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Keller and Heckman LLP is excited to announce the agenda for our upcoming E-Vapor and Tobacco Law Symposium! Please click here to register and click here to view the agenda.

In addition to the firm’s attorneys, we have several notable experts joining as guest speakers this year, including Derek Yach, the former World Health Organization lead on the development of the Framework Convention on Tobacco Control, as well as leading scientific thought leaders Willie McKinney, Ph.D., Christopher Russell, Ph.D., and Ian Fearon, Ph.D.

This year’s program will feature timely topics specifically designed to help vapor, deemed tobacco product and cannabis-derived manufacturers stay in compliance with rapidly evolving laws and policies. Topics that will be discussed include:

  • Challenging MDOs and NSEs – Can you still appeal your denial?
  • Litigation Update – Status of appeals, flavor bans and new challenges
  • FDA’s new guidance and proposed rulemakings
  • Preparing for Increased Enforcement, and defending your business
  • Premarket Tobacco Product Application (PMTA) and Substantial Equivalence (SE) Report strategies for small businesses
  • Scientific arguments for flavors and flavor choices
  • Flavor Variety Longitudinal Study: Call to Action
  • Marketing plans, post-market surveillance, and youth-access prevention strategies
  • Age-gating and supply chain security
  • FDA Remote Regulatory Assessments and Inspections
  • New state laws (California and other local flavor bans, licensing and excise requirements, and state enforcement actions)
  • European Union and China Regulatory Update
  • Updates on CBD, Delta-8, and cannabis/hemp-derived product regulation
  • …and much more!

We have decided to extend the deadline for our Super Early-Bird discount to Friday, December 2. Register now to save $200 on your registration fee!

SEMINAR DETAILS

Dates
Wednesday, February 15 – Thursday, February 16, 2023

Registration Fees
Super Early-Bird Rate: $899, if registered by Friday, December 2, 2022
Early-Bird Rate: $999, if registered by Friday, January 13, 2023
Standard Registration Rate: $1,099, if registered after January 13, 2023

Location
Courtyard Irvine Spectrum
7955 Irvine Center Drive
Irvine, CA 92618

Click here to book your hotel room. Keller and Heckman has negotiated a preferred room rate of $229 per night, plus tax, at the Courtyard Marriott Irvine Spectrum. Please book your room by Tuesday, January 17, 2023, in order to take advantage of the negotiated room rate.

Group Discount
Register three or more people from the same company and receive 10% off the total registration fee. Contact maxwell@khlaw.com for instructions on how to receive the discount.

Continuing Legal Education (CLE)
CLE credit is available, pending individual state approval.

Certificate of Attendance
All seminar attendees will be eligible to receive a certificate of attendance upon completion of the course.

Cancellation Policy
Cancellations are accepted, and registration fees are refunded if notice is received by January 13, 2023. If notice is given after January 13, no refunds will be granted; however, substitutions are welcome.

For questions concerning the 2023 E-Vapor and Tobacco Law Symposium, please contact:

Abby Maxwell-Morrisroe
Marketing and Events Specialist
maxwell@khlaw.com
202.434.4223


Keller and Heckman Partner Azim Chowdhury authored the Filter article, “Fundamental Flaws of Tobacco Control Act—and FDA’s Implementation,” published on November 14, 2022. The article discusses the Tobacco Control Act, passed by Congress in 2009, which gave the U.S. Food and Drug Administration (FDA) authority over tobacco and nicotine products. Azim describes some of the flaws in the law, primarily the premarket authorization requirement for “new” tobacco products. “Preexisting products, including the combustible cigarette, can mostly escape FDA scrutiny. But new and potentially reduced-harm products have an enormous regulatory hurdle,” writes Azim. The article also explains that FDA’s implementation of the statute has also been “fundamentally flawed from the beginning.” Azim concludes the article by suggesting measures the FDA can take to successfully implement the Tobacco Control Act, and therefore protect public health.

To read the full article, please click here.

