Category: Regulation

BAT Urges South Africa to Lift Cigarette Ban

Photo: Taco Tuinstra
British American Tobacco South Africa (BATSA) is urging the South African government to lift a cigarette ban that went into effect with a stay-at-home order to prevent the spread of the coronavirus.
The government imposed a 21-day lockdown, closing all nonessential services and banning essential businesses from selling tobacco and alcohol. The ban on tobacco sales is meant to help prevent smokers from suffering from severe complications of the virus—studies have shown that smokers and vapers may face more severe complications from the respiratory illness.
BATSA, however, argues that the ban may thwart the efforts to contain the virus. “It will unintentionally force 11 million smokers to go outside of their neighborhood in search of outlets willing to defy the ban, as we’ve seen in some media reports,” the company said. “This would lead to greater movement of people and more interactions than if smokers were able to buy cigarettes at their nearest legal outlet at the same time as buying all their other essential goods.”
The company also fears the ban would lead to more illegal trade, forcing smokers to search for cigarettes and other tobacco products on the black market.
The Fair Trade Independent Tobacco Association (FITA) supports lifting the ban. “Uplifting the ban would, amongst other things, save jobs, bring more money into the state coffers, stimulate the economy and decrease the psychological impact on South Africans of the lockdown period,” said Sinenhlanhla Mnguni, FITA chairperson.
BATSA holds a 78 percent market share of the legal cigarette market in South Africa.
April 6, 2020
FDA Likely to Delay PMTA Deadline to September

Photo: Jhvephotos | Dreamstime.com
While not yet official, the deadline for submitting premarket tobacco product authorizations (PMTA) to the U.S. Food and Drug Administration (FDA) is one step closer to being delayed from May 12, 2020 to Sept. 9, 2020 due to the Covid-19 pandemic.
Judge Paul Grimm of the U.S. District Court for the District of Maryland issued an “indicative ruling” granting the FDA’s request to delay the deadline by 120 days.
The ruling is not yet final, however, due to procedural issues that are expected to be resolved expeditiously. Due to appeals filed by several organizations, including the Vapor Technology Association and the FDA itself, Grimm no longer has the authority to modify his original ruling which moved the deadline to May 2020. That power now lies with the U.S. Court of Appeals for the Fourth Circuit.
For the ruling to become valid, the Fourth Circuit must remand the case back to Grimm’s court where Grimm says he would modify the order to allow the FDA to delay the change. The FDA will then need to update its regulations to move the PMTA date to Sept. 9, 2020.
April 6, 2020
U.S. House Subcommittee Asks FDA to Ban Vapor

In what turned out not to be an April Fool’s Day joke, Rep. Raja Krishnamoorthi, the Chairman of the Subcommittee on Economic and Consumer Policy, sent a letter urging the U.S. Food and Drug Administration (FDA) to use its authority to clear the market of e-cigarettes for the duration of the coronavirus pandemic and use all available tools to encourage Americans to stop smoking and vaping.
Earlier this week, FDA asked a federal court to delay by four months its order requiring e-cigarette manufacturers to submit applications to remain on the market by May 12, 2020, according to a statement from, according to a statement for the House Committee on Oversight and Reform.
The Subcommittee did not oppose this request, but instead asked FDA to take the following steps for the duration of the coronavirus crisis:
(1) use all available tools to encourage Americans to stop smoking combustible cigarettes and using e-cigarettes;|
(2) suspend all approvals of Premarket Tobacco Product Applications; and
(3) commit to immediately clearing the market of all e-cigarettes by prioritizing enforcement against them.
April 2, 2020
A Pointless Exercise

The EU’s upcoming ban on menthol cigarettes serves no purpose.
By George Gay
According to Hannah Devlin, science correspondent of The Guardian, astronomers are to sweep the entire sky for signs of extraterrestrial life for the first time, using 28 giant radio telescopes in an unprecedented hunt for alien civilizations (Feb. 15, 2020, page 3). Toward the end of her piece, Devlin quotes the theoretical physicist Stephen Hawking as having warned against attempting alien contact, suggesting the outcome for humans would not necessarily be good. But she quotes, too, Andrew Siemion, the director of the Berkeley Seti center, as saying that he thought such contact should be attempted, and adding that, “I think without a doubt, we would.”
I think both comments are right up to a point. It is unarguable that the outcome of such contact would not necessarily be good for humans, but history has taught us that, whatever the risk, scientists somewhere would not hold back from making the attempt. Scientific knowledge is no bar to stupidity.
I cannot think in terms of light years, so I find it impossible to imagine making contact with life forms in other galaxies. But I do find it instructive, often in what turns out to be a cautionary way, to consider what extraterrestrials might make of us earthlings if, because of their super-advanced technology, they could view us in real time through a telescope. What might they say to one another, I wonder? “Hey, come and look at these jerks! Their environment is going down the toilet, and what are they doing? They’re worrying about menthol cigarettes! These are supposed to be intelligent beings! Let’s not go there.”
I think that the EU is a great experiment in international cooperation, and I am sad—and if I were younger I would be angry—that the U.K. is leaving it, but ridiculous legislation such as its ban on the production and sale of menthol cigarettes sometimes makes it difficult for people such as me to defend the institution against its detractors. In the great scheme of things, what is the point of banning menthol cigarettes?

