FDA Warns About Ingredients in Illegal 'Supplements' Sold for Sexual Enhancement - AnabolicMinds.com

FDA Warns About Ingredients in Illegal 'Supplements' Sold for Sexual Enhancement

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    FDA Warns About Ingredients in Illegal 'Supplements' Sold for Sexual Enhancement


    No wonder some of these worked so well.


    FDA News
    FOR IMMEDIATE RELEASE
    P06-97
    July 12, 2006
    Media Inquiries:
    Kimberly Rawlings, 301-827-6242
    Consumer Inquiries:
    888-INFO-FDA



    FDA Warns Consumers About Dangerous Ingredients in "Dietary Supplements" Promoted for Sexual Enhancement
    The U.S. Food and Drug Administration (FDA) is warning consumers not to purchase or consume Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx, or 4EVERON. These products are promoted and sold on web sites as "dietary supplements" for treating erectile dysfunction (ED) and enhancing sexual performance, but they are in fact illegal drugs that contain potentially harmful undeclared ingredients. These products have not been approved by FDA, and there is no guarantee of their safety and effectiveness, or of the purity of their ingredients.

    FDA advises consumers who have used any of these products to discontinue use and to consult their health care provider. FDA encourages anyone experiencing ED to seek guidance from a health care provider before purchasing a product to treat this medical condition.

    "These products threaten the public health because they contain undeclared chemicals that are similar or identical to the active ingredients used in several FDA-approved prescription drug products. This risk is even more serious because consumers may not know that these ingredients can interact with medications and dangerously lower their blood pressure," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research.

    Chemical analysis by FDA revealed that Zimaxx contains sildenafil, which is the active pharmaceutical ingredient in Viagra, a prescription drug approved in the United States to treat ED. The other products contain chemical ingredients that are analogues of either sildenafil or a pharmaceutical ingredient called vardenafil. Vardenafil is the active ingredient in Levitra, a prescription drug that, like Viagra, is approved in the United States to treat ED. There is no mention of any of these ingredients in any of the illegal products' labeling.

    This deception poses a threat to consumers because the undeclared ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin) and lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and they may seek products like the ones noted above because these products claim that they are "all natural" or that they do not contain the active ingredients used in FDA-approved ED drugs. In addition, because the manufacturing source of the active ingredients in these "dietary supplements" is unknown, there is no assurance that the ingredients are safe, effective, or pure.

    FDA Warning Letters to the firms marketing these products state that the products are illegal drugs based on claims made for the products or their ingredients. The letters also state that the products' labeling is false and misleading because it fails to disclose the presence of the chemical ingredients or the potential side-effects associated with the products' consumption. FDA instructed agency staff to stop the importation of Libidus, and the agency recently stopped a shipment of 4 EVERON from entering the United States. Based on responses to these actions, FDA may take additional enforcement steps.

    Today's actions follow a first-of-its-kind FDA survey, in which the agency analyzed 17 dietary supplements marketed on the internet to treat ED and to enhance sexual performance in men. "Our survey found that many of the so-called 'dietary supplements' marketed as treatments for erectile dysfunction actually contain non-dietary chemicals, including chemicals used as active ingredients in FDA-approved drugs. The claims made for these products were in fact claims made for the undeclared non-dietary chemicals they contain, which rendered them illegal drugs. FDA is committed to protecting the public health by removing such illegal and dangerous products from the market," said Margaret O'K. Glavin, FDA's Associate Commissioner for Regulatory Affairs.

    ####

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    Why do I see Nasutra selling out the Ass pretty soon. And Stamina-RX as well.

    Weird thing is Stamina Rx is sold at GNC.
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    they should warn people who supplement with cigarettes on a daily basis instead
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    There is a good point though in all that. Some people do indeed search for alternative products that will not interact with their perscriptions and do not take the real viagra etc because of the harm it could do. I think that they should be up front on their ingrediants but i also think they should be able to sell them.
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    Good point Jay. FDA is actually doing their jobs on this one and protecting public health.



