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On March 27, 2018, a coalition of public health organizations including the Campaign for Tobacco-Free Kids, the Truth Initiative, the American Cancer Society and the American Academy of Pediatrics, among others, as well as several individual physicians (collectively the “NGOs”) filed a lawsuit in the United States District Court for the District of Maryland challenging the Food and Drug Administration’s (“FDA’s”) ability to extend the compliance policy deadlines for premarket authorization applications for deemed tobacco products (Case No. 8:18-cv-00883). On July 10, 2018, the NGOs filed a motion for summary judgment, available here.

The case challenges FDA’s August 2017 Guidance Document, Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule (the “Guidance”) which, among other things: (1) extended the deadlines for premarket applications for deemed tobacco products, such as e-liquids and vapor products, as well as cigars, hookah, and pipe tobacco; and (2) ended the one-year “sunset provision” in the initial compliance policy, permitting manufacturers to continue marketing deemed products that are the subject of timely filed premarket applications that have been accepted by FDA for scientific review.

The NGOs make three main arguments: (1) the Guidance unlawfully authorizes manufacturers to continue marketing newly-deemed tobacco products without obtaining the required FDA marketing order, contrary to the requirements of the Family Smoking Prevention and Tobacco Control Act (“TCA”); (2) the Guidance is an administrative “rule” and FDA issued it without providing the public notice and an opportunity to comment in violation of the Administrative Procedure Act (“APA”);[1] and (3) the Guidance is arbitrary and capricious because it provided inadequate justification for suspending premarket review and did not account for the public health cost of the continued marketing of unreviewed new tobacco products. The NGOs seek to have the Guidance vacated, which could prove disastrous for the vapor industry.

We summarize the NGO’s motion in more detail below.

Background on Premarket Authorization and FDA Compliance Policy for Deemed Tobacco Products

When the “Deeming Rule” became effective on August 8, 2016, the FDA extended its tobacco product authority to previously unregulated categories of products including, but not limited to, e-liquids and vapor products, as well as cigars, hookah, pipe tobacco and heat-not-burn products.[2] Deemed tobacco products are now subject to the Federal Food, Drug and Cosmetic Act (“FDCA”), as amended by the TCA, including, most critically, the requirement that all new tobacco products obtain FDA premarket authorization. A new tobacco product is any product introduced or modified after the February 15, 2007 “grandfather date”. Because there are no known grandfathered e-liquids or vapor products, all such products, including those that have been on the market for years, are required to obtain FDA marketing authorization through the onerous Premarket Tobacco Product Application (“PMTA”) process, which is separately being challenged by the vapor industry.[3]

In the preamble to the Deeming Rule, although it chose not to amend the grandfather date for deemed products, FDA included a “compliance policy” which effectively created marketing grace periods for newly deemed, finished tobacco products that do not have FDA premarket authorization.[4] Pursuant to the compliance policy, manufacturers were permitted to continue marketing e-liquids and vapor products in the U.S. that were on the market on August 8, 2016 until the end of the compliance period, at which time a PMTA would be due. Initially, this compliance period was only 24 months after the effective date of the rule, meaning PMTAs would have been due by August 8, 2018 for all vapor products.[5]

Further, the initial compliance policy created a marketing sunset period that permitted manufacturers of products for which premarket applications were submitted to continue sales for only an additional 12 months, pending FDA review of the applications. After that, if FDA had not yet ruled on an application, it would “consider, on a case-by-case basis, whether to defer enforcement of the premarket authorization requirements for a reasonable time period.”[6]  In other words, companies that submitted PMTAs for vapor products by August 8, 2018 would only be permitted to continue marketing the subject products until August 8, 2019, after which they would have to remove the products from the market while FDA reviewed the applications, no matter how long that would take, unless the Agency granted an exception.

However, in July 2017, FDA announced a new “comprehensive regulatory plan to shift the trajectory of tobacco-related disease, death” that, among other things, extended the premarket application compliance period for non-combustibles, including e-liquids and vapor products, until August 8, 2022. In other words, those products on the market as of August 8, 2016 can now remain on the market at least until August 8, 2022; after that date, only products that are the subject of PMTAs that have been accepted for review can remain on the market. FDA also eliminated the 12-month sunset period, allowing companies to continue marketing products while FDA reviews the PMTAs. FDA formalized the new deadlines in its August 2017 Guidance.

