data says about their safety and efficacy?CNCCurrency said:
Wait, what? This guy backs peptides! He takes them himselfltjltj said:
The filter keeps flagging most of what I wanted to say as prohibited content, and I honestly can't work out why
I'm not convinced health is the real motive here. We'll find out soon enough who sits on the panel that signs off on this, and whether things like Melanotan 2 end up getting "approved". I have no desire to return to the days of pre-FDA snake oil and poison peddlers.
With far less pharma and far more of him, GLP-1 drugs and vaccines wouldn't exist — and I want both of those very much.
(As for efficacy, that's arguable, but since I'm quite open to off-label use, I'm far less worried about proof of efficacy in this area than I am about safety.)
I also don't see any reason why peptides should be reviewed by a separate panel compared with other kinds of drugs.
Broadly speaking, I'm very open to a pathway that assesses drugs backed by substantial data — particularly ones already approved elsewhere — without a sponsoring company driving them through. That fits a couple of the peptides on the list, but not the majority. So, as I said above, let's see who ends up on this panel, and what safety justification is given for the ones that pass and get approved. It's still early.
Two buckets ought to exist: one for things the FDA has approved, one for things it hasn't. Just label them that way and leave the decision to individuals. The non-FDA-approved bucket would cover every wild energy shot, supplement, peptide and so on, unless a given company chose to pursue the FDA path. The majority of people simply don't care. After all, the government already permits you to put seriously harmful substances into your body (provided you're past a certain age).
CNCCurrency
Explorer
ltjltj
Explorer
Is it accurate that GLP-1s are unapproved FDA drugs with a severe shortage of safety data? No. (As of today Reta is unapproved, though there is certainly no shortage of safety data on it.) Arguing that doctors should prescribe some of the peps on that list even without safety data also opens up an enormous can of malpractice worms.CNCCurrency said:
I don't get what your problem is with this. At the moment, where do you actually source your GLP-1 and your other peptides?ltjltj said:
That's no different from any other medication — so why should peptides be exempt from at least having safety data?CNCCurrency said:
What do you mean? After they are rescheduled, compounders will be permitted to produce them once more! A doctor's prescription is still required.ltjltj said:
Peptides are simply drugs. Why would they all be made available automatically to everyone through compounding, without regard to what the data says about their safety and efficacy?CNCCurrency said:
Wait, what? This guy backs peptides! He takes them himselfltjltj said:
The filter keeps flagging most of what I wanted to say as prohibited content, and I honestly can't work out why
I'm not convinced health is the real motive here. We'll find out soon enough who sits on the panel that signs off on this, and whether things like Melanotan 2 end up getting "approved". I have no desire to return to the days of pre-FDA snake oil and poison peddlers.
With far less pharma and far more of him, GLP-1 drugs and vaccines wouldn't exist — and I want both of those very much.
(As for efficacy, that's arguable, but since I'm quite open to off-label use, I'm far less worried about proof of efficacy in this area than I am about safety.)
I also don't see any reason why peptides should be reviewed by a separate panel compared with other kinds of drugs.
Broadly speaking, I'm very open to a pathway that assesses drugs backed by substantial data — particularly ones already approved elsewhere — without a sponsoring company driving them through. That fits a couple of the peptides on the list, but not the majority. So, as I said above, let's see who ends up on this panel, and what safety justification is given for the ones that pass and get approved. It's still early.
Like I said, I have no idea how this will shake out - I floated some plausible outcomes (an approval path for drugs that have safety data but no corporate muscle behind them), but the FDA going full YOLO across the board runs completely against its mission.
Do you think any compound a company comes up with ought to be obtainable through compounding before safety data exists? If you don't, then why should peptides be treated as a special category of drug that justifies skipping that safety step?
