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2021-10-13
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RLX Technology shares surged 15% in premarket trading<blockquote>RLX科技股价在盘前交易中飙升15%</blockquote>
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{"i18n":{"language":"zh_CN"},"detailType":1,"isChannel":false,"data":{"magic":2,"id":822887597,"tweetId":"822887597","gmtCreate":1634114950963,"gmtModify":1634114952207,"author":{"id":3582036219515358,"idStr":"3582036219515358","authorId":3582036219515358,"authorIdStr":"3582036219515358","name":"boonchek","avatar":"https://static.tigerbbs.com/c615abbfde8feafcbdd8e88179f1e152","vip":1,"userType":1,"introduction":"","boolIsFan":false,"boolIsHead":false,"crmLevel":2,"crmLevelSwitch":0,"individualDisplayBadges":[],"fanSize":412,"starInvestorFlag":false},"themes":[],"images":[],"coverImages":[],"extraTitle":"","html":"<html><head></head><body><p>Give a like </p></body></html>","htmlText":"<html><head></head><body><p>Give a like </p></body></html>","text":"Give a like","highlighted":1,"essential":1,"paper":1,"likeSize":10,"commentSize":4,"repostSize":0,"favoriteSize":0,"link":"https://laohu8.com/post/822887597","repostId":1140623432,"repostType":4,"repost":{"id":"1140623432","kind":"news","weMediaInfo":{"introduction":"Providing stock market headlines, business news, financials and earnings ","home_visible":1,"media_name":"Tiger Newspress","id":"1079075236","head_image":"https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba"},"pubTimestamp":1634113895,"share":"https://www.laohu8.com/m/news/1140623432?lang=zh_CN&edition=full","pubTime":"2021-10-13 16:31","market":"us","language":"en","title":"RLX Technology shares surged 15% in premarket trading<blockquote>RLX科技股价在盘前交易中飙升15%</blockquote>","url":"https://stock-news.laohu8.com/highlight/detail?id=1140623432","media":"Tiger Newspress","summary":"RLX Technology shares surged 15% in premarket trading after FDA permitted marketing of e-cigarette p","content":"<p>RLX Technology shares surged 15% in premarket trading after FDA permitted marketing of e-cigarette products, marking first authorization of its kind by the agency.</p><p><blockquote>在FDA允许销售电子烟产品后，RLX科技股价在盘前交易中飙升15%，这标志着该机构首次获得此类授权。</blockquote></p><p> <img src=\"https://static.tigerbbs.com/15852df28c7376cb27050a7959053554\" tg-width=\"848\" tg-height=\"618\" referrerpolicy=\"no-referrer\"></p><p><blockquote></blockquote></p><p> The U.S. Food and Drug Administration announced it hasauthorized the marketingof three new tobacco products, marking the first set of electronic nicotine delivery system (ENDS) products ever to be authorized by the FDA through the Premarket Tobacco Product Application (PMTA) pathway. The FDA issued marketing granted orders to R.J. Reynolds (RJR) Vapor Company for its Vuse Solo closed ENDS device and accompanying tobacco-flavored e-liquid pods, specifically, Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% G1, and Vuse Replacement Cartridge Original 4.8% G2. As the RJR Vapor Company submitted data to the FDA that demonstrated that marketing of these products is appropriate for the protection of public health, today’s authorization allows these products to be legally sold in the U.S.</p><p><blockquote>美国。美国食品药品监督管理局宣布已授权三种新烟草产品上市，这标志着FDA通过上市前烟草产品申请（PMTA）途径授权的第一套电子尼古丁输送系统（ENDS）产品。FDA向R.J.发布了营销授权令。Reynolds(RJR)Vapor Company为其Vuse Solo封闭式装置和随附的烟草味电子液体容器提供服务，特别是Vuse Solo动力装置、Vuse替换墨盒原装4.8%G1和Vuse替换墨盒原装4.8%G2。由于RJR Vapor公司向FDA提交的数据表明这些产品的营销适合保护公众健康，因此今天的授权允许这些产品在美国合法销售。</blockquote></p><p> <b>“Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation. The manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products – either completely or with a significant reduction in cigarette consumption – by reducing their exposure to harmful chemicals,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “We must remain vigilant with this authorization and we will monitor the marketing of the products, including whether the company fails to comply with any regulatory requirements or if credible evidence emerges of significant use by individuals who did not previously use a tobacco product, including youth. We will take action as appropriate, including withdrawing the authorization.”