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On August 24, 2020, Keller and Heckman LLP filed a citizen petition (here) with the U.S. Food and Drug Administration (FDA) on behalf of a group of small vapor product manufacturers, retailers, and trade associations requesting that the agency seek a 180-day extension of the September 9, 2020 deadline (until March 8, 2021) for filing Premarket Tobacco Product Applications (“PMTAs”) due to continuing delays experienced by manufacturers in preparing the applications caused by the COVID-19 pandemic.

The current PMTA deadline was set by a federal district court in Maryland as part of a lawsuit filed by anti-vaping groups challenging an earlier August 2022 deadline established by FDA through guidance issued in 2017. Attached to the petition were 20 declarations demonstrating that many small vapor companies, without an extension, will either have to file incomplete PMTAs or not submit applications at all, thus forcing them to layoff thousands of employees, close their doors permanently, and remove from the market less risky vapor products that addicted adult smokers rely on to move away from cigarettes.

The petition specifically asks FDA to request from the district court an extension on the court-imposed deadline that would apply only to small manufacturers that demonstrate to the agency that they have been working in good faith to complete PMTAs by the September 9, 2020 cutoff and have otherwise taken steps to ensure that their products will not contribute to underage use. In particular, each manufacturer would need to show that it:

  • Has fewer than 50 employees and/or 10MM in annual revenue
  • Only manufactures open system products (g., e-liquids) and does not produce products used in cartridge or pod-based systems
  • Has taken steps to prohibit access by and sales to underage consumers for its brick-and-mortar stores and/or retail websites
  • Will only market to adults and not rely on kid-friendly advertising (g., using age-gated social media accounts)
  • Is otherwise in compliance with TCA and Deeming Rule requirements (g., facility registration, product listings, etc.)
  • Has already made progress in completing PMTAs prior to the September 9, 2020 deadline, but has been materially delayed in one or more tasks due to COVID-19

The court had previously granted a similar request by FDA for a 120-day extension at the beginning of the COVID-19 outbreak, which extended the court’s initial May 2020 deadline to September 9, 2020. The FDA justified the need for the extension based on the extensive impact that the spread of coronavirus was having on U.S. workers and businesses, and particularly on the ability of vapor product manufacturers to complete tasks necessary to file compliant PMTAs. The agency cited to: (i) laboratory testing delays; (ii) the inability of consultants to complete required Environmental Assessments; (iii) suppliers who were unable to provide products (e.g., devices) for testing; (iv) travel restrictions associated with China where key PMTA information is located; and (v) stay-at-home orders forcing employees to work remotely.

The petition and accompanying declarations request an additional 180-day extension given that the COVID-19 conditions justifying the first court extension still exist today and show no signs of improving. Many small manufacturers are still: (i) unable to secure lab testing and consulting services; (ii) obtain PMTA-related information from suppliers (e.g., where flavor producers have not been able to complete Tobacco Product Master Files); (iii) retain or dedicate a sufficient number of employees to work on the applications; and (iv) overcome a steep decline in revenues that would otherwise be used to complete the PMTAs. To prevent a mass exit from the marketplace of small manufacturers and their products, the petition also points to Executive Order 13924, in which President Trump directs agencies like the FDA to grant temporary extensions from regulatory requirements and otherwise exercise enforcement discretion to promote job creation and economic growth during the coronavirus outbreak.

Also critical to the petition’s extension proposal is that it is limited to manufacturers of open system vapor products. FDA has concluded, based on extensive data collected as part of the 2019 National Youth Tobacco Survey (“NYTS”), that flavored, cartridge or pod-based systems are driving underage use, and that open systems should remain on the marketplace to help adult smokers transition away from more dangerous cigarettes. The proposed extension would therefore not be available to larger manufacturers who make products that may attract young consumers. This approach is consistent with FDA’s repeated statements over the years that the agency must balance concerns about minors having access to vapor products with potential health benefits to adults of using less risky, non-combustible options.

Since the petition was filed just over a week ago, nearly 6,000 public comments have been submitted to FDA’s docket (FDA-2020-P-1797) (here). Additional comments can be filed here.

