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FDA Targets E-Cig Manufacturer JUUL

FDA Targets E-Cig Manufacturer JUUL


The US Food and Drug Administration on Wednesday fired a shot at JUUL Labs and several Big Tobacco-backed cigalike brands that the agency alleges are primarily to blame for growing numbers of youth experimenting with nicotine products. The consequences of the FDA's actions, however, could ripple across the entire US vape community.


What Happened?


The FDA simultaneously issued more than 1,300 warning letters, some imposing fines, to vapor product manufacturers and online and brick-and-mortar vape retailers. Violations include selling products to undercover minor decoys and selling or advertising liquids "resembling kid-friendly food products such as candy and cookies."


The underage sales component is fairly straightforward, and it comprises a bulk of the complaints. This problem has an obvious solution: stronger enforcement, as the agency is currently undertaking, is needed to keep products out of the hands of youth. You can read about the steps we've taken to prevent minors from purchasing at Breazy here.


The subject of marketing "kid-friendly" flavors is more complex. A recent survey indicates that a full 89 percent of adult vapers prefer fruit, dessert, or candy-flavored liquids, while less than five percent report tobacco or menthol as their preferred flavor.


What's Next?


In addition to the violation letters, the FDA is giving JUUL, Vuse (owned by tobacco giant RJ Reynolds), MarkTen XL (Altria, parent of Marlboro), blu e-cigs (Imperial Tobacco), and Logic (Japan Tobacco) 60 days "describing how they will address the widespread youth access and use of their products."


That doesn't sound so bad. But we're not finished.


"If they fail to do so, or if the plans do not appropriately address this issue, the FDA will consider whether it would be appropriate to revisit the current policy that results in these products remaining on the market without a marketing order from the agency," the agency's statement continues. "This could mean requiring these brands to remove some or all of their flavored products."


No specifics were provided on what the agency is looking for in a youth-prevention plan, but it appears Juul's often-touted $30 million investment in advertising discouraging youth use and independent retailer checks falls far short of expectations.


What's more, the FDA is ramping up efforts to stamp out any new products that may have been released after an August 2016 deadline without explicit FDA approval. Under new deeming regulations released that year, any new products (and eventually even old ones) are required to complete a costly review process before being allowed to market. With a cost potentially running into the millions to bring a single e-liquid flavor to market, it's long been feared that these regulations could drive most vapor product manufacturers out of business.


When new FDA Commissioner Scott Gottlieb arrived, the vapor community breathed a sigh of relief. Gottlieb, a onetime investor in brick-and-mortar vape shops, was vocal in his support of vaping, and even extended a 2017 deadline for manufacturers to submit their products for compliance or pull them from shelves by five years, to 2022.


Many took this as a sign of more rule relaxation to come, but with the recent media uproar surrounding teens and Juul it appears companies that took liberties in continuing to release new products may have pushed the agency too far.


What does this all mean to me?


Consequences of the FDA's action could be widespread, eventually affecting many more vapers than just users of the cigalikes it's targeting.


The agency says it's reconsidering its extension for compliance with the deeming regulations which could, in a worst-case scenario, result in any products introduced to the market after 2007 (note: that's all of them) being pulled from shelves.


They're also promising "a sustained campaign to monitor, penalize and prevent e-cigarette sales in convenience stores and other retail sites." Unless that's a typo, the implications from this move alone are massive.


An effort to examine the role of flavor in e-liquid with an eye toward a potential nationwide ban is already underway. With the FDA declaring that youth vaping has reached "an epidemic proportion," Gottlieb has suggested that protecting adults' flavor choices is less important than stopping youth from being attracted to nicotine.


Finally, a massive FDA ad campaign targeting underage use of vapor products is in the works. This comes in addition to another that more broadly attacks vapor in general, which was recently launched by the Truth Initiative, a non-profit funded through the tobacco Master Settlement Agreement of the '90s.


We'll say it one more time: this is big news. At this point it's difficult to predict just how far the fallout will spread, but as the news sinks in and industry leaders begin responding we'll be here, delivering news as it breaks.