Be sure to register for Keller and Heckman’s Annual E-Vapor and Tobacco Law Symposium on February 15 – 16, 2023, in Irvine, California. Details and registration information can be found here.

 

 

 

Recently, California’s Office of Environmental Health Hazard Assessment (OEHHA) adopted safe harbor warning regulations for cannabis smoke and delta-9-tetrahydrocannabinol (delta-9-THC) under California Proposition 65.[1]

What is Proposition 65?

The Safe Drinking Water and Toxic Enforcement Act of 1986 (also known as Proposition 65) requires the governor of California to publish, at least annually, a list of chemicals known to the State to cause cancer or reproductive toxicity.[2] Among other things, the law prohibits the knowing exposure of any individual to an amount of a listed chemical without first providing a “clear and reasonable warning” to such individual.[3] The law requires these warnings to be provided for Proposition 65 exposures from consumer products, the workplace, and the environment unless “the person responsible can show that the exposure [to a listed carcinogen] poses no significant risk assuming lifetime exposure at the level in question,” or, for a listed reproductive toxin, that the substance “will have no observable effect assuming exposure at 1,000 times the level in question.”[4] Other limited exemptions from the warning requirement also may apply under the law.

Safe Harbor Warning Regulations for Cannabis Smoke and Delta-9-THC

OEHHA initially added cannabis smoke and delta-9-THC to the Proposition 65 list for developmental toxicity in 2020, while cannabis smoke has been listed as a carcinogen since 2009. In late 2021, OEHHA initially proposed the safe harbor warning regulations for cannabis smoke and delta-9-THC. After two updated draft proposals, OEHHA adopted this final version.

The new regulations suggest specific safe harbor methods of transmission and warning language for retail products that can expose consumers to cannabis smoke or delta-9-THC via inhalation, ingestion, or dermal application, and for environmental exposures to cannabis smoke and delta-9-THC at businesses where smoking of cannabis or vaping or dabbing of delta-9-THC occurs.

As is the case with other safe harbor warnings set out in the regulations, the specific warning language is not mandatory. Thus, businesses may use another method or provide other language to satisfy the warning obligations under the law. However, those alternative warnings must satisfy the statutory “clear and reasonable” standard.

In OEHHA’s final statement of reasons for the regulations, the agency stated that “[t]he safe harbor warning content for these regulations identifies the chemical, route of exposure and provides specific information to consumers about the risks of using cannabis products including cancer and, while pregnant, the impact exposures can have on the unborn child.”[5]

The newly adopted rule took effect October 1, 2022, and includes both a one-year phase-in period and an unlimited sell-through provision for products manufactured and labeled with compliant warnings prior to October 1, 2023.

Be sure to register for Keller and Heckman’s Annual E-Vapor and Tobacco Law Symposium on February 15 – 16, 2023, in Irvine, California. Details and registration information can be found here.

[1] See Cal. Code Regs. tit. 27, §§ 25607.38-25607.47 (2022).

[2] See Cal. Health & Safety Code §§ 25249 et seq.

[3] Cal. Health & Safety Code § 25249.6

[4] Cal. Health & Safety Code § 25249.10(c).

[5] See The Safe Drinking Water and Toxics Enforcement Act of 1986 Proposition 65, Final Statement of Reasons (June 2022), https://oehha.ca.gov/media/downloads/crnr/fsorcannabisdelta9thc080822.pdf.

Logo for Keller and Heckman podcast Food and Chemicals Unpacked
Food and Chemicals Unpacked, a Keller and Heckman LLP podcast, just published its fourth episode, “Blowing Smoke: FDA’s Evolving Regulation of Tobacco and Nicotine Products,” featuring Tobacco and E-Vapor Partner Azim Chowdhury. The episode illuminates the regulatory landscape for tobacco products and reports on current trends in the industry. Azim shares his knowledge of the process for obtaining authorization to market new tobacco products in the U.S. The episode also provides the inside scoop on industry-shaping litigation that Keller and Heckman has led. Finally, the episode discusses recent changes at FDA’s Center for Tobacco Products and how the changes might impact industry.

