- 联邦监管机构已批准了三种电子烟产品，这是在美国获得批准的第一个此类项目。
- 监管机构说，使用电子烟的人的好处是试图使用烟草戒烟的风险大于青少年的风险。
- Health experts say there are still significant health dangers associated with vaping e-cigarettes.
Electronic cigarettes have been unregulated but legally sold in the United States for more than a decade.
现在，食品药品监督管理局（FDA）在禁止成千上万的其他人被销售之后，首次获得了少数电子烟产品的监管批准。
Last week, FDA officials
“[The] FDA’s orders confirm that the marketing of Vuse Solo products are appropriate for the protection of the public health, underscoring years of scientific study and research dedicated to ensuring that adult nicotine consumers age 21+ have access to innovative and potentially less harmful alternatives to traditional tobacco products,” company officials said in a news release.
在一份声明中，倡导和政府事务副执行董事安妮·玛丽·汉梅尔（Anne Marie Hummel）在一份声明中American Association for Respiratory Care，称为FDA的决定“鉴于烟草使用的有害作用及其与慢性呼吸系统疾病的关系非常令人失望”。
其他医学专家同意。
“无论您得到的任何方式，尼古丁的使用都会对心血管系统产生很多负面影响，”Sanjivan Singh Kohli博士加利福尼亚州普罗维登斯宣教医院的肺部和重症监护医学医生告诉Healthline。雷竞技app官网
Kohli说，Vaping“以任何方式都不是良性的”，他指出他已经照顾了许多与烟相关的肺部疾病的人，称为电子烟vaping急性肺部疾病。
长期，科利补充说，由吸入尼古丁引起的血管收缩可能损害动脉以及其他形式的心血管疾病。
科利说：“一方面，Vapes从吸入烟草的有害烟雾中删除了所有的致癌物质。”“但是人们仍在得到大剂量的尼古丁。因此，这是最好的选择。唯一的好选择是完全停止。”
批准的产品是FDA首次通过该机构的新上市烟草产品应用程序（PMTA）流程授权的产品。
They include the Vuse Solo electronic nicotine delivery system (ENDS) device and two accompanying tobacco-flavored e-liquid pods.
“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
“我们必须保持警惕与这个授权,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.”
根据该声明
The PMTA requires that manufacturers demonstrate to the FDA that any new tobacco products coming on the market protect public health.
In its review, the agency found that Vuse Solo users were exposed to fewer harmful and potentially harmful constituents (HPHCs) from aerosols than users of combusted cigarettes.
They also reported that the vapor from these products is significantly less toxic than combusted cigarettes, and the health benefit to smokers who switch from combusted cigarettes to e-cigarettes outweigh the risk of youth use of e-cigarettes.
根据CDC的最新信息
However, the FDA noted that research shows that few teens later switch from e-cigarettes to the more dangerous combustible 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,” according to the FDA.
“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,” the FDA stated.
RJR竞标FDA批准其薄荷醇味的Vuse墨盒仍在审查中。
“The FDA is right to continue to deny authorization for tobacco companies to sell flavored e-cigarettes, which have fueled the nicotine epidemic among youth nationwide and put millions of kids at risk for a lifetime of tobacco use and addiction,” according to the American Heart Association.
“ FDA应遵循今天的宣布，还否认了RJR对Vuse Solo Menthol风味墨盒的申请。几十年来，烟草公司积极向黑人社区，其他有色人种和青年群体推销薄荷味的烟草产品，从而助长了尼古丁成瘾的祸害。”该协会说。
The FDA’s decision on Vuse comes after the agency denied marketing approval for 55,000 flavored e-cigarette products from three different applicants: JD Nova Group LLC, Great American Vapes, and Vapor Salon.
The FDA stated in August that these products “lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products.”
所有被拒绝的产品均为非烟草调味，包括苹果崩溃，可乐博士和肉桂吐司谷物等品种。