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Section 904(a)(3) of the Food, Drug and Cosmetic Act, as amended by the Tobacco Control Act, (FDCA) requires manufacturers and importers to report the quantities of Harmful and Potentially Harmful Constituents (HPHCs) found in their tobacco products, or in the smoke produced by their products, by brand and sub-brand.  21 U.S.C. § 387d(a)(3).  This requirement was extended to all deemed products such as e-cigarettes, e-liquid, cigars, hookah and pipe tobacco when the Deeming Rule went into effect on August 8, 2016.

Pursuant to the initial compliance policy set forth in the Deeming Rule, HPHC reports for all deemed finished tobacco products on the market at that time were due by August 8, 2019.  Not long after soon-to-be-departing FDA Commissioner Dr. Scott Gottlieb began his term in 2017, FDA announced that it would be delaying several compliance dates, including the HPHC reporting deadline, by three months to November 8, 2019 for all deemed products.  Since then, FDA has failed to provide any actual guidance on which HPHCs should be assessed and how.  Now, FDA has published a Revised Guidance for Industry: Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule that further extends the reporting deadline for deemed finished tobacco products to a date to be determined in the future depending on when FDA publishes its final guidance on the HPHC reporting requirement (the “Final HPHC Guidance”).  Specifically, HPHC reports for deemed products are now due either nine (9) months after the Final HPHC Guidance is published for small tobacco product manufacturers, or six (6) months after the Final HPHC Guidance is published for large tobacco product manufacturers.  Importantly, FDA has indicated that here a small tobacco product manufacturer is any company (including any entity that it controls, is controlled by, or is under common control with) that has fewer than 350 employees pursuant to Section 900(16) of the FDCA, 21 U.S.C. § 387(16). 

In 2012, FDA finalized a list of 93 HPHCs, focusing on five disease outcomes: cancer, cardiovascular disease, respiratory effects, developmental or reproductive effects, and addiction.  See 77 Fed. Reg. 20034 (Apr. 3, 2012).  When this list was published, only cigarettes, smokeless tobacco and roll-your-own tobacco products were regulated by FDA.  In recognition of testing limitations, laboratory capacity concerns, and the short time between the establishment of the HPHC list and the reporting deadline, rather than require manufacturers to test for and report on all 93 HPHCs, FDA published a guidance document identifying abbreviated lists of representative HPHCs for which testing methods were well established for each of the product categories (cigarettes, roll-your-own, and smokeless tobacco).  FDA also extended the compliance date by 6 months for small tobacco product manufacturers and by 3 months for large tobacco product manufacturers.

Abbreviated List of HPHCs for Traditional Tobacco Products
HPHCs in Cigarette Smoke HPHCs in Smokeless Tobacco HPHCs in Roll-your-own Tobacco and Cigarette Filler
Acetaldehyde Acetaldehyde Ammonia
Acrolein Arsenic Arsenic
Acrylonitrile Benzo[a]pyrene Cadmium
4-Aminobiphenyl Cadmium Nicotine (total)
1-Aminonaphthalene Crotonaldehyde NNK
2-Aminonaphthalene Formaldehyde NNN
Ammonia Nicotine (total and free)
Benzene 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK)
Benzo[a]pyrene N-nitrosonornicotine (NNN)
1,3-Butadiene
Carbon monoxide
Crotonaldehyde
Formaldehyde
Isoprene
Nicotine (total)
NNK
NNN
Toluene

With respect to deemed products, other than broadening the definition of an HPHC to include chemicals in the “aerosol (vapor) or any other emission” that may be potentially inhaled, ingested, or absorbed into the body, FDA has not yet provided any meaningful guidance (or initiated rulemaking) to help companies meet the reporting requirement.