Argument No. 1: The Guidance’s authorization to continue marketing newly-deemed tobacco products without the required FDA marketing order is contrary to the requirements of the TCA.

The NGOs argue first that the Guidance is contrary to the mandates of the TCA.  They emphasize that the TCA directs that an FDA order authorizing a manufacturer to sell a new tobacco product “is required” before that product “may be introduced or delivered for introduction into interstate commerce.”[7] Therefore, the NGOs argue, both the Guidance’s extension of PMTA deadlines and its compliance policy effectively grant permission to market new tobacco products before FDA authorizes their sale, contrary to the TCA’s requirements.

The NGOs further note that the TCA requires that, “as promptly as possible, but in no event later than 180 days after receipt of a PMTA,” FDA “shall” issue an order that the new product may or may not be introduced.[8] The NGOs argue that this requirement renders the Guidance’s revised compliance policy unlawful because the policy permits the indefinite sale of new tobacco products without FDA ever having to complete premarket review.

The NGOs also address a defense likely to be invoked by FDA—that of “enforcement discretion,” the principle that, in the absence of statutory text to the contrary, executive agencies prioritize their own obligations, thereby reserving to their discretion the ability to effectively delay enforcement. The NGOs argue that the TCA does not grant FDA discretion to delay and that publishing a new policy that authorizes conduct Congress made unlawful is not within an agency’s enforcement discretion as the term is understood by courts.

Argument No. 2: The Guidance is a “rule” and FDA issued it without providing the public notice and an opportunity to comment in violation of the APA. 

Second, the NGOs contend that the Guidance is effectively a final rule and thus must undergo the procedural requirements of a rule, including the obligation to give the public notice of the proposed rule and an opportunity to make comments.[9]

The NGOs argue that the Guidance is a “rule” within the meaning of the APA because it affects the “rights and obligations” of stakeholders and “constrains the agency’s discretion.”[10] According to the NGOs, the Guidance creates a “right” to market products for several years without a marketing order from FDA and constrains FDA to engage in a premarket review or to bring enforcement actions against manufacturers marketing new products without first obtaining an order. The NGOs dismiss the Guidance’s disclaimer language that it is not “binding” by citing to case law stating that courts look at the “actual function and effect” of guidance over how it labels itself.

Argument No. 3: The Guidance is arbitrary and capricious because it provided inadequate justification for suspending premarket review and did not account for the public health cost of the continued marketing of unreviewed new tobacco products.

Continuing under the premise that the Guidance is a “rule” and thus a “final agency action” as those terms are defined by APA case law, the NGOs argue that the Guidance must be struck down because it is “arbitrary and capricious.”[11] An agency action is arbitrary and capricious under the APA if it is not the product of reasoned agency decision-making.

The NGOs maintain that FDA did not advance an explanation for the Guidance. Agencies must consider factors considered important by Congress when passing the law and other important aspects of the problem addressed by the statute (the TCA in this case).[12] Further, an agency must show that there are good reasons for a change in policy.[13] FDA published a press release before the Guidance explaining industry’s need for more time to comply with PMTA deadlines,[14] but the NGOs allege that the press release’s reasoning is vague and insufficient and therefore not persuasive.

Finally, the NGOs argue that the Guidance’s effect ultimately has a detrimental impact on public health, particularly youth. The NGOs assert that the detrimental effect to public health outweighs any advantage gained by the Guidance’s effects.

Potential Impact on the Vapor Industry

If successful, the NGO’s lawsuit, which paints an unfavorable, and inaccurate, portrait of a vapor industry bent on targeting and addicting minors could have a devasting impact for vapor companies. If the Guidance is vacated, for example, and the original compliance policy reinstated, vapor products without grandfathered status or premarket authorization, of which there are none, may have to be immediately removed from the market. This would not only be potentially devasting to the public health, as millions of vapers may go back to smoking cigarettes, but it would also put thousands of small companies out of business.

The case has been assigned to Judge Paul Grimm of the United States District Court for the District of Maryland. FDA’s response to the motion is due August 7, 2018. We will continue to monitor the progress of this lawsuit and will provide a summary of FDA’s response.

