FDA Letter: BAN's second coming?

Grunt76

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http://www.fda.gov/bbs/topics/NEWS/2006/NEW01332.html

FOR IMMEDIATE RELEASE
P06-37
March 9, 2006

FDA Warns Manufacturers About Illegal Steroid Products Sold as Dietary Supplements

The U.S. Food and Drug Administration today warned several manufacturers and distributors of unapproved drugs containing steroids that continued distribution and sale of these products without FDA approval could result in regulatory action including seizure and injunction. FDA is concerned that the use of these products, which are marketed as dietary supplements and promoted for building muscle and increasing strength, may cause serious long-term adverse health consequences in men, women, and children. These products claim to be anabolic and problems associated with anabolic steroids include: liver toxicity, testicular atrophy and male infertility, masculinization of women, breast enlargement in males, short stature in children, adverse effects on blood lipid levels, and a potential to increase the risk of heart attack and stroke.

“FDA takes its responsibility to protect Americans from dangerous unapproved drugs seriously. Today’s action is indicative of our resolve,” said Margaret O’K. Glavin, FDA’s Associate Commissioner for Regulatory Affairs.

Consumers who have any of the products listed below should stop taking them and return them to their place of purchase. FDA issued warning letters for the following so-called dietary supplement products:

* Anabolic Xtreme Superdrol, manufactured for Anabolic Resources LLC, Gilbert, Arizona, and distributed by Supplements To Go, Cincinnati, Ohio
* Methyl-1-P, manufactured for Legal Gear, Brighton, MI and distributed by Affordable Supplements, Wichita, Kansas

These warning letters are part of FDA’s continued efforts to protect consumers from dangerous steroid products. In March 2004, FDA sent warning letters to 23 manufacturers and distributors of products containing androstenedione.

Warning Letters:

Affordable Supplements
http://www.fda.gov/foi/warning_letters/g5739d.pdf
http://www.fda.gov/foi/warning_letters/g5739d.htm

Anabolic Resources LLC
http://www.fda.gov/foi/warning_letters/g5736d.pdf
http://www.fda.gov/foi/warning_letters/g5736d.htm

Legal Gear
http://www.fda.gov/foi/warning_letters/g5738d.pdf
http://www.fda.gov/foi/warning_letters/g5738d.htm

Supplementstogo.com, LLC
http://www.fda.gov/foi/warning_letters/g5737d.pdf
http://www.fda.gov/foi/warning_letters/g5737d.htm
http://pogue972.blogspot.com/2006/03/breaking-news-from-fda-superdrol-and.html
 

The Experiment

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Where were these letters for arthritis medication when 10,000 people died from Vioxx? Or Oxycontin?
 
CyberMuscle

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Why are they only after those two products?
 
Grunt76

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'cause these are the 2 they have conclusive lab results about?
 
bioman

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You have to figure that there will be a 2nd, 3rd, 4th wave of bans. FDA, unless granted broader powers can only stop so much of the market. It takes an act of Congress to really get things shut down and thus far, no bills are on the house floor...yet.

It is the nature of the business and efferts to stop these supplements will only intensify.
 

BioHazzard

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If you read the FDA letter, you will find that if they can show that something that is labelled as a dietary supp is actually a steroid, then they are enpowered to act.
 

deaffob

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Wow I'm actually suprised that you guyz didn't know it was comming. I knew they were gonna ban those.
 

russy_russ

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Why only superdrol and m1p? Why didn't they go after pheraplex, finigenx, and h-50?
 
bioman

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They will. It takes them awhile to get on track with all the new compounds. Hell..it takes me awhile to get up to speed with what is what and I'm here everyday.
 

meowmeow

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...may cause serious long-term adverse health consequences in men, women, and children.
But not in chickens, dogs or frogs. Why couldn't they just say "...may cause serious long-term adverse health consequences."? Because then they couldn't emphasize the children. Always the children.
 