Reposted from Keller and Heckman’s Blog, The Daily Intake

  • The U.S. Food and Drug Administration recently issued a warning letter to Smart Toothpicks LLC, of Tempe, Arizona, for several violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act. Smart Toothpicks sells nicotine-infused birch toothpick products in different flavors, including “Peppermint Ice,” “Wintergreen,” and “Cinnamon” Nicotine Toothpicks.  FDA’s warning letter focused on the following, specific violations: (1) selling a tobacco product to a minor through the company’s website;  (2) selling unauthorized modified risk tobacco products; and (3) failing to include required nicotine addiction warning statements on both packaging and advertising. In making the illegal sales finding, FDA cited the fact that a person younger than 18 years of age was able to purchase Peppermint Ice Nicotine Toothpicks from the company’s website. The company’s website also contained some advertising claims that came under scrutiny as modified risk claims because they represented that the product presents a lower risk of tobacco-related disease or is less harmful than other commercially marketed tobacco products (such as its website claims, “Nicotine Satisfaction without smoke damage to your lungs” and “Smart Toothpicks – A catalyst to promote a healthier way of life… in a flavorful way!”). The products were also found to be misbranded because both the website and the product packaging were missing the required nicotine addiction warning statement.
  • This action provides an illustration of the Agency’s interpretation of “tobacco product,” which FDA defines broadly as any product made or derived from tobacco that is intended for human consumption. The Agency takes the position that this definition includes novel, non-tobacco products that contain nicotine derived from tobacco, such as nicotine-infused toothpicks. Referring to the nicotine-infused toothpicks as “dissolvable tobacco products,” the Agency concluded that the products are “covered tobacco products” under 21 C.F.R. § 1140.3, and thus subject to the same FDA requirements as other deemed products, including sales restrictions to minors and marketing authorization requirements.
  • This action also signifies the extensive reach of FDA’s regulatory authority, and highlights to others in the growing novel nicotine products industry that FDA remains focused on holding retailers and manufacturers accountable for marketing and sales practices that can lead to increased youth appeal of tobacco products.  In fact, FDA has gone on record to state that it is increasingly focused on “novel nicotine-containing products” as one such way to facilitate youth access and nicotine addiction. Accordingly, others in the industry would be prudent to heed this warning and ensure full compliance with FDA regulations, including heightened age verification for online sales and reviewing product advertising and any use of non-tobacco flavors appealing to minors.

Be sure to register for Keller and Heckman’s E-Vapor and Tobacco Law Symposium on February 11-12, 2020 in Irvine, California.  Details and Registration information can be found here.

On January 8, 2020 FDA published its latest compliance policy guidance, Guidance for Industry: Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization (January 2020), which goes into effect in February. Pursuant to the final guidance, beginning February 6, 2020, FDA intends to prioritize enforcement of premarket review requirements for the following products:

  • Any flavored, cartridge-based ENDS product (other than a tobacco or menthol-flavored ENDS product);
  • All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and
  • Any ENDS product that is targeted to minors or likely to promote use of ENDS by minors.

Importantly, FDA also intends to prioritize enforcement of any ENDS product (on the market as of August 8, 2016[1]) that is offered for sale after May 12, 2020, and for which the manufacturer has not submitted a premarket application (or after a negative action by FDA on a timely submitted application). The May 12, 2020 deadline was initially established by a federal district court in Maryland; that decision is now pending appeal in the Fourth Circuit.

With respect to the flavored cartridge/pod-system ban, the definition of “cartridge-based ENDS” in the guidance is somewhat unique and does not fall squarely within meaning of “open” and “closed” systems in industry parlance:

Cartridge-based ENDS products are a type of ENDS product that consists of, includes, or involves a cartridge or pod that holds liquid that is to be aerosolized through product use. For purposes of this definition, a cartridge or pod is any small, enclosed unit (sealed or unsealed) designed to fit within or operate as part of an electronic nicotine delivery system. [Footnote: An example of products that would not be captured by this definition include completely self-contained, disposable products.]

