Photo of Azim Chowdhury

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

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

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

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

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

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

Admissions: District of Columbia; Maryland

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!

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.

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.

_____________________________________________________

[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).

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.

We have observed two recent enforcement trends at the Consumer Product Safety Commission (CPSC) that may affect the e-vapor industry: (1) a spike in recalls of products harmful or fatal to children if ingested but lacking required child-resistant packaging; and (2) an increased focus on the absence of certificates of compliance. Both forms of regulatory violations were also the subject of a recent Nicotine Packaging Advisory Letter from the Director of CPSC’s Office of Compliance and Field Operations. Companies that bottle and sell liquid nicotine for use in open-system e-vaping devices should therefore ensure that their containers are fitted with compliant child-resistant closures if required, and that they create, furnish, and keep on file accurate and updated General Certificates of Conformity (GCCs) evincing compliance. Failure to do so could result in detention and destruction of shipments or products stored in warehouses, recalls from distribution, and consumer-level recalls, and could put companies at risk of civil penalties for violations. We advise many clients on child-resistant packaging and related obligations. Given scrutiny of the e-vapor industry by multiple federal agencies, it is especially important for industry members to pay close attention to CPSC requirements as well as obligations under laws administered by other agencies.

Child Resistant Closures

As we previously reported, the Child Nicotine Poison Prevention Act of 2015 (CNPPA) requires that “liquid nicotine containers,” which are defined as containers “from which nicotine is accessible through normal and foreseeable use by a consumer,” be packaged in child-resistant packaging. Pods and similar containers that are designed for use in closed-system electronic vaping devices do not need child-resistant packaging if consumers will not come into contact with the nicotine “through customary or reasonably foreseeable handling or use, including reasonably foreseeable ingestion or other contact by children.” The requirements for child-resistant packaging are found in CPSC’s regulations implementing the Poison Prevention Packaging Act (PPPA) and are specifically cited in the CNPPA. The packaging must be difficult for children to open (80% of children should be unable to open the packaging after 10 minutes of trying), but should also be easy for older adults to open (90% of adults must be able to open it). See 16 CFR § 1700.15. CPSC regulations set out the testing protocol, which includes panels of at least 50 children and 100 adults aged 50-70. 16 CFR § 1700.20.

CPSC’s recent Nicotine Packaging Advisory Letter cautions companies that child resistant closures may apply to dispensing caps that come with the products. Notably, the Advisory Letter stresses that if the dispensing cap or other secondary closure sold with the product is reasonably expected to replace the original child resistant closure, it must also be child resistant. This appears to be a new area of concern for CPSC with respect to liquid nicotine, as it was not mentioned in CPSC’s June 7, 2016 Nicotine Packaging Surveillance letter. Companies should therefore expect enhanced CPSC enforcement focus on products sold with secondary caps.

CPSC is not the only agency concerned about the possibility that children could be poisoned by liquid nicotine if they accidentally ingest it. In May of this year, the Food and Drug Administration (FDA) together with the Federal Trade Commission (FTC) issued 13 warnings letters to e-liquid companies that sold liquid nicotine in packages resembling soft drinks, candy, or other foods appealing to children. The letters alleged that these products were misbranded in violation of the Food, Drug and Cosmetics Act and that the labeling was unfair or deceptive in violation of the FTC Act. In the letters, the agencies states that “children are at particular risk because exposure to the nicotine in the e-liquid product, even in relatively small amounts, could result in acute toxicity. Child poisonings due to the ingestion of liquid nicotine have recently increased substantially.  Severe harms can occur in small children from ingestion of liquid nicotine, including death from cardiac arrest, as well as seizure, coma, and respiratory arrest.” FTC staffers also highlighted use of child-appealing characters and themes by e-cigarette companies in packaging and advertising at a recent National Advertising Division (NAD) advertising conference, stressing that the practice was unfair and deceptive, and that ingesting nicotine could be fatal to children.

Separately, the CPSC appears to have increased its targeted enforcement of child-resistant packaging requirements for other product categories. CPSC announced six consumer-level recalls of products that did not have mandatory child-resistant packaging over the last twelve months. This is a sharp increase in such recalls, as there had been only twenty-two between 1992 and late 2017. Companies that recalled products lacking child-resistant packaging generally provided consumers a refund, a new product, or a replacement child-resistant cap. They also reworked packaging for new products to add child-resistant cap. Be advised that it takes time to source appropriate child-resistant closures that are technically suitable for the package, can be implemented on existing product packaging lines, and meet cost considerations. Additionally, because child-resistant packaging requirements are enshrined in mandatory regulations, firms that learn of a failure to comply must of course consider their obligation to file a report to CPSC under Section 15(b) of the Consumer Product Safety Act (CPSA). We advise companies that determine that their existing product packaging fails to meet child-resistant requirements to begin the search for alternative packaging or closures at the same time they prepare their reports to the CPSC.