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[1] 5 U.S.C. § 551 et seq.; 5 U.S.C. § 553.

[2] Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 81 Fed. Reg. 28,974 (May 10, 2016).

[3] Alternative premarket authorization pathways exist through submission of Substantial Equivalence (“SE”) Reports and SE Exemption Requests, but those pathways require reference to a grandfathered or predicate tobacco product, and thus are not available for the e-liquids and vapor products.

[4] 81 Fed. Reg. at 28,978.

[5] 81 Fed. Reg. at 28,978.

[6] 81 Fed. Reg. at 28,978.

[7] 21 U.S.C. §§ 387j(a)(2), (c)(1)(A)(i).

[8] 21 U.S.C. § 387j(c)(1)(A).

[9] N.C. Growers’ Ass’n, Inc. v. UFW, 702 F.3d 755, 764 (4th Cir. 2012).

[10] Chrysler Corp. v. Brown, 441 U.S. 281, 302 (1979) (internal quotation omitted); McLouth Steel Prods. Corp. v. Thomas, 838 F.2d 1317, 1320 (D.C. Cir. 1988).

[11] 5 U.S.C. § 706(2)(A).

[12] Motor Vehicle Mfrs. Ass’n of US., Inc. v. State Farm Mut. Auto Ins. Co., 463 U.S. 29, 43 (1983).

[13] FCC v. Fox Television Stations, Inc., 556 U.S. 502, 515 (2009).

[14] FDA News Release, “Protecting American Families: Comprehensive Approach to Nicotine and Tobacco,” https://www.fda.gov/NewsEvents/Speeches/ucm569024.htm (July 18, 2017) (last accessed: 08/02/18).

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UST-2016

On February 2, 2018, U.S. Smokeless Tobacco Company LLC (UST), a wholly owned subsidiary of Altria Group, Inc., filed suit against the U.S. Food and Drug Administration (FDA), U.S. Department of Health and Human Services (HHS), HHS Secretary Alex Azar, and FDA Commission Scott Gottlieb in the U.S. District Court for the District of Columbia challenging FDA’s application of the Substantial Equivalence (SE) Report standard. (Case 1:18-cv-00251.) The suit follows on FDA’s recent Not Substantially Equivalent (NSE) determinations for UST’s Copenhagen Bold Wintergreen Flavor Packs (Copenhagen Bold), and the agency appeal order upholding the NSE determinations, which UST argues is arbitrary, capricious, and contrary to the Tobacco Control Act. You can download UST’s complaint here.

Pursuant to the Food, Drug and Cosmetic Act (FDCA), as amended by the Family Smoking Prevention and Tobacco Control Act (TCA), all new tobacco products must be authorized by FDA before entering the market via either the Premarket Tobacco Product Application, SE Report or SE Report Exemption pathways.[1] A “new” tobacco product is a tobacco product that was either introduced to the U.S. market after February 15, 2007 (the “grandfather date”), or, if it was already on the market as of that date, had any modifications made other than to its labeling (e.g., a change in any design, component, part, constituent, including a smoke constituent, or in the content, delivery, or form of nicotine, or any other additive or ingredient).[2]

The SE Report requires comparing the new product to a “predicate” product (e.g., a grandfathered product or a product that has already obtained SE marketing authorization). To be substantially equivalent, the new tobacco product must either (i) have the same (e.g., identical) “characteristics”[3] as the predicate tobacco product, or (ii) if it has different characteristics, the submission must demonstrate that the new product “does not raise different questions of public health”. In other words, even if the characteristics of the new and predicate products differ, FDA may still determine the new tobacco product is substantially equivalent, and thereby permit its marketing, if the differences in the characteristics do not implicate new or different public health concerns.

The Copenhagen Bold products are smokeless tobacco products that consist of mint flavored loose tobacco packaged in a mesh pouch, which is intended to be placed under the lip. The lawsuit explains that the Copenhagen Bold products contain the same loose tobacco that was marketed as loose tobacco as of February 15, 2007, and have the same packaging format (i.e., a mesh pouch) as other grandfathered UST smokeless tobacco products, but that used different loose tobacco. In other words, the specific loose tobacco and mesh pouch combination used in the new Copenhagen Bold products was not on the market as of the grandfather date.

