Category: Regulation

Ireland: Call for Outdoor Smoking Ban as Pubs Reopen

Image by Rudy and Peter Skitterians from Pixabay
The Royal College of Physicians of Ireland (RCPI) has called for a smoking ban in outdoor pub areas.
As businesses begin opening back up in Ireland and social distancing policies are put into place to keep the coronavirus from spreading further, the RCPI has stated that outdoor areas of pubs should be nonsmoking areas to prevent secondhand smoke exposure.
“Des Cox, chair of the policy group on tobacco at RCPI, has sent a letter to Minister Simon Harris at the Department of Health calling for this proposal to be implemented as part of the country’s reopening strategy,” wrote the Limerick Post.
“Customers who are seated in the outdoor areas of bars should not be exposed to secondhand smoke,” Cox said. “If bar staff are providing table service to all customers—including customers seated in the outdoor areas—they too will be exposed to secondhand smoke.”
May 13, 2020
FOREST Worries About Timing of Menthol Ban

Simon Clark, speaking at the 2019 TABEXPO conference in Amsterdam
Photo: Taco Tuinstra
Simon Clark, director of the smokers’ group Forest, says the upcoming ban on menthol cigarettes in the EU and the U.K. will hit consumers at the worst possible time.
“The Covid-19 pandemic is having a huge impact on people’s daily lives,” he said. “This is not the moment to prohibit a product many smokers enjoy and take comfort from. Given the current crisis, and the disruption and anxiety it is causing, the ban is going to hit consumers at the worst possible time.”
From May 20, 2020, it will be an offense for manufacturers to produce menthol cigarettes and for retailers to sell menthol cigarettes in the U.K. and throughout the European Union.
The ban also applies to hand-rolling tobacco with mentholated filters or papers if they are supplied together in the same product.
Clark worries that the menthol ban will catch many smokers unprepared. “We believe that a significant number of smokers are unaware of the forthcoming ban,” he said. “They will be shocked when they find that their favorite brands are no longer available via legitimate retailers. The government is understandably preoccupied with more serious issues, but imposing prohibition on so many consumers without a proper awareness campaign is inexcusable.”
May 5, 2020
U.S. Fourth Circuit Denies PMTA Appeal

The Fourth Circuit on Monday dismissed an appeal from various vaping groups challenging a compliance deadline for vapor products. The decision states that January directives from the U.S. Food and Drug Administration (FDA) have rendered the appeal moot.
In a per curiam opinion, the appellate judges held that guidance issued by the FDA in January moots the vape groups’ appeal because that guidance supersedes older directives from August 2017 at issue in the appeal and leaves “no possible meaningful relief” that the court could grant, according to law360.com.
“Any ruling by this court as to the procedural or substantive reasonableness of the August 2017 guidance would amount to nothing more than an advisory opinion,” the court said.
The appeal stems from a Maryland district court ruling that ordered the agency to set a May 2020 deadline for premarket tobacco product applications (PMTA) on smokeless tobacco products. The FDA, along with various health and anti-vaping groups, had argued that the January guidance restricting the sale of flavored, cartridge-based vapes rendered moot the vape groups’ appeal.
“Because the enforcement timetable for e-cigarettes set out in the January 2020 guidance is independent of the district court’s order, an order by this court reversing the district court would have no effect on FDA’s enforcement of the statute and regulations against e-cigarette manufacturers,” the agency had previously said.
But the vape groups disagreed, saying the January guidance was enacted without proper notice-and-comment procedures, according to the opinion.
While the court said it can’t offer the vape groups relief in this case, the panel added in a footnote that the groups can challenge the January guidance in a separate action in federal court. The panel also ruled that a Maryland district court did not abuse its discretion in denying cigar industry groups’ motion to intervene, saying those groups did not intervene in a timely manner.
Counsel for the cigar and vape groups and a representative of the FDA did not immediately respond to requests for comment Monday.
Last month, a Maryland federal judge said that in light of the coronavirus pandemic, he would grant a 120-day extension to the May 12 deadline for e-cigarette PMTAs, which have proceeded slowly since the FDA first determined vapes should be regulated like tobacco products. The new deadline is Sept. 9, 2020.
The FDA had previously asked the Fourth Circuit for approval for the lower court to extend the May deadline, saying it would not affect the merits of the appeal brought by the industry groups. The FDA said many of the laboratories and research organizations conducting the clinical trials for the regulatory applications have shut down or otherwise halted in-person testing in light of the COVID-19 pandemic.
Public health groups previously sought to accelerate the FDA’s regulation of vaping products under the Tobacco Control Act, citing vaping-related lung injuries that sickened thousands of people and left nearly 70 dead in 2019. In July 2019, a Maryland district judge effectively allowed the FDA to set the May 2020 deadline, prompting the vape groups to claim the decision was an arbitrary overextension of both the FDA and the court’s authority.
The vape groups had also argued that the May deadline left too little time for manufacturers to file complete applications. Cigar industry groups that filed joint briefs on appeal argued that the district court’s order on deadlines unfairly ensnared cigar and pipe tobacco manufacturers as well.
May 5, 2020
Stay of Execution