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Background
Well, before I attempt to answer that question, a couple of notes about what the ban entails and how it came about. The production and sale of menthol cigarettes and cigarettes with capsule-containing filters are to be banned within the EU from May 20, 2020, as is the sale of roll-your-own (RYO) tobaccos sold with mentholated filter tips and/or papers. However, RYO tobacco and “accessories,” such as mentholated filter tips and papers, may all be sold separately.
This regulation has been a long time coming. Its origins go back to a December 2012 proposal by the European Commission to update the EU’s Tobacco Products Directive (TPD) and, a year later, to the EU Parliament’s support for stiffening the rules against tobacco and related products, and, de facto, against committed tobacco users. Early in 2014, the TPD2 was approved by the Parliament and adopted by the EU Council; and it entered into force in May of that year. Aspects of TPD2 were challenged, but it was declared valid by the European Court of Justice in May 2016. Most of the provisions of TPD2, including a ban on the sale of cigarettes with characterizing flavors except menthol, came into effect in May 2017, following a year’s sell-through period. There is no sell-through period in respect of menthol cigarettes.
Now, let’s return to the question above: what is the point of the ban? Well, according to some commentators, it is aimed at reducing smoking; but this must be hokum. Trying to reduce smoking by banning the sale of menthol cigarettes is like trying to reduce alcohol consumption by banning the sale of wine with characterizing flavors other than grape—such as peach wine.
Meanwhile, the EU put forward as part of its justification for the ban what the U.S. Food and Drug Administration (FDA) had concluded in 2013: that menthol cigarettes pose a public health risk above that seen with nonmenthol cigarettes. It also quoted the FDA as saying that menthol use is likely associated with increased smoking initiation by youth and young adults; that menthol in cigarettes is likely associated with greater addiction; and that menthol smokers are less likely to successfully quit smoking than their nonmenthol-smoking counterparts.
Of course, the EU did not point out that the FDA was so concerned about menthol cigarettes in 2013 that it did nothing about them.
Reading the above, I was amused by the way the FDA, this self-styled bastion of rigorous science, apparently throws the word “likely” about as if it were confetti at a wedding. And I found myself not convinced by what seemed to me to be some muddled thinking. If the FDA thinks it’s necessary to say that it’s possible “to successfully [my emphasis] quit smoking,” rather than “to quit smoking,” I take it that it believes also that it is possible to unsuccessfully quit smoking. But whereas you might make an unsuccessful attempt to quit smoking, you cannot unsuccessfully quit smoking—not in this galaxy.
I have trouble also with the concept of “greater addiction.” The word “addiction” has become so malleable in the minds of a lot of people that it is now like mental chewing gum. No more than I can imagine a million light years, can I imagine how degrees of addiction would be measured in a scientifically rigorous manner.

