Category: Regulation

New rules seen as infantile
The smokers’ group Forest says that new tobacco regulations coming into force in the UK ‘infantilise’ consumers and will make no difference to public health.
The new rules, which must be fully implemented by this weekend, include a minimum pack size of 20 cigarettes, a minimum pouch size of 30g of rolling tobacco, a ban on branded packaging for cigarettes and rolling tobacco, and the imposition of larger health warnings.
“The new regulations treat adults like naughty children, said Simon Clark, the director of Forest, which campaigns for smokers’ rights. “They infantilise consumers by attacking freedom of choice and personal responsibility.
“Adults and even teenagers are under no illusions about the health risks of smoking. Consumers don’t need larger health warnings to tell them what they already know.
“Banning smaller packs is a pathetic attempt to target the less well-off in the hope they will be forced to quit, but smokers will soon adapt and buy the larger packs instead.
“If you’re trying to cut down it will be harder now because the option of buying a smaller number of cigarettes has been taken away.”
Clark was scathing also about standardized packaging.
He described as absurd the idea that people smoked because of the packaging and said there was no evidence that plain packaging had any impact on youth smoking rates, and without such evidence there was no justification for the policy.
“The new regulations are a disgraceful attempt to denormalize both the product and legitimate consumers,” Clark said.
“There’s no evidence they will have the slightest impact on public health.
“Politicians and tobacco control campaigners are grasping at straws if they think people will give up something they enjoy just because the packaging has changed.”
Clark said the new government [the UK is holding a general election next month] should review the measures as soon as the UK has left the European Union.
“With the exception of plain packaging all these regulations were imposed on the UK by the EU’s Tobacco Products Directive,” he said.
“Brexit will give the government the chance to review the impact of these policies and, where necessary, amend or repeal regulations that deliberately discriminate against millions of adult consumers.”
May 17, 2017
Ray of hope for e-cigs
In his first remarks to staff at the US’ Food and Drug Administration, the new commissioner, Scott Gottlieb, signaled an openness to electronic cigarettes that might hint at a future weakening of the Obama-era rule that clamped down on the industry driving the development of these products, according to a story by Dan Diamond for Politico.
“We need to have the science base to explore the potential to move current smokers — unable or unwilling to quit — to less harmful products, if they can’t quit altogether,” Gottlieb was reported to have said on Monday.
Gottlieb did not mention electronic cigarettes directly, but his comments echoed proponents’ arguments that such products can be a stepdown from traditional tobacco cigarettes.
However, Diamond said that critics were saying that the reality was less rosy, without explaining why they thought this way.
The FDA announced last week that it was delaying aspects of a rule that aimed to regulate electronic cigarettes as traditional cigarettes.
May 17, 2017
Anti-tobacco bill passed
The Azerbaijani parliament has passed a bill restricting tobacco use, according to a story on News.az quoting AzVision.
Few details of the bill were given, though the story said that it comprised three chapters and 17 articles setting out a number of anti-tobacco measures, including a list of those places where tobacco smoking was to be banned.
The bill was discussed at the plenary session of Azerbaijan’s Milli Majlis (parliament), put to the vote and adopted at its first reading.
The chairman of the parliament’s Labor and Social Policy Committee Hadi Rajabli was said to have provided information on the bill, which he described as being in line with ‘social demands’.
He told parliament that 67.5 percent of men and 52.5 percent of women suffered from tobacco dependence.
“It is intolerable that this all leads to drug addiction, which causes discontent in society” he said.
“I am glad that the draft law has also been discussed in the press and the society appreciated it,” he added.
However, the mood wasn’t totally anti-tobacco. The committee chairman noted that interest in Azerbaijani tobacco had increased abroad, and that the adoption of the new bill did not mean that less tobacco would be produced in the country.
May 17, 2017
FDA deadlines guidance
The US Food and Drug Administration has issued its guidance on the Three-Month Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule. The extension applies only to dates set for May 10 or later.
In a press note, the FDA’s Center for Tobacco Products said the extension was first communicated in legal filings in federal court on May 1, and was then shared with stakeholders. It was announced also that the FDA intended to issue the latest guidance document.
‘As announced, and under the guidance being released today, all provisions with compliance dates that have already occurred – such as mandatory age and photo-ID checks to prevent illegal sales to minors – will remain in effect,’ the note said. ‘The FDA will continue to enforce such requirements.