</b></p><p><blockquote><b>“今天的授权是确保所有新烟草产品都经过FDA严格、科学的上市前评估的重要一步。制造商的数据表明，其烟草味产品可以使改用这些产品的成瘾成年吸烟者受益——无论是完全还是显著减少香烟消费——通过减少他们对有害化学物质的接触，”FDA烟草产品中心主任米奇·泽勒法学博士说。“我们必须对这一授权保持警惕，我们将监控产品的营销，包括该公司是否未能遵守任何监管要求，或者是否有可信的证据表明以前没有使用过烟草产品的个人（包括年轻人）大量使用烟草产品。我们将酌情采取行动，包括撤销授权。”</b></blockquote></p><p> Under the PMTA pathway, manufacturers must demonstrate to the agency that, among other things, marketing of the new tobacco product would be appropriate for the protection of the public health. These products were found to meet this standard because, among several key considerations, the agency determined that study participants who used only the authorized products were exposed to fewer harmful and potentially harmful constituents (HPHCs) from aerosols compared to users of combusted cigarettes. The toxicological assessment also found the authorized products’ aerosols are significantly less toxic than combusted cigarettes based on available data comparisons and results of nonclinical studies. Additionally, the FDA considered the risks and benefits to the population as a whole, including users and non-users of tobacco products, and importantly, youth. This included review of available data on the likelihood of use of the product by young people. For these products, the FDA determined that the potential benefit to smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth, provided the applicant follows post-marketing requirements aimed at reducing youth exposure and access to the products.</p><p><blockquote>根据PMTA途径，制造商必须向该机构证明，除其他外，新烟草产品的营销有利于保护公众健康。这些产品被发现符合这一标准，因为在几个关键考虑因素中，该机构确定，与燃烧香烟的使用者相比，仅使用授权产品的研究参与者暴露于气溶胶中的有害和潜在有害成分(HPHC)更少。毒理学评估还发现，根据现有数据比较和非临床研究结果，授权产品的气雾剂的毒性明显低于燃烧的香烟。此外，FDA考虑了对整个人群的风险和益处，包括烟草产品的使用者和非使用者，更重要的是，年轻人。这包括审查关于年轻人使用该产品可能性的现有数据。对于这些产品，FDA确定，如果申请人遵循旨在减少青少年接触和接触这些产品的上市后要求，对完全改用或显著减少吸烟的吸烟者的潜在益处将超过对青少年的风险。</blockquote></p><p> Today, the FDA also issued 10 marketing denial orders (MDOs) for flavored ENDS products submitted under the Vuse Solo brand by RJR. Due to potential confidential commercial information issues, the FDA is not publicly disclosing the specific flavored products. These products subject to an MDO for a premarket application may not be introduced or delivered for introduction into interstate commerce. Should any of them already be on the market, they must be removed from the market or risk enforcement. Retailers should contact RJR with any questions about products in their inventory. The agency is still evaluating the company’s application for menthol-flavored products under the Vuse Solo brand.</p><p><blockquote>今天，FDA还针对RJR以Vuse Solo品牌提交的调味终端产品发布了10份营销拒绝令(MDO)。由于潜在的机密商业信息问题，FDA没有公开披露具体的调味产品。这些受上市前申请MDO约束的产品不得引入或交付用于引入州际商业。如果它们中的任何一个已经在市场上，它们必须从市场上移除或进行风险执法。如果零售商对其库存中的产品有任何疑问，请联系RJR。该机构仍在评估该公司以Vuse Solo品牌申请薄荷醇味产品。</blockquote></p><p> The FDA is aware that the 2021 National Youth Tobacco Survey (NYTS) found approximately 10 percent of high school students who currently used e-cigarettes named Vuse as their usual brand. The agency takes these data very seriously and considered risks to youth when reviewing these products. The evidence also indicated that, compared to users of non-tobacco flavored ENDS products, young people are less likely to start using tobacco-flavored ENDS products and then switch to higher-risk products, such as combusted cigarettes. The data also suggest that most youth and young adults who use ENDS begin with flavors such as fruit, candy or mint, and not tobacco flavors. These data reinforce the FDA’s decision to authorize the tobacco-flavored products because these products are less appealing to youth and authorizing these products may be beneficial for adult combusted cigarette users who completely switch to ENDS or significantly reduce their cigarette consumption.</p><p><blockquote>FDA意识到，2021年全国青少年烟草调查(NYTS)发现，大约10%的高中生目前使用名为Vuse的电子烟作为他们的常用品牌。该机构非常重视这些数据，并在审查这些产品时考虑了对青少年的风险。证据还表明，与非烟草风味末端产品的使用者相比，年轻人不太可能开始使用烟草风味末端产品，然后转向高风险产品，如燃烧的香烟。