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The new European Union (EU) General Data Protection Regulation (GDPR) replaces the Data Protection Directive on May 25, 2018 and will directly impact all companies, including vapor product retailers and businesses, that market and sell products to consumers in the EU and/or employ residents of the EU. The reforms will give European consumers new rights and control over the personal data collected from and about them, and impose new obligations on businesses within and outside of the EU that collect personal information from EU citizens, regardless of where they reside, or from individuals who reside in the EU, regardless of their nationality.  Given the magnitude of potential penalties for violations of the GDPR (supervisory authorities are authorized to impose fines of up to 4% of global annual turnover for serious infringements and 2% for less serious infringements), it is imperative that vapor product retailers and others selling into the EU or handling data about Europe-based individuals ensure they are GDPR-ready.

The new rules empower individuals by, among other things, (1) providing easier access to personal data and more information on how data is processed, (2) facilitating data portability, or transfers of personal data between service providers, (3) clarifying the fundamental “right to be forgotten” for individuals who no longer wish for their data to be processed, and (4) requiring expedited notifications to the national supervisory authority by companies that experience a data breach affecting personal data.

Most companies operate with multiple streams of data, such as HR data, consumer data, vendor/supplier data, and the like. A good starting point is for businesses to assess their current data collection practices and identify gaps, and use that to map out a step-by-step compliance plan specific to their data collection practices that fully prepares them for the new GDPR world.

We provide below a summary of the key requirements in the GDPR and a compliance checklist for businesses. Please note that the summary and checklist are provided for informational purposes only, and do not constitute legal advice regarding specific facts or circumstances.

GDPR KEY REQUIREMENTS
Personal Data The term “personal data” means “any information concerning an identified or identifiable natural person.” An identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, identification number, location data, online identifier or to one or more factors specific to the individual’s physical, physiological, genetic, mental, economic, cultural or social identity.
Extraterritorial Effect The Regulation applies not only to the processing of personal data by controllers and processors in the EU, but also the processing of personal data of data subjects who are in the EU by a controller or a processor not established in the EU, if the processing activities are related to offering goods or services to the data subjects or monitoring their behavior within the EU.
Lawfulness of Processing To be lawful, at least one of the following must apply:

  • The data subject consents;
  • Processing is necessary for the performance of a contract to which the data subject is a party;
  • Processing is necessary for compliance with a legal obligation to which the controller is subject (under EU or Member State law);
  • Processing is necessary to protect the vital interests of the data subject or another natural person;
  • Processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller (under EU or Member State law);
  • Processing is necessary for legitimate interests pursued by the controller or a third party, except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child.
Consent Consent to processing must be unambiguous, specific, informed, and freely given (for example, checking a box at a website or choosing technical settings). Pre-checked boxes do not constitute consent. For sensitive data (for example, data revealing race or ethnic origin, political opinions, religious or philosophical beliefs, trade union membership, genetic data, biometric data, data concerning health or data concerning a natural person’s sex life or sexual orientation), consent must be explicit. When processing has multiple purposes, consent should be given for all of them. Consent may be withdrawn.
Data Processing Processing of personal data must be lawful, fair, and transparent. Individuals should be made aware of the risks, rules, safeguards and their rights in relation to the processing of personal data. The specific purposes for which personal data are processed should be explicit and legitimate and determined at the time of the collection. Personal data should be adequate, relevant and limited to what is necessary for the purposes for which they are processed. Time limits should be established for erasure or periodic review. Personal data should be processed in a manner that ensures appropriate security and confidentiality.
Right to be Forgotten Individuals have a right to request deletion of data, with some exceptions (for example, if retention is legally required).
Data Portability Individuals have the right to easily transfer personal data between different service providers.
Children Special rules apply to children’s data. Where a child is below age 16, processing is lawful only if parents or guardians consent. Member States may establish a lower age for these purposes, so long as the age is not below age 13.
Controller Responsibility Personal data must be processed under the responsibility and liability of the controller, who must ensure and document compliance for each processing operation. Controllers should only use processors who provide sufficient guarantees in terms of expert knowledge, reliability and resources to implement technical and organizational measures that will meet the requirements of the Regulation. Adherence to an approved code of conduct or certification mechanism may be used to demonstrate compliance. There must be controller-processor agreements in place that describe the subject matter, duration, nature and purposes of the processing, type of personal data, and categories of data subjects. Upon completion of the processing, the processor must, at the controller’s election, return or delete the data, unless the processor is required by law to store it. Joint and several liability for controllers and processors.
Data Protection Impact Assessments