‘For all future compliance dates related to the final deeming rule, the FDA is deferring its enforcement for an additional three months. Provisions for which this extension will apply include, but are not limited to:
- Submission of cigar rotational warning plans
- Registration and listing
- Ingredient listing
- Health documents
- Substantial Equivalence (SE) exemption requests
- Substantial Equivalence (SE) applications
- Premarket tobacco product applications (PMTAs)
- Harmful and potentially harmful constituent (HPHC) reports.’
The guidance is at https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm557714.htm?source=govdelivery&utm_campaign=ctp-compliancedeadlines&utm_content=guidance&utm_medium=email&utm_source=govdelivery.
May 11, 2017
Senate confirms FDA head
The US Senate voted 57 to 42 yesterday to confirm Dr. Scott Gottlieb as commissioner of the Food and Drug Administration, where he will be responsible for regulating drug companies to which he has had close ties in recent years, according to a story by Katie Thomasmay.
Gottlieb has promised to divest himself from several health care companies and recuse himself for one year from decisions involving those businesses, but that was not enough for many Democratic senators, including Patty Murray of Washington.
“He has not convinced me he can withstand political pressure from this administration, or that he will be truly committed to putting our families’ health first,” Murray said during the debate before Tuesday’s vote. “I’ve grown increasingly concerned about whether he can lead the FDA in an unbiased way, given his unprecedented industry ties.”
In a statement, Tom Price, the health and human services secretary, said Dr. Gottlieb’s “background will be crucial” for maintaining the FDA’s high standards for safe treatments “while advancing new, innovative solutions” to the nation’s public health challenges.
For Gottlieb, this is a return to the agency where, during the administration of President George W. Bush, he held various jobs, including that of deputy commissioner.
He will take over a sprawling agency that regulates everything from food to drugs, medical devices and tobacco products, which include, according the FDA’s deeming regulations, products such as electronic cigarettes.
Unless the regulations on vapor products are changed, many observers believe that most of these products will disappear from the market along with the hopes of many people trying to quit smoking.
The full story is at: https://www.nytimes.com/2017/05/09/health/scott-gottlieb-senate-fda-commissioner.html?emc=edit_tnt_20170509&nlid=60534081&tntemail0=y&_r=1.
May 10, 2017
Opportunity missed
US Congressional leaders reached a budget compromise on an omnibus revenue bill that allowed them to avoid a government shutdown but excluded language that would have changed the predicate date applying to Food and Drug Administration regulation of vapor products, according to the Reason Foundation.
‘Democratic leadership identified the change to the predicate date for vapor products as a “poison pill” and vowed to oppose any budget deal and force a government shutdown if the provision was included, said the foundation’s Nicotine, Vapor and Harm Reduction Newsletter.
‘On May 3, the FDA announced that it will defer enforcement of all future compliance deadlines under the rules published in May 2016 affecting e-cigarettes and cigars by three months. The communication from the Center for Tobacco Products specifically stated the following: “This extension will allow new leadership at the FDA and the Department of Health and Human Services additional time to more fully consider issues raised by the final rule that are now the subject of multiple lawsuits in federal court”.’
Meanwhile, The Heartland Institute said that when Congress passed the $1.1 trillion omnibus spending bill, ‘notably absent was the Cole-Bishop amendment, which would have reversed a terrible regulatory decision by the Food and Drug Administration’.
‘In May 2016, the FDA’s “deeming regulations” required all e-cigarette products brought to market since February 2007 to apply for approval by the federal government,’ it said in a press note. ‘The rule, though being phased in over three years, essentially makes every vaping product in America illegal until manufacturers get government approval for every product – which would cost manufacturers more than $300,000 per product.
‘The amendment by Reps. Tom Cole (R-OK) and Sanford Bishop (D-GA) – long-expected to be a part of the budget bill – would have amended the deeming regulations to apply only to e-cigarette products introduced after the “predicate date” of the rule (2016), not retroactively to 2007.’
May 8, 2017
Pagodas ruled no-smoking
Myanmar’s Public Health Foundation chairperson, Dr. Than Sein, has said that three pagodas in Mandalay will be declared no-tobacco-smoking zones to protect visitors, according to a story in The Myanmar Times.
He was speaking last week at a workshop on establishing smoke-free areas.
“Women and children are among the visitors to the pagodas,” he said. “Pregnant women and parents are also among them and thus we plan to ban it. We plan to make those areas free from cigarette smoke.”
The three pagodas are the Maha Myat Muni Pagoda, which is a tourist attraction site, the Maha Lawka Marrazein Pagoda, where world-heritage-listed stone inscriptions are located, and the Kyauk Taw Gyi Pagoda.
