Unanswered FDA at it againšŸ¤·šŸ¼ā€ā™‚ļø

WesleyInman

WesleyInman

Well-known member
Awards
4
  • Established
  • First Up Vote
  • Best Answer
  • RockStar
If you use herbs, essential oils, supplements (vitamin and minerals), and/or compounds, or make or sell them, even from your garden, the FDA is currently undergoing hearings to determine the fate of 68 substances commonly used by herbalists, such as astragalus extract, nettle leaf, and tea tree oil.

Even B12 methylcobalamin, the best form that the body can utilize, could be eliminated which then will stop detoxification or make it more difficult.

In addition, 242 additional substances were deemed unworthy of a hearing, placed on a Category 3 list, and will become illegal to compound if this FDA process is enacted as a federal rule (Anderson, 2019). These include alfalfa, anise seed, Chinese rhubarb, dandelion (Taraxacum officinale), grapeseed oil, ginger root powder, Ginkgo biloba extract, cedarwood essential oil, Jamaican dogwood (Piscidia erythrina), mullein, myrrh tincture, parsley, passionflower extract, peppermint oil, pine tar, pipsissewa, psyllium, sage oil, saw palmetto, and uva ursi extract.


Here is the complete list of the products/supplements/herbs etc.. https://www.fda.gov/downloads/Drugs/.../PharmacyCompounding/UCM467373.pdf
 
ValiantThor08

ValiantThor08

Board Sponsor
Awards
4
  • First Up Vote
  • Established
  • Best Answer
  • RockStar
The FDA is doing no wrong. You just falsely accuse and misunderstand them. They are doing us a great legitimate service. (End sarcasm)
 
WesleyInman

WesleyInman

Well-known member
Awards
4
  • Established
  • First Up Vote
  • Best Answer
  • RockStar
Iā€™m personally disgusted by much on those lists.

I use and clients grapeseed oil weekly.

What reason to ban it? Gonna try and lie and say itā€™s ā€œnot safeā€?šŸ˜‚šŸ˜‚

What spin will they put on itšŸ¤·šŸ¼ā€ā™‚ļø
 
VaughnTrue

VaughnTrue

Well-known member
Awards
3
  • RockStar
  • Established
  • First Up Vote
this doesnt involve dietary supplements.

This potential legislation would only affect those who procure compounded ā€œmedicinesā€ from pharmacies, the pharmacies that do the compounding, and those who are licensed to prescribe them. Physicians, integrative medicine practitioners, or naturopaths who mix up tinctures or other preparations in their offices may be considered compounders so this legislation, if enacted, could affect them.
 
ValiantThor08

ValiantThor08

Board Sponsor
Awards
4
  • First Up Vote
  • Established
  • Best Answer
  • RockStar
Iā€™m personally disgusted by much on those lists.

I use and clients grapeseed oil weekly.

What reason to ban it? Gonna try and lie and say itā€™s ā€œnot safeā€?

What spin will they put on itšŸ¤·šŸ¼ā€ā™‚ļø
I personally think it is a control issues. Big pharma loses money when people treat themselves naturally for problems.
 
soxbsbll05

soxbsbll05

Active member
Awards
2
  • First Up Vote
  • Established
Whats the ETA for dmha to be removed from supplements? Going to have to stock up on some of my favorites! I've already noticed a few companies removing their dmha products from their sites...
 

Brienn8989

Active member
Awards
1
  • Established
Whats the ETA for dmha to be removed from supplements? Going to have to stock up on some of my favorites! I've already noticed a few companies removing their dmha products from their sites...
Their will be something new to replace it anyways haha You can still get dmaa preworkouts fairly easy and cheap.
 
VaughnTrue

VaughnTrue

Well-known member
Awards
3
  • RockStar
  • Established
  • First Up Vote
Guys, the amount of half truths being thrown around here is insane.

This revolves around COMPOUND PHARMACIES selling drugs. You can't put a natural herb/extract in with a drug unless it has an established monograph. This is a GOOD thing.

If you have 5mg of drug "A" and 500mg of herb "B", the expected result is every pill, every bottle, and every run will be identical, right? The problem is that without an established monograph you can't have this be the case. Herbs vary (even if its only slightly) on a season by season/harvest by harvest basis. This means that if you have a higher amount of compound "c" in herb "B" in 1 run than another, it can have a significant effect on drug "A"'s effectiveness.

The only way to combat this is to have herb "B" provide an established monograph (like a fingerprint of a product) to make sure it's identical each and every run.

This isn't "omg FDA trying to ruin the industry to fuel pharma", this is "herbal ingredients REALLY shouldn't be sold as drugs or in conjunction with drugs".


