Fight for the right of vapers to be smoke-free
What we stand for
The Right to be Smoke-Free Coalition is a non-profit, industry-led trade association of e-vapor businesses dedicated to promoting the interests of the industry by advocating for reasonable and responsible laws and regulations, and fighting for the right of vapers to be smoke-free.
The Right to be Smoke-Free Coalition works with expert legal counsel and the broader industry to develop comprehensive litigation strategies to challenge unlawful Federal and State Laws and Regulations. Our current activities and information will be updated periodically. To join the fight please contribute to become a member of the Coalition.
Our Coalition is positioned to enforce and defend the industry, and we need your help. Lawsuits of these nature are costly and we expect vigorous defense against our efforts. If you are an industry advocate, e-liquid producer, device manufacturer, vape shop owner or internet retailer that believes in responsible and appropriate regulations, you can join the Coalition or contribute to the cause.
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The Right to be Smoke-Free Coalition is a 501(c)(6) non-profit trade association organized under the laws of Washington, D.C. We are not a charitable organization. Your contribution allows you to become a member. All funds raised go toward litigation fees and related expenses. Please check with your tax advisor to determine the tax deductibility of any contributions
Learn about our fight
Right To Be Smoke Free Coalition and E-Vapor Industry Trade Associations File Lawsuit Challenging FDA’s Deeming Regulation and the Tobacco Control Act
On behalf of the Right To Be Smoke Free Coalition and the entire e-vapor industry, yesterday Keller and Heckman LLP filed a 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:
- Right To Be Smoke Free Coalition (RSF –www.r2bsmokefree.org)
- American E-Liquid Manufacturing Standards Association (AEMSA – www.aemsa.org)
- American Vaping Association (AVA –http://vaping.info/)
- Electronic Vaping Coalition of America (EVCA – http://evapingcoalition.org/)
- Georgia Smoke Free Association (GSFA –http://www.gasmokefree.org/)
- Kentucky Vaping Retailers Association, Inc., d/b/a Kentucky Smoke Free Association (KSFA – http://www.kysmokefree.com/)
- Louisiana Vaping Association (LAVA)
- Maryland Vape Professionals, LLC (https://vape-professionals.myshopify.com/)
- Ohio Vapor Trade Association (OHVTA –http://www.ohvta.org/)
- New Jersey Vapor Retailers Coalition (NJVRC – http://www.njvaporcoalition.org/)
- Tennessee Smoke Free Association (TSFA –http://tnsmokefree.org/)
Also supporting the lawsuit are the Shenzhen E-Vapor Industry Association USA (SEVIA-USA -www.seviausa.org), the Smoke-Free Alternatives Trade Association (SFATA – http://sfata.org/), the Consumer Advocates for Smoke-free Alternatives Association (CASAA – http://casaa.org/) and NOT Blowing Smoke (http://notblowingsmoke.org/).
In the Complaint, the Industry argues 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 (defined as Electronic Nicotine Delivery Systems or 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 implementing 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, then 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 adult consumers – 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, among other things, 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 products 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 (i.e., 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. 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. Again,FDA substantially overestimates the benefits of the Deeming Rule and underestimates the costs. 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.
The State of Indiana recently adopted a law that could wipe out the e-liquid industry in that state and, if not taken off the books permanently, could create dangerous precedent for other states. Effective July 2016, the law prohibits e-liquid manufacturers, whether or not they are located in the state, from selling products to retailers and distributors in Indiana without a permit which requires compliance with expensive and burdensome manufacturing and security protocols that may be impossible to meet. Indiana vape shops will also be required to obtain a tobacco sales certificate and are prohibited from selling e-liquids where the manufacturer has failed to obtain a permit. Of most concern, the statute is aimed solely at e-liquids used in “open-system” products, while giving manufacturers of “closed-system” cigalikes a free pass.
Three e-liquid producers and an Indiana vape shop recently filed a lawsuit in federal district court challenging the statute on various constitutional grounds. Because it is absolutely critical for the court to understand that this statute poses a substantial risk to the entire e-vapor industry, as well as for an industry-wide association to take charge of advocacy efforts across the country, The premium e liquid company Cosmic Fog Vapors came together with Vapor Shark and Mt. Baker Vapor to form the Right to be Smoke-Free Coalition.
On May 24, 2016 the companies working with the Mulhaupt’s security firm filed a Motion to Intervene in our case and argued that we, the plaintiffs, be required to post a bond in case our preliminary injunction is granted. A similar motion was made by the permit holders in the parallel state court case filed by Hoosier Vapers. (In that case, the state court granted the permit holders’ motion to intervene and denied Hoosier Vaper’s motion for preliminary injunction, which made the bond request moot.)
In our response, we argue that the permit holders failed to satisfy the requirements necessary to intervene in our case because (1) they rely on unsupported, vague and conclusory allegations, (2) they did not comply with the procedural requirements to intervene pursuant to the Federal Rules of Civil Procedure, (3) their efforts are untimely, (4) they lack a cognizable legal interest to intervene, including the fact that the purposes underlying a bond requirement do not exist here, (5) we, the Right to be Smoke Free Coalition, will be substantially prejudiced, and (6) the State of Indiana has adequately represented the permit holders’ interests in this case. Instead, we make clear for the court that the permit holders seek to intervene for the inappropriate purpose of preventing us from exercising our constitutional rights and to make us post a bond because they chose to comply with an unconstitutional regulatory scheme, even though they were well aware of our lawsuit.
