Juul Labs on Friday said it is in the early stages of exploring several options including financing alternatives, as the company deals with lawsuits and a potential ban on sales of its e-cigarettes by U.S. health regulators.
Bloomberg News earlier reported, citing sources, that Juul’s bankers at Centerview Partners are sounding out investors for a possible $400 million first-lien term loan due August 2023.
The proceeds would help refinance an existing term loan, which has around $394 million outstanding and matures on the same date, the report added.
A spokesperson for Juul told Reuters that the company is looking at options to protect its business and to address the “impact of the FDA’s now stayed order so we can continue offering our products to adult consumers who have or are looking to transition away from traditional cigarettes.”
Bloomberg News in its report said Juul was also considering a new $150 million second-lien term loan, which may have an August 2024 maturity, to help pay down some of the first-lien term loan and to increase liquidity, the report said.
Financing proposals for either loan are due July 21, according to the report.
Last month, the Food and Drug Administration (FDA) blocked sales of Juul e-cigarettes and said the applications “lacked sufficient evidence” to show that sale of the products would be appropriate for public health.
Several tobacco companies have reached an agreement in long-running litigation brought by the U.S. Department of Justice (DOJ) and certain public health organizations regarding the communication of tobacco-related messaging at retail locations.
The agreement will require Altria, Philip Morris USA, R.J. Reynolds Tobacco and ITG Brands to supply their contracted stores with court-ordered signs that must be posted for 21 months.
The agreement covers the last remaining dispute from the lawsuit DOJ filed against Altria, Philip Morris USA and R..J Reynolds in the 1990s, according to the National Association of Convenience Stores (NACS).
“This litigation has always put the retailers in a uniquely bad position,” said Doug Kantor, NACS general counsel. “Retailers were not parties to the lawsuit and should not be burdened with a court-ordered remedy, but this negotiated outcome avoids even worse results that DOJ and public health groups were advocating.”
The agreement provides that each store under contract with one of the manufacturers will have to post at least one sign carrying one of 17 different, pre-approved health messages that will be distributed at random to retailers around the country.
Each store will be required to rotate to a new message halfway through the time period required in the agreement. The manufacturers will be required to hire auditors to check whether the signs are properly posted. A summary of the agreement explaining the requirements on retailers as well as answers to frequently asked questions about it can be found here.
A hearing on the proposed agreement will be held in the U.S. District Court for the District of Columbia on July 28 and 29. The court will then decide whether to accept the agreement and enter an order to implement it.
The timing of the requirements for signs to be posted will depend on when the court decides whether to accept the agreement.
The U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) upheld the validity of a VPR Brands patent that is considered one of the first patents for modern electronic nicotine-delivery system (ENDS) products.
The PTAB denied an appeal by Jupiter Research to invalidate VPR’s U.S. Patent 8,205,622 B2. The decision of the PTAB final.
The VPR patent dates to 2009 and includes independent claims covering electronic cigarette products containing an electric airflow sensor, including a sensor comprised of a diaphragm microphone.
The sensor turns the battery on and off, and covers most auto-draw, buttonless e-cigarettes, cigalikes, pod devices and vaporizers using an airflow sensor rather than a button.
According to VPR, the PTAB’s decision clears the way for infringement litigation against Jupiter pending in the District of Arizona.
VPR Brands and its legal representative, SRIPLAW, have started to identify and notify more than 50 of the leading companies using the auto-draw technology. VPR Brands says it intends to vigorously enforce its patent.
“These companies were prioritized, based on sales volume and popularity,” VPR wrote in a press release. “Most recently VPR Brands LP and its legal team, headed by Joel B Rothman of SRIPLAW, have filed litigation against nine of the companies. Additional lawsuits will continue to be filed as necessary to protect the company’s intellectual property rights.”
A majority of the vaping devices sold in the U.S. now utilize an auto-draw/button-less technology. The company is investigating all buttonless vape devices within the nicotine, CBD and cannabis space that initiate vaporization from the user’s airflow inhalation as those types of products would be suspect of infringement.
The company may also seek a buyer for this patent in the future. In August 2013, Imperial Tobacco Group (now ITG Brands) purchased the intellectual property behind the Ruyan e-cigarette, often considered the first modern ENDS product, for $75 million.
Indian cigarette sales are set to touch 93 billion sticks this year on the back of a stable tax regime and increased mobility after the ebbing of pandemic restrictions, reports The Financial Express, citing a study by rating agency Crisil.
Covid-19 lockdowns caused cigarette volumes to plunge to 77 billion sticks in 2021 from 90 billion sticks in 2020. As restrictions eased, cigarette sales recovered to 88 billion sticks.
The higher volumes will help cigarette manufacturers cope with the rising cost of inputs, which Crisil expects to shave manufacturers’ gross margins by 100-150 basis points.