Food & Chemicals Unpacked is your go-to podcast for hot topics in the food and chemical industry.

Food & Chemicals Unpacked provides clear and concise updates on legislative developments, new regulations, and other non-governmental initiatives that impact these industries. Each episode will present critical information on these topics along with supporting resources from Keller and Heckman’s websites, including packaginglaw.com, The Daily Intake (our food blog), and The Continuum of Risk.

Questions? Contact us at marketingdepartment@khlaw.com.

Be sure to register for Keller and Heckman’s Annual E-Vapor and Tobacco Law Symposium on February 15 – 16, 2023, in Irvine, California. Details and registration information can be found here.

On October 18, 2022, the U.S. Department of Justice (DOJ), on behalf of the U.S. Food and Drug AdministratDepartment of Justice Sealion (FDA), filed complaints for permanent injunctions against six domestic e-liquid manufacturers across different federal district courts, all of which appear to be small vape shops that were producing nicotine-containing e-liquids used in open-system e-cigarette devices. The injunctions would require the manufacturers and named individuals to stop manufacturing, selling, and distributing any unauthorized new tobacco products, including their own nicotine e-liquids and components and parts thereof, as well as unauthorized third-party produced vaping products that might still be wading through the onerous Premarket Tobacco Product Application process.[1]

As noted in FDA’s press release, “these cases represent the first time FDA has initiated injunction proceedings to enforce the [Federal Food, Drug, and Cosmetic Act (FFDCA)] premarket review requirements for new tobacco products.”[2]

FDA stated that they previously warned each of the defendant-manufacturers that they were in violation of the premarket review requirements set forth in the FFDCA, as amended by the Family Smoking Prevention and Tobacco Control Act. However, according to FDA, the defendant-manufacturers allegedly “continued to illegally manufacture, sell, and distribute their products.”[3]

These actions, in connection with earlier activities such as the warning letters sent to EVO Brands LLC and PVG2 LLC (d/b/a Puff Bar),[4] consist of a larger “comprehensive approach to enforcing the law,” according to FDA.[5]

This joint DOJ/FDA action against these six comparatively small vape shops, and FDA’s strong words on preventing manufacturers from allegedly skirting FFDCA’s compliance, draws a strong contrast to the lack of Agency enforcement action against importers and distributors of mass-marketed and often youth-appealing Chinese-manufactured disposable e-cigarettes and counterfeit products, none of which have FDA marketing authorization. These importers and distributors consist of a significantly larger fraction of the e-cigarette market than the de minimis market share the six named defendant-manufacturers represent.

The defendant-manufacturers now can either agree to consent decrees of a permanent injunction, thereby preventing the small businesses from directly or indirectly manufacturing, selling, or distributing any new tobacco products that do not have marketing authorization or, should the defendant-manufacturers reject the consent decrees, the government can request the relevant courts to enter injunctions preventing those defendants from directly or indirectly manufacturing, selling, or distributing any unauthorized tobacco products.

Be sure to register for Keller and Heckman’s Annual E-Vapor and Tobacco Law Symposium on February 15 – 16, 2023, in Irvine, California. Details and registration information can be found here.

[1] See FDA, DOJ Seek Permanent Injunctions Against Six E-cigarette Manufacturers, available at: https://www.fda.gov/news-events/press-announcements/fda-doj-seek-permanent-injunctions-against-six-e-cigarette-manufacturers?utm_medium=email&utm_source=govdelivery.

[2] Id.

[3] Id.

[4] See 2022 National Youth Tobacco Survey Indicates Modest Increase in Youth Vaping Rates, available at: https://www.thecontinuumofrisk.com/2022/10/2022-national-youth-tobacco-survey-indicates-modest-increase-in-youth-vaping-rates/.

[5] See FDA, DOJ Seek Permanent Injunctions Against Six E-cigarette Manufacturers, available at: https://www.fda.gov/news-events/press-announcements/fda-doj-seek-permanent-injunctions-against-six-e-cigarette-manufacturers?utm_medium=email&utm_source=govdelivery.

