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<div id="overviewDiv" class="divsummary"><span class="divheading">Overview</span><div class="tableddiv"><table class="tablesummary"><tr><th>Case Number</th><th>Received Date</th><th>Finalised Date</th><th>Product/s</th><th>Responsible Person</th></tr><tr><td>CC-FRMA0QPH/2020*</td><td>14/04/2020</td><td>23/08/2021</td><td><ul><li>Molecular Hydrogen/Oxygen Generators and Nannobubble Infusion Pumps</li></ul></td><td><ul><li>Hydrogen Technologies Holdings Pty Ltd</li></ul></td></tr></table></div></div><div id="summaryDiv" class="divsummary"><span class="divheading">Case Summary</span><div class="tableddiv"><span class="divheadingtwo">Alleged Breaches</span><div id="allegationAdvertisingTherapeutic Goods Act 1989" class="divadvertisingcode"><span class="allegationtype"><a href="https://www.legislation.gov.au/Series/C2004A03952" target="_blank">Therapeutic Goods Act 1989</a></span><ul><li>s42DL(3) - Advertises therapeutic goods or causes the advertising, by any means, of therapeutic goods and subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to the advertisement.</li><li>s42DLB(9) - Advertisement refers to therapeutic goods that are not entered in the Register and that are prescribed by the regulations for the purposes of this subsection, other than a reference authorised/required by a government/Government authority (not including a foreign government/authority)</li><li>s42DL(3) - Advertises therapeutic goods or causes the advertising, by any means, of therapeutic goods and subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to the advertisement.</li><li>s42DLB(2)(a) - Advertisement contains a prohibited representation about the goods and no permission under section 42DK is in force in relation to the prohibited representation.</li><li>s42DL(3) - Advertises therapeutic goods or causes the advertising, by any means, of therapeutic goods and subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to the advertisement.</li><li>s42DLB(4)(a) - Advertisement contains a restricted representation and neither an approval under section 42DF nor a permission under section 42DK is in force in relation to the restricted representation</li></ul></div><span class="divheadingtwo">Summary</span><div class="breachDiv"><div data-wrapper="true" style="font-size:9pt;font-family:'Segoe UI','Helvetica Neue',sans-serif;">
<div>In April 2020, the company allegedly advertised on its website and social media page therapeutic goods, being hydrogen/oxygen generators and nanobubble infusion pumps, that are not entered in the Australia Register of Therapeutic Goods (ARTG).&nbsp;<br>
Unless a specific exemption, approval or authority applies, therapeutic goods must be entered in the ARTG before they can be lawfully supplied or advertised in Australia.<br>
It was also alleged the company’s website made unlawful representations regarding the goods, including references to serious diseases and conditions such as COVID-19, diabetes and cancer. Under the Therapeutic Goods Act 1989 (the Act), representations relating to the treatment, cure, prevention, diagnosis (including screening), monitoring or susceptibility of, or pre-disposition to neoplastic diseases (including all types of cancer) are prohibited representations. Representations concerning a serious form of a disease, condition, ailment or defect, such as COVID-19 and diabetes, are restricted representations under the Act. The use of prohibited or restricted representations in advertisements for therapeutic goods is unlawful without the express permission of the TGA.<br>
Advertisements of this nature were of significant concern given the pandemic.<br>
The TGA issued the company four infringement notices totalling $50,400.<br>
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</div></div></div></div><div id="actionsDiv" class="divsummary"><span class="divheading">Actions</span><div class="tableddiv"><table class="tablesummary"><tr><th>Date</th><th>Action</th><th> </th></tr><tr><td>20/05/2020</td><td>Initial contact made with advertiser</td><td></td></tr><tr><td>20/05/2020</td><td>Infringement notice issued</td><td>4x Infringement notices issued &amp; immediate notice to Cease and Desist. <br></td></tr></table></div></div><div id="outcomeDiv" class="divsummary"><span class="divheading">Case Outcome</span><div class="tableddiv"><table class="tablesummary"><tr><th>Date</th><th>Case Outcome</th><th> </th></tr><tr><td>17/06/2021</td><td>Case closed</td><td>Infringement notices paid in full</td></tr></table></div></div><div id="previewDiv"></div>
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