The vapor industry had its day in court Tuesday — or, perhaps, the first of many days. Attorneys representing Nicopure Labs and the Right to be Smoke-Free Coalition faced off with Justice Department lawyers who spoke for the FDA in the U.S. District Court for the District of Columbia, and each side summarized its arguments and answered questions from the judge presiding over the case.
The lawsuits by the plaintiffs — Nicopure Labs (maker of Halo E-Liquid), and the E-Vapor Coalition, an alliance of 11 vaping advocacy groups, led by the Right to be Smoke-Free Coalition — were combined on June 28 by Judge Amy Berman Jackson. Two sets of lawyers spoke for the plaintiffs, laying out the vapor industry arguments. Azim Chowdhury and Eric Gotting of Keller and Heckman LLP represented the Right to be Smoke-Free Coalition, and Nicopure Labs was represented by Benjamin Block and Kevin King of Covington & Burling LLP.
The judge listened to the presentations and asked questions of attorneys for both sides. Judge Jackson is an Obama appointee to the bench, but earlier this year ruled against the administration on another case. She is a graduate of Harvard Law School.
According to Law360, the judge seemed skeptical of the vapor companies’ arguments, and aimed most of her questions at Benjamin Block, the counsel representing Nicopure Labs. Noting that Nicopure and the FDA agree that most of the vapor market consists of tobacco products that are subject to regulation (that is, they contain nicotine derived from tobacco), she asked why the FDA should not keep its authority just because some consumers may use nicotine-free liquids.
“Is there anything else in the universe that anyone would do with a vaping device than put a liquid in it and vape with it?” Judge Jackson asked the Nicopure attorney. The FDA contends it may regulate devices because they are intended to be used with nicotine-containing e-liquid.
Block argued that the Tobacco Control Act (the law that grants the FDA its “deeming” authority) does not give the agency the power to define a product as tobacco based on its intended use. Block, describing vaping devices, said that “an open system, that is neither made or derived from tobacco or for human consumption, is not subject to the regulation.”
He told the judge the agency cannot extend its authority to products that do not contain nicotine, or those that contain non-tobacco-derived nicotine. “Congress did not say, ‘We are giving you the keys to the kingdom; you can do whatever you want,’” Block told Judge Jackson.
“We’re dealing with a plaintiff whose name is Nicopure,” said counsel Daniel Crane-Hirsch, representing the FDA. “Clearly their very reason for existing is to deliver nicotine to consumers.”
The attorneys speaking on behalf of the FDA — Crane-Hirsch and Eric Beckenhauer — were from the U.S. Department of Justice.
Judge Jackson challenged the government attorneys on the time required to produce studies that could satisfy a premarket tobacco application (PMTA). Dimitris Agrafiotis of the Tennessee Smoke Free Association, one of the coalition plaintiffs, thinks that is a potential point for our side. If the judge rules that the two-year window to submit a PMTA is insufficient, she might impose a different standard or throw out that part of the rule.
Agrafiotis also noted that she didn’t seem to understand the difference between open- and closed-system products, and was misinformed about the size of the open-system market. She has the typical outsider’s view of a vapor “wild west” of bathtub products containing who knows what. He thought the attorneys should have taken some time to demonstrate and instruct.
The judge asked whether the number of e-liquid companies that could not comply with the rules wasn’t itself a point in favor of regulations, according to Law360. She also noted that the predicate date of 2007 is required by the Tobacco Control Act and not subject to FDA discretion. “I don’t see the authority for the FDA to change a congressionally mandated compliance date,” she said.
The waiting is the hardest part - so don't wait!
That is precisely why vapor advocates are working so hard to get the Cole-Bishop amendment included in the budget bill that Congress will pass later this year. Without a change to the predicate date, it’s unlikely that the vaping industry will survive long enough to fight for a long-term solution, like separating e-cigarettes from the Tobacco Control Act.
Sure, maybe the judge will force the FDA to give PMTA applicants more time. That means a couple extra years before small companies are killed. It won’t solve the problem. Only Congress can stop the slow motion destruction of the market.
As we wait for Judge Jackson’s decision, which is unlikely to come before early next year, vapers should be doubling down on the push for a predicate date change. We need to continue to share the August8th.org link with friends and family, speak to non-vapers about the FDA’s overreach, write letters to the editor of local newspapers, and contact our own house members and senators.
Those are things that can have real effects. We can’t wait for Judge Jackson — or any judge — to save us. If vapers don’t stay strong and continue to fight, we’ll lose. So, please, write a letter. Make a call. Talk to someone who doesn’t understand.