Keller and Heckman Partner Azim Chowdhury will present at the Food and Drug Law Institute’s (FDLI) Tobacco and Nicotine Products Regulation and Policy Conference, taking place virtually and in Washington, DC on October 20 – 21, 2022. Azim will serve as a panelist on the panel titled, “Novel Products and Future Innovation: How Would New or Streamlined Pathways to Market Impact Public Health?” The panel will explore the practical side of the PMTA and Substantial Equivalence (SE) pathways and how CTP could lessen the burden of bringing a product to market, while also considering whether a wider array of products would increase public health risks, including greater nicotine use among youth and young adults.

For more information on this event, including registration, please click here.

  • On October 6, 2022, FDA and CDC released data from the 2022 National Youth Tobacco Survey, a school-based, cross-sectional, self-administered survey of U.S. middle school (grades 6–8) and high school (grades 9–12) students. The study was conducted from January to May 2022. According to the survey, 14.1% of U.S. high school students and 3.3% of middle school students reported having used an e-cigarette at least once in the last 30 days.
  • This number is up slightly from 2021, when about 11.3% of high school students and 2.8% of middle school students reported using an e-cigarette at least once in the last month. That year, the survey was administered online as students around the country were engaged in remote learning due to COVID-19. As a result, FDA cautioned, “[d]ue to changes in methodology, including differences in survey administration and data collection procedures in recent years due to the COVID-19 pandemic, the ability to compare estimates from 2022 with those from prior NYTS waves is limited; differences between estimates might be due to changes in methodology, actual behavior, or both.”
  • Overall, the 2022 numbers indicate a sharp decline from the 19.6% of high school students and 4.7% of middle school students who reported previous-month e-cigarette use in 2020, the last time the survey was conducted completely in schools, and just after the federal legal age to purchase tobacco products, including e-cigarettes, was officially raised from 18 to 21 in January 2020. The year before, in 2019, past-30 day youth vaping peaked at 27.5% of high schoolers and 10.5% of middle schoolers:
    Past-30 day E-Cigarette Use Reported Among High Schoolers Past-30 day E-Cigarette Use Reported Among Middle Schoolers
    2022 14.1% 3.3%
    2021 11.3% 2.8%
    2020 19.6% 4.7%
    2019 27.5% 10.5%
  • FDA emphasized that the number of minors vaping illegally is still far too great, and that much works needs to be done. “It’s clear that we still have a serious public health problem that threatens the years of progress we have made combatting youth tobacco product use,” said FDA Commissioner Robert M. Califf. “We cannot and will not let our guard down on this issue.”
  • Also according to the CDC, traditional, combustible cigarette use among youth continues to fall to historically low levels. In 2021, 1.9% of high school students and 1.0% of middle school students reported smoking cigarettes in the past 30 days. A little over a decade ago, in 2011, 15.8% of high schoolers and 4.3% of middle schoolers reported smoking cigarettes.
  • FDA also announced the issuance of a warning letter to the distributors of Puff Bar, the synthetic nicotine disposable e-cigarette brand most popular among those students who reported vaping, as well as a Marketing Denial Order (MDO) denying marketing authorization for the Hyde disposable e-cigarette. The manufacturer of that product, however, indicated in a press release that it had actually received a Refuse-to-Accept (RTA) letter for a technical error in its Premarket Tobacco Product Application (i.e., failure to include a translation certification for certain materials in its application that were not in English), and not an MDO, which follows after a scientific review of a marketing application.
  • It is illegal for a retailer or distributor to sell or distribute e-cigarettes that the FDA has not authorized, and those who engage in such conduct are at risk of FDA enforcement, such as a seizure, injunction, or civil money penalty. All authorized e-cigarettes are posted on the FDA’s Tobacco Product Marketing Orders
  • Be sure to register for Keller and Heckman’s Annual E-Vapor and Tobacco Law Symposium on February 15-16, 2023 in Irvine, California. Details and registration information can be found here.

