Photo of Azim ChowdhuryPhoto of Eric Gotting

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.

Photo of Azim ChowdhuryPhoto of Adam Susser

Committee on the Review of the Health Effects of Electronic Nicotine Delivery Systems Releases Report Documenting Massive Review of Existing Scientific Literature

On January 23, 2018, the National Academies of Sciences, Engineering and Medicine (hereinafter referred to as the “National Academies”) Committee on the Review of the Health Effects of Electronic Nicotine Delivery Systems (ENDS) (hereinafter referred to as the “Committee”) released a report entitled, “Public Health Consequences of E-Cigarettes” (hereinafter referred to as the “Report”).[1] The Report, which was the result of the Committee’s review of over 800 articles identified from a massive literature search of six different databases, noted that the Committee found sufficient literature to suggest that, “while there are risks associated with e-cigarettes, compared with combustible tobacco cigarettes, e-cigarettes contain fewer toxicants; can deliver nicotine in a manner similar to combustible tobacco cigarettes; show significantly less biological activity in a number of in vitro, animal, and human systems; and might be useful as a cessation aid in smokers who use e-cigarettes exclusively.”[2] In sum, the Report acknowledges that vaping is significantly less harmful than smoking traditional combustible tobacco cigarettes

Background on the Report
The Consolidated Appropriations Act of 2016 included language directing the Center for Tobacco Products (CTP) of the U.S. Food and Drug Administration (FDA) to “contract with the Institute of Medicine to conduct an in-depth evaluation of available evidence of health effects from e-cigarettes and recommendations for future federally funded research.”[3] CTP contracted with the National Academies to convene an ad-hoc committee to conduct this evaluation, which resulted in the creation of the Committee. The Committee’s literature review included an analysis of data on both short-term and long-term health effects in: (1) users of ENDS, including health effects associated with the use of these devices (e.g., cigalikes, tank systems, mods); (2) vulnerable populations of users (e.g., youth, pregnant women, individuals with underlying medical conditions (e.g., heart disease, pulmonary disease); and (3) non-users of ENDS exposed to second-hand and third-hand aerosol generated by use of these devices.[4]

The Report Concludes That Vapor Products Are Less Harmful Than Combustible Tobacco Cigarettes
Perhaps the most significant aspect of the Report is the Committee’s implicit and explicit conclusion that e-cigarettes are safer than combustible tobacco cigarettes. Although the Report is more cautious than the Royal College of Physicians Report,[5] the Committee nevertheless acknowledged that the “current evidence points to e-cigarettes being less harmful than combustible tobacco cigarettes.”[6]

Moreover, several of the Report’s findings bolster the Committee’s conclusion that e-cigarettes are less harmful than combustible tobacco cigarettes. For example, the Committee found “conclusive evidence that completely substituting e-cigarettes for combustible tobacco cigarettes reduces users’ exposure to numerous toxicants and carcinogens present in combustible tobacco cigarettes.”[7] Indeed, all cross-sectional and longitudinal studies comparing exposure to nicotine and toxicants in smokers who substituted e-cigarettes for their combustible cigarettes, showed that smokers who substitute e-cigarettes for their combustible cigarettes had significantly reduced levels of biomarkers of exposure to potentially toxic chemicals.[8] Similarly, the Committee observed that “although some studies found similar harm from e-cigarettes, no studies found that e-cigarettes were more harmful than combustible tobacco cigarettes among combustible tobacco cigarette smokers who switched to exclusive e-cigarette use.”[9]

Further, the Committee concluded that there was “substantial evidence that completely switching from regular use of combustible tobacco cigarettes to e-cigarettes results in reduced short-term adverse health outcomes in several organ systems.”[10] In addition, studies reviewed by the Committee showed that use of an e-cigarette in indoor environments may involuntarily expose non-users to nicotine and particulates, but such exposure is at lower levels compared with exposure to secondhand tobacco smoke from combustible tobacco cigarettes.[11] The Report also noted that, “among dual users, e-cigarettes may help maintain smoking reduction.”[12]

At the same time, the Report notes that “the proportion of U.S. adults who consider [e-cigarettes] to be as harmful as combustible tobacco cigarettes has increased over time,” indicating that the public needs information related to the relative harm of e-cigarette products.[13] However, the “modified risk” provisions of the Tobacco Control Act (the “Act”) prohibit vapor companies from making truthful claims that their products present reduced-risk compared to combustible cigarettes, or even that their products do not contain or produce smoke or tar, without submitting an extensive application and securing FDA’s approval to make such claims.[14] Indeed, the modified risk standard is so stringent that it is highly unlikely any such claim will ever be approved for a vapor product.[15]

