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Governmental Warnings - Important Reading (Read 63392 times)
Scott Stevenson
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Governmental Warnings - Important Reading
01/26/09 at 23:57:25
 
With the growing popularity of the usage of the Melanotan peptides, this forum would be remiss if we did not bring to the attention of everyone the fact that health regulatory agencies of four governments have issued warnings about using one or the other melanotan peptides (or both).
 
The following is a listing of these warnings with easy-access links to them.  
 
This list is in chronological order:
 
Warning - United States - FDA Sept. 5, 2007: FDA Warns About Unapproved Product, Melanotan II
 
Warning - Norway - NoMA Dec. 13, 2007: Legemiddelverket advarer mot bruk av Melanotan (appears to be available only in Norwegian)
 
Warning - Denmark - DMA Aug. 8, 2008: Warning against the product Melanotan
 
Warning - United Kingdom - MHRA Nov. 17, 2008: "Tan jab" is an unlicensed medicine and may not be safe
 
Warning 2 - Norway -  NoMA  Jan. 23, 2009: Melanotan – farlig og ulovlig brunfarge (appears to be available only in Norwegian)
 
Due to the fact that part of the goal of this forum is to be a public service resource for information about the melanotan peptides it is important that the word of these various agencies be shared here.  
 
 
These are all of the warning that I personally am aware of. If anyone has additional warnings of any additional governments please don't hesitate to add links to this thread.  
 
I invite fellow forum users (this thread is currently open to all even anonymous replies) to thoroughly read these warnings and discuss them here on this thread.  
 
-Scott
 
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Re: Governmental Warnings - Important Reading
Reply #1 - 01/27/09 at 04:41:15
 
Thank you for posting this Scott.  While I myself am on the fence about melanotan II, I continue to take it.  Obviously using a drug that has not been evaluated by the FDA could be dangerous.  However, I think it's important to note here that the FDA has never said melanotan-1 or melanotan II is bad or will hurt you.  They are simply saying, "We have not investigated the effect and side effects and we therefore warn against using it."  The same goes for any non-FDA-evaluated drug.  
 
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Re: Governmental Warnings - Important Reading
Reply #2 - 01/27/09 at 04:50:56
 
I have my views about these warnings and the overall safety of using pure melanotan peptides but I want to hold off expressing them and allow others to have a chance to express their own views independently with little influence from myself. Since the BBC's Nov. 17, 2008 report on the usage of the melanotan peptides (almost exclusively melanotan II) in the UK there has been an influx of individuals into the forums from whom I have gotten the impression that they were much too casual about using unlicensed drugs like the melanotan peptides. With this post it is my intention to try to snap these folks out of this casual mindset and understand the very real risks of using the melanotan peptides. Folks should be making a very informed and serious decision if they are considering embarking on a melanotan peptide regimen.
 
-Scott
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Re: Governmental Warnings - Important Reading
Reply #3 - 02/10/09 at 13:46:38
 
Thank you for this information.  I agree that it is important that potential new users understand the risks and side effects involved in using any of these peptides.  While I understand the FDA's point in the warnings, you also have to understand the FDA's goal is both about commerce (read money) and about health of consumers... and, most importantly, weighing the two issues together.
 
To put this in perspective, there are drugs that many of us use every day: alcohol, chocolate and caffeine.  Every food you eat, every medication you take, everything you put into your body has the risk of adverse side effects and negative (or positive) interactions with one another.  A prime example is alcoholic beverages.  Alcohol technically both a drug and a controlled substance.  Yet, many people are very casual about it.  Informed choices should be the goal of everything you eat and do.
 
That said, there is one point that should not be overlooked.  The peptide manufacturers are not under control/regulation of the FDA (or any other governing body) and, thus, quality cannot be guaranteed.  But, can it ever be guaranteed even with approved drugs?  Quality control, however, is the one thing that is most troubling about obtaining these peptides... Is the quality there?
 
On the other hand, we have the FDA who can't manage to keep people from getting sick because of Salmonella poisoning in Peanut Butter.  So, on the one hand you have the FDA issuing warnings about peptides and, on the other, you have them unable to manage food stuffs that should be safe for consumption.  Granted, the peanut processing plant didn't do the right things, apparently, but it is still part of the FDA's job to make sure these organizations continue to produce safe goods for consumption.  This is the perspective that one needs to understand when taking these warnings into consideration.
 
Ultimately, it's your body and it's your choice.  Read, understand and weigh all sides and arguments before you embark.
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Re: Governmental Warnings - Important Reading
Reply #4 - 02/27/09 at 16:44:30
 
The Irish Medicines Board has issued a Warning:
 
Warning - Ireland - IMB Feb. 27, 2009: Melanotan Powder for Injection
 
-Scott
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« Last Edit: 05/19/09 at 20:53:11 by Scott Stevenson »  

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Re: Governmental Warnings - Important Reading
Reply #5 - 03/29/09 at 23:19:44
 
My thoughts?
 
