Photo of Azim Chowdhury

Keller and Heckman is pleased to announce the agenda for this year’s E-Vapor and Tobacco Law Symposium. This comprehensive 2-day course will provide you with guidance on how to stay in compliance with FDA’s recent announcements and much more. Click here to view the agenda.

Topics that will be covered include: FDA and State law compliance, HPHCs and PMTAs, Advertising and Marketing, European Union and Global laws, Environmental, OSHA and CPSC compliance, CBD and cannabis-derived products, and more!

To register, click here.

Seminar Details:
Date: January 29 – 30, 2019
Cost: $899 if you register by January 4, 2019; $1,099 if you register after January 4, 2019
*register 3 or more attendees from the same company and receive a 10% discount. Email seminars@khlaw.com for additional information.

Continuing Legal Education (CLE)
CLE credits are available, pending state approval

Location

Marriott Miami Biscayne Bay
1633 N Bayshore Drive
Miami, FL 33132

Keller and Heckman has negotiated a preferred room rate of $259 per night, plus tax at the Marriott Miami Biscayne Bay. Reservations must be received no later than January 7, 2019. To make your reservation, please click here.

This year’s E-Vapor and Tobacco Law Symposium will feature a conference app; stay tuned for details on downloading the app!

Photo of Azim ChowdhuryPhoto of Benjamin Wolf

As a reminder, the registration requirement for domestic U.S. tobacco product manufacturing establishments, including manufacturers of deemed products such as e-liquids and cigars, is a biannual obligation that requires each such establishment to “update” their Registration and Product Listing information with FDA by December 31 every year (product listing information must also be updated by June 30 every year). See Section 905(b) of the Food, Drug, and Cosmetic Act (FDCA) as amended by the Family Smoking and Tobacco Control Act, 21 U.S.C. 387e(b).

FDA strongly encourages electronic submission of establishment Registrations and Product Listings through the FDA Unified Registration and Listing System (FURLS) which can be accessed here.  By December 31, 2018, all domestic manufacturers of tobacco products will need to log in to their FURLS accounts and confirm that the registration information in the system is correct (or make any necessary changes), and domestic manufacturers of deemed products who updated their product labels after June 30, 2018 to comply with the nicotine addiction warning and other labeling requirements (which became effective on August 10, 2018), will need to upload their new labels and associate them with the correct products.  Domestic manufacturers who have otherwise changed the list of products they manufacture or the label or labeling, advertising, or consumer information for their products will also need to update their product list and associated information.

Although FURLS was recently updated with a more user-friendly interface, the system is notorious for running slowly and glitches during high use periods should be expected (especially if users are attempting to upload many large files).  We encourage anyone who needs to update files in FURLS to develop a plan and to start updates as soon as possible ahead of the deadline.

Tobacco products that are produced in an establishment that is not registered are considered misbranded per FDCA § 903(a)(6) (21 U.S.C. 387c(a)(6)); the sale of a misbranded product is a prohibited act under FDCA § 301(a). In addition, failure to update a tobacco product list or to register a facility are violations of FDCA § 301(p) (21 U.S.C. 331(p)) and can lead to enforcement actions such as fines, seizures, or injunctions.

If you have any questions or need assistance updating your Registration and Listing, please contact Azim Chowdhury at chowdhury@khlaw.com or 202-434-4230 or Ben Wolf at wolf@khlaw.com or 202-434-4103.

Learn how to stay in compliance with FDA’s recent announcements and much more at Keller and Heckman’s upcoming E-Vapor and Tobacco Law Symposium on January 29 – 30, 2019, in Miami, Florida. Below is a sampling of topics that will be covered at the event. Sign up now and take advantage of our early bird discount!

FDA Regulation Update and Preparing for What’s Next
Azim Chowdhury

  • FDA’s New Announcement: How it Will Impact Your Business
  • Product Compliance Overview: Vapor, Cigars, Hookah
  • Flavors and Product Standards
  • Reporting on Harmful and Potentially Harmful Constituents (HPHCs)
  • Premarket Review for Deemed Tobacco Products
  • PMTAs, SE Reports, and Using Master Files
  • Potential Over-the-Counter Drug Pathway
  • Status of Proposed Rulemakings
  • Modified Risk Tobacco Products
  • Online Sales – “Heightened” Age-Verification
  • Retailer Compliance and Adults-Only Requirement
  • Enforcement and Penalties
  • …and much more!

FDA Inspections: Are You Prepared?
Azim Chowdhury and Daniel Rubenstein

  • Overview of FDA Inspection Authority
  • Update on Tobacco Product Manufacturing Practices
  • The FDA Inspection: Before, During and After
  • Enforcement and Penalties
  • Keller and Heckman’s Audit and Inspection Program (AIP)

Key Litigation Update
Eric Gotting

  • Nicopure and Right to be Smoke-Free Coalition v. FDA (Deeming Rule Appeal)
  • American Academy of Pediatrics v. FDA
  • Potential Upcoming Litigation (e.g., flavor and convenience store bans)

Environmental Issues Affecting Nicotine-Containing Products
JC Walker

  • Overview of Hazardous Waste Regulations Governing E-Liquid Manufacturers and Distributors
  • Considerations for Minimizing Regulatory Exposure

OSHA’s Hazard Communication Standard and Considerations for the E-Liquid Industry
Manesh Rath

  • Overview of OSHA’s Hazard Communication Standard (HCS)
  • Scope of Standard and Exemptions
  • Safety Data Sheets (SDSs)
  • Labeling
  • Employee Training
  • Future Challenges for E-liquid Industry

Advertising and Marketing: Implications for Global Public Policy and the Role of Self-Regulation
Sheila Millar

  • Marketing Practices: Impact on Public Perception, Regulations, Enforcement and Litigation
  • Expanding Global Concerns About Child-Appealing Marketing
  • Creating and Implementing Effective Advertising Self-Regulation

Business, IP, and Advertising Issues – How to Stay in Compliance                                       
Tracy Marshall and Bob Niemann