The lawsuit centers on the legal standard for substantial equivalence under the TCA. UST argues that while the first prong of the SE definition requires a comparison between a new product and a predicate product, the second prong of the definition does not mention a predicate product, but instead requires a broader inquiry regarding the “public health” impact of the new product.

UST argues that rather than considering whether the new Copenhagen Bold products generally raise different questions of public health compared to other similar products that were on the market as of February 15, 2007, FDA’s SE review relied only on a characteristic-by-characteristic comparison of the new products to the identified predicate products. Furthermore, FDA’s NSE determination provided no explanation about how those characteristics (i.e., the mesh pouch) caused the new products to raise “different questions of public health.” FDA failed to identify what those “different questions” supposedly were.

Rather, UST claims that the use of the mesh pouch with the loose tobacco actually decreases the release of nicotine and certain carcinogens, without any increase in harmful constituents. Thus, the Copenhagen Bold products present no new health risks compared to moist smokeless products marketed as of February 15, 2007, and do not raise different questions of public health. Accordingly, in UST’s view, the new Copenhagen Bold products readily satisfy the second prong of the SE standard.

UST also takes issue with FDA’s fluctuating advice regarding predicate products. It points out that FDA has changed its position as to whether a company may rely on more than one predicate product in an SE application, and has restrictively required that a predicate product have the same “format” as the new product (e.g., requiring that a new product that is a pouch of tobacco be supported by comparison to a predicate product that also is a pouch of tobacco). UST also discusses that, through private communications during the SE review process, FDA introduced a new concept of a “surrogate product” that could be used to provide supplemental information about other legally marketed products that are like the new product, but was not a predicate product per se. Ultimately, however, the Agency did not consider information on the surrogate product, as it had indicated it would.

UST charges that, “[b]y failing to define either ‘same characteristics’ or ‘different questions of public health,’ by regulating through ad hoc decisions, punctuated with vague, inconsistent guidance documents, not to mention unreliable private advice, FDA has made the SE provisions of the TCA indecipherable to regulated entities like UST.”

In the view of UST, it is appropriate to assess the second prong of the SE standard by looking to the public health impacts of the relevant category of tobacco products as a whole on the grandfather date, and to determine whether the new product poses “different questions of public health” in type or magnitude from the known risks of the grandfathered products generally. If a comparison of new and predicate products indicates that they are the same (i.e., identical) with respect to material characteristics, the analysis should end with the first prong. Otherwise, the analysis should proceed under the second prong, and comparison should be made to the public health impact of grandfathered products falling into the same category of tobacco products as the new product, not just a comparison of the new product to a single identified predicate.

In summary, the UST suit requests the following main forms of relief:

a. Declare that the NSE orders and agency appeal order for the Copenhagen Bold products are arbitrary and capricious, not in accordance with law, all in violation of the Administrative Procedure Act and the TCA, because the orders misconstrue the SE standard;

b. Declare that the NSE orders and agency appeal order failed to give UST fair notice of the applicable SE standards, depriving UST of due process of law, in violation of the Constitution;

c. Vacate and set aside the NSE orders and the agency appeal order.

d. Remand the matter to FDA to apply the correct legal standard; and

e. Enter a permanent injunction restraining FDA from implementing or enforcing the NSE orders and agency appeal order.

The case has been assigned to Judge Emmet G. Sullivan of the District Court. He issued a standing order regarding the proceedings of the case on February 6, 2018. The government’s answer to the UST complaint has not yet been filed. We will keep updated on the progress of the lawsuit.

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[1]  21 U.S.C. § 387j(a)(1) and (2).

[2]  21 U.S.C. § 387j(a)(3)(A)(i)–(ii).

[3] Characteristics means the materials, ingredients, design, composition, heating source, or other features of the tobacco product. See FDA’s Guidance for Industry, Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions (Edition 3), available at https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM436468.pdf

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amicus

On February 20, 2018 several organizations filed amicus (“friend of the court”) briefs in support of Plaintiff-Appellants Nicopure Labs’ and the Right to be Smoke-Free Coalition’s appeal in the Deeming Rule challenge now pending in the U.S. Court of Appeals for the D.C. Circuit.

