Photo of Azim ChowdhuryPhoto of Eric Gotting

The U.S. Seventh Circuit Court of Appeals ruled in favor of the Right to be Smoke-Free Coalition holding that portions of Indiana’s E-Liquid Law are unconstitutional as applied to out-of-state manufacturers

On January 30, 2017, the U.S. Court of Appeals for the Seventh Circuit issued its decision in Legato Vapors LLC et al. v. David Cook et al., No. 16-3071, striking as unconstitutional portions of Indiana’s Vapor Pens and E-Liquid Act (the Act) as it applies to out-of-state manufacturers.

Among other things, the Act prohibited the sale of “unpermitted” e-liquid products used in refillable open-system e-vapor devices starting June 30, 2016. Actually obtaining a manufacturing permit from the Indiana Alcohol and Tobacco Commission (ATC), however, was effectively impossible for out-of-state companies for several reasons; most critically, e-liquid manufacturers were required to (1) build facilities compliant with the Indiana Commercial Kitchen Code and (2) contract with a qualified third-party security firm to provide certain specific services (such as 24/7 video surveillance). For a security firm to qualify under the law, however, it must have a certified Rolling Steel Fire Door Technician and an Architectural Hardware Consultant under its employ – certifications not common in the security industry. Moreover, those certified employees had to be hired by July 2015, preventing future security companies from ever being able to comply. Indeed, the ATC determined that only one security firm in the country, located in Lafayette, Indiana, qualified under the law.

In September 2015, the Right to be Smoke-Free Coalition (the Coalition), a trade association of e-vapor companies represented by Keller and Heckman Partners Eric Gotting and Azim Chowdhury, intervened in a lawsuit challenging the Act. Among other things, the Coalition argued that the Act violated the dormant Commerce Clause of the United States Constitution, which prohibits extraterritorial legislation, by regulating e-liquid manufacturing activities that occur completely outside of Indiana. After their motions for preliminary injunction and summary judgment were denied by the Southern District of Indiana, the Coalition and co-petitioners Legato Vapors LLC et al. appealed to the Seventh Circuit. Oral arguments were heard in Chicago on December 8, 2016 and the decision issued on January 30, 2017.

Ruling in the Coalition’s favor, the appellate Court declared that the “unprecedented” application of the Act’s security provisions, clean room (kitchen code) requirements, and audit provisions as they relate to facility design and production processes to out-of-state manufacturers was clearly extraterritorial and a violation of the dormant Commerce Clause. Indeed, the Court stated that “with almost two hundred years of precedents to consider, our review of prior dormant Commerce Clause decisions has not revealed a single appellate case permitting any direct regulation of out-of-state manufacturing processes and facilities comparable to the Indiana Act.” The Court also noted that the Act directly regulates production facilities and processes of out-of-state manufacturers and “thus wholly out-of-state transactions.” It also “poses the clear risk of multiple and inconsistent regulations that would unduly burden interstate commerce.”

The Circuit Court reversed the district court’s grant of summary judgment to Indiana and remanded the case to the district court to declare the challenged provisions unenforceable against out-of-state manufacturers and to enjoin their enforcement against the Coalition and co-petitioners.

Co-petitioners Legato Vapors, Rocky Mountain E Cigs and Derb E Cigs were represented by D. Epstein and James A. Tanford of Epstein Cohen Seif & Porter LLP, and J. Gregory Troutman of Troutman Law Office PLLC.

Photo of Azim Chowdhury

Azim Chowdhury was interviewed in VB2B’s Winter Edition. Azim discussed current events in the e-vapor industry and what companies need to do in the face of rapid regulatory change.

  1. What are the different services Keller Heckman offers the business owners?

We are a regulatory law firm specializing in the U.S. Food and Drug Administration (FDA), European Union (EU), and global requirements for e-vapor products. Our expertise is in promoting, protecting, and defending products made by the spectrum of industries regulated by government agencies which, in the United States, now includes e-vapor products since FDA’s Deeming Regulation became effective on August 8, 2016. For over 50 years, Keller and Heckman has provided global legal counseling in the areas of regulatory law, litigation, and business transactions. With offices in Washington, D.C., Brussels, Paris, San Francisco, and Shanghai, the firm is a pioneer in the use of interdisciplinary approaches to problem-solving. Further details regarding our services and personnel can be found at www.khlaw.com. With respect to e-vapor products specifically, our comprehensive and extensive experience dealing with the regulation of food, drugs, medical devices, dietary supplements, and packaging before FDA and regulatory agencies around the world uniquely positions us to guide e-vapor companies through the Deeming Regulation and other requirements for various products. We currently represent e-liquid and device manufacturers and trade associations in matters of federal, state, and global regulatory compliance. We defend lawsuits, including class actions, against e-liquid companies. We are also currently representing the Right to be Smoke-Free Coalition and a number of industry trade associations in Federal district court in Washington, D.C., challenging aspects of the Deeming Regulation and the Tobacco Control Act. You can learn more about our e-vapor specific practice on our website at www.khlaw.com/evapor.