Indian cigarette makers use flue-cured Virginia (FCV) tobacco, which is grown mostly in Andhra Pradesh, Telangana and Karnataka. FCV prices have risen 15 percent since last year as cultivation was impacted by untimely rainfall in December 2021 and January 2022.
Meanwhile, prices of paper are estimated to be 10 percent higher this fiscal year on an already-elevated base from 2020. India’s recently enacted ban on single-use plastics has driven up products costs, too, as cigarette manufacturers shift to biodegradable materials.
Between 2013 and 2017, excise duties on cigarettes rose annually at 15.7 percent. In fiscal 2018, the industry saw a further 20 percent hike in taxes as a result of the increase in excise duty and transition to a good and services tax.
Despite such challenges, cigarette manufacturers appear to be in good financial shape.
According to Crisil Associate Director Gopikishan Dongra, tobacco companies are likely to retain around 65 percent operating margins, due to the strong competitive advantage of established manufacturers and high entry barriers such as entrenched distribution channels and restrictions on advertising.
The U.S. Food and Drug Administration on July 13 sent its first warning letters to manufacturers for unlawfully marketing non-tobacco nicotine e-liquid products without the required authorization.
In March, President Joe Biden signed into law a spending bill that gives the FDA authority over synthetic nicotine. The provision took effect in April and gave manufacturers until May 14, 2022, to submit marketing applications to the FDA.
Products did not receive marketing authorization by July 13, 2022, are considered illegal and must be removed from the market.
The recipients of the FDA’s first warnings letters, AZ Swagg Sauce and Electric Smoke Vapor House, have listed a combined total of approximately 10,000 products with FDA. Neither company submitted a premarket application for its non-tobacco nicotine products by the deadline, according to the FDA.
In addition, the FDA issued 107 warning letters to retailers in the last two weeks for illegally selling non-tobacco nicotine products, including certain e-cigarette or e-liquid products, to underage purchasers.
“FDA has been fully committed to actively implementing this critical new law regulating non-tobacco nicotine products since its passage, and the warning letters announced today are just the beginning of our compliance and enforcement actions” said Brian King, director of the FDA’s Center for Tobacco Products, in a statement. “In the coming weeks, we will continue to investigate companies that may be marketing, selling, or distributing non-tobacco nicotine products illegally and will pursue action, as appropriate.”
The FDA says it is currently processing applications for approximately 1 million non-tobacco nicotine products submitted by more than 200 manufacturers by the May 14, 2022, deadline.
“FDA is working diligently to process the substantial number of applications submitted and, as always, will make marketing decisions based on the best available science and will pursue compliance and enforcement actions when warranted,” said King. “We remain fully committed to taking whatever steps are necessary to protect the public health and to provide timely updates on our ongoing progress regulating non-tobacco nicotine products.”
The American Vapor Manufacturers Association (AVMA) has asked the U.S. Department of Health and Human Services’ (HHS) Inspector General to investigate whether the Food and Drug Administration’s marketing denial orders for vaping products are driven by political pressure.
The AVMA says it wants the inspector general to help the public learn about FDA Commissioner Robert Califf’s coordination with elected officials, allied activists and reporters as his agency continues its review of premarket tobacco product applications (PMTA).
Amanda Wheeler
In a letter sent to HHS Inspector General Christi A. Grimm, AVMA President Amanda Wheeler contends that interference has corrupted FDA’s statutory obligation to properly implement its PMTA review process based solely on scientific, empirically based judgment.
“Manufacturers are routinely meeting the PMTA requirements to scientifically demonstrate how their products are appropriate for the protection of public health,” Wheeler wrote. “Despite compliance, the agency isn’t approving the vape products sought by adults who want to quit smoking. The Office of Inspector General should open the door and hold the FDA accountable to its standards.”
The U.S. Senate on Tuesday voted to confirm Steve Dettelbach to serve as director of the Bureau of Alcohol, Tobacco, Firearms and Explosives.
Dettelbach, 56, was confirmed by a 48-46 vote that went largely along party lines.
“Following the passage of the Bipartisan Safer Communities Act, today’s vote is another important sign that both parties can come together to support law enforcement and stand up against the horrific scourge of gun violence,” President Joe Biden said in a statement following the vote.
Prior to landing the job as the head of the ATF, Dettelbach worked as a federal prosecutor for the Justice Department – the ATF’s parent agency.
“Steve understands the importance and urgency of ATF’s mission and I am confident he will lead ATF with integrity, dedication and skill,” U.S. Attorney General Merrick Garland said in a statement.
Tuesday’s vote marked the first time the Senate has confirmed an ATF director since 2013.
According to a new study, individuals who viewed tobacco content on social media were more than two times as likely to use the substance compared with those who were not exposed. Both organic content, such as friends’ post, and curated content, or advertisements, were included in the study.