The Washington Legal Foundation (WLF) is a nonprofit, public-interest law firm and policy center dedicated to defending and promoting free enterprise, individual rights, limited government, and the rule of law. In particular, WLF has devoted substantial resources over the years to promoting the free-speech rights of consumers and merchants in the marketplace, appearing before many federal courts in raising First Amendment issues. WLF has actively litigated First Amendment limits on the Food and Drug Administration’s (FDA) authority to restrict manufacturer speech.  In its amicus brief, WLF argues that FDA’s regulation of the vapor industry unjustifiably restricts truthful, non-misleading speech in violation of the First Amendment. By requiring vapor product companies to obtain FDA’s preapproval of “modified risk” claims before communicating their products’ uncontested health and related benefits to prospective consumers, the Deeming Rule effectively bans legally protected speech. The Rule will also harm those members of the public trying to quit smoking, who have a right to receive truthful information about comparatively safer alternatives to combustible tobacco.  Download the full brief here.

NJOY develops, imports, and distributes e-cigarettes and other electronic nicotine delivery products, and is committed to helping adult smokers switch completely from combustible cigarettes to e-cigarettes.  Like WLF, NJOY’s amicus brief addresses the First Amendment issue, i.e., “a government-imposed gag order” that blocks NJOY from truthfully describing its products to consumers.  Specifically, NJOY argues that FDA’s MRTP preclearance requirement is an unconstitutional speech-licensing regime that silences e-cigarette manufacturers and perpetuates misinformation about the comparative health risks of e-cigarettes and combustible cigarettes, jeopardizing the health of millions of smokers. Download the full brief here.

The State of Iowa also filed an amicus brief because it felt “compelled to defend its strong interest in reducing the number of Iowans who smoke combustible tobacco products,” noting that Iowa advocates for a harm-reduction approach and that “the difference between combustible cigarettes and non-combustibles, like e-cigarettes, is dramatic”.  Iowa argues that the MRTP process places a roadblock in the path of public health advocates and frustrates harm-reduction objectives by requiring pre-market review of truthful, non-misleading modified risk claims – which are protected by the First Amendment.  While Iowa supports rules that require pre-market review of any modified risk claim offered for a combustible tobacco product, generalized modified risk claims for e-cigarettes are different because they are true – and the MRTP process undermines momentum towards critical harm reduction by effectively silencing them. Download the full brief here.

The Consumer Advocates for Smoke-free Alternatives Association (CASAA), a non-profit 501(c)(4) organization with an all-volunteer board and a grassroots membership, is dedicated to ensuring the availability of reduced harm alternatives to smoking and to providing smokers and non-smokers alike with honest information about those alternatives so that they can make informed choices.  CASAA submitted an amicus brief to provide helpful information to the Court about the importance of flavors and sampling in connection with consumers (a) receiving information about products and (b) making a successful transition from smoking to vaping.  The brief discusses the critical need for consumers to receive truthful information from manufacturers and retailers about the low-risk nature of vapor products.  Download the full brief here.

Last, but certainly not least, Clive Bates, Director of The Counterfactual and former Director of the UK’s primary anti-smoking non-profit Action on Smoking in Health, as well as additional public health advocates Philip Alcabes, Scott Ballin, Konstantinos Farsalinos, Bill Godshall, Jacques Le Houezec, Bernd Mayer, Jeff Nesbit, Joel Nitzkin, Riccardo Polosa, Sally L. Satel, Michael B. Siegel, Jeff Stier, and David Sweanor, submitted an amicus brief because of their concern that excessively burdensome or restrictive regulation of e-cigarettes by FDA will have unintended consequences, effectively protecting the combustible cigarette market, increasing smoking and causing harm to health. The authors argue that vaping is proving highly beneficial to the health of millions of American adults as a low-risk alternative to cigarette smoking – which has fallen rapidly and reached record lows since vaping was introduced.  FDA’s approach to regulating e-cigarettes failed to account for the likelihood of the risks of harmful unintended consequences arising from its own interventions in the e-cigarette market.  Indeed, the authors make clear that the costs of the current regulatory approach are likely to overwhelm the claimed benefits, and a failure to account for them undermines the Deeming Rule.  Download the full brief here.

