Author: Staff Writer

  • Navigating the Regulatory Wave

    Navigating the Regulatory Wave

    Photo: Avail

    Retailers must focus on Online Rules

    By Nicholas A. Ramos, Agustin E. Rodriguez and Bryan M. Haynes

    Online businesses selling electronic nicotine delivery systems (ENDS) to consumers must contend with a “patchwork quilt” of state laws. This patchwork of laws creates significant regulatory uncertainty and risk for businesses selling online in this space. There are many legal issues facing online retailers, like bans or restrictions on “flavored” tobacco products, minimum age and age-verification requirements, and state and local licensing and tax requirements. This article discusses some of the key legal issues associated with selling ENDS to consumers online and highlights proposed state legislation that may impose more requirements on the industry.

    State licensing

    Online retailers looking to comply with the myriad of state laws should first look at the states in which consumers purchase their products and, for each state, identify potentially applicable licensing laws. States may require licensing or registration under tax laws, health and welfare laws, and/or general business laws before online retailers may sell to consumers in their states. Idaho, for example, requires licenses from its Department of Health and Welfare to prevent youth access to tobacco products and electronic smoking devices. Washington, D.C., however, requires a basic business license from its Department of Consumer and Regulatory Affairs.

    In addition, online retailers of ENDS should determine whether state licensing law definitions actually cover their products. While states have required licenses for the sale of tobacco products for years, they have only recently added definitions of ENDS to their licensing statutes. ENDS may be covered under licensing laws either because the category is explicitly defined, or the definition of tobacco products is broad enough to cover ENDS products.

    Online retailers should also determine whether state licensing laws actually cover remote sales. Some states only require licenses for retailers that have a “place of business” or “business location” in their states. Hawaii, for example, is unique in that it requires ENDS retailers to obtain a registration from the Hawaii Attorney General. At this time, however, the Attorney General only requires retailers to register if they are located in the State, which excludes out-of-state online retailers.

    It is also important to keep in mind that most state laws regulating ENDS were only passed within the last 3-5 years. Many of those new laws simply amended existing tobacco product laws, and legislatures may not have carefully incorporated those changes in all of the critical statutory sections. Consequently, there are often situations in which the legal requirements are not clear. In those cases, it may be prudent to reach out to regulators to better understand how they interpret their statutes.

    State taxes

    When online retailers face ambiguous licensing laws, it may be helpful to look to the purpose of those laws. For example, if licenses are required by a tax department, the online retailer should look at the tax statute to determine who and what is subject to taxes. Many states require licenses to facilitate payment of sales or excise taxes.

    Almost all states impose sales and use taxes on remote sales of products. For out-of-state online retailers, most states follow the analysis outlined in South Dakota v. Wayfair, Inc., 138 S. Ct. 2080 (2018), which generally permits a state to impose sales tax on an out-of-state seller where the seller has a “substantial nexus with the taxing State.” Some states require a business or tax registration to file returns and pay sales taxes.

    Missouri, for example, does not tax or regulate ENDS as tobacco products, but it requires online retailers to obtain a retail sales tax license for sales tax purposes. Furthermore, states typically only require sales taxes from remote sellers when a certain sales volume or revenue threshold has been met. Virginia, for example, requires a remote seller to register for the collection of sales and use tax if it received more than $100,000 in gross revenue from sales in Virginia or engaged in 200 or more separate retail sales transactions during the previous or current calendar year.

    In addition, like state licensing laws, the applicability of excise taxes to ENDS products sold online can depend on the specific product definitions in the relevant statutes. Some states’ excise tax statutes explicitly define and include ENDS products, while others attempt to fit those definitions into terms like “tobacco products” or “other tobacco products.” Utah, for example, explicitly taxes “electronic cigarette substances,” “prefilled electronic cigarettes,” “alternative nicotine products,” “nontherapeutic nicotine device substances,” and “prefilled nontherapeutic nicotine devices” in its Electronic Cigarette and Nicotine Product Licensing and Taxation Act.

    Some states explicitly exclude ENDS from definitions that would subject them to excise taxes. Texas, for example, provides defines taxable “tobacco products” to exclude e-cigarettes, or any other device that simulates smoking using a mechanical heating element, battery, or electronic circuit to deliver nicotine or other substances through inhalation.

