The FDA issues a warning against the use of SARMs

[The Solution]

The FDA issues a warning against the use of SARMs

https://www.stack3d.com/2017/10/fda-sarms-warning.html

The FDA has issued a release today in relation to selective androgen receptor modulators, better known as SARMs, typically promoted to help users build muscle. It’s essentially a warning against the use of bodybuilding and sports supplements containing those types ingredients, some examples being Ostarine and Cardarine.

In the release from the FDA, the agency says that while there are SARMs products out there marketed as dietary supplements, they are not dietary supplements, and are actually considered unapproved drugs. It warns against the use of the products saying that life-threatening reactions have occurred including liver toxicity.

The FDA also mentions that SARMs also have the potential “to increase the risk of heart attack and stroke, and the long-term effects on the body are unknown.” You can read the main exert from the FDA’s release below or check out the entire story on the agency’s website at fda.gov.

“We are extremely concerned about unscrupulous companies marketing body-building products with potentially dangerous ingredients. Body-building products that contain selective androgen receptor modulators, or SARMs, have not been approved by the FDA and are associated with serious safety concerns, including potential to increase the risk of heart attack or stroke and life threatening reactions like liver damage,” said Donald D. Ashley, J.D., director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.”

 

[SFreed]

Thank God the government's looking out for us.

 

[De__eB]

Almost every company selling SARMs in supplements has an RC site they could sell them on.

Every single company selling them knew they were patented prescription drugs.

Every company selling them knew they were unapproved investigational drugs and that selling them for human consumption is illegal.

And yet instead of just doing the smart thing and selling them not for human consumption, a bunch of idiots decided to start calling them supplements and selling them in the u.s. for human consumption.

Blame the greedy bastards in the industry not the FDA for this one.

 

[Justlooking5]

Strangely too much Burger King has been linked to some of the same issues. As has too much TV time, overwork for low pay, etc.

However, one reason I wont try sarms personally is because the long term effects are unknown.

 

[The_Old_Guy]

This is aimed at the "Reads the Ads, Doesn't Research" crowd (which I get). A high % of the members here already know this. Sadly, the "Class of 2018 Nineteen Year Old Ad Readers" is what keeps some unscrupulous people in business - year, after year, after year...

 

[TrainerTone]

So now we're supposed to listen to the FDA?? The same FDA that approves oxycontin. But that's safe right??

 

[HIT4ME]

You think SARMS are bad? Check this out!!

https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm277152.htm

Like SFreed says, thank god the gov't is looking out for us.

But in all reality, education never hurt. As De_eb says, it's one thing to sell something and tell people it's not safe and there are sides, it's another to not mention the dangers at all and do things you know aren't right.

And let's face it, learning how to research this stuff is a skill in itself. I know when I started researching things, I didn't pick up on half of what I'd pick up on now. Someone may be TRYING to research but may not have the ability to do so - we often take this for granted - and having someone with knowledge point out that, "Hey, this could increase your risk of a stroke" may be the red flag you didn't understand.

In other words, I am all for education - but draw the line at someone else making decisions for the individual. You should be able to do what you want to do, and you should be responsible for the consequences.

 

[Swindler]

doesn't surprise me...

 

[HIT4ME]

So now we're supposed to listen to the FDA?? The same FDA that approves oxycontin. But that's safe right??

lol - have you ever read about how the FDA came to being? It was essentially a marketing tool for industry. And, to this day, largely remains so.

 

[booneman77]

my favorite part... Cardarine isn't even a SARM. Idiots.

 

[TheNietzsche]

This is a situation where I'll be the one to side with the FDA. I certainly don't think companies should be allowed to mass market research chemicals as dietary supplements. It is one thing when they're sold as an RC and the risk is implied, and it is explicitly stated that the product is a drug. However, we've got Ostarine pills on the market from a variety of brands. Some contain the full chemical name, but I've seen just "Ostarine." Following this logic to the end, we should just deregulate all drugs and allow free marketing of them to the public. Like back in 1920.

On a completely unrelated note, Ostarine elevated my liver enzymes when I took it.

 

[bosskardo]

So do Nsaids.

 

[TheNietzsche]

misses the point...

 

[Jiigzz]

So now we're supposed to listen to the FDA?? The same FDA that approves oxycontin. But that's safe right??

What kind of argument is this?

 

[bosskardo]

What kind of argument is this?

That FDA is only slightly interested in safety. Commercial pressure comes first.

 

[TrainerTone]

What kind of argument is this?