  • Drafting and Negotiating Vendor, Manufacturing, and Distribution Agreements
  • Insurance Policies for Vapor Companies
  • Protecting Trademarks, Copyrights, and Trade Secrets and Avoiding IP Infringement
  • Privacy and Data Security
  • Using Digital Marketing to Promote Your Business
  • Conducting Contests, Sweepstakes, and Other Promotions

State Law Update
Azim Chowdhury

  • Overview of State permit, licensing and tax requirements for tobacco and vapor products
  • Age-verification and delivery requirements

CBD and Cannabis – Legal Overview and Practical Tips for Businesses
Chris Van Gundy

  • Latest on Federal and State Developments
  • Legal Issues in Sourcing
  • Tinctures, E-liquids, Edibles and “Medibles”
  • Risk Mitigation Checklist
  • FDA Considerations
  • State Requirements: Florida

How to Sell Your Products in the EU (Without Getting into Problems): TPD and Beyond
Marcus Navin-Jones

  • Refresher on TPD Requirements
  • EU Requirements which Apply in Addition to the TPD
  • EU Law vs National Law: Areas where EU Countries are Allowed to Have their Own Rules
  • Recalls Withdrawals and Legal Crisis Management.
  • Brexit and How Brexit is Affecting the Vape Industry

Going International: Preparing Your Business for Global Compliance
David Ettinger

  • Current Regulatory Status of Vapor Products Around the World
  • China and Asia
  • New Zealand
  • Australia
  • Russia, India, Middle East, and More
  • World Health Organization

In addition to the topics above, we will also have special guest speakers from Cardno ChemRisk, Broughton Laboratories and others on topics including Premarket Tobacco Product Applications and HPHC Reporting. Stay tuned for the full agenda!

To register, click here.

Seminar Details:
Date: January 29 – 30, 2019
Cost: $899 if you register by January 4, 2019; $1,099 if you register after January 4, 2019
*register 3 or more attendees from the same company and receive a 10% discount. Email seminars@khlaw.com for additional information.

Continuing Legal Education (CLE)
CLE credits are available, pending state approval

Location
Marriott Miami Biscayne Bay
1633 N Bayshore Drive
Miami, FL 33132

Keller and Heckman has negotiated a preferred room rate of $259 per night, plus tax at the Marriott Miami Biscayne Bay. Reservations must be received no later than January 7, 2019. To make your reservation, please click here.

For additional information, please contact:

Sara A. Woldai, CMP
Manager, Marketing Meetings and Events
woldai@khlaw.com
202.434.4174

Photo of Azim ChowdhuryPhoto of Benjamin Wolf

The U.S. Food and Drug Administration (FDA) is expected to announce today detailed plans to curtail the growing number of youth who are using certain types of e-cigarette products. Below is a summary of the Agency’s recent actions and compliance deadlines.

September 12, 2018 Letters to Vuse, Blu, JUUL, MarkTen XL, and Logic

  • On September 12, FDA sent letters to the manufacturers of five Electronic Nicotine Delivery System (ENDS) products (Vuse [British America Tobacco], Blu [Imperial Brands], JUUL [JUUL Labs], MarkTen [Altria] and Logic [Japan Tobacco]) “requiring them to submit important documents to better understand the reportedly high rates of youth use and the particular youth appeal of their products.”  These cartridge-based (closed system) products account for 97% of the closed-system cartridge-based e-cigarette market.
  • FDA indicated that it believes e-cigarette use by youth “is reaching epidemic proportions”.  FDA Commissioner Dr. Scott Gottlieb asked the five manufacturers to “come back to the FDA in 60 days with robust plans on how they’ll convincingly address the widespread use of their products by minors, or [FDA will] revisit the FDA’s exercise of enforcement discretion for [flavored ENDS] products currently on the market.”  Dr. Gottlieb continued, “This may require those brands to revise their sales and marketing practices, including online sales; to stop distributing their products to retailers who sell to kids; and to remove some or all of their flavored e-cig products from the market until they receive premarket authorization and otherwise meet applicable requirements.”
  • In an October 31 Statement,  Commissioner Gottlieb announced that he had met with the five manufacturers and heard their comments and proposals on how each company would address sales to minors, and how each company thought FDA should regulate to address the same issue.  Altria subsequently announced that it would cease sales of its MarkTen cartridge-based products, as well as its flavored cigalike products other than tobacco and menthol; Fontem Ventures indicated it will tighten its age-verification process and raise the age for online sales to 21;  and JUUL has announced that it will only permit the sale of flavored products (e.g., cucumber, mango, crème and fruit) through its age-verified online-store, while restricting brick-and-mortar retailers to only tobacco, mint and menthol-flavored pods. JUUL further announced it would be increasing retailer compliance efforts, reduce its social media presence, and develop technology to further reduce the use of its products by youth.

October 12, 2018 Letters to 21 Manufacturers Regarding Potentially Unauthorized New Tobacco Products

  • On October 12, FDA “sent letters to 21 e-cigarette companies . . . seeking information about whether more than 40 products . . . are being illegally marketed and outside the agency’s current compliance policy.”  These letters asked manufacturers to provide documentation within 30 days of receipt demonstrating that the identified products were on the market on August 8, 2016 and have not been modified since that date.
  • This effort is a clear indication that FDA intends to ramp up its enforcement of the marketing authorization provisions and that ENDS products introduced to the market after August 8, 2016 can expect enforcement.

October 22 – 23, 2018 FDA Public Meeting on Tobacco Product Application Review

  • FDA held a meeting (video available) to discuss FDA’s review of premarket applications.
  • Topics included:
    • Substantial Equivalence (and requests for exemption);
    • Premarket Tobacco Product Applications (PMTAs);
    • Modified Risk Tobacco Product Applications (MRTPAs);
    • Pre-submission meetings;
    • Tobacco Product Master Files (TPMFs);
    • Resources available;
    • Environmental Assessments; and
    • Newly Deemed Tobacco Products

November 8, 2018 Ingredient Listing for Small-Scale Tobacco Product Manufacturers

  • Ingredient Listing submissions were due to FDA on November 8 for small-scale manufacturers of Newly Deemed Tobacco Products.  Ingredient listing is a requirement for all tobacco products marketed in the United States, regardless of where manufactured.  For more on ingredient listing, see our most recent blog posts here and here (all ingredient listing related posts are here).
  • For small-scale manufacturers impacted by recent natural disasters, FDA has extended the deadline to submit until May 8, 2019.
  • In a revised guidance published in April 2018, FDA clarified that it now intends to enforce the ingredient listing requirement only with respect to those tobacco product components or parts, such as e-liquids, that are made or derived from tobacco, or contain ingredients that are burned, aerosolized or ingested (i.e., consumed) during use.