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Other risks
The EU aligns with the FDA also on smoking initiation among young people. One of the EU’s original justifications for the ban cited scientific studies that have shown that flavors such as menthol facilitate inhalation and may play a role in smoking initiation. I would have thought scientific studies that purport to show that something may be the case should be binned, but, having said that, I am ready to believe that it is possible that menthol does aid smoking uptake by the young. However, there are laws to prevent the sale of all types of cigarettes to these people, and it seems unbalanced to spoil the enjoyment only of adult smokers of menthol cigarettes because the authorities in the EU’s member states are failing to enforce laws that apply to all cigarettes, especially given the fragility of the scientific studies referred to above.
After all, the EU seems not to take issue with another product that has been linked with cancer and that young people consume—the younger ones at the behest of adults. In fact, according to the headline above another story that appeared in the same newspaper as Devlin’s report, the EU has been under attack for spending more than €200 million ($225.78 million) on the promotion of meat. As writer Daniel Boffey points out in his piece, “Scientists have provided evidence of a link between cancer and diets involving pork, beef and lamb products.”
And how those extraterrestrials must be laughing. Boffey points out too that the livestock sector is responsible for about 14.5 percent of human-derived greenhouse gas emissions. How can it be in the interests of young people for the EU to spend millions of euro promoting something that is linked with cancer and that is helping to flush the environment down the toilet? It is young people, not older adults, who are going to have to settle, at best, for a life squatting on the toilet’s event horizon.
But it isn’t really about the young, is it? How can we have the temerity to maintain, against all the evidence, that we want to protect young people? And I’m not talking only of governments here, I’m calling out ordinary people. One example. In my country, the U.K., voters have recently given a huge parliamentary majority to a party that, during the past 10 years, has overseen a big increase in child poverty and that will almost certainly cause more such poverty during the next five years—a party led by a person who many commentators say is unable or unwilling to account for how many children he has. Elsewhere, the abuse of children in the U.K. is accepted to the point that those in authority often look the other way, and it is even “celebrated” in one of our poetic forms, the limerick. I don’t know what became of the young chaplain from Kings, but some of the leaders of his church sit, by right, in our second chamber, the House of Lords; I presume, to provide us with spiritual guidance. This is way beyond irony.
I would not argue that the EU should concentrate on nothing but the environment. But it should certainly take off the table any nonessentials and put all available hands to the environment pump. The climate crisis is not a future event. It is already upon us.
By comparison, the menthol-cigarette ban is pure faff. I presume that it has been devised by people who haven’t moved against gooseberry and elderflower wine because most of them consume alcohol. They want to put a stop to a pleasure that they cannot understand. You can see this in the rules about roll-your-own tobacco. Allowing the sale of menthol papers and tips as separate items but not in conjunction with tobacco seems to be aimed at inconveniencing smokers. The EU’s bureaucrats should be put to work on critical projects. Announcing the European Green Deal is all well and good but, from what I read, making it work is going to be a huge challenge. The carbon scammers will already be jostling for position.

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Accommodation
Inevitably, products have been appearing on the market aimed at helping menthol-cigarette smokers through the difficult time being ushered in by the May 20 ban. One, a menthol-infusion card that smokers can slip into a pack of regular cigarettes or fine-cut, is particularly clever, mimicking as it does the RYO accessory exemption, and thereby presumably staying well within the spirit and the letter of the law. Ironically, menthol smokers might end up preferring this system because they can tailor their preferred menthol level by adjusting the length of time they leave the cards in the pack. And of course, menthol smokers can help themselves after May 20 by putting regular cigarettes, together with some menthol crystals bought from their local pharmacies, into a sealed jar and leaving them there for a time based on their preferred menthol strength.
Despite the fact that I see the menthol cigarette ban as being unnecessary and unfair, discriminating against and collectively punishing a minority group of smokers, you have to accept that what is done is done and try to make the most of it. I suppose you have to hope that those menthol-cigarette smokers in the EU who do not want to take advantage of the new DIY methods react by quitting or switching to menthol vaping.
But it’s those extraterrestrials who will have the last laugh. They will hardly be able to contain themselves as more EU energy is expended on TPD3 while the environment tips over the event horizon to the strains of “Goodnight Irene.”
George Gay is Tobacco Reporter’s European editor, but his territory spans the globe. Based in London, George has covered the tobacco industry since 1982, initially for a U.K.-based publication and since 2004 for Tobacco Reporter. George’s understanding of industry issues, combined with his keen sense of observation and dry wit, have earned him a loyal following among Tobacco Reporter’s readers.

March 31, 2020
FDA Requests PMTA Extension

The U.S. Food and Drug Administration (FDA) has requested a 120-day extension to the May 12 premarket tobacco product application (PMTA) deadline due to complications associated with the coronavirus.
The FDA submitted a letter to the Maryland District Court requesting that Judge Grimm, the judge who ordered the original deadline, postpone the court-ordered May 12 PMTA deadline to Sept. 9.
The FDA cited lab and research organization closures; travel restrictions creating limits on information gathering; factory closures; the reallocation of some Center for Tobacco Products employees to the U.S. Public Health Service; and FDA employees working remotely, making it difficult to review applications.
The FDA’s request follows an earlier request from Altria to extend the PMTA deadline and letters from more than 15 manufacturers requesting extensions.
As of February 2020, the FDA has received 30 PMTAs for e-cigarettes and 28 substantial equivalence applications for cigars.
March 31, 2020
Altria Asks for Delay PMTA Deadline
Altria has sent a letter to the U.S. Food and Drug Administration (FDA) requesting that the agency push back the May 12 authorization deadline by eight weeks due to the coronavirus outbreak.
In order to keep certain tobacco and nicotine products on the market, companies must submit applications to the FDA by May 12, but many companies have been disrupted due to the virus outbreak; many companies have asked employees to work from home, factories have temporarily closed and Altria’s CEO contracted the virus.
Altria has requested that the FDA seek an extension following the eight-week social distancing recommendation from the U.S. Centers for Disease Control and Prevention.
“Although we make this request and raise these issues given these unprecedented times, we remain committed to working with the agency on these important product submissions,” Paige Magness, Altria’s senior vice president, said in a letter. The company has asked that if an extension is not possible the FDA allow companies to submit data and product samples after the deadline if they are affected by the outbreak.
March 30, 2020
New Zealand Classifies Tobacco as Essential Business