  1. Without exposing any confidential information or creating a conflict of interest, what types of companies in this industry do you represent? 

We represent a broad spectrum of e-vapor industry stakeholders, including ingredient suppliers, manufacturers (both e-liquid and devices), distributors and retailers, and trade associations of such companies located in the United States and around the world.

  1. What is the R2B foundation? How can businesses help support its cause?

In July 2015, a group of e-liquid companies came together to form the Right to be Smoke-Free Coalition—a non-profit, industry-led trade association of e-vapor businesses dedicated to promoting the interests of the industry, as well as for the right of vapers to be smoke-free. The specific goal of the Coalition is to legally challenge in court unconstitutional state and federal laws related to the vape industry. The first case that we took on for the Coalition was the unconstitutional e-liquid ban in Indiana. We are still fighting that battle in the 7th Circuit Court of Appeals. We are also challenging the approach FDA took in the Deeming Regulation in regulating vapor products.

Specifically, our position is that FDA’s treatment of vapor products, which is more onerous than cigarette products, violates the Administrative Procedure Act (APA), among other laws. Our main concern is that forcing all vapor products on the market today to go through the Premarket Tobacco Application (PMTA) process within 2 years (where each application is expected to cost hundreds of thousands if not millions of dollars), will result in a virtual ban of all products within 3 years. In short, this regulation will kill the industry. That is why we must come together now to fight this regulation and force FDA to take a more reasonable approach.

The FDA litigation is expected to cost between $1-2 million over the next couple of years (including appeals).  The Coalition is actively recruiting responsible vapor companies to join and contribute to the cause. The more reputable companies that join the Coalition, the less the financial burden will be for all members to fight these laws in court. In terms of contribution amounts, companies have donated between $5,000 and $50,000. But, any amount will help! You can join and contribute here: www.r2bsmokefree.org.

  1. What was going through your mind when you started R2B?

The original e-liquid companies that came together—Vapor Shark, Cosmic Fog Vapors, Mt Baker Vapor and NicQuid—recognized that there was a huge need for an industry-led coalition to challenge laws in court, particularly when the lobbying efforts to prevent such laws were unsuccessful. Indiana was the first example of this, but there are many other states with laws that may challenge, including California and Pennsylvania.

  1. What is your background of expertise? How many years have you been experienced in the field?

I have been practicing law for 10 years and am a Partner in Keller and Heckman’s food and drug law group, where I have been focusing on the e-vapor industry since 2009. Beyond my tobacco and e-vapor work, I advise domestic and foreign corporations in matters of FDA and international regulatory compliance. In particular, I assist companies in establishing clearances for food and drug additives and food-contact substances. I am also a frequent contributor to the Tobacco Reporter and the Food and Drug Law Institute’s (FDLI’s) Update magazine. I have edited and co-authored FDLI’s upcoming manual: Tobacco and Nicotine Delivery: Regulation and Compliance, 2nd Edition. I have also previously served on the Editorial Advisory Board of the Food and Drug Law Journal.

  1. What types of law can your firm practice for potentially interested readers?

We practice in a wide variety of areas of potential interest to your readers including: Advertising & Promotion, Business Counseling and Transactional, Chemical Control (REACH, TSCA), Environmental, Litigation, Product Safety, Telecommunications, Workplace Safety and Health, among other areas. Our full practice list can be found here: http://www.khlaw.com/areas.aspx.

  1. How many partners does Keller Heckman currently have, how many on staff? 

We currently have 41 Partners, 24 of which practice in our food and drug law group. In addition to our legal staff, we have about 20 in-house scientists who work closely with the firm’s attorneys on matters of technical complexity (including e-liquid toxicity assessments, for example).

  1. What are some of the obstacles manufacturers and retailers have to overcome to manufacture finished American vapor products for retail sale in the USA, while now under federal regulation?

