Category: Regulation

A difficult question
A US public health expert has made the point that people – young people in this case – who vape are not tobacco users. They are vapers.
Dr. Michael Siegel, a professor in the Department of Community Health Sciences, Boston University School of Public Health, was responding to a press release issued by city attorney Dennis Herrera and supervisor Shamann Walton announcing the introduction of legislation to ban the sale of all electronic cigarettes in the city of San Francisco.
In part, Siegel’s point-by-point response to the press release focuses on the seemingly strange disconnect between the way that e-cigarettes and combustible cigarettes are viewed by legislators.
This is the second point of the press release that Siegel addressed:
“San Francisco has never been afraid to lead,” Herrera said, “and we’re certainly not afraid to do so when the health and lives of our children are at stake.”
And this is what Siegel had to say:
‘San Francisco is apparently afraid to lead because they are willing to take the politically expedient step of requiring safety testing for e-cigarettes, but they are not willing to place the same requirement on real cigarettes. In fact, tobacco cigarettes have already had their safety testing and they failed miserably. If San Francisco wants to lead, then why isn’t it taking cigarettes off the shelves?’
Siegel’s The Rest of the Story blog is here.
March 26, 2019
Rights polluted
Halting the spread of the tobacco ‘epidemic’ worldwide would align with a human right that global leaders should recognise and act upon, according to a story by Sarantis Michalopoulos for euractiv.com quoting public health activists.
“The tobacco industry floods countries with an addictive and lethal product, cigarettes, which kill over seven million people per year,” said Laurent Huber, director of US Action on Smoking & Health (ASH), talking ahead of two anti-tobacco conferences in Bucharest, Romania.
“For this reason, the global health community and some human rights agencies recognise that the tobacco industry violates the rights to life and health and undermines many other rights including children’s rights and women[‘s] rights.”
A Global Forum on Human Rights and a Tobacco-Free World was due to be held today in Romania by the European Network for Smoking and Tobacco Prevention (ENSP) and ASH. It was to be hosted by the Romanian President Klaus Iohannis.
In addition, on March 27-29, ENSP is due to hold its 4th International Conference on Tobacco Control, together with the Romanian Society of Pneumology.
Both conferences were said to be aimed at bringing together global leaders in health and human rights in order to co-ordinate the fight against tobacco and upgrade it to the level of a human right.
‘The nexus between tobacco control and recognised human rights is clear, particularly in the case of the rights to health and life recognised in numerous human rights treaties and national constitutions, but encompassing many other rights as well,’ the organisers reportedly said in a statement.
“Human rights norms and obligations can be powerful tools to combat tobacco industry interference in policy-making and litigation.’
March 26, 2019
Andorra raises price issue
A French member of the EU Parliament has asked the Commission if the Association Agreement between the European Union and Andorra will enable tobacco-product prices to be aligned.
In a preamble to two questions, Philippe Juvin said that March 18, 2015, had seen the start of official negotiations between the EU on the one hand and Andorra, Monaco and San Marino on the other, with the aim of deepening their relations.
‘The resulting agreement will enable the three states and their economic operators to participate in the European internal market by removing the barriers currently hampering their trade,’ he said.
‘In the light of the Council Conclusions of 3 December 2018, the EU “is fully committed, and stands ready to work towards finalising the discussions on the framework of the Agreement by spring 2019”.
‘According to our information, the agreement currently being negotiated, as far as the Protocol on Andorra is concerned, will include elements aimed at resolving the issue of tobacco prices, which gives rise to a large amount of traffic at the borders.’
Juvin then asked:
‘Would the Commission kindly explain to us what the provision in the Protocol is which will enable this issue to be resolved?
‘Will this provision enable tobacco prices to be aligned?’
The Commission is due to answer the questions in writing.
March 26, 2019
FDA final guidance
US vape shops that modify a product so that it is deemed by the US Food and Drug Administration to be a ‘new tobacco product’ are required to comply with the agency’s premarket authorization requirements, according to a final FDA guidance.