Findings of the meta-analysis were published in JAMA Pediatrics and also showed that even among never-users, those who viewed tobacco-related content on social media were more than twice as likely to use it in the future than non-viewers.
Because results are based largely on surveys conducted at one point in time, a direct cause cannot be confirmed, according to The Hill.
The review included 24 datasets, complete with information from 139,624 individuals, the majority of whom were adolescents. The studies also took place in a range of countries that included the United States, Indonesia and Australia.
“The proliferation of social media has offered tobacco companies new ways to promote their products, especially to teens and young adults,” said study co-author Jon-Patrick Allem of the Keck School of Medicine in a statement.
Those exposed to tobacco on social media were also more likely to have had past 30-day tobacco use, while similar associations of past, current and future use were seen for exposure to tobacco promotions, active engagement with content, passive engagement and exposure among youths and adolescents.
Individuals who consumed content on more than one platform were more likely to report current use or future susceptibility compared with single platform viewers.
Facebook, Twitter, YouTube, Pinterest, Tumblr, Instagram and Snapchat were among the platforms hosting tobacco-related content. Notably, relative social media newcomer TikTok was not included in the analysis, but researchers have plans to conduct further studies on new platforms including TikTok and refine associations by different tobacco form, such as e-cigarettes and smokeless tobacco.
Under the new law governing synthetic nicotine products signed on March 15, 2022, Congress imposed a short 60-day deadline for companies to file premarket tobacco product applications (PMTAs) and declared that if such applications were not approved within 120 days (the Act) they would be “in violation of” the Federal Food Drug & Cosmetic Act’s (FDCA) PMTA requirement.
Since no authorizations have been granted as of today, the question is will FDA use its enforcement discretion to continue reviewing PMTAs, or will it precipitously declare that all synthetic nicotine products must be removed from the market after July 13, 2022?
There is no question that the FDA should use its enforcement discretion. In a series of direct engagements with FDA since the Act’s passage, the Vapor Technology Association (VTA) has provided a complete set of scientific and policy justifications for synthetic nicotine products, and specific recommendations on how FDA should use its enforcement discretion – just as it has in the past – to allow synthetic nicotine products to remain on the market during the PMTA review process.
However, some have suggested that Congress mandated all products be removed from the market this week if they are not approved by FDA. But a close review of the Act reveals that the opposite is true: Congress did not require synthetic nicotine products with pending PMTAs to be removed from the market after July 13.
In interpreting laws, a court will first look to the plain language of the Act and, only if there is an ambiguity, will it look to Congressional intent to resolve such a question. Here, both support the FDA’s continued use of enforcement discretion for pending PMTAs.
The Plain Language Supports Enforcement Discretion
There are four relevant sections of the Act. First, under Section (d)(2)(A), Congress expressly stated that “as a condition to market” all manufacturers wishing to continue selling their products must file a PMTA no later than May 14, 2022.
Tony Abboud
Second, under Section (d)(2)(B), Congress expressly stated that companies which filed PMTAs “may continue to market” their products during what the Act calls a “transition period.”
Third, under Section (d)(2)(C), Congress expressly required that if a company did not file a PMTA for its synthetic products by May 14, 2022, that company is “not eligible for continued marketing.” In each of these sections, Congress expressly uses some variation of the term “market” to articulate its direction on what may (not) be marketed and when.
However, in the operative Section (d)(3), which addresses what happens after July 13, 2022, Congress makes no statement regarding marketing at all. Instead, it states that products with pending PMTAs not yet approved would be “in violation of…section 910” of the FDCA (21 USC 387g).
When presented with this question, a court likely would rule that because Congress did not expressly state that pending applicants are “not eligible for continued marketing” or that they “may not market” after July 13, as it clearly said in the immediately preceding sections, Congress did not require the removal of products with pending PMTAs.
This places synthetic nicotine products with pending PMTAs in precisely the same position as all other products with pending PMTAs which, for years, FDA has made clear are “illegal” (i.e., in violation of section 910) but are allowed to remain on the market at FDA’s enforcement discretion.
Even if a court finds that Section (d)(3) is ambiguous, there is nothing in Congressional intent that would lead to the conclusion that Congress intended for products with pending PMTAs to be removed from the market.
First, Congress could have banned synthetic nicotine products, if that is what it intended, but it did not do so. To the contrary, Congress expressly authorized manufacturers to bring new products to market after the Act’s passage. Thus, it would be folly to suggest that Congress intended all synthetic nicotine products be removed from the market without PMTA review.
Second, Congressional intent is generally divined by on the record statements made in committee hearings and in floor debate (not from press releases or media statements). But there is little to nothing which a court could rely on [with] this question because the provision was quietly slipped into the Ukraine-omnibus spending bill with no relevant hearing or floor debate.
