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Big News From the FDA Today Regarding e-cigarettes

written by Marsha Seidelman, M.D.
on Wednesday, 12th September ,2018

Well, we’re finally seeing some action on e-cigarette use in youth! It’s a few years too late, but hopefully we can catch up. E-cigarettes are a form of ENDS, or electronic nicotine delivery systems. We reviewed some pros and cons of the first generation of these devices in October, 2014. “We've worked so hard for decades to limit teen use of cigarettes. Why create a mirror image with another potentially harmful related product?” Since then, according to FDA Commissioner, Dr. Scott Gottlieb, there has been a “… disturbing and accelerating trajectory“ in youth.

Above, you can see versions of cigarettes, cigars, tanks and others. The devices that look like a USB device for computers (not pictured above) are the most commonly used now; the most popular brand is Juul. They are small and emit so little ‘vapor’ that they are used in classrooms right in front of the teacher.

A number of years ago, the FDA predicted that ENDS would help lower the adult smoking rate from 15% to 1.4%.  Smokers who had not been successful with FDA approved methods such as nicotine patches, gum, inhalers or prescription pills such as Chantix or Zyban, could use ENDS. They are not yet approved as a smoking cessation device, but they are widely available, and praised by some smokers as the only device that has helped them decrease or stop smoking.

Unfortunately, we did not see the expected level of success, and at the same time saw a huge increase in teen use - an increase in the ON ramp instead of the OFF ramp, if you will. The major dangers for youth are two-fold. One is that the adolescent brain is more vulnerable to nicotine addiction, and the other is that the addiction will result in  subsequent use of regular cigarettes once the teens are old enough to smoke.  You can see why the tobacco companies might have bought up the little e-cig makers and marketed their products big time!

As of 2017, 2 million middle school and high school students identify as current users of e-cigarette products. The FDA started an educational campaign last year to educate teens about the dangers of nicotine. Recognizing that the campaign was not successful and that e-cigarette use is rampant in youth, the FDA announced plans today for a dramatic turnaround.

An FDA undercover blitz last year of brick-and-mortar and online stores revealed that many sales were to minors, or to young adults making ‘straw’ purchases of large quantities of ENDS, which would in turn be distributed to minors. Today, the FDA announced the largest coordinated initiative regarding illegal sales in its history. They issued 1100 warning letters and 131 civil fines based on the recent investigations. They have identified 5 companies whose products have been sold to kids, including JUUL, Use, MarkTen, blu e-cigs and Logic and given them 60 days to answer with robust plans about how they will address widespread use by minors. “If they don’t know, or if they don’t want to know, that straw purchases are occurring, we’ll now be helping them identify it for them.”

In April of this year, the FDA requested that Juul supply them with information about their marketing, toxicology information, research as to why they’re so popular and which design features in particular appeal to youth, and any documented adverse events and consumer complaints.  All this, of course, to be used to reverse the trend.

Starting next week, a stepped-up national education campaign to warn teens of dangers of nicotine and e-cigarettes will be starting. Some youths are using them, evidently, without even knowing that they contain nicotine. In other studies, some that were labeled as not having nicotine, in fact contained it when tested.  These have not been regulated by the FDA, therefore all bets are off as to the contents.  They are also marketed in many flavors that would particularly appeal to youth. The chemicals used for the flavors can be harmful - yes, they may have been on the market for years, but for eating, not for heating up and inhaling.  

To date, the FDA has joined forces with the Federal Trade Commission to address misleading labels and packaging, especially those geared to teens. They were being sold as juice boxes, candy, cookies, with flavors like berry, mint and chocolate. As part of the Youth Tobacco Prevention Plan the FDA will continue to work on preventing access, curbing marketing and educating teens.

“The FDA won’t tolerate a whole generation of young people becoming addicted to nicotine as a tradeoff for enabling adults to have unfettered access to these same products."  It seems like a difficult situation. HOWEVER, we did this fairly successfully with traditional cigarettes after decades of changes - available for adults, not so much for kids. This seems like a re-run, with the added difficulty of having internet sales abound. It never should have gotten this far, but I’m glad that there’s finally some action.

9/12/18 FDA action against e-cigs, Press Release

April, 2018 announcement by Dr. S. Gottlieb, FDA Commissioner

Electronic cigarette update - more potential for addiction and poisonings - M. Seidelman, M.D.,  Ladydocscornercafe.com

Tags: FDA, ENDS, e-cigarettes

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