FOIAengine: Hundreds of FOIA Requests Signaled Challenge to FDA
Two companies that go by the names of Triton Distribution and Vapetasia are small players in America’s fast-growing $28 billion e-cigarette market.
Despite their size, they’ve become the unlikely protagonists in a federal lawsuit that points a dagger at the heart of the Food and Drug Administration’s authority to regulate flavored e-cigarettes and vaping products. The case has received scant media attention thus far. But that may be about to change.
The nine justices of the U.S. Supreme Court plan to decide whether to hear the case – FDA v. Wages and White Lion – when they gather at their conference on June 20. If the justices take it, the outcome could affect the 26 million – you read that right, 26 million – marketing applications for e-cigarettes that the FDA has denied since 2020.
During the same period, the agency approved 23 such applications.
As the justices consider whether to hear the case in their next term, the stakes in the case are high, for the FDA as well as the agency’s antagonists in the huge and growing vaping industry. An FDA spokesperson told us the agency would have no comment on the case. Asked to verify the 26 million number, the spokesperson noted that one unnamed company accounted for 17 million of those denials.
The two companies that originally brought the lawsuit are punching above their weight. Wages and White Lion owns the Dallas-based vape wholesaler Triton Distribution; Triton’s LinkedIn page says it has 11 to 50 employees. Vapetasia is a Las Vegas “e-liquid” maker that “strive[s] to make only the highest quality juice for your e-cigarettes.” It lists a similar employee count.
Triton sought FDA pre-market approval for e-liquids with names like “Jimmy the Juice Man Peachy Strawberry” and “Suicide Bunny Mother’s Milk and Cookies.” Vapetasia wanted to market flavors called “Iced Pineapple Express” and “Killer Kustard Blueberry.”
Those applications must have looked like just two more slam-dunk denials to the FDA, which has never approved a vaping product having any flavor other than tobacco, and which typically avoids litigation with bigger, well-funded vaping-industry players.
Once denied, the two small companies chose a friendly venue, the Fifth Circuit, for their appeal. They claimed the FDA acted arbitrarily in keeping their vape products off the market. And soon there was big money at the table.
You can see the full list of parties in the Fifth Circuit case – from the American Vaping Association and the American Vapor Manufacturers to the American Lung Association and the American Heart Association; 22 amici curiae in all – here. Although most other federal circuits had turned aside similar claims, the en banc Fifth Circuit sided with the companies in a 10-6 opinion that was highly critical of the FDA. The split among the circuits makes it more likely that the Supreme Court may take the case. Both sides have filed their briefs.
As often happens, we first got interested in this case because of the cascade of Freedom of Information Act requests coming into the FDA. In recent months, PoliScio Analytics’ competitive-intelligence database FOIAengine – which tracks FOIA requests in as close to real-time as their availability allows – logged hundreds of FOIA requests about e-cigarettes and vaping from law firms with numerous vaping-industry clients. The FOIA requests were signals that something important was happening.
We started digging deeper to see what was being sought, and by whom. FOIA requests to the federal government can be an important early warning of bad publicity, uncertainties to be hedged and gamed out, or litigation to come. The FOIA requests fell into the latter category.
Two law-firm requesters stood out.
Washington-based Kleinfeld Kaplan & Becker, which specializes in FDA law, logged 114 FOIA requests, all but a few of those to the FDA, from October 2020 through April 2024 (the most recent month available). Tobacco- and vaping-related FOIA requests predominated. In April, the law firm made 25 identical FOIA requests to the FDA for Marketing Denial Orders (MDOs) issued against various vaping-industry players – including Vapetasia and Wages and White Lion. We reached out to Kleinfeld Kaplan, but the law firm didn’t respond to our questions about why it filed those identical requests. Kleinfeld Kaplan isn’t listed as counsel for any of the parties in the Wages and White Lion case.
Keller & Heckman, with offices in Washington and elsewhere, filed 155 FOIA requests with the FDA during the same four-year period. Keller & Heckman calls itself “the premier global law firm” serving companies that produce “tobacco, nicotine, e-cigarettes, or related products such as cannabis, hemp, or CBD, or are engaged in the vaping supply chain.” The Keller & Heckman FOIA requests in our FOIAengine database were filed on behalf of a broad range of vaping-industry clients seeking details about product inspections, approvals, and denials. Docket Alarm lists hundreds of court cases in which Keller & Heckman is or has been involved. But the law firm didn’t show up as counsel for any of the parties in the Wages and White Lion case.
What’s next? We may have an answer soon. A few months ago, when the government filed its appeal with the Supreme Court, commentator Jonathan Adler weighed in with a viewpoint that may be prescient: “While the Supreme Court does not grant certiorari all that often, this would seem like a strong candidate. The circuit split, and its ongoing effects on the FDA’s ability to administer the [pre-market] approval process, makes eventual Supreme Court review inevitable. And if this is the case the DOJ pushes to tee up this issue, this is likely the case the Court will accept.”
FOIAengine access now is available for all professional members of Investigative Reporters and Editors, a non-profit organization dedicated to improving the quality of journalism. IRE is the world’s oldest and largest association of investigative journalists. Following the federal government’s shutdown of FOIAonline.gov last year, FOIAengine is the only source for the most comprehensive, fully searchable archive of FOIA requests across dozens of federal departments and agencies. FOIAengine has more robust functionality and searching capabilities, and standardizes data from different agencies to make it easier to work with. PoliScio Analytics is proud to be partnering with IRE to provide this valuable content to investigative reporters worldwide.
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John A. Jenkins, co-creator of FOIAengine, is a Washington journalist and publisher whose work has appeared in The New York Times Magazine, GQ, and elsewhere. He is a four-time recipient of the American Bar Association’s Gavel Award Certificate of Merit for his legal reporting and analysis. His most recent book is The Partisan: The Life of William Rehnquist. Jenkins founded Law Street Media in 2013. Prior to that, he was President of CQ Press, the textbook and reference publishing enterprise of Congressional Quarterly. FOIAengine is a product of PoliScio Analytics (PoliScio.com), a new venture specializing in U.S. political and governmental research, co-founded by Jenkins and Washington lawyer Randy Miller. Learn more about FOIAengine here. To review FOIA requests mentioned in this article, subscribe to FOIAengine.
Write to John A. Jenkins at [email protected].