Data controllers must conduct Data Protection Impact Assessments (DPIAs) for “risky” processing. DPIAs should be completed before beginning any type of processing which is “likely to result in a high risk.” This means even though the actual level of risk may not have been assessed, a DPIA may be necessary based on identifying factors that point to the potential for a widespread or serious impact on individuals. Some jurisdictions may impose DPIA requirements on specific types of processing.

 

If the DPIA indicates that processing involves a high risk that cannot be mitigated, controller should consult supervisory authority (DPA) prior to the processing.
Data Protection Officer Organizations must appoint a data protection officer (DPO) in three situations: the processing is carried out by a public authority; the core activities of the controller or processor consist of processing operations which require regular and systematic processing of data subjects on a large scale; or the core activities involve processing sensitive data or criminal convictions on a large scale.
Documentation Controllers and processors must document all processing and make documentation available to DPA on request.
Data Breach Notification Controllers must notify DPA within 72 hours of learning of a breach, where feasible; no notification is required if a breach is unlikely to result in risk to the rights or freedoms of individuals. Controllers must notify data subjects without undue delay, where the breach is likely to result in a high risk to their rights or freedoms. Notifications to data subjects should describe the nature of the breach and recommendations for individuals to mitigate potential adverse effects. Processors must notify controllers.
Streamlined Approvals A single DPA can be designated the lead, enabling multiple DPAs to handle cases in a more streamlined manner.
Codes of Conduct and Certification Codes of conduct are encouraged, and are subject to approval by the Commission, and compliance should be monitored by an appropriate expert, accredited body. Approved codes of conduct will be registered and published. Data protection certification mechanisms, seals and marks are encouraged.
Transfers to Other Countries Transfers to other countries are permitted based on a determination that the country provides adequate protection of privacy; transfers are subject to adequate safeguards (for example, binding corporate rules, standard contractual clauses, an approved code of conduct, approved certification mechanisms, explicit informed consent).
Reduced Notifications Supervisory notifications about data processing are no longer required, but permission is required to process certain categories of data.
Art 29 Working Party (WP29) WP29 will be “upgraded” to an independent European Data Protection Board.
WP29 Guidance WP29 has issued guidance on several aspects of the GDPR that provide clarification and recommendations:
DPA Enforcement DPAs have enhanced enforcement powers, including expanded investigatory authority.
Complaints and Remedies EU citizens can lodge complaints with local DPAs, even where data is processed extra-territorially, and have the right to a judicial remedy against supervisory authorities who fail to act and against controllers and processors.
Penalties DPAs are authorized to impose fines of up to 4% of global annual turnover for certain serious infringements; 2% for less serious infringements.


GDPR Compliance Checklist 

Types of Personal Data Collected
Identify types of data collected
Identify sensitive data
Identify data collected from children/ whether parental consent is required
Data Processing
Appoint data protection officer (DPO)
DPOs must be appointed if:

  • The processing is carried out by a public authority;
  • The core activities of the controller or processor consist of processing operations which require regular and systematic processing of data subjects on a large scale; or
  • The core activities involve processing sensitive data or criminal convictions on a large scale.
  • May also be Operating/established in a jurisdiction (such as Germany) with more stringent requirements.
  • WP29 guidance on DPOs
  • “Core activities”: defined by WP29 as those that are integral to “the controller’s or processor’s activity.”
  • “Large scale”: WP29 recommends that businesses consider the number of data subjects concerned; the volume of data or range of data items; and the duration and the geographical extent of the processing.
  • “Regular and systematic monitoring”: WP29 states this would “include all forms of tracking and profiling on the internet, including for the purposes of behavioral advertising.”
Confirm the lawful basis for the processing:

  • Consent
  • Necessary for compliance with a legal obligation to which the controller is subject
  • Necessary for the performance of a contract to which the data subject is a party
  • Necessary to protect an individual’s vital interest
  • Legitimate interests of the controller (i.e., providing client services or preventing fraud)
  • Transfers of personal data among controllers within an affiliated group for internal administrative purposes
  • Strictly necessary and proportionate for ensuring network and information security
If consent is the basis for the processing:

  • Must be unambiguous, specific, informed, and freely given
  • Must obtain consent for each processing activity/purpose
  • Explicit consent required for sensitive data
Confirm that personal data collected is adequate, relevant and limited to what is necessary for the purpose(s)
Determine whether a data protection impact assessment (DPIA) is required (high-risk processing)

  • Systems that analyze a person’s economic situation, location, health, personal preferences, reliability or behavior
  • Video surveillance systems
  • Data in large scale filing systems on children, genetic or biometric data
DPIA, if required, should address

  • Contemplated processing and purposes
  • Necessity and proportionality of the processing in relation to the purposes
  • Risks to the rights and freedoms of data subjects
  • Safeguards and security measures to address the risks
If DPIA indicates that processing would result in high risk, then consult DPA prior to processing
Data subjects must be informed about:

  • Identity and contact information for controller and DPO
  • Purposes of the processing and legal basis
  • Recipients/ categories of recipients of personal data
  • Period for which personal data will be stored
  • Right to request access to and correction or erasure of personal data or to restrict processing
  • Right to withdraw consent at any time
  • Right to file complaint with supervisory authority
Review privacy policies and update as necessary
Establish system for documenting processing operations
Amendments to third-party contracts to ensure compliance with GDPR and e-Privacy Directive (and eventually e-Privacy Regulation)
Data Storage
Determine where and how data is stored
Establish limits for erasure of data and periodic reviews
Review data retention policies to ensure data only kept for as long as necessary
Establish and/or review processes for rectifying or deleting inaccurate data
Prepare template responses for data access requests
Data Transfers to Other Countries
Review and analyze global data flows
Assess validity of current mechanisms for transfers of personal data from the EU to the U.S. or other countries, for example:

  • Adequacy determination
  • Binding corporate rules
  • Standard contractual clauses
  • EU–U.S. Privacy Shield
  • Codes of conduct
  • Certification mechanisms
  • Explicit, informed consent in limited circumstances
Assess feasibility/benefits of approved codes of conduct and certification mechanisms
Assess need for controller-controller and/or controller-processor agreements; review content for compliance with new requirements
Data Security
Review technical and organizational measures in place to prevent unlawful destruction, loss, alteration, disclosure of/ access to personal data

  • Pseudonymization and encryption
  • Ability to ensure ongoing confidentiality integrity, availability, and resilience of processing systems and services
  • Ability to restore availability and access to data in timely manner in the event of a physical or technical incident
  • Process for regularly testing, assessing and evaluating the effectiveness of the security measures in place
Ensure that processors are employing adequate technical and organizational measures; address in contracts
Establish and/or update data breach response plan

For more information on the GDPR or other privacy or data security matters, and how they affect businesses involved in e-liquid and vapor products, please contact Tracy Marshall (+1 202.434.4234, marshall@khlaw.com), Azim Chowdhury (+1 202.434.4230, chowdhury@khlaw.com), or Nathan A. Cardon (+1 202.434.4254, cardon@khlaw.com).

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FDA is Coming webinar

At yesterday’s meeting with the U.S. House Subcommittee on Agriculture and Rural Development to discuss FDA’s Fiscal Year 2019 budget, Food and Drug Administration (FDA) Commissioner Scott Gottlieb discussed the Agency’s regulation of the tobacco industry and noted, among other things, that when all the requirements for the newly deemed products, including vapor products, went into effect last year, FDA now has authority to inspect and impose GMP standards and enforce age restrictions.  Gottlieb indicated that FDA would be “stepping into this fight in a vigorous way in the coming weeks.”