Accordingly, an unintended consequence of FDA’s approach to implementing the Act may be the proliferation of misinformation concerning the relative risks of vapor products and combustible tobacco cigarettes.[16]

Youth Use of E-Cigarettes
A frequent area of concern for courts[17], FDA, and public interest groups involves the use of e-cigarettes among youth.  As background, the Committee notes that the “proportion of youth who reported ever using e-cigarettes varies substantially across surveys” from as low as 10.7 percent to as high as 27.1 percent.[18] The Committee indicates that “early results suggest” that e-cigarette use “stabilized or decreased in youth between 2015 and 2016, despite increases between 2011 and 2015 across a range of surveys.”[19] Among those who reported having ever used an e-cigarette, youth most commonly reported using rechargeable/refillable tank-style devices, with more than half (53.4 percent) of middle and high school students reporting using only this kind of device.”[20]

In its consideration of the impact of e-cigarette use on “ever-use” of combustible tobacco products, which critically, is defined as smoking a single cigarette at any point in one’s life, the Report considers two dueling hypotheses (i.e., the diversion hypothesis and the catalyst hypothesis).  The Committee explains that e-cigarettes could have a preventive effect if the diversion hypothesis – the hypothesis that because some youth possess an elevated drive to engage in exploratory or risk-taking behavior, the availability of e-cigarettes allows such young people to satisfy their curiosity and drive for novelty without resorting to combustible tobacco cigarettes – is proven. Similarly, if the catalyst hypothesis – the hypothesis that e-cigarettes attract low risk teens who would not otherwise try combustible tobacco cigarettes and, once these teens have tried e-cigarettes, they are more likely to try combustible tobacco cigarettes – holds, e-cigarette use would increase the risk of ever-smoking.[21] Of course, e-cigarette use may also have no effect on combustible tobacco cigarette ever use in adolescents and young adults.

Keeping in mind the definition of “ever-use” noted above (i.e., smoking a single cigarette at some point) the Committee concluded, among other things, that “there is substantial evidence that e-cigarette use increases the risk of ever using combustible tobacco cigarettes among youth and young adults.”[22] While news headlines across the world ran with this conclusion to claim that e-cigarettes “lure” kids into smoking, the Report also observes that “the population-based data broadly show opposing trends in e-cigarette and cigarette use prevalence across time among U.S. youth in recent years and thus do not provide confirmatory evidence of the epidemiologic person-level positive associations of vaping and smoking.”[23] In this regard, we note that the National Youth Tobacco Survey data shows that youth smoking rates have been falling rapidly.[24] Between 2011 and 2016, current use of cigarettes by high school students fell from 15.8 percent to 8.0 percent, and use of cigars and pipes also fell.

Implications of the Report
Ultimately, the Report is the most complete analysis of existing research on the public health consequences of e-cigarettes in the United States. Further, the Report provides the imprimatur of the National Academies on a conclusion long recognized by the vaping community: e-cigarettes are significantly less harmful than combustible tobacco cigarettes.

 

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[1] National Academies of Science, Engineering and Medicine: Committee on the Review of the Health Effects of Electronic Nicotine Delivery Systems, The Public Health Consequences of E-Cigarettes (eds. Kathleen Stratton et al., 2018), available at https://tinyurl.com/ya4w37kb (hereinafter, referred to as the “Report”).

[2] Report, supra n.1., at S-9.

[3] Id., supra n.1., at 1-1, 1-2 (Box 1-1 Statement of Task).

[4] Id., supra n.1., at S-9.

[5] Tobacco Advisory Group of the Royal College of Physicians, Nicotine Without Smoke: Tobacco Harm Reduction (2016), at 87, available at https://tinyurl.com/h5ypa7s (stating, “although it is not possible to precisely quantify the long-term health risks associated with e-cigarettes, the available data suggest that they are unlikely to exceed 5% of those associated with smoked tobacco products, and may well be substantially lower than this figure.”).

[6] Report, supra n.1., at 18-23.

