Category: Regulation

Catch as catch can
The outgoing Food and Drug Administration (FDA) commissioner Scott Gottlieb, MD, has said his departure won’t have any impact on the agency’s crackdown on youth vaping, according to a story by Jessie Hellmann at thehill.com.
“I’m very confident of that, and I’m very confident that we’re going to continue with this policy over the next month, including the policy that we’ve been formulating,” Gottlieb was quoted as saying during an event hosted by The Hill on Wednesday.
Hellmann wrote that Gottlieb had proposed limiting the sales of most flavored electronic cigarettes to age-restricted, in-person locations, effectively ending sales at gas stations and convenience stores.
“I think there is widespread recognition that this is a major public health crisis,” Gottlieb said. “I think for the vaping community and the tobacco industry this is an existential threat.
“I don’t think they fully appreciate what they’re facing and the tsunami that they’re facing if we don’t get this under control.
According to the story at The Hill quoting FDA data, there was a 78 percent increase in e-cigarette use among US high school students from 2017 to 2018, and a 48 percent increase among middle school students.
Gottlieb’s actions have been questioned by some people who argue the proposed changes would make it harder for adults who are trying to quit smoking to get e-cigarettes as an alternative.
But Gottlieb seemed not to buy that argument.
“I think the arguments that the folks who are advocating a completely laissez-faire hands-off approach with respect to vaping don’t hold true,” he was quoted as saying.
“We’re catching the beginning of an epidemic.”
March 8, 2019
Nightmare scenario
In Sri Lanka, the Vavuniya South Tamil Pradeshiya Sabha (the town of Vavuniya’s local authority) has banned the sale of cigarettes in areas which fall under its purview, according to a story in The Times.
The ban was brought in on March 1 after a proposal to this effect was unanimously approved by the members of the Pradeshiya Sabha (legislative body that presides over the third-tier municipality).
Meanwhile, the Vavuniya South Sinhala Pradeshiya Sabha was said to have mostly implemented a similar ban in areas under its purview.
The sale of cigarettes in Vavuniya was said to have dropped by 78 percent by October last year as a result of the ban.
March 8, 2019
Easy to lose track
The EU Commission said yesterday that the EU’s traceability system for tobacco products contains multiple safeguards, including independence requirements that ensure the system is controlled by member states and is independent of the tobacco industry.
The Commission was replying to questions posed by a French member of the EU Parliament who had claimed that the Commission’s tobacco-products tracking-and-tracing acts did not take into account the entry into force of the World Health Organization’s ‘Protocol to Eliminate Illicit Trade in Tobacco Products’.
In a preamble to two written questions, Michèle Rivasi said that parallel trade in tobacco resulted in increased smoking, particularly among adolescents, who were more sensitive to prices, and an annual tax loss for EU member states estimated at between €15 billion and €20 billion.
‘The World Health Organization (WHO) considers that the best way to put an end to this phenomenon is to apply its Protocol “to Eliminate Illicit Trade in Tobacco Products,” which was drawn up in 2012 and entered into force on 25 September 2018,’ she wrote.
‘To date, there are 48 parties to this international treaty, including the European Union, which ratified the WHO Protocol on 24 June 2016, following the vote of the European Parliament on 9 June 2016.
‘Article 8 of the Protocol requires, in particular, that a tracking and tracing system be set up for tobacco products which is strictly independent of tobacco manufacturers, who are suspected of fuelling parallel trade.
‘At the beginning of 2018, the implementing and delegated acts on the traceability of tobacco products adopted by the European Commission entrusted several essential traceability-related tasks to cigarette manufacturers themselves.’
Rivasi then asked:
1. ‘Why do the Commission’s acts not take into account the entry into force of the WHO Protocol?
2. When will the Commission revise them?’
In reply, the Commission said that the traceability system for tobacco products contained multiple safeguards, including independence requirements that ensured that the system was controlled by the authorities of the member states and that it remained independent from the tobacco industry. ‘To that extent, Article 15 of Directive 2014/40/EU (on tobacco traceability), along with the relevant implementing and delegated legislation, is fully in line with the World Health Organization Framework Convention on Tobacco Control’s Protocol (notably Article 8), it said.
‘Article 35(9) of Commission Implementing Regulation (EU) 2018/574 provides that the procedures governing the appointment of service providers and the monitoring of their compliance with the independence criteria set out in the secondary legislation will undergo a periodic review by the Commission. Conclusions of that review will form part of the report on the application of Directive 2014/40/EU provided for under Article 28 of that Directive. Following the publication of the report, the Commission may, if deemed necessary, table a proposal for amending respective legislation.’
March 7, 2019
Lazy regulation
At least one manufacturer of cigarette alternatives has criticized the Greek Government for lumping heat-not-burn products and electronic cigarettes with combustible cigarettes when considering legislation, according to a story at ekathimerini.com.
An urgent bill debated in Parliament yesterday provides for the alternative products to be treated in the same way as conventional tobacco products are treated.
The story said that, under the provisions of the bill, the alternatives would have to carry warnings saying that they damage health, but it wasn’t clear from the report whether those warnings would mirror those carried by combustible products.
In a statement, the Philip Morris International subsidiary Papastratos accused the Health Ministry of avoiding launching a dialogue and examining the scientific data relating to alternative products.
It said that because the bill assumed cigarette alternatives to be equal to cigarettes [in respect of risk], eventually, smokers would choose the most damaging option – continuing to smoke.
March 7, 2019
Caught on camera
A study by researchers at the Limerick Institute of Technology, Ireland, has found that ‘diversity is ostensibly lacking’ in images used as part of the EU’s Tobacco Products Directive, according to a story by Sarah Burns for The Irish Times.
