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Azim Chowdhury

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Azim Chowdhury is a regulatory and public policy attorney with a focus on vapor, nicotine and tobacco product regulation. He is a Partner in Keller and Heckman’s nationally-ranked food and drug law practice.

Mr. Chowdhury advises domestic and foreign corporations in matters of Food and Drug Administration (FDA) and international regulatory compliance. In particular, he has developed expertise in tobacco and vapor product regulation relating to the implementation of the Family Smoking Prevention and Tobacco Control Act, and spearheaded the Tobacco and E-Vapor practice at Keller and Heckman. Specifically, Mr. Chowdhury has experience representing tobacco, e-cigarette and e-liquid manufacturers, distributors, retailers, suppliers and trade associations in matters of FDA, state and global regulatory compliance. He also assists corporations in establishing clearances for food and drug additives in the U.S., Canada, and European Union, with an emphasis on indirect additives used in food-contact materials.

Mr. Chowdhury is also a frequent contributor to the Food and Drug Law Institute's (FDLI) Update Magazine, has served on the Editorial Advisory Board of the Food and Drug Law Journal, and has authored and edited numerous articles and publications, including Tobacco Regulation and Compliance: An Essential Resource, FDA Regulation of Tobacco: A Comprehensive Guide – An FDLI Primer and Tobacco and Nicotine Delivery: Regulation and Compliance, 2nd Edition. He frequently speaks at industry conferences and events, was featured in U.S. News and World Reports Best Lawyers Edition (2016) and was named one of “10 Names to Know in the Vape World” in the October 2015 issue of Vape Magazine.

Mr. Chowdhury also has an active pro bono practice through Keller and Heckman’s Pro Bono Program, and has been featured in the Baltimore Sun for successfully obtaining asylum in the United States for a family who fled their home country of El Salvador because of violence they faced from an international gang.

Prior to entering private practice, he served as a judicial law clerk on the Court of Special Appeals of Maryland. Mr. Chowdhury received a B.A. and B.S. from Johns Hopkins University, a MBA from the University of Maryland Robert H. Smith School of Business, and a JD, cum laude, from the University of Maryland School of Law.

Education: Johns Hopkins University (B.A., B.S., 2003); University of Maryland Robert H. Smith School of Business (M.B.A., 2006); University of Maryland School of Law (J.D., 2006, cum laude).

Admissions: District of Columbia; Maryland

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Seal_of_the_Court_of_Appeals_for_the_District_of_Columbia

On May 2, 2018, the U.S. Food and Drug Administration (FDA) filed its brief in response to Appellants Nicopure and Right to be Smoke-Free Coalition’s appeal in the lawsuit challenging aspects of the Tobacco Control Act (TCA) and the Deeming Rule now pending before the U.S. Court of Appeals for the D.C. Circuit. FDA’s brief was supported by amici briefs filed by several NGOs and public health groups (who recently dropped their motion to intervene as actual parties to the appeal). Appellants filed their reply brief on May 16, 2018. (Links to all the appeal briefs are below.)

Issues on Appeal

In their opening brief, which was supported by a number of amici (Washington Legal Foundation, NJOY, CASAA, the State of Iowa, and Clive Bates et al.), appellants argue that (1) FDA was obligated to consider a less burdensome Premarket Tobacco Product Application (PMTA) process for vapor products while still protecting the public health, (2) the Modified Risk Tobacco Product (MRTP) provision of the TCA as it is being applied to vapor products violates the First Amendment of the U.S. Constitution, and (3) the ban on free samples of vapor products also violates the First Amendment.  We summarize FDA’s response to the appeal, and appellants counter-arguments below.

The Premarket Tobacco Application (PMTA)

With respect to the PMTA, FDA predictably argues that, once deemed, vapor products are tobacco products subject to all the requirements in the TCA, including premarket review. According to the agency, FDA has no choice but to apply the statutory requirements established by Congress, and that the decision not to tailor such requirements for vapor products was not arbitrary and capricious. Appellants, however, counter that they are not actually seeking a complete exemption from the PMTA or the “population effects” (public health) standard, but rather are only arguing FDA either was required to, or arbitrarily and capriciously failed to, tailor how the vapor industry demonstrates compliance with this standard. Such tailoring is necessary because requiring randomized, controlled trials or long-term epidemiological studies for each e-liquid and device would, by FDA’s own admission, eliminate up to 97% of manufacturers and the vast majority of products on the market – which flies in the face of the TCA’s clear intent to ensure that adults continue to have access to less harmful tobacco products.

While FDA maintains it will consider this option on a case-by-case basis, that is simply not enough when entire categories of vapor products could be effectively banned before PMTAs are even submitted. FDA must allow vapor companies on an industry-wide basis to file PMTAs that rely on information and data alternatives to satisfy the public health standard without having to conduct prohibitively expensive, long-term studies for each product before submitting an application. At a minimum, it was arbitrary and capricious for FDA not to adopt this option or adequately consider it during the rulemaking.

Modified Risk Tobacco Product (MRTP) Claims

FDA argues that the requirement that the agency conduct a “premarket review” of modified risk tobacco products is not a regulation of commercial speech subject to First Amendment protection (just like FDA’s review of new drug products) and that, even if it were, the requirement is narrowly tailored to further the government’s substantial interest, as required to meet the “intermediate scrutiny” standard for government limitations on commercial speech. FDA points to Congress’s extensive findings concerning Big Tobacco’s long history of marketing light, mild and low tar cigarettes as safer than regular cigarettes, and the resulting public health consequences.