December 5, 2018 Public Hearing Announced to Discuss FDA’s Efforts to Eliminate Youth Electronic Cigarette Use

  • As previously reported on Keller and Heckman’s Daily Intake blog, On November 2, 2018 FDA announced a public hearing scheduled for December 5, 2018 to discuss continued efforts to curb e-cigarette use and to aid cessation amongst youth. Topics of interest noted in Dr. Gottlieb’s press release focus on cessation and include:
    • Potential role of drug therapies to support cessation of e-cigarettes and traditional tobacco products use (including cigarettes and smokeless tobacco) amongst youth;
    • Behavioral interventions to aid in cessation;
    • Development of cessation drugs;
    • Development of methods, study designs, and measures for evaluating drugs for use in youth cessation; and
    • Funding opportunities for research on youth use, attitudes, and cessation.

Modification to FDA’s Unified Registration and Listing System Tobacco Registration and Listing Module

  • In early November, FDA updated its FDA Unified Registration and Listing (FURLS) Tobacco Registration and Listing Module (TRLM) to be more user friendly.  The information required for registering a facility and providing product lists does not appear to have changed, but the process should be simpler and more user-friendly.
  • As a reminder, facility registrations must be renewed annually by December 31. Changes to product lists to reflect new products being manufactured, products no longer being manufactured, or changes to labeling/packaging, advertising, or consumer information, must be made by June 30 and December 31 every year.  This means that any labels that have changed to include FDA’s required nicotine warning statement, for example, will need to be updated in FURLS.

Impending FDA Actions

  • In recent weeks, FDA has announced through the press that it is considering banning, or otherwise severely limiting, the sales of flavored (except tobacco and menthol), cartridge-based e-liquids in convenience stores and gas stations, and that it is considering proposing a rule to ban menthol in cigarettes as well as characterizing flavors in other combusted tobacco products (e.g., cigars).

We will report further as additional details of any marketing or other restrictions are released.

Photo of Azim Chowdhury

Azim Chowdhury and Sam Jockel have been published in the latest Issue of Food and Drug Law Institute Update Magazine, “Spotlight on Tobacco – Future Developments in the Regulation of Electronic Nicotine Delivery Systems: Potential Over-the-Counter Pathway.” Update is open access online. To read the article, click here. This article is republished with the permission of FDLI.

Photo of Azim ChowdhuryPhoto of Kristina DiPano

On May 23, 2018, Bill S-5 (“An Act to amend the Tobacco Act and the Non-smokers’ Health Act and to make consequential amendments to other Acts”) became law in Canada, representing a major shift in Canada’s regulatory framework, as the Bill establishes a nationalized approach to the regulation of vaping products and tobacco products through the implementation of the Tobacco and Vaping Products Act (TVPA).

This legislation represents a milestone for vaping products. Prior to the TVPA, vaping products were not expressly acknowledged as legal at the federal level in Canada. Further, vaping products containing nicotine were regulated under the Food and Drugs Act and required premarket approval. Canada’s modernized approach seeks to strike a balance between the goals of restricting access to tobacco and vaping products for minors, while allowing adult smokers to access vaping products and less harmful alternatives to traditional tobacco products.

 General Overview of the TVPA and Related Legislation

Under the new TVPA framework, vaping products that are not marketed with therapeutic claims are now legal and may be manufactured, distributed, and sold in Canada.[1] A “vaping product” is defined in Section 2 (Interpretation) of the TVPA as: (a) a device that produces emissions in the form of an aerosol and is intended to be brought to the mouth for inhalation of the aerosol; (b) a device that is designated to be a vaping product by the regulations; (c) a part that may be used with those devices; and (d) a substance or mixture of substances, whether or not it contains nicotine, that is intended for use with those devices to produce emissions.  Therefore, e-liquids, including zero-nicotine e-liquid, fall within this definition.

While vaping products will be permitted under the TVPA, they will be subjected to substantial regulation. The Act addresses the manufacture, sale, labeling, and promotion of tobacco products and vaping products, and major provisions will:

  • Largely apply existing tobacco regulations to vaping products[2];
  • Prohibit the sale of vaping products to minors[3];
  • Place heavy restrictions on advertising and promotion of vaping products by restricting lifestyle advertising, use of testimonials, and related claims[4];
  • Restrict the promotion of certain flavors—especially those that may allegedly appeal to minors, e.g., dessert flavors[5]; and
  • Empower Health Canada to implement regulations, including plain and standardized tobacco packaging.[6]

Certain provisions of the TVPA became effective upon Bill S-5 receiving Royal Assent on May 23, 2018 (e.g., prohibition on sale to youth), while other provisions give manufacturers and importers 180 days to comply, following Royal Assent (e.g., provisions that prohibit the manufacture and sale of vaping products containing an ingredient set out in Schedule 2, such as “colouring agents”).

