Is Melanotan 2 FDA authorized? – 2021


When you tan your entire body, you’re exposing all your skin to harmful UV rays. If your skin consistently gets revealed to UV rays way too much, it’ll cause wellness concerns as well as skin problems for you.

Thankfully, Melanotan peptide can assist you manage these tanning issues by enabling your body to boost its production of melanin. Whenever your body suffers UV damage, it normally reacts by generating melanin. This is a peptide hormonal agent which normally darkens the skin in order to shield it from the destructive UV rays.


Advice on the use on infusing tanning agents, e.g. Melanotan


As a result of the current publicity and cautions concerning the risks of infusing melanotan the HSE has launched information and also suggestions on the use on injecting tanning agents, e.g. Melanotan.

What is Melanotan?

Melanotan is based on a medicine (afamelanotide) which was established by the College of Arizona in 1981 to be used for photo protection versus sunlight damages. This medicine is currently going through scientific trials for usage in patients with details sun-sensitive skin disease and also is not readily available for basic sale.

The drug is chemically connected to the alpha-melanocyte stimulating hormonal agent (α-MSH) and binds to receptors (melanocortin receptors) in human skin cells. This binding to the α-MSH receptor, which has a vital function in establishing skin as well as hair pigmentation, enhances production of melanin in the skin, causing a ‘sun tan’.

Melanotan is a synthetic analog of α-MSH and is unlawful, untried and unregulated which is presently being offered online for self-administration. α-MSH is very breakable as well as requires an extensive production environment which can not be guaranteed in unlicensed production laboratories. The item has to also be stored in a fridge.

What is the difference between Melanotan I as well as Melanotan II?

Melanotan I particularly binds to receptors responsible for tanning and so has less negative effects. Nevertheless much more of it is required for effect as well as consequently it is a lot more expensive than Melanotan II.

Melanotan II binds to receptors apart from those in charge of tanning as well as as a result causes even more side-effects.

What are the side-effects?

As this is an unregulated as well as untried medication the complete series of prospective side-effects are unidentified. Boosted sex drive, spontaneous erections, nausea or vomiting (with succeeding weight reduction), facial flushing on management, flu-like symptoms, and raised high blood pressure have actually been reported.

Exactly how is Melanotan carried out?

Melanotan is administered subcutaneously by infusing into the fatty layer of cells around the tummy switch location. Clients infuse daily till a desired colour is accomplished and then continue to inject one or two times a week to keep the colour.

Some dimming of the skin might occur utilizing the shot alone yet the effects are much more significant when used together with direct exposure to UV light (sunlight or tanning bed) 2-3 times a week at first and afterwards 1-2 times a week afterwards.

How is Melanotan available?

Products on the marketplace consist of:

  • A multi- dosage vial of 10, 20 or 30 doses for subcutaneous injection.
  • A collection of pre-filled syringes for subcutaneous shot.
  • A nasal spray.

Main worries

Item purity and also material:

  • This is an unlicensed, uncontrolled product. This is a fragile medication which needs refrigeration.
  • Users may unwilling to place the product in their household refrigerator. If pre-filled syringes are placed in the refrigerator this has ramifications in terms of access of youngsters to syringes.

Unidentified side-effects:

  • There are no medical trials available on the short and also long term effects of using these items or if the doses advised by producers are safe.
  • There is no trial information readily available on exactly how these products might interact with various other drugs or their effect on an unborn youngster.

Injecting tools

  • Needles used to infuse can also lug physical fluids, which can pass on infections such as HIV and hepatitis. In some cases, there is an undersupply of needles by the online providers for the quantity of management needed, e.g. 1 needle supplied with a 10 dosage vial.
  • This might lead to sharing and also reusing of needles. There are reports of clients using the same needle for a month and also trying to sterilise after every use.
  • A multi-dose vial produced in a non-rigorous manufacturing setting may not remain sterile for the duration of its usage e.g. a 30mg vial is created to be used for 30 doses which may extend a period of 10 weeks.
  • Some sites supply pre-filled syringes in which the item is already re-constituted with bacteriostatic water, nevertheless there is no assurance that these pre-filled items will certainly stay secure and clean and sterile during delivery or for the life span of their usage.

Disposal of used sharps

There have actually been records of needles being gotten rid of in household rubbish.

Raised direct exposure to UV rays

As the impacts of the tanning representatives are more remarkable when utilized together with exposure to UV light (by all-natural sunlight or by tanning beds) use of the agents might enhance UV direct exposure with all the enhancement threats associated such as raised risk of skin cancer cells, skin ageing, etc

Damage decrease activities

  • Describe to customers regarding the dangers related to injectable tanning items.
  • Highlight the threats connected with increased UV direct exposure (the unwell impacts of sun tanning still happen even in customers who have a deep tan). Clients can get in touch with the Irish Cancer cells Culture if they have concerns concerning skin cancer on the cancer helpline 1800 200 700 or
  • Motivate individuals to quit making use of, and to look for medical suggestions if needed.

If utilizing

Tidy injecting tools:

  • Suggest that they utilize a tidy needle each time and also dispose of needles in a sharps container. The needles readily available in the infusing pack readily available in pharmacies joining the Drug store Needle Exchange Program are designed like a diabetic needle and also appropriate for subcutaneous shot.
  • Recommend clients on the threat of blood birthed diseases and also supply guidance on whom to speak to if the client is concerned that they may have subjected themselves to a blood birthed disease by sharing needles.
  • A checklist of pharmacies participating in your area is readily available through the Medicines helpline 1800 459 459.

Safe disposal.

The pack also includes a small sharps container for utilized sharps. Pharmacies will certainly accept made use of sharps if returned in the sharps container.

Contamination and instability of product.

  • The quantity of item in the vial may differ significantly, may be infected with microorganisms or other chemicals.
  • Inspect the vial prior to use and also do not make use of if stained or if particles noticeable.
  • It should be saved in the fridge.
  • All medications ought to be shut out of the reach of youngsters which might be hard in a fridge.


  • Encourage that side-effects are unidentified, as well as the doses being utilized may not be risk-free.
  • Results of the medication on an expected youngster are unknown.
  • Impacts when taken with various other drugs are unknown.


Melanotan in WikiPedia

Melanotan II is a synthetic analogue of the peptide hormone α-melanocyte-stimulating hormone (α-MSH) that stimulates melanogenesis and increases sexual arousal.

It was under development as drug candidate for female sexual dysfunction and erectile dysfunction but clinical development ceased by 2003, and as of 2018, no product containing melanotan II was marketed and all commercial development had ceased.

Unlicensed, untested, or fraudulent products sold as “melanotan II” are found on the Internet, and purported to be effective as “tanning drugs”, though side effects such as uneven pigmentation (it makes already uneven pigmentation more noticeable), new nevi (moles), and darkening or enlargement of existing moles have been reported and have led to medical authorities discouraging its use. There has been no scientific study into the long term and permanent side effects the use of this peptide may cause. Products:

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