The major industry coalition lawsuit challenging the FDA’s deeming regulations just got even more interesting. The E-Vapor Coalition, representing the Right to be Smoke-Free Coalition and 10 other industry associations, has filed a motion for summary judgement, asking the US District Court to set aside the deeming rule or declare it unconstitutional.
The Coalition lawsuit was consolidated with the Nicopure Labs lawsuit in the US District Court for the District of Columbia on June 28. Nicopure filed its own motion on July 8. The two sets of plaintiffs will attack the deeming rule on separate legal grounds. The Coalition suit challenges the FDA’s application of the predicate (or grandfather) date of February 15, 2007, for deemed vapor products.
According to a press release issued by Keller and Heckman LLP, the law firm representing the E-Vapor Coalition, the FDA has until August 16 to respond to both motions. Oral arguments before the court have been scheduled for October 19 in Washington, DC.
The E-Vapor Coalition's motion highlights several of the Deeming Rule's shortcomings, specifically:
- FDA has applied a statutory February 15, 2007 grandfather date to e-vapor products that was intended for traditional tobacco products, like cigarettes. FDA was required under the statute to set a new grandfather date which would allow e-vapor products to take advantage of the more flexible SE pathway.
- FDA did not consider, as required under the Regulatory Flexibility Act ("RFA"), 5 U.S.C. §§ 601, et seq., any significant alternatives that, in the absence of a new grandfather date, would have allowed vaping product manufacturers sufficient time to develop the extensive information, including long-term clinical studies, necessary to successfully navigate the more stringent Premarket Tobacco Application (PMTA) process. As it stands now, such data cannot be generated by the PMTA deadline of August 2018.
- Even if FDA is correct in that it must apply the February 15, 2007 grandfather date to e-vapor products, this means that the Tobacco Control Act (TCA) itself violates substantive due process and is unconstitutional. Under this scenario, there would be no rational relationship between the TCA's underlying purposes and the means chosen by Congress to accomplish such goals. Indeed, as FDA conceded during the rulemaking, virtually all manufacturers will exit the vaping market, thus depriving adults of a relatively safer tobacco product and a chance to reduce or, better yet, quit their smoking habits.Accordingly, the E-Vapor Coalition has requested the court grant it summary judgment and: (1) declare that the Deeming Rule exceeds FDA's statutory authority, is arbitrary and capricious, or an abuse of discretion under the Administrative Procedure Act with respect to FDA's failure to either establish a new grandfather date for all deemed e-vapor products or exercise its enforcement discretion in this regard; (2) set aside the Deeming Rule to the extent that FDA has applied the February 15, 2007 grandfather date to e-vapor products, and remand the rule to FDA so that the agency can set a new grandfather date for all deemed e-vapor products consistent with the Court's decision; (3) remand the rule to FDA so that the agency can conduct a proper regulatory impact analysis that addresses the lack of long-term clinical data for e-vapor products; and/or (4) declare the rule unconstitutional to the extent that it applies the February 15, 2007 grandfather date to e-vapor products.
The Right to be Smoke-Free Coalition was formed to fight unconstitutional state and federal e-cig and vaping laws. Its original focus was challenging the recently passed HEA 1432 in Indiana, which the coalition’s lawyers have challenged in both state and federal courts. Those efforts are still in progress. R2B retained the services of Washington, D.C. legal firm Keller and Heckman, LLC. Keller partner Azim Chowdhury is recognized as an expert in vapor products law, and he has handled the vaping cases.
The plaintiffs in the E-Vapor Coalition lawsuit are
The R2B suit has also been endorsed by all major American vaping advocacy organizations who weren’t named in the suit, including CASAA, Not Blowing Smoke, SEVIA USA, and SFATA. While vapor businesses will certainly bear most of the cost, everyone who is a stakeholder in the fight to keep vapor products legal and available should consider donating to the fund supporting this lawsuit.