The postponed due date for premarket tobacco product applications is unlikely to help those who weren’t ready for the May 12 deadline.
By Kenneth Robeson
In 2009, the Family Smoking Prevention and Tobacco Control Act authorized the U.S. Food and Drug Administration (FDA) to regulate cigarettes, smokeless tobacco and roll-your-own tobacco. This federal law requires products introduced to the marketplace after Feb. 15, 2007, to receive marketing authorization from the FDA prior to being offered for sale. The same marketing authorization requirement was later extended to cigars, pipe tobacco, electronic cigarettes, vapor products, hookah and alternative nicotine products, effective Aug. 8, 2016.
The deadline to file premarket tobacco product applications (PMTAs) has changed several times. Following a lawsuit by public health groups, the District Court of Maryland in July 2019 ordered the FDA to bring forward its due date from Aug. 8, 2022, to May 12, 2020.
After the coronavirus erupted, the FDA requested a 120-day extension, citing lab and research organization closures, travel restrictions and the reallocation of some Center for Tobacco Products employees to the U.S. Public Health Service among other reasons that were making it difficult to review applications.
On April 22, a U.S. court granted the FDA’s request, postponing the deadline to Sept. 9, 2020.
While the ruling is welcome, the disruption caused by the coronavirus does not necessarily buy time for applicants, many of whom are confronting the same obstacles to their operations as the FDA. Before the coronavirus hit the U.S. in full swing, Tobacco Reporter assessed the industry’s preparedness for the May 12 deadline. Because the Covid-19 crisis has stalled many corporate activities, the conclusions of our assessment are likely to be just as valid for September as they were for May.
So, is the industry ready?
“Not as a whole,” believes Barnaby Page, editorial director of London-based ECigIntelligence and TobaccoIntelligence, a provider of global market and regulatory analysis, legal tracking and quantitative data for the e-cigarette, heated tobacco and combustible alternatives sector. “Many of the more well-resourced and clued-up companies are ready; many of the others are not.”
The reason, Page thinks, is that the requirements of the PMTA process “will certainly have been a difficulty for many smaller companies. But it is also fair to say that much of the industry ignored the issue for a long time even while it was obviously coming—and that even if the PMTA deadline were another two years away, many companies probably still wouldn’t be ready,” he says. “So I certainly don’t think it can be blamed entirely, or even substantially, on the change in deadline [from Aug. 8, 2022, to May 12, 2020].”
“The question of readiness is irrelevant,” insists Darryl Jayson, vice president of TMA, a member-driven nonprofit source of industry information and a convener of stakeholders. Vapor product manufacturers and importers must file their PMTAs with the FDA Center for Tobacco Products (CTP) by the deadline, he argues, and cigar and pipe tobacco manufacturers and importers must file their substantial equivalence (SE) reports by the deadline. “If the application is in any way incomplete, the FDA CTP, through its case worker, will contact the applicant and work toward a complete application. The burden of work for an SE applicant is less than that of a PMTA applicant.”
All PMTA and SE applicants are currently working toward the deadline, Jayson emphasizes. “A company starting at this late date—early March—would not be able to adequately issue an initial draft of the application,” he says. Product testing remains paramount for all PMTA applicants, who must accompany their applications with population studies.
For retailers, Jayson continues, the FDA CTP will issue sales bans for those products that are not within the PMTA/SE process. Retailers are to follow these sales bans and pull all illegal product off their shelves or web menu lists. For consumers, says Jayson, the deadline might mean that some of the tobacco/vapor products that they use may no longer be for sale [on] the U.S. market.”