CNCCurrency
Explorer
When a GLP-1 isn't the brand-name product, then correct — it isn't an FDA-approved drug. In other words, compounded GLP-1s lack FDA approval.ltjltj said:
Is it accurate that GLP-1s are unapproved FDA drugs with a severe shortage of safety data? No. (As of today Reta is unapproved, though there is certainly no shortage of safety data on it.) Arguing that doctors should prescribe some of the peps on that list even without safety data also opens up an enormous can of malpractice worms.CNCCurrency said:
I don't get what your problem is with this. At the moment, where do you actually source your GLP-1 and your other peptides?ltjltj said:
That's no different from any other medication — so why should peptides be exempt from at least having safety data?CNCCurrency said:
What do you mean? After they are rescheduled, compounders will be permitted to produce them once more! A doctor's prescription is still required.ltjltj said:
Peptides are simply drugs. Why would they all be made available automatically to everyone through compounding, without regard to what the data says about their safety and efficacy?CNCCurrency said:
Wait, what? This guy backs peptides! He takes them himselfltjltj said:
The filter keeps flagging most of what I wanted to say as prohibited content, and I honestly can't work out why
I'm not convinced health is the real motive here. We'll find out soon enough who sits on the panel that signs off on this, and whether things like Melanotan 2 end up getting "approved". I have no desire to return to the days of pre-FDA snake oil and poison peddlers.
With far less pharma and far more of him, GLP-1 drugs and vaccines wouldn't exist — and I want both of those very much.
(As for efficacy, that's arguable, but since I'm quite open to off-label use, I'm far less worried about proof of efficacy in this area than I am about safety.)
I also don't see any reason why peptides should be reviewed by a separate panel compared with other kinds of drugs.
Broadly speaking, I'm very open to a pathway that assesses drugs backed by substantial data — particularly ones already approved elsewhere — without a sponsoring company driving them through. That fits a couple of the peptides on the list, but not the majority. So, as I said above, let's see who ends up on this panel, and what safety justification is given for the ones that pass and get approved. It's still early.
Like I said, I have no idea how this will shake out - I floated some plausible outcomes (an approval path for drugs that have safety data but no corporate muscle behind them), but the FDA going full YOLO across the board runs completely against its mission.
Do you think any compound a company comes up with ought to be obtainable through compounding before safety data exists? If you don't, then why should peptides be treated as a special category of drug that justifies skipping that safety step?
ltjltj
Explorer
I feel like we're not really hearing each other. As far as I'm concerned, my position on the safety evidence is straightforward. If what you're saying is that compounded GLP-1 has no safety evidence behind it while pharma GLP-1 does, then that's a distinction we'll just have to disagree on.CNCCurrency said:
When a GLP-1 isn't the brand-name product, then correct — it isn't an FDA-approved drug. In other words, compounded GLP-1s lack FDA approval.ltjltj said:
Is it accurate that GLP-1s are unapproved FDA drugs with a severe shortage of safety data? No. (As of today Reta is unapproved, though there is certainly no shortage of safety data on it.) Arguing that doctors should prescribe some of the peps on that list even without safety data also opens up an enormous can of malpractice worms.CNCCurrency said:
I don't get what your problem is with this. At the moment, where do you actually source your GLP-1 and your other peptides?ltjltj said:
That's no different from any other medication — so why should peptides be exempt from at least having safety data?CNCCurrency said:
What do you mean? After they are rescheduled, compounders will be permitted to produce them once more! A doctor's prescription is still required.ltjltj said:
Peptides are simply drugs. Why would they all be made available automatically to everyone through compounding, without regard to what the data says about their safety and efficacy?CNCCurrency said:
Wait, what? This guy backs peptides! He takes them himselfltjltj said:
The filter keeps flagging most of what I wanted to say as prohibited content, and I honestly can't work out why
I'm not convinced health is the real motive here. We'll find out soon enough who sits on the panel that signs off on this, and whether things like Melanotan 2 end up getting "approved". I have no desire to return to the days of pre-FDA snake oil and poison peddlers.
With far less pharma and far more of him, GLP-1 drugs and vaccines wouldn't exist — and I want both of those very much.
(As for efficacy, that's arguable, but since I'm quite open to off-label use, I'm far less worried about proof of efficacy in this area than I am about safety.)
I also don't see any reason why peptides should be reviewed by a separate panel compared with other kinds of drugs.
