<p>5 月 8 日（路透社）- 美国食品药品监督管理局（FDA）周五表示，如果相关公司的营销申请正在接受审查，该局将不会优先对某些未授权的电子烟和尼古丁袋产品采取执法行动。</p><p>该机构表示，新指南适用于已受理审查的上市前申请或待审超过 180 天的补充备案产品。</p><p>由于担心青少年使用问题而面临更严格审查的非烟草口味电子烟制造商，还必须提供充足的科学数据，以评估这些产品是否 “适合保护公众健康”。</p><p>这一变化意味着，符合该机构条件的产品制造商，即使在未获得法律要求的许可证的情况下销售产品，也不太可能面临执法行动。</p><p>这对菲利普莫里斯国际公司（Philip Morris International，股票代码：PM.N）等公司来说是一个利好消息。这些公司在等待监管机构决定的期间一直推迟推出新产品，有时甚至以牺牲市场份额为代价。</p><p>烟草公司一直在游说唐纳德·特朗普总统及政府其他关键官员，要求包括加快并明确 FDA 授权流程在内的变革。</p><p>本周早些时候，该机构批准了某些水果味电子烟的营销，这是首次授权非烟草口味的电子烟产品。</p><p>FDA 周五还表示，包含有关产品成分、健康风险和设备规格详细数据的申请更有可能符合监管标准。</p><p>该局表示：“通过不将这些烟草产品列为执法重点，FDA 能够更好地分配其执法资源。FDA 缺乏对每一种未获授权的产品进行执法的资源。”</p><p>FDA 仍可能对具有某些 “推定吸引未成年人” 元素的产品采取行动，例如描绘卡通虚构角色、掩盖其作为电子烟产品的性质，或类似于儿童玩具、手机或游戏平台。</p>

菲利普莫里斯

VICE

<p>May 8 (Reuters) - The U.S. Food and Drug Administration (FDA) said on Friday it would not prioritize enforcement against certain unauthorized e-cigarettes and nicotine pouch products if the companies have marketing applications under review.</p>
<div class="lb-trans"><p>5 月 8 日（路透社）- 美国食品药品监督管理局（FDA）周五表示，如果相关公司的营销申请正在接受审查，该局将不会优先对某些未授权的电子烟和尼古丁袋产品采取执法行动。</p></div><p>The new guideline applies to products with premarket applications that have been accepted for review or supplemental filings that have been pending for more than 180 days, the agency said.</p>
<div class="lb-trans"><p>该机构表示，新指南适用于已受理审查的上市前申请或待审超过 180 天的补充备案产品。</p></div><p>Non-tobacco-flavored vape makers, who face heightened scrutiny due to youth usage concerns, must also provide sufficient scientific data to assess whether the products are “appropriate for the protection of the public health”.</p>
<div class="lb-trans"><p>由于担心青少年使用问题而面临更严格审查的非烟草口味电子烟制造商，还必须提供充足的科学数据，以评估这些产品是否 “适合保护公众健康”。</p></div><p>The change means that manufacturers with products that meet the agency’s conditions are unlikely to face enforcement action even if they sell their products without the legally-required license.</p>
<div class="lb-trans"><p>这一变化意味着，符合该机构条件的产品制造商，即使在未获得法律要求的许可证的情况下销售产品，也不太可能面临执法行动。</p></div><p>It marks a boost for companies like Philip Morris International (PM.N) , which have held off on launching new products while waiting for an agency decision, sometimes at the expense of market share.</p>
<div class="lb-trans"><p>这对菲利普莫里斯国际公司（Philip Morris International，股票代码：PM.N）等公司来说是一个利好消息。这些公司在等待监管机构决定的期间一直推迟推出新产品，有时甚至以牺牲市场份额为代价。</p></div><p>Tobacco companies have been lobbying President Donald Trump and other key officials in the administration for changes including a faster, clearer FDA authorization process.</p>
<div class="lb-trans"><p>烟草公司一直在游说唐纳德·特朗普总统及政府其他关键官员，要求包括加快并明确 FDA 授权流程在内的变革。</p></div><p>Earlier this week, the agency approved the marketing of certain fruit-flavored e-cigarettes in a first authorization of non-tobacco-flavored vaping products.</p>
<div class="lb-trans"><p>本周早些时候，该机构批准了某些水果味电子烟的营销，这是首次授权非烟草口味的电子烟产品。</p></div><p>The FDA also said on Friday that applications that include detailed data on product composition, health risks and device specifications are more likely to meet regulatory standards.</p>
<div class="lb-trans"><p>FDA 周五还表示，包含有关产品成分、健康风险和设备规格详细数据的申请更有可能符合监管标准。</p></div><p>“By not prioritizing these tobacco products for enforcement, FDA will be able to better allocate its enforcement resources. FDA lacks the resources to pursue enforcement against every product that has not received authorization,” it said.</p>
<div class="lb-trans"><p>该局表示：“通过不将这些烟草产品列为执法重点，FDA 能够更好地分配其执法资源。FDA 缺乏对每一种未获授权的产品进行执法的资源。”</p></div><p>The FDA may still take action against products that have certain “presumptively underage-appealing elements such as depicting a cartoon-like fictional character, disguising its nature as a vaping product, or resembling a children’s toy, phone, or gaming platform.”</p>
<div class="lb-trans"><p>FDA 仍可能对具有某些 “推定吸引未成年人” 元素的产品采取行动，例如描绘卡通虚构角色、掩盖其作为电子烟产品的性质，或类似于儿童玩具、手机或游戏平台。</p></div>

美国FDA将放松对部分待审未授权电子烟的打击力度