FDA’s reply brief in the appeal is due by April 18, 2018. We will keep you updated on the progress of the appeal.

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r2bnicopure

On February 12, 2018, Nicopure Labs, LLC and the Right to be Smoke-Free Coalition[i] (the Appellants) filed their opening brief in the appeal of last year’s decision from the U.S. District Court for the District of Columbia, which ruled in favor of FDA in the first lawsuit challenging aspects of the Tobacco Control Act (TCA) and the Food and Drug Administration’s (FDA’s) Deeming Rule as they are being applied to the vapor industry. In the brief, the Appellants respectfully disagree with the lower court’s conclusions and believe that both the law and the facts compel a different result.

Specifically, Appellants argue that (1) the Modified Risk Tobacco Product (MRTP) provision of the TCA, as well as the ban on free samples of vapor products, violate the First Amendment of the U.S. Constitution, and (2) FDA was obligated to consider a less burdensome Premarket Tobacco Product Application (PMTA) process for vapor products while still protecting the public health. We summarize these issues in turn below, and you can download the full brief here.

1. Modified Risk Claims and Free Sample Ban

The MRTP provision in Section 911 of the TCA prohibits vapor companies from, among other things, representing without FDA authorization that their products: (i) present a lower risk of disease or is less harmful than another tobacco product; or (ii) contain a reduced level of, or is free from, a substance, or that exposure to a substance is reduced or eliminated.  In other words, this means that vapor companies require explicit FDA approval to tell adult consumers, for example, that their products do not contain certain substances (“no diacetyl” or “no allergens”), that they are unlike more dangerous cigarettes because they have “no tar” or produce “no combusted smoke,” and they pose less health risk to individuals than smoking cigarettes (as FDA itself has publicly stated numerous times). Obtaining such MRTP authorization is an incredibly onerous and expensive process (which no company has been able to achieve yet) that requires applicants to demonstrate that their product will:

(i) significantly reduce harm and the risk of tobacco-related disease to individual users; and

(ii) benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.

21 USC § 387k(g)(1). As to the latter “population effects” prong of the standard, applicants must establish not only the relative health risks of the subject product, but also the potential impact the product will have on overall tobacco use initiation and cessation. 21 USC § 387k(g)(4).

In reality, this imposes a prophylactic ban on MRTP claims and violates the First Amendment because it effectively prohibits truthful, non-misleading statements by vapor companies that convey information needed by adult consumers to make informed purchasing decisions and switch away from cigarettes to less risky vapor products. The First Amendment protects the rights of consumers in the marketplace to obtain product-related information so they can make educated decisions.

But vapor companies cannot make these claims without prior FDA approval and, in all likelihood, will never be able to because the Agency has never approved a claim under the stringent and cost prohibitive MRTP standard. As such, and as detailed in the brief, the MRTP process fails to meet the “intermediate scrutiny” standard required when the government regulates commercial speech.  Central Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n of N.Y., 447 U.S. 557 (1980).

Similarly, the free sample ban violates the First Amendment because it prohibits adult consumers from trying different vapor products and obtaining valuable information about a novel product category that will help them transition away from cigarettes. Sampling is an “expressive” act that is protected speech. As FDA conceded, sampling conveys information that allows consumers to make individualized choices and change their purchasing behavior. This is important where, as FDA also acknowledged, smokers may have a better chance of switching to vapor products if they can continually sample a variety of e-liquid flavors. Indeed, numerous consumer surveys and other data indicate that smokers rely heavily on flavor variability and the opportunity to try different e-liquids and devices when considering vaping as a substitute for deadly smoking. But, as set forth in the brief, neither Congress nor FDA demonstrated that the free sample ban survives intermediate scrutiny.

2. PMTA Process

Since the Deeming Rule took effect on August 8, 2016, the restrictions on vapor products have been even more onerous than combustible cigarettes, most of which are grandfathered and exempt from FDA’s premarket review requirements. While FDA’s announcement last year for a “comprehensive regulatory plan to shift trajectory of tobacco-related disease, death” acknowledged, among other things, the tobacco harm reduction potential of vapor products and extended the compliance policy deadline for PMTAs for pre-August 8, 2016 vapor products to August 8, 2022, the reality is that safety advances and innovation have been stifled, and the industry still faces effectively being banned in a few short years.