We are hopeful that the judge will deny their motion to intervene and grant our preliminary injunction, preventing the law from going into effect on July 1. We will keep you updated.
The Right to be Smoke-Free Coalition is currently in the trenches in the battle for Indiana, where e-liquids used in open-systems will be effectively be banned starting July 1, 2016. Defeating this law is critical not only for doing business in Indiana, but for setting precedent in other states. The situation in Indiana is critical for the entire industry. This is no longer about advocacy – it’s about survival. The law is already on the books and, in just a few short weeks, practically the entire e-liquid industry will be shut out of the state. Click here for the latest updates!
In July 2015, a group of e-liquid companies came together to form the Right to be Smoke-Free Coalition for the specific goal of challenging unconstitutional state and federal laws related to the e-vapor industry that are starting to pop up all over the country. The most egregious of these laws is HEA 1432 in Indiana, which will prohibit the sale of “unpermitted” e-liquid products used in refillable open-system devices starting June 30, 2016. When we discovered that parts of the law (e.g., the security firm certification and Indiana commercial kitchen code requirements needed to obtain a permit) are essentially impossible to comply with, we knew we had to take this to court. We would soon learn, however, that this was not a situation where the legislators were genuinely trying to protect the public safety and just weren’t familiar with vapor products. Rather, the Indiana law turned out to be completely driven by special interests in the casino and security industries trying to establish an e-liquid monopoly. .
In September 2015, the Coalition intervened in a lawsuit filed a few months before by Derb E-Cigs/Legato Vapors challenging the constitutionality of the Indiana law. In January, we deposed the Indiana Alcohol and Tobacco Commission (ATC) and got them to admit to several important facts; namely, that they were not aware of any security companies that would qualify under the law. On January 29, 2016, we filed our motion for permanent injunction and partial summary judgment, in which we argue that the Indiana law violates several provisions of the Constitution, including:
- The Dormant Commerce Clause of the Constitution Because It Regulates E-Liquid Manufacturing Activities Occurring Outside the State;
- The Due Process Clause of the Constitution Because There Are No Security Companies That Qualify Under the Statute;
- The Equal Protection Clause of the Constitution Because It Only Regulates Open System E-Liquid Manufacturers;
- The Indiana Constitution Because It Only Regulates Open System E-Liquid Manufacturer;
- The U.S. and Indiana Constitutions Because It Improperly Classifies E-Liquids As A “Tobacco Product” Under Indiana Law; and
- The U.S. and Indiana Constitutions Because It Only Regulates Retailers Selling Open System E-Liquids.
As a result of our deposition and lawsuit, those interests pushing the law realized that because of ATC’s admission, they weren’t going to be able to get ATC to certify any security firms – even though they were the ones that drafted the law! To get around this, they pushed an amendment to the law (now codified in HEA 1386) that would modify the certification requirements to allow only one security firm to qualify. That amendment has now been signed by the Governor of Indiana. Unless we win this lawsuit, that single security firm will be able to pick and choose who it does business with and who gets to sell e-liquid in Indiana. We understand they are no longer accepting clients.
The Right to be Smoke-Free Coalition is not just going to walk away from this and we will continue to fight court. But, we need your help. We are actively recruiting responsible e-liquid manufacturers and distributors to join the Coalition or contribute to the cause. The more reputable companies that join the Coalition, the less the financial burden will be for all members. Moreover it is critically important that the e-liquid industry come together in a broad coalition and make clear for the court that this law threatens the continued viability of this industry, both in Indiana and abroad.
The Coalition in also reviewing potential lawsuits in other states, as well as against FDA to be filed as soon as the Deeming Regulation is published, if we determine that is necessary.
On Wednesday April 13, 2016, the Right to be Smoke-Free Coalition filed its response to Indiana’s reply to our Motions for Summary Judgment and Permanent Injunction. Our response also addressed arguments raised in an amicus brief filed in support of the law by Indiana Vapor Company and Crown Liquors. In our response we address the points raised by the State and amici, and argue that they:
1. Failed to show that the Indiana statute only indirectly regulates e-liquid manufacturing outside of the state (we argue that, as a practical matter, the law directly regulates e-liquid manufacturing outside of Indiana in violation of the Commerce Clause of the Constitution);
2. Failed to identify a rational basis under the Equal Protection Clause of the Constitution (and the Indiana Constitution) for only regulating e-liquids manufactured for open systems, while exempting closed-systems (they only reason proffered by State, which is completely false, was that closed-system e-liquids are already regulated by FDA since most of those products are made by regulated tobacco companies);
3. Failed to cite a rational basis for regulating open system e-liquid as a “tobacco product” under the Indiana tobacco laws; and
4. Failed to cite a rational basis for only regulating retailers (i.e., vape shops) who sell e-liquid used in open systems.
Indiana has until April 20, 2016 to respond. We will keep you updated.
(1) Complaint – RSF Petition for Declaratory Judgment and Injunctive Relief
(2) Legal Brief – Memorandum in Support of RSF Motion for Partial Summary Judgment and Permanent Injunction
(3) RSF Response and Reply on Cross Motions for Summary Judgement