U.S. Smokeless Tobacco Company said on Friday that the Food and Drug Administration had accepted and filed for substantive scientific review a Modified Risk Tobacco Product application for its moist smokeless tobacco product Copenhagen® Snuff Fine Cut.
The application requests FDA authorization to make one claim: ‘IF YOU SMOKE CONSIDER THIS: Switching completely to this product from cigarettes reduces risk of lung cancer’.
“It’s critical that smokers have accurate, non-misleading health information about different tobacco products,” said Joe Murillo, senior vice president, regulatory affairs at Altria Client Services.
“We filed this application because we think adult smokers looking for potential reduced risk alternatives to cigarettes should have accurate information about the relative risks of Copenhagen Snuff.”
The Agency is due to begin a substantive scientific review process, which includes opportunities for public comment.
Category: Other Tobacco Products
FDA to review risk claim
It's time for action
The US Food and Drug Administration has failed to approve a single reduced-harm nicotine product in the past year, despite having unveiled a new ‘roadmap’ in July 2017 that emphasized the role such products can play in reducing tobacco-related illness, according to a piece by Michelle Minton at cei.org.
‘That lapse does a huge disservice to millions of smokers who could benefit from switching from cigarettes to a far less harmful product,’ Minton said.
‘A year ago, the FDA claimed it would balance regulation against encouraging the development of harm-reducing products. But with each passing week it’s become clear that the biggest roadblock on the path to tobacco harm reduction is the agency’s own cumbersome product approval process.’
Minton pointed out that it would be easy for the FDA to encourage the development of less harmful nicotine products for smokers. The market already provided alternatives in the form of e-cigarettes, smokeless tobacco, and heat-not-burn devices, she said. All that was needed to make these products available and viable as smoking cessation tools was for the FDA to establish a regulatory structure that made it easier and cheaper for manufacturers to earn FDA approval to sell the products and advertise them as being of lower risk than combustible cigarettes.
But the FDA seemed to have done nothing to reform its pre-market tobacco approval gauntlet. During the past two years, the agency had received 367 premarket tobacco applications, which are required for the products to be sold legally in the US. None had been approved. The agency had received also 35 Modified Risk Tobacco Product applications (MRTP), which would allow tobacco products to be advertised as lower risk. The agency had not approved any such application, ever.
Minton pointed out that snus had helped Sweden get its smoking rate down to five percent, lower by far than any other EU nation and the US; and, as a result, Sweden had one of the lowest incidences of lung cancer and oral cancers in the EU.
While snus could be sold in the US, it could not be advertised as being of lower risk than cigarettes, even though it was. Consequently, US consumers saw little reason to switch from smoking to smokeless tobacco.
So far, the FDA had considered MRTPs from several snus companies, including Swedish Match, which submitted an application in 2014 and was denied two and half years later. Currently, R.J. Reynolds, which submitted an MRTP in March 2017, was still waiting on a decision from the FDA.
[In December 2016, the FDA announced a partial ruling offering Swedish Match two years to submit an amended application, and TR understands that the company is finalizing its amendment and plans to submit it soon.]What price truth?
The US Food and Drug Administration is being urged by The Heartland Institute to recognize the reduced harm of Camel Snus products
The FDA recently issued a ‘public comment of modified risk tobacco product applications (MRTPAs) for six Camel Snus smokeless tobacco products submitted by R.J. Reynolds Tobacco Company’.
In a comment to the FDA, Lindsey Stroud, state government relations manager at the Institute said the Institute had researched the effects of smokeless tobacco and tobacco harm reduction products for more than 20 years.
‘According to our research, the smoke in combustible cigarettes poses the biggest threat to smokers,’ Stroud said. ‘Therefore, smokeless tobacco can deliver nicotine more safely. Evidence indicates snus products, including Camel Snus, deliver nicotine effectively without the associated harms of combustible cigarettes.
‘FDA recognizes a continuum of risk among tobacco products: Combustible cigarettes are the most harmful and smokeless tobacco and snus are less harmful. However, despite this acknowledgement, FDA regulations prevent snus manufacturers from marketing their products as less harmful than combustible cigarettes. In fact, the warnings required on snus products misinform the public.
‘Therefore, The Heartland Institute urges FDA to regulate Camel Snus products and combustible cigarettes differently.
‘Because FDA has recognized and accepted the continuum of harm posed by different tobacco products, FDA should approve the modified risk tobacco product application. Approving the application would clarify the health effects of different tobacco products and hopefully incentivize smokers to quit using combustible cigarettes.’ITMGroup now 12 companies
Thomas Automation Management (TAM) has joined ITMGroup.
TAM will operate as an independent company within the group, continuing to serve its customers as a provider of automation solutions and technical services. TAM’s current management will continue to manage the business from its existing location in Woodlawn, Virginia, USA.
“This merge is the natural progression of our eight-year relationship with ITMGroup”, says Ricky Thomas, CEO of TAM. “Our common customers in the tobacco industry will definitely benefit from the combined experience of our two companies. TAM is very excited to be part of a strong and well-respected group, with such a rich history.”