 
All of the most popular and reliable suppliers are no longer shipping to the us. This leaves those in the market for melanotan with very few options. Not only that, but people are much more likely to use a supplier who may not be as well known and may supply product of good quality. I fear that this will lead to inexperienced users injecting themselves with what they think it melanotan when in fact it may not be, or may even be loaded with mannitol. All of this equates to bad PR for melanotan as a whole, and will slow or stop any possibility of it's approval and widespread use.
 
Perhaps I'm just being paranoid, but this scenario seems like a real possibility. I'm also pretty pissed about all of this. I've lurked this forum for the past year or so, and just recently decided to make the jump and start my loading phase. Two days ago I go to the USlabs website, which seemed to be the most reputable, only to find that I'm S.O.L.
 
not happy  cry
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Re: Governmental Warnings - Important Reading
Reply #6 - 04/02/09 at 03:59:13
 
When reading the FDA warning I once again come to a question I asked before but am still unsure on the answer.
 
Is it illegal to buy melanotan II from an online source within the US?  The article made it sound like it would be, however, the FDA just "warns" against use and does not actually say it's illegal.  
 
Is it only illegal to advertise and sell as a drug?
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Re: Governmental Warnings - Important Reading
Reply #7 - 04/04/09 at 07:09:22
 
^^^^
 
Melanotan is not a controlled substance. It is not illegal.
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Reply #8 - 05/19/09 at 20:51:30
 
The Austrian Bundesamt für Sicherheit im Gesundheitswesen has issued a Warning:
 
Warning - Austria - BASG May 18, 2009: Melanotan II (Appears to only be available in German)
 
This warning consists primarily of links to the FDA's Melanotan II warning and the MHRA's warnings.
 
-Scott
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Re: Governmental Warnings - Important Reading
Reply #9 - 07/02/09 at 03:23:50
 
The Lithuanian Valstybinė vaistų kontrolės tarnyba has issued a warning for melanotan II:
 
Warning - Lithuania - VVKT July 1, 2009: Dėl preparato Melanotan-2 (Appears to only be available in Lithuanian)
 
-Scott
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Re: Governmental Warnings - Important Reading
Reply #10 - 01/18/10 at 23:54:05
 
Warning - Lithuania - VVKT July 1, 2009: Dėl preparato melanotan II (Appears to only be available in Lithuanian)  
 
Hi, here i am translating a government report about Melanotan - 2, sorry for my english but i will try to translate as good as i can...
 
The Lithuanian State Medicines Control Agency informs, information that appeared on the Internet tan on their sales incentive injectables melanotan II. This product active ingredient (melanocytes-stimulating hormone) is not known.
Melanotis-2 is not registered neither in the European Union than in other countries. The use of this product may be unsafe, the The Lithuanian State Medicines Control Agency warns residents not to buy and not to use this product.
Melanocyte-stimulating hormone is not used to treat or prevent. Especially since it is not healthy for human consumption cosmetic purposes.
 
That's it Smiley
 
 
 
 
 
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Re: Governmental Warnings - Important Reading
Reply #11 - 01/20/10 at 03:53:16
 
Hundreds if not thousands of people have been using these peptides for approx 2-5 years now.  
Most have been using huge amounts (compared to the implant) on and off for for months at a time. Some have even been dosing each and every day for a number of years.
If these peptides produced dangerous effects to the immune and cardiovascular systems you would think that there would be a number of people showing the signs already.  
 
  
  
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Re: Governmental Warnings - Important Reading
Reply #12 - 06/29/10 at 23:29:45
 
Quote from Sport81 on 04/02/09 at 03:59:13:
When reading the FDA warning I once again come to a question I asked before but am still unsure on the answer.

Is it illegal to buy melanotan II from an online source within the US?  The article made it sound like it would be, however, the FDA just "warns" against use and does not actually say it's illegal.  

Is it only illegal to advertise and sell as a drug?

 it is not illigal the goverment will say anything, if it so bad it would be band , the stuff is ok if u dont use to much if u do use to much u will go abnormal dark
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Re: Governmental Warnings - Important Reading
Reply #13 - 07/26/10 at 10:48:50
 
The Swedish Läkemedelsverket (Medical Products Agency, MPA) has issued a warning against using Melanotan II:
 
Warning - Sweden - LV July 26, 2010: Läkemedelsverket varnar för användning av Melanotan II (Appears to only be in Swedish)
 
-Scott
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Re: Governmental Warnings - Important Reading
Reply #14 - 09/01/10 at 15:03:22
 
Iv'e tried  melanotan II.
 
