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Melanotan – Illegal therapeutic goods

Consumer Alert

3 November 2017

Consumers are advised not to use Melanotan-I, Melanotan-II and similar injectable tanning products.

These injectable tanning products are generally obtained through websites, which are often based overseas.

They may cause serious side effects and should not be used.

Side effects: darkened skin, moles, and freckles, nausea, vomiting, loss of appetite, spontaneous erections, flushing of the face, involuntary stretching and yawning

If you are experiencing side effects after using these products, please see your healthcare professional.

Consumers should be aware that Melanotan-I and Melanotan-II and other injectable tanning products:

  • may cause serious side effects
  • are not included on the ARTG and therefore have not been assessed by the TGA as safe and effective, and are not registered or approved for sale in Australia.
  • are not subject to Australia’s stringent requirements for quality, safety or efficacy (effectiveness).
  • are considered to be prescription only medicines.

It is unlawful to import Melanotan I or Melanotan II or any other injectable into Australia for personal use unless you have a prescription from medical practitioner registered in Australia.

Products supplied by mail order from overseas are not regulated by the TGA. If care is not taken, consumers may inadvertently risk their health and waste their money.

Information for consumers

If you, or someone you care for, have purchased Melanotan-I, Melanotan-II or any other injectable tanning product, the TGA recommends that you stop using the product and take any remaining product to a pharmacy for safe disposal.

If you suspect that you or someone you care for has experienced a serious side effect after using these products, please consult your health professional.

Consumers are also advised that there are health and safety risks associated with self-injection as it could cause serious infection.

Injectable cosmetic products including tanning or beauty treatments should be used with caution and should only ever be administered under the supervision of an authorised healthcare professional.

Information for health professionals

If you are treating a patient who is using Melanotan-I, Melanotan-II or any other injectable tanning product advise them to discontinue use and take any remaining product to a pharmacy for safe disposal.

Additional information

  • The TGA is responsible for the regulation of medicines and other therapeutic goods in Australia. In order for a medicine to be sold in Australia, a person or company must submit an application to the TGA. The TGA must review the clinical and scientific data before deciding to approve or not approve the sale of the medicine in Australia.
  • It is unlawful to import, export, manufacture and supply medicines that are not included on the ARTG.
  • Consumers can import small quantities of medicines for personal use as long as certain conditions are met. Any injectable medicine imported into Australia must have a written prescription from a medical practitioner that is registered in Australia.
  • The TGA continually advises consumers to exercise extreme caution when purchasing medicines from overseas internet sites, particularly if the supplier does not require a prescription which is a requirement in Australia for injectable products.
  • Products purchased online or from overseas may be counterfeit and contain undisclosed ingredients or potentially harmful ingredients or contaminants and may not meet the same standards of quality, safety and efficacy as those approved by the TGA for supply in Australia.

See Buying medicines and medical devices online for more information.

Reporting problems

If you have encountered promotional material or products that you are concerned about, you can Report a perceived breach of the Therapeutic Goods Act or questionable practices relating to therapeutic products.