Manufacturers should note that because a cartridge/pod may be “sealed or unsealed” this definition appears to cover devices that use refillable pods. As discussed below, manufacturers of such devices, particularly small and easily-concealable devices, should not assume that their products are safe from immediate enforcement because they are open-systems or sold without flavored e-liquid.

While FDA has identified non-tobacco and non-menthol flavored cartridge-based ENDS (such as the JUUL) as the primary source of rising underage use, the Agency is also targeting (a) manufacturers of all types of ENDS that are not adequately preventing minor access, and (b) any ENDS products (open or closed systems, including e-liquids sold in vape shops) that, in FDA’s view, are targeted to minors or likely to promote ENDS use by minors. FDA’s broad approach could put a significant portion of the vapor industry at risk of immediate enforcement.

When determining whether an ENDS manufacturer is taking or has taken adequate measures to prevent minors’ access to its products, the Agency will consider, for example:

  1. Whether adequate programs to monitor retailer compliance with age-verification and sales restrictions are being implemented;
  2. Whether retailers face manufacturer-established penalties for failing to comply with age verification and sales restrictions, and whether there is a policy of notifying FDA of retailer violations;
  3. If the manufacturer is also a retailer, whether programs have been implemented to ensure age-verification (g., check ID at the door, adult-only access, etc.);
  4. For online sales, whether the manufacturer uses adequate age-verification technology or requires that online retailers use such technology to prevent minor access and underage sales; and
  5. Whether a manufacturer limits or requires retailers to limit the quantity of ENDS products that a customer may purchase in a given period of time (e., no bulk purchases).

When determining whether an ENDS product is targeted to minors or is marketed in a manner that is likely to promote ENDS use by minors, the Agency will consider, for example:

  • Whether the labeling and/or advertising of a product resembles kid-friendly foods and drinks or resemble other non-ENDS products that are appealing to youth. Here FDA highlights the numerous warning letters issued to e-liquid manufacturers since 2018. Those warning letters alleged that the e-liquid products were misbranded and misleading because the labeling and/or advertising of the products (e., color schemes, label images, brand names, etc.) inappropriately imitated specific food products that are generally marketed toward and/or appealing to children, including cereals (e.g., Cinnamon Toast Crunch, Lucky Charms, Fruit Loops, Franken Berry), candies and snacks (e.g., Life Savers, Sour Patch Kids, Gummy Worms, War Heads, Pocky Sticks, Goobers, Tree Top Apple Juice), and desserts (e.g., Unicorn Cakes, Nilla Wafers, Reddi Wip).
  • Whether marketing materials utilize youth appealing cartoon or animated characters or use popular children’s characters and titles;
  • Whether paid social media influencers are used; and
  • Whether a product is promoted for being easily concealable (from parents and teachers, for example). In this regard, FDA makes clear in the guidance that the following types of devices and device features present a unique concern for youth, even if adults may prefer these as well:
    1. Small size that allows for easy concealability and features that facilitate the ease of use (draw activation, prefilled cartridges or pods, and USB rechargeability);
    2. Small size that allow for use in school, quick concealment, product use in a social setting without others’ awareness, and products’ ability to be concealed with other equipment;
    3. Products with no settings to change and very little assembly required; and
    4. Products with features such as pre-filled cartridges, draw activated batteries, and that can be recharged via a USB port, charging adapters or cell phone.

While FDA carved out “self-contained disposable products” from the definition of cartridge-based ENDS as noted above, such products, particularly flavored high-nicotine salt disposables (as opposed to low nicotine cigalikes) could also be targeted by FDA for these reasons.

In short, while FDA’s focus is on flavored cartridge and pod-systems, ENDS companies should be aware that FDA’s guidance is broad enough to capture a wide variety of open and closed-system products that may be viewed by FDA as accessible to youth, marketed to youth or easily used and/or concealed by youth.

Other Deemed Products

With respect to other deemed tobacco products, including cigars and hookah, FDA indicated that available data does not support utilizing limited Agency resources for increased enforcement in advance of the May 12, 2020 premarket application deadline. FDA will make enforcement decisions on a case-by-case basis and intends to prioritize enforcement based on the likelihood of youth use and initiation. Factors the Agency may consider include:

  • What FDA understands about the number of youth currently using the product or category of product;
  • Trends in the numbers of youth use (since 2016);
  • Whether the product contains added flavors;
  • What FDA understands about how the product is typically sold and how likely to impact access and use by minors;
  • What FDA understands about the frequency and other demographics of use by minors.

