COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
PUBLICATION OF NOTIFICATION AND RECOVERY OF THERAPEUTIC GOODS, SECTION 30EA OF THE THERAPEUTIC GOODS ACT 1989
I, Pio Cesarin, delegate of the Secretary to the Department of Health for the purposes of section 30EB of the Therapeutic Goods Act 1989 (the Act), hereby publish particulars of the my decision under section 30EA of the Act to undertake public notification and recovery of LOVher Herbal Viagra for Her capsules and require Mr Raymond Walter Thorpe, Director and Secretary, Happy Herb Company Pty Ltd to:
- Take steps to recover to consumer level any of the goods that have been distributed in Australia;
- Within 7 days put arrangement into place to publish a notice in a prominent position on the home page of the www.happyherbcompany.com website to the effect that:
- LOVher, for HER, Herbal Viagra capsules pose a risk to your health and safety and should not be taken. You should stop taking LOVher, for HER, Herbal Viagra 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.
- The Therapeutic Goods Administration has tested LOVher, for HER, Herbal Viagra capsules and found that they contain the undisclosed prescription-only substances tadalafil and sildenafil and also contain diclofenac, a non-steroidal anti-inflammatory ingredient used in pharmacy only and prescription only medicines.
- LOVher, for HER, Herbal Viagra capsules have not been assessed by the TGA for quality, safety or efficacy as required by the TGA, these capsules should not have been supplied.
- TGA investigations have shown that a number of people in Australia may have bought the product online and / or in store.
3. The notice should appear on the website for at least 30 days.
(Signed by)
Pio Cesarin
Head, Office of Parliamentary and Strategic Support
Therapeutic Goods Administration
(Delegate of the Secretary to the Department of Health).
28 March 2014.
Overview
The Therapeutic Goods Administration, acting under the authority of the Therapeutic Goods Act 1989, has mandated the public notification and recovery of LOVher Herbal Viagra for Her capsules. Enacted in 1989, the Therapeutic Goods Act 1989 was established to address the need for regulation and oversight of therapeutic goods in Australia, ensuring that such products are safe, of high quality, and effective for their intended use. This recent action was taken to rectify the issue of undisclosed prescription-only substances and non-compliant ingredients in the product, which pose significant health risks to consumers. The decision to publish a public notification and enforce recovery was made by Pio Cesarin, a delegate of the Secretary to the Department of Health, aiming to safeguard public health by ensuring that consumers are adequately informed and that the potentially harmful product is removed from circulation.
Scope and Application
The Therapeutic Goods Act 1989 applies to the regulation and control of therapeutic goods in Australia, including their advertising, manufacturing, and distribution. The Act applies to individuals, companies, and entities that manufacture, supply, or advertise therapeutic goods within Australia. The geographic reach of the Act is national, covering the entire Commonwealth of Australia. The Therapeutic Goods Administration, a department of the Australian Government, administers the Act and has the authority to take action against those who breach its provisions. The Act includes provisions for the public notification and recovery of therapeutic goods that pose a risk to health and safety, as demonstrated in this decision by Pio Cesarin, a delegate of the Secretary to the Department of Health. The Act also includes exclusions and exemptions for certain goods and activities, and its application may be extended or restricted through subordinate instruments. This decision to publicly notify and recover LOVher Herbal Viagra for Her capsules is an example of the Act's application to regulate therapeutic goods and protect public health.
Key Provisions
The main operative sections of the Therapeutic Goods Act 1989 (the Act) in this context are sections 30EA and 30EB, which allow for the public notification and recovery of therapeutic goods that pose a risk to health and safety. Under section 30EA, the delegate of the Secretary to the Department of Health has the authority to make decisions regarding public notification and recovery, as evidenced in the decision made by Pio Cesarin to address the risks associated with LOVher Herbal Viagra for Her capsules. Section 30EB outlines the process for notifying the public about the risks of the specified goods and ensuring their recovery.
The obligations imposed by the Act on the parties or entities it governs are detailed in the decision. Specifically, Mr Raymond Walter Thorpe, Director and Secretary of Happy Herb Company Pty Ltd, is required to take immediate steps to recover any distributed LOVher Herbal Viagra for Her capsules to the consumer level. Within a specified timeframe of seven days, he must also arrange to publish a prominent notice on the company’s website, www.happyherbcompany.com, warning consumers about the health risks associated with the product and advising them to cease use and seek safe disposal of any remaining capsules. Additionally, the notice must remain visible for a minimum of 30 days to ensure adequate public awareness.
Under the Act, failure to comply with the obligations and requirements set forth can result in legal consequences. The Therapeutic Goods Administration has the authority to enforce these obligations, and breaches may lead to civil or criminal penalties. While the specific penalties are not detailed in the provided text, it is reasonable to infer that non-compliance with such directives could result in fines or other legal actions as stipulated by the Act. The seriousness of the potential health risks associated with the undisclosed substances in the product underscores the importance of strict adherence to these regulatory measures.