[7] Id., supra n.1., at 18-13; See also Id., at 5-32 (“Conclusion 5-3. There is substantial evidence that except for nicotine, under typical conditions of use, exposure to potentially toxic substances from e-cigarettes is significantly lower compared with combustible tobacco cigarettes.”) (emphasis in original).

[8] Id., supra n.1., at 18-13.

[9] Id., supra n.1., at 18-23.

[10] Id., supra n.1, at 18-24.

[11] Id., supra n.1., at 18-28.

[12] Id., supra n.1., at 18-25.

[13] Id., supra n.1., at 18-2.

[14] 21 U.S.C. § 387k.

[15] FDA may issue a modified risk order only after the manufacturer makes numerous showings based on scientific data.  Specifically, the applicant must demonstrate that the product will:

  • significantly reduce harm and the risk of tobacco-related disease to individual users; and
  • 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) (emphasis added).  As to the “population effects” prong of the standard, FDA must consider:

  • relative health risks of the subject tobacco product;
  • likelihood that those who do not use tobacco products will start using the subject product (e., initiation); and
  • likelihood that users who would otherwise stop using tobacco products will start using the subject product (e., cessation)

21 USC § 387k(g)(4).

[16] See Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, 123 Stat. 1776 (2009) (hereinafter referred to as the “Act”); See also 21 U.S.C. § 387k.

[17] See e.g., Discount Tobacco City & Lottery, Inc. v. United States, 674 F.3d 509(6th Cir. 2012), (finding a “substantial state interest in curbing juvenile tobacco use that can be directly advanced by imposing limitations on the marketing of tobacco products.”).

[18] Report, supra n.1., at 1-3 (compare the Population Assessment of Tobacco and Health (PATH) survey (Wave 1 in 2013-2014) finding only 10.7% of youth ages 12-17 reporting ever using an e-cigarette once or twice with the National Youth Tobacco Survey finding that 27.1% of middle and high school students ever used e-cigarettes.).

[19] Id., supra n.1., at S-1, 2.

[20] Id., supra n.1., at 1-5.

[21] Id., supra n.1., at 16-3.

[22] Id., supra n.1., at 16-30 (emphasis added).

[23] Id., supra n.1, at 16-28; See also Sheila Kaplan, Vaping Can be Addictive and May Lure Teenagers to Smoking, Science Panel Concludes, The N.Y. Times (Jan. 23, 2018), available at https://tinyurl.com/y86naj7u.

[24] Jamal A, Gentzke et al. Tobacco Use Among Middle and High School Students — United States, 2011–2016, 66 MMWR Morb Mortal Wkly Rep. No. 23, at 597-603 (June 16, 2017), available at https://tinyurl.com/y8ce2w9a.

 

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At its 2nd Annual E-Vapor and Tobacco Law Symposium today in Irvine, California, Keller and Heckman announced its latest law blog, The Continuum of Risk.  Learn more about the blog here.  We will be providing all our Client Alerts and relevant industry information through this blog, and encourage you to stay connected by subscribing on the right under “Subscribe By Email” (good news – if you are receiving this email you have been automatically subscribed).

Check out Keller and Heckman’s other blogs: Beyond Telecom Law Blog, Consumer Protection Connection, and The Daily Intake.

 

Photo of Azim Chowdhury

This interview originally appeared here: https://www.cyclopsvapor.com/blog/qa-with-azim-chowdhury-pRight to be Smoke-Free artnerfda-group-tobacco-evapor-food-packaging-at-keller-and-heckman-llp/

Azim Chowdhury is nationally recognized as an expert on FDA issues as they relate to the tobacco and e-vapor industries. He represents tobacco, e-cigarette and e-liquid manufacturers, suppliers and trade associations in matters of FDA regulatory and corporate compliance, and spearheaded Keller and Heckman’s FDA tobacco and e-cigarette practice group. Keller and Heckman LLP, founded in 1962, has a broad practice in regulatory law and related litigation and business transactions. Keller and Heckman’s comprehensive and extensive experience dealing with the regulation of food, drugs, medical devices and dietary supplements before the FDA uniquely positions the firm to guide tobacco, e-cigarette and e-liquid companies through the myriad of statutory and regulatory requirements that will soon be applicable to these products.

In the anticipation of Keller and Heckman’s *2018 E-Vapor and Tobacco Law Symposium, spoke with Chowdhury about what to expect at the second annual event.