Based on these factors, given what FDA understands to be their comparatively lower youth usage rates, FDA’s lowest priority among other deemed products include relatively expensive, large hand-rolled cigars that do not have flavors (e.g., fruit, candy, or mint). FDA further states in the guidance that it is actively working towards a proposed rule that would ban the use of characterizing flavors in cigars.

Keep your business in compliance! Be sure to register for Keller and Heckman’s E-Vapor and Tobacco Law Symposium on February 11-12, 2020 in Irvine, California. Details and Registration information can be found here.

[1]   All deemed tobacco products, including ENDS, intended to be introduced to the U.S. market for the first time after August 8, 2016 still require FDA premarket authorization “up front” and do not qualify for the compliance policy.

Ahead of the Food and Drug Law Institute’s (FDLI) annual Tobacco and Nicotine Products Regulation and Policy Conference in Washington, DC, on October 23, 2019, Keller and Heckman attorneys Ben Wolf and Kathryn Skaggs presented on FDA’s “Pathways to Market” for new tobacco products during the pre-conference seminar, Introduction to Tobacco and Nicotine Law and Regulation. The presentation slides are available here.

Registration is now open for Keller and Heckman’s E-Vapor and Tobacco Law Symposium on February 11-12, 2020, in Irvine, CA.  For more information, click here.

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Azim Chowdhury and Eric Gotting, partners at Keller and Heckman, will discuss the recent decision in the case American Academy of Pediatrics et al. vs. FDA, which struck down the extended premarket review compliance policy for deemed tobacco products.  Find out what the decision will mean to your business, both short and long term.

All vapor and deemed tobacco product industry stakeholders should attend.

See our previous blog posts on this case here and here.

Conference Call Details:

Date: TODAY– Friday, May 17, 2019

Time: 1:00 pm EDT

Registration fee: $50; Smoke-Free Alternatives Trade Association (SFATA) members FREE

Register: Click here to register.

If you are in the Vape Industry, you cannot afford to miss today’s call.

18plus

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).

FDA-logo_Square

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

ecig pic fda

On September 12, 2018, in a self-described “blitz”, FDA announced a deluge of enforcement actions, including more than 1,300 warning letters and fines to retailers aimed at addressing youth use of e-cigarettes, which FDA asserts has reached “epidemic” proportions, based on new, not-yet-released survey data.[1]  FDA also requested manufacturers of five “national brands,” whose cartridge (pod) based e-cigarettes the Agency claimed make up 97% of the “current e-cigarette market” (but apparently excluding the open-system vapor products market), and allegedly represent the majority of e-cigarettes sold to minors, to provide detailed plans to curtail youth use of their products.  FDA also threatened drastic action that could impact the entire vapor industry, and millions of former smokers that rely on a variety of vapor products, if adequate responses are not received.

Addressing Increase in Underage E-Cigarette Use; Stopping Access at the Retail Level

In its press release, FDA clarified that these enforcement actions were part of a “large-scale, undercover nationwide” crack down on the sale of e-cigarettes to minors at both brick-and-mortar and online retailers.  FDA Commissioner Dr. Scott Gottlieb further stated that FDA had failed “to predict what [he] now believe[s] is an epidemic of e-cigarette use among teenagers.”  While he reiterated that FDA is “fully committed to the concept that products that deliver nicotine exist on a continuum of risk, with combustible products representing the highest risk, and [e-cigarettes] perhaps presenting an alternative for adult smokers who still seek access to satisfying levels of nicotine, but without all of the harmful effects that come from combustion,” he was unequivocal with respect to underage use, emphasizing FDA’s Youth Tobacco Prevention Plan launched earlier this year, and stating that he “won’t tolerate a whole generation of young people becoming addicted to nicotine as a tradeoff for enabling adults to have unfettered access to these same products.”  On September 18, 2018, FDA issued another press release announcing that it would be advancing “The Real Cost” Youth E-Cigarette Prevention Campaign to educate teens about the dangers of using e-cigarettes.

