, 28 tweets, 11 min read Read on Twitter
The U.S. is facing a new epidemic sparked by the surging popularity of e-cig use by kids. Halting this public health crisis requires forceful steps from FDA. In today’s #FDA #SundayTweetorial I’ll detail what we advanced last week – and why. And what additional steps we may take.
To explain, let’s go back a bit in time to see how this issue has evolved. In 2017, early after I became commissioner, #FDA was poised to put us on a path to overcome one of the most pernicious public health challenges of our times – death and disease caused by cigarette smoking.
I saw the chance to advance new technologies like electronic cigarettes as part of that plan. We saw these products as potentially less harmful alternatives to cigarettes for some adult smokers seeking access to nicotine, without all the deadly effects of combustion.
Our plan: To regulate nicotine in combustible tobacco to render cigarettes minimally or non-addictive at the same time we advanced a path for e-cigs as a potentially less harmful alternative for adults who still wanted access to nicotine that was no longer available in cigarettes
But we’ve been rethinking our strategy amid new data showing an epidemic-level rise in youth e-cig use. The 2018 National Youth Tobacco Survey (NYTS) found that over 3.6 million middle & high school students currently used e-cigs, from 2.1 million in 2017 go.usa.gov/xE6bQ
Why the concern? We know that most e-cigs contain nicotine – a highly-addictive substance that can rewire teen brains to make them want more of it. Nicotine exposure can affect brain development in youth and may have long-lasting effects including impulse control, mood disorders
E-cigarettes deliver nicotine to your brain quickly, which can keep you using once you start, even if you want to stop. And some may e-cigarettes contain as much as nicotine as 20 cigarettes.
And even e-cigarettes without nicotine may contain flavoring chemicals and other chemicals such as formaldehyde, that can be harmful to the lungs, as well as heavy metals such as nickel, chromium and lead. They are not risk free. There's mounting data they can affect the lungs.
Given nicotine’s addictive properties, it’s really not surprising to see data showing that 27.7% of current high school e-cig users reported using the product 20 or more days in the past month go.usa.gov/xE6DA.
The NYTS data are especially troubling - they don’t just show that more kids are experimenting with e-cigs, they show many teens already use them on a regular basis. I’m worried that by the next survey, even more kids will be heavily addicted to e-cigs. So, we have to act now.
Even more concerning: kids using e-cigs are more likely to start using combustible cigarettes, according to research published in JAMA, and not all would have otherwise smoked cigarettes bit.ly/2tdq5Ri.
The epidemic-rise in youth e-cig use has prompted a series of escalating actions by FDA in enforcement, regulatory steps, and public health education over the past year. The agency will continue to take new actions, and consider other regulatory changes if these trends continue.
Last summer we issued > 1,300 warning letters and fines to retailers who illegally sold e-cig products to minors. This nationwide undercover blitz of brick and mortar and online stores was the largest coordinated enforcement effort in #FDA history go.usa.gov/xPbCy.
We took actions in partnership with the FTC to target e-liquid manufacturers whose products used misleading kid-appealing imagery that mimicked juice boxes, lollipops and other foods.
We called on manufacturers to take voluntary actions to prevent youth access to these products and to take meaningful steps to curb their youth appeal. Data show that 70% of current youth ENDS users said they used ENDS products “because they come in flavors I like.”
With research showing a significant portion of youth do not see great risk of harm in regularly vaping nicotine, there is a need for targeted education efforts focused on the potential dangers of e-cig use in adolescence bit.ly/2u8rR6D.
So last year #FDA launched “The Real Cost” E-cigarette Prevention Campaign, a campaign designed to snap teens out of their “cost-free” mentality by educating them about the potential risks of these products, urging them to “know the real cost of vaping.” We'll soon launch TV ads
Last week we announced a proposal to end our current compliance policy as it applies to certain flavored ENDS products (except tobacco-, mint-, or menthol-flavored) go.usa.gov/xE6WA, and we issued a draft guidance outlining our proposed enforcement priorities.
The guidance go.usa.gov/xE6WM discusses ways to limit youth access to and appeal of flavored e-cigs, such as heightened age verification, sales only in locations that minors are not able to enter at any time, and quantity limits for online sales.
Our draft guidance also states that #FDA expects manufacturers of flavored ENDS products (other than tobacco, mint and menthol) to submit premarket applications by Aug. 8, 2021 – a year earlier than expected under our previous policy.
Recent evidence indicates that tobacco, mint and menthol flavored ENDS are more preferred by adults than minors, and adults may be using these products to cease use of combustible tobacco. Thus, we’re not currently proposing to change the compliance policy for these products.
Last week’s action is another step in preventing youth use and access to e-cigs - but it doesn’t end there.
The 2019 National Youth Tobacco Survey begins this month. To ensure the survey addresses youth who don’t think JUUL, or similar products, are e-cigs, we have worked with the CDC to ask kids what product brands they use, including JUUL. We’ll be closely monitoring the results.
If youth use spikes again in 2019, the #FDA will have to consider additional regulatory steps, including action to require flavored pod-based e-cigs to come off the market until they have successfully completed the application process. These are the product kids are using.
If youth use rises again in 2019, whatever redeeming public health value this category of pod-based products may have for adult smokers, that potential benefit will be fully offset by the youth use. These products are on the market only out of enforcement discretion by #FDA.
Later this year we’ll also expand “The Real Cost” E-Cig Prevention Campaign to television to further reach youth about the dangers of e-cigarette use. I urge others to consider stepping up their efforts to educate and protect children as well.
E-cig use among kids is so widespread, so pervasive, that we risk addicting an entire generation of children on nicotine and watching the dramatic gains we’ve made in reducing smoking rates be reversed.
The #FDA will not allow a generation of children to become addicted to nicotine. This effort will carry on after I leave the agency. These efforts are embedded in the public health DNA of this agency and strongly supported by @SecAzar and the White House.
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