But appellants argue that modified risk designation of tobacco products does not rely on a manufacturer’s intent (unlike new drugs), and so MRTP claims are protected by the First Amendment. Moreover, FDA cites nothing in either the TCA or the administrative record showing that the agency gave any consideration, as the Administrative Procedure Act requires, to how plainly truthful claims about vapor products (e.g., “no tar,” “no combustible smoke,” “no ash,” “no diacetyl”), which are designed to help smokers move away from cigarettes, might actually be interpreted by consumers. Insisting that, because of Big Tobacco’s past indiscretions, it is the vapor industry’s duty – not the government’s – to demonstrate in the first instance that entirely truthful statements are not potentially misleading puts the cart-before-the-horse.

Free Sample Ban

FDA argues that the ban on the distribution of free vapor product samples (1) does not implicate the First Amendment because it is effectively a price regulation focused on conduct that regulates economic activity rather than expression and that, (2) even if the prohibition were viewed as a speech restriction, it would withstand review under the intermediate scrutiny standard because it is narrowly tailored to further the government’s substantial interest in preventing youth access to tobacco products.

But according to the Appellants, FDA’s position completely ignores the underlying purpose of the commercial speech doctrine, i.e., the free flow of commercial information through advertising, which warrants First Amendment protection so consumers can make intelligent and well-informed purchasing decisions. As Consumer Advocates for Smoke-Free Alternatives Association (CASAA) made clear in its amicus brief in support of the appellants, a substantial amount of information is furnished through free samples regarding e-liquid flavors and device performance that adult consumers require. Record evidence shows that when deciding whether to switch from significantly more harmful cigarettes, consumers must be able to understand how vapor products work, taste various flavors, and experience the sensation and performance levels of different devices. Samples are needed to convey this information – it is not enough for sellers to simply make representations through other channels, such as written materials or retailer demonstrations.

Moreover, requiring companies to charge a fee to sample products will limit the amount of information conveyed through sampling, whether because consumers are price sensitive, reluctant to spend money on an unfamiliar or novel product, or otherwise. Vapers engage in a routine and ongoing sampling process of multiple products as they switch from cigarettes. The act of constantly paying for each sample tested presents an unnecessary hurdle.

FDA also never acknowledges the Supreme Court’s test for determining whether the ability to distribute free samples possesses sufficient communicative elements (i.e., an intent to convey a particularized message) to bring the First Amendment into play. Rather, FDA asserts that it is only regulating conduct, turning a blind eye to the extensive record evidence that manufacturers and retailers not only offer free samples with the specific intent to convey important information to consumers, but also that consumers themselves understand testing free samples will help them make critical choices in the marketplace affecting their health and well-being.

Finally, FDA points to how cigarette manufacturers in the past failed in their efforts to limit youth access (and would distribute cigarettes at youth-oriented events like concerts), and argues that the exception in the TCA permitting free samples of smokeless tobacco in qualified-adult-only-facilities will not work for vapor products. But nowhere in FDA’s brief or the administrative record, according to appellants, is there any evidence – whether through studies, surveys, anecdotal reports, or otherwise – demonstrating that underage individuals are obtaining free samples of vapor products from venues or events only frequented by adults – e.g., vape shops, trade shows, and adult-oriented concerts. In fact, vast swaths of the vapor marketplace – primarily vape shops – are swept-up in the free sample ban when it is pure speculation and conjecture on FDA’s part to conclude that minors have easy access to samples through such channels. This approach is not permitted under the First Amendment.

Rather than a prophylactic ban on free vapor product samples, there are a number of non-speech related alternatives that FDA could implement to restrict youth access to free tobacco product samples, such as:

  1. prohibiting free samples at youth-oriented events;
  2. limiting free samples to adult-only, age-verified facilities where the sample must be used or consumed on-site so as to prevent removal and any access by the general public;
  3. aggressively enforcing minimum age requirements; and
  4. conducting education campaigns aimed at minors.

In short, FDA’s treatment of free vapor product samples fails to balance the government’s interest in preventing youth access with Congress’s stated goal of allowing adults continued access to less harmful tobacco products.

Links to all briefs:

Oral arguments will likely be scheduled in the Fall of 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.

Warning_Icon

On May 1, 2018 the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued 13 warning letters to companies that they claim misleadingly labeled or advertised nicotine-containing e-liquids as kid-friendly food products such as juice boxes, candies, and cookies.  Warning letters were issued to manufacturers, distributors, and retailers of eight products.

All of the warning letters included allegations of misbranding under Sections 903(a)(1) and 903(a)(7) of the Food, Drug, and Cosmetic Act (FDCA) – both of which relate to labeling or advertising that is misleading or untrue in any particular – and Section 5 of the FTC Act for unfair or deceptive advertising.  Both the FDA and FTC alleged violations are based on the risk of confusion, especially by children, between the e-liquid products and foods that are marketed toward, or appealing to, children.

In some of the warning letters issued to distributors and retailers, FDA added allegations that the e-liquids were sold to minors in violation of Section 903(a)(7)(B) of the FDCA.  In one instance, FDA alleged that the company violated Section 201(rr)(4) of the FDCA – which bars the marketing of a tobacco product “in combination with any other article or product regulated” by FDA – because a combination pack of candy and e-liquid were offered together.  The warning letters also highlighted the potential harm that could result if nicotine-containing e-liquids are ingested by children, although the number of poison center calls regarding e-liquids has fallen dramatically since the Children’s Nicotine Poisoning Prevention Act went into effect in 2016.  That law requires “liquid nicotine containers” use child-resistant packaging just like prescription drugs, some over-the-counter (OTC) drugs, and other potentially hazardous products found in the home, pursuant to the Poison Packaging Prevention Act.