Buying time
For a company that has not yet started preparations, time is now tight, Page warns. Submitting bare-bones applications for a very limited number of products “just might buy them enough time to get fuller applications in place.” In the meantime, planning for the removal of some products from the market “would be wise. And some companies, of course, are looking at markets outside vapor—for example, CBD—to avoid the PMTA process entirely or minimize its impact on them.”
For retailers and consumers, Page predicts, the immediate impact will be negligible. Longer term, some brands and product lines will undoubtedly disappear from the market, but most consumers will be able to find a substitute. “Vape stores could be badly hit. Our research suggests 20 percent-plus could close, though exactly how strong this impact is depends on what is and isn’t approved by the FDA.” The market “will likely be less confusing due to a smaller number of products, and at the low end, there could be less price competition.”
“I think [the PMTA deadline] is going to get delayed anyway,” noted Ed Kashouty before the coronavirus hit the U.S. Kashouty is the owner of cigar maker Hiram & Solomon, which is based in Nicaragua, has offices in Brick, New Jersey, and distributes across Florida. “We are not ready for it,” he says. “We have no clue what it’s going to take because the FDA has no clue about what they are going to do. What we have heard is that any product sent to [the] FDA for approval is going to take two or three years anyway; they have no guidelines themselves on what they want.”
At present, adds Kashouty, who also owns and operates the Lakewood Exxon convenience store in New Jersey, “it doesn’t mean very much for us. But some of our product we may not be able to display anymore because they are not pre-2007.” The inevitable result, he figures, will be that “the big companies like General Cigar are going to pump more cigars [onto] the market. The new companies are going to disappear.”
As yet, it is not known how many applications will be submitted “or, crucially, how many will be approved,” Page notes. “But assuming the number is more than minimal, the outlook for consumers and the retail industry as a whole is not terrible, though there’s much more risk for vape stores than for mainstream retail.” For manufacturers, “it’s either very positive or highly negative, depending on the FDA’s response.”
Leaving aside legal challenges that he characterizes as “probably more hopeful than realistic,” Page feels the biggest complaint probably concerns the requirements of the PMTA process in terms of demonstrating a product’s effect on public health. “A lot of information is required.” However, he continues, the FDA has taken definite steps to make this easier without destroying the value of the process, and many other regulated industries have to put up with similar regimens. “It’s simply that the vapor industry is not accustomed to it.”
So what will the landscape look like after the filings?
Page says it is impossible to say at this stage. “The first approvals may provide an indicator of what the FDA is looking for. Its decision on Juul applications will also be significant. And, beyond the PMTA process, how well IQOS fares in the market over the next year to 18 months is also a potentially game-changing factor.”
Industry players need to know today “only that the time for railing against the injustices of the PMTA system is probably past,” Page concludes. “More important now is to figure out how to work within it.”

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May 1, 2020
Fontem Submits PMTAs for Myblu Products

Photo courtesy of Imperial Brands
Imperial Brands subsidiary Fontem US has submitted Premarket Tobacco Product Applications (PMTAs) to the U.S. Food and Drug Administration (FDA) seeking authorization for the continued marketing of a wide range of its Myblu electronic vapor products.
Fontem US’s Blu products play a fundamental role in the company’s goal of providing adult smokers with options that are potentially less harmful than combustible tobacco products. The PMTA submissions include data from a comprehensive range of laboratory and clinical scientific studies, including product analyses, behavioral data, nonclinical health risk information, and information on the impact to both users and non-users of tobacco products.
Fontem US believes the evidence provided shows that Blu electronic vaping products could play a role in the protection of the public health, in line with the guidance issued by FDA.
“We agree that the electronic vaping industry should be held to the highest product and marketing standards while providing adult smokers with alternative products that could serve the interest of the public health,” said Antoine Blonde, president of Fontem US.
“Fontem US looks forward to working with the FDA as the agency develops and enforces an evidence-based regulatory policy.”
April 29, 2020
COP9 and MOP2 Postponed to November 2021

