On behalf of the E-Vapor Industry, tonight we filed the attached Complaint in the U.S. District Court for the District of Columbia challenging portions of FDA’s Deeming Regulation and the Tobacco Control Act on various constitutional and administrative grounds. The named Plaintiffs in the lawsuit are:
1. Right To Be Smoke Free Coalition (www.r2bsmokefree.org)
2. American E-Liquid Manufacturing Standards Association (www.aemsa.org)
3. American Vaping Association, Hoboken, New Jersey (http://vaping.info/)
4. Electronic Vaping Coalition of America, New Berlin, Wisconsin (http://evapingcoalition.org/)
5. Georgia Smoke Free Association, Fort Oglethorpe, Georgia (http://www.gasmokefree.org/)
6. Kentucky Vaping Retailers Association, Inc., d/b/a Kentucky Smoke Free Association, Louisville, Kentucky (http://www.kysmokefree.com/)
7. Louisiana Vaping Association, Chalmette, Louisiana (http://laecr.org/)
8. Maryland Vape Professionals, LLC, Baltimore, Maryland (https://vape-professionals.myshopify.com/)
9. Ohio Vapor Trade Association, Miamisburg, Ohio (http://www.ohvta.org/)
10. New Jersey Vapor Retailers Coalition, Roseland, New Jersey (http://www.njvaporcoalition.org/)
11. Tennessee Smoke Free Association (https://tnsmokefree.org/)
Also supporting the lawsuit are the Smoke-Free Alternatives Trade Association (http://sfata.org/), the Consumer Advocates for Smoke-free Alternatives Association (http://casaa.org/) and NOT Blowing Smoke (http://notblowingsmoke.org/).
In the Complaint, we argue the following:
(1) Count I – Violation of Administrative Procedure Act – Grandfather Date: FDA had the authority and the statutory duty to establish a new Grandfather Date for e-vapor products (ENDS) or apply its enforcement authority so that some ENDS manufacturers, including e-liquid companies, would have the opportunity to forego the Premarket Tobacco Application (PMTA) pathway and avail themselves of the option to submit Substantial Equivalence (SE) Reports. By not doing so, FDA violated the Administrative Procedures Act.
(2) Count II – Violation of Administrative Procedure Act – Pre-market Authorization Process: FDA was obligated to consider the continuum of risk of tobacco products and exercise flexible enforcement authority mandated by Congress, instead of a “one-size-fits-all” regulatory regime treating ENDS the same as cigarettes and other harmful products and forcing ENDS manufacturers into the PMTA process, which will all but ban the entire e-liquid and device categories. Accordingly, FDA’s application of the PMTA process to ENDS products violates the Administrative Procedures Act.
(3) Count III – Violation of Due Process and Equal Protection Clauses – Tobacco Control Act: In the Tobacco Control Act, Congress made clear that different tobacco products present different risks and that FDA should exercise its enforcement authority in a flexible manner. But if, as FDA argues, the Agency is mandated to enforce a “one-size-fits-all” regime to all products, including less harmful ENDS, than Congress did not provide FDA with the necessary tools and regulatory flexibility to achieve the Tobacco Control Act’s stated goals, which include allowing newer and safer products to enter the market. As a result, the Tobacco Control Act is unconstitutional under the Due Process and Equal Protection Clauses.
(4) Count IV – Violation of First Amendment and Administrative Procedure Act – Ban on Free Samples: FDA does not have a substantial interest in prohibiting access to free samples of ENDS products by – including taste testing e-liquids in vape shops. The complete ban on free samples does not directly advance the government’s interests. There were more narrow options available to FDA to advance their stated interest in preventing youth access while still allowing vape shops and others to market using free samples. Accordingly, the total ban on free samples violates the First Amendment and the Administrative Procedures Act.
(5) Count V – Violation of First Amendment and Administrative Procedure Act – Modified Risk Tobacco Products: The Modified Risk Tobacco Product (MRTP) provision of the Tobacco Control Act, as applied to ENDS products – which do not produce smoke, combust e-liquid when used as intended, or produce aerosol that contains the harmful substances found in tobacco smoke – does not advance any purported government interests (which focus on traditional tobacco products), and captures commercial and non-commercial speech that is clearly not misleading (e.g., smoke free claims). By applying the MRTP provision and its extensive review process to ENDS products, FDA violated the Administrative Procedures Act and the prior restraint doctrine.
(6) Count VI – Violation of Administrative Procedure Act – Definition of “Tobacco Product” and Application to ENDS: FDA considers a broad range of ENDS products to be regulated as tobacco products or “components or parts,” including software that operates devices, batteries, displays, tanks, etc. FDA intends to regulate these products as tobacco products despite the fact that they do not contain tobacco, are not derived from tobacco and are not components and parts of an actual tobacco product. There is nothing in the legislative history of the Act, and FDA has provided no supporting rationale, for why these items should be regulated as tobacco products merely because they are used to consume the product. Accordingly, FDA’s application of the Tobacco Control Act’s definition of “tobacco product” to certain ENDS is unreasonable and unlawful under the Administrative Procedures Act.