Save the date! Keller and Heckman’s Annual E-Vapor and Tobacco Law Symposium is back in person in 2023. Please join us on February 15-16, 2023, for a two-day comprehensive seminar focused on legal and regulatory issues critical to e-vapor, tobacco, and CBD industries.

This year’s program will feature new, timely topics specifically designed to help vapor and deemed tobacco product manufacturers stay in compliance with rapidly evolving laws and policies. Topics that will be discussed include:

  • Challenging MDO’s and NSEs – Can you still appeal your denial?
  • FDA Litigation Update
  • FDA’s new guidance and proposed rulemakings
  • Preparing for Increased Enforcement
  • Premarket Tobacco Product Application (PMTA) and Substantial Equivalence (SE) Report strategies for small businesses
  • Scientific arguments for flavors and flavor choices
  • Marketing plans, post-market surveillance, and youth-access prevention strategies
  • FDA Remote Regulatory Assessments and Inspections
  • Prevent All Cigarette Trafficking (PACT) Act – Key Updates
  • New state laws (local flavor bans, licensing requirements, and state enforcement actions)
  • EU and Global Regulatory Update
  • Updates on CBD, Delta-8, and cannabis regulation
  • …and much more!

Registration for the seminar will open next week!

SEMINAR DETAILS

Dates
Wednesday, February 15 – Thursday, February 16, 2023

Registration Fees
Super Early-Bird Rate: $899, if registered by Friday, November 18, 2022
Early-Bird Rate: $999, if registered by Friday, January 13, 2023
Standard Registration Rate: $1,099, if registered after January 13, 2023

Location
Courtyard Irvine Spectrum
7955 Irvine Center Drive
Irvine, CA 92618

For questions concerning the 2023 E-Vapor and Tobacco Law Symposium, please contact:

Abby Maxwell-Morrisroe
Marketing and Events Specialist
maxwell@khlaw.com
202.434.4223

With the implementation of the Management Rules of E-cigarettes and the forthcoming effective date for the GB Standard on E-cigarettes (October 1, 2022), China has been regularly updating its e-cigarette regulations. Following up on our recent articles on China’s GB Standard and manufacturer license requirements, below we summarize various e-cigarette regulations recently promulgated by the State Tobacco Monopoly Administration (STMA). Although these new regulations are mostly targeted at e-cigarettes sold in China, there are also many requirements that need to be met for e-cigarettes intended for export only (e.g., notification in the technical review management system and export and transportation notifications on the national trading platform).

Technical Review

E-cigarettes intended for sale domestically in China (including imported e-cigarettes) must first pass a technical review. The prerequisites for applying for technical review are (1) compliance with the GB Standard; (2) use of trademarks approved for registration in China; (3) compliance with the relevant regulations on e-cigarette packaging labels and warnings.

The application for technical review is submitted through the “Technical Review Management System for E-Cigarette Products.” Required materials include product formula and raw material reports, key production process descriptions related to safety, testing reports, safety assessment reports, etc. The applicant also is required to submit physical samples by mail. Imported e-cigarette products must additionally have certifications for production or sales approvals in the country of origin.

Notably, although e-cigarettes manufactured in China for export to overseas markets are not subject to technical review, notification through the technical review management system is required prior to export, with a written commitment to the product’s compliance with relevant regulations and standards.[1]

Warnings and Packaging

The Chinese GB Standard on E-cigarettes contains detailed labeling requirements for e-cigarettes. STMA has further developed a regulation on warning label requirements, which applies to e-cigarettes sold in China.

The warnings are divided into three groups.

  • Group 1: Smoking e-cigarettes is harmful to health. Do not smoke e-cigarettes in non-smoking places.
  • Group 2: Quitting e-cigarettes as soon as possible is good for health. Quitting e-cigarettes can reduce health risks.
  • Group 3: Discourage adolescents from smoking e-cigarettes. No e-cigarettes for primary and secondary school students.