Notably, all of the cartridge-based e-cigarettes now being targeted by FDA (and the Big Tobacco brands in particular) are sold primarily in convenience stores, gas stations and similar outlets (along with cigarettes and other tobacco products), and appear to be the main source of youth access, as well as the focus of FDA’s retailer enforcement efforts.  Indeed, the vast majority of the 1,300 warning letters and civil monetary penalties were sent to these types of retailers, rather than to vape shops dedicated to open-system vapor products.  While dozens of vape shops and online vape retailers have also been cited by FDA for selling products to minors, those instances appear to represent just a fraction of the millions of transactions that occur annually in the 10,000+ dedicated vape shops across the country.[2]

FDA Focuses on JUUL and JUUL-Like E-Cigarettes; Distinguishes Youth Concerns Between Closed and Open System Vapor Products

Although FDA’s recent announcement refers simply to the “e-cigarette market”, the vapor industry is actually very diverse and complex. Closed-system and cartridge-based e-cigarettes (like JUUL), the adolescent use of which FDA has made clear is its primary public health concern, is only a portion of the overall U.S. vapor products market, along with open-system vapor products (e.g., tanks, mods, e-liquids, etc.).

Indeed, FDA has been focusing on youth-use of cartridge-based e-cigarettes, and JUUL in particular, for several months, as stories about rampant teenage use have been heavily reported in the media, and the focus of Congressional inquiries.

Back on April 24, 2018, FDA announced its first set of 40 warning letters to retailers for underage sales of JUUL e-cigarettes and that it was examining the youth appeal of these products in an effort to end their sale to minors.  FDA used its authority under Section 904(b) of the Family Smoking Prevention and Tobacco Control Act (TCA) to request JUUL Labs submit information regarding its marketing and research studies, and any other information it had on how certain product features might appeal to different age groups.  Subsequently, in May 2018 FDA sent a second set of requests to several manufacturers seeking information on their JUUL-like products, including information on product marketing and design (as it may relate to the appeal or addictive potential for youth and youth-related adverse experiences), and consumer complaints, among other things.[3]

FDA has now announced that it is targeting five national brands that dominate the closed-system e-cigarette market –  JUUL and four other cartridge-based e-cigarettes, all of which are marketed by large tobacco companies: Vuse (Reynolds American), MarkTen XL (Altria), blu e-cigs (Fontem Ventures), and Logic (Japan Tobacco International, USA).  Importantly, Gottlieb indicated that these specific e-cigarettes make up “the majority of products sold to minors,” while noting that “the biggest youth use seems to be among cartridge-based e-cigarettes, and not open-tank vaping products.” (Emphasis added.)

The Agency has requested these five manufacturers submit within 60 days detailed plans describing how they will address and mitigate widespread youth use of their products.  For example, the FDA stated that such a plan may include:

  • Discontinuing sales to retail establishments that have been subject to an FDA civil monetary penalty for sale of tobacco products to minors within the prior 12 months;
  • Developing or strengthening any internal program in place to check on retailers, and reporting to FDA the name and address of retailers that have sold products to minors;
  • Eliminating online sales, whether through Internet storefronts controlled by the company or other retailers, or providing evidence to demonstrate that the company’s online sales practices do not contribute to youth use of e-cigarette products;
  • Revising current marketing practices to help prevent use by minors; and
  • Removing flavored products from the market until those products can be reviewed by FDA as part of a PMTA.

The requests that the companies eliminate all online sales and remove flavored products from the market are extremely onerous and effectively require the companies to cease sales of legal products.  FDA further noted that these actions are only examples of things the manufacturers might do to demonstrate FDA should continue to defer enforcement of the premarket review requirement with respect to their products, as discussed below, and encouraged the companies to “provide additional youth use prevention tools” for the Agency’s consideration.

