Sexual enhancement supplements found to contain undeclared prescription medicines

The Therapeutic Goods Administration (TGA) is advising consumers that several sexual enhancement products have been found to contain undeclared ingredients and may pose a serious risk to your health.

TGA laboratory testing of several sexual enhancement products that claimed to be dietary supplements or natural formulas has confirmed the products contained undeclared prescription-only substances sildenafil, tadalafil and dapoxetine. 

The presence of these prescription-only substances was not declared on the product labels.

None of the products are included in the Australian Register of Therapeutic Goods and have not been assessed by the TGA for quality, safety or efficacy, as required under Australian legislation. 

We urge consumers to exercise extreme caution when purchasing unapproved products, whether buying online or in retail stores. These products:

• may be fake
• may contain undisclosed or harmful ingredients
• may not meet the same standards of quality, safety and efficacy as those approved by us for supply in Australia
• may be available for sale despite not being approved for supply in Australia.

Supplying unapproved products that contain undisclosed ingredients is illegal under Australian therapeutic goods legislation. 

The TGA regularly undertakes compliance and enforcement action against suspected unlawful advertising, importation, manufacture, supply and possession of therapeutic goods. Significant criminal and civil penalties apply to such unlawful conduct. 

Information for consumers

• Stop using the products and take any remaining product to your local pharmacy for safe disposal.
• If you have any concerns arising from your use of these products, consult your health care practitioner.
• If you suspect you have had a side effect (also known as an adverse event) to these or a similar medicine, report it to the TGA.
• If you are considering purchasing medicines from overseas watch this short video on the risks associated with buying medicines and medical devices online.

Action we are taking

These products were located during a search warrant as part of an ongoing investigation.

Our investigation and compliance activities identify therapeutic goods that compromise the health and safety of consumers. The TGA has a regulatory compliance framework which is used when determining appropriate compliance action. Individuals, health practitioners and businesses must understand their legal obligations under the Act before supplying, advertising or importing therapeutic goods. 

Consequences for non-compliance may include infringement notices, direction or prevention notices, or civil or criminal penalties. Penalties that can be imposed for breaches of the Act include civil penalties of up to $1.82 million per breach for individuals or $18.2 million per breach for corporations, and criminal penalties of up to 7 years imprisonment.  For more information on the actions we may take in relation to alleged non-compliance, please see the Compliance and enforcement hub on the TGA website.

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:

Testing results

#	Product Name	Findings	Product Photo
1	Nano Volume capsules	Contains undeclared tadalafil
2	Lustra 80 tablets	Contains undeclared tadalafil
3	Candy Power For Man lozenges	Contains undeclared tadalafil
4	Kama Exstasy200 tablets	Contains undeclared sildenafil
5	Kama Super Platinum tablets	Contains undeclared sildenafil and dapoxetine
6	Nano Epigen Size capsules	Contains undeclared tadalafil
7	Rock II Hard tablets	Contains undeclared tadalafil
8	Cobra Max capsules	Contains undeclared sildenafil
9	Black Bull Extreme cream	Contains undeclared sildenafil and tadalafil
10	Gold Lion tablets	Contains undeclared tadalafil
11	Black Cat capsules	Contains undeclared sildenafil and tadalafil