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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Turn the raw legal text into a practical explanation grounded in Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) Order 2021.
(1) This section applies to the main label of a container that is not a small container or a very small container. (2) Where the container of a therapeutic vaping substance is enclosed in a primary pack, the main label on the container 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 a container</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 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 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>for a therapeutic vaping substance that is menthol flavour—the words “menthol flavour”</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>for a therapeutic vaping substance that is mint flavour—the words “mint flavour”</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>6</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 that is tobacco flavour—the words:</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>“tobacco flavour”; or</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>“classic flavour”</span></p></td></tr><tr><td style="width:13.58%; border-top:0.75pt solid #000000; border-bottom:2.25pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>7</span></p></td><td style="width:86.42%; border-top:0.75pt solid #000000; border-bottom:2.25pt solid #000000; padding-right:5.4pt; padding-left:5.4pt"><p class="Tabletext"><span>the fill volume in mL</span></p></td></tr></tbody></table>
(3) The information required by subsection (1) must:
(a) be orientated in the same direction; and
(b) for the information mentioned in items 1 to 3—be displayed in a text size of at least 3 mm; and
(c) for all other text—be displayed in a text size of at least 1.5 mm.
(4) The name of the good on the main label of the container must be presented in a continuous, uninterrupted manner and not be broken up by additional words or images. (5) Where a therapeutic vaping substance contains nicotine, the name of the good, the word “nicotine” and the concentration of nicotine must:
(a) appear as a cohesive unit by placing the word “nicotine” and the concentration of nicotine together in a single line of text immediately below the name of the good; and
(b) not be separated by additional words or images.
(6) Where a therapeutic vaping substance does not contain nicotine, the name of the good and concentration of nicotine must:
(a) appear as a cohesive unit by placing the words “nicotine 0 mg/mL” immediately below the name of the good; and
(b) not be separated by additional words or images.
(7) Where a therapeutic vaping substance contains nicotine, the main label on the container must contain a warning statement panel as specified in section 20.