The World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) said it would postpone its major conferences for a year.
“In light of the COVID-19 global pandemic and its impact on the conduct of international global conferences and travel, the Bureaus elected by COP8 and MOP1, after consulting the host country, have decided that convening the Ninth Session of the Conference of the Parties to the WHO FCTC (COP9) and the Second Session of the Meeting of the Parties to the Protocol to Eliminate Illicit Trade in Tobacco Products (MOP2), scheduled for November 2020, is no longer possible,” the organization states on its website.
As a result, the Bureaus, in consultation with the host country and the Secretariat, decided during their Third Joint Meeting on 21 April 2020 to postpone the sessions of COP9 and MOP2 to the following dates:
COP9: 8–13 November 2021; .
MOP2: 15–17 November 2021.
The meetings will convene on those dates in The Hague, Netherlands.
April 28, 2020
FDA Sends Warnings for Targeting Youth
Today, the U.S. Food and Drug Administration (FDA) issued 10 warning letters to retailers and manufacturers who sell, manufacture and/or import unauthorized electronic nicotine delivery system (ENDS) products targeted to youth or likely to promote use by youth.
The warning letters were sent to establishments marketing unauthorized products, such as a backpack and sweatshirt designed with stealth pockets to hold and conceal an e-cigarette, ENDS products that resemble smartwatches, or devices appearing as children’s toys such as a portable video game system or fidget spinner.
Warning letters were also issued to companies marketing e-liquids that imitate packaging for food products that often are marketed and appeal to youth, such as candy, or feature cartoon characters like SpongeBob SquarePants.
“The FDA is focused on manufacturers and retailers that make and sell ENDS products that are targeted to youth and increase their appeal. The public should really be outraged by these products. The FDA is especially disturbed by some of these new products being marketed to children and teens by promoting the ease with which they can be used to conceal product use, which appeals to kids because it allows them to conceal tobacco product use from parents, teachers, law enforcement or other adults,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “Even in the midst of the COVID-19 pandemic, we have not lost our focus on protecting youth against the dangers of e-cigarettes and will do everything we can to take action. These warning letters should send a clear message to all tobacco product manufacturers and retailers that the FDA is keeping a close watch on the marketplace. If you’re marketing or selling these products to youth, the FDA will not tolerate it.”
The following retailers and/or manufacturers or importers received a warning letter:
Vaprwear Gear, LLC (manufacturer, online retailer)
Vapewear, LLC (manufacturer, online retailer)
Wizman Limited (manufacturer, online retailer)
EightCig, LLC (online retailer)
Ejuicepack, LLC (online retailer)
Vape Royalty, LLC (online retailer)
VapeCentric, Inc. (online retailer)
Dukhan Store (online retailer)
VapeSourcing (online retailer)
Shenzhen Uwell Technology Co., Ltd. d/b/a DTD Distribution Inc. (importer, retailer)
The FDA has also issued warning letters to 73 brick-and-mortar retailers for selling unauthorized flavored, cartridge-based ENDS products. This follows 22 warning letters that FDA issued last month for similar violations to online and brick-and-mortar retailers and manufacturers across the country. These warning letters are part of a series of ongoing actions consistent with the FDA’s recently issued policy of enforcement priorities for e-cigarettes and other deemed products on the market.
April 27, 2020
France Bans the Online Sale of Nicotine Products

Image by lydia-threads from Pixabay
France has banned online sales of nicotine gum and patches after researchers suggested that nicotine may help protect against the coronavirus, reports the BBC. Sales of nicotine products are now restricted to pharmacies.
The French government says people will be allowed to buy only one month’s supply of these products, with pharmacies registering buyers.
The goal is to stop people putting too much nicotine into their bodies and to protect the supply for people who need it.
Last week, data from a Paris hospital indicated that smokers were statistically less likely to be admitted for treatment for Covid-19.
The revelation triggered a run on nicotine products.
The theory that nicotine could play a role in blocking the virus is due to be tested at a hospital in Paris, using nicotine patches.
The government’s chief health official said the study was interesting but warned that smoking killed 75,000 people a year in France.
The official also warned that smokers who did become infected with coronavirus tended to have more serious symptoms.
France has reported nearly 22,000 coronavirus-related deaths since the start of the outbreak earlier this year.
April 24, 2020
FDA Warns Against Illegal CBD Claims