数据还表明，大多数使用ENDS的年轻人从水果、糖果或薄荷等口味开始，而不是烟草口味。这些数据加强了FDA授权烟草风味产品的决定，因为这些产品对年轻人的吸引力较小，授权这些产品可能有利于完全转向末端或显著减少香烟消费的成年燃烧香烟使用者。</blockquote></p><p></p><p> Additionally, today’s authorization imposes strict marketing restrictions on the company, including digital advertising restrictions as well as radio and television advertising restrictions, to greatly reduce the potential for youth exposure to tobacco advertising for these products. RJR Vapor Company is also required to report regularly to the FDA with information regarding the products on the market, including, but not limited to, ongoing and completed consumer research studies, advertising, marketing plans, sales data, information on current and new users, manufacturing changes and adverse experiences.</p><p><blockquote>此外，今天的授权对该公司施加了严格的营销限制，包括数字广告限制以及广播和电视广告限制，以大大降低青少年接触这些产品烟草广告的可能性。RJR Vapor Company还需要定期向FDA报告有关市场上产品的信息，包括但不限于正在进行和已完成的消费者调查研究、广告、营销计划、销售数据、当前和新用户信息、生产变更和不良经历。</blockquote></p><p> The FDA may suspend or withdraw a marketing order issued under the PMTA pathway for a variety of reasons if the agency determines the continued marketing of a product is no longer “appropriate for the protection of the public health,” such as if there is a significant increase in youth initiation.</p><p><blockquote>如果FDA确定产品的继续营销不再“适合保护公众健康”，例如如果青少年入会人数显著增加，FDA可能会出于各种原因暂停或撤销根据PMTA途径发布的营销令。</blockquote></p><p> While today’s action permits the tobacco products to be sold in the U.S., it does not mean these products are safe or “FDA approved.” All tobacco products are harmful and addictive and those who do not use tobacco products should not start.</p><p><blockquote>虽然今天的行动允许烟草产品在美国销售，但这并不意味着这些产品是安全的或“FDA批准的”。所有的烟草制品都是有害的和容易上瘾的，那些不使用烟草制品的人不应该开始。</blockquote></p><p> Applications for many ENDS and other new deemed tobacco products on the market as of Aug. 8, 2016 were required to be submitted to FDA by Sept. 9, 2020. The agency has taken action on over 98% of the applications submitted by that deadline. This includes issuing MDOs for more than one million flavored ENDS products that lacked sufficient evidence that the benefit to adult smokers who used the flavor products would overcome the public health concern posed by the well-documented and considerable appeal of the products to youth. Recently, FDA posted as ample MDO decision summary. This sample does not reflect the decision rationale for each MDO action taken by the FDA.</p><p><blockquote>截至2016年8月8日，市场上的许多末端和其他新的烟草产品的申请必须在2020年9月9日之前提交给FDA。该机构已对截止日期前提交的98%以上的申请采取了行动。这包括为100多万种调味终端产品发布MDO，这些产品缺乏足够的证据证明使用调味产品的成年吸烟者的益处将克服这些产品对青少年的有据可查和相当大的吸引力所带来的公共健康问题。最近，FDA发布了大量MDO决定摘要。该样本并未反映FDA采取的每项MDO行动的决策依据。</blockquote></p><p> The agency will continue to issue decisions on applications, as appropriate, and is committed to working to transition the current marketplace to one in which all ENDS products available for sale have demonstrated that marketing of the product is “appropriate for the protection of the public health.”</p><p><blockquote>该机构将继续酌情对申请做出决定，并致力于将当前市场转变为一个市场，在这个市场中，所有可供销售的终端产品都证明该产品的营销“适合保护公众健康”。</blockquote></p><p></p>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>RLX Technology shares surged 15% in premarket trading<blockquote>RLX科技股价在盘前交易中飙升15%</blockquote></title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 12.5px; color: #7E829C; margin: 0;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nRLX Technology shares surged 15% in premarket trading<blockquote>RLX科技股价在盘前交易中飙升15%</blockquote>\n</h2>\n<h4 class=\"meta\">\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1079075236\">\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Tiger Newspress </p>\n<p class=\"h-time smaller\">2021-10-13 16:31</p>\n</div>\n</a>\n</h4>\n</header>\n<article>\n<p>RLX Technology shares surged 15% in premarket trading after FDA permitted marketing of e-cigarette products, marking first authorization of its kind by the agency.</p><p><blockquote>在FDA允许销售电子烟产品后，RLX科技股价在盘前交易中飙升15%，这标志着该机构首次获得此类授权。