Promotional Claims

Stakeholders and Health Canada are working together to ensure that the various restrictions set out in the TVPA, including those impacting promotional claims and advertising, are not overly burdensome.[7] Health Canada has acknowledged competing interests that push back on its obligation to ensure that the public is not misled by promotional practices, including a strong interest in allowing adults to access the information needed to make informed decisions about the vaping products available on the market (especially adults who are working to quit the use of tobacco products). One example is the current dialogue between Health Canada and stakeholders related to TVPA Section 30.43. Specifically, while TVPA Section 30.43 seeks to prohibit the use of certain promotional statements, e.g., statements that could lead a consumer to believe that certain health benefits will result from vaping, Health Canada has distributed a draft list of relative risk statements about vaping products that would be permitted under the TVPA, if finalized.[8] The September 4, 2018 draft of the “List of Statements for Use in the Promotion of Vaping Products” was circulated, and Health Canada accepted comments until September 17, 2018.[9] The list is now under review with the Scientific Advisory Board on Vaping Products (SAB). The seven proposed statements are:

  1. If you are a smoker, switching completely to vaping is a much less harmful option;
  2. While vaping products emit toxic substances, the amount is significantly lower than in tobacco smoke;
  3. By switching completely to vaping products, smokers are exposed to a small fraction of the 7,000 chemicals found in tobacco smoke;
  4. Switching completely from combustible tobacco cigarettes to e-cigarettes significantly reduces users’ exposure to numerous toxic and cancer-causing substances;
  5. Completely replacing your cigarette with a vaping product will significantly reduce your exposure to numerous toxic and cancer-causing substances;
  6. Switching completely from smoking to e-cigarettes will reduce harms to your health; and
  7. Completely replacing your cigarette with an e-cigarette will reduce harms to your health.

While the list has not yet been finalized, the collaborative effort between Health Canada and stakeholders in bringing clarity to the TVPA through exemptions and other regulatory measures evidences an effort to balance the goals of the legislation. This is in stark contrast to the Tobacco Control Act in the United States, which bans all “modified risk” claims made with FDA authorization. As we have previously blogged about here, this provision of the Tobacco Control Act is being challenged by the vapor industry.

Related Legislation

Additional legislation, such as Canada’s Food and Drugs Act and the Non-smokers’ Health Act, will play a role in the approval of vaping products that contain therapeutic claims and will address other issues, such as exposure to second-hand smoke in public spaces and workplaces. The Canada Consumer Product Safety Act (CCPSA) will also play a role in the regulation of vaping products as a whole.

The CCPSA sets forth mandatory reporting and document retention requirements, as well as a prohibition on the manufacture, import, advertisement, or sale of any consumer product that is a “danger to human health or safety,” as defined by Paragraphs 7(a) and 8(a) of the CCPSA. Further, the CCPSA empowers Health Canada to order recalls (including less severe actions, depending on degree of risk), as well as to order that testing be conducted on the consumer product of interest.[10]

Health Canada intends to introduce regulations under the CCPSA to address health and safety risks posed by vaping products. While there are currently no product-specific regulations for vaping products under the CCPSA, the CCPSA and applicable regulations, including the Consumer Chemicals and Containers Regulations, 2001 (CCCR), will apply until regulations specific to vaping products are implemented.  After specific regulations take effect, general provisions of the CCPSA will continue to apply.

Canada’s Guidance Document, Vaping Products not Marketed for a Therapeutic Use (July 12, 2018), provides an overview of the health and safety requirements that exist under the CCPSA and related CCCR regulations that relate to vaping products marketed without therapeutic claims (i.e., vaping products that are not regulated as drugs under Canada’s Food and Drugs Act). The CCCR sets forth a classification-based approach to rules for consumer chemicals, including a prohibition on the sale of very toxic substances and requirements for labeling.  Child-resistant containers are also required for toxic substances.

Importantly, Section 3 of Health Canada’s Guidance Document summarizes the classifications related to nicotine that are applicable to vaping products “manufactured, imported, advertised, or sold as consumer products.” The summary from the Guidance Document states the following:

  1. Vaping liquids containing equal to or more than 66 mg/g nicotine meet the classification of “very toxic” under the CCCR, 2001 and are prohibited from being manufactured, imported, advertised, or sold under Section 38 of the CCCR, 2001.
  2. Vaping liquids containing between 10 mg/g and less than 66 mg/g nicotine meet the classification of “toxic” under the CCCR, 2001.  Stand-alone containers of these liquids must meet the CCCR, 2001 requirements for “toxic” chemicals, including child-resistant containers and hazard labelling.
  3. While the CCCR, 2001 excludes ingredients present between 0.1 mg/g and 10 mg/g when calculating a chemical product’s toxicity, Health Canada has determined that nicotine is potentially toxic via oral exposure in this concentration range. Therefore, vaping liquids containing nicotine between 0.1 mg/g and 10 mg/g or under 1% (m/m) (representations of nicotine concentration in mg/mL and mg/g are not necessarily interchangeable as mass varies with the density of the vaping liquid) that do not meet the requirements for the “toxic” classification under the CCCR, 2001 are a violation of the general prohibition set out in Paragraphs 7(a) or 8(a) of the CCPSA and are subject to enforcement action.

Section 4.3 of the Guidance Document (“Vaping Liquid Considerations”) describes additional considerations regarding whether a consumer product that is a “danger to human health or safety,” as defined by Paragraphs 7(a) and 8(a) of the CCPSA. As noted above, products that are considered to be a “danger to human health or safety” may not be manufactured, imported, advertised, or sold as a consumer product. Specific considerations for e-liquids include those related to nicotine, as described above, diluents, additives and flavors, impurities and thermal degradations products, and microbial contamination. Considerations for vaping devices focus on electrical and mechanical aspects of the product, batteries, and chargers.

Importing E-liquids into Canada from the United States

Under the TVPA, vaping products such as e-liquids may now be imported into Canada, according to Customs Notice 18-05.[11] A step-by-step guide to importing commercial goods into Canada is available here, which serves as a valuable tool.

While many manufacturers and distributors have looked to Canada as a potential market, navigating the process of importing vaping products does not come without its challenges. In addition to licensing and permits, tariff classification numbers are needed for each item, and duties and taxes must be determined prior to shipping the goods and having them released from customs. Further, provincial or territorial legislation may impose additional requirements that retailers must follow. We expect that additional guidance will be forthcoming in this regard.

Joint Efforts to Regulate Vaping Products in North America

The North American Vapor Alliance (NAVA) recently emerged as an outlet to ensure practical regulation of vaping products, and to create a unified approach to standards and regulatory regimes across the U.S. and Canada. On September 5, the American E-Liquid Manufacturing Standards Association (AEMSA), the Smoke-Free Alternatives Trade Association (SFATA), and the Canadian Vaping Association (CVA) announced that they would be engaging in this joint effort. For a copy of the press releases, see here and here.

We will continue to provide updates regarding the evolving regulatory landscape that will impact vaping products in Canada.