For our readers who don’t know, can you talk a little bit about how you got into vaping law/education as a specialty?

The first time I came across a vapor product was back in 2009. While shopping at the mall, I came across a kiosk selling Smoking Everywhere cigalikes. I had been practicing law for a few years at that point and was focusing on medical devices and FDA regulations. I was immediately intrigued by the so-called “electronic cigarettes,” and started researching. When and how FDA was going to regulate vapor products was very much uncertain — the Tobacco Control Act had just become law, giving FDA the authority to regulate tobacco products, but the agency had already come out against e-cigarettes (the first time) arguing that they were unauthorized drug delivery devices. I wrote one of the first law articles on what FDA might do and how it would impact the burgeoning vapor industry for the Food and Drug Law Institute’s Update magazine (which you can findhere). I continued to write articles following the Sottera lawsuit, began speaking at conferences and attending vape expos, edited a couple of books, and quickly came to be recognized as a legal expert on vapor products.

In March 2010, I joined Keller and Heckman, a firm best known for its nationally-ranked FDA practice that includes lawyers as well as scientists, and spearheaded the E-Vapor Law Practice here. Now, we represent dozens of vapor businesses in the U.S. and around the world, including trade associations, manufacturers, suppliers, distributors and retailers in matters of federal, state and global regulatory compliance, as well as litigation, business and intellectual property issues.

This year is the second E-Vapor and Tobacco Law Symposium. Can you talk about how this year’s agenda came into play and how it changed from last year’s?

Last year we launched the inaugural E-Vapor and Tobacco Law Symposium from our offices in Washington, D.C. It was an experiment to see how this industry, which is mostly used to vape expos, trade shows and advocacy events, would react to a legal training seminar. Keller and Heckman’s well-established food, packaging and environmental practices have a long history of hosting these types of seminars, so this is right up our alley. Because the Deeming Rule had just become effective, we knew it was the right time to bring this type of event to the vapor industry to help companies understand how to stay in compliance.

With the success of last year’s Symposium, we decided to take the event “on the road” to Irvine, Calif., to reach a broader audience and make it easier for businesses on the West Coast to attend. With all the changes with the new administration, a new FDA commissioner and new policies that seem to indicate a shift in the agency’s view of these products (we hope), we are covering a lot more material at this year’s event. In addition to our Keller and Heckman experts, we are particularly excited for our guest speakers, several coming from overseas, who will be presenting on topics including good manufacturing practices, state laws, EU and UK laws, and vapor device standards.

Stepping further into that, what are some of the biggest challenges that vapers and business owners need to be aware of this year?

Companies must understand that even though the deadline for premarket applications for products on the market today has been delayed until 2022, the Deeming Rule is still in effect, and there are several fast-approaching deadlines for requirements such as ingredient reporting and HPHC testing that companies need to comply with in the meantime. We are expecting FDA to ramp up enforcement and inspections of facilities, so being prepared for that is critical. We will also be addressing the elephant in the room — Premarket Tobacco Product Applications (PMTAs) — and how companies might be able to work together to save money and submit applications to FDA.

Beyond FDA, more states are passing legislation impacting this industry, including new taxes and licensing requirements. Much of this will be covered at the Symposium. We are also seeing more companies get notices from state environmental regulators regarding how they are storing and disposing of nicotine and other hazardous chemicals. We think that is going to be a big issue in 2018 and moving forward.

Finally, if you’re looking to expand your business beyond the U.S. to the EU or Asia, we are going to have a lot of great presentations on how to do that.

Have there been any wins within the law that you’ve seen for our industry?

There have been a lot of victories at the state level by advocacy organizations such as SFATA, VTA and the Smoke-Free Associations fighting for vaper’s rights. We also had a huge victory last year on behalf of the Right to be Smoke-Free Coalition in Indiana, where we got the Seventh Circuit Court of Appeals to strike down the unconstitutional parts of Indiana’s e-liquid law (seehere). The industry should also consider FDA’s extension of the PMTA deadline as a victory that resulted from everyone’s lobbying efforts, as well as the threat from the lawsuits.

One topic we will be discussing at the Symposium is the appeal of the Nicopure and Right to be Smoke-Free challenge to the Deeming Rule, and how companies can still help with that effort.

The symposium schedule is jam packed and really looks like a must-attend event. Can you talk further about the importance of this two-day event?