For vapor products, potential HPHCs of interest to FDA may be found in the draft guidance document on Premarket Tobacco Product Applications (PMTA) for Electronic Nicotine Delivery Systems (ENDS) that was published in May 2016 along with the final Deeming Rule.  In that guidance, and in the context of developing PMTAs, FDA identified 29 constituents, along with “other chemicals and toxic chemicals as appropriate,” that it recommends ENDS manufacturers analyze in the aerosol produced by their products (see pages 26-27).  Other than a handful of substances, e.g., acetyl propionyl, diacetyl, diethylene glycol, ethylene glycol, glycerol, menthol, propylene glycol, all of the below substances are also on FDA’s official 93 HPHC list:

FDA PMTA Draft Guidance Analyte List for ENDS
Acetaldehyde (CASRN 75-07-0) 2-Aminonaphthalene (CASRN 91-59-8) Cadmium (CASRN 7440-43-9) Formaldehyde (CASRN 50-00-0) Nicotine, including total nicotine and unprotonated nicotine (CASRN 54-11-5)
Acetyl Propionyl (CASRN 600-14-6) Ammonia (CASRN 7664-41-7) Chromium (CASRN 7440-47-3) Glycerol (CASRN 56-81-5) 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) (CAS Reg. No. 64091-91-4)
Acrolein (CASRN 107-02-8) Anabasine (CASRN 494-52-0) Crotonaldehyde (CASRN 4170-30-3) Isoprene (CASRN 78-79-5) N-nitrosonornicotine (CASRN 16543-55-8)
Acrylonitrile (CASRN 107-13-1) Benzene (CASRN 71-43-2) Diacetyl (CASRN 431-03-8) Lead (CASRN 7439-92-1) Propylene glycol (CASRN 57-55-6)
4-Aminobiphenyl (CASRN 92-67-1) Benzo[a]pyrene (CASRN 50-32-8) Diethylene glycol (CASRN 111-46-6); Menthol (CASRN 1490-04-6)

Toluene

(CASRN 108-88-3)

1-Aminonaphthalene (CASRN 134-32-7) 1,3-Butadiene (CASRN 106-99-0) Ethylene glycol (CASRN 107-21-1) Nickel (CASRN 7440-02-0) Other chemicals and toxic chemicals as appropriate (e.g., potentially toxic pyrolytic products of the chemicals listed above)

Of relevance, in Footnote 28 of the draft PMTA guidance FDA states (emphasis added):

These constituents are constituents that, to FDA’s current thinking, potentially could cause health hazards depending on the level, absorption, or interaction with other constituents. FDA intends to establish a revised list of harmful and potentially harmful constituents (HPHCs) that include HPHCs in ENDS products in the Federal Register, issue guidance regarding constituent reporting (i.e., harmful or potentially harmful constituent (HPHC) reporting) under section 904(a)(3) of the FD&C Act, and later issue a testing and reporting regulation as required by section 915. While applicants should submit certain information about HPHCs as part of their applications, the requirement to submit HPHC listings under section 904 of the FD&C Act (21 U.S.C. 387d) is separate and distinct from the premarket review requirements under section 910. HPHC information submitted under section 904 will assist FDA in assessing potential health risks and determining if future regulations to address a product’s health risks are warranted. For PMTAs, FDA expects that applicants will report the levels of HPHCs as appropriate for each product, so the reported HPHCs will differ among different product categories. The Agency recommends that manufacturers consult with CTP’s Office of Science about what is appropriate in the context of a specific application.

For manufacturers of deemed products seeking to comply with the HPHC requirement, critical areas remain unclear, including (1) which HPHCs must be assessed, (2) whether such HPHCs will need to be identified in the e-liquid or tobacco itself or in the vapor/aerosol/smoke produced (particularly for open-system products), (3) what analytical methodologies and testing equipment should be used, and (4) the number of appropriate test samples and replicates, among other things. These are all issues that should be addressed in FDA’s Final HPHC Guidance, which could take several more months or longer to be finalized (especially considering that FDA will be transitioning to a new Commissioner).  At that point, pursuant to FDA’s announced extension, large and small tobacco product manufacturers must submit HPHC reports for their products by six and nine months, respectively, thereafter.