Since the Deeming Regulation became effective on August 8, 2016, e-liquid and e-vapor products are now regulated by FDA as tobacco products. That means they are subject to a host of regulatory requirements including establishment registration, product listing, ingredient reporting, health document submissions, warning requirements and, most critically, premarket review via the Premarket Tobacco Product Application (PMTA).  Products on the market on the August 8 effective date can take advantage of a two-year grace period before the PMTA deadline on August 8, 2018. But, new products cannot enter the market today (post-8/8/16) without first getting PMTA authorization.

  1. What are some of the requirements, and the timelines, for manufacturers who had their products on the market before August 8, 2016?

FDA’s full Deeming compliance calendar is available here: http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM501016.pdf. For products that were on the market on August 8, 2016, here are the important deadlines:

  • Register facilities and submit product listings by December 31, 2016 for all U.S. establishments (this does not yet apply to foreign establishments, including Chinese manufacturers, but FDA has indicated it will propose a new rule to extend this requirement to foreign establishments).
  • Submit ingredient lists (i.e., product formulations) by February 8, 2017 (or by August 8, 2017) for small-scale manufacturers.
  • Submit health and safety studies (developed between June and December 2009) by February 8, 2017 (or by August 8, 2017 for small-scale manufacturers).
  • Submit PMTAs by August 8, 2018.
  • Have compliant labeling by May 10, 2018 (e.g., name and place of business, quantity of the contents, and “Sale only allowed in the United States” disclaimer), and the nicotine addiction warning by August 8, 2018.
  1. What are some of the scientific requirements of PMTA applications and how would you recommend manufacturers to go about obtaining such information about their products?

The Tobacco Control Act requires a PMTA to include the following:

  • full reports of all investigations of health risks;
  • a full statement of the components, ingredients, additives and properties, and principles of operation of the tobacco product;
  • a full description of methods of manufacturing and processing;
  • an explanation of how the product complies with any applicable tobacco product standards;
  • samples of the product and its components; and
  • specimens of proposed labeling.

FDA has issued a guidance document to assist manufacturers with preparing and submitting a PMTA, which is available here: http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM499352.pdf. The guidance details the information that should be submitted in order to meet the statutory criteria set forth above, and it further recommends the submission of particular additional materials (such as a cover letter and executive summary) that will assist FDA in the review of the submission. Of particular note, FDA has interpreted the provision regarding the “full reports of investigations of health risks” required under the Act to require submission of not only investigations that support the PMTA, but also any investigations that do not support, or are adverse to, the application. FDA further recommends that a PMTA provides information on both nonclinical and clinical investigations, including, but not limited to, any studies assessing constituents of tobacco or tobacco smoke, toxicology, consumer exposure, and consumer use profiles. In addition, FDA recommends that manufacturers provide information on (i) investigations concerning products with novel components, ingredients, additives or design features that are similar or related to those of the new tobacco product, and (ii) investigations concerning products that share novel components, ingredients, additives, or design features with the new tobacco product so that FDA may adequately assess the health risks of the product. The PMTA Guidance contains other detailed recommendations to assist manufacturers in making the required statutory showings, including general principles for scientific studies, product chemistry, nonclinical studies, and studies in adult human subjects.

  1. What would you say was the biggest hurdle you had to overcome throughout your venture as one of the partners of Keller Heckman?

The highlight of my career is actually not related to my food and drug or e-vapor practice, but to my pro bono work. A few years ago, I had the opportunity to assist a young boy and his family obtain asylum in the United States. It was a heartbreaking story—my clients had fled their home country of El Salvador because of the physical violence and threats of death they faced at the hands of the notorious, internationally-known criminal enterprise, the Mara Salvatrucha (MS-13). The gang had singled out my clients and an additional family member for refusing to join them, and actually murdered one of the brothers. Although asylum is rarely granted to the victims of gang-based violence abroad, the Executive Office of Immigration Review agreed that my clients’ case was distinguishable from other cases involving victims of gang violence. They are now productive U.S. residents and hope to become citizens.

  1. What’s the firm’s number one goal for the future?

Our goal is to continue to provide creative legal, scientific, and business solutions for our clients. We are here to help you grow your business, using both law and science.

  1. If you yourself could share one piece of advice with retailers what would it be?

Work with reputable suppliers who plan on doing their best to comply with the law itself (check IDs, no free samples, etc.) and help fund the litigation and lobbying efforts to change the law.