“We are proud to have such a capable representation in this part of the world for services and upgrades, close to our main customers in the tobacco industry,” says Arend van der Sluis, chairman of the board of ITMGroup.
“TAM’s strong innovative spirit is a great fit to our group and over the past years, many colleagues from TAM have mastered the most advanced machines of our portfolio, such as Capricorn, Saturn, Gemini, Polaris and Solaris,” says Van der Sluis.
“The TAM team have installed and serviced these machines not only in the U.S., but across the globe. This is a very solid base to deploy new projects together, both in the combustible area as in the area of next-generation products.”
TAM was established in 2010 and has become a regional provider of automation integration services in a variety of U.S. industries, including tobacco. From the beginning, TAM has worked closely with ITMGroup on multiple projects.
Following the addition of TAM, ITMGroup comprises 12 companies, with 22 sites and service centers worldwide. Headquartered in Kampen, the Netherlands, ITMGroup now employs more than 1200 people.
Harm reduction within reach
Members of parliament have warned the UK Government that misconceptions about electronic cigarettes mean that it is missing an opportunity to tackle a major cause of death.
In a press note issued today alongside its report, E-cigarettes, the House of Commons Science and Technology Committee said that these products, estimated to be 95 percent less harmful than conventional cigarettes, were too often being overlooked as a stop-smoking tool by the National Health Service (NHS).
‘Regulations should be relaxed relating to e-cigarettes’ licensing, prescribing and advertising of their health benefits,’ the note said. ‘Their level of taxation and use in public places must be reconsidered.’
In what will be seen by many as one of its most important interventions, the Committee said that it believed the risk for smokers of continuing to use conventional cigarettes was greater than the uncertainty over the long-term use of e-cigarettes. ‘To gather independent health-related evidence on e-cigarettes and heat-not-burn products, the Committee is calling on the Government to support a long-term research programme overseen by Public Health England and the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment,’ the note said. ‘The Government should make its research available to the public and to health professionals.’
The chair of the Committee, Norman Lamb MP (pictured in 2017), said smoking remained a national health crisis and the Government should be considering innovative ways of reducing the smoking rate. “E-cigarettes are less harmful than conventional cigarettes, but current policy and regulations do not sufficiently reflect this and businesses, transport providers and public places should stop viewing conventional and e-cigarettes as one and the same,” he said. “There is no public health rationale for doing so.
“Concerns that e-cigarettes could be a gateway to conventional smoking, including for young non-smokers, have not materialised. If used correctly, e-cigarettes could be a key weapon in the NHS’s stop smoking arsenal.”
The Committee is recommending that:- ‘The Government, the MHRA (Medicines and Healthcare products Regulatory Agency) and the e-cigarette industry should review how approval systems for stop smoking therapies could be streamlined should e-cigarette manufacturers put forward a product for medical licensing.
- ‘There should be a wider debate on how e-cigarettes are to be dealt with in our public places, to help arrive at a solution which at least starts from the evidence rather than misconceptions about their health impacts.
- ‘The Government should continue to annually review the evidence on the health effects of e-cigarettes and extend that review to heat-not-burn products. Further it should support a long-term research programme overseen by Public Health England and the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment with an online hub making evidence available to the public and health professionals.
- ‘The limit on the strength of refills should be reviewed as heavy smokers may be put off persisting with them — and the restriction on tank size does not appear to be founded on scientific evidence and should therefore urgently be reviewed.
- ‘The prohibition on making claims for the relative health benefits of stopping smoking and using e-cigarettes instead has prevented manufacturers informing smokers of the potential benefits and should be reviewed to identify scope for change post-Brexit.
- ‘There should be a shift to a more risk-proportionate regulatory environment; where regulations, advertising rules and tax duties reflect the evidence of the relative harms of the various e-cigarettes, heat-not-burn and tobacco products available.
- ‘NHS England should set a policy of mental health facilities allowing e-cigarette use by patients unless trusts can demonstrate evidence-based reasons for not doing so.
- ‘The Government should review the evidence supporting the current ban on snus as part of a wider move towards a more risk aware regulatory framework for tobacco and nicotine products.’
In welcoming the report, the UK’s New Nicotine Alliance (NNA) said that it contained several evidence-based policy proposals that would positively transform the way vaping was viewed by businesses, institutions and the public alike.
It said that it ‘warmly welcomes this report for its clear and unequivocal message that e-cigarettes and other alternative nicotine products are far safer than combustible tobacco and should be treated as such’.
“E-cigarettes are a proven safer alternative to smoking and the UK boasts 1.5 million former smokers who have converted from combustible tobacco to exclusively vaping instead,” said Sarah Jakes, the NNA chair. “The Science and Technology Committee has wisely recognised that misconceptions about e-cigarettes are threatening further progress in encouraging their use by smokers who choose to quit.
“We welcome the Committee’s call for a root and branch review of how risk-reduced products are treated by businesses, institutions and government itself. The report is a beacon of enlightenment in an area of public health which is often burdened by dogma and outdated thinking towards the use of nicotine…”
Jakes said also that there was a lot of confusion about e-cigarettes among the public, health institutions and businesses; so the report was timely and could have hugely positive implications for public health if its recommendations were implemented in full.