If you have any questions regarding HPHC reporting requirements contact Azim Chowdhury (chowdhury@khlaw.com). For more information about our Tobacco and E-vapor Practice, visit https://www.khlaw.com/evapor.

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On February 21, 2019, FDA released the second of two draft guidance documents related to the development of novel nicotine replacement therapies (NRT).  The first draft guidance document, Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products Guidance for Industry is available here, and the second draft guidance document,  Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products is available here.

The draft guidance documents are one part of FDA’s efforts in reevaluating and modernizing the agency’s approach to the development and regulation of NRT products.  These efforts are particularly relevant for those seeking approval of novel NRT products, including electronic nicotine delivery systems (ENDS), such as e-cigarettes, through FDA’s drug regulatory pathway.

NRT Regulation and E-Cigarettes

Currently, FDA has approved numerous NRT products, as well as other prescription drugs, for smoking cessation.  Specifically, FDA has approved three types of over-the-counter (OTC) NRTs–nicotine gum, transdermal nicotine patch, and nicotine lozenge, as well as two types of prescription NRTs-nicotine nasal spray and nicotine inhaler.  Besides the lozenge formulation, which was approved in 2002, all of these products have been approved for over 20 years.

Currently, there are no electronic nicotine delivery system (ENDS) products approved for use as an NRT for smoking cessation.  ENDSs generally available today, such as e-cigarettes and personal vaporizers are marketed for recreational use and so are regulated by FDA as tobacco products.  Marketing an ENDS as a smoking cessation tool with smoking cessation claims would require FDA premarket approval as a “drug.”

In a February 21, 2019 statement from FDA Commissioner Scott Gottlieb, the Commissioner included ENDS within his characterization of novel NRTs, which could be marketed as prescription or OTC drug products with medical claims for smoking cessation, but noted that they would need to be proven safe and effective for smoking cessation and regulated as drug products.[i]  See our full analysis on the potential OTC pathway for ENDSs here.

Recent Developments on Novel NRTs

As part of FDA’s efforts to support the development of novel nicotine replacement therapies for smoking cessation, in September 2017, FDA announced the establishment of the FDA Nicotine Steering Committee (NSC) as a forum for development and implementing nicotine policy and regulation.[ii]  Moreover, a public hearing on FDA’s approach to evaluating the safety and efficacy of NRT products was held on January 26, 2018.[iii]  Further, on August 3, 2018, FDA issued a draft guidance entitled, “Nonclinical Testing of Orally Inhaled Nicotine Containing Drug Products.”[iv] The guidance provides sponsors of NDAs with recommendations on the nonclinical information necessary to support development and approval for orally inhaled nicotine-containing products.  Commissioner Gottlieb noted that this guidance recognizes that while toxicity information is available for nicotine, that information may not be available for other compounds contained in e-liquids, such as flavorings and heat-generated chemicals.[v]

The second draft guidance, “Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products,”[vi]  lays out a framework for the development of appropriate trial designs and new potential clinically relevant endpoints for smoking cessation products, such as reducing the chance of a smoker going back to using cigarettes long term.

Ultimately, FDA’s efforts related to reevaluating the development of novel NRTs for smoking cessation point to the agency’s recognition that e-cigarettes, and other ENDSs, may have a place in the development of novel NRTs sold as new drugs.

[i] U.S. Food and Drug Administration (FDA Statement from FDA Commissioner Scott Gottlieb, M.D., on additional steps by the agency to support the development of safe and effective novel nicotine replacement therapies to help smokers quit cigarettes, FDA. GOV, (Feb. 21, 2019), https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631748.htm

[ii] Nicotine Steering Committee, FDA.GOV, https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/ucm587918.htm.

[iii] U.S. Food and Drug Administration (FDA) Website, Public Meeting on FDA Approach to Evaluating Nicotine Replacement Therapies, FDA.GOV (Sept. 13, 2018), https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm580561.htm.

[iv] U.S. Food and Drug Administration (FDA) Draft Guidance, Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products Guidance for Industry, FDA.GOV (Sept. 13, 2018), https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm615575.pdf.