I can't believe I'm actually defending the FDA here. I absolutely LOATHE the FDA.
 
WesleyInman

WesleyInman

Well-known member
Awards
4
  • Established
  • First Up Vote
  • Best Answer
  • RockStar
Yes but it does effect compounders. This effects me personally. I work with 2 companies that I will not name (Legal) and this effects "us" in a big way.

We already are talking about having to get rid of a few things.

It's def not good news.
 
VaughnTrue

VaughnTrue

Well-known member
Awards
3
  • RockStar
  • Established
  • First Up Vote
Yes but it does effect compounders. This effects me personally. I work with 2 companies that I will not name (Legal) and this effects "us" in a big way.

We already are talking about having to get rid of a few things.

It's def not good news.
it is good news. there is absolutely NO business combining herbs with drugs for exactly the reason I listed above. compound pharmacies are supposed to be PHARMACIES and sell drugs.

You want to sell dietary supplements? Awesome. Have them manufactured as such and sold as such while following the laws pertaining to dietary supplements.

Want to sell drugs? Then start a pharma company.
 
WesleyInman

WesleyInman

Well-known member
Awards
4
  • Established
  • First Up Vote
  • Best Answer
  • RockStar
"Physicians, integrative medicine practitioners, or naturopaths who mix up tinctures or other preparations in their offices may be considered compounders so this legislation, if enacted, could affect them. "

This effects even our Tinctures. And yeah we have Prescription abilities as you stated. Prescribing and Administration legally. But my point is this. If we want to sell HRT and we blend in some Grapeseed Oil to eliminate PIP, then why should the compounding Pharmacy not be able to use it? What good reason do they have?

So all other oils are ok? I can use peanut oil, (which look how many people are allergic to peanuts and might die). So that's cool, but for no reason except they draw this invisible line in the sand, we can't use??

I understand the "law" is not on my side. Let's talk principles. And yes, it is not an argument I can win. Bc the Law is "the law"...but that doesn't make it right....
 
VaughnTrue

VaughnTrue

Well-known member
Awards
3
  • RockStar
  • Established
  • First Up Vote
"Physicians, integrative medicine practitioners, or naturopaths who mix up tinctures or other preparations in their offices may be considered compounders so this legislation, if enacted, could affect them. "

This effects even our Tinctures. And yeah we have Prescription abilities as you stated. Prescribing and Administration legally. But my point is this. If we want to sell HRT and we blend in some Grapeseed Oil to eliminate PIP, then why should the compounding Pharmacy not be able to use it? What good reason do they have?

So all other oils are ok? I can use peanut oil, (which look how many people are allergic to peanuts and might die). So that's cool, but for no reason except they draw this invisible line in the sand, we can't use??

I understand the "law" is not on my side. Let's talk principles. And yes, it is not an argument I can win. Bc the Law is "the law"...but that doesn't make it right....
Peanut oil is non-allergenic as it does not contain the proteins that cause allergy reactions. Come on Wesley. Stop being purposefully obtuse.

Know what peanut oil has on its resume? A monograph.

Want to use grapeseed oil? Get a damn monograph.
 
WesleyInman

WesleyInman

Well-known member
Awards
4
  • Established
  • First Up Vote
  • Best Answer
  • RockStar
Peanut oil is non-allergenic as it does not contain the proteins that cause allergy reactions. Come on Wesley. Stop being purposefully obtuse.

Know what peanut oil has on its resume? A monograph.

Want to use grapeseed oil? Get a damn monograph.

Serious question

You work for Hi-Tech anymore? I thought you did in the recent past. Apologies if I am wrong.

But, if you do. I would ask you your opinion on the whole 1,3dmaa issue going on over the past years. I don't see how you can have a stance as you do and simulataneously back them. I do. I have zero clue where that case exists at this point, last track about a year ago. But I'm curious.
 
VaughnTrue

VaughnTrue

Well-known member
Awards
3
  • RockStar
  • Established
  • First Up Vote
Serious question

You work for Hi-Tech anymore? I thought you did in the recent past. Apologies if I am wrong.

But, if you do. I would ask you your opinion on the whole 1,3dmaa issue going on over the past years. I don't see how you can have a stance as you do and simulataneously back them. I do. I have zero clue where that case exists at this point, last track about a year ago. But I'm curious.
I am not employed by HTP in any fashion. They were my employer until summer '18.


As for DMAA, my non-employed opinion is simple and it echoes my statements above.

If DMAA is found within the food chain (in this instance as a botanical), was not investigated as a drug prior to its release on the dietary supplement market, and meets the qualifications set forth within DSHEA guidelines, then it should be legal to be sold as a dietary supplement.

If these provisions are not met, it should not be able to be sold as a dietary supplement.
 