For more information, contact Azim Chowdhury (+1 202.434.4230, chowdhury@khlaw.com). For more information on our tobacco and e-vapor regulatory practice in general, visit khlaw.com/evaporFollow Keller and Heckman Tobacco and E-Vapor Partner Azim Chowdhury on Twitter.

 

__________________________________

[1]              We note that vaping products that make therapeutic claims continue to fall within the scope of Canada’s Food and Drugs Act and require premarket approval.

[2]              See TVPA, Part I.1 (Vaping Products); see also Part III (Labelling).

[3]              TVPA, Part II (Access).

[4]              TVPA, Part IV (Promotion), Division 2 (Vaping Products).

[5]              See TVPA, Sections 30.48 and 30.49 and the “Flavours” table set out in Schedule 3.

[6]              See Canada Gazette, Part I, Volume 152, Number 25: Tobacco Products Regulations (Plain and Standardized Appearance.

[7]              See, e.g., TVPA, Sections 30.1 through 30.8.

[8]              In preparing the list of statements, Health Canada considered public opinion from the 2018 Public Health Consequences of E-Cigarettes report, prepared by the U.S. National Academies of Sciences, Engineering and Medicine (report highlights are available here), and consulted with the external Scientific Advisory Board on Vaping Products (SAB).

[9]              The draft list of statements was circulated in a September 4, 2018 email from Mathew Cook, Manager of the Regulations Division of the Tobacco Products Regulatory Office, which is part of Health Canada’s Tobacco Control Directorate.

[10]             See Sections 12(a), 31, and 32 of the CCPSA.

[11]             “Commercial shipments of vaping products with no health claims and no health product ingredients (can contain nicotine as a sole ingredient) may now be imported into Canada under the TPVA [sic].”  (See Customs Notice 18-05 (May 24, 2018), Paragraph 5).

Registration is open for Keller and Heckman’s 3rd Annual E-Vapor and Tobacco Law Symposium being held January 29-30, 2019 in Miami, Florida. Click here to register.

This comprehensive 2-day course will address regulatory and business issues relevant to e-vapor, e-liquid and tobacco product manufacturers, distributors and retailers including, among other things:

  • FDA enforcement and inspections – how to prepare and protect your business;
  • Product compliance – including advertising and labeling compliance, and preparing for Premarket Tobacco Product Applications (PMTAs);
  • Testing for Harmful and Potentially Harmful Constituents (HPHCs) – how to comply before the November 2019 deadline;
  • Going global – Presentations by experts on EU TPD, Canada, Asia and more;
  • State law update – Overview of new state and local laws, permitting/licensing and tax requirements, local flavor bans;
  • Environmental, hazardous waste and OSHA compliance;
  • Update on Deeming Rule appeal – Modified Risk Claims, PMTA and free samples;
  • Potential product standards including flavors and online sales;
  • Getting into CBD – how to stay legal; and
  • Business and intellectual property issues to protect your growing business.

A detailed agenda will be provided soon.  Register now for the early bird rate!

Seminar Details
Dates:
January 29 – January 30, 2019

Location:
Miami Marriott Biscayne Bay

Price:
$899 early rate
$1,099 regular rate

More information on speakers and a final agenda will be available soon. We look forward to seeing you at the program!

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

 

For additional information, please contact:

Sara Woldai
Manager, Meetings and Events
Keller and Heckman LLP
woldai@khlaw.com

Photo of Azim ChowdhuryPhoto of Benjamin Wolf

On Tuesday October 2, at 2PM EST, Azim Chowdhury and Ben Wolf will present a webinar, “Ingredients Listing: Walk Through” sponsored by the Smoke-Free Alternatives Trade Association (SFATA). Ingredient listing reports for small-scale tobacco product manufacturers are due by November 8, 2018. This program is recommended for manufacturers of deemed tobacco products, including e-liquids, their management, and staff who are responsible for regulatory compliance. Participants will learn how to prepare and submit ingredient listing reports to FDA. The floor will also open for questions regarding FDA compliance. For more information and to register, click here.

 

Photo of Azim ChowdhuryPhoto of Eric GottingPhoto of John Gustafson

Defendant U.S. Food and Drug Administration (FDA) and the Right to Be Smoke-Free Coalition (RSF) recently submitted briefs to the federal district court of Maryland opposing a motion for summary judgment filed by various public health NGOs in American Academy of Pediatrics v. FDA.[1] The NGOs are challenging various extensions to premarket application compliance deadlines for deemed tobacco products that were announced as part of FDA’s new comprehensive tobacco and nicotine regulatory plan, and finalized in its August 2017 Guidance Document, Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule (the “Guidance”). This includes the August 8, 2022 compliance deadline for filing vapor product Premarket Tobacco Applications (PMTAs), which was extended from the original August 8, 2018 cutoff for products on the market on August 8, 2016, as initially set forth in the Deeming Rule. RSF is not a party to the lawsuit, but filed an amicus (or “friend of the court”) brief defending the compliance period so that vapor product manufacturers have adequate time to prepare compliant applications. We provide background on the case and the NGOs’ opening positions in our August 2, 2018 post, linked here, and highlight below key points from FDA’s and RSF’s briefs.

FDA Argues that the Court Lacks Jurisdiction to Hear the Case or, In the Alternative, the NGOs’ Motion for Summary Judgment Fails on the Merits

In its opposition brief (available here), FDA begins by arguing that the Court does not have jurisdiction to even hear the dispute.

First, FDA maintains that the NGOs lack “standing” – i.e., that the NGOs do not have a sufficient connection to the PMTA issue to bring the lawsuit.[2] In essence, FDA claims that the NGOs will not suffer a concrete and redressable injury if the August 8, 2022 compliance date is upheld. The NGOs complain that if PMTAs are not filed until that date then they will not be able to educate the public in the near-term about information that would otherwise be contained in the PMTAs. But as FDA points out, this argument was soundly rejected by another federal court in Cigar Ass’n of Am. v. FDA after the NGOs tried to intervene in that lawsuit challenging aspects of the Deeming Rule filed by the cigar and pipe tobacco industries.[3] In that case, it was not enough for the NGOs – who are not subject to the PMTA requirements themselves – to rely on generalized and speculative allegations that it might somehow be more difficult or costly to disseminate information to the public in the absence of PMTAs. According to FDA, the same holds true here. Moreover, FDA argues that the NGOs fail to cite any authority that gives them a legal right to the type of information, whether now or at a later date, contained in a PMTA.