Broadly speaking, I'm very open to a pathway that assesses drugs backed by substantial data — particularly ones already approved elsewhere — without a sponsoring company driving them through. That fits a couple of the peptides on the list, but not the majority. So, as I said above, let's see who ends up on this panel, and what safety justification is given for the ones that pass and get approved. It's still early.
Like I said, I have no idea how this will shake out - I floated some plausible outcomes (an approval path for drugs that have safety data but no corporate muscle behind them), but the FDA going full YOLO across the board runs completely against its mission.
Do you think any compound a company comes up with ought to be obtainable through compounding before safety data exists? If you don't, then why should peptides be treated as a special category of drug that justifies skipping that safety step?
CNCCurrency
Explorer
The same argument applies to the peptides they're looking to reschedule. You still haven't said where yours come from?ltjltj said:
I feel like we're not really hearing each other. As far as I'm concerned, my position on the safety evidence is straightforward. If what you're saying is that compounded GLP-1 has no safety evidence behind it while pharma GLP-1 does, then that's a distinction we'll just have to disagree on.CNCCurrency said:
When a GLP-1 isn't the brand-name product, then correct — it isn't an FDA-approved drug. In other words, compounded GLP-1s lack FDA approval.ltjltj said:
Is it accurate that GLP-1s are unapproved FDA drugs with a severe shortage of safety data? No. (As of today Reta is unapproved, though there is certainly no shortage of safety data on it.) Arguing that doctors should prescribe some of the peps on that list even without safety data also opens up an enormous can of malpractice worms.CNCCurrency said:
I don't get what your problem is with this. At the moment, where do you actually source your GLP-1 and your other peptides?ltjltj said:
That's no different from any other medication — so why should peptides be exempt from at least having safety data?CNCCurrency said:
What do you mean? After they are rescheduled, compounders will be permitted to produce them once more! A doctor's prescription is still required.ltjltj said:
Peptides are simply drugs. Why would they all be made available automatically to everyone through compounding, without regard to what the data says about their safety and efficacy?CNCCurrency said:
Wait, what? This guy backs peptides! He takes them himselfltjltj said:
The filter keeps flagging most of what I wanted to say as prohibited content, and I honestly can't work out why
I'm not convinced health is the real motive here. We'll find out soon enough who sits on the panel that signs off on this, and whether things like Melanotan 2 end up getting "approved". I have no desire to return to the days of pre-FDA snake oil and poison peddlers.
With far less pharma and far more of him, GLP-1 drugs and vaccines wouldn't exist — and I want both of those very much.
(As for efficacy, that's arguable, but since I'm quite open to off-label use, I'm far less worried about proof of efficacy in this area than I am about safety.)
I also don't see any reason why peptides should be reviewed by a separate panel compared with other kinds of drugs.
Broadly speaking, I'm very open to a pathway that assesses drugs backed by substantial data — particularly ones already approved elsewhere — without a sponsoring company driving them through. That fits a couple of the peptides on the list, but not the majority. So, as I said above, let's see who ends up on this panel, and what safety justification is given for the ones that pass and get approved. It's still early.
Like I said, I have no idea how this will shake out - I floated some plausible outcomes (an approval path for drugs that have safety data but no corporate muscle behind them), but the FDA going full YOLO across the board runs completely against its mission.
Do you think any compound a company comes up with ought to be obtainable through compounding before safety data exists? If you don't, then why should peptides be treated as a special category of drug that justifies skipping that safety step?