General Certificates of Conformity

Because containers of liquid nicotine are subject to a mandatory CPSC regulation, manufacturers must also create GCCs for their products. GCCs must accompany a product shipment, which can be done either as a hard copy or as a link to a URL where the retailer, or the CPSC if it requests one, can find an electronic copy. CPSC’s recent Nicotine Packaging Advisory Letter specifically reiterated the requirement to issue GCCs. GCCs must include certain specific information.  As it is not always straightforward to create these records, we outline the requirements below with some tips on compliance:

1. Identification of the product covered by the certificate.

  • This would include the brand name, size, SKU and similar information.

2. Citation to each CPSC product safety regulation or statutory requirement to which the product is being certified.

  • The relevant citation is 16 CFR § 1700.15.

3. Identification of the importer or domestic manufacturer or private labeler certifying compliance of the product, including the importer or domestic manufacturer’s name, full mailing address, and telephone number.

  • The manufacturer listed is the company that filled the bottle, or the private labeler, e., the company named on the label in the case of product that was filled by a supplier that is not named on the label.
  • The manufacturer of the child-resistant packaging is not the manufacturer of the e-liquid and should be listed here.

4. Contact information for the individual maintaining records of test results, including the custodian’s name, e-mail address, full mailing address, and telephone number.

  • The manufacturer responsible for creating the GCC must designate a responsible individual and provide this information.

5. Date (month and year at a minimum) and place (including city and state, country, or administrative region) where the product was manufactured.

  • The date and place where the e-liquid was filled should be provided.

6. Date and place (including city and state, country or administrative region) where the product was tested for compliance with the applicable regulation(s).

  • This would be the date and location of testing for compliance with child-resistant packaging requirements.
  • If the e-liquid manufacturer or private labeler has relied on a GCC from the supplier of the container rather than conducting its own tests, list the date of the certificate provided by the packaging suppliers.

7. Identification of any third-party laboratory on whose testing the certificate depends, including name, full mailing address and telephone number of the laboratory (to the extent this is relevant).

  • If the e-liquid manufacturer or private labeler has relied on a GCC from the supplier of the container, the response is “N/A” but the underlying GCC should be attached to the e-liquid manufacturer’s GCC.

CPSC has dramatically increased its enforcement for violations of “paperwork” requirements, including certificate of compliance and tracking labels for children’s products, at the port over the last year. CPSC is on pace to issue more Letters of Advice (LOA) for such violations than in any year since 2012, the earliest year for which data are available. CPSC’s Office of Import Surveillance also recently released a report on a study it conducted that found a high correlation between the lack of certificates and additional regulatory violations. If CPSC requests a GCC and one is not furnished within 24 hours, it is highly likely that the shipment will be detained and subjected to additional scrutiny by the agency. Companies should, therefore, make sure that they create full and accurate GCCs and that they appropriately provide them to their retailers. Companies should also maintain their GCCs in a readily accessible electronic file so that they can be quickly accessed and sent to CPSC upon request.

Conclusion

In an era of heightened attention to the potential harm to minors stemming from e-vaping, sellers of liquid nicotine should diligently comply with child-resistant packaging requirements and should carefully document their compliance with GCCs. Failure to meet these requirements could lead to consumer-level recalls and destruction of all existing non-compliant product in the supply chain. Companies with noncompliant products that want to avoid a prolonged absence from the market will have to quickly secure appropriate packaging, which may be expensive and difficult to integrate with existing production lines. Additionally, failure to use required child-resistant closures may give rise to reporting obligations to the CPSC, and failure to report could lead to enforcement actions and potentially millions of dollars in penalties.

The e-vapor industry is facing scrutiny from multiple federal agencies on multiple fronts. It is essential that industry members understand and adhere to all applicable regulatory requirements, and as always, Keller and Heckman is here to help.

If you have any questions regarding CPSC requirements contact Sheila Millar (millar@khlaw.com, 202-434-4143) or Boaz Green (green@khlaw.com, 202-434-4267. For more information about our Product Safety Practice in general, visit https://www.khlaw.com/Product-Safety. For more information about our Tobacco and E-vapor Practice, visit https://www.khlaw.com/evapor.

Register for Keller and Heckman’s 3rd Annual Tobacco and E-Vapor Law Symposium in Miami, Florida on January 29-30, 2019 here.