VaughnTrue

VaughnTrue

Well-known member
Awards
3
  • RockStar
  • Established
  • First Up Vote
beyond my comment above however, if i was still employed at HTP, I could very easily have the same opinion or even "DMAA should not be legal" and still be employed and do my job well at HTP.

Note, in just about every post I ever made in reference to HTP and DMAA, I made it apparent that my personal opinions were not being discussed, but the opinions of HTP as a whole. I did my best to keep my personal "fee fee's" out of the equation.


Before I left HTP I stated to them that I didn't think DMHA made much sense to use as a DMAA replacement. My opinion was heard but disregarded and they made the choices they made. An employee can disagree with an employer and still keep working for said employer.
 
WesleyInman

WesleyInman

Well-known member
Awards
4
  • Established
  • First Up Vote
  • Best Answer
  • RockStar
beyond my comment above however, if i was still employed at HTP, I could very easily have the same opinion or even "DMAA should not be legal" and still be employed and do my job well at HTP.

Note, in just about every post I ever made in reference to HTP and DMAA, I made it apparent that my personal opinions were not being discussed, but the opinions of HTP as a whole. I did my best to keep my personal "fee fee's" out of the equation.


Before I left HTP I stated to them that I didn't think DMHA made much sense to use as a DMAA replacement. My opinion was heard but disregarded and they made the choices they made. An employee can disagree with an employer and still keep working for said employer.

And I agree though I am kind of surprised that you back the FDA in this entire new development.

I mean truly they are taking away everything little by little. It's very disturbing. I know you and I have similar time frame experiences. I started in 96' at GNC and since then so much good stuff is gone. And now they are taking more. Little by little. What will be left? I'm shocked caffeine hasn't been attacked yet tbh.
 
VaughnTrue

VaughnTrue

Well-known member
Awards
3
  • RockStar
  • Established
  • First Up Vote
And I agree though I am kind of surprised that you back the FDA in this entire new development.

I mean truly they are taking away everything little by little. It's very disturbing. I know you and I have similar time frame experiences. I started in 96' at GNC and since then so much good stuff is gone. And now they are taking more. Little by little. What will be left? I'm shocked caffeine hasn't been attacked yet tbh.
I'm a huge fan of DSHEA. I believe we should be held to it strictly.

The OP in this does not impact or deviate from DSHEA.
 
WesleyInman

WesleyInman

Well-known member
Awards
4
  • Established
  • First Up Vote
  • Best Answer
  • RockStar
I'm a huge fan of DSHEA. I believe we should be held to it strictly.

The OP in this does not impact or deviate from DSHEA.
I can respect that but I simply just agree to disagree.

Nice chatting w you sir and I truly hope u and ur family are well :)
 
brundel

brundel

Board Sponsor
Awards
3
  • RockStar
  • Established
  • First Up Vote
this doesnt involve dietary supplements.
If the above is correct then it will help the supp industry. Time to start adding single herbal extracts to the lineup!
 
Aleksandar37

Aleksandar37

Well-known member
Awards
4
  • RockStar
  • Established
  • First Up Vote
  • Best Answer
it is good news. there is absolutely NO business combining herbs with drugs for exactly the reason I listed above. compound pharmacies are supposed to be PHARMACIES and sell drugs.

You want to sell dietary supplements? Awesome. Have them manufactured as such and sold as such while following the laws pertaining to dietary supplements.

Want to sell drugs? Then start a pharma company.
This captures so much of what I'm seeing happen today. Thank you for this post.
 

stimtron

Member
Awards
3
  • First Up Vote
  • Established
  • Best Answer
I'm a huge fan of DSHEA. I believe we should be held to it strictly.

The OP in this does not impact or deviate from DSHEA.
So you agree entirely with the DSHEA? No opinions or constructive criticisms?
 
VaughnTrue

VaughnTrue

Well-known member
Awards
3
  • RockStar
  • Established
  • First Up Vote
So you agree entirely with the DSHEA? No opinions or constructive criticisms?
I think my major gripe with DSHEA is its lack of details. This is what is fueling the DMAA argument.

How many studies does it take to prove something is found within a botanical? Is it 1 single study conducted in India? Do Indian/Chinese studies not count? Is it 5 studies? A meta study...etc. We need more concrete definitions to be able to utilize the law(s) effectively and not inadvertently break them.
 

stimtron

Member
Awards
3
  • First Up Vote
  • Established
  • Best Answer
I think my major gripe with DSHEA is its lack of details. This is what is fueling the DMAA argument.