The issuance of the 13 warning letters comes about a week after FDA Commissioner Gottlieb announced that FDA (1) recently issued warning letters to 40 retailers for underage sales of JUUL products, (2) was in the midst of a “new blitz of retail establishments targeting youth sale violations”, (3) is seeking to end sale of JUUL products to minors, and (4) would examine the youth appeal of JUUL products.  FDA also requested JUUL Labs submit information regarding, among other things, its marketing, research studies, and how certain product features might appeal to different age groups.  While some have argued that the panic over JUUL, which appears to be based on anecdotal evidence and media reports, could actually adversely impact the public health, there is no doubt that FDA is committed to cracking down on underage sales and reducing youth appeal of tobacco products, including vapor products.

In light of the warning letters issued on April 24 and May 1 and the Agency’s interest in tobacco product flavors, it appears that FDA may be setting its sights on the elimination of flavored e-liquids, which have also been shown to help adult smokers transition to less harmful vaping alternatives, as part of its effort to curb the use of vapor products by youth. Of note, a recent study evaluating how young people use vapor products in the United Kingdom, where the products are actively promoted by the government as less harmful than cigarettes and as a way to quit smoking, found that most product experimentation does not turn into regular use, and that regular use of vapor products in young people who have never smoked remains very low.

Industry and other stakeholders interested in maintaining the availability in the U.S. of flavored e-liquids have until June 19, 2018 to submit comments to FDA’s Advanced Notice of Proposed Rulemaking.

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).

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.

ingredient listing (002)2

The vapor device industry has been requesting FDA for years to exempt devices from the Tobacco Control Act Section 904(a)(1) ingredient listing requirement, respectfully arguing, among other things, that the information required for non-consumable hardware products and components provides no meaningful information to FDA that would help it protect the public health.[1]  On April 13, 2018, just 25 days before the reporting deadline for large manufacturers of deemed tobacco products, FDA published a revised Guidance for Industry: Listing of Ingredients in Tobacco Products.  FDA now intends to enforce the ingredient listing requirement only with respect to those tobacco product components or parts that are made or derived from tobacco, or contain ingredients that are burned, aerosolized or ingested (i.e., consumed) during use.  Although the revised guidance is late – and comes after many companies have spent considerable time and funds to comply with the reporting requirement – it is welcome news for the industry.

The ingredient listing deadlines for the applicable components and parts of deemed finished tobacco products[2], however, have not changed – large manufacturers of such products still have only until May 8, 2018, while small-scale manufacturers[3] have until November 8, 2018.

Manufacturers of vapor devices and finished deemed tobacco product components and parts should keep in mind that FDA’s decision to exempt such products from ingredient listing does not change the fact that these products are still subject to FDA’s premarket authorization requirements.  It remains the case, for example, that any new vapor device intended for introduction into the U.S. market after August 8, 2016 requires Premarket Tobacco Product Application (PMTA) authorization (which requires ingredient information, along with a significant amount of additional data) before it can be marketed, and any devices on the market on August 8, 2016 have until August 8, 2022 before PMTAs are due, and can remain on the market after that date only if PMTAs for the products are accepted by FDA for review.

Components and Parts Subject to Ingredient Listing 

The revised guidance provides examples of “consumable” components and parts that still require ingredient listing including, but not limited to:

  • Cigar filler;
  • Cigar binder;
  • Cigar wrapper;
  • Pipe tobacco;
  • Waterpipe tobacco;
  • E-liquids;
  • Cigarette tobacco;
  • Cigarette paper;
  • Smokeless tobacco;
  • Roll-your-own (RYO) tobacco;
  • RYO rolling paper;
  • RYO tube; and
  • Cigarette filter that contains any ingredient that burns, aerosolizes, or is ingested during use (e.g., cigarette filter with menthol because the menthol will aerosolize during cigarette smoking).

Ingredients of tobacco product components and parts that are not made or derived from tobacco or consumed during use, e.g., pipes, hookah apparatus, vapor devices, etc., need not be submitted to FDA.  Examples of components or parts for which FDA does not intend to enforce the ingredient listing submission requirement at this time include, but are not limited to:

  • Electrical components including, but not limited to, batteries, charging systems, circuit boards, wiring, and connectors;
  • System software;
  • Digital display, lights, and buttons to adjust settings;
  • Connection adapters;
  • Cartomizers;
  • Coils;
  • Wicks;
  • Tanks;
  • Mouthpieces;
  • Pipes;
  • Waterpipes;
  • Hoses;
  • Bowls;
  • Charcoal; and
  • Cigarette filter that does not contain any ingredient that is burned, aerosolized, or ingested during tobacco use.

Based on this, e-liquid manufacturers need only provide ingredient information on the liquid component of their products, not other non-consumable components such as bottles, drippers and packaging.  FDA expects to receive ingredient information for these non-consumable components and parts during its pre-market review of finished tobacco products (e.g., Premarket Tobacco Applications and Substantial Equivalence Reports).

Single Submissions for Multiple Products

With respect to consumable components and parts, the revised guidance also now makes clear that there are a number of situations where ingredients for multiple products may be listed together under a single submission, provided all of the different brands/subbrands and product sizes for the associated products in the submission are identified.  Examples of situations allowing a single ingredient listing for multiple products are provided in the guidance as follows:

  • Identical per weight composition of ingredients for tobacco products sold under multiple brands/subbrands:
    • Pipe tobacco with identical per weight composition of ingredients sold under 30 brands/subbrands;
    • E-liquids with identical per weight composition of ingredients sold under 200 brands/subbrands; and
    • Waterpipe (shisha) tobacco with identical per weight composition of ingredients sold under 15 brands/subbrands.
  • Identical per weight composition of ingredients for tobacco products sold in multiple product sizes:
    • E-liquid with identical per weight composition of ingredients sold in volumes of 30mL, 60mL, 90mL or sold in a range of product sizes (e.g., 20mL-100mL);
    • Pipe tobacco with identical per weight composition of ingredients sold in product sizes of 5g, 10g, 50g;
    • Waterpipe (shisha) tobacco with identical per weight composition of ingredients sold in product sizes of 100g, 200g, 500g; and
    • Pouched snus with identical per weight composition of ingredients sold in a can of 12 snus sachets or a can of 15 snus sachets.