Warning Letters to E-Liquid Manufacturers

Beyond illegal underage sales at the retail level, open-system vapor products have not been free from FDA scrutiny.  In May 2018, FDA and the Federal Trade Commission (FTC) issued 17 warning letters to e-liquid manufacturers for marketing products the agencies claimed were both misbranded under Sections 903(a)(1) and 903(a)(7) of the FDCA and false and misleading under Section 5 of the FTC Act, for being packaged and/or labeled in a manner that imitated “kid-friendly” foods such as apple juice, candy, whipped cream and cereal.  On August 23, 2018, FDA announced that all 17 companies that were warned have cooperated and have ceased all sales of the offending products.  FDA has now issued 12 additional warning letters to retailers for continuing to sell those e-liquids, making clear that any existing inventory of the misbranded products must be removed from commerce.

Drastic Action by FDA Could Destroy the Vapor Industry

a. Premarket Compliance Policy

Commissioner Gottlieb has made clear that the recent increase in youth use may force FDA to revisit its premarket review compliance policy, pursuant to which manufacturers of deemed noncombustible tobacco products (such as vapor products) that were on the market as of August 8, 2016, when the Deeming Rule went into effect, have until August 8, 2022 to submit PMTAs, and can remain on the market through that date.[4]  Moreover, under this compliance policy, if an application is timely submitted and accepted for scientific review, the subject product is permitted to remain on the market pending FDA review.  This compliance policy was first announced in July 2017 as part of the Agency’s comprehensive plan for tobacco and nicotine regulation, and extended the original compliance policy in the Deeming Rule, which only gave e-cigarette manufacturers until August 8, 2018 to submit PMTAs for their existing products.[5]

As noted, FDA’s letter to JUUL and the other large manufacturers indicates that it is seriously reconsidering its compliance policy, at least for cartridge-based e-cigarettes, due to widespread youth use (emphasis added):

To fulfill our public health mandate to address youth addiction to nicotine, FDA is reconsidering its compliance policy for submission of PMTAs for [the JUUL e-cigarette] and other similar products that were illegally sold by retailers during this blitz, including whether earlier enforcement of the premarket review provision might be warranted.

FDA further noted it is “seriously considering a policy change that would lead to the immediate removal of these flavored products from the market.”

Critically, Commissioner Gottlieb stated that if the five companies referenced above do not submit plans to combat youth use of their products, or if those plans are insufficient to address the problem, the companies “face a potential decision by FDA to reconsider extending the compliance dates for submission of premarket applications.”

If FDA does decide to modify the compliance policy for cartridge-based e-cigarettes because of their apparent unique impact on youth compared to other types of vapor products, such action does have precedent.  In its comprehensive plan, for example, FDA required deemed combustible products, such as cigars and hookah, on the market as of August 8, 2016 to submit premarket review applications by August 8, 2021, because of the known-health risks of combustible tobacco.

However, open-system vapor product manufacturers should be aware that Gottlieb did note in his statement that FDA’s “policy reconsiderations apply to the entire category” and that FDA is “also re-examining the enforcement discretion we currently exercise for other e-cig products currently on the market without authorization.”

While it remains unclear what, if anything, FDA might do with respect to its current compliance policy, any move to shorten the PMTA grace period for the vapor industry at-large will have devastating consequences not only for thousands of small businesses that would effectively be banned, but also for the public health.  These impacts were recently summarized in an amicus brief submitted by the Right to be Smoke-Free Coalition in the federal lawsuit filed by the public health groups challenging FDA’s compliance policy.  You can read about that lawsuit and the amicus brief, which makes clear that the vapor industry needs at least until August 2022 to prepare applications given the need for long-term clinical data, on our previous blog post here.

b. Flavored Products

Also of concern for the vapor industry is the potential targeting of flavored products, which the industry has argued are, in fact, appropriate for the protection of the public health (see here). It is important to first recognize that there is no such thing as an unflavored e-cigarette or vapor product. Unlike combustible cigarettes or other tobacco-containing products, there is simply no “natural” tobacco or other flavors inherent to e-liquids.  Rather, all flavors for these products are chemically synthesized and added to the base propylene glycol/vegetable glycerin solution.  Thus, unlike cigarettes, a ban on characterizing flavors would effectively result in a ban of all vapor products.