</blockquote></p><p> <img src=\"https://static.tigerbbs.com/15852df28c7376cb27050a7959053554\" tg-width=\"848\" tg-height=\"618\" referrerpolicy=\"no-referrer\"></p><p><blockquote></blockquote></p><p> The U.S. Food and Drug Administration announced it hasauthorized the marketingof three new tobacco products, marking the first set of electronic nicotine delivery system (ENDS) products ever to be authorized by the FDA through the Premarket Tobacco Product Application (PMTA) pathway. The FDA issued marketing granted orders to R.J. Reynolds (RJR) Vapor Company for its Vuse Solo closed ENDS device and accompanying tobacco-flavored e-liquid pods, specifically, Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% G1, and Vuse Replacement Cartridge Original 4.8% G2. As the RJR Vapor Company submitted data to the FDA that demonstrated that marketing of these products is appropriate for the protection of public health, today’s authorization allows these products to be legally sold in the U.S.</p><p><blockquote>美国。美国食品药品监督管理局宣布已授权三种新烟草产品上市，这标志着FDA通过上市前烟草产品申请（PMTA）途径授权的第一套电子尼古丁输送系统（ENDS）产品。FDA向R.J.发布了营销授权令。Reynolds(RJR)Vapor Company为其Vuse Solo封闭式装置和随附的烟草味电子液体容器提供服务，特别是Vuse Solo动力装置、Vuse替换墨盒原装4.8%G1和Vuse替换墨盒原装4.8%G2。由于RJR Vapor公司向FDA提交的数据表明这些产品的营销适合保护公众健康，因此今天的授权允许这些产品在美国合法销售。</blockquote></p><p> <b>“Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation. The manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products – either completely or with a significant reduction in cigarette consumption – by reducing their exposure to harmful chemicals,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “We must remain vigilant with this authorization and we will monitor the marketing of the products, including whether the company fails to comply with any regulatory requirements or if credible evidence emerges of significant use by individuals who did not previously use a tobacco product, including youth. We will take action as appropriate, including withdrawing the authorization.”</b></p><p><blockquote><b>“今天的授权是确保所有新烟草产品都经过FDA严格、科学的上市前评估的重要一步。制造商的数据表明，其烟草味产品可以使改用这些产品的成瘾成年吸烟者受益——无论是完全还是显著减少香烟消费——通过减少他们对有害化学物质的接触，”FDA烟草产品中心主任米奇·泽勒法学博士说。“我们必须对这一授权保持警惕，我们将监控产品的营销，包括该公司是否未能遵守任何监管要求，或者是否有可信的证据表明以前没有使用过烟草产品的个人（包括年轻人）大量使用烟草产品。我们将酌情采取行动，包括撤销授权。”</b></blockquote></p><p> Under the PMTA pathway, manufacturers must demonstrate to the agency that, among other things, marketing of the new tobacco product would be appropriate for the protection of the public health. These products were found to meet this standard because, among several key considerations, the agency determined that study participants who used only the authorized products were exposed to fewer harmful and potentially harmful constituents (HPHCs) from aerosols compared to users of combusted cigarettes. The toxicological assessment also found the authorized products’ aerosols are significantly less toxic than combusted cigarettes based on available data comparisons and results of nonclinical studies. Additionally, the FDA considered the risks and benefits to the population as a whole, including users and non-users of tobacco products, and importantly, youth. This included review of available data on the likelihood of use of the product by young people. For these products, the FDA determined that the potential benefit to smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth, provided the applicant follows post-marketing requirements aimed at reducing youth exposure and access to the products.</p><p><blockquote>根据PMTA途径，制造商必须向该机构证明，除其他外，新烟草产品的营销有利于保护公众健康。这些产品被发现符合这一标准，因为在几个关键考虑因素中，该机构确定，与燃烧香烟的使用者相比，仅使用授权产品的研究参与者暴露于气溶胶中的有害和潜在有害成分(HPHC)更少。毒理学评估还发现，根据现有数据比较和非临床研究结果，授权产品的气雾剂的毒性明显低于燃烧的香烟。此外，FDA考虑了对整个人群的风险和益处，包括烟草产品的使用者和非使用者，更重要的是，年轻人。这包括审查关于年轻人使用该产品可能性的现有数据。对于这些产品，FDA确定，如果申请人遵循旨在减少青少年接触和接触这些产品的上市后要求，对完全改用或显著减少吸烟的吸烟者的潜在益处将超过对青少年的风险。</blockquote></p><p> Today, the FDA also issued 10 marketing denial orders (MDOs) for flavored ENDS products submitted under the Vuse Solo brand by RJR. Due to potential confidential commercial information issues, the FDA is not publicly disclosing the specific flavored products. These products subject to an MDO for a premarket application may not be introduced or delivered for introduction into interstate commerce. Should any of them already be on the market, they must be removed from the market or risk enforcement. Retailers should contact RJR with any questions about products in their inventory. The agency is still evaluating the company’s application for menthol-flavored products under the Vuse Solo brand.