Natural Model capsules

Safety advisory

10 February 2016

Natural Model capsules pose a serious risk to your health and should not be taken.

The Therapeutic Goods Administration (TGA) has tested a product labelled Natural Model capsules and found that:

Packaging and blister pack of Natural Model capsules
  • the capsules contain the undeclared substance sibutramine; and
  • the capsules contain the undeclared substance phenolphthalein

Consumers are advised that sibutramine and phenolphthalein are both prescription-only substances in Australia. Sibutramine was withdrawn from world markets in 2010 due to increased risk of cardiac events and stroke, and phenolphthalein was withdrawn from sale on many markets in the late 1990's due to concerns over its carcinogenicity with long term use.

The supply of Natural Model capsules containing sibutramine and phenolphthalein is illegal.

Natural Model capsules have not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation, and the place of manufacture is not approved by the TGA.

TGA investigations have shown that a number of people in Australia may have bought the product online.

Information for consumers

  • Stop taking Natural Model capsules and take any remaining capsules to your local pharmacy for safe disposal.
  • If you have any concerns arising from your use of this product, consult your health care practitioner.

Action the TGA is taking

The TGA is working with the Australian Border Force (ABF) to help stop future shipments of Natural Model capsules from entering Australia.

If these capsules are found at the border by the ABF they will be seized and destroyed.

The TGA is advising consumers to exercise extreme caution when purchasing medicines from unknown overseas Internet sites. Products purchased over the Internet:

  • may contain undisclosed and potentially harmful ingredients
  • may not meet the same standards of quality, safety and efficacy as those approved by the TGA for supply in Australia.

Report counterfeit medicines and medical devices

If you are worried about counterfeit medicines or medical devices, and want to report an issue, you can report the matter to the TGA:

Phone: 1800 020 653
Online: Report a perceived breach of the Therapeutic Goods Act or questionable practices relating to therapeutic products