[v] U.S. Food and Drug Administration (FDA Statement from FDA Commissioner Scott Gottlieb, M.D., on additional steps by the agency to support the development of safe and effective novel nicotine replacement therapies to help smokers quit cigarettes, FDA. GOV, (Feb. 21, 2019), https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631748.htm

[vi] U.S. Food and Drug Administration (FDA) Draft Guidance, Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products, FDA.GOV (March 1, 2019), https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM631719.pdf

Sam Jockel has been published in the Food and Drug Law Institute’s Update Extra, an electronic-only feature of Update Magazine. The article “FDA Holds Public Hearing on Strategies to Address Youth E-Cigarette Use” is available online here. This article is republished with the permission of FDLI.

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As previously reported on this blog, on November 15, 2018, citing new data from the 2018 National Youth Tobacco Survey (NYTS) that showed a surge in e-cigarette use among youth, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D. announced new steps aimed at curtailing illegal underage use of e-cigarettes by limiting where such products can be purchased.  More specifically, the Commissioner indicated that FDA would seek to limit the sale of flavored e-cigarettes (excluding tobacco, mint and menthol flavored products) to (1) brick-and-mortar retailers that permit entry only to adults (18+), or that have a walled-off adult-only section where flavored products can be viewed and purchased; and (2) in online stores that implement soon-to-be-announced “heightened” age-verification measures.[1]

With respect to online sales of flavored e-cigarettes, while FDA has not yet provided direction on how companies should verify the age of those purchasing such products over the internet, FDA said that it plans to identify and publish a list of best practices for online retailers. It is possible that the Agency will implement guidance that includes similar requirements to those found in California’s Stop Tobacco Access to Kids Enforcement Act (STAKE Act) – a law which California authorities are increasingly enforcing.

California’s STAKE Act

California law prohibits the sale of tobacco products to anyone under the age of 21[2], and the STAKE Act imposes mandatory steps that online distributors and sellers of tobacco products are required to follow to verify that a purchaser of these items is 21 years of age or older. The Act defines “tobacco products” to include an “electronic device that delivers nicotine or other vaporized liquids to the person inhaling from the device, including, but not limited to, and electronic cigarette, cigar, pipe, or hookah.”[3]

The steps required under the STAKE ACT are summarized below.

  • Attempt to match the name, address and date of birth provided by the customer to information contained in records in a database of individuals whose age has been verified to be 21 years or older by reference to an appropriate database of government records kept by the distributor, a direct marketing firm or any other entity.
  • Verify that the billing address on the check or credit card offered for payment by the purchaser matches the address listed in the database.
  • If unable to verify that the purchaser is 21 years of age through the above, require the customer or recipient to submit an age-verification kit consisting of an attestation signed by the customer that he or she is 21 years of age or older and a copy of a valid form of government identification.
  • Verify that the billing address on the check or credit card provided by the consumer matches the address listed in the form of government identification.
  • For credit card transactions, submit information to each credit card company so that the words “tobacco product” may be printed in the purchaser’s credit card statement.
  • Regardless of the form of payment, prior to shipping the tobacco product to a California customer, make a telephone call after 5 p.m. to the purchaser or recipient confirming the order. The call may be a recorded message left on voicemail.
  • Deliver only to the purchaser or recipient’s verified billing address on the check or credit card used for payment. Delivery to a post office box address is prohibited.[4]

Enforcement of the STAKE Act

California is actively pursuing businesses that violate the STAKE Act, both through warning letters from the state Department of Justice, as well as legal action. The warning letters, which may include violations of additional statutes (e.g., Propositions 56 and 65), outline the obligations to businesses and the requirements that they must to take to ensure that their tobacco products—including electronic cigarettes and vapor devices—are not being sold to anyone under 21 years of age. The letters also remind recipients that:

“Section 22963 [the STAKE Act] provides for civil penalties of up to $2,000 for the first violation of its requirements, $3,500 for the second violation, $5,000 for the third violation, $6,500 for the fourth violation, and $10,000 for each subsequent violation in a five-year period.”