Second, FDA claims that the Court lacks jurisdiction because the agency was simply exercising its enforcement discretion not to require PMTAs for a specified period of time, the type of decision that typically is not subject to review by federal courts. Not only is the revised compliance period limited in duration, it is also part of a broader comprehensive policy to address tobacco-related issues and ensure that high-quality applications are filed, which will include upcoming efforts by FDA to further delineate through guidance and rulemaking what information must be included in PMTAs. For support, the agency cites to Supreme Court case law that reserves to agencies the discretion to prioritize their activities, allocate resources, and adopt overall policies – including those involving enforcement – in the absence of statutory mandates to the contrary.[4] FDA concludes that the Tobacco Control Act (TCA)[5] does not prohibit the agency from establishing reasonable compliance deadlines.

Finally, the agency relies on long-standing law that guidance documents are typically not subject to review by federal courts under the Administrative Procedure Act (APA).[6] Unlike a formal rule, guidance does not impose obligations on the agency or legal duties on regulated entities; rather, guidance only represents an agency’s current thinking, which in this case is that FDA does not intend to enforce the PMTA requirements until August 8, 2022 for products that were already on the market when the Deeming Rule went into effect on August 8, 2016. In other words, the Guidance does not have the finality of a regulation – it merely summarizes FDA’s exercise of discretion – that would lend itself to judicial review.

FDA further maintains that, even if the Court has jurisdiction to hear the case, the NGOs’ motion should be denied on the merits. The agency first argues that the Guidance does not conflict with the TCA’s PMTA provisions[7] because it does not modify any statutory requirements.[8] Manufacturers are still required to submit PMTAs. The Guidance merely describes FDA’s intention not to enforce the PMTA requirements for a limited period of time, which is a discretionary determination reserved to the agency. In fact, FDA notes that the NGOs submitted comments during the rulemaking acknowledging that the agency has discretion to establish a compliance period for new tobacco products. Moreover, FDA points to more practical reasons for setting an August 8, 2022 filing deadline, all of which are consistent with the TCA, including the agency’s need to more efficiently manage those PMTAs that are eventually filed and to ensure high-quality submissions.

Second, FDA rebuts the NGOs’ claim that the agency, before it extended the compliance period, failed under the APA to provide notice to the public, and solicit and accept comments on the Guidance.[9] Underpinning the NGOs’ argument, however, is the premise that the Guidance is a formal rule and thus subject to the APA’s notice and comment requirements. But a rule has the force of law and imposes legal rights and obligations, which contrasts with a guidance document that merely advises the public on how the agency intends to assert its discretionary power.[10] As FDA points out, the Guidance does nothing more than simply indicate when it will exercise its enforcement discretion as to the filing of premarket applications for deemed tobacco products.

Finally, FDA maintains that it sufficiently justified the extension, contrary to the NGOs’ claims.  Under the APA, agencies must explain their actions and engage in reasoned decision-making.[11] In support, FDA explicitly cited to arguments made by RSF in Nicopure, et al. v. FDA – that the original August 8, 2018 deadline was not sufficient and that the judge in that case indicated that other filing deadlines may have been reasonable.[12] The agency then noted that the new compliance period is part of an overarching comprehensive plan to regulate nicotine and tobacco, and that the extension will allow the agency to provide further direction to industry through guidance and rulemaking on how the PMTA process will work.[13] As characterized by the agency, the plan is intended “to make certain that the FDA is striking an appropriate balance between regulation and encouraging the development of innovative tobacco products that may be less dangerous than cigarettes,” such as vapor products.[14]

RSF Argues that the Original PMTA Deadlines in the Deeming Rule Were Unattainable and that Vacating the Guidance Would Virtually Ban the Industry and Deprive the Public of the Health Benefits Provided by Vapor Products 

To provide the vapor industry perspective, RSF filed an amicus brief in support of the extended compliance deadline (available here). RSF makes two arguments in favor of the new PMTA filing date: (1) that no vapor company could have met the initial two-year deadline because industry would not have had sufficient time to complete the burdensome applications, including the long-term, product-specific clinical/epidemiological studies that FDA will likely require; and (2) that the two-year deadline, were it reinstated by setting aside the Guidance and granting the NGOs’ motion, would effectively ban vapor products, which provide an important public health benefit to transitioning smokers.

Vapor product manufacturers could not have met the original August 8, 2018 deadline because of the tremendous expectations set forth by FDA in its 2016 draft guidance for PMTA submissions for Electronic Nicotine Delivery Systems (PMTA draft guidance).[15] Among other things, the PMTA draft guidance states that:

  • Manufacturers should file a separate PMTA for each “finished tobacco product”;
  • Components should be tested for each device in which they could reasonably be used;
  • The relative health risks of each new e-liquid or device should be compared to the anticipated risks of other tobacco products on the market;
  • Literature relevant to each product should be thoroughly reviewed and the findings included in any PMTA submission; and
  • Manufacturers should test each product for a broad range of characteristics, including chemical identity, constituent composition, aerosol emissions under a range of operating conditions, toxicological and pharmacological profiles, storage and stability profiles, environmental effects, and use patterns at different nicotine levels.

The most significant concern, however, is that under the PMTA draft guidance manufacturers will likely be expected to conduct exceedingly expensive and long-term clinical/epidemiological studies. In its brief, RSF presents publicly available evidence from long-term studies recently funded by the federal government showing that this type of research, on average, takes at least two years, and in many circumstances far longer. In fact, RSF points out that FDA’s own long-term epidemiological study (called the Population Assessment of Tobacco and Health or “PATH” study) on tobacco products, including e-liquids and devices, has already taken seven years and is still on-going. As such, it was completely unrealistic for FDA to expect that industry would have been able to file compliant applications by the original August 2018 deadline[16] and, as a consequence, the vast majority of manufacturers would have had to leave the marketplace after that compliance period expired.