    It is also important to keep in mind that states tax various parts of ENDS products in different ways. Virginia, for example, imposes an excise tax on liquid nicotine products at the rate of $0.066 per milliliter of liquid nicotine, but the State does not impose taxes on other components of ENDS. Washington, D.C., on the other hand, taxes vapor products by making the tax rate equal to the cigarette tax, expressed as a percentage of the average wholesale price of a pack of 20 cigarettes.

    Finally, if online retailers determine state excise tax laws apply to their ENDS products, they must still determine who is required to pay those taxes and when they are due. For example, some states, like Kentucky, require that excise taxes be paid by the licensed distributor that first possesses the ENDS products for sale to a retailer or unlicensed person in the State.

    Potential penalties & enforcement climates

    Online retailers facing ambiguous licensing statutes should consider two major factors in their risk analysis—statutory penalty provisions and enforcement climate.

    Penalties for operating without a license can be steep. In Idaho, for example, it is a criminal offense to sell ENDS without a permit issued by the Department of Health and Welfare. In addition, a court may impose a fine of $1,000 per day beginning the day following the date of citation as long as the illegal ENDS sales continue.  In other states, however, penalties are relatively low. In Montana, for example, failure to obtain a vapor product license is punishable by a civil penalty of $100.

    Finally, online retailers should consider the enforcement climate surrounding regulation of ENDS products in certain states. For example, Attorneys General in various states have filed lawsuits against an ENDS manufacturers and online retailers. Although these cases do not directly implicate licensing or tax issues, enforcement actions by Attorneys General may suggest a more aggressive enforcement climate when it comes to licensing or tax violations.

    Proposed state legislation

    Online retailers should expect upcoming state legislative sessions to be fairly active with regard to regulation of ENDS products. In Colorado, for example, there is no current nicotine products or ENDS tax or licensing scheme. But Colorado HB20-1472 established a voter referendum on whether there should be a tax on “nicotine products,” which would include “products that contain nicotine and that are ingested into the body.”

    In Georgia, the legislature is considering a bill that will amend its tax and revenue laws “to provide for excise taxes to be levied on certain alternative nicotine products and vapor products” and to “require licensure of importers, manufacturers, distributors, and dealers of alternative nicotine products or vapor products.” HB 1229.

    South Carolina is also considering a bill (H.4714) that will “provide for the levying, assessment, collection, and payment of certain taxes on vapor products.”

    These are just a few examples of states that are considering ways to regulate and tax ENDS products. Therefore, it is important for online retailers to incorporate accurate state legislative tracking into their compliance strategies.

    Conclusion

    As with any other new technology, the law is often playing catch up with new business models and products, like the online sale of ENDS products. But given the issues discussed above, online retailers should prioritize compliance with varying state laws to reduce the risks of enforcement action.

  • FDA Draft Guidance for Perception Studies

    FDA Draft Guidance for Perception Studies

    Photo: Jhvephotos | Dreamstime.com

    The U.S. Food and Drug Administration (FDA) has released a draft guidance for tobacco product perception and intention (TPPI) studies. The studies must be submitted as part of a modified risk tobacco product application, a premarket tobacco product application or a substantial equivalence report.

    The guidance is aimed at helping applicants design and conduct the studies that can be used to assess, among other things, individuals’ perceptions of tobacco products, understanding of tobacco product information (e.g., labeling, modified risk information), and intentions to use tobacco products.

    It is possible for a TPPI study to also include an actual use component (e.g., an actual product utilized in a simulated use setting or a real environment of use); however, a discussion of actual use research is beyond the scope of this draft guidance, according to the FDA.

    This draft guidance addresses the following scientific issues for applicants to consider as they design and conduct TPPI studies to support tobacco product applications:

    • Developing TPPI study aims and hypotheses
    • Designing quantitative and qualitative TPPI studies
    • Selecting and adapting measures of TPPI study constructs
    • Determining TPPI study outcomes
    • Selecting and justifying TPPI study samples
    • Analyzing TPPI study results

    The agency is accepting public comments related to the draft guidance through Dec. 28. The application deadline was Sept. 9 for deemed new tobacco products that were on the market as of Aug. 8, 2016, and the FDA said it intends to make a public list of what products were submitted on time. 