Pagoda trustee secretary U Kyaw Kyaw Oo said that signboards would be put up stating ‘gain merit by not smoking or chewing betel quid’.
“If that method fails, we will start imposing fines,” he said. “Details will be discussed with leading monks.”
The secretary said that no-smoking areas had been declared in the past, but that enforcement had been weak.
Than Sein said that in time and in co-operation with the other trustees of the board, the no smoking zone would apply to other pagodas.
May 8, 2017
GFN program complete
The organizers of the Global Forum on Nicotine (GFN) have said that the program for the 2017 event is complete.
The GFN is due to be held at the Marriott Centrum Hotel, Warsaw, Poland, on June 15-17.
The main GFN program, which is scheduled for June 16 and 17, will examine the rapidly developing science in relation to nicotine use and the changing landscape, including policy responses and the influence of different stakeholders in this.
The program will comprise plenary sessions, symposia, panel discussions and poster presentations – including video posters.
June 15 is scheduled to include the Michael Russell oration, and satellite and side meetings, including one for consumers organised by the International Network of Nicotine Consumer Organisations.
It will include, too, the first International Symposium on Nicotine Technology designed to showcase the latest technological advances in alternative nicotine delivery systems, next generation devices and the science behind them (http://isontech.info/).
The program is at: https://gfn.net.co/2017/programme-details.
The speakers and chairpersons are at: https://gfn.net.co/home-2017/bios/.
May 8, 2017
WTO upholds plain packs
Australia’s standardized tobacco packaging law has been upheld by the World Trade Organization after a five-year legal battle, according to a story by Tom Miles and Martinne Geller for Reuters.
The Reuters story cited a Bloomberg news report that, in turn, cited ‘two people familiar with the situation’.
Although the WTO’s ruling is not expected to be made public until July, a ‘confidential draft’ said Australia’s laws were a legitimate public health measure, Bloomberg was said to have reported.
A spokeswoman for British American declined to comment on the ruling until it was made public, but suggested the complainants would keep fighting.
“As there is a high likelihood of an appeal by some or all of the parties, it’s important to note that this panel report is not the final word on whether plain packaging is consistent with international law,” she said.
A spokeswoman for Japan Tobacco also declined to comment on the ruling, but said the fact that the draft had been leaked was disconcerting and a breach of WTO rules.
“Such breaches completely undermine the integrity of the process, which has not yet run its full course,” she said.
The Reuters story said that the plodding pace of WTO decision-making prompted Australia, which had the backing of the World Health Organization, to complain that its challengers were deliberately stalling the proceedings, producing a ‘regulatory chilling’ effect on other countries wishing to follow its example.
Nevertheless, such a ruling from the WTO is likely to be interpreted as giving a green light for other countries to introduce similar laws in respect of tobacco products.
It could have implications also for other products deemed to cause health problems, such as alcohol, junk food and sugary drinks.
May 5, 2017
Looming health concerns
The fundamental right to health in the UK will be lost if the government proceeds with its plan not to convert the EU Charter of Fundamental Rights into UK law, as announced in the white paper on the Great Repeal Bill, according to an editorial in the British Medical Journal by Peter Roderick and Allyson M. Pollock
‘The value of this charter was shown last year, in both EU and UK courts, when the tobacco industry unsuccessfully challenged the new rules on plain packaging of cigarettes,’ the editorial said.
‘One of the industry’s arguments was that the rules violated its rights. Both the EU Court of Justice and the High Court in London used the right to health in article 35 of the charter as a counter weight to that argument.
‘Mr Justice Green made the strongest judicial statement yet in the UK on this critical point: [Tobacco regulations] are health measures. This is an area of legislative activity to which immense importance is attached and legislatures and decision makers are habitually accorded a wide margin of appreciation. Health is recognized as a fundamental right. Article 35 of the Fundamental Charter identifies access to health care as a fundamental right but also [original emphasis] makes a statement as to the weight to be attached to this right, namely “high.”‘
The editorial said that the government’s proposal not to maintain the fundamental rights charter meant that after Brexit it would not be possible for a UK judge to use article 35 or other charter rights when interpreting UK laws that had derived from the EU. ‘These include laws to protect public health such as on pesticide residues in food, health and safety at work, management and disposal of hazardous substances, regulation of medicinal products, and air and water quality,’ it said. ‘The change will considerably weaken the ability of judges in future to uphold the law if it is challenged by industry in the courts.’
The editorial is at: http://www.bmj.com/content/357/bmj.j2013.
May 5, 2017