bitwise

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Simple to get around. Don't sell to people out of the state it is marketed in. FDA only has power over interstate commerce. Also, don't make any claims as to what it is supposed to do. No marketing = no violation. Read carefully what the complaints are. If you really want to shut them down, go ahead and file an NDA and start doing the studies to show it is safe and effective.
 

russy_russ

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I highly doubt that will happen with SD, considering the effect it has on lipids
 

bitwise

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The lipid effect is short term and there appear to be no long term effects from it. There are approved drugs that have worse sides.
 

ex_banana-eater

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It doesn't matter how healthy/unhealthy it is. The banning of steroids is a war on ambition and productivity.
 
wideguy

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It's simply a detterent from REAL issues that politicians (aka scumbag sacks of ****) can use to bandstand on with the government right behind them because unlike all the prescription meds that KILL thousands of people a year, they stand to make no profit. So the politicians have something to shout about and the government/pharm companies stay nice a fat.
 

russy_russ

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I totally agree that they are trying to make it hard for drug companies that do not work with the government to make it in the business. But, a month with low HDL and high LDL can clog arteries a little bit and takes months to undo.
 

russy_russ

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Do you think that superdrol knock-offs are banned as well? They weren't addressed in the letter. Maybe not?
 

Rogue Drone

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I'm issuing a warning letter on this so-called Representative Government. Please return their dangerously unapproved products and services to your place of purchase.
 
yeahright

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What's interesting about this FDA letter is the approach taken. Previously, they said (summarizing): "The chemical contained in this supplement matches one on our list of banned steroids. Therefore stop selling it."

With this letter, the FDA is taking a new tact. They are saying (summarizing): "Since the chemical contained in this supplement is not food nor does it meet any identified nutritional need, it must be for the purpose of altering the body, and that makes it a drug, not a supplement. So stop selling it."

Taking this latter approach, they effectively have the ability to ban anything that isn't a vitamin or a food derivative, without getting legislation changed (like they did with the last ban). If the FDA actually has the administrative authority to do this, then this approach is much nimbler and will allow them to move with great speed to ban any supplement put on the market.
 
UnicronSpawn

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There was no solid proof of the alleged long term health risks of most of the drugs in the first wave of AAS criminalized in 1990 either, but that didnt seem to matter to anybody. They have to prove something is harmful in order to ban it if its naturally occuring right? So, does that mean they only have to prove that Superdrol, and m1-p are drugs not natural to ban them? Doesnt a new bill need to be enacted in order to actually add the new ones to the schedule III list? (as opposed to merely banning sale wich wouldnt result in prosecution for possesion.)
 

BMW

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Do you think that superdrol knock-offs are banned as well? They weren't addressed in the letter. Maybe not?
AX superdrol is a knockoff the original was made by designer supplements, very rare to find as they stoped production long ago
 

x_muscle

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17hydroxyprogestrone in M1P..............hum intesresting
 

PumpingIron

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so how long do you think this little dance between the FDA and Supp companies is going to go on? Or should I say how long is it going to profitable for the Supp companies to keep hitting up thier R&D and making new versions?
 
yeahright

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so how long do you think this little dance between the FDA and Supp companies is going to go on? Or should I say how long is it going to profitable for the Supp companies to keep hitting up thier R&D and making new versions?
It seems to me the next move in the dance is to put out vitamins that have anabolic "filler" in them. That would take away this new FDA argument (if it's not meant to meet a nutritional need, it's a drug not a supplement).:study:
 
milwood

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The way I see it is this:

-The Feds "saved" me from Androstenedione. :icon_lol:

-They tried to "save me" from the scourge of ephedra, but the evil proponents of the free market have lashed back, endangering the world anew. :trout: :trout: :nutkick:

-Now, they are gonna "save me" from Prostanozol.