Legal action taken by California includes a lawsuit filed in the Superior Court of the State of California, County of Los Angeles on October 31, 2018, naming Kandypens Inc., a manufacturer and online retailer of vaping products, as the defendant. The enforcement action seeks injunctive relief and civil penalties for violating the STAKE Act, and other statutes.

Noting that “…any child with a prepaid gift card and an internet connection can easily purchase Kandypens’ vaping devices and e-liquids through Kandypens’ website because Defendant fails to follow state-mandated procedures for verifying a purchaser’s age,” the enforcement action requests that Kandypens be enjoined from selling vaping products over the internet without first verifying the purchaser’s age. It also requests that the Defendant be assessed civil penalties for each violation of the STAKE Act, in addition to penalties for violating of other statutes.

While we await FDA’s final guidance for online e-cigarette retailers, businesses selling tobacco products to consumers in California over the internet need to be in compliance with the STAKE Act now. Although it is not yet clear what “heightened” online age-verification measures FDA will require, it is certainly possible that the Agency will turn to states like California for guidance.

______________________________________

[1]           U.S. Food & Drug Admin., FDA Statement, Statement From FDA Commissioner Scott Gottlieb, M.D., on Proposed New Steps to Protect Youth by Preventing Access to Flavored Tobacco Products and Banning Menthol in Cigarettes (Nov. 15, 2018) (hereinafter, the “FDA Nov. 15, 2018 Statement”), https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM625884.htm?utm_campaign=111518_Statement_FDA%20Commissioner%20statement%20on%20p

[2] Cal. Bus. & Prof. Code § 22958(a).

[3] Cal. Bus. & Prof. Code § 22963(a).

[4] SB 7, amending Cal. Bus. & Prof. Code § 22963.

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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

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 Adam Susser

Following a series of actions over the last several months, on November 15, 2018, the U.S. Food and Drug Administration (“FDA”) announced new steps aimed at protecting youth from tobacco, including, among other things, preventing access to flavored electronic nicotine delivery system (“ENDS”) sold in certain retail locations, and potentially banning menthol in combustible tobacco products.[1]  Spurred by the release of new data from the 2018 National Youth Tobacco Survey (“NYTS”) showing a rise in e-cigarette use among youth over the past year, FDA Commissioner Scott Gottlieb, M.D., announced a number of steps to prevent youth access to, and use of, tobacco products, including: (i) directing the Center for Tobacco Products (“CTP”) to revisit FDA’s premarket review compliance policy for flavored ENDS, other than tobacco, mint and menthol flavors, sold in retail outlets that are not adult (18+) only; (ii) directing CTP to publish additional information regarding best practices for age-restricting online sales; (iii) issuing a Proposed Rulemaking that would seek to ban menthol in combustible tobacco products, including cigarettes and cigars; (iv) issuing a Proposed Rulemaking to ban, through appropriate means, all flavors in cigars; and (v) advancing a policy that aggressively pursues the removal of ENDS products that appear to too kid-friendly.

National Youth Tobacco Survey Data

On November 15, 2018, the FDA and the U.S. Centers for Disease Control and Prevention (“CDC”) released new findings from the 2018 National Youth Tobacco Survey showing that more than 3.6 million middle and high school students were “current e-cigarette users” – defined as having used e-cigarettes once in the past thirty days – in 2018, which FDA described as a “dramatic increase of more than 1.5 million students since last year.”[2]  As background, the NYTS “is a cross-sectional, voluntary, school-based, self-administered, pencil-and-paper survey of U.S. middle and high school students.”[3]

