Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) Order 2021
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Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) Order 2021
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(1) The main label on the intermediate packaging (if any) of a therapeutic vaping substance or a therapeutic vaping substance accessory must contain all of the information listed in column 2 of the following table.
<table cellspacing="0" cellpadding="0" style="width:100%; border-collapse:collapse"><thead><tr><td colspan="2" style="border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Information to be included on main label of intermediate packaging</span></p></td></tr><tr><td style="width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 1</span></p></td><td style="width:86.42%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 2</span></p></td></tr><tr><td style="width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Item</span></p></td><td style="width:86.42%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Information</span></p></td></tr></thead><tbody><tr><td style="width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1</span></p></td><td style="width:86.42%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>the name of the good</span></p></td></tr><tr><td style="width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>2</span></p></td><td style="width:86.42%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for a therapeutic vaping substance or a therapeutic vaping substance accessory that contains nicotine—the word “nicotine” and the concentration of nicotine as follows:</span></p><p class="Tabletext" style="margin-left:16.5pt; text-indent:-16.5pt"><span>(a)</span><span style="width:5.4pt; text-indent:0pt; display:inline-block"> </span><span>where the nicotine is in base form—the base form concentration of nicotine in mg/mL;</span></p><p class="Tabletext" style="margin-left:16.5pt; text-indent:-16.5pt"><span>(b)</span><span style="width:4.84pt; text-indent:0pt; display:inline-block"> </span><span>where the nicotine is in single salt form—the equivalent base form concentration of nicotine in mg/mL, with the name of the salt form in brackets immediately after the word “nicotine”;</span></p><p class="Tabletext" style="margin-left:66.1pt; text-indent:-49.6pt"><span>Example:</span><span style="width:11.28pt; text-indent:0pt; display:inline-block"> </span><span>For a therapeutic vaping substance containing 15</span><span> </span><span>mg/mL of nicotine lactate, with an equivalent base form concentration of 10</span><span> </span><span>mg/mL nicotine, the statement of concentration required to be on the main label is “nicotine (as</span><span> </span><span>lactate) 10</span><span> </span><span>mg/mL”.</span></p><p class="Tabletext" style="margin-left:16.5pt; text-indent:-16.5pt"><span>(c)</span><span style="width:5.4pt; text-indent:0pt; display:inline-block"> </span><span>where the nicotine is a combination of salt forms or a combination of salt and base forms—the total equivalent base form concentration of nicotine in mg/mL, with the names of all the forms of nicotine in brackets immediately after the word “nicotine”</span></p><p class="Tabletext" style="margin-left:66.1pt; text-indent:-49.6pt"><span>Example:</span><span style="width:11.28pt; text-indent:0pt; display:inline-block"> </span><span>For a therapeutic vaping substance containing 5</span><span> </span><span>mg/mL of nicotine as benzoate salt and 15</span><span> </span><span>mg/mL nicotine lactate, with an equivalent base form concentration of 12</span><span> </span><span>mg/mL nicotine, the statement of concentration required to be on the main label is “nicotine (as</span><span> </span><span>benzoate and lactate) 12</span><span> </span><span>mg/mL”.</span></p></td></tr><tr><td style="width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>3</span></p></td><td style="width:86.42%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>for a therapeutic vaping substance or a therapeutic vaping substance accessory that does not contain nicotine—the concentration of nicotine in the form of “nicotine 0</span><span> </span><span>mg/mL”</span></p></td></tr><tr><td style="width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>4</span></p></td><td style="width:86.42%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>the batch number preceded by the batch number prefix</span></p></td></tr><tr><td style="width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>5</span></p></td><td style="width:86.42%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>the expiry date preceded by the expiry date prefix</span></p></td></tr><tr><td style="width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>6</span></p></td><td style="width:86.42%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt"><p style="margin-top:2pt; margin-left:82.2pt; text-indent:-82.2pt; line-height:normal; font-size:10pt"><span>all of the following warning statements:</span></p><p class="paragraphsub" style="margin-left:16.5pt; text-indent:-16.5pt; font-size:10pt"><span>(a)</span><span style="width:5.4pt; text-indent:0pt; display:inline-block"> </span><span>for a therapeutic vaping substance or a therapeutic vaping substance accessory that contains nicotine—“THIS PRODUCT CONTAINS NICOTINE, WHICH IS A HIGHLY ADDICTIVE SUBSTANCE”;</span></p><p class="paragraphsub" style="margin-left:16.5pt; text-indent:-16.5pt; font-size:10pt"><span>(b)</span><span style="width:4.84pt; text-indent:0pt; display:inline-block"> </span><span>“Keep out of reach of children”;</span></p><p class="paragraphsub" style="margin-left:16.5pt; text-indent:-16.5pt; font-size:10pt"><span>(c)</span><span style="width:5.4pt; text-indent:0pt; display:inline-block"> </span><span>“Avoid contact with eyes and skin”;</span></p><p class="Tabletext" style="margin-left:16.5pt; text-indent:-16.5pt"><span>(d)</span><span style="width:4.84pt; text-indent:0pt; display:inline-block"> </span><span>“Do not swallow”</span></p></td></tr></tbody></table>
(2) The information required by subsection (1) must be displayed in a text size of at least 1.5 mm. (3) The warning statement required by paragraph (a) in column 2 of item 6 in the table in subsection (1) must be displayed in capital letters.