ltjltj
Explorer
For the majority of the peptides on that list, that claim simply doesn't hold up. How many of them have an FDA-approved commercial counterpart? How many are supported by meaningful safety data?CNCCurrency said:
The same argument applies to the peptides they're looking to reschedule. You still haven't said where yours come from?ltjltj said:
I feel like we're not really hearing each other. As far as I'm concerned, my position on the safety evidence is straightforward. If what you're saying is that compounded GLP-1 has no safety evidence behind it while pharma GLP-1 does, then that's a distinction we'll just have to disagree on.CNCCurrency said:
When a GLP-1 isn't the brand-name product, then correct — it isn't an FDA-approved drug. In other words, compounded GLP-1s lack FDA approval.ltjltj said:
Is it accurate that GLP-1s are unapproved FDA drugs with a severe shortage of safety data? No. (As of today Reta is unapproved, though there is certainly no shortage of safety data on it.) Arguing that doctors should prescribe some of the peps on that list even without safety data also opens up an enormous can of malpractice worms.CNCCurrency said:
I don't get what your problem is with this. At the moment, where do you actually source your GLP-1 and your other peptides?ltjltj said:
That's no different from any other medication — so why should peptides be exempt from at least having safety data?CNCCurrency said:
What do you mean? After they are rescheduled, compounders will be permitted to produce them once more! A doctor's prescription is still required.ltjltj said:
Peptides are simply drugs. Why would they all be made available automatically to everyone through compounding, without regard to what the data says about their safety and efficacy?CNCCurrency said:
Wait, what? This guy backs peptides! He takes them himselfltjltj said:
The filter keeps flagging most of what I wanted to say as prohibited content, and I honestly can't work out why
I'm not convinced health is the real motive here. We'll find out soon enough who sits on the panel that signs off on this, and whether things like Melanotan 2 end up getting "approved". I have no desire to return to the days of pre-FDA snake oil and poison peddlers.
With far less pharma and far more of him, GLP-1 drugs and vaccines wouldn't exist — and I want both of those very much.
(As for efficacy, that's arguable, but since I'm quite open to off-label use, I'm far less worried about proof of efficacy in this area than I am about safety.)
I also don't see any reason why peptides should be reviewed by a separate panel compared with other kinds of drugs.
Broadly speaking, I'm very open to a pathway that assesses drugs backed by substantial data — particularly ones already approved elsewhere — without a sponsoring company driving them through. That fits a couple of the peptides on the list, but not the majority. So, as I said above, let's see who ends up on this panel, and what safety justification is given for the ones that pass and get approved. It's still early.
Like I said, I have no idea how this will shake out - I floated some plausible outcomes (an approval path for drugs that have safety data but no corporate muscle behind them), but the FDA going full YOLO across the board runs completely against its mission.
Do you think any compound a company comes up with ought to be obtainable through compounding before safety data exists? If you don't, then why should peptides be treated as a special category of drug that justifies skipping that safety step?
Sigh...
I'm not going to answer your question, because it isn't relevant and it only serves as a distraction. For what it's worth, I personally wouldn't feel comfortable injecting any compound lacking safety data behind it, and because of that I've stuck to FDA-approved compounds so far (something like Reta I'd make an exception for, given the published data, though I haven't had the need). So my own standard is what governs: I wouldn't use the compounds that, in my view, the FDA shouldn't approve. As for how those compounds are sourced (commercial vs compound), that doesn't personally worry me, and when it comes to the grey market, I believe proper testing can keep that risk in check.
CNCCurrency
Explorer
On this forum, that view almost certainly makes you an outlier.
ltjltj
Explorer
That works for me 100%! Honestly, I doubt that's accurate. Going from a drug with solid research behind it to ones that have barely been studied, simply because their chemical structures look alike, is a big stretch. Regardless, it doesn't seem to matter much. Are you implying that means I'm unwelcome here or something?
Criticizing pharma is legitimate, but that doesn't justify throwing out science or evidence based practice.
Speaking along those lines... a label like “the name of health” doesn't make something evidence based or safe. And this person isn't merely “a guy trying to help” — there's a track record of pushing claims that run against established evidence, particularly in public health.
In a space where getting it wrong can genuinely hurt people, that's a credibility problem.
Also, peptides are not harmless supplements; certain ones carry serious systemic effects and demand genuine expertise to use responsibly.
Since yes, several of these truly call for a solid grasp of:
dosing and half-life
downstream hormonal effects
interactions (especially anything touching GH/IGF-1, insulin sensitivity, immune modulation)
contraindications (kidney, liver, cancer risk, etc.)
Widening access without that context isn't automatically beneficial.
And the fact that I use peptides myself doesn't mean I'll ignore someone's missing credibility or label them “good” just because we roughly agree on one point.