A logical one

Sent from my SAMSUNG-SM-G935A using AnabolicMinds mobile app

 

[EricMM]

Come on did you really think people could sell SARM's as dietary supplements? Researched new drugs that haven't passed clinical trials? This was a huge black eye for the industry. No one should have sold or made these... There's not even a hint of legality here.

 

[user567]

Come on did you really think people could sell SARM's as dietary supplements? Researched new drugs that haven't passed clinical trials? This was a huge black eye for the industry. No one should have sold or made these... There's not even a hint of legality here.

Many have gone through clinical trials. Ostarine has gone through many trials. LGD a few as well. The standard is certainly not whether a drug is approved because the FDA is corrupt as all. Tons of drugs were never approved simply for financial reasons or BS FDA standards. I agree none should have ever been "supplements" and some (GW50156) should not be sold anywhere research or not.

 

[USPlabsRep]

Almost every company selling SARMs in supplements has an RC site they could sell them on.

Every single company selling them knew they were patented prescription drugs.

Every company selling them knew they were unapproved investigational drugs and that selling them for human consumption is illegal.

And yet instead of just doing the smart thing and selling them not for human consumption, a bunch of idiots decided to start calling them supplements and selling them in the u.s. for human consumption.

Blame the greedy bastards in the industry not the FDA for this one.

so, you work for a snitch...

 

[Jiigzz]

That FDA is only slightly interested in safety. Commercial pressure comes first.

They are not supplements. They were never supplements.

Regardless of how overzealous the FDA may be, they're not wrong in this particular case whether we like it or not.

 

[EricMM]

About time. Was a black eye for the industry and never should have happened!

 

[Jiigzz]

A logical one

Sent from my SAMSUNG-SM-G935A using AnabolicMinds mobile app

How so?

(Most) Drugs have years of drug trials before being sold for human consumption, and then have post release trials so we know most of the risks, down to ones that affect only a small few.

Then medications must be prescribed by a Doc.

Where is the relevance to SARMs being sold as supplements?

 

[ThatOneGuy1]

Correct me if I'm wrong but the only sarm that MAY be liver toxic is YK-11 due to its structure?

Sarms are mostly less dangerous than andros except for S23.

Cardarine is a PPAR that was only shown to have cancer growth in RATS, after having blasted them well over the recommended dosage AND for a few months.

Aside from lethargy and suppression/shutdown which can be easily comabtted with a test base and proper PCT, is there any real danger from sarms?

 

[EricMM]

At the levels being dosed they have a host of side effects. Liver toxicity, shut down etc...

They should never have been sold as dietary supplements PERIOD!

 

[EricMM]

Correct me if I'm wrong but the only sarm that MAY be liver toxic is YK-11 due to its structure?

Sarms are mostly less dangerous than andros except for S23.

Cardarine is a PPAR that was only shown to have cancer growth in RATS, after having blasted them well over the recommended dosage AND for a few months.

Aside from lethargy and suppression/shutdown which can be easily comabtted with a test base and proper PCT, is there any real danger from sarms?

Structure isn't an indicator of liver toxicity. It's about the enzymes ability to break these down. There are lots of non-steroidal things that have liver toxicity. Tylenol for example is very liver toxic and isn't steroidal!

 

[EricMM]

Correct me if I'm wrong but the only sarm that MAY be liver toxic is YK-11 due to its structure?

Sarms are mostly less dangerous than andros except for S23.

Cardarine is a PPAR that was only shown to have cancer growth in RATS, after having blasted them well over the recommended dosage AND for a few months.

Aside from lethargy and suppression/shutdown which can be easily comabtted with a test base and proper PCT, is there any real danger from sarms?

Structure isn't an indicator of liver toxicity. It's about the enzymes ability to break these down. There are lots of non-steroidal things that have liver toxicity. Tylenol for example is very liver toxic and isn't steroidal!

 

[Jiigzz]

Correct me if I'm wrong but the only sarm that MAY be liver toxic is YK-11 due to its structure?

Sarms are mostly less dangerous than andros except for S23.

Cardarine is a PPAR that was only shown to have cancer growth in RATS, after having blasted them well over the recommended dosage AND for a few months.

Aside from lethargy and suppression/shutdown which can be easily comabtted with a test base and proper PCT, is there any real danger from sarms?

A huge issue is that most companies will not state those types of warnings on the bottle. People dont know they are being shut down, and in a lot of cases won't even think to look because they assume if it is sold as a supplement it should be safe for them to consume. Then people counter that with, "well they should have done research".

That's not how it works. A supplement shouldn't pose risks like cancer development, eye sight loss, hair loss, shut down etc. Those are heavy side effects for what people usually assume to be safe products.

On top of that, supplements are generally herbals in a bottle, not experimental drugs with incomplete safety profiles.