How many studies does it take to prove something is found within a botanical? Is it 1 single study conducted in India? Do Indian/Chinese studies not count? Is it 5 studies? A meta study...etc. We need more concrete definitions to be able to utilize the law(s) effectively and not inadvertently break them.
Under this scenario any new supplement would be approved after a company does safety data then only that company would be allowed to sell that sup. I'm not at all in favor of this type of sup approval process. I do not want nor am asking every company to do clinical research everything they sell. This should be optional. Otherwise you're over regulating to the point nothing is available or it's extremely expensive...like you know pharmaceutical drugs which is what some are try to avoid by buying supplements. Many dietary supplements are prescribed in other countries and has a fair amount of safety data but for those that don't with potential benefits I should have a right to access.

I think insuring companies produce products tested for quality, without contaminants or non sup drugs, and has the amounts it says it has on the label is more than enough. If something is toxic and people start getting sick then pull it from the market and review what's going on before allowing it back with restrictions if there's an abuse or specific safety issue like kava it is safe but when contaminated can cause liver toxicity.
 
Last edited:

stimtron

Member
Awards
3
  • First Up Vote
  • Established
  • Best Answer
And I agree though I am kind of surprised that you back the FDA in this entire new development.

I mean truly they are taking away everything little by little. It's very disturbing. I know you and I have similar time frame experiences. I started in 96' at GNC and since then so much good stuff is gone. And now they are taking more. Little by little. What will be left? I'm shocked caffeine hasn't been attacked yet tbh.
This how how extinction happens through regulation over time gradually increasing and justificated in the name of safety. When a sup is a threat to pharma it gets pulled or overregulated, when a sup gets too popular because it's effective is gets pulled or banned.

There are many great companies out there who know what their doing with products and have no quality issues. I hate seeing some bad apples negatively affect all of them and reduce my options for what I see are advanced chemical formulas designed solely to improve my health.

Everyone who takes or believe in the idea of taking chemicals (sups) to protect, prevent, treat, cure, alter their conditions or health goals like muscle building and recovery should show a wider concern for when any sup is threatened even if they themselves don't take it or even agree with it. We may be the last generation of people who believe and practice in taking sups and chemicals outside of a doctor's office because we either did the research or seen the benefits firsthand.
 

stimtron

Member
Awards
3
  • First Up Vote
  • Established
  • Best Answer
it is good news. there is absolutely NO business combining herbs with drugs for exactly the reason I listed above. compound pharmacies are supposed to be PHARMACIES and sell drugs.

You want to sell dietary supplements? Awesome. Have them manufactured as such and sold as such while following the laws pertaining to dietary supplements.

Want to sell drugs? Then start a pharma company.

So if there's a combination of an herb like silymarin and a liver toxic drug you're saying the doctor does not have the right to request this for his patient and have it filled at the pharmacy? Or CoQ10 and lipitor (Coq10 is reduced when taking statins) I would disagree with you immensely. We need to constant learn what combinations may be more effective or safer not all of it can be done through large clinical studies. Just like many drugs are offlabeled prescribed for non FDA approved uses widely by doctors because newer studies have suggestive effectiveness and most importantly those patients have failed at other treatments.

Not allowing doctors to prescribe what they believe is best for the patient only hinders discovery and options for those in most need of medical help of what is effective for them.
 
Jiigzz

Jiigzz

Legend
Awards
5
  • RockStar
  • Legend!
  • Established
  • First Up Vote
  • First Up Vote
Guys, the amount of half truths being thrown around here is insane.

This revolves around COMPOUND PHARMACIES selling drugs. You can't put a natural herb/extract in with a drug unless it has an established monograph. This is a GOOD thing.

If you have 5mg of drug "A" and 500mg of herb "B", the expected result is every pill, every bottle, and every run will be identical, right? The problem is that without an established monograph you can't have this be the case. Herbs vary (even if its only slightly) on a season by season/harvest by harvest basis. This means that if you have a higher amount of compound "c" in herb "B" in 1 run than another, it can have a significant effect on drug "A"'s effectiveness.

The only way to combat this is to have herb "B" provide an established monograph (like a fingerprint of a product) to make sure it's identical each and every run.

This isn't "omg FDA trying to ruin the industry to fuel pharma", this is "herbal ingredients REALLY shouldn't be sold as drugs or in conjunction with drugs".


I can't believe I'm actually defending the FDA here. I absolutely LOATHE the FDA.
Opening line couldn't be more accurate.
 
