The U.S. District Court for the District of Columbia has ruled in favor of the U.S. Food and Drug Administration (FDA) in a motion for Summary Judgment in a case against Nicopure LLC and the Vaping Industry. For now, this essentially throws out the legal challenge initiated by the vaping community last year. The decision was made by Judge Amy Berman Jackson. There is one item of concern to the cigar industry – namely the Court upheld the FDA’s claim that the predicate date can only be changed by an act of Congress.
In the Court Ruling:
After considering the record, the points and authorities set forth in the briefs submitted by both sides and the amici, and the arguments presented at a hearing on the motions, the Court will uphold the Deeming Rule.
The Court wishes to reassure the many worried vapers who followed these proceedings closely that this case is not about banning the manufacture or sale of the devices. That is not what the Deeming Rule does or what it was intended to accomplish. In the Deeming Rule, the FDA simply announced that electronic cigarettes, or electronic nicotine delivery systems (“ENDS”) would be subject to the same set of rules and regulations that Congress had already put in place for conventional cigarettes.
While this ruling doesn’t directly affect the cigar industry, there is one precedent that was set in this case – namely, the Court states very clearly that the February 15, 2007, predicate date for products grandfathered from the Deeming Rule can only be changed by Congress. This is a position the FDA has held from the very beginning. The Court ruling states:
Thus, it was Congress that set the grandfather date in the TCA, and RSF has not pointed the Court to any authority for the proposition that the agency can ignore a statutory command. RSF argues that “[w]hen viewed in the TCA’s overall statutory context, it is apparent that Congress did not intend for the February 15, 2007 grandfather date to be strictly applied to all categories of deemed products.” RSF Mem. at 18. But “the starting point for interpreting a statute is the language of the statute itself.” CPSC v. GTE Sylvania, Inc., 447 U.S. 102, 108 (1980). The statute unambiguously points to a specific date – February 15, 2007 – and it contains no exceptions for items deemed to be tobacco products in the future. 21 U.S.C. § 387j(a)(2)(A).27 While the Court is sympathetic to RSF’s policy argument that as new products come to market, the grandfather date will become obsolete, see RSF Mem. at 18–19, the path forward is to seek an amendment to the statute, which is already underway. Hr’g Tr. at 57:22–58:1 (“THE COURT: Isn’t your problem with Congress and not the agency? And aren’t you already working on that right now? [Counsel for RSF]: We are. There are two bills in front of Congress right now.”).
The statute is clear, and FDA had no power to change it. So RSF’s challenge to the grandfather date fails.
In particular interest to the Vaping Community was whether or not the FDA exceeded its authority to regulate liquids and devices. The ruling by the Court was that it did not. The Court made it clear that it believed the FDA did not exceed its authority, but worked within the framework of the law enacted by Congress.
It bears repeating that the provisions the plaintiffs find most objectionable were not crafted by the FDA as part of the Deeming Rule. Instead, they are requirements of the Tobacco Control Act that was enacted by Congress. Congress gave the FDA broad authority to deem new products to be “tobacco products” subject to that existing statutory regime, and the Court finds that it was not arbitrary and capricious for the agency to decide to take that action with respect to e-cigarettes.
It was Nicopure Labs LLC, an e-liquid company that filed the first legal challenge against the FDA Deeming Rule. This was followed by a joint legal challenge of Eleven Vaping/E-Liquid Trade Associations against the FDA. Judge Jackson then ordered the Nicopure and Trade Association cases to be consolidated. Both Nicopure and the Vaping Community filed for a motion for Summary Judgement. The FDA filed for a cross motion for Summary Judgment. A Summary Judgment is a procedural move that essentially requests the Court to promptly dispose of a case because there are no facts at issue. For this case, the ruling was in favor of the FDA.
The cigar industry has a separate lawsuit against the FDA, and has also filed a separate motion for Summary Judgment.
CLICK HERE FOR THE FULL COURT RULING
Hopefully the new information the CRA has added to the lawsuit Will help