In its brief, RSF also notes that such a large-scale market exit could have a significant adverse impact on the public health. RSF demonstrates, in particular, that having access to a large variety of products and e-liquid flavors is often a key component in any individual’s attempt to switch away from cigarettes and transition to less risky vapor products. As Julie T. Woessner, National Policy Director for the Consumer Advocates for Smoke-free Alternatives Association (CASAA), explains in an accompanying affidavit filed with the court, “a significant number of our members use more than one flavor or brand of e-liquid . . . we find those making a complete transition from smoking to vaping most often report that finding a non-tobacco flavor was instrumental in helping them distance themselves from their smoking habit, and sampling a variety of different flavors actually served to make vaping more enjoyable than smoking.”

Ms. Woessner then articulates the public health benefit that could be lost: “[I]f consumers do not have access to these products, there is a substantial risk that they will return to their old smoking habits or feel forced to rely on do-it-yourself (“DIY”) activities or an unregulated black market for e-liquids and devices. This is not merely a theoretical concern. . . [w]hen asked what they would do in response to a total ban on all vapor products – the entire product category – 93% of the CASAA [Member] Survey respondents indicated that they would continue to use the products they enjoy by either purchasing them from overseas or a domestic black market, or by engaging in DIY activities.”

The Right to be Smoke-Free Coalition is represented by Keller and Heckman Partners Azim Chowdhury and Eric Gotting. We will continue to monitor the progress of this lawsuit and will provide a summary of the court’s decision on the NGOs’ motion for summary judgment.

_________________________________________

[1] Case No. 8:18-cv-00883 (D. Md.)  It bears noting that an amicus brief in support of Plaintiff NGOs was filed on July 17, 2018 on behalf of the American Thoracic Society and other public health organizations. The brief, which is available here, addresses the health effects of all products newly-deemed by the Deeming Rule, including combustible tobacco products, like cigars. The brief does not address legal arguments in the case, nor does it address the potential public health benefits of newly available, non-combustible products for longtime smokers.

[2] See, e.g., Lujan v. Defenders of Wildlife, 504 U.S. 555, 560 (1992).

[3] Cigar Ass’n of America v. FDA, 323 F.R.D. 54 (D.D.C 2017).

[4] Heckler v. Chaney, 480 U.S. 821 (1985).

[5] 21 U.S.C. §§ 387 et seq.

[6] Bennett v. Spear, 520 U.S. 154, 177–79 (1997); Am. Tort Reform Ass’n v. Occupational Safety & Health Admin., 738 F.3d 387, 395 (D.C. Cir. 2013).

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

[8]  As detailed in the Nicopure v. FDA litigation (Case No. 17-5196) (D.C. Cir.), RSF maintains that FDA had a statutory obligation to tailor the PMTA process to less risky vapor products and allow the vapor industry to submit PMTAs that do not include product-specific long-term clinical/epidemiological studies; instead, industry could rely on an existing scientific literature review showing that vapor products present substantially less risk than cigarettes on the whole and are thus appropriate for the public health.  Indeed, Congress gave FDA such authority within the PMTA provision itself, only requiring clinical studies “when appropriate” and permitting use of other “valid scientific evidence.”  21 U.S.C. § 387j(c)(5).  Unfortunately, FDA rejected this approach during the rulemaking.  See 81 Fed. Reg. at 28,997.

[9] 5 U.S.C. § 551 et seq.; 5 U.S.C. § 553.

[10] See Bennett, 520 U.S. at 178.

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

[12] Nicopure Labs, LLC v. FDA, 266 F. Supp. 3d 360, 399–400 (D.D.C. 2017).  That case is now on appeal before the U.S. Court of Appeals for the District of Columbia Circuit, with oral arguments scheduled for September 11, 2018.  See Update on Deeming Rule Appeal available at https://www.thecontinuumofrisk.com/2018/07/fda-commissioner-dr-scott-gottliebs-recent-remarks-vapor-products-continuum-risk-update-deeming-rule-appeal/.

[13] FDA News Release, “Protecting American Families: Comprehensive Approach to Nicotine and Tobacco,” https://www.fda.gov/NewsEvents/Speeches/ucm569024.htm (July 18, 2017) (last accessed: 08/21/18).

[14] Id.

[15] FDA, Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems: Guidance for Industry (Draft Guidance) (May 2016).

[16] Indeed, as summarized previously on this blog here, on August 2, 2018, just before the initial PMTA deadline would have expired, FDA announced it would soon be issuing additional guidance, holding a public hearing and begin a new rulemaking regarding the PMTA process.  See FDA, Advancing Tobacco Regulation to Protect Children and Families: Updates and New Initiatives, https://tinyurl.com/y8wked2z.  As such, it is not clear how manufacturers would have been able to submit complete applications by the original cutoff if FDA itself is still in the process of finalizing the PMTA framework.

Photo of Azim ChowdhuryPhoto of Benjamin WolfPhoto of Adam Susser

Today, August 10, 2018, is the compliance date for the health warnings contained in the FDA’s Deeming Rule and codified in 21 C.F.R. Part 1143.  In particular, as of today, roll-your-own (RYO) tobacco, cigarette tobacco, or covered tobacco products (except cigars and pipe tobacco) such as e-liquids that contain tobacco-derived nicotine manufactured, packaged, sold, offered for sale, distributed, or imported for sale or distribution within the United States must bear the required warning statement (i.e., “WARNING: This product contains nicotine.  Nicotine is an addictive chemical.”) on the package label, per 21 C.F.R. § 1143.3(a)(1).  This warning statement requirement also applies to advertising (including websites and social media) for RYO tobacco, cigarette tobacco, and covered tobacco products (except cigars and pipe tobacco).