Aleksandar37

Aleksandar37

Well-known member
Awards
4
  • RockStar
  • Established
  • First Up Vote
  • Best Answer
Everyone who takes or believe in the idea of taking chemicals (sups) to protect, prevent, treat, cure, alter their conditions or health goals like muscle building and recovery should show a wider concern for when any sup is threatened even if they themselves don't take it or even agree with it. We may be the last generation of people who believe and practice in taking sups and chemicals outside of a doctor's office because we either did the research or seen the benefits firsthand.
Doing research isn't listening to a stranger on the internet or finding a paper from the 50s that agrees with your already made up mind while ignoring countless other papers. If you're truly interested in better living through chemistry, then go learn the chemistry. I'm not saying you need a degree, but at least put in the effort to learn the science and the history before spreading this propaganda based on nothing. The amount of people modifying their bodies and health through supplements and technology is only increasing.
 

stimtron

Member
Awards
3
  • First Up Vote
  • Established
  • Best Answer
Doing research isn't listening to a stranger on the internet or finding a paper from the 50s that agrees with your already made up mind while ignoring countless other papers. If you're truly interested in better living through chemistry, then go learn the chemistry. I'm not saying you need a degree, but at least put in the effort to learn the science and the history before spreading this propaganda based on nothing. The amount of people modifying their bodies and health through supplements and technology is only increasing.
You seem to be talking about people who barely read taking these chemicals. I'm not really concerned about what they do but it's pretty easy to have basic regulations about the competency of those ordering if that's somehow a concern. Not that we test those who drink or eat themselves to death.

I think with prescription drugs or potentially dangerous chemicals it's not unreasonable to have a doctor to review the risks and benefit ratio. Provided it's not limiting access in any meaningful way like selling them 100,000% over cost.
 
thebigt

thebigt

Legend
Awards
6
  • Best Answer
  • The BigT Award
  • Established
  • Legend!
  • RockStar
  • First Up Vote
what I find humorous is these threads about the FDA 'banning' stuff....by now the FDA/GOVERNMENT should know they can't ban anything-all they can do is make it more difficult to get...if there is demand, supply is sure to follow.
 
Aleksandar37

Aleksandar37

Well-known member
Awards
4
  • RockStar
  • Established
  • First Up Vote
  • Best Answer
You seem to be talking about people who barely read taking these chemicals. I'm not really concerned about what they do but it's pretty easy to have basic regulations about the competency of those ordering if that's somehow a concern. Not that we test those who drink or eat themselves to death.

I think with prescription drugs or potentially dangerous chemicals it's not unreasonable to have a doctor to review the risks and benefit ratio. Provided it's not limiting access in any meaningful way like selling them 100,000% over cost.
I'm talking about you and your claims of doing "research." You want other people to do the work for you and not charge too much. Which btw, the FDA doesn't actually set or control drug prices which I've seen repeated over a few of these threads. As for doctors reviewing benefit:risk, who do you think is reviewing at the FDA or even within pharma companies? Plumbers?
 

stimtron

Member
Awards
3
  • First Up Vote
  • Established
  • Best Answer
I'm talking about you and your claims of doing "research." You want other people to do the work for you and not charge too much. Which btw, the FDA doesn't actually set or control drug prices which I've seen repeated over a few of these threads. As for doctors reviewing benefit:risk, who do you think is reviewing at the FDA or even within pharma companies? Plumbers?
I don't see the need to require every supplement sold to have been out through expensive safety studies just to have it available. I would prefer the FDA does this themselves or with NIH but because of capitalism and less patent protections we don't have anywhere as much research as we could have. I think alot more research should be done publically to understand the human body, role of various natural chemicals (supplements), and health conditions.

The fact the FDA regulates is a large factor in prices. Less regulation more competition and lower prices.

Pharma reps and stockholder usually.
 
Aleksandar37

Aleksandar37

Well-known member
Awards
4
  • RockStar
  • Established
  • First Up Vote
  • Best Answer
I don't see the need to require every supplement sold to have been out through expensive safety studies just to have it available. I would prefer the FDA does this themselves or with NIH but because of capitalism and less patent protections we don't have anywhere as much research as we could have. I think alot more research should be done publically to understand the human body, role of various natural chemicals (supplements), and health conditions.

The fact the FDA regulates is a large factor in prices. Less regulation more competition and lower prices.

Pharma reps and stockholder usually.
Until you do your homework on what the FDA actually does and how they work, or at the very least listen to those of us telling you these facts, every comment that you make up out of thin air is completely foolish. You're completely ignoring facts to push some socialized research dream where others put in the hard work and investment and are supposed to give you cheap drugs and supplements.

Pharma reps and stockholders?! Where are you getting that from?

If you want something done, stop waiting for somebody else to do it for you. Nobody cares what you think you're entitled to. If you want research done, do the steps needed to get into research, and then go do the research.
 

jamesm11

Well-known member
Awards
2
  • Established
  • First Up Vote
Until you do your homework on what the FDA actually does and how they work, or at the very least listen to those of us telling you these facts, every comment that you make up out of thin air is completely foolish. You're completely ignoring facts to push some socialized research dream where others put in the hard work and investment and are supposed to give you cheap drugs and supplements.

