Is Melanotan FDA authorized? – 2021

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Recommendations on the use on injecting tanning agents, e.g. Melanotan


Because of the recent promotion and also cautions regarding the dangers of infusing melanotan the HSE has actually launched info and also guidance on the usage on infusing tanning representatives, e.g. Melanotan.

What is Melanotan?

Melanotan is based on a medication (afamelanotide) which was created by the University of Arizona in 1981 to be utilized for image protection against sun damages. This drug is presently going through professional tests for usage in individuals with certain sun-sensitive skin disease and is not available for basic sale.

The drug is chemically connected to the alpha-melanocyte stimulating hormone (α-MSH) and also binds to receptors (melanocortin receptors) in human skin cells. This binding to the α-MSH receptor, which has a key duty in figuring out skin and also hair pigmentation, enhances manufacturing of melanin in the skin, resulting in a ‘sunlight tan’.

Melanotan is a synthetic analog of α-MSH and is prohibited, untried and also uncontrolled which is presently being marketed online for self-administration. α-MSH is extremely vulnerable and needs a rigorous manufacturing setting which can not be guaranteed in unlicensed manufacturing labs. The product has to also be saved in a fridge.

What is the difference between Melanotan I and Melanotan II?

Melanotan I particularly binds to receptors in charge of tanning and so has much less adverse effects. However much more of it is needed for result and therefore it is more expensive than Melanotan II.

Melanotan II binds to receptors other than those responsible for tanning as well as for that reason results in more side-effects.

What are the side-effects?

As this is an unregulated and also untried medication the complete series of possible side-effects are unknown. Increased libido, spontaneous erections, nausea (with subsequent weight management), face flushing on management, flu-like signs, as well as boosted high blood pressure have actually been reported.

How is Melanotan provided?

Melanotan is carried out subcutaneously by infusing right into the fatty layer of tissue around the tummy button location. Clients inject daily till a wanted colour is attained and after that remain to infuse one or two times a week to keep the colour.

Some darkening of the skin might happen utilizing the shot alone however the effects are much more dramatic when utilized in addition to direct exposure to UV light (sunlight or tanning bed) 2-3 times a week initially and after that 1-2 times a week thereafter.

How is Melanotan available?

Products on the market include:

  • 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.

Key concerns

Product purity as well as material:

  • This is an unlicensed, uncontrolled item. This is a vulnerable medicine which calls for refrigeration.
  • Users may hesitant to position the product in their family members fridge. If pre-filled syringes are positioned in the refrigerator this has ramifications in regards to accessibility of youngsters to syringes.

Unidentified side-effects:

  • There are no clinical trials offered on the brief and also long-term impacts of using these items or if the dosages recommended by suppliers are safe.
  • There is no test information available on exactly how these items may connect with other medications or their impact on a coming youngster.

Infusing devices

  • Needles made use of to inject might also carry physical liquids, which can hand down infections such as HIV and also hepatitis. In some cases, there is an undersupply of needles by the on the internet vendors for the amount of management called for, e.g. 1 needle supplied with a 10 dosage vial.
  • This might lead to sharing and also recycling of needles. There are reports of customers utilizing the same needle for a month and trying to sterilise after every use.
  • A multi-dose vial manufactured in a non-rigorous production atmosphere might not remain sterilized throughout of its use e.g. a 30mg vial is made to be made use of for 30 doses which might cover an amount of time of 10 weeks.
  • Some sites use pre-filled syringes in which the product is already re-constituted with bacteriostatic water, however there is no assurance that these pre-filled products will continue to be secure and also sterilized during distribution or for the life span of their usage.

Disposal of used sharps

There have been records of needles being thrown away in house rubbish.

Enhanced exposure to UV rays

As the results of the tanning agents are extra significant when used in conjunction with exposure to UV light (by all-natural sunshine or by tanning beds) use of the agents might increase UV exposure with all the addition dangers associated such as raised threat of skin cancer, skin ageing, etc

Injury reduction actions

  • Describe to individuals about the threats connected with injectable tanning items.
  • Highlight the threats associated with increased UV direct exposure (the unwell impacts of sun tanning still take place also in clients that have a deep tan). Customers can contact the Irish Cancer cells Society if they have concerns concerning skin cancer cells on the cancer helpline 1800 200 700 or
  • Motivate individuals to stop using, and to seek medical advice if required.

If utilizing

Clean infusing devices:

  • Advise that they use a clean needle each time and also throw away needles in a sharps container. The needles available in the infusing pack available in pharmacies participating in the Drug store Needle Exchange Program are created like a diabetic person needle as well as are suitable for subcutaneous injection.
  • Recommend customers on the danger of blood birthed conditions as well as provide advice on whom to call if the client is concerned that they might have revealed themselves to a blood borne illness by sharing needles.
  • A listing of pharmacies taking part in your location is readily available with the Medications helpline 1800 459 459.

Safe disposal.

The pack also contains a tiny sharps container for used sharps. Drug stores will certainly accept utilized sharps if returned in the sharps container.

Contamination and also instability of product.

  • The amount of product in the vial might differ significantly, might be infected with germs or other chemicals.
  • Check the vial prior to usage as well as do not utilize if stained or if fragments noticeable.
  • It needs to be stored in the refrigerator.
  • All medications must be kept out of the reach of kids which may be tough in a fridge.


  • Suggest that side-effects are unidentified, as well as the doses being made use of may not be secure.
  • Results of the drug on an expected youngster are unknown.
  • Effects when taken with various other drugs are unidentified.


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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