A 16 year old may buy this then end up with a host of issues down the track. They're young and naive. Who reads the 18+ warning anyway? I was playing GTA, drinking and doing things like that well before i was legally allowed.

 

[De__eB]

so, you work for a snitch...

You and I both know there's a hell of a lot more to that story beyond what has been publicly speculated.

--

But I'm really not sure what that has to do with the stupidity of supplement companies selling these research chems for human consumption?

 

[TrainerTone]

How so?

(Most) Drugs have years of drug trials before being sold for human consumption, and then have post release trials so we know most of the risks, down to ones that affect only a small few.

Then medications must be prescribed by a Doc.

Where is the relevance to SARMs being sold as supplements?

I'm not saying SARMs should be sold as supplements. My indictment is moreso on the FDA being a complete sham. They warn you about certain things but when it benefits them or the powers that be monetarily, then they'll approve stuff that kills hundreds of thousands of people.

 

[De__eB]

Many have gone through clinical trials. Ostarine has gone through many trials. LGD a few as well. The standard is certainly not whether a drug is approved because the FDA is corrupt as all. Tons of drugs were never approved simply for financial reasons or BS FDA standards. I agree none should have ever been "supplements" and some (GW50156) should not be sold anywhere research or not.

Going through clinical trials is not the same as passing clinical trials as Eric is meaning it.

Also, look at the side effect profile of the drugs in those clinical trials.

Now remember that bodybuilders are taking 10...20...sometimes more...times the doses used in clinical trials.

 

[BCseacow83]

1. I think you should be able to buy take ANYTHING you want, ANYTHING.
2. Drugs should be freely available any it should be CRYSTAL F'ING clear that this is a drug/synthetic chemical. So freedom but full disclosure is a MUST.
3. Drugs being sold as supplements hurts the industry and gives them the exact thing they want....an IN to regulation and more control.
4. In my perfect society the freedom to use ANYTHING, yes crystal, H, crack ANYTHING comes with an equal amount of RESPONSIBILITY. Use all the rock you want but you steal a purse you are looking at MINIMUM 20 years NO PAROLE. No one will do a minute of time for possession but commit any other crime related to your use, think DUI, the hammer falls. This would also ensure that the total amount of years served would be about even so the prison industrial complex still makes their cash(BIG HURDLE FOR LEGALITY OF RECS.)

So sell them as RC's. They never should have been put in "supplements."

I have NO love for the FDA but they are absolutely right on this, these are experimental drugs being sold as supplements. Nothing in that release was opinion. Yes they can be hypocritical but right is right and this time, checks to see if pigs are taking flight out window, they got it right.

 

[TheNietzsche]

I'm not saying SARMs should be sold as supplements. My indictment is moreso on the FDA being a complete sham. They warn you about certain things but when it benefits them or the powers that be monetarily, then they'll approve stuff that kills hundreds of thousands of people.

I see. I agree that the FDA is flawed but this particular decision is sound. And doesn't your company sell SARMs? :thinking:

Going through clinical trials is not the same as passing clinical trials as Eric is meaning it.

This. Aside from that many of these products out there have less data than Ostarine does.

There are lots of non-steroidal things that have liver toxicity. Tylenol for example is very liver toxic and isn't steroidal!

And without any warnings at all like most of these "supplements", people can't make an informed decision regarding risks/rewards or monitor liver enzymes, etc.

 

[booneman77]

1. I think you should be able to buy take ANYTHING you want, ANYTHING.
2. Drugs should be freely available any it should be CRYSTAL F'ING clear that this is a drug/synthetic chemical. So freedom but full disclosure is a MUST.
3. Drugs being sold as supplements hurts the industry and gives them the exact thing they want....an IN to regulation and more control.
4. In my perfect society the freedom to use ANYTHING, yes crystal, H, crack ANYTHING comes with an equal amount of RESPONSIBILITY. Use all the rock you want but you steal a purse you are looking at MINIMUM 20 years NO PAROLE. No one will do a minute of time for possession but commit any other crime related to your use, think DUI, the hammer falls. This would also ensure that the total amount of years served would be about even so the prison industrial complex still makes their cash(BIG HURDLE FOR LEGALITY OF RECS.)

So sell them as RC's. They never should have been put in "supplements."

I have NO love for the FDA but they are absolutely right on this, these are experimental drugs being sold as supplements. Nothing in that release was opinion. Yes they can be hypocritical but right is right and this time, checks to see if pigs are taking flight out window, they got it right.

