FDA Hits Juul With Warning Letter as Challenges Mount for E-Cigarette Maker


2019-09-10 10:30:00 TheStreet.com


Juul's challenges mounted Monday as the Food and Drug Administration issued a warning letter to the e-cigarette maker. The FDA warned Juul it was breaking the law by marketing its vaping products as less harmful than traditional tobacco products. In particular, Juul is breaking the law by selling and distributing its e-cigarettes "as modified risk tobacco products without an FDA order in effect that permits such sale or distribution," the FDA's letter stated. Shares of Altria (MO - Get Report) , which owns 35% of Juul, were slow to see an impact from the FDA crackdown, rising 0.25% to $43.96. "We are reviewing the letters and will fully cooperate," a spokesperson for Juul Labs said in a statement   While the FDA letter makes no mention of the issue, e-cigarette makers have come under mounting pressure in the last few weeks amid hundreds of mysterious lung ailments around the country that have been tied to vaping, resulting in three deaths. Some of those who fell ill reported vaping nicotine and THC, with a smaller number just vaped nicotine.   "Regardless of where products like e-cigarettes fall on the continuum of tobacco product risk, the law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful. JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation's youth," said acting FDA Commissioner Ned Sharpless, in a press statement. The letter cited evidence aired at the House Committee on Oversight and Reform's Economic and Consumer Policy subcommittee hearing in July that included questionable statements by Juul executives. The panel heard testimony that, among other things, a Juul representative speaking with students had stated Juul "was much safer than cigarettes" and that "FDA would approve it any day."[1] British American Tobacco, which makes rival vaping products, released a statement saying the company is "monitoring the situation in the USA and will work closely with all relevant Public Health Authorities around the world such as the FDA, the Centre for Disease Control and Prevention and Public Health England."
由于美国食品药品监督管理局(Food and Drug Administration)( FoodandDrugAdministration )向这家电子烟制造商发出警告信, Juul 的挑战在周一加剧。 美国食品和药物管理局警告朱鲁说,由于销售其 vaping 产品不如传统烟草产品有害,这违反了法律。 特别是, Juul 违反法律,销售和分销其电子香烟“作为修改后的风险烟草产品,没有 FDA 的命令,实际上允许这种销售或分销,” FDA 的信中说。 拥有 Juul 35%股份的奥驰亚( MO-Get Report )股价增长0.25%,至43.96美元,受美国食品及药物管理局打击行动影响缓慢。 Juul Labs 的一位发言人在一份声明中说:“我们正在审查这些信件,并将全力配合。 虽然 FDA 的信没有提到这一问题,但电子香烟制造商在过去几周面临着越来越大的压力,全国各地数百种神秘的肺病都与吸食有关,导致三人死亡。一些生病的人报告说他们在吸食尼古丁和 THC ,而少量的人只是吸食尼古丁。 “不管像电子香烟这样的产品在哪里属于烟草产品风险的连续统一体,法律清楚地表明,在销售烟草产品以降低风险之前,公司必须以科学证据证明其特定产品确实具有较低的风险或较低的危害。美国食品和药物管理局代理专员 Ned Sharpless 在一份新闻声明中说:“ JUL 无视法律,非常一致地,在学校向我们的年轻人发表了一些声明。” 这封信引用了众议院监督和改革委员会经济和消费者政策小组委员会( House Committee on Oversight and Reform's Economic and Consumer Policy Committee )7月份举行的听证会上公布的证据,其中包括 Juul 高管的可疑陈述。 专家小组听取了证词,除其他外, Juul 的一名代表与学生交谈时说 Juul “比香烟安全得多”,而且“ FDA 会在任何时候批准它。”[1] 英美烟草公司( BritishAmerican Tobacco )发布了一份声明,称该公司正在“监测美国的情况,并将与世界各地的相关公共卫生当局密切合作,如 FDA 、疾病控制和预防中心以及英国公共卫生部门。”