Azim Chowdhury and Adam Susser have been published in the Washington Legal Foundation’s Critical Legal Issues Working Paper Series, Number 210, October 2018 edition. In the paper, Implementing the Continuum of Risk: Modified Risk Tobacco Products, Azim and Adam address how the Food and Drug Administration (FDA) can better implement the Tobacco Control Act’s Modified Risk Tobacco Product (MRTP) provisions to benefit the public health.  To read the full article, click here.

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

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

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

 General Overview of the TVPA and Related Legislation

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

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

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

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

Promotional Claims

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

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

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

Related Legislation

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

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

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

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

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

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

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

Importing E-liquids into Canada from the United States

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

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

Joint Efforts to Regulate Vaping Products in North America

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

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

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

 

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

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

[3]              TVPA, Part II (Access).

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

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

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

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

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

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

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

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

On September 11, 2018, Nicopure Labs, LLC and the Right to be Smoke-Free Coalition (the “Appellants”) appeared for oral argument before a three-judge panel in the United States Court of Appeals for the District of Columbia Circuit to appeal a decision issued last year by the U.S. District Court for the District of Columbia, which ruled in favor of the U.S. Food and Drug Administration (“FDA”) in the first lawsuit challenging various provisions of the Family Smoking Prevention and Tobacco Control Act (“TCA” or “Act”) and FDA’s Deeming Rule as they are being applied to the vapor industry.[1]

During oral argument, the Appellants argued that the Modified Risk Tobacco Product (“MRTP”) preclearance requirement imposed by Section 911 of the TCA violates the First Amendment as applied to vapor products. In addition, the Appellants argued that application of the Act’s free sample ban to vapor products violates the First Amendment, and that FDA failed to tailor the Premarket Tobacco Application (“PMTA”) requirements to ensure the continued availability of vapor products.  Below, we provide a brief overview of the issues discussed at the oral argument. The recording of the hearing is available here.[2]  For background on the appeal, see our previous blog posts, including copies of the legal briefs, available here and here.

Modified Risk Claims

Appellants argued that the dichotomy in the current law – that manufacturers are legally permitted to sell vapor products for recreational purposes, but not allowed to make objectively truthful statements about those products (e.g., that they do not contain or produce tar, ash, or smoke, among other harmful chemicals found in cigarette smoke), or simply repeat FDA’s and various public health organizations’ statements that vapor products pose less risk than cigarettes – runs afoul of the First Amendment, which protects commercial speech. Indeed, Appellants stated that the requirement to ask permission is a First Amendment injury itself. Further, the Appellants contended that under current law, even if every federal judge in the country found a vapor company’s statements about its products to be true, if FDA determines that such a statement does not benefit public health, it would still be prohibited.

Appellants also discussed application of the Supreme Court’s intermediate scrutiny test to the MRTP provision. Under that approach, restrictions on commercial speech are judged under the four-pronged Central Hudson test, in which Courts ask whether: (1) the speech concerns a lawful activity and is not misleading; (2) the asserted government interest is “substantial”; (3) the restriction directly and materially advances the governmental interest; and (4) the restriction is no more extensive than is necessary to serve that interest.[3] As to the third prong, Appellants maintained that the MRTP provision does not directly and materially advance the government’s interest because others can make similar public statements without any preclearance approval.

The Appellants also noted that the clear trajectory of modern U.S. Supreme Court First Amendment jurisprudence requires that, under the fourth prong of Central Hudson, if the government can achieve its interest in a way that is less restrictive than a prior restraint, it must do so. For example, FDA could rely on non-speech alternatives standing alone or in combination with each other to prevent potentially misleading modified risk claims, such as enforcing the TCA’s misbranding and adulteration provisions, requiring manufacturers to maintain records substantiating such claims, requiring the use of disclaimers, and conducting post-market surveillance.

Free Sample Ban & PMTA Tailoring

Appellants also argued that under the Supreme Court’s decision in Tex. v. Johnson free samples are protected under the First Amendment. [4] Under that case, whether conduct is “sufficiently imbued with elements of communication” to warrant First Amendment protection depends on whether there is “an intent to convey a particularized message” and “the likelihood [is] great that the message [will] be understood by those who view it.”[5] Here, vapor companies intend to send a message to consumers through their distribution of free samples; thus sampling is a form of protected speech. Appellants argued that it is not enough for vapor companies to simply state that their e-liquid tastes better than a conventional cigarette, for example, but instead the only way to convey this information – the personalized experience of vaping a particular flavor – is through providing a sample. This is expressive conduct. Appellants also maintained that the ban on free samples violates the third and fourth prongs of Central Hudson. For instance, neither Congress nor FDA produced any evidence that minors are, in fact, obtaining access to vapor products through free samples, and there are ample non-speech restrictions that could limit access by youth, such as enhanced enforcement initiatives and minimum age verification at retailers.