Back when I first became a member here, the only thing I felt okay pinning was Tirzepatide, and that was down to its FDA approval under the Zepbound and Mounjaro names.
Since then my comfort zone has grown, and Survo is now part of it, given how far along it sits in the approval pipeline.
More recently my stance has shifted on certain compounds that were approved in Russia (Semanx, Selanx), since there is some clinical research standing behind them, and likewise on ghk-cu and BPC. Those last two made the list because getting FDA approval would need a financial motive to run the necessary clinical trials. That motive disappears when a peptide can't be patented, and therefore can't be marketed, which means Pharma has no way to recoup what it spent and the risk it took. That's simply how things work.
Since then my comfort zone has grown, and Survo is now part of it, given how far along it sits in the approval pipeline.
More recently my stance has shifted on certain compounds that were approved in Russia (Semanx, Selanx), since there is some clinical research standing behind them, and likewise on ghk-cu and BPC. Those last two made the list because getting FDA approval would need a financial motive to run the necessary clinical trials. That motive disappears when a peptide can't be patented, and therefore can't be marketed, which means Pharma has no way to recoup what it spent and the risk it took. That's simply how things work.
On its face it looks straightforward, yet it overlooks the way risk truly functions. Saying something is “not FDA approved” gives no indication of whether the danger is minimal or possibly serious — it simply throws every substance into one bucket. Few people possess the knowledge needed to sort out that distinction.
Nor do the effects remain confined to one person. Problems, trips to the hospital, and LONG term outcomes place a burden on the healthcare system overall. That is precisely why public health cannot operate on a “slap a label on it and trust people to sort it out” basis.
CNCCurrency said:
When a GLP-1 isn't the brand-name product, then correct — it isn't an FDA-approved drug. In other words, compounded GLP-1s lack FDA approval.ltjltj said:
Is it accurate that GLP-1s are unapproved FDA drugs with a severe shortage of safety data? No. (As of today Reta is unapproved, though there is certainly no shortage of safety data on it.) Arguing that doctors should prescribe some of the peps on that list even without safety data also opens up an enormous can of malpractice worms.CNCCurrency said:
I don't get what your problem is with this. At the moment, where do you actually source your GLP-1 and your other peptides?ltjltj said:
That's no different from any other medication — so why should peptides be exempt from at least having safety data?CNCCurrency said:
What do you mean? After they are rescheduled, compounders will be permitted to produce them once more! A doctor's prescription is still required.ltjltj said:
Peptides are simply drugs. Why would they all be made available automatically to everyone through compounding, without regard to what the data says about their safety and efficacy?CNCCurrency said:
Wait, what? This guy backs peptides! He takes them himselfltjltj said:
The filter keeps flagging most of what I wanted to say as prohibited content, and I honestly can't work out why
I'm not convinced health is the real motive here. We'll find out soon enough who sits on the panel that signs off on this, and whether things like Melanotan 2 end up getting "approved". I have no desire to return to the days of pre-FDA snake oil and poison peddlers.
With far less pharma and far more of him, GLP-1 drugs and vaccines wouldn't exist — and I want both of those very much.
(As for efficacy, that's arguable, but since I'm quite open to off-label use, I'm far less worried about proof of efficacy in this area than I am about safety.)
I also don't see any reason why peptides should be reviewed by a separate panel compared with other kinds of drugs.
Broadly speaking, I'm very open to a pathway that assesses drugs backed by substantial data — particularly ones already approved elsewhere — without a sponsoring company driving them through. That fits a couple of the peptides on the list, but not the majority. So, as I said above, let's see who ends up on this panel, and what safety justification is given for the ones that pass and get approved. It's still early.
Like I said, I have no idea how this will shake out - I floated some plausible outcomes (an approval path for drugs that have safety data but no corporate muscle behind them), but the FDA going full YOLO across the board runs completely against its mission.
Do you think any compound a company comes up with ought to be obtainable through compounding before safety data exists? If you don't, then why should peptides be treated as a special category of drug that justifies skipping that safety step?
That comparison doesn't hold up.