I agree with the sentiment that you should be able to use whatever you want, however you want... but mostly because I think this would help speed the process of darwinism taking care of the idiots haha

 

[Jiigzz]

I'm not saying SARMs should be sold as supplements. My indictment is moreso on the FDA being a complete sham. They warn you about certain things but when it benefits them or the powers that be monetarily, then they'll approve stuff that kills hundreds of thousands of people.

The thing with prescribed medication is that it has gone through all phases of clinical trials - from I right through to III and IV (post release trials) costing hundreds of millions of dollars, and taking, on average, 12 years to get from lab to medicine cabinet.

That's 12 years worth of trials, testing and countless other things.

Most of the SARMs people use have not passed phase 2 or 3 trials, none have been authorized for human consumption and long term safety for any has not been established. We know the concerns with Oxycontin because it had been tested prior to its release more than 30 years ago, and are repeatedly testing it as it's lifespan continues. It has a high potential for abuse, which hasn't been helped because of Doctors repeatedly prescribing it, however it also has far more users than what SARMs do, and so any stats need to be calculated as a % of total users, not a total.

The argument itself is a false analogy as they cannot be compared fairly

 

[TrainerTone]

The thing with prescribed medication is that it has gone through all phases of clinical trials - from I right through to III and IV (post release trials) costing hundreds of millions of dollars, and taking, on average, 12 years to get from lab to medicine cabinet.

That's 12 years worth of trials, testing and countless other things.

Most of the SARMs people use have not passed phase 2 or 3 trials, none have been authorized for human consumption and long term safety for any has not been established. We know the concerns with Oxycontin because it had been tested prior to its release more than 30 years ago, and are repeatedly testing it as it's lifespan continues. It has a high potential for abuse, which hasn't been helped because of Doctors repeatedly prescribing it, however it also has far more users than what SARMs do, and so any stats need to be calculated as a % of total users, not a total.

The argument itself is a false analogy as they cannot be compared fairly

You have your opinion and i have mine. We can just agree to disagree on this matter. The FDA is a business in and of itself. That is all

 

[TheNietzsche]

I'm glad we're all on the same page

 

[thebigt]

off topic...but Flomax is a fda approved drug-and that stuff is poison, I recommend not to ever take that crap!!!

just one example.....

 

[TheNietzsche]

off topic...but Flomax is a fda approved drug-and that stuff is poison, I recommend not to ever take that crap!!!

just one example.....

Oh I'll rant to anyone who asks how the FDA is flawed and approves bad drugs, and doesn't approve good drugs. Everyone else in this thread also acknowledged that. But sometimes, the FDA makes a good decision, and this is one of them. I could give you several other examples of good regulatory action by the FDA if you'd like, for the sake of balance. They do a decent job of in the cautious approval of drugs for children, particularly psychiatric drugs (although unfortunately that can't stop off-label usage). Either way, Flowmax is a terrible analogy for this particular case (I know, you said its off-topic), just as OxyContin is a terrible analogy.

I'm done now

 

[thebigt]

Oh I'll rant to anyone who asks how the FDA is flawed and approves bad drugs, and doesn't approve good drugs. Everyone else in this thread also acknowledged that. But sometimes, the FDA makes a good decision, and this is one of them. I could give you several other examples of good regulatory action by the FDA if you'd like, for the sake of balance. They do a decent job of in the cautious approval of drugs for children, particularly psychiatric drugs (although unfortunately that can't stop off-label usage). Either way, Flowmax is a terrible analogy for this particular case (I know, you said its off-topic), just as OxyContin is a terrible analogy.

I'm done now

it was just a personal rant....I was prescribed Flomax, but fortunately I'm wise enough to research all drugs before using, and in this case throwing in trash....

sorry, it was an inappropriate post for this thread...I apologize!!!

 

[TheNietzsche]

No worries man, I just get passionate when talking about drug regulation

 

[SFreed]

FDA decisions aside, I can walk outside my front door in upper class neighborhood, and within 20 minutes have a pocket full of methamphetamines. Why is it easier for me to procure highly illegal drugs than it is to get LGD? Or Clomid? Why does the FDA feel the need to stop me from getting Ostarine? Is this actually about saving people from a dangerous drug, or is this more about the fact that the government hasn't been given it's share.

 

[Jiigzz]

FDA decisions aside, I can walk outside my front door in upper class neighborhood, and within 20 minutes have a pocket full of methamphetamines. Why is it easier for me to procure highly illegal drugs than it is to get LGD? Or Clomid? Why does the FDA feel the need to stop me from getting Ostarine? Is this actually about saving people from a dangerous drug, or is this more about the fact that the government hasn't been given it's share.

Because you're friendly local drug dealer doesn't sell LGD? Maybe you can hit him up today and ask him to stock it

It's more about the fact that it is a drug that hasn't been approved for human consumption, and shouldn't be sold as a supplement.

