Published: Fri, September 14, 2018
Health Care | By Cedric Leonard

FDA takes 'historic action' on youth e-cigarette 'epidemic'

FDA takes 'historic action' on youth e-cigarette 'epidemic'

Federal officials called it a blitz - "the largest coordinated enforcement effort in the FDA's history" in response to concerns that e-cigarette use has become an "epidemic" among youths. The stressful and accelerating trajectory of employ we're seeing in formative years, and the following path to addiction, must always pause. It's simply not tolerable.

"We are committed to preventing underage use of our product, and we want to be part of the solution in keeping e-cigarettes out of the hands of young people", he added. The products being targeted are: Juul, MarkTen by the Altria Group, the maker of Malboro cigarettes in the US, Blu by Fontem Ventures, Vuse, by British American Tobacco, the company that makes Camel cigarettes, and a device called Logic.

The FDA plans to step up enforcement actions to monitor, penalize and prevent e-cigarette sales in convenience stores and other retail sites. "We're going to have to take action". If the don't, the FDA said it may pull the devices containing flavors that appeal to children from the market.

To the extent that teenagers who otherwise would be smoking are vaping instead, that is an unambiguous gain in public health terms, since the latter habit is much less risky.

"This day we can gape that this epidemic of addiction changed into as soon as emerging when we first launched our conception final summer", said Gottlieb.

The agency said it allowed the extra time to strike an appropriate balance between regulation and encouraging the development of innovative tobacco products that may help older smokers quit.

On Wednesday, Gottlieb criticized e-cigarette companies' handling of underage use of their products, saying they approached it as "a public relations challenge rather than seriously considering their legal obligations".

It cited estimates from Public Health England that e-cigarettes are 95 percent less harmful than normal cigarettes.

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"Today, we asked five e-cigarette manufacturers to put forward plans to immediately and substantially reverse these trends or face a potential decision by the FDA to reconsider extending the compliance dates for submission of premarket applications", Gottlieb announced.

The FDA has given makers of e-cigarettes until 2022 to seek its approval for products that were on the market by August 2016.

"I certainly am in possession of evidence that warrants that", Gottlieb said, without disclosing the evidence.

In April the agency launched a Youth Tobacco Prevention Plan, created to address some of the known public health risks, such as flavors, that contribute to adolescent use of e-cigarettes. "Hindsight, and the data that's now available to us, fully reveal these trends".

There is no industry-wide data to show how many customers vaping companies steal from tobacco, but a survey of 19,000 Juul users, conducted by the company and detailed in a Piper Jaffray note, said that about 62 percent were smokers when starting to use Juul.

Congress gave the FDA the authority to regulate tobacco products in 2009. Gottlieb would be on much firmer ethical ground if he took the opposite position: In trying to stop teenagers from vaping, we won't deny adult smokers access to products that could save their lives. If underage consumption does not justify a ban on tobacco cigarettes (and I don't think it does), it can not possibly justify a ban on competing products that are much safer.

In April the agency launched a Youth Tobacco Prevention Opinion, created to take care of some of the crucial identified public successfully being dangers, equivalent to flavors, that make contributions to adolescent employ of e-cigarettes.

He also notes that while many adults who use e-cigarettes report that these products helped them stop smoking combustible tobacco, "the benefits of vaping devices for cessation has not yet been borne out at the population level in clinical or observational studies".

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