The warning statement must also comply with certain requirements, with respect to font, text, size, placement, and formatting of the warning statement on the package labels.  Indeed, the regulation requires that the required warning statement “appear directly on the package” and “be clearly visible underneath any cellophane or other clear wrapping as follows”:

  • Be located in a conspicuous and prominent place on the two “principal display panels” of the package;
  • Comprise at least 30 percent of each of the principal display panels;
  • Be printed in at least 12-point font size and must occupy the greatest possible proportion of the warning label area set aside for the required text;
  • Be printed in conspicuous and legible Helvetica bold or Arial bold type or other similar sans serif fonts and in black text on a white background or white text on a black background in a manner that contrasts by typography, layout, or color, with all other printed material on the package;
  • Be capitalized and punctuated as indicated in 21 CFR § 1143.3(a)(1); and
  • Be centered in the warning area in which the text is required to be printed and positioned such that the text of the required warning statement and the other information on the principal display panels have the same orientation.[1]

For covered tobacco products (other than cigars), cigarette tobacco products, and RYO tobacco products that are too small or otherwise unable to accommodate a label with sufficient space to bear the required warning statement, the required warning statement must appear on one of the following: carton, outer container, wrapper, or tag firmly and permanently affixed to the tobacco product package.

Compliance Policy and Safe Harbor for Retailers

FDA created a compliance policy for the 21 C.F.R. § 1143.3 nicotine addiction warning in its Guidance Document, Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule, which provides (on page 5):

 

The Deeming Rule also contains a retailer safe harbor, which provides that a retailer of cigarette tobacco, RYO tobacco, or covered tobacco products (other than cigars) will not be in violation of 21 C.F.R. § 1143.3 for packaging that: (i) contains a health warning; (ii) is supplied to the retailer by the tobacco product manufacturer, importer, or distributor, who has the required state, local, or Alcohol and Tobacco Tax and Trade Bureau (TTB)-issued license or permit, if applicable; and (iii) is not altered by the retailer in a material way.[2]

If you have questions about the compliance policy or the retailer safe harbor, please let us know.

Alternative Required Warning Statement for Zero Nicotine Products

For products that do not contain nicotine, but that are made or derived from tobacco, a tobacco product manufacturer is permitted to display an alternative statement (i.e., “This product is made from tobacco”) on all packages and advertisements in accordance with the requirements of 21 C.F.R. § 1143.3.  An example of such a product would be a zero-nicotine e-liquid that contains tobacco-derived flavors or extracts.  To be permitted to make such a statement, manufacturers are required to submit a confirmation statement to FDA certifying to be true that the product does not contain nicotine and that the tobacco product manufacturer has data to support that assertion.[3] If you would like to submit such a self-certification to FDA, let us know.

A zero-nicotine e-liquid that does not contain any other tobacco-derived ingredients is not a covered tobacco product subject to either the nicotine addiction warning or alternative statement.

Effect of Injunction in Cigar Association of America v. FDA

Importantly, due to a recent decision by the United States District Court for the District of Columbia, the warnings set forth in 21 C.F.R. §§ 1143.3 and 1143.5 are not applicable to cigars and pipe tobacco until 60 days after final disposition of the plaintiffs’ appeal of the courts’ order on the health warning requirements.[4]   FDA has stated that the Agency intends to comply with the court’s order in Cigar Association of America.[5]  Further, FDA explained that the Agency does not intend to enforce the labeling requirements under sections 903(a)(2) (i.e., requirement that label contain the name and place of business of the tobacco product manufacturer, packer, or distributor; an accurate statement of the quantity of contents in terms of weight, measure, or numerical count; and an accurate statement of the percentage of domestically grown vs. foreign grown tobacco) and 920(a)(1) (i.e., requirement to bear “Sale only allowed in the United States” statement) for cigars and pipe tobacco while the injunction is in effect so that firms are able to make required label changes at one time.[6]

Notably, the court’s order does not enjoin FDA from enforcing the health warning requirements for other product categories, including electronic nicotine delivery systems (ENDS) products, hookah tobacco, and cigarette tobacco and RYO tobacco.

Other Labeling Requirements

The Deeming Rule also imposed additional labeling requirements on newly deemed products. For example, tobacco products deemed under the Deeming Rule to be subject to FDA’s authority, if in package form, are required to bear a label containing:

  • the name and place of business of the tobacco product manufacturer, packer, or distributor;
  • an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; and
  • the statement “Sale only allowed in the United States” on labels, packaging, and shipping containers pursuant to Section 920(a) of the Federal Food, Drug, and Cosmetic Act (FDCA).

In addition, pursuant to Section 903(a)(2)(C) of the FDCA, a tobacco product in package form is misbranded if its label does not include an accurate statement of the percentage of foreign and domestic grown tobacco used in the product.  However, in a draft guidance document entitled, “Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops,” FDA stated that, at this time, it does not intend to enforce this requirement for products made or derived from tobacco, such as tobacco-derived liquid nicotine and e-liquid made or derived from tobacco.[7]  FDA explained that it provided this compliance policy “because it recognizes the current difficulty, in many circumstances, qualifying the percentage of foreign and domestic grown tobacco used in these products.”[8]

If you have any questions about warning requirements for product labels and advertisements or any of the other Tobacco and Control Act requirements, contact Azim Chowdhury, Partner (202) 434.4230, (chowdhury@khlaw.com).  For more information on our Tobacco and E-Vapor Practice in general, visit www.khlaw.com/evapor. You can also follow Azim Chowdhury on Twitter for updates.

[1] 21 C.F.R. § 1143.3(a)(2).

[2] 21 C.F.R. § 1143.3(a)(3).

[3] 21 C.F.R. § 1143.3(c).

[4] See Order, Cigar Ass’n of Am. v. U.S. Food & Drug Admin., No. 1:16-cv-01460 (D.D.C. July 5, 2018).

[5] See FDA, “Covered” Tobacco products and Roll-Your-Own Cigarette Tobacco Labeling and Warning Statement Requirements, https://www.fda.gov/TobaccoProducts/Labeling/Labeling/ucm524470.htm?utm_source=CTPTwitter&utm_medium=social&utm_campaign=ctp-warninglabel.

[6] See Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 81 Fed. Reg. 28974, 29006 (noting that the compliance date for the 903(a)(2) and 920(a)91) requirements is intended to match the date for health warnings).

[7] FDA, Draft Guidance for Industry: Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops (Jan. 2017), https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM536997.pdf .

[8] Id., at 5-6.