  1. If you had all of the vapor product manufacturers in America in one room, what would you say to them?

The industry must come together with one voice if it is going to survive. We are all on the same team.

     15. What are some new regulations or upcoming changes we can expect to see on the market in the  near future?

The Deeming Regulation is a “foundational” rule that gives FDA authority over deemed products, including e-vapor. There will be more regulations in the future covering, for example, advertising restrictions, Good Manufacturing Practices, online sales, and possible restrictions or prohibitions on the use of flavors. Those regulations would have to go through separate Notice and Comment Rulemaking processes and so are likely years away.

Photo of Azim ChowdhuryPhoto of Eric Gotting

On July 25, 2016, Keller and Heckman LLP, on behalf of the Right to be Smoke Free Coalitionand ten national and state e-vapor industry trade associations (the “E-Vapor Coalition”), filed a Motion for Summary Judgement in a lawsuitchallenging parts of the Tobacco Control Act (TCA) and the Food and Drug Administration’s (FDA’s) recently published “Deeming Rule” which, effective August 8, 2016, captures most e-vapor products as regulated tobacco products under the TCA. To review the motion and supporting brief, click here.

The named Plaintiffs in the E-Vapor Coalition lawsuit are the Right to be Smoke Free Coalition, the American E-Liquid Manufacturing Standards Association (AEMSA), the American Vaping Association (AVA), the Electronic Vaping Coalition of America (EVCA), the Georgia Smoke Free Association (GSFA), the Kentucky Smoke Free Association (KFSA), the Louisiana Vaping Association (LAVA), Maryland Vape Professionals (MVP), the Ohio Vapor Trade Association (OHVTA), the New Jersey Vapor Retailers Coalition (NJVRC) and the Tennessee Smoke Free Association (TSFA). Also supporting the lawsuit are the Shenzhen E-Vapor Industry Association-USA (SEVIA-USA), the Smoke-Free Alternatives Trade Association (SFATA), the Consumer Advocates for Smoke-Free Alternatives Association (CASAA) and NOT Blowing Smoke (NBS).

The E-Vapor Coalition lawsuit, which was filed on June 20, 2016 in the U.S. District Court for the District of Columbia, was consolidated with the lawsuit filed earlier in the same court, Nicopure Labs v. FDA, No. 1:16-cv-878 (D.D.C. 2016), on June 28, 2016. Following consolidation, the parties agreed to a briefing schedule that allowedNicopure Labs to file its Motion for Summary Judgment on July 8, 2016, and the E-Vapor Coalition to file a separate summary judgment motion on its unique counts on July 25, 2016 (while incorporating by reference all of Nicopure Labs’ arguments). FDA has until August 16, 2016 – eight days after the Deeming Regulation becomes effective – to respond to both motions. All briefing will be completed by September 8, 2016, and oral arguments have been scheduled for October 19, 2016 at 10:00 AM ET in Washington, D.C.

In its Motion for Summary Judgment, the E-Vapor Coalition argues that FDA’s authority over tobacco products is not unfettered, but circumscribed by the statute’s underlying purposes – which strike a careful balance between various policy issues. Specifically, the statute provides that adults must have continued access to tobacco products (i.e., FDA cannot ban or virtually eliminate such products from the marketplace), while at the same time prohibiting access to such products by underage consumers. Along similar lines, the TCA requires FDA to regulate in a flexible manner so that relatively safer products can be developed and commercialized while more dangerous ones are kept off the market. Any effort by FDA to deem additional tobacco products under the TCA must reflect these compromises.

During the rulemaking, FDA repeatedly acknowledged that using e-vapor products likely presents far less risk than smoking cigarettes, and that individuals switching from combusted tobacco products to e-vapor products may significantly reduce their harm. The agency also recognized that the availability of e-vapor products could potentially lead to increased smoking cessation rates in this country and ultimately reduce tobacco-related disease and death – another one of the primary purposes of the TCA. These conclusions are consistent with scientific research, both in the United States and abroad, finding that e-vapor products are substantially less risky than combustible tobacco products. See, for example, Public Health England’s recent report finding that e-vapor products are 95% less harmful than traditional cigarettes, which was followed by the Royal College of Physicians’ ground breaking reportlauding the public health benefits of e-vapor products.