I do believe this is a must-attend event for businesses who truly are interested in complying with the law and staying around for the long-term. This will also be a great opportunity to network with Keller and Heckman attorneys and other experts, as well as with other businesses. So far, we have over 100 registered attendees that include some of the biggest names in the industry, but also a lot of smaller companies who are looking to do things the right way.

*Seating is limited, but it is still not too late to register! Keller and Heckman is also exploring options for next year’s Symposium, and may take it to the Midwest or back to the East Coast.

Photo of Azim ChowdhuryPhoto of JC Walker

Beyond the Food and Drug Administration (FDA) and Tobacco Control Act requirements that now apply to deemed tobacco products, manufacturers and retailers of vapor products, and particularly e-liquids, also face stringent environmental and waste management regulations and compliance issues that are significantly more complex than those faced by cigarette and traditional tobacco product companies. This dichotomy arises because regulations promulgated pursuant to the federal Resource Conservation and Recovery Act (RCRA) treat nicotine in tobacco-based products differently than when found in e-cigarettes and other vaping products.

Compliance with the waste management regulations can be confusing because their scope and extent will vary by the amount of waste nicotine produced at a manufacturing facility or the amount of nicotine-containing products collected for disposal by a retailer. Further complicating the issue, even if exempted from the RCRA regulations, certain nicotine-containing products may be subject to state regulation of nicotine as a dangerous or industrial waste. Although there have been few enforcement actions brought against vapor or e-liquid manufacturers or retailers, regulators have noted the industry’s growth and potential for noncompliance. Going forward, we expect regulators to focus less on educating the industry about waste management obligations and follow a more active enforcement approach.

RCRA Overview

The federal RCRA regulations and state analogues establish a comprehensive system for managing hazardous waste from “cradle to grave,” that is from the point the waste is generated until its ultimate disposal. Broadly speaking, the regulations prescribe how to determine if and when a material is regulated as a hazardous waste, and how to manage the waste once the determination is made. Critically, RCRA only applies when the material becomes solid waste, meaning that it has been discarded by being abandoned, recycled, or treated as “inherently-waste like,” or the decision to discard has been made.[1]

Having decided to discard a material, the waste generator must next determine whether the waste is hazardous. This is done in one of two ways: (1) does the waste contain materials that EPA has listed in one of the three hazardous waste lists codified at 40 C.F.R. Part 261, subpart D; or (2) does the waste exhibit one or more of four characteristics: ignitability, corrosivity, reactivity, or toxicity?[2] With regards to e-liquids and other nicotine-bearing products, certain unused chemicals are listed hazardous wastes when discarded.[3] The hazardous waste listing applies when the following three criteria have been met. First, the chemical must be listed at 40 C.F.R. § 261.33(e) or (f). Nicotine and its salts are listed at 40 C.F.R. § 261.33(e) as an acute hazardous waste with the P075 waste code. Second, the listing applies “if and when they are discarded or intended to be discarded” prior to use.[4] Given its intended function, nicotine in e-cigarettes is not used until it has been inhaled by the end user.

Third, the listed chemical must be discarded in the form of a “commercial chemical product or manufacturing chemical intermediate having the generic name of the listed chemical” (CCP). The term CCP refers to a chemical substance which is manufactured or formulated for commercial or manufacturing use and which consists of the commercially pure grade of the chemical, any technical grades of the chemical that are produced or marketed, all formulations in which the chemical is the sole active ingredient, and any off-specification forms of the foregoing chemicals.[5] Products with more than one active ingredient are not regulated as CCP, although they may still be regulated hazardous wastes if they exhibit one of the hazardous characteristics.

According to the U.S. Environmental Protection Agency (EPA), nicotine is the “sole active ingredient” in e-cigarettes because it is the “only chemically active component that performs the function of the product.[6] Flavorings, sweeteners, colorants and other components are considered inert ingredients. Consequently, raw material (i.e., nicotine), off-spec e-liquids, container residues, and spill residues are hazardous wastes when they are discarded or intended to be discarded from businesses. In addition, EPA has stated that because certain e-cigarettes contain cartridges that are containers of a CCP, they too must be treated as hazardous waste when disposed.[7] This also applies to tanks and pods used in open-systems and advanced vaporizers to hold the nicotine-containing e-liquid.