Third, Congress was fully aware that FDA could not review PMTAs within 180 days (as required under the FDCA). In fact, the FDA told a court it will not be finished reviewing tobacco derived PMTAs until June of 2023. Thus, no one could suggest that there ever was any reasonable expectation or intent that the FDA would rule on synthetic nicotine PMTAs in 60 days.
Hence, the only reasonable conclusion that can be drawn from the plain language and Congressional intent is that Congress did not require removal of products with pending PMTAs but, rather, expected the FDA to continue to use its discretion in enforcing its PMTA regulation after July 13.
Congress did, however, expressly state that products for which no PMTA was timely filed have no continuing ability to market, authorizing the FDA to take immediate action. VTA has repeatedly communicated to the FDA the need for it to aggressively remove all tobacco products from the market for which no PMTA has been filed and to publish a list of all products covered by a synthetic nicotine PMTA so that retailers know which products can be sold.
A Careful and Complete Evaluation of Synthetic Nicotine PMTAs is Required
We live in a world that remains captive to [combustible] cigarettes. Congress won’t ban them and Congress has prevented the FDA from doing so. While electronic nicotine-delivery system (ENDS) products offer a technological solution to delivering nicotine in a substantially less harmful way, synthetic nicotine now represents the first technological innovation in nicotine itself.
Synthetic nicotine uniquely offers consumers the cleanest and purest form of nicotine with numerous benefits, i.e., the absence of heavy metals, nitrosamines, and pesticides. Synthetic nicotine uniquely offers consumers the opportunity to break free from the last remaining vestige of the tobacco plant.
Synthetic nicotine uniquely offers the FDA unprecedented product constituent clarity, replicability, and traceability down to the batch level. Not only does synthetic nicotine offer companies the opportunity to change the dynamics regarding total reliance on tobacco-derived nicotine for all tobacco and pharmaceutical nicotine products, but it also provides companies the ability to address their ESG [sustainability] goals and take a significant step to ameliorate the adverse environmental impacts of tobacco.
Our message to the FDA has been constructive and clear: it is critical to the adult smoker that FDA takes aggressive steps to create an orderly and regulated marketplace with a diversity of desirable nicotine alternatives.
Given recent history with tobacco derived PMTAs, the best way for FDA to realize that objective now is to avoid the blanket denial mistakes of the past which have mired the agency in protracted litigation. Such litigation will only delay the time until we achieve an orderly and regulated marketplace.
Instead, we have asked the FDA to work companies which timely filed synthetic nicotine PMTAs – the good actors – through the PMTA scientific process and provide them the requisite time and guidance to fulfill FDA’s requirements.
At the same time, we have asked the FDA to aggressively enforce against the non-compliant companies that have refused participate in the PMTA process – the bad actors – by interdicting such products at the border and removing such products from the market Congress has clearly required.
In the end, it is incumbent on the new FDA leadership to use its power to create an orderly marketplace by embracing scientific innovations, stimulating additional financial investment, accelerating authorizations of pending tobacco-derived PMTAs, and ensuring that synthetic nicotine products which now contain the cleanest and purest form of nicotine that science has created are available to adult smokers.
Tony Abboud serves as president for Strategic Government Solutions, and executive director of the Vapor Technology Association.
Brazil’s Growing Up Right Institute organized a seminar on child labor prevention at the Santa Cruz Country Club in Santa Cruz do Sul on July 7.
Under the theme, “Child labor: care, welcome and protection,” participants discussed the progress made in combatting child labor, along with the work that still needs to be done.
“The Institute was founded with the mission to fight child labor and generate opportunities for adolescents from the rural setting, especially in tobacco growing regions,” said Iro Schunke, president of the Growing Up Right Institute, in a statement. “It is a complex task, but with good partnerships we have achieved great results. We have already become known nationally and internationally for the innovative method of offering opportunities to adolescents from the countryside through the learning law.”
Since 2016, the rural professional learning program has benefited 596 young people in Rio Grande do Sul. As part of the program, tobacco companies associated with the Growing up Right Institute hire young apprentices and pay them a salary proportional to 20 hours a week.
Instead of working, however, the apprentices attend a rural management and entrepreneurship course in the shift opposite to their regular school hours. The classes typically take place in the apprentices’ normal schools or in venues provided by the municipal administrations, which also provide for food and transport logistics thus making it viable for the adolescents to attend the course.
According to a report by the International Labor Organization and by the United Nations Children’s Fund, 160 million children and adolescents, aged 5 to 17, were subjected to child labor in early 2020. The Covid-19 pandemic has exacerbated the problem of child labor around the world, with a sharp increase in poverty, closure of schools and consequent school evasion.
In Brazil, the National Household Sample Survey, demonstrated that 1.77 million children and adolescents works, 53.7 percent of whom are in the 16-17 year age group.