In this regard, it is critical to recognize that the TCA has an overarching goal of ensuring that adult smokers continue to have access to innovative, less risky tobacco products. Despite this, and even though the Agency acknowledged that forcing vapor products to complete a one-size-fits-all PMTA process would eliminate over 95% of manufacturers (along with product variety those companies supply), FDA failed to tailor the PMTA process to less risky vapor products.  Indeed, to date FDA has only approved one PMTA (which was not for a vapor product) and, as provided in the brief, Deeming Rule commenters submitted compelling evidence showing the PMTA will be time and cost prohibitive. FDA was obligated, therefore, not just to extend the filing deadlines, but to consider a less burdensome PMTA process for vapor products (e.g., one that does not require long-term, clinical or epidemiological studies for each vapor product) while still protecting the public health.

FDA’s reply brief is due by April 18, 2018. We will keep you updated on the progress of the appeal.

The Right to be Smoke-Free Coalition and Nicopure Labs are represented in the appeal by Keller and Heckman LLP Partners Eric Gotting and Azim Chowdhury. For more information on the lawsuit and to contribute to the appeal efforts, visit www.r2bsmokefree.org.

[i]  The Right to be Smoke-Free Coalition trade association members supporting the appeal include the American E-Liquid Manufacturing Standards Association (AEMSA), American Vaping Association (AVA), Georgia Smoke Free Association (GSFA), Kentucky Smoke Free Association (KYSFA), Louisiana Vaping Association (LAVA), Maryland Vape Professionals, LLC (MVP), New Jersey Vapor Retailers Association (NJVRA), Ohio Vapor Trade Association (OHVTA), Tennessee Smoke Free Association (TSFA), and the Shenzhen E-Vapor Industry Association (SEVIA).  For a full list of members see www.r2bsmokefree.org.

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On August 30, 2017, the Right to be Smoke-Free (RSF) Coalition, a non-profit, industry-led trade association of vapor businesses dedicated to advocating for reasonable and responsible laws and regulations, joined Nicopure Labs LLC in appealing the recent decision in Nicopure Labs, LLC and Right to be Smoke-Free Coalition et al. v. Food and Drug Administration et al., Civ. No. 1:16-cv-0878-ABJ to the U.S. Court of Appeals for the District of Columbia.  The lawsuit challenges aspects of FDA’s Deeming Regulation and the Tobacco Control Act as they are being applied to the vapor industry.  The RSF Coalition respectfully disagrees with the conclusions reached by the lower court and believes that both the law and the facts compel a different result.

While FDA’s recent announcement acknowledging the tobacco harm reduction potential of vapor products and extending the compliance policy deadline for Premarket Tobacco Product Applications (PMTAs) for pre-August 8, 2016 vapor products to August 8, 2022 is welcome news, the RSF Coalition believes that there remains much worth fighting for on behalf of the industry – which still faces effectively being banned in a few short years.

“There is no greater risk to public health than traditional combustible tobacco use-related morbidity and mortality”, said Scott Eley, RSF Coalition Director and Co-Founder of coalition member, NicQuid. “We believe vapor products can help make tobacco-related death and disease part of America’s past and not it’s future. While we fully support all efforts to prevent access to vapor products to kids, we would hate to see a future where FDA’s overly burdensome regulatory approach prohibits access to these products by adult smokers looking for an alternative to their tobacco addiction.”

Since the Deeming Rule took effect on August 8, 2016, the restrictions on vapor products have been even more onerous than combustible cigarettes, most of which are grandfathered and exempt from FDA’s premarket review requirements. Among other things, vapor companies today cannot legally introduce new products, or improve the safety and quality of their existing products, without FDA PMTA authorization; distribute free samples to adults; or make truthful statements about the relative safety of their products.

The RSF Coalition and Nicopure Labs are being represented in the appeal by Keller and Heckman LLP Partners Eric Gotting and Azim Chowdhury. For more information on the lawsuit and to contribute to the RSF Coalition appeal efforts, visit www.r2bsmokefree.org.

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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.