    Yeah..I'd say those companies are busted.
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    I took 2 pills of Nasutra once, just cause I was curious and cause I'm stupid of course( as I do not need this stuff), and my vision started getting "blue-ish", and after I did the deed I was useless, cause I got one of the most deblitating headaches I have gotten!! I got **** from my significant other, cause I was crippled for the rest of the night with a pounding headache
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    Quote Originally Posted by swole210
    I took 2 pills of Nasutra once, just cause I was curious and cause I'm stupid of course( as I do not need this stuff), and my vision started getting "blue-ish", and after I did the deed I was useless, cause I got one of the most deblitating headaches I have gotten!! I got **** from my significant other, cause I was crippled for the rest of the night with a pounding headache
    So, You took dangerous, unknown substances into your body, just to increase her satifaction,...and she gives you s*h*i*t*,..dude we have to talk!
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    This is not surprising. The "drugs" are available at very low cost so adding them is easy to do. The problem though is that this is a real health hazard. Indidivuals want to know and should know what they are ingesting.
    Last edited by size; 07-14-2006 at 02:36 PM.
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    That's true. Some old man takes nitro for a heart condition then goes to take his "natural" supplement called stamina-rx that has Sildenafil in it. And bam he's ****ing dead.
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    Nasutra has many positive reviews, at least we know the cause of good reviews.
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    Quote Originally Posted by anabolicrhino
    So, You took dangerous, unknown substances into your body, just to increase her satifaction,...and she gives you s*h*i*t*,..dude we have to talk!
    !! Yeah, she just likes to tease me about it once in a while and crack jokes about my headache But anyhow, yeah, this stuff could be dangerous for some like Jay said especailly with heart conditions and meds!!! That is real carelessnes on the part of these companies, but they are just in it for the quick buck so they don't care, and that right there can be VERY dangerous!
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    Quote Originally Posted by size
    Nasutra has many positive reviews, at least we know the cause of good reviews.

    Yeah I looked up some info about it and some reviews, and of course it works, but I did find a lot of other people complain about the huge headaches. Not sure why though Does anyone know if this "headache" is a side effect with some of the prescribed enhancers?
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    Yes, headaches are common with viagra and cialis. These companies likely mix other stuff like yohimbine into the pills and I can see that as being a pretty gnarly headache.

    But one HECk of a boner!

    lol
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    Quote Originally Posted by anabolicrhino
    So, You took dangerous, unknown substances into your body, just to increase her satifaction,...and she gives you s*h*i*t*,..dude we have to talk!
    Bud...he took an OTC "performance enhancer" assuming that it was safe. They were "illegal" because the substances were undeclared, but I use to sell Stamina-RX as a (then legal) OTC supp. Now I know why all the guys swore by it...lol
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    In all reality these guys should get there asses handed to them, they could have easily killed somone. hard to believe but the FDA did do something right here for once.
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    Quote Originally Posted by swole210
    Yeah I looked up some info about it and some reviews, and of course it works, but I did find a lot of other people complain about the huge headaches. Not sure why though Does anyone know if this "headache" is a side effect with some of the prescribed enhancers?
    Many of the Nitric enhancing supps give me headaches and sinus aches(arginine hcl,cnidium,viagra) I usually take advil to counter the pain. I find there is no substitute for quality wood so youi must take extreme measures, when necessary.
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    Any idea why Stamina-RX is still being sold in GNC?

    I'm guessing it still contains Sildenafil right?
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    I don't want to be protected. Can I opt out?

    I just don't want my supplements contaminated with heavy metals and other stuff that's not on the ingriedents list.

    'just let me know what the product contains, and let me make my own decision.

    If the government really gave a ratt's behind about protecting the public's health, cigarettes and alcohol would be gone tomorrow.

    -Tinytoad

    Quote Originally Posted by bioman
    Good point Jay. FDA is actually doing their jobs on this one and protecting public health.



    Yeah..I'd say those companies are busted.
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    Quote Originally Posted by bioman
    Good point Jay. FDA is actually doing their jobs on this one and protecting public health.

    Yeah..I'd say those companies are busted.
    Quote Originally Posted by Skye
    In all reality these guys should get there asses handed to them, they could have easily killed somone. hard to believe but the FDA did do something right here for once.
    I fail to see how the FDA is protecting people. People wanted lower cost and nonprescription alternatives to the typical boner pills. It was because of the FDA/government rules protecting other manufacturers that these manufacturers felt the need to hide ingredients. And now the FDA will not merely force them to divulge what's in the product, the products will simply be removed from the shelves and people's choices restricted. Sounds to me like the only people who will benefit in the end are insurance companies and the makers of government approved boner pills.
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    Yo F*ck an FDA.
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    Interesting, to say the least.
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    Quote Originally Posted by CDB
    I fail to see how the FDA is protecting people. People wanted lower cost and nonprescription alternatives to the typical boner pills. It was because of the FDA/government rules protecting other manufacturers that these manufacturers felt the need to hide ingredients. And now the FDA will not merely force them to divulge what's in the product, the products will simply be removed from the shelves and people's choices restricted. Sounds to me like the only people who will benefit in the end are insurance companies and the makers of government approved boner pills.
    Yeah, I would say most of the people that take "sexual enhancing" supps take them because they do not have "access" to the prescription stuff, not because they are trying to "avoid" the chemistry
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    This really isn't the issue, by not tell people what was in their product they were risking peoples lives. I would be all for it if people knew what they were getting. But they didn't and it could/may have cost lives. This is the type of thing that the FDA was supposed to do in the first place rather then play big brother knows best. They should be warning us that someone is pulling a fast one at our expense.