The first vial seemed ok nd did exactly what it said it would do
I'm afraid i had a very bad reaction on the second vial.
I had fever like symptoms( shivering uncontrollably then high temperature
 
I WONT USE IT Again
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Re: Governmental Warnings - Important Reading
Reply #15 - 10/13/10 at 19:28:38
 
I read this board from time to time and I just need to comment on FDA "warning" .  This is the same body that has deemed aspartame safe.  I would confidently take melanotan over aspartame.   Don't believe everything coming form the governments. There is a lot of money involved in getting something FDA approved or whatever country your in.
 
Just because something is approved doesn't mean its safe and just because it is not approved does mean its not safe. The internet is a great place to receive information from all sides.  Read, do your homework and make your own decision.  Yes you are injecting something into your body for cosmetic purposes, but then again people are injecting Botox, a poison into their face.  FDA approved, but now the FDA is doing an about face and falling short of tell people to stop using it.  
 
So lets not judge a drug on government approval but on what the users are experiencing.
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Re: Governmental Warnings - Important Reading
Reply #16 - 10/29/10 at 04:49:53
 
The German Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) has issued a warning regarding cosmetic usage of the melanotan peptides:
 
Warning - Germany -  BfArM October 28, 2010: 14/10 BfArM warnt vor Anwendung melanotanhaltiger Produkte für kosmetische Zwecke (Appears to only be in German)
 
-Scott
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Re: Governmental Warnings - Important Reading
Reply #17 - 10/29/10 at 18:33:58
 
Im Internet werden Produkte angeboten, die die Stoffe melanotan-1 oder Melanotan II enthalten. Einige sind zur Injektion eines Implantats vorgesehen, d.h. über kleine Stäbchen, die unter der Haut ins Fettgewebe eingesetzt werden. Dort geben sie den Wirkstoff in den Körper ab und lösen sich langsam auf. Neuerdings werden die Wirkstoffe auch in Kapseln oder Nasensprays angeboten. Melanotan fördert die Bildung von Melanin, ein körpereigener Stoff, der für die dunkle Färbung der Haut verantwortlich ist. melanotan-1 und II werden deshalb vor allem zur einfachen Bräunung der Haut ohne Sonnenbad angeboten.
 
Die Anwendung melanotanhaltiger Produkte ist mit Gefahren für die Gesundheit verbunden. Diese betreffen, soweit bekannt, das Herz-Kreislaufsystem, den Verdauungstrakt und unbeabsichtigte Veränderungen der Hautfärbung. Die Selbstinjektion eines Melanotan-Implantats kann mit der Gefahr von Infektionen verbunden sein.

 
---
 
This is so poorly researched and written, it's ridiculous.
 
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Re: Governmental Warnings - Important Reading
Reply #18 - 10/29/10 at 19:03:18
 
Quote from Jacques on 10/29/10 at 18:33:58:

This is so poorly researched and written, it's ridiculous.

 
Other than through Clinuvel's government authorized programs availability of the peptides in implant form has never been shown to exist.
 
Also, concerns about blood pressure and immune system effects stem from one report by the substance use team at Liverpool John Moores University that was based upon studies not involving either peptide. The blood pressure concern in particular is based upon a clinical trial examining nasal administration of bremelanotide, a different though related peptide. Nasal administration and subcutaneous administration have rather different effect profiles. Palatin themselves performed an additional trial only using subcutaneous administration rather than nasal and reported that blood pressure was not an issue.  Of course nowhere is this explained. It would be helpful if academic scholars like the Liverpool substance use team and health authorities kept strictly to complete facts rather than abridged versions.
 
-Scott
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Re: Governmental Warnings - Important Reading
Reply #19 - 10/29/10 at 19:22:56
 
Quote from Scott Stevenson on 10/29/10 at 19:03:18:

Also, concerns about blood pressure and immune system effects stem from one report by the substance use team at Liverpool John Moores University that was based upon studies not involving either peptide. The blood pressure concern in particular is based upon a clinical trial examining nasal administration of bremelanotide, a different though related peptide. Nasal administration and subcutaneous administration have rather different effect profiles. Palatin themselves performed an additional trial only using subcutaneous administration rather than nasal and reported that blood pressure was not an issue.  Of course nowhere is this explained. It would be helpful if academic scholars like the Liverpool substance use team and health authorities kept strictly to complete facts rather than abridged versions.

-Scott

Excellent! I was going to post about this. This argument is used all the time, yet I've never seen it validated by studies. Thanks.
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