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FDA responds to Nicopure Labs and R2B Smoke-Free Lawsuits

Just four days after the announcement of the revised FDA deeming regulations on May 5, 2015, Tampa-based Nicopure Labs filed the first-ever lawsuit opposing the new federal oversight.   Several other companies and vaping advocacy groups followed suit, including the R2B Smoke-Free organization.

By October 19, so many court cases had been filed against the FDA in the Federal District Court of Washington, D.C. that Judge Amy Berman Jackson was forced to combine eleven of them into one consolidated lawsuit, including those from Nicopure Labs and R2B Smoke-Free.  In August 16, just two days ago, the FDA finally issued a lengthy,101-page response to the allegations.


Although the entire document is still being reviewed by legal experts in the vaping community, a few points of concern become instantly apparent even to the average vaper who decides to begin reading the often strange and confusing manuscript.  A few highlights include:

  • The FDA claims that e-liquids contain several dangerous and toxic compounds, including heavy metals and silicates.
  • The FDA labels nicotine as “one of the most addictive substances known to man.”
  • The FDA regularly quotes several medical “studies” that suggest all sorts of untrue allegations, including the notion that e-cigs contain 200 times more nickel compound than conventional Marlboro cigarettes.
  • The FDA believes that these sorts of lawsuits are essentially frivolous and a waste of time because the FDA deeming regulations were the direct result of an Executive Order by President Obama.
  • And so much more!


Here is a brief paragraph taken from the 101-page response letter.  Throughout this section, the lawyers for the FDA are very careful to include past court cases which allegedly support their outlandish claims regarding the current lawsuits.  It’s as if the FDA is giving Judge Amy Berman Jackson a set of very precise reasons to dismiss the entire case before it even sees the light of day.  Hopefully, Judge Amy will find this smug sense of entitlement as offensive as the vaping community does.

“There is also evidence that toxic heavy metals and silicates can be transferred from e-cigarette parts into the inhaled aerosol. One study of devices with a “cartomizer” (i.e., a combined cartridge and atomizer) found that they produced lead and chromium concentrations ‘within the range of conventional cigarettes,’ and nickel concentrations ‘2–100 times higher . . . than in Marlboro brand cigarettes.’ Williams et al. (2013) at 5 (AR 6977). Likewise, the packaging of e-liquids may affect the chemicals ultimately inhaled. Vials of e-liquid can leach Case 1:16-cv-00878-ABJ Document 42-2 Filed 08/16/16 Page 28 of 102 14 toxic compounds, and ‘these leachates may be inhaled when the e-liquids are used as intended, posing additional health risks.’"

The 101-page response letter from the FDA was quickly shared on social media over the past two days, and the document is being met with mixed emotions, to say the least.  Some people consider the tone of the letter to be somewhat patronizing.  Others are crossing their fingers and hoping for the best.   And some people are beginning to wonder more and more about this Judge Amy Berman Jackson, hoping that she is a real stand-up-gal.  Here are a few examples of social media comments by Reddit fans:

“I really would like to give the judicial system and this judge the benefit of the doubt -- people don't become judges by accident, it does require a lot of work and I'm assuming intelligence -- but the cynic in me worries that the FDA will use its "influence" here as well. I don't see how any rational person could look at their response as anything but incredibly condescending tripe. I'd like to think if us hobbyists/enthusiasts/laymen have a pretty good grasp on how full of shit the FDA is, that the judge will too, but its impossible to know that. I don't personally think the FDA did themselves any favors with that ridiculously patronizing tone but I'm not a lawyer and I'm gonna leave the litigation and opinions to those who know what the hell they're doing. I believe the hearing for these suits is in late September or early October, so we'll see what happens.”


The tone in this is very much (imo) "aw look that's a cute little lawsuit let us show you how really expensive lawyers work and make you feel dumb." Hopefully this actually makes it to court, but to the layman who doesn't have a dog in the fight, it's gonna look really bad for us.
The way it reads might actually bode well for us. Judges generally don't take too kindly to big corporations and government entities treating the little guy like they're stupid and acting smug. I'm hoping this judge sees it that way.

Many political pundits of the vaping community are rather surprised that the FDA response came so quickly, if at all.  Sen. Ron Johnson, Chairman of Committee on Homeland Security and Governmental Affairs, has been sending letters to the FDA since early May, and even he has trouble getting them to write back.  In fact, when the FDA finally did send a letter in response to the Senator’s many specific questions, Ron Johnson called it “insufficient” and “burdensome.”  Let’s hope that Judge Amy feels the same way about this latest FDA document.


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