  • Imperial Completes Sale of Cigar Business

    Imperial Completes Sale of Cigar Business

    photo: Image by Chris Frenzel from Pixabay

    Imperial Brands completed the sale of its worldwide premium cigar businesses for a total consideration of €1.23 billion ($1.4 million) of which net cash proceeds of €1.1 billion will be used to reduce debt, the company announced on its website.

    As announced on April 27, 2020, €88 million of consideration will be deferred for 12 months from today’s close, with a further €69 million deferred and contingent upon the transfer of the Dominican Republic factory, which is expected to complete in 2021. As subsequently announced on Sept. 28, Imperial has provided a further six-month deferral of €250 million while the buyers finalize long-term financing arrangements.

  • Premium Tobacco Launches Website

    Premium Tobacco Launches Website

    The Premium Tobacco Group’s website, www.premiumtobaccogroup.com, is now up and running.

    Following the company’s steady growth in recent years, Premium Tobacco’s management decided a website was warranted to illustrate the group’s operations. Among other things, the website highlights the compliance and sustainability policies that the group rigorously adheres to in all its origins.

    “The group’s board is proud of the achievements of all employees and stakeholders in delivering year on year growth and wanted to provide a platform where these achievements could be shared,” Premium Tobacco wrote in a statement.

  • KT&G Receives High Marks for Governance

    KT&G Receives High Marks for Governance

    Photo: KT&G

    KT&G has obtained a Grade A in the environment, social and governance (ESG) evaluation conducted by Morgan Stanley Capital International (MSCI).

    Every year, MSCI evaluates about 8,500 listed companies worldwide by dividing them into different types of businesses and rating their business status related to the environment, social responsibilities, and corporate governance in the range of AAA to CCC. This year, KT&G was evaluated along with 11 global tobacco companies.

    This year’s grade is one level up from last year’s BBB.

    Last year, KT&G obtained an A+ for the second consecutive year and won the “Grand Prize” in the domain of governance in the ESG evaluation performed by the Korea Corporate Governance Service in recognition of its establishment of an excellent sustainable management system.

    The company has also been publishing the KT&G Report since 2007 to deliver transparent and accurate ESG information to domestic and overseas stakeholders as well as share various social responsibility activities with them.

  • TPB Raises Guidance After Strong Quarter

    TPB Raises Guidance After Strong Quarter

    Image by Steve Buissinne from Pixabay

    Turning Point Brands (TPB) reported net sales of $104.2 million in the third quarter of 2020, up 7.6 percent over those of last year’s third quarter.

    Gross profit increased 12.8 percent to $48.3 million. Net income increased $1.5 million to $7.8 million, despite PMTA costs incurred during the current quarter.

    Adjusted EBITDA increased 27.4 percent to $23.9 million.

    “Streamlining and repositioning the business at the end of 2019 has paid dividends throughout 2020,” said Larry Wexler, president and CEO of TPB, in a statement.

    “Smokeless saw continued same store sales momentum in MST and newfound strength in loose leaf chewing tobacco. Smoking (Zig-Zag) saw its highest growth rate in recent history driven by product and channel growth initiatives behind rolling papers, the benefits of greater control of our MYO cigar wraps business after the Durfort transaction closed in the second quarter, and a burgeoning e-commerce presence, he said.

    “The NewGen segment navigated admirably through significant market disruption caused by the PMTA application deadline, said Wexler. “Overall, we are seeing ongoing benefits from reshaping our business towards a more growth-oriented mindset and are able to raise our outlook once again for the remainder of the fiscal year.”

    TPB also revised its 2020 guidance provided on July 28, 2020. Absent any further acquisitions, the company projects 2020 net sales to be between $395 million and $401 million, up from previous guidance of $370 million to $382 million.

  • Taat Starts Commercial-Scale Production

    Taat Starts Commercial-Scale Production

    Photo: Taat Lifestyle and Wellness

    Taat Lifestyle & Wellness’ contract manufacturing partner has begun commercial-scale production after receiving a supply of Beyond Tobacco base material from the company.