Pharma reps and stockholders?! Where are you getting that from?

If you want something done, stop waiting for somebody else to do it for you. Nobody cares what you think you're entitled to. If you want research done, do the steps needed to get into research, and then go do the research.
Lot of tinfoil hats conspiracies regarding the FDA on this foum. Almost as crazy as the people who think there's a cure for cancer that is being kept hidden (while fundamentally not underatanding how cancer works).

I deal with this stuff when people talk about the legal system. It's easier to ignore.
 

stimtron

Member
Awards
3
  • First Up Vote
  • Established
  • Best Answer
Until you do your homework on what the FDA actually does and how they work, or at the very least listen to those of us telling you these facts, every comment that you make up out of thin air is completely foolish. You're completely ignoring facts to push some socialized research dream where others put in the hard work and investment and are supposed to give you cheap drugs and supplements.

Pharma reps and stockholders?! Where are you getting that from?

If you want something done, stop waiting for somebody else to do it for you. Nobody cares what you think you're entitled to. If you want research done, do the steps needed to get into research, and then go do the research.
I know exactly what the FDA does. What facts are you stating?

When the DSHEA act was created it didn't demand anyone to suddenly spend millions to get each and every vitamin, mineral, amino acid approved. Most got grandfathered in.

If you're suggesting 1 or several ultra rich companies do research and then only they can profit from it? That's ridiculous. The whole point of the DSHEA was to make these potential health benefiting chemicals available to people without overregulation. Right now if you look at most supplements there's varying degrees of research the more basic ones from NIH but also various groups. For supplements the ones with the most research were approved in other countries by drug companies there. Yes people publically benefit from this research and I see nothing wrong with it.

Do you think Ma Sups or any brands here should perform clinical studies on their products before selling anything?
 
Aleksandar37

Aleksandar37

Well-known member
Awards
4
  • RockStar
  • Established
  • First Up Vote
  • Best Answer
I know exactly what the FDA does. What facts are you stating?

When the DSHEA act was created it didn't demand anyone to suddenly spend millions to get each and every vitamin, mineral, amino acid approved. Most got grandfathered in.

If you're suggesting 1 or several ultra rich companies do research and then only they can profit from it? That's ridiculous. The whole point of the DSHEA was to make these potential health benefiting chemicals available to people without overregulation. Right now if you look at most supplements there's varying degrees of research the more basic ones from NIH but also various groups. For supplements the ones with the most research were approved in other countries by drug companies there. Yes people publically benefit from this research and I see nothing wrong with it.

Do you think Ma Sups or any brands here should perform clinical studies on their products before selling anything?
The FDA doesn't run clinical trials. The FDA doesn't set drug prices. I'll let you keep guessing on who reviews the trial data.

This illuminati view of research that you have shows that you really have no clue what you're talking about, which would be fine if you were actually interested in learning. In addition to all of the academia research being done, the private sector isn't just huge pharma companies. There are a lot of very small pharma companies. There are countless biotech companies and startups. They have an idea, they get funding from grants or some other backing, and then they go and run with it.

And I never said any supplement company needs to provide safety or efficacy data, let alone run a trial. I said that you can't keep claiming something is safe if a safety trial was never performed (e.g. a short efficacy trial from Soviet era Russia is not a safety trial). You also can't claim it's dangerous without data either, but continually saying something has been shown to be safe based on anecdotal evidence is not valid. You're the one who has gone off on this tangent of what the FDA should do even though it's things that they do not do.
 
Jiigzz

Jiigzz

Legend
Awards
5
  • RockStar
  • Legend!
  • Established
  • First Up Vote
  • First Up Vote
I know exactly what the FDA does. What facts are you stating?

When the DSHEA act was created it didn't demand anyone to suddenly spend millions to get each and every vitamin, mineral, amino acid approved. Most got grandfathered in.

If you're suggesting 1 or several ultra rich companies do research and then only they can profit from it? That's ridiculous. The whole point of the DSHEA was to make these potential health benefiting chemicals available to people without overregulation. Right now if you look at most supplements there's varying degrees of research the more basic ones from NIH but also various groups. For supplements the ones with the most research were approved in other countries by drug companies there. Yes people publically benefit from this research and I see nothing wrong with it.

Do you think Ma Sups or any brands here should perform clinical studies on their products before selling anything?
IMO it appears that you have a thought, and religiously adhere to that thought despite evidence to the contrary. Learning is more than just being right, it's a willingness to accept when you're wrong and making a concerted effort to understand the counter evidence.

A lot of the people on these boards have a huge wealth of knowledge on individual concepts within the supplement world. My advice would be to contribute without always trying to find conflict.
 