RCRA Requirements Depend on Quantity

Hazardous waste compliance requirements vary significantly under RCRA depending on the amount of hazardous waste a facility generates each month. Thus, the generator category of a company and commensurate requirements, including storage and accumulation, recordkeeping and reporting, and training requirements could change from month to month.[8] Keeping up with these changes and ensuring a facility complies can be particularly burdensome for small businesses, such as those that constitute a large portion of the vapor industry.

Nicotine’s status as an acute hazardous waste is likely the primary driver for determining the “generator” category for an e-liquid or vapor product manufacturer. Businesses that generate acute hazardous waste (“generators”) are categorized as very small quantity generators (VSQGs) when generating up to 2.2 pounds (1 kilogram) per month, and large quantity generators (LQGs) when generating more than 2.2 pounds per month.[9] Regulatory requirements are significantly greater for LQGs, as is clear from a guidance chart developed by EPA.[10] Thus, e-liquid manufacturers have a strong incentive to operate as VSQGs or small quantity generators (SQGs).

When a generator has multiple hazardous waste streams, the generator must quantify each waste stream separately and abide by the more stringent generator category.[11] An e-liquid manufacturer will be classified as an SQG if the manufacturer does not exceed the 2.2 pound per month threshold for acute hazardous waste but generates greater than 100 pounds of non-acute hazardous waste per month.[12] For example, a generator of up to 2.2 pounds of acute hazardous waste that crossed the 220 pound threshold for non-acute hazardous waste may need to comply with SQG requirements, as opposed to VSQG requirements.

Fortunately, a generator has some options for managing hazardous wastes: recycling, treatment, storage, or disposal. Each approach has its own implications and requirements under RCRA. Recycling (e.g., nicotine reclamation) is a management method that can have a meaningful impact on the standards applicable to hazardous waste generators. Provided that the company can demonstrate the recycling is legitimate, the reclaimed nicotine will not be considered solid waste.[13] Recycling is a particularly appealing option as it can reduce the amount of material counted as hazardous waste for purposes of determining the generator category.

E-liquids May Be an Increasing Focus for Enforcement

Compliance with RCRA requirements by vapor product and e-liquid manufacturers is an increasing area of emphasis for both the states and EPA. Thus far, states have focused on outreach to the industry regarding compliance measures.[14] Such outreach typically lasts from six months to a year to provide a chance for the industry to come into compliance before the agencies transition to enforcement. Given that the e-cigarette and vaping industries have been growing for several years, and that the past two years have seen an increase in state proposals and communications concerning this issue, industry members need to consider whether regulators will pursue a more aggressive enforcement agenda in the new year and going forward. Accordingly, e-cigarette and e-liquid manufacturers should evaluate their processes and potential impact on generator status to determine whether their facilities are complying with RCRA or state analogues.

To learn more about the environmental and hazardous waste management regulations that apply to your e-liquid or vapor business, be sure to attend our upcoming E-Vapor and Tobacco Law Symposium on February 6-7, 2018 in Irvine, California. Click here to register and for more information.

For more information on our Tobacco and E-Vapor Practice, visit www.khlaw.com/evapor. For more information on our Environmental Practice, visit www.khlaw.com/Environmental. Follow Keller and Heckman Tobacco and E-Vapor Partner Azim Chowdhury on Twitter.