In addition, Appellants argued that the PMTA requirements were insufficiently tailored to ensure the continued availability of vapor products. Specifically, given that FDA determined that the vast majority of manufacturers will exit the market before filing PMTAs due to the high cost of long-term, product-specific studies (for more on this see here), Appellants maintained that FDA should have considered accepting for scientific review PMTAs for vapor products that do not contain such studies but otherwise comply with the PMTA informational requirements. FDA could still do a complete review of those PMTAs, which would include a scientific literature review of the population effects of vapor products as such evidence exists in 2022, when PMTAs are expected to be filed under FDA’s current compliance policy for products on the market as of August 8, 2016.

Post-Argument Activity

One day after the oral argument, FDA submitted a letter to the D.C. Circuit Clerk of the Court, informing the court that, on September 12, 2018, FDA announced significant new actions, including enforcement initiatives, to address an alleged “epidemic of e-cigarette use among teenagers.”[6] We previously blogged about FDA’s enforcement “blitz” here.  The letter notes that “FDA is reconsidering the extended compliance dates for the submission of new product applications when it is apparent that there is widespread youth use of the product, and is also considering a policy change that would lead to the immediate removal of flavored e-cigarette products from the market.”

Indeed, in letters to several large manufacturers of cartridge-based e-cigarettes, FDA threatened to revisit the August 8, 2022 PMTA compliance date (for those companies’ and potentially similar products), if the targeted companies failed to submit within 60 days comprehensive plans to address sales of their products to minors.

On September 17, 2018, Appellants submitted a response to the FDA’s letter, arguing that it “provides no new authorities [as required by Federal Rule 28(j)] and instead describes enforcement actions that have nothing to do with appellants and target a portion of the e-cigarette industry.”[7] Appellants point out that FDA’s enforcement actions, which ostensibly target 97 percent of the e-cigarette market – actually only address the “cartridge-based” e-cigarette market, which is only a portion of the overall vapor products market. Indeed, FDA Commissioner Dr. Scott Gottlieb pointed out that sales of open-tank vaping products, which Appellants primarily market, do not appear to be driving the government’s claimed increase in underage use. Regardless, Appellants maintained that FDA’s recent enforcement actions prove their point: if FDA is concerned about purchases by or marketing of vapor products to youth, it can and should advance that interest through actions targeted at that problem (e.g., warning letters to retailers), not through a blanket prohibition on all truthful, non-misleading speech by manufacturers to adults.[8]

Next Steps

While it is impossible to state with certainty when the D.C. Circuit will rule on the case, we believe it is reasonable to expect a decision sometime in early 2019. We will keep readers of this blog updated on the outcome of the case.

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[1] At the hearing, Miguel Estrada of Gibson, Dunn & Crutcher represented Nicopure Labs, and Eric Gotting of Keller and Heckman represented both Nicopure Labs and the Right to be Smoke-Free Coalition.

[2] Oral argument, Nicopure Labs et al. v. FDA, Case No. 15-5196 (D.C. Cir. Sept. 12, 2018), recording available at https://tinyurl.com/y8xzmsr4.

[3] Lorillard Tobacco Co. v. Reilly, 533 U.S. 525, 554-55 (2001) (summarizing test outlined in Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n of N.Y., 447 U.S. 557 (1980)).

[4] See Tex. v. Johnson, 491 U.S. 397 (1989).

[5] Id. at 404 (citations and internal quotations omitted).

[6] See Letter from Tyce R. Walters to Mr. Mark Langer, Clerk of the Court re: Nicopure Labs, LLC v. FDA, No. 17-5196 (oral argument heard Sept. 11, 2018);  See also 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), https://tinyurl.com/y9gh3dyg; U.S. Food & Drug Admin., FDA Statement, Statement From FDA Commissioner Scott Gottlieb, M.D., on New Steps to Address Epidemic of Youth E-Cigarette Use (Sept. 12, 2018), https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620185.htm.

[7] See September 17, 2018 letter from Miguel A. Estrada and Eric P. Gotting to Mr. Mark Langer, Clerk of the Court re: Nicopure Labs, LLC v. FDA, No. 17-5196 (oral argument heard Sept. 11, 2018).

[8] Id.; See also Thompson v. W. States Med. Ctr., 535 U.S. 357, 371 (2002) (“[I]f the Government could achieve its interests in a manner that does not restrict speech, or that restricts less speech, the Government must do so.”) (emphasis added).

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