Nevertheless, FDA chose to regulate e-vapor products in a manner that is even more stringent than its regulation of cigarettes. Resulting in what will be a virtual ban on many (if not all) vaping product categories is FDA’s decision to force vaping product manufacturers into a Pre-Market Tobacco Application (“PMTA”) process that was actually designed to prevent the introduction of relatively more harmful tobacco products to the market. Accordingly, PMTAs require, inter alia, long-term clinical studies which, as FDA concedes, do not yet exist. These longitudinal studies must focus on population-level effects, such as the impact of each e-liquid or vaping device on overall smoking initiation or cessation rates.

FDA’s approach also effectively writes out of the TCA one of the pre-market authorization pathways – the Substantial Equivalence (“SE”) Report – that Congress intended for FDA to use in a more flexible exercise of enforcement authority so that relatively less risky products, like e-vapor products, remain on the market and are available to adult consumers so long as they do not raise different questions of public health compared to a predicate (grandfathered) product. The SE Report pathway, while also imposing substantial informational requirements on manufacturers, does not necessarily require long-term clinical studies and, as such, is not as burdensome in terms of time and financial resources as PMTAs. However, without any grandfathered products available for use as predicates, all e-vapor products introduced after February 15, 2007 are forced to go through the PMTA process, which the agency admits will eliminate, at a minimum, 97% of the industry.

With no way to avail themselves of the SE Report pathway, for each vaping product on the market on August 8, 2016, manufacturers will have to file a PMTA within a two-year compliance period (i.e., by August 2018). Vaping product manufacturers will not have sufficient time over the next two years to conduct such long-term clinical studies or have the financial resources to meet other PMTA informational requirements that, according to the agency, will likely reach into the millions of dollars for each product application. Moreover, any new e-vapor products intended to be introduced after the effective date of the rule will have to first obtain PMTA authorization – essentially freezing the market on August 8, 2016.

Thus, instead of tailoring the pre-market process based on the type of tobacco product involved, the agency unlawfully adopted a “one-size-fits-all” pre-market regime that ignores e-vapor products’ overall lower risk profile. The E-Vapor Coalition’s motion highlights several of the Deeming Rule’s short-comings, specifically:

  • FDA has applied a statutory February 15, 2007 grandfather date to e-vapor products that was intended for traditional tobacco products, like cigarettes. FDA was required under the statute to set a new grandfather date which would allow e-vapor products to take advantage of the more flexible SE pathway
  • FDA did not consider, as required under the Regulatory Flexibility Act (“RFA”), 5 U.S.C. §§ 601, et seq., any significant alternatives that, in the absence of a new grandfather date, would have allowed vaping product manufacturers sufficient time to develop the extensive information, including long-term clinical studies, necessary to successfully navigate the more stringent PMTA process. As it stands now, such data cannot be generated by the PMTA deadline of August 2018.
  • Even if FDA is correct in that it must apply the February 15, 2007 grandfather date to e-vapor products, this means that the TCA itself violates substantive due process and is unconstitutional. Under this scenario, there would be no rational relationship between the TCA’s underlying purposes and the means chosen by Congress to accomplish such goals. Indeed, as FDA conceded during the rulemaking, virtually all manufacturers will exit the vaping market, thus depriving adults of a relatively safer tobacco product and a chance to reduce or, better yet, quit their smoking habits.

Accordingly, the E-Vapor Coalition has requested the court grant it summary judgment and: (1) declare that the Deeming Rule exceeds FDA’s statutory authority, is arbitrary and capricious, or an abuse of discretion under the Administrative Procedure Act with respect to FDA’s failure to either establish a new grandfather date for all deemed e-vapor products or exercise its enforcement discretion in this regard; (2) set aside the Deeming Rule to the extent that FDA has applied the February 15, 2007 grandfather date to e-vapor products, and remand the rule to FDA so that the agency can set a new grandfather date for all deemed e-vapor products consistent with the Court’s decision; (3) remand the rule to FDA so that the agency can conduct a proper regulatory impact analysis that addresses the lack of long-term clinical data for e-vapor products; and/or (4) declare the rule unconstitutional to the extent that it applies the February 15, 2007 grandfather date to e-vapor products.

For more information on the lawsuit and updates, visit www.r2bsmokefree.org. To learn more about Keller and Heckman’s e-vapor practice, visit www.khlaw.com/evapor.

Photo of Azim ChowdhuryPhoto of Eric Gotting

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.

For more information on the lawsuit and updates, visit www.r2bsmokefree.org. To learn more about Keller and Heckman’s e-vapor practice, visit www.khlaw.com/evapor.