For open-system e-liquids more specifically, the revised guidance indicates that manufacturers can satisfy the ingredient listing requirement by providing one listing that corresponds to multiple products if the manufacturer sells e-liquids that (1) are identical in chemical composition to one another or (2) are identical in chemical composition to one another except the quantities of propylene glycol (PG), vegetable glycerin (VG), and/or nicotine differ.8 For example:

  • E-liquids with identical nicotine concentrations (e.g., 0.5 mg/ml nicotine) but varying PG/VG ratios (e.g., 20/80, 50/50, 80/20) and all other ingredients having identical per weight composition.
  • E-liquids with identical PG/VG ratio (e.g., 50/50) but different nicotine concentrations (e.g., 0.5, 1.0 1.5 mg/ml) and all other ingredients having identical per weight composition.
  • E-liquids with varying PG/VG ratios (e.g., 20/80, 50/50, 80/20) and different nicotine concentrations (e.g., 0.5, 1, 2 mg/mL) with all other ingredients having identical per weight composition.

However, changes to relative ratios of ingredients or to the quality or type of an ingredient will require separate submissions.  For e-liquids, the revised guidance provides several examples of when separate submissions to correspond to each brand/subbrand of a product are required:

  • E-liquids that have identical PG/VG chemical structure, but the nicotine chemical structure is different (e.g., moving from free nicotine to nicotine salt), even with identical per weight composition of all other ingredients.
  • E-liquids that have identical PG/VG chemical structure and identical nicotine chemical structure but where the per weight composition of all other ingredients is different in any way (e.g., increased amount of cherry flavor #1 added when all other ingredient ratios stay the same).
  • E-liquids where the grade of the PG/VG is different in any way (e.g., percent purity changes).

For more detailed background on the ingredient listing information needed and submission process, see here.

*          *          *          *

If you need assistance with ingredient listing or for more information regarding other regulatory obligations facing tobacco product manufacturers, distributors, importers, or retailers, please contact Azim Chowdhury at chowdhury@khlaw.com or 202-434-4230.

 

_________________________________________________________

[1]           See e.g., comment to the FDA Ingredient Listing Guidance document submitted by Shenzhen E-Vapor Industry Association (SEVIA) in May 2017, available at https://www.regulations.gov/document?D=FDA-2009-D-0524-0034.

[2]              The term “finished tobacco product” means a tobacco product, including all components and parts, sealed in final packaging intended for consumer use. Components and parts that are sold separately from other tobacco products are finished tobacco products if they are sold in final packaging intended for consumer use.

[3]           The term small-scale tobacco product manufacturer means a manufacturer of any regulated tobacco product that employs 150 or fewer full-time equivalent employees and has annual total revenues of $5 million or less. FDA considers a manufacturer to include each entity that it controls, is controlled by, or is under common control with.

eSubmitter logo

Per Section 904(a)(1) of the Tobacco Control Act (TCA), one of the core requirements for manufacturers, including manufacturers of deemed tobacco products such as e-liquid, vapor devices, cigars and hookah, is the requirement to submit to the Food and Drug Administration (FDA) a list of all ingredients that are “added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product….”  Unlike the Registration and Product Listing requirement, which only applies to domestic U.S. manufacturing establishments, ingredient listing is required for all finished deemed tobacco products marketed in the United States, regardless of where the product was produced.[1]

Upcoming Deadlines

When the Deeming Rule became effective on August 8, 2016, FDA’s initial compliance policy required large deemed tobacco product manufacturers (i.e., manufacturers earning over $5M in annual revenues or who have over 150 full-time employees) to submit ingredient lists to FDA for all of their finished products by February 8, 2017; small-scale manufacturers had until August 8, 2017.  Over the course of 2017 these deadlines were extended several times for various reasons; now, large-scale manufacturers have until May 8, 2018 and small-scale manufacturers have until November 8, 2018.[2]  While it is always possible FDA could further push the deadlines back, we think it is unlikely to do so for ingredient listing.

Information Required

The ingredient listing process can be complicated and time consuming, particularly for manufacturers of e-liquids and vapor devices, for whom FDA has provided little specific guidance, and that may have hundreds of SKUs or more.  Broadly speaking, ingredient listing reports require the following:

  • Contact information for the manufacturer/submitter and U.S. agent;
  • A product list (similar to the product list U.S. manufacturers had to prepare for establishment registration);
  • For each product, a list of “components”;
  • For each component, a list of “ingredients” (e.g., single chemical substances and complex purchased ingredients); and
  • Specific information regarding each ingredient (e.g., quantity, ingredient number, SKU number, supplier information for complex purchased ingredients, etc.).

For more detailed background on the information needed to prepare ingredient listing reports, see our previous postings.

Submission Process

Although companies can submit ingredient listing reports manually to the CTP Document Control Center using the paper Form 3742, FDA encourages electronic submission through the CTP Portal.  This should not be confused with the separate FDA Unified Registration and Listing System (FURLS), which is only for U.S. Establishment Registration and Product Listing.  Obtaining CTP Portal access typically takes a few weeks, so you should apply for an account as soon as possible if you do not yet have one.