According to the FDA news release, “the number of U.S. high school students who reported being current e-cigarette users increased 78 percent between 2017 and 2018 to 3.05 million (or 20.8 percent).”[4]  Further, “among middle school students, numbers rose 48 percent [from the previous year] to 570,000 (or 4.9 percent) [of total middle school students].”  What is more, the NYTS data showed that high school students who reported being current e-cigarette users reported using these products more frequently.  Indeed, “[i]n the last year, the proportion of those [high school students] using the product more regularly (on 20 or more of the past 30 days) increased from 20 percent to 27.7 percent[.]”[5]  The study authors suggest that rising e-cigarette use in the last year is likely attributable “to the recent popularity of certain types of e-cigarettes, such as JUUL,” noting that these and similar products “have a high nicotine content and come in appealing fruit and candy flavors.”[6]

In his statement, FDA Commissioner Scott Gottlieb, M.D. explained that “[w]e still believe that non-combustible forms of nicotine delivery, such as e-cigarettes, may be less harmful alternatives for currently addicted adult smokers who still seek nicotine[,]” but clarified that “FDA will not allow” the opportunity presented by e-cigarettes “to come at the expense of addicting a whole new generation of kids to nicotine.”[7]  CDC Director, Robert R. Redfield, M.D., echoed these concerns stating that “[t]he markedly accelerating rate of e-cigarette use among U.S. youth within the past year is a cause for grave concern” and noting that it is “critical that we implement proven strategies to protect our Nation’s youth from this preventable health risk.”[8]

FDA Announces New Policy Framework to Combat Rising Youth Use of Tobacco Products, Including ENDS

In response to the NYTS data, FDA announced a new policy framework designed to address rising youth use of tobacco products, including ENDS.

Limiting Sales of Flavored ENDS (Other Than Tobacco, Mint and Menthol) to Adults-Only Retailers  

First, FDA announced that all flavored ENDS products (other than tobacco, mint, and menthol flavors, or non-flavored products) will be required to be sold in age-restricted, in-person locations, or else potentially be subjected to a revised Premarket Tobacco Product Application (“PMTA”) deadline.  This policy revision would apply to all ENDS products, including e-liquids, cartridge-based systems and cigalikes, in flavors except tobacco, mint, and menthol, sold in physical locations where people under age 18 are permitted.[9]  This policy revision would not apply to ENDS products sold exclusively in age-restricted locations (e.g., a stand-alone tobacco retailer (such as a vape shop)) that adequately prevent persons under age 18 from entering the store at any time; or, a section of an establishment that adequately prevents entry of persons under age 18 and prevents persons under age 18 from viewing or accessing flavored ENDS products.[10]  As noted, this policy revision does not apply to ENDS products with tobacco, mint, or menthol flavors, as well as to non-flavored ENDS products, sold in any location.

In other words, vape shops that restrict access to adults (18+) only will be able to continue to sell a wide variety of flavored e-liquids/ENDS.  ENDS products sold in locations that are not adults-only, however, will be limited to only tobacco, mint and menthol flavored products; other flavors (e.g., cherry, vanilla, crème, tropical, melon, etc.) sold in such locations, while not “banned” per se, will be subject to a revised compliance policy that could move the PMTA deadline earlier than the current August 8, 2022 deadline for ENDS products on the market as of August 8, 2016.

The Commissioner also noted that FDA plans to continue to aggressively pursue removing ENDS products marketed to children and/or appealing to youth from the market.  These marketing practices may include “using popular children’s cartoon or animated characters” or “names of products favored by kids like brands of candy or soda.”[11]

Heightened Age Verification for Online Sales

Second, FDA announced that it would seek to curtail the sale of flavored ENDS products (other than tobacco, mint and menthol) that are sold online without “heightened age verification” processes.  To advance this goal, FDA plans to identify and publish a list of best practices for online retailers.

Earlier this week, in addition to promising to cease selling flavored products (other than tobacco, mint and menthol) in all brick-and-mortar retailers, JUUL announced its own comprehensive online age-verification process:

Flavored Cigars and Menthol Cigarettes

Third, FDA announced that flavored cigars will no longer be subject to the extended compliance date for premarket authorization (which currently sets the premarket application deadline for cigars on the market on August 8, 2016 to be August 8, 2021).  However, this policy does not apply to the entire product category, as certain flavored cigars are considered “grandfathered” and exempt from premarket review if they were on the market as of February 15, 2007.[12]  To address this gap in regulatory authority, FDA plans to propose a product standard that would ban all flavored cigars.