</p><p><blockquote>今天，FDA还针对RJR以Vuse Solo品牌提交的调味终端产品发布了10份营销拒绝令(MDO)。由于潜在的机密商业信息问题，FDA没有公开披露具体的调味产品。这些受上市前申请MDO约束的产品不得引入或交付用于引入州际商业。如果它们中的任何一个已经在市场上，它们必须从市场上移除或进行风险执法。如果零售商对其库存中的产品有任何疑问，请联系RJR。该机构仍在评估该公司以Vuse Solo品牌申请薄荷醇味产品。</blockquote></p><p> The FDA is aware that the 2021 National Youth Tobacco Survey (NYTS) found approximately 10 percent of high school students who currently used e-cigarettes named Vuse as their usual brand. The agency takes these data very seriously and considered risks to youth when reviewing these products. The evidence also indicated that, compared to users of non-tobacco flavored ENDS products, young people are less likely to start using tobacco-flavored ENDS products and then switch to higher-risk products, such as combusted cigarettes. The data also suggest that most youth and young adults who use ENDS begin with flavors such as fruit, candy or mint, and not tobacco flavors. These data reinforce the FDA’s decision to authorize the tobacco-flavored products because these products are less appealing to youth and authorizing these products may be beneficial for adult combusted cigarette users who completely switch to ENDS or significantly reduce their cigarette consumption.</p><p><blockquote>FDA意识到，2021年全国青少年烟草调查(NYTS)发现，大约10%的高中生目前使用名为Vuse的电子烟作为他们的常用品牌。该机构非常重视这些数据，并在审查这些产品时考虑了对青少年的风险。证据还表明，与非烟草风味末端产品的使用者相比，年轻人不太可能开始使用烟草风味末端产品，然后转向高风险产品，如燃烧的香烟。数据还表明，大多数使用ENDS的年轻人从水果、糖果或薄荷等口味开始，而不是烟草口味。这些数据加强了FDA授权烟草风味产品的决定，因为这些产品对年轻人的吸引力较小，授权这些产品可能有利于完全转向末端或显著减少香烟消费的成年燃烧香烟使用者。</blockquote></p><p></p><p> Additionally, today’s authorization imposes strict marketing restrictions on the company, including digital advertising restrictions as well as radio and television advertising restrictions, to greatly reduce the potential for youth exposure to tobacco advertising for these products. RJR Vapor Company is also required to report regularly to the FDA with information regarding the products on the market, including, but not limited to, ongoing and completed consumer research studies, advertising, marketing plans, sales data, information on current and new users, manufacturing changes and adverse experiences.</p><p><blockquote>此外，今天的授权对该公司施加了严格的营销限制，包括数字广告限制以及广播和电视广告限制，以大大降低青少年接触这些产品烟草广告的可能性。RJR Vapor Company还需要定期向FDA报告有关市场上产品的信息，包括但不限于正在进行和已完成的消费者调查研究、广告、营销计划、销售数据、当前和新用户信息、生产变更和不良经历。</blockquote></p><p> The FDA may suspend or withdraw a marketing order issued under the PMTA pathway for a variety of reasons if the agency determines the continued marketing of a product is no longer “appropriate for the protection of the public health,” such as if there is a significant increase in youth initiation.</p><p><blockquote>如果FDA确定产品的继续营销不再“适合保护公众健康”，例如如果青少年入会人数显著增加，FDA可能会出于各种原因暂停或撤销根据PMTA途径发布的营销令。</blockquote></p><p> While today’s action permits the tobacco products to be sold in the U.S., it does not mean these products are safe or “FDA approved.” All tobacco products are harmful and addictive and those who do not use tobacco products should not start.</p><p><blockquote>虽然今天的行动允许烟草产品在美国销售，但这并不意味着这些产品是安全的或“FDA批准的”。所有的烟草制品都是有害的和容易上瘾的，那些不使用烟草制品的人不应该开始。</blockquote></p><p> Applications for many ENDS and other new deemed tobacco products on the market as of Aug. 8, 2016 were required to be submitted to FDA by Sept. 9, 2020. The agency has taken action on over 98% of the applications submitted by that deadline. This includes issuing MDOs for more than one million flavored ENDS products that lacked sufficient evidence that the benefit to adult smokers who used the flavor products would overcome the public health concern posed by the well-documented and considerable appeal of the products to youth. Recently, FDA posted as ample MDO decision summary. This sample does not reflect the decision rationale for each MDO action taken by the FDA.