Moreover, numerous published studies demonstrate, and FDA has acknowledged, that flavored vapor products and e-liquids can help adult smokers reduce their cigarette use and/or switch completely to vapor products.  For example, a recently-released survey of almost 70,000 U.S. vapers found that 87.3% of respondents who quit smoking with e-cigarettes said that flavors were “extremely” or “very” important to their quit attempts.[6]

Remaining Compliant in a Rapidly Changing Regulatory Landscape

The new FDA enforcement actions and broader threats against the industry raise the possibility of dramatically altering the regulatory landscape for e-cigarettes and other vapor products.  FDA’s September 12 letters to the large manufacturers of cartridge-based e-cigarettes threaten to potentially end the premarket review compliance policy for those types of products, but it is not clear if FDA would extend this to all vapor product manufacturers.  Indeed, the stock market appears to have recognized this possibility, as legacy tobacco stocks rallied after FDA’s announcement.  Apparently, the markets have concluded that if adults are not going to be permitted to vape, they could return to traditional combustible tobacco cigarettes – the most harmful nicotine delivery system.  From our vantage point, and to the detriment of public health, it is hard to argue with this conclusion.

Accordingly, in view of FDA’s enforcement blitz and the Agency’s current focus on manufacturer advertising, marketing, and manufacturing practices, we recommend vapor product companies:

  • Start preparing premarket applications (including PMTAs) sooner rather than later (and attend FDA’s public hearing on October 22-23, 2018).
  • Work with retailers (both brick-and-mortar and online) that have age and photo-ID verification procedures that comply with requirements applicable to tobacco retailers, including requirements that:
    • the retailer checks the photo ID of everyone under age 27 who attempts to purchase any tobacco product;
    • the retailer only sells tobacco products to customers age 18 or older (consider whether age-gating may be appropriate for online retailers); and
    • the retailer does not sell tobacco products in vending machines unless in an adult-only facility.
  • Work with legal counsel to ensure that your product labeling and marketing would not cause the product to be misbranded or misleading (i.e., by imitating potentially “kid-appealing” foods).
  • Make sure your advertising and product labeling fully comply with the nicotine addiction warning (and other labeling requirements).
  • Comply with TCA requirements, including registration and listing for U.S. establishments, ingredient listing, and health document disclosures.
  • Do not introduce new products after August 8, 2016 without receiving FDA premarket authorization.
  • Comply with all sales and marketing restrictions, including use of any modified risk claims and the ban on free samples.
  • Prepare to be inspected by FDA and other authorities (sign up for our audit and inspection program here).
  • Consider developing an internal audit program to evaluate the procedures used by retail partners to avoid youth-access to your products.

If you have any questions about FDA’s announcements contact Azim Chowdhury (202.434.4230, chowdhury@khlaw.com). For more information on our Tobacco and E-vapor Practice in general, visit www.khlaw.com/evapor. Follow Keller and Heckman Tobacco and E-Vapor Partner Azim Chowdhury on Twitter.

[1]              See U.S. Food & Drug Admin., FDA News Release, FDA Takes New Steps to Address Epidemic of Youth E-Cigarette Use, Including a Historic Action Against More Than 1,300 Retailers and 5 Major Manufacturers for Their Roles Perpetuating Youth Access (Sept. 12, 2018).

[2]              Christopher Groskopf, What Yelp Data Reveal About the Sudden Rise of Vape Shops in America, Quartz, (Feb. 10, 2016), https://qz.com/608469/what-yelp-data-tells-us-about-vaping/.

[3]              The first set of letters were sent on May 17, 2018 to J Well, of Paris, France, for Bo Starter Kit; YGT Investment LLC and 7 Daze LLC, of Baldwin Park, California, for Zoor Kit; Liquid Filling Solutions LLC, of King of Prussia, Pennsylvania, for Myle Products; and SVR Inc., of Las Vegas, for SMPO Kit. Subsequently, in late May additional letters were sent to Myle Vape Inc. regarding Myle Products, and to MMS ECVD LLC regarding the Bo Starter Kit, to reflect additional relevant companies in the manufacturing and distribution chain.