All I can say is they should just go ahead and raise my taxes for all this great work!:saw:
 

Rogue Drone

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AX superdrol is a knockoff the original was made by designer supplements, very rare to find as they stoped production long ago
A "knockoff" is kind of a negative term for a product that was licensed to Ax by Matt Cahill, the founder of DS, and Nutraplanet still has 194 bottles in stock as of 5:30PM 3/11.
 
Grassroots082

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A "knockoff" is kind of a negative term for a product that was licensed to Ax by Matt Cahill, the founder of DS, and Nutraplanet still has 194 bottles in stock as of 5:30PM 3/11.
Kinda off topic, but how do you find out how much stock is left?
 

Rogue Drone

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It's an avaliable to anyone exploit of the OS and Ecommerce using websites,like Nutra and Custom, just update the quantity in your shopping cart till you hit "Out of Stock" and work down in increments.
 
motiv8er

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For Volusia, BUMP!
 
milwood

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Regarding the ban, be of good cheer; several things to consider:

1) Without all these Super-, Mega-, Max-, Methoxy-, Ergo-, Phera-, etc. goodies, you will be forced to work harder in the gym, eat smarter, and learn more about nutrition and exercise. Plus you'll have a boatload of extra cash to spend on food (and porn; just kidding!)

2) Your body will probably thank you for the break from overly-relying on potent and sometimes toxic "magic pills" when trying to reach fitness and BB'ing goals.

3) every time this happens, a new crop of ingenious "anabolic-esque" supps come to the fore anyway, and the minds behind these fascinating things go into overdrive to produce new, high-tech items to replace the old ones.

4) Perhaps as a bonus, more people are made aware of the dangers of large and intrusive Federal governmental power. When your rights and freedoms are eroded, it really hits home how important it is to be mindful of what goes on behind the scenes.
 
raider1

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Just when it was getting quiet again from Shipley's article :study: .. A new book all about Barry Bond's and his long term use of steroids ... brings it right back to the front page... :wtf:
 
anabolicrhino

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It is a simple legal issue. A company cannot exist that trades in products that are designed specifically to skirt an established law. These product are undone by their own marketing hype. The ads clearly outline the androgen ban, then state that their product is not illegal because it is a progestin not an androgen. Even the least informed FDA lawyer can put together the facts. People take androgens to gain a competitive advantage. That advantage disrupts the "fair market' so specific legislation is created to protect the participants(pro athletes)
Once that law is established, a company that markets products that give the same advantage as the "banned" products are subject to cease and desist orders.

Lucky for us it is a slow legal process. The larger companies with larger legal departments can afford to sweat out any appeals of unfair fines, so they can still make a profit. A company can stop production and sell all their product to a variety of vendors with in the alotted timeframe of the cease and desist. Then it is a matter of the effacy in the enforcement of the law down the distibution chain. It is not worth the time and money of the FDA.
All is not lost my friends!...act casual say nothing!
 
yeahright

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Any other company receive a warning letter yet?
 

MaynardMeek

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"FDA Letter: BAN's second coming?"


humm did anyone tell jesus this??? He is going to be PISSED
 
UnicronSpawn

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He's probably allready pissed cuz the innocent people our empire has been persecuting since the original law in 1990. (actually he has alot of other things to be pissed about too.)
 
Grunt76

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I agree. I hear he's pretty scary when he vents the anger...
 
Pioneer

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i have a question for you all, do you think the reason for the active war on gear is largely due to baseballs steroid problems by the players and their publicity?
 
Grunt76

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I believe it has to do with training the public into seeing Problem / Solution for better submission to governments. Here's how it goes:

1. Designate a bad guy
2. Spread misinformation about the bad guy, how BAD he really is
3. Bash on him
4. After bashing is done, laws get passed
5. Politicians can point to the bashing / lawmaking as "accomplishment" and "protecting the citizen against evil"

ALL politicians do this. It is what they need to do to validate their activity as politicians and also of course the general job of politician in the first place. Hence, the power of the position as well as the position itself are protected by these actions. It does not matter who or what the bad guy is, so long as you can make a case for something being "bad".