In a note issued through its Center for Tobacco Products, the FDA said it had posted a notice in the Federal Register announcing the publication of the final guidance, Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops. This guidance was said to finalize the draft guidance of the same title, which was available for public comment on January 17, 2017.
‘Under section 903(a)(2)(C) of the Food, Drug, and Cosmetic Act [FD&C], a tobacco product in package form is misbranded if its label does not include an accurate statement of the percentage of tobacco used in the product that is foreign-grown and domestic-grown,’ the note said. ‘This guidance clarifies FDA’s interpretation of this as applying only to tobacco products that are made or derived from tobacco. Tobacco products (such as components, parts, and accessories) that are not made or derived from tobacco would not be required to bear the statement.
‘Additionally, at this time, FDA does not intend to enforce this requirement for certain products, including tobacco-derived liquid nicotine, e-liquid made or derived from tobacco, cigars, smokeless tobacco, and waterpipe tobacco. FDA is providing this compliance policy as the agency recognizes the current scientific and technical difficulties of quantifying the percentage of foreign and domestic tobacco used in these products.
‘The guidance also clarifies [that] vape shops that are tobacco product manufacturers are subject to the requirements in section 904(a) and (c) of the FD&C Act, including the requirements to provide ingredient listings, report harmful and potentially harmful constituents, and submit health documents. Those vape shops that modify a product so that it is a new tobacco product are required to comply with the premarket authorization requirements. Vape shops that are engaged in the manufacture, preparation, compounding, or processing of tobacco products are required to comply with the establishment registration and product listing requirements in section 905 of the FD&C Act.
‘The final guidance explains certain activities which modify a product, and which would subject the vape shop to the requirements of the Act that apply to manufacturers and includes a compliance policy for limited circumstances for which FDA does not intend to enforce these requirements…’
March 25, 2019
Problem cannot be patched
Taxpayers in the state of South Australia will pay for nicotine substitutes for prisoners as the state moves to make its jails smoke-free, according to a story by Rebecca Puddy at abc.net.au.
The Department for Correctional Services has estimated that 80 percent of South Australia’s 2,800 prisoner-population comprises smokers, with 75 percent smoking daily.
Under the current smoking rules, prisoners can buy their own cigarettes and tobacco from canteens.
A $2 million bill for nicotine patches and lozenges will form part of the $6.2 million cost to taxpayers of keeping cigarettes out of the state’s prisons in the years to 2022, with additional funding set aside for health and security measures, staff costs and quit support.
The smoking ban has received bipartisan support and strong backing from Cancer Council SA and the Public Service Association, the union representing the state’s prison guards.
Under the current structure, SA Health pays for NRT in prisons that have not enacted a smoking ban but will hand over this cost to the Department for Correctional Services when the ban is introduced at the end of the year.
Under the rules to be introduced as prisons become smoke-free, taxpayers will foot the bill for the first six weeks of a nicotine replacement program, with prisoners required to pay one quarter of the cost for the next three weeks, and 50 percent of the cost for the final three weeks.
Cancer Council SA spokeswoman Alana Sparrow said the Government had worked with stakeholders to develop a “good evidence-based approach”, learning from the experiences of other states.
“We have looked at evaluations in different states and territories – in some it has worked extremely well but we are also learning from the experiences in other states like Victoria,” she said.
A 2018 study of former prisoners in Queensland found 94 percent relapsed to smoking within two months of their release, with 72 percent doing so on the day of their release
March 22, 2019
E-cig epidemic explodes
The US Food and Drug Administration Commissioner Scott Gottlieb, MD, has said that his agency might need to pull pod-based nicotine products off the market to fight teen vaping, according to a story by Anna Edney published by the LA Times.
Speaking at the Brookings Institution on Tuesday, Gottlieb said he had had a contentious meeting last week with executives of Altria and Juul Labs.