Only files that are packaged using FDA’s eSubmitter software can be submitted through the CTP Portal (download eSubmitter here). The eSubmitter tool does not transmit data over the Internet, but resides locally on your computer along with any output files, allowing you to work on a submission offline, save, and continue later.  Once a submission is complete, eSubmitter “packages” (i.e., compiles) the submission into a format that can be securely submitted through the CTP Portal.

Preparing Reports in eSubmitter

The eSubmitter tool contains templates for various FDA required submissions, including health documents and ingredient listing reports, among other things.

Of note, on March 5, 2018, FDA Center for Tobacco Products published a new set of instructions which provides a step-by-step guide on using eSubmitter to list ingredients in tobacco products.  At the same time, eSubmitter was updated to include two new options for preparing ingredient listing reports, which are discussed in the new instructions.

The first new option (“Option (c)”) allows for the use of a single spreadsheet to input ingredient information for all of a company’s products, rather than using multiple spreadsheets (Option (b)). The Option (c) spreadsheets come in both e-liquid specific (download here) and any tobacco templates (download here).

The second new option to attach your own spreadsheet (“Option (d)”) permits manufacturers to create and submit their own ingredient listing files in any format they wish.  While FDA requests that a spreadsheet be generated, eSubmitter will support the submission of a number of file types: .pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .sgml, .mol, .xls, .xlsx, .csv or .txt.

New eSubmitter Spreadsheets

The new Option (c) spreadsheets require all the same information as before, but has several unique differences compared to the original, multiple-spreadsheet method.  For example, now combinations of flavors and other additives can be saved as “master recipes” that can be added to any e-liquid formulations that contain it, along with levels of nicotine, PG and VG, making it easier to list ingredients for e-liquids that differ only in concentration of nicotine or other ingredients.  In addition, the Option (c) spreadsheets simplifiy the process of inputting component information, making it easier to, for example, “link” different bottle sizes to a formulation without re-inputting all the ingredient information. The new spreadsheet is also less cumbersome to complete and, so far, appears not to have as many bugs that often made importing the original tobacco ingredient spreadsheets into eSubmitter an onerous process (see our May 2017 webinar here which demonstrates how to use the original, multiple-spreadsheet method in eSubmitter).

E-liquid manufacturers should also keep in mind that the Option (c) e-liquid spreadsheet can only be used for the e-liquid component of a product; information regarding the other components of the finished product (e.g., bottle, cap/dripper, label, packaging, etc.) will need to be entered separately (either manually in eSubmitter or with a separate spreadsheet).

Manufacturers of vapor devices and hardware components, many of whom have argued that the current “ingredient” listing requirement and process does not make sense for such products[3], will also need to report ingredients to FDA either manually in eSubmitter, using the original multiple spreadsheet method, the Option (c) spreadsheet for products other than e-liquids, or by developing and submitting their own files as attachments using Option (d).

*          *          *          *

While the new eSubmitter spreadsheet options could make submitting ingredients to FDA easier for some manufacturers, the process still presents a significant time commitment.  Companies should not hesitate to start the process sooner rather than later.

If you need assistance with ingredient listing or for more information regarding other regulatory obligations facing deemed tobacco product manufacturers, distributors, importers, or retailers, please contact Azim Chowdhury at chowdhury@khlaw.com or 202-434-4230.

 

______________________________________________

[1]              A finished tobacco product is defined in the Deeming Rule and FDA guidance as “a tobacco product, including all components and parts, sealed in final packaging intended for consumer use. See FDA, Guidance for Industry (Revised)*: Listing of Tobacco Products, pg. 5 (Nov. 2017).

[2]           See FDA, Guidance for Industry (Revised)*: Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule (Nov. 2017).

[3]           See e.g., comment to the FDA Ingredient Listing Guidance document submitted by Shenzhen E-Vapor Industry Association (SEVIA) in May 2017, available at https://www.regulations.gov/document?D=FDA-2009-D-0524-0034.

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: 

 

In FDA’s latest effort to implement its comprehensive plan for tobacco and nicotine regulation, the Agency published two additional advanced notice of proposed rulemakings (ANPRMs) concerning regulation of premium cigars and tobacco product flavors.  Specifically, on March 21, 2018, the FDA published an ANPRM, “Regulation of Flavors in Tobacco Products,” which solicited comments on, among things, the role of flavors (other than tobacco) (hereinafter, “flavors”) on initiation and patterns of tobacco product use and on transitioning combustible to non-combustible tobacco product use.[1]  The next week, on March 26, 2018, the FDA published another ANPRM, “Regulation of Premium Cigars,” which requested input on the definition and use patterns of premium cigars as well as public health considerations associated with premium cigars.[2]  While these regulatory actions were initially promised in FDA’s July 28, 2017 comprehensive plan for tobacco and nicotine regulation, publication of the ANPRMs in the Federal Register provide an indication of the Agency’s regulatory priorities going forward. [3]

Flavored Tobacco Products ANPRM

In the ANPRM regarding regulation of tobacco product flavors, FDA requests comments on, among other topics, the following:

  • The Role of Flavors (other than tobacco) in Tobacco Products: FDA requested studies or information regarding the role of flavors generally in tobacco products, as well as the appropriateness of extrapolating research from other areas (e.g., consumer products) to the tobacco space.[4]
  • Flavors (other than tobacco) and Initiation and Patterns of Tobacco Product Use, Particularly Among Youth and Young Adults: FDA requested studies or information regarding the role of flavors in: (1) initiation and/or patterns of use of combusted and non-combusted tobacco products among youth and young adults; (2) in non-combusted tobacco products on initiation of tobacco product use or progression to use of other tobacco products among youth and young adults.[5]
  • Flavors (other than tobacco) and cessation, dual use, and relapse among current and former tobacco product users: FDA requested information on the role of flavors in helping adult cigarette smokers reduce cigarette use and/or switch to potentially less harmful tobacco products. Further, FDA requested studies or information concerning the role of flavors in non-combusted tobacco products on the likelihood of: (i) cessation of combusted tobacco product use; (ii) cessation of all tobacco product use; and (iii) uptake of dual use of combusted and non-combusted tobacco products among current and former tobacco product users.”[6]  FDA also requested information on the role of flavors in combusted products on the likelihood of: (1) delayed or impeded cessation among users who would have otherwise quit combusted tobacco product use; or (2) delayed or impeded cessation among users who would have otherwise quit all tobacco product use.  FDA also solicited studies or information regarding the role of flavors in non-combusted tobacco on the likelihood that former combusted tobacco product users relapse.[7]
  • Additional Public Health Considerations: FDA requested studies or information regarding (1) the potential toxicity or adverse health effects to the user or others from any flavors (e.g., flavor additives, compounds or ingredients) in tobacco products; (2) the impact of public health efforts by local jurisdictions, States, and members of the international community to impose restrictions on the manufacture, marketing, sale or distribution of all or a subset of tobacco products with flavors, including but not limited to, cigars, ENDS, menthol cigarettes, and smokeless tobacco products; (3) consumer perceptions of the health risk of tobacco products with flavors when compared to other tobacco products both with and without flavors; (4) consumer perceptions, if any, of the addictiveness of tobacco products with flavors.

In a contemporaneous statement accompanying the ANPRM, FDA Commissioner Scott Gottlieb, M.D called upon all stakeholders to “share data, research, and information that can inform our process for examining the role that flavors – including menthol – play in initiation, use and cessation of tobacco products.[1]  Importantly, the FDA Commissioner also requested “personal stories” from individuals that have been aided by flavors in making the transition between combustible tobacco cigarettes and vaping.  As seen in the litigation surrounding the deeming rule, these regulatory comments could be cited in any future litigation regarding either of these issues.

Comments are due on the tobacco product flavors ANPRM by June 19, 2018.

Premium Cigars ANPRM

In the preamble to the ANPRM regarding premium cigars, FDA noted that it received “numerous comments on the deeming proposed rule with respect to premium cigars, both in favor of, and against, regulating these products.”[8]  However, FDA explains that there was a lack of data supporting the opinions expressed in the comments received by the Agency regarding the Deeming Rule.  For that reason, the ANPRM explains that “FDA is seeking comments, evidence, information, data, and analysis that were not submitted in response to the proposed deeming rule” that could inform FDA’s thinking with respect to regulation of premium cigars.[9]

As an example of the type of information that would be responsive to the ANPRM, FDA cites a PATH Study Paper, which analyzed findings from the 2013-2014 Population Assessment of Tobacco and Health (PATH) Study with a focus on smokers of filtered cigars, cigarillos, and traditional cigars, which were further classified by study authors as either “premium” or “nonpremium.”[10]  That study concluded that “use characteristics, cigar smoking patterns, and dual smoking with cigarettes varied by cigar type.”[11]

Specifically, in the ANPRM, FDA requests comments on, among other topics, the following:

  • Definition of Premium Cigars: Among other things, FDA requested comments from the public concerning the defining characteristics of premium cigars, which may include: size; tobacco filler type; fermentation type; wrapper and binder composition; where the tobacco used for premium cigar filler or wrappers is grown; presence or absence of a filter or mouthpiece; manufacturing and assembly process; rate of production; presence or absence of flavor imparting compounds, flavor additives, or characterizing flavors other than tobacco; presence or absence of any additives other than cigar glue; nicotine content; tar and carbon monoxide delivery amounts; retail price; frequency with which price changes; packaging quantity and size; any action directed to consumers by a retailer or manufacturer.[12]
  • Use Patterns of Premium Cigars: FDA solicited studies or information regarding, among other things, and as compared to other cigars: (1) the potential role of premium cigars on tobacco initiation and progression to use of other tobacco products; (2) behavioral data related to dual use of premium cigars and other tobacco products; (3) the frequency and intensity of premium cigar use; (4) the proportion of premium cigar smokers showing symptoms of dependence; (5) the abuse liability of premium cigars; (6) the impact of premium cigar labeling, advertising, and marketing efforts on patterns of use.  Lastly, FDA also requested information on the extent to which users of other tobacco products might switch to premium cigars if FDA were to exempt premium cigars from regulation or regulate premium cigars differently from other cigars.[13]
  • Public health considerations associated with premium cigars: FDA requested studies or information regarding, among other things, and as compared to other cigars: (1) nicotine concentrations for premium cigars; (2) the risk of cancer, heart disease, aortic aneurysm, periodontal disease, stroke, and chronic obstructive pulmonary disease associated with premium cigar use; (3) the addictiveness, and consumer perceptions of the addictiveness, of premium cigars; (4) the required warning statements for premium cigars; and (5) the applicable manufacturing, marketing, sale, distribution, advertising, and labeling and/or packaging requirements and restrictions in the FDCA and its implementing regulations and whether they should be applied differently to premium cigars.

Comments are due on the premium cigar ANPRM by June 25, 2018.

Summary

An Advanced Notice of Proposed Rulemaking constitutes the earliest (and optional) stage of the administrative process that must be followed before eventually issuing an administrative rule.  As such, there is still ample time for efforts to influence the FDA’s regulatory approach to both premium cigars and tobacco product flavors by submitting comments to the administrative docket.  Companies or individuals interested in providing such feedback should consult with counsel to determine the best approach to maximize their impact with FDA.