Yes, compounded GLP1s aren't "FDAapproved products," but the actual drugs in them have been studied extensively and approved, with safety profiles that are well established.
Which means you can't just say....
"So they're basically the same as unapproved, poorly studied peptides"
Huge difference
CNCCurrency
Explorer
What are you talking about? If it isn't a brand-name product, then there's no FDA approval behind it. Every compounded version is produced differently, and because of that none of them carry FDA approval.Jfrick11 said:
CNCCurrency said:
When a GLP-1 isn't the brand-name product, then correct — it isn't an FDA-approved drug. In other words, compounded GLP-1s lack FDA approval.ltjltj said:
Is it accurate that GLP-1s are unapproved FDA drugs with a severe shortage of safety data? No. (As of today Reta is unapproved, though there is certainly no shortage of safety data on it.) Arguing that doctors should prescribe some of the peps on that list even without safety data also opens up an enormous can of malpractice worms.CNCCurrency said:
I don't get what your problem is with this. At the moment, where do you actually source your GLP-1 and your other peptides?ltjltj said:
That's no different from any other medication — so why should peptides be exempt from at least having safety data?CNCCurrency said:
What do you mean? After they are rescheduled, compounders will be permitted to produce them once more! A doctor's prescription is still required.ltjltj said:
Peptides are simply drugs. Why would they all be made available automatically to everyone through compounding, without regard to what the data says about their safety and efficacy?CNCCurrency said:
Wait, what? This guy backs peptides! He takes them himselfltjltj said:
The filter keeps flagging most of what I wanted to say as prohibited content, and I honestly can't work out why
I'm not convinced health is the real motive here. We'll find out soon enough who sits on the panel that signs off on this, and whether things like Melanotan 2 end up getting "approved". I have no desire to return to the days of pre-FDA snake oil and poison peddlers.
With far less pharma and far more of him, GLP-1 drugs and vaccines wouldn't exist — and I want both of those very much.
(As for efficacy, that's arguable, but since I'm quite open to off-label use, I'm far less worried about proof of efficacy in this area than I am about safety.)
I also don't see any reason why peptides should be reviewed by a separate panel compared with other kinds of drugs.
Broadly speaking, I'm very open to a pathway that assesses drugs backed by substantial data — particularly ones already approved elsewhere — without a sponsoring company driving them through. That fits a couple of the peptides on the list, but not the majority. So, as I said above, let's see who ends up on this panel, and what safety justification is given for the ones that pass and get approved. It's still early.
Like I said, I have no idea how this will shake out - I floated some plausible outcomes (an approval path for drugs that have safety data but no corporate muscle behind them), but the FDA going full YOLO across the board runs completely against its mission.
Do you think any compound a company comes up with ought to be obtainable through compounding before safety data exists? If you don't, then why should peptides be treated as a special category of drug that justifies skipping that safety step?
That comparison doesn't hold up.
Yes, compounded GLP1s aren't "FDAapproved products," but the actual drugs in them have been studied extensively and approved, with safety profiles that are well established.
Which means you can't just say....
"So they're basically the same as unapproved, poorly studied peptides"
Huge difference
There can be situations where a compounded drug is the right call — for instance, when a patient's medical need can't be satisfied by an FDA-approved drug, or when that approved drug simply isn't available on the commercial market. That said, compounded drugs do not have FDA approval. What this means is that before such a product reaches the market, the agency has not reviewed it for safety, for effectiveness, or for quality.
For compounded GLP-1 drugs, the agency has flagged certain areas of concern. FDA is coordinating with its state regulatory partners on this, and it will keep communicating with compounders about those concerns.