Imperial Tobacco’s factory in Petone, New Zealand, has been listed as an essential business by the government, allowing it to stay operational amid the coronavirus outbreak.
The Ministry of Business, Innovation and Employment (MBIE) stated that “ongoing supply of consumer goods needs to continue.”
“The suppliers to an essential business are also considered an essential business, including those who sell cigarettes. However, it can only sell to the essential business. It cannot be open to the public,” the MBIE said.
“Imperial can supply the demand safely,” an Imperial spokesperson said. “The number of factory staff has been reduced and are working to a production layout and shift format that maintains physical distance between them.”
Not everyone is happy about the facility remaining open, however. “We’re dealing with a major health crisis and it doesn’t seem to make any sense that a tobacco factory that produces cigarettes is an essential service when so many other [industries] have been required to shut down,” said Richard Edwards, a professor at the University of Otago and part of the Asthma Foundation’s scientific advisory board.
March 30, 2020
South Africa Suspends Cigarette Sales During Shutdown

As part of its 21-day nationwide shutdown of business to curtail the spread of Covid- 19, South African Trade and Industry Minister Ebrahim Patel noted that cigarette sales would be prohibited during the shutdown. Alcohol sales will be strictly confined to bars, nightclubs, restaurants, liquor stores and taverns at set hours.
“We have to contain the spread of the virus,” said Patel. “If this virus spreads widely, it can cause very, very serious damage. So, we will implement and learn from implementing, and we can amend the regulations as we go on. We have a 21-day lockdown, it’s not a year, it’s not two years. It’s a 21-day lockdown to try to see if we can contain this.
“On the items that people can buy, obviously we wanted to keep the list as short and simple as possible so that we can do a quick turnaround at shops so that people spend the minimum amount of time there and travel as infrequently to the shops as possible, Patel added.
“Cigarettes is not a basic good.”
March 27, 2020
Covid-19 Bill Passes U.S. Senate

The U.S. Senate voted unanimously to pass a $2 trillion stimulus package. The deal is expected to clear the U.S. House of Representatives early Friday morning before being sent to President Donald Trump, who has said he will sign the bill into law immediately.
The signing of the bill in the Senate came after intense negotiations. The bill is said to be one of the most expensive and far-reaching measures passed by Congress. House Majority Leader Steny Hoyer said Wednesday evening that the House plan is to pass the bill by voice vote, which would avoid forcing all representatives to return to Washington for a recorded roll call vote.
“Members are further advised that due to the limited flight options, members participating in self-quarantine and several states mandating stay-at-home orders,” Hoyer announced in a statement Wednesday evening.
The deal was heavily scrutinized by some Republican senators who argued that language incentivizing unemployment would keep some workers from returning to their jobs because unemployment benefits would pay them more money than they would make working. “This bill pays you more not to work than if you were working,” GOP Senator Lindsey Graham of South Carolina said. “You’re literally incentivizing taking people out of the workforce at a time when we need critical infrastructure supplied with workers.”
The goal of the legislation is to flood the U.S. economy with funds during a period of time that has seen financial systems in chaos, including having several states on lockdown. Numerous businesses have closed and the numbers of infections and deaths from Covid-19 have risen rapidly across the U.S.
Key components of the proposal are $500 billion in loans for distressed companies, $350 billion in small business loans, $250 billion set aside for direct payments to individuals and families, and $250 billion in unemployment insurance benefits. The plan would provide individuals who earn $75,000 in adjusted gross income or less direct payments of $1,200 each. Married couples earning up to $150,000 would receive $2,400. There would also be an additional $500 per child, according to news reports. Payments scale down by income, phasing out entirely at $99,000 for singles and $198,000 for couples without children.
In a press release, Minority Leader Chuck Schumer said the bill also contained a provision that would prevent President Trump and his family, as well as other top government officials and members of Congress, from getting loans or investments from Treasury programs in the stimulu
March 26, 2020
Cigar Industry Petitions for SE Delay

The Premium Cigar Association and the Cigar Rights of America filed a petition to extend the May 12 deadline for Substantial Equivalence reports with Alex Azar, secretary of Health and Human Services, and Stephen Hahn, the U.S. Food and Drug Association (FDA) commissioner.
Azar and Hahn both have the power to stay regulatory deadlines during a public health emergency.
“These Substantial Equivalence reports are required to continue to sell the thousands of premium cigars introduced to the market between Feb. 15, 2007, and Aug. 8, 2016, and each report requires time, considerable cost and effort,” said the Premium Cigar Association.
A Maryland judge declined to extend the Substantial Equivalence deadline to 2021 last July.
March 26, 2020