Being prepared for an FDA inspection is critical to maintaining compliance.  Just a few weeks ago, FDA’s recently-issued Request for Proposal (RFP), Vape Inspection Services (FDA-RFP-18-1190619), was extended on March 22, 2018 to allow for additional time for FDA to receive, review and consider responses from government contractors submitting bids to conduct inspections of establishments engaged in the retail sale of FDA-regulated tobacco products.

The RFP provides valuable insight into the Agency’s current thinking with regard to the scope of inspections that are expected to begin shortly, as mandated by the Tobacco Control Act.

Specifically, the RFP indicates that the contractor(s) shall, in the course of a facility inspection:

  • Complete and provide FDA with a signed Form FDA 482 (“Notice of Inspection”);
  • Complete an inspection form, detailing:
    • Administrative information;
    • The scope of the facility’s business (e.g., manufacturing, retail, import/export of products);
    • A list of potential violations of the Federal Food, Drug, and Cosmetic Act; and
  • Be prepared to testify on behalf of FDA in any regulatory or judicial proceeding.

The RFP focuses extensively on the type of evidence collection and storage permissible under the Agency’s guidelines – including the collection of photographic and physical evidence.  The RFP further requires that the contractor complete required Agency training regarding the permissibility of collecting reports, data, documents, and photos (including limitations on Confidential Business Information (CBI), sales data, and personnel data).

The RFP describes the scheduling of inspections on a continuing, quarterly basis, in accordance with designated quotas.  The program allocates funding for one full-time program manager, approximately 10 program coordinators, and 20 inspectors (based on 2,080 annual hours per full-time equivalent).

Keller and Heckman continues to monitor developments relating to FDA’s forthcoming inspections of tobacco and vapor manufacturing establishments, and, to help companies prepare, recently launched the Audit and Inspection Program (AIP).  The AIP provides establishments with an opportunity to conduct advance, client-confidential, independent auditing to identify and remedy any deficiencies.  In addition, the AIP provides establishments with training regarding FDA’s inspection authority, the permissibility of Agency collection of business information, and optional environmental and occupational health and safety components.  For additional details on the AIP Program and to register, click here.

On May 2, 2018 (3:00 PM ET), attorneys Azim Chowdhury and Daniel Rubenstein will be participating in a free webinar hosted by the Smoke-Free Alternatives Trade Association (SFATA), “The FDA is Coming – Are You Ready” and will be discussing Keller and Heckman’s AIP and how manufacturers and retailers can prepare for an FDA inspection. Register for the webinar here.

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The 2nd Annual Keller and Heckman E-Vapor and Tobacco Law Symposium held on February 6-7, 2018 in Irvine, California was a huge success with over 100 attendees from all over the country and world.  Check out the highlight video below.  We are in the process of securing a location for next year’s symposium and would like your feedback on potential locations (Irvine, Miami, Dallas or Washington, DC).  Please take a moment to complete the brief survey here.

Take a look at highlights from this year’s conference:

Click on the link below to receive updates on the 2019 E-Vapor and Tobacco Law Symposium.

For questions or additional information,  please contact:

Sara A. Woldai

Manager, Marketing Meetings and Events

Keller and Heckman LLP

woldai@khlaw.com

Connect with us on: 

 

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February 26, 2018 – Keller and Heckman LLP is pleased to announce the introduction of its Audit and Inspection Program (AIP) for Tobacco and Vapor Product Manufacturing Establishments.

The AIP was developed in response to the Food and Drug Administration’s (FDA) inspection authority under the Food, Drug, and Cosmetic Act (FDCA or the Act), as amended by the Tobacco Control Act, which provides that FDA shall inspect each factory, warehouse, establishment, or vehicle in which tobacco products, including deemed tobacco products, are manufactured, processed, packed, or stored.  Pursuant to Sections 704 and 905 of the Act, FDA is directed to inspect every establishment at least once every two years.