(7) Count VII – Violation of Regulatory Flexibility Act – Unlawful Cost/Benefit Analysis: The Regulatory Flexibility Act requires administrative agencies to consider the effects of their regulatory actions on small business entities. FDA failed to consider significant alternatives, including, but not limited to, the impact of any compliance period on the ability of small entities to successfully navigate the PMTA process given that FDA concedes that there are no long-term clinical studies or other data necessary to support such applications. FDA only considered several, modest alternatives focused on discrete issues like labeling burdens. The Agency did not make a reasonable, good faith effort to consider alternatives that would have an overall impact on all small entities. In short, FDA substantially overestimates the benefits of the Deeming Rule and underestimates the costs. Accordingly, the Court should take corrective action, set aside and remand the Deeming Rule to FDA, and defer enforcement until the Agency complies with the Regulatory Flexibility Act.
(8) Count VIII – Violation of Administrative Procedure Act – Unlawful Cost/Benefit Analysis: The Tobacco Control Act makes clear that FDA was required to adequately consider the costs and benefits of the Deeming Rule. As with the Regulatory Flexibility Act, FDA failed to consider regulatory alternatives, such as an extended compliance period, that would have significantly increased the chance that ENDS manufacturers would be able to comply with the PMTA process, thus avoiding what will be close to an effective ban on ENDS products. The Agency also failed to properly estimate key factors necessary to an adequate cost/benefit analysis, including the number of entities and products affected, as well as the number of PMTA applications that will be filed. For many of these numbers, FDA did not adequately explain or support its conclusions. As a result, FDA violated the Administrative Procedures Act and, therefore, the Deeming Rule must be remanded to the Agency so that a proper cost/benefit analysis may be conducted.
On Wednesday, June 8, 2016, I had the honor of embarking Capitol Hill side by side with Dimitris Agrafiotis and 20 Tennessee vape store owners in representation of the Tennessee Smoke Free Association. Our objective was very clear, to discuss FDA deeming regulations with our representatives, the impact they will have on small businesses, and to ask for support on the Cole-Bishop Amendment.
We started at the Hart Building with a briefing from the exceptional Shimmy Stein of West Front Strategies to review the day’s schedule and outlined discussion topics to cover with each representative. Once we had our strategy laid out, we headed to our first meeting with staffers from the HELP Committee. With an even larger group than the last visit to their office, we all piled around a table and were met with friendly and familiar faces and updated their staff of the recent burdensome FDA regulations, the challenges we face in compliance, and the importance of changing the predicate date from February 2007 to August 2016. After a somewhat lengthy visit and their support for our industry, we were off to our next representative.
Much of the same talking points resounded throughout the day with each meeting. With the groundwork laid during TSFA’s visit to Capitol Hill in June 2015 with many of the same representatives, our goals were easier to get across since they had more insight into the industry from our prior visit. We reinforced that there are over 380 vape stores across the state, with an average of 5 employees per store, occupying over 900,000 sq. ft. of previously unoccupied space, including several in revitalizing areas. TSFA currently represents 75 of those stores, with a total of almost 500 employees and at least 150,000 sq. ft. of space. We explained not only how costly the PMTA process is on every vapor product, but how the required studies of proving each product as having a positive impact on human health is impossible given the short 24 month time frame.
In addition, Steve Nair of MOV pointed out how his vape store employees are like family, and telling them the possibility of them not having jobs in the future was devastating. The Livezeys of Knoxville Vapor described their customer base and how they are able to provide a family atmosphere to several, including a few over 70 years old. The Morins of West Tennessee Vapor expressed concern for opening new stores and that any future expansions to other cities within Tennessee are now on hold. Jerud Blake of H20 Vape Shop touched on distribution. This is just a sampling of discussions that pulled on my heartstrings and had staffers fervently scribbling in their notepads.
Dimitris and the Chattanooga store owners headed to Congressman Chuck Fleischmann’s office to thank him once again for his support of the Cole-Bishop amendment, meanwhile the Knoxville vape store owners gained support from Congressman Duncan, which was an outstanding surprise! Overall the day was extremely productive and the outcomes of the six meetings were positive.
Personally, it was an unforgettable experience that not only reinforced my pride in the people I’m blessed with representing on a day to day basis, but also gave me powerful insight into the legislative process. It was fulfilling to read of the successes that other states had on the hill that day as well, including UTSFA and FSFA.
Even Greg Conley was spotted doing a presentation on the fly with the US Surgeon General! I’m relieved that somebody spotted Conley. Another trip, another missed opportunity to meet the man, although I managed to catch a mere glimpse of him on my way to the cab. Maybe next time.
With regulations coming into effect on August 8th, right now is a critical time to inform our representatives of the impact they will have on our industry and garner support from them. Please take a moment to thank those in favor of moving the predicate date and contact your local representative to let them know how important it is to you, your store, your quality of health, and the lives of current smokers who may not have the chance to benefit from innovative technology that is 95% safer than smoking. A huge thanks goes out to VTA for organizing such an important event.
Vice President/Executive Director of West Tennessee
Tennessee Smoke Free Association
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