[4]           Guidance for Industry: Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule (Revised) (August 2017), available at: https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM557716.pdf.

[5]              The original Deeming Rule compliance policy also had a sunset period that only permitted manufacturers who submitted timely PMTAs to continue to market those products for an additional year, i.e., until August 8, 2019. Unless an application was authorized during that year, it would have to be removed from the market at that time, and could only be re-introduced if it received FDA authorization.

[6]              Konstantinos F., M.D., MPH, et al., Patterns of flavored e-cigarette use among adult vapers in the United States: an internet survey (2018), at 6, 20.

inspection_cartoon

In a widely anticipated move, FDA has significantly increased the frequency of inspections of vapor manufacturing and retail facilities over the past few weeks, with some inspections spanning two days. We have received reports from vapor businesses across the country that they are receiving unannounced visits from FDA investigators conducting biannual inspections pursuant to Sections 704 and 905 of the Food, Drug, and Cosmetic Act as amended by the Tobacco Control Act. Under the Act, FDA is required to inspect every tobacco manufacturing facility at least once every two years. FDA uses a broad definition of manufacturing – repacking and relabeling are considered manufacturing acts and retailers that mix e-liquids for consumer sale are considered manufacturers.

During the course of their inspection, FDA investigators have requested product samples, labeling and invoices for raw materials, and labeling and invoices for finished goods. We understand that inspections have included both production (cleanroom) and non-production areas and have made use of photography and recordings. FDA appears also to be doing a lot of “fact finding” – learning as much as they can about the industry and how these products are manufactured and distributed, potentially for use in the development of future guidance documents and rulemakings.

We have also received reports of inspectors visiting vapor businesses from other agencies, including the Federal Aviation Administration (FAA), federal and state Environmental Protection Agencies (EPA), as well as state inspectors (e.g., California Department of Tax and Fee Administration).

As FDA continues to visit facilities across the country, it is critical that manufacturers, including retailer-manufacturers, understand the types of information that they are required to provide to the Agency upon request, as well as the type of that information that can or should be withheld. Similarly, Companies should understand the scope of authority that an FDA Investigator has in asking for specific product details. Vapor product manufacturers should fully prepare for their impending inspection now, so that they can demonstrate a high-degree of confidence when FDA arrives. Critically, and as third-party consultants begin to enter the Good Manufacturing Practice (GMP) space, manufacturers and retailer-manufacturers should ensure that the guidance they receive from outside counsel is accurate and based on experience in sound science and law and is protected from disclosure to FDA by attorney-client privilege.

Audit and Inspection Program Completes Coast-to-Coast Site Visits in First Half of 2018

Keller and Heckman’s Audit and Inspection Program (AIP) provides companies that are involved in any aspect of the tobacco or vapor product supply chain with assurance that their facilities are operating in accordance with FDA requirements. AIP Program attorneys have completed audits from Florida to California since the Program first began in early 2018, and feedback has been overwhelmingly positive:

Having your team run a thorough inspection was extremely helpful in preparing us for a “real” FDA inspection. The knowledge and insight you guys were able to provide my “Team Awesome” will certainly help us navigate through the regulations and future inspections. During this interesting time for the industry, and as a responsible manufacturer, we must do everything possible to ensure we are going above and beyond what potential GMP’s may be down the road to keep consumers and the industry’s reputation safe.

As “cool” as some people think it is to be a manufacturer in the vape industry, it’s not to be taken lightly. We try to do everything possible to provide our consumers and retailers with top quality products that are manufactured in a clean and safe environment. Having your team come in to review our facility and manufacturing practices gives us confidence that we are doing exactly what we have set out to accomplish!

The AIP Program includes both audit and training components from attorneys experienced in tobacco and vapor law, inspections, and good manufacturing practices, and addresses a broad range of inspection activities, including: recordkeeping, product labeling, product samples, requests for video/audio/photographic recordings, standard operating procedures, cleanliness and sanitation, inventory control, and personnel interviews.

Audits by the AIP Program staff are covered by attorney-client privilege and attorney work-product privilege.

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

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

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

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

Space is limited, and scheduling is generally available on a first-come, first-serve basis.