</p><p><blockquote>截至2016年8月8日，市场上的许多末端和其他新的烟草产品的申请必须在2020年9月9日之前提交给FDA。该机构已对截止日期前提交的98%以上的申请采取了行动。这包括为100多万种调味终端产品发布MDO，这些产品缺乏足够的证据证明使用调味产品的成年吸烟者的益处将克服这些产品对青少年的有据可查和相当大的吸引力所带来的公共健康问题。最近，FDA发布了大量MDO决定摘要。该样本并未反映FDA采取的每项MDO行动的决策依据。</blockquote></p><p> The agency will continue to issue decisions on applications, as appropriate, and is committed to working to transition the current marketplace to one in which all ENDS products available for sale have demonstrated that marketing of the product is “appropriate for the protection of the public health.”</p><p><blockquote>该机构将继续酌情对申请做出决定，并致力于将当前市场转变为一个市场，在这个市场中，所有可供销售的终端产品都证明该产品的营销“适合保护公众健康”。</blockquote></p><p></p>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"RLX":"雾芯科技"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1140623432","content_text":"RLX Technology shares surged 15% in premarket trading after FDA permitted marketing of e-cigarette products, marking first authorization of its kind by the agency.\n\nThe U.S. Food and Drug Administration announced it hasauthorized the marketingof three new tobacco products, marking the first set of electronic nicotine delivery system (ENDS) products ever to be authorized by the FDA through the Premarket Tobacco Product Application (PMTA) pathway. The FDA issued marketing granted orders to R.J. Reynolds (RJR) Vapor Company for its Vuse Solo closed ENDS device and accompanying tobacco-flavored e-liquid pods, specifically, Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% G1, and Vuse Replacement Cartridge Original 4.8% G2. As the RJR Vapor Company submitted data to the FDA that demonstrated that marketing of these products is appropriate for the protection of public health, today’s authorization allows these products to be legally sold in the U.S.\n“Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation. The manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products – either completely or with a significant reduction in cigarette consumption – by reducing their exposure to harmful chemicals,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “We must remain vigilant with this authorization and we will monitor the marketing of the products, including whether the company fails to comply with any regulatory requirements or if credible evidence emerges of significant use by individuals who did not previously use a tobacco product, including youth. We will take action as appropriate, including withdrawing the authorization.”\nUnder the PMTA pathway, manufacturers must demonstrate to the agency that, among other things, marketing of the new tobacco product would be appropriate for the protection of the public health. These products were found to meet this standard because, among several key considerations, the agency determined that study participants who used only the authorized products were exposed to fewer harmful and potentially harmful constituents (HPHCs) from aerosols compared to users of combusted cigarettes. The toxicological assessment also found the authorized products’ aerosols are significantly less toxic than combusted cigarettes based on available data comparisons and results of nonclinical studies. Additionally, the FDA considered the risks and benefits to the population as a whole, including users and non-users of tobacco products, and importantly, youth. This included review of available data on the likelihood of use of the product by young people. For these products, the FDA determined that the potential benefit to smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth, provided the applicant follows post-marketing requirements aimed at reducing youth exposure and access to the products.\nToday, the FDA also issued 10 marketing denial orders (MDOs) for flavored ENDS products submitted under the Vuse Solo brand by RJR. Due to potential confidential commercial information issues, the FDA is not publicly disclosing the specific flavored products. These products subject to an MDO for a premarket application may not be introduced or delivered for introduction into interstate commerce. Should any of them already be on the market, they must be removed from the market or risk enforcement. Retailers should contact RJR with any questions about products in their inventory. The agency is still evaluating the company’s application for menthol-flavored products under the Vuse Solo brand.