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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. (Related Article: FEDERAL JUDGE CONSOLIDATES HISTORIC LAWSUITS: NICOPURE LABS VS. FDA E-CIG REGULATIONS) 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! (Related Article: NICOPURE MAKES HISTORY; FILES FIRST LAWSUIT OVER FDA E-CIG REGULATIONS) 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.’