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[1] 40 C.F.R. §§ 261.2(a), 261.33.
[2] 40 C.F.R. §§ 261.20-261.24.
[3] See 40 C.F.R. § 261.33.
[4] 40 C.F.R. § 261.33. See also EPA Letter to Merck Sharp & Dohme, FaxBack #11012, May 13, 1981.
[5] 40 C.F.R. § 261.33(b)
[6] Letter from Barnes Johnson, EPA, to Daniel K. DeWitt, Warner, Norcross & Judd LLP (May 8, 2015), RCRA Online #14850.
[7] Id.
[8] Recent revisions to the regulations do provide some relief to companies that consistently qualify under one category but experience an episodic event that shifts them to a more burdensome one. The rules generally limit the facility to one episodic event, however. See Hazardous Waste Generator Improvements Rule, 81 Fed. Reg. 85,732 (November 28, 2016).
[9] 40 C.F.R. § 262.13.
[10] U.S. EPA, “Hazardous Waste Generator Regulatory Summary,” available at:https://www.epa.gov/hwgenerators/hazardous-waste-generator-regulatory-summary.
[11] 40 C.F.R. § 262.13.
[12] See 40 C.F.R. § 262.13.
[13] Four factors are used to determine whether recycling is “legitimate.” 40 C.F.R. § 260.43(g). First, recycling must involve a hazardous secondary material that provides a useful contribution to the recycling process or to a product or intermediate of the recycling process. For example, the nicotine-containing materials may be the source of a valuable constituent (i.e., nicotine) recovered in the recycling process. Second, the recycling process must produce a valuable product or intermediate, which can be demonstrated by sale of the recycled product to a third party, by its use as an effective substitute for a commercial product, or by its use as ingredient in a process. Third, the generator and the recycler must manage the hazardous secondary material as a valuable commodity when it is under their control. This would entail management of nicotine-containing materials consistent with how raw nicotine is managed. Fourth, the product of the recycling process must be comparable to a legitimate product or intermediate. For example, the recycled product should meet widely recognized specifications for the raw material and not contain hazardous constituents in greater levels than a non-recycled analogue. See Letter from Barnes Johnson, EPA, to Scott DeMuth, g2revolution LLP (May 8, 2015), RCRA Online #14851.
[14] See, e.g., New Jersey Department of Environmental Protection, “Compliance Advisory Update – Compliance Assistance Available for Vape Shops and Manufacturers” (June 20, 2017), available at: http://www.nj.gov/dep/enforcement/advisories/2017-03.pdf.

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Azim Chowdhury authored a chapter in “Dual Markets – Comparative Approaches to Regulation.” The book, first published on November 14, 2017, analyzes dual markets for regulated substances and services and aims to provide a framework for effective regulation. A “dual market” refers to the existence of both a legal and an illegal market for a regulated product.The volume focuses on nine types of markets and examines the relationship between regulation, the emerging illegal market, and the resulting overall access to each product or service. Azim’s chapter, “Regulation of E-Cigarettes in the United States” focuses on the FDA regulation of e-cigarettes under the Deeming Rule, including the current pre-market authorization requirements that could result in an effective ban on e-cigarettes in the United States. For more information, or to purchase the book, click here.

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Electronic cigarette and e-liquid (collectively “e-vapor”) manufacturers are increasingly the targets of California Proposition 65 enforcement actions brought by private plaintiffs.  Of the 168 private enforcement actions brought against e-vapor manufacturers, 150 of these have been filed since 2016.  We provide background on Proposition 65 below, followed by specifics regarding how the e-vapor industry has been targeted.

What is Proposition 65?

The Safe Drinking Water and Toxic Enforcement Act of 1986 (also known as Proposition 65) requires the governor of California to publish, at least annually, a list of chemicals known to the State to cause cancer or reproductive toxicity. See Cal. Health & Safety Code §§ 25249 et seq.  Among other things, the law prohibits the knowing exposure of any individual to a significant amount of a listed chemical without first providing a “clear and reasonable warning” to such individual. Cal. Health & Safety Code § 25249.6. The law requires these warnings to be provided for consumer product, workplace, and environmental exposures unless “the person responsible can show that the exposure [to a listed carcinogen] poses no significant risk assuming lifetime exposure at the level in question,” or, for a listed reproductive toxin, that the substance “will have no observable effect assuming exposure at 1,000 times the level in question.” Cal. Health & Safety Code § 25249.10(c).

Proposition 65 Enforcement Against E-Vapor Products

The 60-day notices sent to e-vapor manufacturers have focused on four listed chemicals:  acetaldehyde (listed as a carcinogen), formaldehyde (listed as a carcinogen), nicotine (listed as a reproductive toxicant), and tobacco smoke (listed as a carcinogen).  We have identified approximately 150 60-day notices sent to e-vapor companies.  Almost all of these notices have been filed by the Center for Environmental Health (CEH).  CEH has either detected listed chemicals in the products by analytical testing (e.g., testing the e-liquid) or has alleged that the intended use of the product (e.g., the e-vapor device) will result in exposure to the listed chemical(s).

Out of the enforcement actions since 2015, there have been nearly 100 settlements that have amounted to approximately $3.9 million in combined fees and penalties.  The highest settlements amounted to $355,000, with the average settlement amount being in the range of $42,000.

E-Vapor manufacturers should be aware of their rights and responsibilities under Proposition 65, particularly in light of new warning requirements, which differ from the current Proposition 65 warnings in terms of presentation and content, that become mandatory on August 30, 2018 – around the same time the nicotine addiction warning required by the FDA’s Deeming Regulation goes into effect for e-vapor products.