\nThe FDA is aware that the 2021 National Youth Tobacco Survey (NYTS) found approximately 10 percent of high school students who currently used e-cigarettes named Vuse as their usual brand. The agency takes these data very seriously and considered risks to youth when reviewing these products. The evidence also indicated that, compared to users of non-tobacco flavored ENDS products, young people are less likely to start using tobacco-flavored ENDS products and then switch to higher-risk products, such as combusted cigarettes. The data also suggest that most youth and young adults who use ENDS begin with flavors such as fruit, candy or mint, and not tobacco flavors. These data reinforce the FDA’s decision to authorize the tobacco-flavored products because these products are less appealing to youth and authorizing these products may be beneficial for adult combusted cigarette users who completely switch to ENDS or significantly reduce their cigarette consumption.\nAdditionally, today’s authorization imposes strict marketing restrictions on the company, including digital advertising restrictions as well as radio and television advertising restrictions, to greatly reduce the potential for youth exposure to tobacco advertising for these products. RJR Vapor Company is also required to report regularly to the FDA with information regarding the products on the market, including, but not limited to, ongoing and completed consumer research studies, advertising, marketing plans, sales data, information on current and new users, manufacturing changes and adverse experiences.\nThe FDA may suspend or withdraw a marketing order issued under the PMTA pathway for a variety of reasons if the agency determines the continued marketing of a product is no longer “appropriate for the protection of the public health,” such as if there is a significant increase in youth initiation.\nWhile today’s action permits the tobacco products to be sold in the U.S., it does not mean these products are safe or “FDA approved.” All tobacco products are harmful and addictive and those who do not use tobacco products should not start.\nApplications for many ENDS and other new deemed tobacco products on the market as of Aug. 8, 2016 were required to be submitted to FDA by Sept. 9, 2020. The agency has taken action on over 98% of the applications submitted by that deadline. This includes issuing MDOs for more than one million flavored ENDS products that lacked sufficient evidence that the benefit to adult smokers who used the flavor products would overcome the public health concern posed by the well-documented and considerable appeal of the products to youth. Recently, FDA posted as ample MDO decision summary. This sample does not reflect the decision rationale for each MDO action taken by the FDA.\nThe agency will continue to issue decisions on applications, as appropriate, and is committed to working to transition the current marketplace to one in which all ENDS products available for sale have demonstrated that marketing of the product is “appropriate for the protection of the public health.”","news_type":1,"symbols_score_info":{"RLX":0.9}},"isVote":1,"tweetType":1,"viewCount":874,"commentLimit":10,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"symbols":[],"verified":2,"subType":0,"readableState":1,"langContent":"CN","currentLanguage":"CN","warmUpFlag":false,"orderFlag":false,"shareable":true,"causeOfNotShareable":"","featuresForAnalytics":[],"commentAndTweetFlag":false,"andRepostAutoSelectedFlag":false,"upFlag":false,"length":9,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"isCommentEnd":true,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/822887597"}
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