    Don't get me wrong as I think the money spent on the FDA would be better spent elsewhere but they did, incredibility, did something right here.
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    Quote Originally Posted by Skye
    This really isn't the issue, by not tell people what was in their product they were risking peoples lives.
    By denying them the ability to market the product if it did contain those ingredients, the government made improper labeling an inevitability. I agree that if the FDA kept to a purely informative role here and in general they might be doing some good. But that is not their primary role nor will it be the end of their action.

    I would be all for it if people knew what they were getting. But they didn't and it could/may have cost lives. This is the type of thing that the FDA was supposed to do in the first place rather then play big brother knows best. They should be warning us that someone is pulling a fast one at our expense.

    Don't get me wrong as I think the money spent on the FDA would be better spent elsewhere but they did, incredibility, did something right here.
    You see I wouldn't say so, because it will not stop with informing people. Their good act is going to subsumed into a larger, destructive act of eliminating competition.
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    Quote Originally Posted by CDB
    By denying them the ability to market the product if it did contain those ingredients, the government made improper labeling an inevitability. I agree that if the FDA kept to a purely informative role here and in general they might be doing some good. But that is not their primary role nor will it be the end of their action..
    Yes but a purely informitive role really isn't enough, there has to be penelty. The problem with the FDA is not its intended function its that it has gone beyond it and likes to play big brother. If a company puts something that is potentally harmful into there product and doesn't tell anyone about it that should be crinimal. If a company puts something in a product and tells everyone and warns everyone of what the problems might be then it should be my choice as to wether or not I want to use it. That is were they really cross the line (IMO at least). If I know what the risk are are they do not adversely affect anyone else (narcotics and such do, hence the justification of making them illegal) it should be my choice to use it.
    Quote Originally Posted by CDB
    You see I wouldn't say so, because it will not stop with informing people. Their good act is going to subsumed into a larger, destructive act of eliminating competition.
    They are not to blame for this one ether, our elective officials are the ones to blame here. They make the rules finially. And given the money they get kicked back they are going to do nothing to prevent them from bending the common consumer over and .........
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    Bottom line, the government should not be able to tell us what and what not to take. BUT, the fact that the government is extending its reach into parts of our lives where it doesn't belong DOES NOT give supplement companies a pardon on the fact that they KNOWINGLY endangered peoples lives.

    To say otherwise is similar to saying: My employer wouldn't give me the wages I deserve, so it was inevitable that I stole those peoples things. Therefore, I should not be punished for being a thief and hurting other people because i was driven to such actions.

    We have to take this "specific" case into consideration. They really did put people's lives at risk. The bigger issues should be addressed separately.
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    Quote Originally Posted by Skye
    Yes but a purely informitive role really isn't enough, there has to be penelty. The problem with the FDA is not its intended function its that it has gone beyond it and likes to play big brother. If a company puts something that is potentally harmful into there product and doesn't tell anyone about it that should be crinimal.
    I would generally agree given an open market. However the government doesn't allow those conditions to exist. Demand is still there for the products though and people are going to sell them. That makes improper labeling or labeling with a 'wink' much more likely. In other words the government created the conditions. Yes these manufacturers deserve to be penalized, but you just can't lose site of the large fact that they likely wouldn't have done it had not the government set the market as it is.

    If a company puts something in a product and tells everyone and warns everyone of what the problems might be then it should be my choice as to wether or not I want to use it. That is were they really cross the line (IMO at least). If I know what the risk are are they do not adversely affect anyone else (narcotics and such do, hence the justification of making them illegal) it should be my choice to use it.
    We agree. I just think you need to allow for the fact that the government is basically not allowing this situation to come about, and is in fact actively working against it.

    They make the rules finially. And given the money they get kicked back they are going to do nothing to prevent them from bending the common consumer over and .........
    Actually a lot of the rules come down from the agencies themselves and even though they aren't the direct result of legislation by elected representatives they have the force of law.
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    Thanks for sharing the info.

    The other products contain chemical ingredients that are analogues of either sildenafil or a pharmaceutical ingredient called vardenafil. Vardenafil is the active ingredient in Levitra, a prescription drug that, like Viagra, is approved in the United States to treat ED. There is no mention of any of these ingredients in any of the illegal products' labeling.

    Does anyone know the how long Vardenafil is in your system. I am having a drug test done for a govt. security position, in a couple days, and am wondering if I should list this as something I took?
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    Quote Originally Posted by RMT
    Thanks for sharing the info.

    The other products contain chemical ingredients that are analogues of either sildenafil or a pharmaceutical ingredient called vardenafil. Vardenafil is the active ingredient in Levitra, a prescription drug that, like Viagra, is approved in the United States to treat ED. There is no mention of any of these ingredients in any of the illegal products' labeling.

    Does anyone know the how long Vardenafil is in your system. I am having a drug test done for a govt. security position, in a couple days, and am wondering if I should list this as something I took?
    They don't test for sexual ingredients. Only MDMA, Marijuana, Cocaine, Heroine, Crystal Meth, PCP, LSD. That's about it.
  

  
 

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