“The e-cigarette industry has been overly dismissive” of the risk that young people could become addicted to nicotine through e-cigarette use, Gottlieb said. “We’re capturing an exploding epidemic right now.”
Gottlieb said the FDA was working on defining what constituted a pod-based product in case it needed to ban them temporarily.
Sales of vaping pods could resume if manufacturers showed that their devices were geared toward adult cigarette smokers trying to quit, and not toward young people.
“It was a difficult meeting,” the commissioner said, noting that there was a “disconnect” between the companies’ priorities and those of health officials.
He added that it appeared Altria’s decision to purchase a stake in Juul was purely a business decision and not driven by public health concerns.
Edney said that Altria and Juul hadn’t responded to Gottlieb’s characterization of the meeting.
But she added that both companies said they remained committed to combating underage use of e-cigarettes.
March 21, 2019
E-cig ban proposed
Two San Francisco officials on Tuesday introduced bills that would ban the sale of electronic cigarettes in the city until the US Food and Drug Administration had evaluated their effect on public health, according to a story at cbsnews.com.
Supporters say that if the ban is approved, it will be the first in the country.
City Attorney Dennis Herrera and Supervisor Shamann Walton also proposed a bill at a Board of Supervisors meeting that would prohibit companies that make, sell and distribute tobacco products, including e-cigarettes, from occupying city-owned property.
The San Francisco Chronicle was quoted as saying that tobacco companies were already barred from doing business on city property, but that the proposed legislation would embrace e-cigarettes.
It wouldn’t apply retroactively, so Juul Labs would be allowed to stay in space it rents for its headquarters at Port of San Francisco property on Pier 70. But, says the Chronicle, e-cigarette companies wouldn’t be able to lease city property in the future.
Juul said in a statement to CBS News that the proposed legislation would limit adult smokers’ access to e-cigarettes that could help them kick regular smoking habits.
‘We encourage the City of San Francisco to severely restrict youth access but do so in a way that preserves the opportunity to eliminate combustible cigarettes,’ Juul said.
“This proposed legislation begs the question – why would the City be comfortable with combustible cigarettes being on shelves when we know they kill more than 480,000 Americans per year?”
Herrera said San Francisco, Chicago and New York had sent a joint letter demanding that the FDA begin its review. He said the review should have been done before e-cigarettes ever hit the market.
March 21, 2019
Round one to e-cigarettes
The High Court of Delhi, India, has stayed the Central Government’s attempt to ban electronic cigarettes in the country under the Drugs and Cosmetics Act, saying that these products do not fall within the Act’s definition of a drug, according to a story in the Bar & Bench, relayed by the TMA.
Two e-cigarette companies, Litejoy International Pvt Ltd and M/S Focus Brands Trading were said to have petitioned the court in response to a February 22 Communication from the Directorate General of Health Services asking state licensing authorities to prohibit the sale, manufacture, distribution, importation and advertisement of e-cigarettes and ENDS [electronic nicotine delivery systems] in their jurisdictions.
The petitioners argued that ENDS were less risky substitutes for combustible cigarettes and that the Government’s decision affected the right of consumers to choose e-cigarettes in place of cigarettes.
Additional Solicitor General, Maninder Acharya, submitted that since ENDS assisted smokers to give up their tobacco addiction, ENDS and all other devices fell within the definition of ‘drugs’ as defined under Section 3(b) of the Act.
The court observed that the devices were not sold as therapeutic devices so the Central Government did not have the jurisdiction to issue the circular.
The government has two weeks to issue its response and the case will be heard on May 17.
March 20, 2019
Looking for change
Knowledge∙Action∙Change (KAC), a private sector public health agency based in the UK, has called for action to prevent the dramatic rises in smoking rates in Africa that have been predicted by the World Health Organization.
