RUFF Natural Formula capsules

Safety advisory

25 July 2017

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

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

packet for RUFF Natural Formula capsules

  • the capsules contain the undeclared substances tadalafil, sildenafil and dapoxetine.

Consumers are advised that tadalafil, sildenafil and dapoxetine are all prescription-only substances in Australia.

The supply of RUFF Natural Formula capsules containing undisclosed tadalafil, sildenafil and dapoxetine is illegal.

RUFF Natural Formula 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 RUFF Natural Formula 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 RUFF Natural Formula 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 and has produced a short video on the risks associated with buying medicines and medical devices online. 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:

How to report
Phone: 1800 020 653
Online: Report a perceived breach of the Therapeutic Goods Act or questionable practices relating to therapeutic products
Email: info@tga.gov.au