 

[HIT4ME]

The thing with prescribed medication is that it has gone through all phases of clinical trials - from I right through to III and IV (post release trials) costing hundreds of millions of dollars, and taking, on average, 12 years to get from lab to medicine cabinet.

That's 12 years worth of trials, testing and countless other things.

Most of the SARMs people use have not passed phase 2 or 3 trials, none have been authorized for human consumption and long term safety for any has not been established. We know the concerns with Oxycontin because it had been tested prior to its release more than 30 years ago, and are repeatedly testing it as it's lifespan continues. It has a high potential for abuse, which hasn't been helped because of Doctors repeatedly prescribing it, however it also has far more users than what SARMs do, and so any stats need to be calculated as a % of total users, not a total.

The argument itself is a false analogy as they cannot be compared fairly

I actually agree with most 9f your logic in this thread as your reasoning is pretty dead on. As others have said, I am not against this decision, more against the idea that the FDA is there to protect us...which you get a pass on because you are in Australia.

But the history of the FDA is basically that it's predecessor was founded to benefit the American meat manufacturers. They were canning rotten beef and sending it to the gov't because we weren't at war and they figured it would never be used, so they could sell what they would normally throw away. Then war broke out in Europe, the meat was sent and more people died from our rotten beef then from the war itself. This, of course, killed one of our largest exports.

There was nothing to "fix"...the meat companies knew what they did. So they lobbied Roosevelt to pass regulations and form a "watchdog" to renew confidence in our meat industry abroad. It was all a marketing scheme. And it worked. And it grew and remains a marketing scheme to this day.

As far as oxy - sure, we had decades of data, but Perdue made a huge marketing push to make doctors believe that oxy was not addictive. The FDA looks the other way as long as enough money is being made that they can extract fees through lawsuits and continue their marketing watchdog status.

And in all those decades of data, there isn't ANY evidence that opiates even have any safety nor efficacy past 12 weeks. None. Yet the FDA never did a thing to ensure prescriptions never lasted past 12 weeks. Making the argument that 12+ weeks of opioid use is safe and effective is so difficult that rather than even attempt to raise such a defense, Pfizer recently settled with the city if Chicago for $2.3B - that's a B - because they can't prove anything past short term acute use.

 

[SFreed]

Because you're friendly local drug dealer doesn't sell LGD? Maybe you can hit him up today and ask him to stock it

It's more about the fact that it is a drug that hasn't been approved for human consumption, and shouldn't be sold as a supplement.

I think you're missing the point that the FDA is more concerned with getting their share of money than actually protecting the citizens. But like I said in my first post on this thread, Thank God the Government is looking out for us.

I believe I can make the best decisions for myself. I just wish my government would accept that.

 

[De__eB]

FDA decisions aside, I can walk outside my front door in upper class neighborhood, and within 20 minutes have a pocket full of methamphetamines. Why is it easier for me to procure highly illegal drugs than it is to get LGD? Or Clomid? Why does the FDA feel the need to stop me from getting Ostarine? Is this actually about saving people from a dangerous drug, or is this more about the fact that the government hasn't been given it's share.

Meths way cheaper and easier to make than SARMs

 

[SFreed]

Meths way cheaper and easier to make than SARMs

True story, but also way more dangerous.

 

[Jiigzz]

True story, but also way more dangerous.

But also illegal. The DEA is responsible for enforcing drug related matters

 

[Nac]

Well whether we libertarians like it or not, the voices that yell for "freedom of choice!" will always be drowned out by those that cry out "X killed/harmed my son/daughter/etc, WHY ISNT MORE BEING DONE TO REGULATE X!?!"

 

[HIT4ME]

Well whether we libertarians like it or not, the voices that yell for "freedom of choice!" will always be drowned out by those that cry out "X killed/harmed my son/daughter/etc, WHY ISNT MORE BEING DONE TO REGULATE X!?!"

You have a choice. You can be safe. Or you cam be free.

Oh, yeah, and safety is always an illusion.

Choose wisely.

 

[Nac]

You have a choice. You can be safe. Or you cam be free.

Oh, yeah, and safety is always an illusion.

Choose wisely.

Where was the FDA when our ancestors had to contend with poisonous berries?

Hell, we wouldnt be here now if there had been a regulatory body preventing Adam from eating that bloody apple.

Im with booneman and bseacow. Lets go full tit to the other extreme. Doing so means Ill have to swallow a certain degree of fatalism, where like our ancestors, if any relatives dun goof and harm themselves I have no Big Brother Watchbody to blame or go crying to.