This never-acknowledged mutual agreement between all "democratic" rulers is based on the application of negative emotion to mass thinking. Simply direct the fear and hate of people one way, and they will back you up for whatever you can pass off as going the other way. Hitler did this pretty well. Of course, modern techniques are much more refined, but the basic principle remains.

Mass mind control*. Steroids are just one pawn.
 
anabolicrhino

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i have a question for you all, do you think the reason for the active war on gear is largely due to baseballs steroid problems by the players and their publicity?
It doesn't help the situation, when the media can generate advertizing profits by tracing Barry Bonds dosing regiments. Anyone can google "tren" or "fina" and get
"mas informa" by the way of links and threads, some will lead to this very board!(if your google account is optimized)
Even first year law students and investigative reporters are smart enough to click on a sponcers thread. So, a one dollar click through leads to a blind purchase made by someone who never intends on using the products.

When a grey area of the law becomes black and white, a cease and desist order is soon to follow.
 

MaynardMeek

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its the same reason why someone in a good relationship breaks up with someone for no reason... control.. the illusion of control... if there is something that you can do away with, without causing much of a stir... then you cut it off... to make others around you, and yourself.. feel like you are in control of some aspect of your life
 
yeahright

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i have a question for you all, do you think the reason for the active war on gear is largely due to baseballs steroid problems by the players and their publicity?
Yes, I was at a luncheon recently where the guest speaker was the head of the baseball player's union Donald M. Fehr . When the time for audience questions came, half of them involved steroids. It was clear that Mr. Fehr was getting frustrated with it. He explained in detail how the testing program worked and then interestingly, made a comment about how the testing is being driven by politics, not science. He said "steroids aren't for kids but that nobody is saying kids should take them." He then asked "what the real difference was between someone who was naturally 6 foot tall 230 lbs and someone who achieved that through steroids?" He went on to say that "steroids can enhance the abilities of a talented player but that they can't make a player talented." It was clear that the audience was reacting negatively to this line of thought so he changed the subject.
 
UnicronSpawn

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i have a question for you all, do you think the reason for the active war on gear is largely due to baseballs steroid problems by the players and their publicity?

I think that its a small part of it. The politicians inane agenda's to give the illusion of acomplishment is another part as Grunt pointed out. I suspect that the pharma vs independent supp industry war also has a hand to play in it. The FDA has done more then a few "favors" for the pharmecuetical indurstry. The FDA decides what medical treatments become approved as well as what supps are available. Sometimes a pharm company spends alot on a medication only to find out that treatment with it has unreasonable risk. (ala Vioxx). thats where the FDA comes in and conveniently overlooks the research and approves it anyway so money can be made before too many people start dying. In the case of AAS, healthy individual's that have good diet's and exercise habits make very little money for the industry because they stay healthy longer. The profit that could be made from the sale of AAS to many patients pale's in comparison to the money they would loose if people didnt need the insane ammount of mecication elderly people until they got to be in their late 70's. If the person starts needing those medications in their late 50's, thats a whole 20 years of multiple medications that the person will spend alot of money on. A fact thats often swept under the carpet is that studies have consistantly shown that man on AAS have elevated CD8 immune cell counts. They also tend to stay relatively healthy later in life than the typical non exercising non AAS using, unhealthy diet consuming american. Their ambition is doubled because many cheap otc natural supplements can help with certain ailments and with immune function. Wich fuels their desire to erradicate all supplements, and monopolize them for themselves by making them prescription drugs. The designer hormones are easy targets because allthough they dont violate the "letter of the law", they do violate the "spirit of the law". So it makes for an easy way to pick on the supp industry and make them look dangerously unregulated. We at AM know that its mostly people that are looking for something like theese products specifically that are buying them up. But if they can give the immpression that nutrition store clerks are pedaling these things to kids with sales pitches and not telling them what they are taking, then the industry gets slapped upside the head and gets the Pharma's and FDA closer to the goal of "regulating" supplements in general, by making people think that they are in danger by allowing supplements to be sold without being treated like drugs. So its a lot of things. Not to mention the sports industry feels that if people doubt the level playing field that the validity drops and consumers will not spend as much. That notion is pretty rediculous cuz most people dont care about all that, they just want to see amazing athletes do amazing stuff, and many wouldnt have an opinion on the use of drugs if they didnt have the "drugs are cheating" mantra beating them over the head everytime they turn on the tube. But weather it makes sense or not, the sports industry is certainly a financial force to be reckoned with. The thing is the industry wouldnt mind the drugs if fans didnt know, but they do know, so they have to pretend to be excited about erradicating them.
 