[1]              See FDA, Statement from FDA Commissioner Scott Gottlieb, M.D., on Efforts to Reduce Tobacco Use, Especially Among Youth, by Exploring Options to Address the Role of Flavors – including Menthol – in Tobacco Products, https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM601690.htm?utm_source=CTPEblast&utm_medium=email&utm_term=sro&utm_content=pressrelease&utm_campaign=ctp-flavanprm.

[1]              Regulation of Flavors in Tobacco Products, 83 Fed. Reg. 12294 (Mar. 21, 2018);

[2]              Regulation of Premium Cigars, 83 Fed. Reg. 12901 (Mar. 26, 2018).

[3]              FDA News Release, FDA Announces Comprehensive Regulatory Plan to Shift Trajectory of tobacco-related disease and death (July 28, 2017), https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm568923.htm.

[4]              83 Fed. Reg. 12994, 12998-99 (Mar. 21, 2018).

[5]              83 Fed. Reg. 12999.

[6]              Id.

[7]              Id.

[8]              83 Fed. Reg. 12901, 12902 (Mar. 26, 2018).

[9]              83 Fed. Reg. 12902. (emphasis added).

[10]             83 Fed. Reg. 12902-03, citing, Catherine G. Corey, MPSH et al., U.S. Adult Cigar Smoking patterns, Purchasing Behaviors, and Reasons for Use According to Cigar Type: Findings from the Population Assessment of Tobacco and Health (PATH) study, 2013-2014, Nicotine & Tobacco Research (Sept. 15, 2017), available at https://academic.oup.com/ntr/advance-article-abstract/doi/10.1093/ntr/ntx209/4159211?redirectedFrom=fulltext.

[11]             Catherine G. Corey, MPSH et al., U.S. Adult Cigar Smoking patterns, Purchasing Behaviors, and Reasons for Use According to Cigar Type: Findings from the Population Assessment of Tobacco and Health (PATH) study, 2013-2014, Nicotine & Tobacco Research (Sept. 15, 2017), available at https://academic.oup.com/ntr/advance-article-abstract/doi/10.1093/ntr/ntx209/4159211?redirectedFrom=fulltext.

[12]             83 Fed. Reg. 12903.

[13]             83 Fed. Reg. 12904.

nicotine-in-cigarette (002)

 

In the U.S. Food and Drug Administration’s (FDA’s) latest effort to implement its comprehensive regulatory plan[1] to shift the trajectory of tobacco-related disease and death, the Agency issued, on March 15, 2018, an advanced notice of proposed rulemaking (ANPRM) to obtain information for consideration in developing a tobacco product standard to set a maximum nicotine level for cigarettes.[2]  As described in a contemporaneous statement issued by FDA Commissioner Scott Gottlieb, M.D., the ANPRM provides a wide-ranging review of the current scientific understanding about the role nicotine plays in addiction.[3]  Moreover, the ANPRM clarifies that FDA is considering “issuance of a product standard to set a maximum nicotine level in cigarettes so that they are minimally addictive or nonaddictive.”[4]

As detailed below, FDA requests in the ANPRM comments on, among other topics, the following:

  • Scope: Should the potential maximum nicotine level apply only to cigarettes or should it include other combustible tobacco products as well?
  • Maximum Nicotine Level: What is the maximum nicotine level that should be used as the threshold for “minimally addictive” or “non-addictive” levels?
  • Implementation: Should the maximum nicotine level for cigarettes propose a single target (where nicotine is reduced all at once or a stepped-down approach (where nicotine is reduced gradually over time through a sequence of incremental levels)?  Relatedly, what is the proper timeframe to implement a possible maximum nicotine level?
  • Analytical Testing Method: Should FDA specify a method for manufacturers to use to detect the level of nicotine in their products? If so, which method should be used?

Comments are due by June 14, 2018.

Scope of FDA’s Proposed Tobacco Product Standard

In the ANPRM, FDA seeks comments on whether the standard should cover any or all of the following products:  combusted cigarettes (which FDA has previously interpreted to include kreteks and bidis), cigarette tobacco, roll-your-own (RYO) tobacco, some or all cigars (e.g., including large and “premium” cigars), pipe tobacco, and waterpipe tobacco.[5]  Importantly, the Agency explains that “any nicotine tobacco product standard would cover all brands in a particular product category and, therefore, those products currently on the market and any new tobacco products would be expected to adhere to the standard.”[6]  Key questions raised by the ANPRM also include whether so-called “premium” cigars should be regulated differently from other cigars and whether waterpipe tobacco products should be excluded because they are unlikely to be migration substitutes or dual use candidates.[7]

Identification and Implementation of Appropriate Maximum Nicotine Level

With respect to nicotine levels in cigarettes, FDA requested comments on a potential maximum nicotine level that would be “minimally addictive” or “non addictive” and appropriate for the protection of public health, recognizing that the Family Smoking Prevention and Tobacco Control Act specifically prohibits FDA from “requiring the reduction of nicotine yields of a tobacco product to zero.”[8]  Indeed, FDA is particularly interested in comments concerning the merits of nicotine levels of 0.3, 0.4, and 0.5 mg nicotine/g of tobacco filler.[9]  In addition, the ANPRM requests comments on how any potential maximum nicotine level should be measured (e.g., nicotine yield, nicotine in tobacco filler, something else), how the threshold of nicotine addiction should be measured, and whether the product standard should specify a method for manufacturers to use to detect the level of nicotine in their products.[10]  Further, FDA requests comments on whether a maximum nicotine level for cigarettes should propose either a single target (where the nicotine is reduced all at once) or a stepped-down approach (where the nicotine is reduced gradually over time through a sequence of incremental levels and implementation dates).[11]

Technical Challenges Associated with Implementation

The ANPRM also acknowledges the technical challenges associated with implementation of a maximum nicotine standard.  Indeed, FDA explains that “significant nicotine reductions in cigarettes and other combusted tobacco products can be achieved principally through tobacco blending and cross-breeding plants, genetic engineering, and chemical extraction.”[12]  Similarly, FDA notes that “agricultural practices (e.g., controlled growing conditions, fertilization, and harvest) as well as more recent, novel techniques also can help to reduce nicotine levels.”  With that in mind, FDA explains that it is considering the proper timeframe to allow adequate time for industry to comply with a possible tobacco product standard setting a maximum nicotine level.  Relatedly, the ANPRM requests data and information regarding the potential costs, including the potential costs to farmers, to implement such a standard.