Last edited:
Jiigzz

Jiigzz

Legend
Awards
5
  • RockStar
  • Legend!
  • Established
  • First Up Vote
  • First Up Vote
So if there's a combination of an herb like silymarin and a liver toxic drug you're saying the doctor does not have the right to request this for his patient and have it filled at the pharmacy? Or CoQ10 and lipitor (Coq10 is reduced when taking statins) I would disagree with you immensely. We need to constant learn what combinations may be more effective or safer not all of it can be done through large clinical studies. Just like many drugs are offlabeled prescribed for non FDA approved uses widely by doctors because newer studies have suggestive effectiveness and most importantly those patients have failed at other treatments.

Not allowing doctors to prescribe what they believe is best for the patient only hinders discovery and options for those in most need of medical help of what is effective for them.
I dont think you're following, unless I'm mistaken. They're talking about compound dugs, not individual supplements.
 
VaughnTrue

VaughnTrue

Well-known member
Awards
3
  • RockStar
  • Established
  • First Up Vote
So if there's a combination of an herb like silymarin and a liver toxic drug you're saying the doctor does not have the right to request this for his patient and have it filled at the pharmacy? Or CoQ10 and lipitor (Coq10 is reduced when taking statins) I would disagree with you immensely. We need to constant learn what combinations may be more effective or safer not all of it can be done through large clinical studies. Just like many drugs are unlabeled prescribed for non FDA approved uses widely by doctors because newer studies have suggestive effectiveness and most importantly those patients have failed at other treatments.

Not allowing doctors to prescribe what they believe is best for the patient only hinders discovery and options for those in most need of medical help of what is effective for them.
I'm going to try and go point by point here so I don't miss anything:

So if there's a combination of an herb like silymarin and a liver toxic drug you're saying the doctor does not have the right to request this for his patient and have it filled at the pharmacy? Or CoQ10 and lipitor (Coq10 is reduced when taking statins) I would disagree with you immensely.
Unfortunately (and I mean that seriously), yes. Doctors are not pharmacists. Doctors are generally incredibly intelligent people, but they're not trained in pharmacology...that's why there's a completely separate school for pharmacologists. Since the 1990's, how many doctor's have you heard of that have spoken publicly about the dangers of "creatine"?

Doctors are trained how to diagnose ailments/diseases, and recommend currently accepted best practice treatment to help correct/fix that ailment. They're not trained on how to mix specific compounds for "synergy".

I work in the pharmaceutical industry now (it'll be a year in about 8 week) and I see what goes into the making of a drug. It's very different than I originally thought I understood.

A doctor cannot responsibly order the combination of an herbal product and a drug to be combined until he/she has run the necessary VERY large sample size safety trials...same as anyone else. They CAN however suggest to their patients that they can use a dietary supplement like silymarin or CoQ10 in conjunction with the prescribed product, but even then it's not a very smart idea. This is why every dietary supplement tells users to check with their physician before starting use. Unless a product has an established monograph there is next to no way to determine exactly how it will react to being combined with a prescribed drug. It can get very dangerous.

Think about grapefruit/grapefruit extract and MAOI's. You can literally kill someone by combining the two.


We need to constant learn what combinations may be more effective or safer not all of it can be done through large clinical studies.
That's exactly what I've been saying. I am as big of a fan of natural/herbal remedies as anyone out there, but we lack science on 99.9999% of them. We need more studies, in MUCH larger sample sizes, and we need to conduct these studies similarly to how we test drugs. The problem here is that the studies are EXPENSIVE. For example, the company I work for wants to do a study on an upcoming product of ours for nothing but safety profile, and it's a one ingredient product. The expected study expense is $2,000,000 and its not a robust enough of a study to be able to wash your hands after and say "ok, we're done here!". Subsequent studies will be required. At the end of the day, I expect them to spend ~$10,000,000 before all is said and done. How many supplement companies do you know of that can afford that?

Just like many drugs are unlabeled prescribed for non FDA approved uses widely by doctors because newer studies have suggestive effectiveness and most importantly those patients have failed at other treatments.

Not allowing doctors to prescribe what they believe is best for the patient only hinders discovery and options for those in most need of medical help of what is effective for them.
Using a drug for non-approved uses is a touchy subject for many doctors. It's risky, but at times (like you mentioned) it can be necessary. Those doctors however are able to access an insane amount of data showing average risk factors the drug brings with it which can help allow them to make an informed decision. They can't however find the same amounts of safety data for herbal extracts, and DEFINITELY cannot find that type of safety data for drugs combined with herbal extracts.