What you're doing is splitting hairs over regulations.CNCCurrency said:
What are you talking about? If it isn't a brand-name product, then there's no FDA approval behind it. Every compounded version is produced differently, and because of that none of them carry FDA approval.Jfrick11 said:
CNCCurrency said:
When a GLP-1 isn't the brand-name product, then correct — it isn't an FDA-approved drug. In other words, compounded GLP-1s lack FDA approval.ltjltj said:
Is it accurate that GLP-1s are unapproved FDA drugs with a severe shortage of safety data? No. (As of today Reta is unapproved, though there is certainly no shortage of safety data on it.) Arguing that doctors should prescribe some of the peps on that list even without safety data also opens up an enormous can of malpractice worms.CNCCurrency said:
I don't get what your problem is with this. At the moment, where do you actually source your GLP-1 and your other peptides?ltjltj said:
That's no different from any other medication — so why should peptides be exempt from at least having safety data?CNCCurrency said:
What do you mean? After they are rescheduled, compounders will be permitted to produce them once more! A doctor's prescription is still required.ltjltj said:
Peptides are simply drugs. Why would they all be made available automatically to everyone through compounding, without regard to what the data says about their safety and efficacy?CNCCurrency said:
Wait, what? This guy backs peptides! He takes them himselfltjltj said:
The filter keeps flagging most of what I wanted to say as prohibited content, and I honestly can't work out why
I'm not convinced health is the real motive here. We'll find out soon enough who sits on the panel that signs off on this, and whether things like Melanotan 2 end up getting "approved". I have no desire to return to the days of pre-FDA snake oil and poison peddlers.
With far less pharma and far more of him, GLP-1 drugs and vaccines wouldn't exist — and I want both of those very much.
(As for efficacy, that's arguable, but since I'm quite open to off-label use, I'm far less worried about proof of efficacy in this area than I am about safety.)
I also don't see any reason why peptides should be reviewed by a separate panel compared with other kinds of drugs.
Broadly speaking, I'm very open to a pathway that assesses drugs backed by substantial data — particularly ones already approved elsewhere — without a sponsoring company driving them through. That fits a couple of the peptides on the list, but not the majority. So, as I said above, let's see who ends up on this panel, and what safety justification is given for the ones that pass and get approved. It's still early.
Like I said, I have no idea how this will shake out - I floated some plausible outcomes (an approval path for drugs that have safety data but no corporate muscle behind them), but the FDA going full YOLO across the board runs completely against its mission.
Do you think any compound a company comes up with ought to be obtainable through compounding before safety data exists? If you don't, then why should peptides be treated as a special category of drug that justifies skipping that safety step?
That comparison doesn't hold up.
Yes, compounded GLP1s aren't "FDAapproved products," but the actual drugs in them have been studied extensively and approved, with safety profiles that are well established.
Which means you can't just say....
"So they're basically the same as unapproved, poorly studied peptides"
Huge difference
There can be situations where a compounded drug is the right call — for instance, when a patient's medical need can't be satisfied by an FDA-approved drug, or when that approved drug simply isn't available on the commercial market. That said, compounded drugs do not have FDA approval. What this means is that before such a product reaches the market, the agency has not reviewed it for safety, for effectiveness, or for quality.
For compounded GLP-1 drugs, the agency has flagged certain areas of concern. FDA is coordinating with its state regulatory partners on this, and it will keep communicating with compounders about those concerns.
What I'm doing is talking about what the science actually shows…and those two things aren't the same discussion.
Yes, compounded drugs aren't FDA approved as products. That doesn't mean they aren't built on medications that were well studied and FDA approved.
GLP1s come with a large body of clinical data and safety profiles that are well established.
What compounding typically alters is the dose or concentration, the delivery form (liquid, sublingual, injection, cream), or it strips out or swaps inactive ingredients (preservatives, fillers).
The active ingredient doesn't change, and neither does the evidence base behind the drug itself.
That's a completely different situation from peptides that lack that kind of data altogether.
And BTW.... what they're discovering is the problem of combining GLP1S with vitamin B12, which is itself another active compound. It turns out this creates a brand new molecule. Whether that's good or bad isn't known... Only that it isn't the same. Compounding pharmacies lean on this to claim "reduces nausea" as a way around patents. Basically a game so they can produce these GLP1s.
Calm Logic
Explorer
Right. And for those of us keeping GLPs stocked in our freezers 5-10+ years out, the non-GLPs aren't something we stockpile the same way — or even at all.Jfrick11 said:
Being an individual that does his/her/their own research and decides what's best for them?
Thats the forum I belong to I thought
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