Audit and Inspection Program

Keller and Heckman’s experienced team of attorneys and scientists will provide a comprehensive, on-site training and facility auditing program designed to help your company adequately prepare for an FDA inspection.  As part of the AIP, companies can expect:

  • An introductory presentation and memorandum detailing FDA’s inspection authority, what to expect during an inspection, and how to adequately prepare for – and respond to – an FDA inspection;
  • A full facility audit, consisting of a complete mock-inspection; and
  • A written post-inspection report detailing the overall readiness of the facility for an FDA inspection, including a list of specific recommendations and opportunities for improvement*

Keller and Heckman’s AIP program is designed to provide companies that are involved in any aspect of the tobacco or vapor product supply chain with confidence that their facilities are operating in accordance with FDA requirements.  The AIP will consider a broad range of inspection activities, including: recordkeeping, product labeling, product samples, requests for video/audio/photographic recordings, standard operating procedures, cleanliness and sanitation, inventory control, and personnel interviews.

Supplemental Environmental and OSHA Compliance Components

In addition to FDA compliance, the AIP offers companies the option to include supplemental compliance training and auditing focusing on environmental and occupational health and safety regulations and requirements – efficiently leveraging the FDA mock inspection and full facility audit.

  • Environmental: The AIP program will offer companies the opportunity to add an additional training and compliance component focusing on federal and state environmental and waste management regulations. Specifically, nicotine-bearing products may be subject to regulation under the Federal Resource Conservation and Recovery Act (RCRA) when disposed.  State regulations governing dangerous or industrial wastes also could apply.  This component will provide an overview of how nicotine in tobacco-based products are regulated differently than when found in e-cigarettes and other vaping products, and will provide valuable information regarding companies’ obligations in responding to these additional requirements.  For more information on environmental requirements, see here.
  • Occupational Health and Safety: Participants in the AIP program will also have the opportunity to add an additional training and compliance component focusing on federal and state Occupational Safety and Health laws. OSHA recordkeeping requirements apply to all employers, except very small businesses.  Most other OSHA standards apply to all employers, regardless of size.  This component will provide companies with a review of existing policies and practices, and will recommend specific actions designed to bring companies into compliance with regulations in areas relevant to the industry, including: personal protective equipment, emergency plans, fire protection, and hazard communication (g., labeling and safety data sheets).

Pre-Registration

Pre-registration for the AIP is available immediately by filling out the form available here:

Tobacco and Vapor Product Manufacturing Establishment Audit and Mock Inspection Program Pre-Registration Form

The completed pre-registration form can be E-mailed to chowdhury@khlaw.com, faxed to (202) 434-4646, or mailed to:

Keller and Heckman LLP
Attn: Azim Chowdhury
1001 G Street NW, Suite 500 West
Washington, D.C. 20001

Upon receipt of your pre-registration form, Keller and Heckman will provide your company with a formal written proposal and cost-estimate to conduct on-site training and mock inspection at your facility.  Scheduling is generally available on a first-come, first-serve basis.

*The written post-inspection report is covered by any existing attorney-client relationship between Keller and Heckman and the Company, and is generally not subject to discovery.  The recommendations set forth in the post-inspection report are for informational purposes only, and do not constitute any warranties or guarantees regarding the outcome of an actual FDA, EPA or OSHA inspection.  Keller and Heckman’s attorneys remain available and look forward to the opportunity to assist with any post-inspection activities or questions following completion of the written report.

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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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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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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.

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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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As the e-vapor industry evolves, manufacturers must keep up with an expanding legal and regulatory landscape. In addition to designing their products and services to comply, it is important for e-vapor companies to carefully assess their business practices and relationships with employees and business partners so as to best protect their confidential information and intellectual property, minimize their liability when relying on third party vendors, distributors and independent contractors, and ensure that they comply with applicable laws when advertising, marketing, and selling their products and services to consumers. This checklist highlights ten business, advertising, and intellectual property considerations for e-vapor companies doing business in the United States. Other countries may have different (and in some cases more stringent) requirements, so companies should understand their obligations wherever they conduct business. This checklist is provided for general information purposes. It is not intended to provide a comprehensive summary of applicable laws, and does not constitute legal advice. 

For more information, please contact:

Azim Chowdhury (+1 202.434.4230; chowdhury@khlaw.com)
Tracy P. Marshall (+1 202.434.4234; marshall@khlaw.com)
Robert S. Niemann (+1 415.948.2827; niemann@khlaw.com)

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