The Vapor Technology Association, alongside Vapor Stockroom, LLC have filed suit against the FDA. Coming in at 51 pages long, over 137 paragraphs, and charging two very direct counts of wrongdoing, it could have major implications for the nation's vapor industry.
The lawsuit comes in the wake of the FDA's announcement back in June that vapor manufacturers have until May of 2020 to file their PMTA applications. Premarket Tobacco Authorization applications are required of all manufacturers so they can market and sell vapor products in the United States. The process is expected to be incredibly expensive and so far comes with almost no specific instruction, even though the FDA has revised and re released guidance five different times since 2016.
The lawsuit has been filed on behalf of two parties. The first, the Vapor Technology Association, is a large coalition of manufacturers and small businesses seeking responsible legislation and regulation of vapor products. The other, Vapor Stockroom LLC, is a Kentucky-based vapor products manufacturer and distributor, one of the many locally owned small businesses affected by the FDA's sudden 10-month timetable for submissions. The official filing goes into much more detail, but the main facts the VTA points out are:
1. "A Wide Variety of Innovative Vapor Products Provide an Alternative to Combustible Cigarettes for Existing Smokers and Hold Great Potential to Benefit the Public Health as a Harm Reduction Tool. "
Which, science aside, if you take previous FDA commissioner Scott Gotlieb's own word for it, "E-cigarettes may present an important opportunity for adult smokers to transition off combustible tobacco products and onto nicotine delivery products that may not have the same level of risks associated with them."
It's just hard to dispute that.
2. "Vapor Products, Which Do Not Contain Tobacco, Are Disadvantaged Under the Tobacco Control Act Compared to More Harmful Combustible Cigarettes Because Pre-Market Tobacco Applications Must be Filed for Vapor Products Already On the Market. "
Doesn't it seem strange that a product that contains no tobacco is regulated like it does? To quote the lawsuit "In the three years since the Deeming Rule took effect, all Newly Deemed Products, including vapor products, have been heavily regulated by FDA." And from label requirements to advertising and bottle restrictions, they're right.
3. "FDA Repeatedly Promised, But Has Failed to Deliver, Foundational Rules or Clear Guidance Setting Forth the “Rules of the Road” Upon Which Vapor Manufacturers Could Rely for the Mandatory Pre-Market Tobacco Application Process."
4. "[Vape manufacturers] Delayed Working on Their PMTAs in Reasonable and Detrimental Reliance on FDA’s Oft-Repeated Promises That Further Guidance and a Foundational Rule Setting the “Rules of the Road” for PMTAs Would be Forthcoming and FDA’s Public Statements and Guidance Stating that Stakeholders Would Have Until August 2022 to File Their PMTAs. "
And it's true. The lawsuit alleges the "rules of the road" have yet to be established. By their own press releases, the FDA said it would provide such. It hasn't. How are manufacturers supposed to commit so much time and money if they don't have the rules laid out?
5. "FDA Materially Changed its Recommendations Regarding Harmful and Potentially Harmful Constituent Testing Between the Draft ENDS PMTA Guidance Published in 2016 and the Final ENDS PMTA Guidance Published on June 11, 2019. "
This creates a special challenge for manufacturers and small businesses. Uncertainty is always tough when running a business, but not reaching PMTA compliance has far and away more ramifications than following market trends or keeping your shelves stocked.
6. "FDA Engaged in Unlawful “Regulation by Litigation” By Superfluously Suggesting a Grossly Accelerated Ten-Month Deadline for the Submission of PMTAs Without Any Advance Notice or Opportunity for Comment by VTA or Industry Stakeholders."
This one may be the biggest shock in the FDA/vaping timeline. After so much delay, a federal ruling pushed the FDA into a 10-month deadline for accepting PMTA applications. The FDA so far has opted not to appeal the decision, a peculiar choice given how much work that will make for acting FDA director Ned Sharpless and his staff.
7. "FDA’s Arbitrary and Capricious Suggestion of a Ten-Month Deadline Presents Vapor Manufacturers ... with a Hobson’s Choice of Either Spending Millions of Dollars on PMTAs that They Know Will Be Incomplete by May 11, 2020, or Waiting for Additional Regulations from FDA and Running the Risk that Their Products Will Face Enforcement Action After May 11, 2020."
We really might not have been able to put it better ourselves.
The lawsuit alleges that the FDA violated the Administrative Procedure Act and the Due Process clause of the Fifth Amendment. As of this posting, no file number or judge has been assigned.
This case is one of a few that have come down since the June deadline shrink, but it's easily the most comprehensive and detailed suit to date.