    This batch will be packaged using an updated Taat pack design, similar to the provisional pack designs published in September. Beginning in November 2020, when initial production of Taat is expected to be completed, inventory of Taat is to be shipped from the manufacturer’s warehouse to tobacco wholesalers in Ohio, who will then be able to fulfill orders for Taat from tobacco retailer accounts in the convenience channel.

    Beyond Tobacco is the nicotine-free and tobacco-free base material of Taat, an alternative to traditional cigarettes, the company explained  in a press note. Taat has been engineered to closely replicate every aspect of the cigarette-smoking experience, including a combustible stick format, cigarette-style packaging, an enhanced volume of smoke exhaled, and a taste and smell similar to tobacco attained by way of a patent-pending refinement technique.

  • Turning Point Invests in Cannabinoid Business

    Turning Point Invests in Cannabinoid Business

    Photo: Herbal Hemp from Pixabay

    Turning Point Brands (TPB) will invest $15 million Dosist, a global cannabinoid company. It has also signed an exclusive co-development and distribution agreement for a new CBD brand, created in partnership with Dosist’s THC-free business unit.

    TPB has an option to invest another $15 million at predetermined terms within the next 12 months.

    “The cannabis market is exploding, and now is the opportune time to invest in the space and significantly expand our addressable market,” said Larry Wexler, CEO of TPB, in a statement. “With its leadership in results-oriented plant-based formulas and dose control technology, global recognition, consumer trust and scalability, Dosist was the clear choice to be our new partner in this critical growth market.”

    “We are extremely proud to partner with Turning Point Brands on our next phase of growth and distribution as we continue to transcend the way consumers think about their health and wellness,” said Gunner Winston, CEO of Dosist. “Turning Point’s leadership team has demonstrated remarkable foresight and vision about the future and opportunity for federally legal cannabinoid products. The synergy between our brands around this scope and mission is incredible and we are excited by what we will achieve together with this partnership.”

    Dosist’s cannabis products are currently available in California, Colorado, Nevada and Canada, serving a total dispensary network of more than 700 stores. The company has plans to launch into key new markets in the coming months, adding geographies as they continue their North American expansion.

  • Record Quarter for Swedish Match

    Record Quarter for Swedish Match

    Photo: Swedish Match

    Swedish Match reported record sales and operating profit from product segments in the third quarter of 2020.

    Sales and operating profit increased for the Smokefree and Cigars segments in both the U.S. and Scandinavia, elevated by Covid-19 related effects on consumer demand and channel shifts.

    In local currencies, sales increased by 23 percent for the third quarter. Reported sales increased by 15 percent to SEK4.4 billion ($504 million).

    In local currencies, operating profit from product segments increased by 37 percent for the third quarter. Reported operating profit from product segments increased by 28 percent to SEK2.05 billion

    Operating profit amounted to SEK2.02 billion for the third quarter.

    Profit after tax, which includes a charge of SEK286 million following adverse ruling in a tax case, amounted to SEK1.19 billion for the third quarter.

    Lars Dahlgren

    “Swedish Match delivered an outstanding performance during the third quarter,” said CEO Lars Dahlgren, CEO of Swedish Match in the company’s quarterly report. “While we estimate that Covid-19 related effects had a notably positive net impact on group earnings, the underlying financial development across our product segments was strong.

    “Impressive performance for Zyn in the U.S. continued to be the key contributor to profit growth. For this quarter we also noted a significant upturn in operating profit for our U.S. cigar business, as well as for our Scandinavian smokefree business—even when excluding Covid-19 related positive mix effects from increased domestic volumes in Norway that substituted deliveries to border trade and travel retail outlets.”

  • Japan Tobacco Invests in its Trier Factory

    Japan Tobacco Invests in its Trier Factory

    Japan Tobacco International (JTI) has invested €22.5 million ($26.6 million) in expanding production at its Trier, Germany, plant, reports Lokalo.de.

    “Our plant in Trier has a special place in the JTI group,” said Peter Kilburg, plant manager. “We are one of only two plants in which all production steps are mapped—from raw tobacco storage to preparation and processing of the tobacco to the finished product. The investment in the double-digit million range strengthens the strategic importance of the Trier plant within JTI’s global supply chain—it is a clear commitment to the Trier production location.”

    Further investments are planned for the coming years.

    JTI invested €30 million in 2001 for the construction of the facility.