Fourth, FDA announced plans to publish a Proposed Rule in the Federal Register that would seek to ban menthol in combustible tobacco products, including cigarettes and cigars.

Implications for the ENDS Product Category

FDA’s approach to addressing rising youth use of certain flavored (e.g., non-tobacco, mint, and menthol flavored) cartridge-based e-cigarette products may be effective, but is also potentially subject to legal challenge.  Section 906(d)(3) of the Tobacco Control Act expressly states that “no restrictions under [906(d)(1)] may — (i) prohibit the sale of any tobacco product in face-to-face transactions by a specific category of retail outlets.”  Nevertheless, a prohibition on the sale of flavored ENDS at retail outlets (e.g., convenience stores) appears to be precisely what FDA plan to accomplish, albeit through indirect means.

In particular, FDA’s announcement is framed as a withdrawal of an “enforcement discretion” policy, previously applicable to certain flavored ENDS products.  Arguably, the practical effect of this compliance policy revision is a prohibition on the sale of a tobacco product in face-to-face transactions by a specific category of retail outlets (e.g., generally accessible convenience stores).  That said, FDA will likely argue that it is simply reverting to the state of the law at the time of the Deeming Rule.  Further, FDA is likely to justify its policy by noting that it expressly allows sales of flavored ENDS products at all retail outlets, provided that the retail outlet has an “adults-only” section where flavored ENDS products are not visible to youth who may otherwise be in the store.  This action aligns with the requirements currently applicable to the distribution of samples of smokeless tobacco products in “qualified adult[s]-only” facilities.[13]

In any case, only time will tell whether FDA’s actions to address the rise in youth use of tobacco products, including flavored ENDS products, will be effective at curtailing youth access.  In the interim, e-liquid manufacturers will increasingly rely on specialty tobacco product retailers (e.g., “vape shops”) and age-verified online channels to distribute their products to adults.

If you have any questions regarding FDA’s recent announcements contact Azim Chowdhury (chowdhury@khlaw.com) and be sure to register for Keller and Heckman’s 3rd Annual Tobacco and E-Vapor Law Symposium in Miami, Florida on January 29-30, 2019 here.

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[1] U.S. Food & Drug Admin., FDA Statement, Statement From FDA Commissioner Scott Gottlieb, M.D., on Proposed New Steps to Protect Youth by Preventing Access to Flavored Tobacco Products and Banning Menthol in Cigarettes (Nov. 15, 2018) (hereinafter, the “FDA Nov. 15, 2018 Statement”), https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM625884.htm?utm_campaign=111518_Statement_FDA%20Commissioner%20statement%20on%20proposals%20to%20address%20youth%20tobacco%20use&utm_medium=email&utm_source=Eloqua.

[2] U.S. Food & Drug Admin., FDA News Release, Results from 2018 National Youth Tobacco Survey Show Dramatic Increase in E-Cigarette Use Among Youth Over Past Year (Nov. 15, 2018), https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm625917.htm?utm_campaign=111518_PR_New%20federal%20findings%20show%20dramatic%20increase%20in%20youth%20e-cigarette%20use&utm_medium=email&utm_source=Eloqua.

[3] Id., supra n.2.

[4] Id.

[5] Id.

[6] Id.

[7] Id.

[8] Id.

[9] FDA Nov. 15, 2018 Statement, supra n.1.

[10] Id.

[11] FDA Nov. 15, 2018 Statement, supra n.1.

[12] Family Smoking Prevention and Tobacco Control Act, Pub. L. 111-31, 123 Stat. 1776 (June 22, 2009) (hereinafter, the “Tobacco Control Act”), at § 910(a)(1)(A) (defining a new tobacco product” as “any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007”).

[13] Tobacco Control Act, supra n.11, at § 102(d)(2)(A).

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.

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