The first group of warnings should always be used on the front (main visible panel), and the second and third groups of warnings are used alternately on the back. The regulation also makes detailed provisions on the location, area, font, etc., of the warning area.

Notably, e-cigarette labels are prohibited from containing “misleading and inducing” language, including efficacy-related terms like health, safety, environmental protection, smoking cessation, and quality-related terms like light, ultra-light, low tar, and low nicotine, as well as terms of flavorings that are easy to induce minors.

STMA also promulgated a packaging regulation, which stipulates detailed packaging specifications for e-cigarettes. For example, a single cartridge box must contain 1-3 cartridges, a single box set must contain 1 device and 1-3 cartridges, etc.

The box of an imported e-cigarette should be labeled with “only for sale within China.” While the box of an e-cigarette for export must meet the relevant requirements of the destination country, the serial number of China’s manufacturer license also must be labeled.

In another regulation on traceability management of e-cigarettes sold in China, STMA requires that a QR code must be labeled on the package of e-cigarettes sold in China. The QR code, used to trace information about e-cigarettes, must be generated from a national e-cigarette traceability platform established to unify traceability marks.

Quality Spot Checks

E-cigarette manufacturers or sellers are subject to spot checks on the quality of e-cigarettes, according to the STMA regulation on e-cigarette quality spot checks. The authority may not conduct more than two spot checks on the same products (of the same trademark and specifications, produced by the same manufacturer according to the same standard) within six months.

While quality spot checks generally only apply to products sold in China, this regulation will apply to e-cigarettes for export if the destination country does not have relevant regulations and standards. This is because when the destination country does not have relevant regulations or standards, e-cigarettes for export are required to comply with China’s e-cigarette regulations and the GB Standard.

Trading

The e-cigarette trading management regulation asks to establish a national unified e-cigarette trading management platform for domestic sales in China. E-cigarette manufacturers, wholesalers, retailers, and importers must trade on this platform. For imported e-cigarettes, e-liquids, and nicotine used in e-cigarettes, the importer should first file an import notification on the platform before trading. For those products for export, the manufacturer must file an export notification on the platform.

The platform is membership-based and was launched on June 15, 2022.

Logistics

The e-cigarette logistics regulation applies to the management of warehousing, sorting, transportation, and distribution of e-cigarettes. For e-cigarettes for export, it is required that they must be directly transported from the warehouse of the manufacturer to the place designated by the customs. If it is necessary to transfer these products from the warehouse of the manufacturer to other warehouses in China, the shipper must submit the warehouse and other information to the authority where the warehouse is located. The recipient must report the inventory quantity to the authority on a monthly basis.

Notably, the transportation of e-cigarettes (including e-liquid and nicotine for e-cigarettes) for export requires prior notification on the trading platform. After completion of customs declaration and clearance, relevant forms should be uploaded to the platform in a timely manner.

***

We will continue to monitor the relevant regulatory developments. In the meantime, if you have any questions or need any assistance from us, please do not hesitate to contact David Ettinger (ettinger@khlaw.com), Azim Chowdhury (chowdhury@khlaw.com), or Eric Gu (gue@khlaw.com).

[1] China’s Management Rules for E-Cigarettes require that e-cigarettes solely for export must comply with the regulations and standards of the destination country; when there are no relevant regulations and standards in the destination country, the product must comply with China’s regulations and standards.

Following China’s new GB standard on e-cigarettes that we summarized in early May 2022, the State Tobacco Monopoly Administration (STMA) has now published a rule outlining the process for Chinese e-cigarette manufacturers to obtain the required manufacturer license. This rule applies not only to manufacturers producing e-cigarettes for the domestic Chinese market, but also to the manufacturing of e-cigarettes solely for export. This article summarizes the major requirements for obtaining an e-cigarette manufacturer license in China.

Product Categories

Products subject to the e-cigarette manufacturer license in China are divided into the following three categories:

  • E-cigarette products, i.e., cartridge, device, and cartridge and device for combined sales;
  • E-atomization materials (e-liquids); and
  • E-cigarette-use nicotine.