If you are interested in obtaining additional guidance on this topic, contact Azim Chowdhury (202.434.4230, chowdhury@khlaw.com). For more information on our Tobacco and E-Vapor Practice, visit www.khlaw.com/evapor. For more information on our Proposition 65 Practice, visit  www.khlaw.com/Proposition_65. Follow Keller and Heckman Tobacco and E-Vapor Partner Azim Chowdhury on Twitter.

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Azim Chowdhury and Manon Ombredane will attend the Next Generation Nicotine Delivery Conference in London. Azim will present “Determining the Impact of the FDA’s Stance on Nicotine Containing Products.” Manon will participate on the panel “Roundtable Discussing The Variance of TPD Implementation in Different EU Member States.” The conference will take place November 14-15. 2017. For more information, click here.

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Azim Chowdhury and Adam Susser will participate in the FDLI Tobacco Products and Regulation and Policy Conference, which will take place October 26-27, 2017 in Washington, DC.

This KH sponsored event will bring together public health advocates, researchers, manufacturers, lawyers, consumer interests, entrepreneurs, governmental agencies and others to effectively regulate the broad spectrum of tobacco and nicotine products in the US and globally.

Azim will participate on the panel “The Future of Deeming Regulations: Policy and Litigation” which will engage in discussions about the future of the deeming regulations, including issues pertaining to litigation, regulations, legislation, and the pros and cons of extending the implementation dates to 2021 and 2022. Attention will also be given to the appropriate use of flavoring in both e-cigarettes and cigars and how it can be ensured that children and youth are not being encouraged to use these products.

Adam will present on “Overview of Tobacco Law and Regulation” during the Introduction to U.S. Tobacco Law and Regulation seminar which will explore the essentials of tobacco law and regulation including the Deeming Rule, Premarket Tobacco Applications (PMTAs) and Modified Risk Tobacco Product Applications (MRTPAs), advertising and promotion, compliance, enforcement, and related issues.

For more information on this event, click here.

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Just five days before the September 30, 2017 registration deadline for U.S. manufacturing establishments, on Tuesday, September 26, 2017, the Food and Drug Administration (FDA) Commissioner, Dr. Scott Gottlieb, tweeted that due to “website connectivity problems” with the FDA Unified Registration and Listing System (FURLS), FDA would be “implementing a short term extension to allow firms to register”. On September 28, 2017, FDA officially announced via e-mail  that it was revising its guidance once again to extend the Registration and Product Listing deadline for U.S. manufacturing establishments to October 12, 2017. This applies to U.S. manufacturers of deemed products on the market as of August 8, 2016, but of course does not apply to foreign manufacturing establishments or U.S. importers, distributors or retailers not engaged in manufacturing, packaging or labeling activities.

FDA also indicated that if you continue to have technical issues with FURLS you should send an email to CTPRegistrationandListing@fda.hhs.gov with “IT Questions” in the subject line. In the body of the email provide:

  • Name of the Owner or Operator of the establishment;
  • Name and Address of the establishment;
  • Contact phone number; and
  • The best time for FDA to call the contact.
If IT issues prevent you from completing your registration and product listing by October 12, 2017 let FDA know as soon as possible so that they can work with you to address any technical problems.

FDA also recently issued a separate alert noting that establishments affected by Hurricanes Harvey or Irma may also be eligible for a separate extension, determined on a case-by-case basis. If you would like to be considered for such an extension, send an email with the information bulleted above to CTPRegistrationandListing@fda.hhs.gov and the subject line “Natural Disaster”. We also recommend providing a brief description of how the recent natural disasters have impacted your ability to register on time.

On September 15, 2017 FDA published a Revised Guidance for Industry on Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments. Keller and Heckman’s analysis of this revised Guidance, including a summary of how to register and who must register can be found in our previous Client Alert.

If you have any questions about Registration and Product Listing or any of the other Tobacco and Control Act requirements, contact Azim Chowdhury (202.434.4230, chowdhury@khlaw.com) or Ben Wolf (202.434.4103, wolf@khlaw.com). For more information on our Tobacco and E-vapor Practice in general, visit www.khlaw.com/evapor. Follow Keller and Heckman Tobacco and E-Vapor Partner Azim Chowdhury on Twitter.