Photo: Julia Teichmann | PixaBay
The U.S. Food and Drug Administration has issued warning letters to two companies for illegally selling unapproved products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug and Cosmetic Act. This action is part of the FDA’s efforts to pursue companies that illegally market CBD products with claims that they can treat medical conditions, including opioid addiction or as an alternative to opioids.
“The opioid crisis continues to be a serious problem in the United States, and we will continue to crack down on companies that attempt to benefit from selling products with unfounded treatment claims,” said FDA Principal Deputy Commissioner Amy Abernethy.
“CBD has not been shown to treat opioid addiction. Opioid addiction is a real problem in our country, and those who are addicted need to seek out proper treatment from a health care provider. There are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD, and we will continue to work to protect the health and safety of American consumers from products that are being marketed in violation of the law.”
The two warning letters were issued to Biota Biosciences of Washington state and Homero Corp DBA Natures CBD Oil Distribution of New Hampshire.
April 23, 2020
Court Extends Deadline for Premarket Applications

Tobacco and vapor companies have an extra four months to file their premarket tobacco applications (PMTAs) for newly deemed tobacco products with the Food and Drug Administration (FDA) following a U.S. court ruling.
On July 12, 2019, the United States District Court for the District of Maryland ordered the FDA to require manufacturers of e-cigarettes, cigars and other deemed new tobacco products that were on the market as of Aug. 8, 2016 to submit applications for premarket review by May 12, 2020.
However, the coronavirus pandemic has drastically impaired the FDA’s ability to adhere to this timeline. As a result of the pandemic and these exceptional and unforeseen circumstances, the agency requested on March 30 a 120-day extension of the May 12 deadline. This request has now been granted.
The court order means applications for premarket review for many e-cigarettes, cigars and other new tobacco products are now required to be filed by Sept. 9, 2020. Consistent with the original court order, for companies that submit timely applications, the agency may continue to exercise enforcement discretion, meaning their products would generally continue to be marketed without being subject to FDA enforcement actions, for up to one year from the deadline (up to Sept. 9, 2021), unless a negative action is taken by the FDA on an application during that time.
Following the Covid-19 outbreak, the agency received numerous inquiries from the tobacco industry expressing concern they would be unable to complete premarket applications by the original May 12 deadline due to disruptions at all stages of preparation, including preventions or disruptions to in-person laboratory work and clinical studies or necessary foreign travel, or from the shuttering of manufacturing facilities abroad.
In a statement, the FDA said it believes the public health is better protected by not having these firms compromise their employees’ health or take actions that would risk spreading Covid-19 to others by trying to meet the previous May 12 deadline. In the more than a dozen requests for an extension that the FDA received, this public health concern was mentioned repeatedly.
Another consideration, according to the agency, was that a number of the FDA’s Center for Tobacco Products (CTP) personnel have been deployed to work on Covid-19 pandemic issues for the U.S. Public Health Service (PHS), leaving fewer staff to process applications. Many of those deployed are among the staff that had been playing a critical role as CTP prepared for this deadline.
“Ultimately, a Sept. 9 deadline will better serve the public health by allowing manufacturers to prepare for, and the agency to conduct, the thorough scientific review of these products that is required under law and vital to our mission of protecting Americans while reducing or eliminating physical contact during this critical period,” the FDA wrote in its statement.
“Importantly, this new deadline does not detract from our efforts to prioritize enforcement of certain e-cigarette products currently on the market. Although the FDA’s in-person compliance checks and vape shop inspections are currently on hold due to the pandemic, review of previous inspections continues, and we continue to monitor the online marketplace and will take action as appropriate.
“Accordingly, the January 2020 enforcement priorities guidance, which independently prioritizes earlier enforcement against certain e-cigarette products that are widely used by youth, remains in effect regardless of whether an application is submitted, although we intend to update it for products for which the Sept. 9 date now applies.”
April 23, 2020