If a doctor feels THAT strongly about it however, all he/she has to do is say "head to amazon and grab this product" and the patient can do so. Hell, the doctor can even have bottles of whatever that dietary supplement is in his/her office and sell it to the patient for profit!
 

stimtron

Member
Awards
3
  • First Up Vote
  • Established
  • Best Answer
The FDA doesn't run clinical trials. The FDA doesn't set drug prices. I'll let you keep guessing on who reviews the trial data.

This illuminati view of research that you have shows that you really have no clue what you're talking about, which would be fine if you were actually interested in learning. In addition to all of the academia research being done, the private sector isn't just huge pharma companies. There are a lot of very small pharma companies. There are countless biotech companies and startups. They have an idea, they get funding from grants or some other backing, and then they go and run with it.

And I never said any supplement company needs to provide safety or efficacy data, let alone run a trial. I said that you can't keep claiming something is safe if a safety trial was never performed (e.g. a short efficacy trial from Soviet era Russia is not a safety trial). You also can't claim it's dangerous without data either, but continually saying something has been shown to be safe based on anecdotal evidence is not valid. You're the one who has gone off on this tangent of what the FDA should do even though it's things that they do not do.
The FDA works with companies to design the trials and give feedback on what they want to see. The cost of studies which is done in accordance with FDA rules plays a factor in drug pricing.

Phenibut passed phase 1-3 studies which showed it was safe in many countries. Not sure how you missed that guess you didn't bother to read much into it.

Safety can be based on many factors ideally clinical studies but historial use is also important and was most medicine used before the FDA. TCM, ayurvedic medicine etc.
 

stimtron

Member
Awards
3
  • First Up Vote
  • Established
  • Best Answer
I dont think you're following, unless I'm mistaken. They're talking about compound dugs, not individual supplements.
Compounding pharmacies deal with both drugs and supplements. I'm speaking in general not just to one article.
 

stimtron

Member
Awards
3
  • First Up Vote
  • Established
  • Best Answer
Using a drug for non-approved uses is a touchy subject for many doctors. It's risky, but at times (like you mentioned) it can be necessary. Those doctors however are able to access an insane amount of data showing average risk factors the drug brings with it which can help allow them to make an informed decision. They can't however find the same amounts of safety data for herbal extracts, and DEFINITELY cannot find that type of safety data for drugs combined with herbal extracts.

If a doctor feels THAT strongly about it however, all he/she has to do is say "head to amazon and grab this product" and the patient can do so. Hell, the doctor can even have bottles of whatever that dietary supplement is in his/her office and sell it to the patient for profit!
Most herbs used at compounding pharmacies have safety data. I'm not aware of anyone using unsafe herbs. Many herbs are approved as drugs in other countries and we know exactly what the side effects and interactions are.

If people were getting sick or dying from a compound pharmacy mixing unsafe herbs or drugs that of course would be a problem.

A better example is statins and coq10. It's well known statins lower coq10 which can contribute to many health problems. If a doctor wanted to prescribe a combination of the 2 I see no issue with this.
 
Aleksandar37

Aleksandar37

Well-known member
Awards
4
  • RockStar
  • Established
  • First Up Vote
  • Best Answer
The FDA works with companies to design the trials and give feedback on what they want to see. The cost of studies which is done in accordance with FDA rules plays a factor in drug pricing.

Phenibut passed phase 1-3 studies which showed it was safe in many countries. Not sure how you missed that guess you didn't bother to read much into it.

Safety can be based on many factors ideally clinical studies but historial use is also important and was most medicine used before the FDA. TCM, ayurvedic medicine etc.
Show the studies because again you're lying. A random study done in the USSR isn't a phase anything. Also, no, safety is based on a controlled (first key word) safety (second key word) study. Anything else is a maybe.
 

niklasericson

Active member
Awards
2
  • Established
  • First Up Vote
Holy sh#t.
I thought the US was the land of the freedom and I also thought we have strict laws for supplements over here in Scandinavia but I was wrong.
I believe they have more liberal laws around supplements in a Communist country like China.
 
VaughnTrue

VaughnTrue

Well-known member
Awards
3
  • RockStar
  • Established
  • First Up Vote
Holy sh#t.
I thought the US was the land of the freedom and I also thought we have strict laws for supplements over here in Scandinavia but I was wrong.
I believe they have more liberal laws around supplements in a Communist country like China.
you'd believe it, but you'd be wrong.
 
cheftepesh1

cheftepesh1

Well-known member
Awards
4
  • Established
  • First Up Vote
  • RockStar
  • Best Answer
Holy sh#t.
I thought the US was the land of the freedom and I also thought we have strict laws for supplements over here in Scandinavia but I was wrong.
I believe they have more liberal laws around supplements in a Communist country like China.
Sad but true
 

Similar threads


Top