In a note issued through PRNewswire, KAC said that while globally smoking rates were decreasing, in many lower- and middle-income countries, African nations among them, rates were increasing. WHO data showed a steep rise in smoking in many African countries, with many five-year projected increases at five percent and more.
With this in mind, public health experts from KAC had this week visited Lilongwe, Malawi, and Nairobi, Kenya, to launch No Fire, No Smoke – The Global State of Tobacco Harm Reduction 2018 (GSTHR), ‘a landmark report on the worldwide availability, regulation, and use of lower-risk alternatives to tobacco, such as e-cigarettes (vapes), heat-not-burn devices, and Swedish snus (pasteurized oral tobacco)’.
‘A proven public health strategy, harm reduction refers to policies, regulations, and actions that reduce health risks by providing safer forms of hazardous products or encouraging less risky behaviors, rather than simply banning them,’ the note said.
‘Independent evidence from the UK Government’s leading public health body demonstrated recently that vaping is at least 95 percent safer than smoking tobacco. Yet despite the WHO Framework Convention on Tobacco Control (FCTC) of 2003 citing harm reduction as one of its main tactics, the WHO has been persistently negative about e-cigarettes, has called for their ban or strict regulation, and sees them as a threat, rather than as a public health opportunity.
‘Partnering with the information dissemination project, Tobacco Harm Reduction Malawi, and the newly launched Campaign for Safer Alternatives based in Kenya, the GSTHR report’s publishers presented global findings on tobacco harm reduction, showing that many smokers have switched to safer products and dramatically reduced the risks associated with smoking.’
“We need to halt the dramatic rises in smoking rates in Africa which are predicted by WHO,” Professor Gerry Stimson, director of KAC and Emeritus Professor at Imperial College London, was quoted as saying. “Most smokers want to quit smoking, but they find it hard to stop using nicotine. Around the world, millions of lives depend on both consumer and government acceptance of safer alternatives to smoking.”
Meanwhile, Chimwemwe Ngoma, project manager, Tobacco Harm Reduction Malawi and holder of a Global Tobacco Harm Reduction Scholarship, said that Tobacco Harm Reduction Malawi believed that all citizens of Malawi should be informed of the health consequences, addictive nature, and mortal threat posed by tobacco consumption and exposure to tobacco smoke. “Malawians should be able to make more informed public and personal choices, including having access to safer nicotine products, to enable them to live longer and healthier lives,” he said.
And Joseph Magero, chair of the Campaign for Safer Alternatives and holder of a Global Tobacco Harm Reduction Scholarship, said society’s relationship with tobacco and nicotine was changing due to technical developments in vaping devices and other safer nicotine products. “The Campaign for Safer Alternatives has formally launched this week to ensure more people across East Africa receive accurate information on alternatives to smoking,” he said. “By arming people with information, we can finally begin to curb the tobacco epidemic.”
March 19, 2019
Making their mark
The UAE’s Federal Tax Authority (FTA) has said that the sale or distribution of any ‘unmarked’ tobacco products will be prohibited across all local markets as of August 1, according to a story put out by the Emirates News Agency.
In a press statement issued yesterday, the FTA said that it was holding a series of training workshops to introduce inspectors across the UAE’s economic development departments to the objectives and implementation methods of the Marking Tobacco and Tobacco Products Scheme, which went into effect in January.
The FTA’s director-general, Khalid Ali Al Bustani, was quoted as saying the digital marks would be placed on tobacco packaging and registered in the FTA’s database. The marks contained data that could be read using a sophisticated device, he said.
The digital coding scheme is aimed at preventing the sale of non-tax-compliant tobacco products.
The workshops were said to be part of the Authority’s commitment to maintaining communication with all relevant government and private-sector entities.
They were aimed at keeping these entities informed about developments surrounding tax procedures, while, at the same time, taking account of their opinions and suggestions to ensure the UAE tax system was implemented easily and seamlessly.
March 19, 2019