Among 42 anti-smoking images used on cigarette packages and in campaigns, none ‘distinctly include’ members of a racial or ethnic minority, they found.
‘All visible models, or body parts of models, used in the campaigns are Caucasian,” the researchers concluded.
March 6, 2019
Threat to e-cigs, cigars
A congresswoman in Colorado, US, Diana DeGette, is introducing legislation that, if passed, would ban electronic-cigarette flavors on a national level, according to a story by Michael Nedelman for CNN quoting a Monday announcement by DeGette’s office.
The bill was expected to be introduced to the House of Representatives yesterday.
Nedelman described flavors as being at the center of the regulatory debate, with some people saying they were an important tool in getting adults to switch from combustible cigarettes, while others wanted to ban them entirely because in their view they appealed to young people and minimized how harmful and addictive vapes were perceived to be.
“To me, there is no legitimate reason to sell any product with names such as cotton candy or tutti fruitti, unless you are trying to market it to children,” DeGette, a Democrat, said in a statement on Monday.
“Most experts agree that the kid-friendly flavors that e-cigarette manufactures are selling with these products are one of the leading causes of this spike in use among our high school and middle school students.”
If DeGette’s bill becomes law, it will ban these flavors within a year unless companies can prove to the US Food and Drug Administration that flavors are not implicated in the rise in vaping among young people.
It would require companies also to show that flavors are instrumental in getting smokers to quit combustible cigarettes and that they don’t make vapes ‘more harmful to the user’.
The bill could ban flavors in cigars on the same timeline.
March 6, 2019
Pointless gesture
Campaigners in the UK have criticised calls to raise the legal age for buying tobacco from 18 to 21.
A press note issued by the smokers’ group Forest said this proposal had been included in a report by the All Party Parliamentary Group on Smoking and Health, which was run by the anti-smoking group Action on Smoking and Health (ASH).
Other proposals were said to include further restrictions on the portrayal of smoking on television and in films, and introducing a levy on tobacco companies that would be used to fund further anti-smoking initiatives.
“These proposals infantilise young adults,” Forest director Simon Clark was quoted as saying. “If you’re 18 and old enough to vote, drive a car and join the army you’re old enough to make an informed decision to smoke.
“Raising the current age at which you can buy tobacco, or censoring films and TV programmes that try to depict real life, takes paternalism to a new level.
“The real sickness in society is not smoking, which is in long-term decline across all age groups, but the creeping prohibition that is removing our ability to make choices and take personal responsibility for our own lives.
“Ultimately, if you treat adults like children, don’t be surprised if they behave like children.”
March 5, 2019
New rules of street-cred
A Macau lawmaker Ella Lei has urged the Government to ban smoking in the city’s main streets, according to a story in The Macau Daily Times.
In a written question to the Government, Lei asked the whether it ‘will consider, in the future, to expand the smoking ban to densely populated outdoor spaces’.
Lei asked if streets near schools, kindergartens and public parks could be made into non-smoking areas.
She asked also whether the government would establish non-smoking streets in some areas.
‘It has become a global trend to expand smoking bans to outdoor public places, especially where children are present,’ Lei wrote.
March 4, 2019
Vaping ‘ordeal’ in Thailand
A French woman who was in Phuket, Thailand, for a family holiday in January found herself in court and later deported, thousands of euro poorer, because of an incident involving a vaping device.
According to a story by Tanyaluk Sakoot for thephuketnews.com, Cecilia Cornu, 31, was caught by police in the resort area of Karon holding an e-cigarette [the picture that accompanied the story seemed to show a heat-not-burn device] on January 30. She had been on a scooter with her fiancée, as her parents and brother followed behind.
Cornu alleged she was stopped by four police officers who snatched the e-cigarette and demanded B40,000 [an allegation that was denied by the police], which she refused to pay.
She was then arrested and taken to Karon Police Station where, she alleged, officers tried to bully her into paying a bribe.
Cornu was charged, her passport confiscated, and a trial date set for February 11. Her return flight was scheduled for the following day.
She posted bail of B100,000 and was released the same day pending trial.
On February 11, Cornu attended Phuket Provincial Court where she was convicted for the offence [presumably of being in possession of a vaping device] and fined B827 (€23).
She was then sent to the Phuket Immigration facility prior to being transferred to Bangkok for deportation.
She said that in Bangkok she spent four days and three nights in a prison cell shared with 60 other women in dire conditions, which included sleeping on a hard, dirty floor with no sheets or mattresses.
Cornu claims the ordeal cost her about €8,000 euros (B286,000) in legal fees and travel expenses.
March 4, 2019
Enforcing tobacco rules
The Mysuru City administration in the Indian state of Karnataka is aiming to make the city tobacco- and tobacco-smoking-free by ensuring its compliance with the Cigarettes and Other Tobacco Products Act (COTPA) 2003, according to a story in the latest issue of the BBM Bommidala Group newsletter.
The authorities aim to enforce strictly COTPA regulations in respect of public transport, educational institutions and public places in general.
The story said that the sale of tobacco products was to be banned within 100 years of educational establishments, and that public venues would have to display prominently ‘no smoking’ signage. It wasn’t clear whether these were new requirements or, more likely, COTPA requirements that were going to be enforced.
In addition, restaurants and bars have been directed to remove designated smoking zones on their premises.
All the administration’s departments and the police were being urged actively to enforce the tobacco control laws.
There was no explanation of why the administration had decided to enforce the COTPA regulations at this time, after, presumably, they had previously not bothered to do so.
It was not stated when the city was scheduled to become tobacco- and tobacco-smoking-free.
March 1, 2019