MaynardMeek

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"I was at a luncheon recently"

who the hell still uses the word luncheon.. lol ;-) jk
 
anabolicrhino

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We certainly live in "interesting times!"

This whole steroid issue is a brilliant study of the wisdom of chinese proverbs not to mention psycho-socio-mass cultural behavior-motivation modification.

So, if the difference between a 30,000 a year minor leaguer and a 3 million a year MLB player is a good nutritionist, then the minor leaguer in all of us will get that nutritionist or die trying!
Now, surly not everyone in society wants to be a player. A large portion of society likes to have a larger than life entity to cheer or boo( osama bin laden, jesus or barry bonds) Human nature seems to require this pattern of love and hate. Although, it can be escaped by medication or meditation for some who prefer a different planar existance.
The wheels of capitalism are greased by the sweat of the workers. Those that have, need the have nots to do the things that make the world go round. This is where the American dream comes into play, "any body can be president"...remember! Ofcourse everybody can't be president. So to keep the simple minds in check they (?) invented confusing laws. Luckily, we have lawyers to explain these confusing laws to us.The catch is that lawyers charge money for this service. The better the lawyer the more money you need(not a rule, but it seems to work that way) This little quirk in the system allows for corruption(money)to ultimately direct the system.(boohoo)
There will always be a pharm industry and a non-pharm alternative. It is unfortunate that the only way a company can make money in the alternative side is to create hype and confuse the market with standard degredation advertizing.(you are puny and weak,take this pill and you will rule alongside me...presale $39.99) the revenue draws the attention from the feds...not the potential threat to the kids! This country was built and is run by people who will do anything to win.

Why would anybody what to **** with that!

hint- M---y
 

LCSULLA

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Yes, I was at a luncheon recently where the guest speaker was the head of the baseball player's union Donald M. Fehr . When the time for audience questions came, half of them involved steroids. It was clear that Mr. Fehr was getting frustrated with it. He explained in detail how the testing program worked and then interestingly, made a comment about how the testing is being driven by politics, not science. He said "steroids aren't for kids but that nobody is saying kids should take them." He then asked "what the real difference was between someone who was naturally 6 foot tall 230 lbs and someone who achieved that through steroids?" He went on to say that "steroids can enhance the abilities of a talented player but that they can't make a player talented." It was clear that the audience was reacting negatively to this line of thought so he changed the subject.
Negativity is right. Society at large does know anything about steroids other then "There bad for you" and "Cheaters and weasels use them." Society sees them as almost as bad as crack or coke. For example I have been to other boards (non-bber ones) like Socnet and some noob will ask about steroids or supps like SD and all the BTDT's will flame the hell ouit of them. "Steroids are evil and only cheaters take them", "You don't need anything but food to get the body you want..three squares aday" And calling anyone who uses any anabolic as a "Drug user" and a "Druggie".
Or you have stations, such as CNN, that ran an interview with some kid that supposedly killed himself from steroid depression. They said that steroids cause yellow teeth, bad breath, penile shrinkage, impotance, and a host of other crap. And then the father said that anyone who use these drugs -supps where cowards because they didn't want to work hard enough and took the shortcut.

So the neagtive public perception of these things is what is driving this FDA letter. The government wants the nation to see that their doing something for the perceived greater good.
 

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