From the application form, the applicant can choose from a product type and specify whether the manufacturing of the product is for domestic sales or for export. Note that while one may choose multiple products at the same time, it is not permitted to choose across categories. For example, for a single application, the applicant is not allowed to choose both the cartridge and e-liquids (two separate applications would be required), but it is possible to choose the cartridge for domestic sales and the device for export in the same application.

We further note that, under the Management Rules for E-Cigarettes, “device” includes not only e-cigarette devices but also the device of “heated cigarettes,” i.e., heat-not-burn (HNB) products. Thus, while HNBs are regulated in China as traditional cigarettes rather than e-cigarettes, the manufacturing of a HNB device in China, whether it is for domestic sales or for export, also is subject to the same manufacturer license requirements as e-cigarettes. There is a separate product category for HNB devices in the application form for the manufacturer license.

Application Materials

There are many application materials required to be prepared for the manufacturer license application, which we briefly summarize as follows:

  1. Application form
  2. Investor information form
  3. Business license, etc.
  4. Proof of suitable funds, production and sales information, etc., including the balance sheet, income statement, cash flow statement, and production and sales statistics for the past three years
  5. Materials related to the required technology and equipment:

(1) Ownership certificate or lease agreement for the production site

(2) Description of the surrounding environment of the production site, infrastructure, investment scale, etc.

(3) Production process and quality management materials, including:

    • List of main production equipment and testing instruments
    • Production capacity measurement report and explanatory materials (including factory’s general floor plan, process equipment layout, worker number, labor productivity, flow of process, process/line capacity, effective operation rate, etc.)
    • Main quality control points and control measures (separate descriptions of the production process, work-in-process, and products)
    • Product quality testing (including testing parameters, testing systems, etc.)
    • Production process and relevant standards
  1. Power of attorney (when applicable)
  2. Other materials, including:
    • Documentation for trademark registration in China
    • For the production of e-liquids: License for operating dangerous chemicals, materials explaining the sources of ”e-cigarette use nicotine” used in the past three years, including the total amount of e-cigarette use nicotine purchased (kg), the purchase batch, the name of the supplier, purchase time, purchase quantity (kg), source information (importing country/domestic production), purity information (mass fraction percentage)
    • Applicants for export must submit materials explaining the export business and the scale of export, including the customs declaration forms for the past three years
  1. List of application materials

As shown above, the most important application materials for e-cigarette manufacturers are those about the production process and quality management. Notably, there is an extra burden for manufacturing e-cigarettes for export, as the applicants must provide information about the export business for the past three years. However, the requirement for trademark registration in China seems impractical for manufacturing e-cigarettes solely for export when the products are not sold on the Chinese market. Although it does not appear to us that STMA intended to impose the Chinese trademark registration requirement on manufacturers of e-cigarettes solely for export, it may be prudent for an affected applicant to seek clarification from the authority.

Timeline

Chinese companies can start applying for a manufacturer license on May 5, 2022. Those manufacturers that have registered with the market regulation authority before November 10, 2021, and have completed e-cigarette manufacturer information reporting in December 2021, (a procedure we covered in a prior article) must apply before September 30, 2022. Other applicants can apply only after September 30, 2022.

The time limit for reviewing the manufacturer license application is 20 working days, which can be extended by 10 working days. However, the time for any additional hearings or testing, etc. that may be needed is not counted within the time limit.

In sum, there are already quite detailed rules for how to obtain the e-cigarette manufacturer license in China. At the same time, there are vague areas, such as the trademark registration requirement.

We will continue to monitor the regulatory development in this respect. In the meantime, if you have any questions or need any assistance from us in obtaining an e-cigarette manufacturer license in China, please do not hesitate to contact David Ettinger (ettinger@khlaw.com), Azim Chowdhury (chowdhury@khlaw.com), or Eric Gu (gue@khlaw.com).