Countervailing Effects of Potential Nicotine Standard

Notably, the ANPRM also outlines several possible countervailing effects of a potential nicotine tobacco product standard, including: (1) continued combustible tobacco product use (e.g., current users switching to, or using simultaneously (i.e., dual use), a different combusted tobacco product to maintain their nicotine dependence; (2) continued very low nicotine cigarette smoking with altered behaviors (e.g., increase in number of cigarettes smoked, increased depth of inhalation); (3) cigarette users adding nicotine in liquid or other form to their combusted tobacco product; and (4) increased illicit trade of tobacco products.[13]  FDA plans to consider each of these potential unintended consequences before moving forward with issuing a potential maximum nicotine level for combustible tobacco products.

Projected Health Benefits

As explained in FDA Commissioner Gottlieb’s statement accompanying the ANPRM, new estimates included in the ANPRM and to be published in the New England Journal of Medicine, evaluate a potential policy scenario whereby a maximum nicotine level is implemented.  By the year 2100, the median estimate from the model, based on the experts’ estimates of potential initiation rates because of the policy, is that more than 33 million youth and young adults who would have otherwise initiated regular smoking would not start as a result of the hypothetical policy scenario.[14]  Further, using expert estimates for the percent of current smokers who would quit smoking after implementation of the policy, approximately 5 million additional smokers are estimated to quit smoking within one year after implementation of the standard.[15]  Under the same model, by 2060, it is estimated that a median value of almost 3 million deaths due to tobacco would be avoided.[16]

Impact of Potential Maximum Nicotine Level on Electronic Nicotine Delivery Systems (ENDS)

Of note for the vapor industry, in the Agency’s discussion of the effects of FDA’s potential tobacco product standard establishing a maximum nicotine level for cigarettes, FDA essentially acknowledges, as it has in the past, that ENDS products are less harmful than cigarettes.  Indeed, FDA explains “former smokers that choose to switch completely to a potentially less harmful nicotine product (e.g., electronic nicotine delivery systems (ENDS)) to maintain their nicotine dose also would, to the extent that those products result in less harm, significantly reduce their risk of tobacco-related death and disease.”[17]  By implication, this statement appears to tacitly accept that current combustible tobacco product users are likely to switch to ENDS products not covered by the potential maximum nicotine level rule.

Indeed, this result was recognized in a 2018 update (discussed in the ANPRM) to a previously published discrete system dynamic population model that compared projected outcomes for a status quo scenario (in which no maximum nicotine level is implemented) with outcomes for a policy scenario in which a hypothetical regulation lowering nicotine in cigarettes and selected other combusted tobacco products, to minimally addictive levels.[18]  Importantly, the model of the potential effects of the maximum nicotine level for cigarettes projected a simultaneous reduction in cigarette smoking and an increase in non-combusted tobacco product use.[19]   Lastly, in an industry conference call held on March 15, 2018 to announce the ANPRM, Mitch Zeller, the Director of the Center for Tobacco Products, expressly acknowledged the Agency’s obligation under Commissioner Gottlieb’s new comprehensive plan to ensure that nicotine remains on the market in less harmful forms as FDA works to implement a potential maximum nicotine level for combustible cigarettes.

 

______________________________________________________

[1] FDA News Release, FDA Announces Comprehensive Regulatory Plan to Shift Trajectory of tobacco-related disease and death (July 28, 2017), https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm568923.htm.

[2] FDA, Tobacco Product Standard for Nicotine Level of Combusted Cigarettes Advanced Notice of Proposed Rulemaking (ANPRM), available at https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-05345.pdf (pre-publication copy), at 1.

[3] FDA Statement, Statement from FDA Commissioner Scott Gottlieb, M.D., on Pivotal Public Health Step to Dramatically Reduce Smoking Rates by Lowering Nicotine in Combustible Cigarettes to Minimally or Non-Additive Levels, https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM601039.htm?utm_campaign=Statement_ANPRM%20to%20reduce%20nicotine%20in%20cigs&utm_medium=email&utm_source=Eloqua.

[4] Id., at 6

[5] Id., at 7.

[6] Id., at 8.

[7] Id., at 33.

[8] 21 U.S.C. § 387g(d)(3)(B)

[9] Tobacco Product Standard for Nicotine Level of Combusted Cigarettes Advanced Notice of Proposed Rulemaking (ANPRM), at 9.

[10] Id., at 9.

[11] Id., at 9

[12] Id., at 10.

[13] Id., at 10-12; See also FDA, Draft Concept Paper, “Illicit Trade in Tobacco Products after Implementation of an FDA Product Standard (Mar. 15, 2018), available at https://www.fda.gov/downloads/tobaccoproducts/newsevents/ucm601047.pdf.

[14] Id., at 74.

[15] Id., at 75.

[16] Id., at 75.

[17] Id., at 26.

[18] Id., at 69.

[19] Id., at 74.

UST-2016

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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[1]  21 U.S.C. § 387j(a)(1) and (2).

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

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