“Sir Norman’s Committee has done an excellent job of peering through the mist of misunderstanding surrounding e-cigarettes and its policy proposals can go a long way to dispel the – often deliberately fabricated – misconceptions that are deterring many thousands of smokers from switching,” she said. “We would urge the government to read the Committee’s findings carefully and act on them without delay”
Commenting on the report, the Vaping Industry Association (UKVIA) said that, following an extensive inquiry into e-cigarettes, the Committee had concluded that the government was missing significant opportunities to tackle UK smoking rates.
The UKVIA highlighted that the Committee had urged the government to consider tax breaks for vaping products; to allow wider use of vaping in public places; and to create a streamlined route to medically licenced vaping products.
It pointed out too that the report called on the government to reconsider the regulations around e-cigarette packaging and advertising. ‘Advertising rules currently prevent the industry from making health claims comparing vaping to smoking,’ said the UKVIA. ‘The Committee believes this is stopping UK smokers (almost seven million), from making informed decisions about switching to vaping …’
The report said also that restrictions on nicotine strength, tank size and bottles was not founded on scientific evidence and should be urgently reviewed.
“The Science and Technology Committee report is a ringing endorsement of vaping’s public health potential,” said John Dunne, who appeared before the Committee on behalf of the UKVIA.
“They are absolutely right that advertising restrictions are preventing smokers from hearing the truth. More and more people wrongly believe vaping to be more harmful or as harmful as smoking. This is a direct consequence of advertising restrictions that prevent the industry from telling smokers that vaping is 95 percent less harmful. If health bodies can say it, why can’t we?
“The industry is pleased to see the Committee recognise the nonsensical packaging and nicotine strength regulations, that only hamper vaping’s potential appeal to smokers looking for an alternative.”Risk communication vital
Comparative risk communication might encourage smokers to switch to lower-harm tobacco products, according to the results of a study by US researchers at the Tobacco Center of Regulatory Science, School of Public Health, Georgia State University, Atlanta.
The researchers found also that comparative risk messages with more negative anti-smoking elements in the design might be particularly effective, because they led to ‘higher self-efficacy to quit smoking’.
They concluded that regulatory agencies might want to consider using comparative risk messages with more negative anti-smoking elements ‘to educate the public about lower risk of e-cigarettes’.
An abstract of the Tobacco Control study is available on the BMJ Journals website.Smokers to pay the price
In announcing that it had applied to increase the retail prices of its tobacco products, Japan Tobacco Inc. said today that declining sales made it difficult to maintain quality and services with cost reductions alone.
JT said it had applied to the Minister of Finance for approval to ‘amend’ retail prices of tobacco products in Japan in conjunction with a planned tobacco-excise-tax hike on October 1.
JT said it had applied to increase the retail prices of 143 products, including 122 cigarettes, one cigarillo, three pipe tobaccos, three cut tobaccos and 14 snuff tobaccos. Additionally, it said it had applied for seven Ploom TECH product price rises in the tobacco vapor category.
‘The Japanese domestic tobacco market continues to experience decreasing sales volumes due to structural factors including the aging and declining adult population, as well as increasingly stringent smoking restrictions,’ the company said in a note posted on its website. ‘At the same time the cost per pack for providing the same quality and services has been increasing. Under these circumstances, JT had been maintaining the quality and price levels through cost reducing efforts.
‘However, since JT is projecting a further sales volume decline, it is very difficult to maintain the same quality and services with cost reduction initiatives alone. In this context, JT has applied to amend the retail prices of cigarettes, which exceeds the excise tax hike of ¥1.0 per cigarette, considering further increases in costs including materials. Retail price increases will vary among different brands and products, to ensure that the quality of each product will be maintained and that consumer expectations continue to be met.’
JT added that, within the tobacco vapor category, a new tax system would be imposed in stages over a five-year period. JT said it had decided to apply a ¥30 increase to the retail price of Ploom TECH, whose tax was expected to be increased by ¥30.89 a pack.
A table of representative brands presented in the note indicated that the retail price of a pack of Mevius cigarettes would rise by ¥40 to ¥480, while the price of Winston and Hi-Lite would increase by ¥30 to 450, and the price of Hope would go up by ¥20 to ¥250.
‘New retail prices will be effective on October 1, 2018, following the Minister of Finance’s approval,’ JT said.Warnings on hold
The US Food and Drug Administration has issued a new guidance about how it intends to comply with a recent court order by not enforcing the warning statement requirements for cigars and pipe tobacco products until 60 days after the final decision of the Plaintiffs’ appeal.
In addition, the guidance, Compliance Policy for Certain Labeling and Warning Statement Requirements for Cigars and Pipe Tobacco, states that the agency does not intend to enforce the labeling requirements under sections 903(a)(2) and 920(a) of the Food, Drug, and Cosmetic Act for cigars and pipe tobacco while the injunction remains in effect. During this time, however, cigar and pipe tobacco firms may add the warnings and make these labeling changes.
In a note issued through its Center for Tobacco Products, the FDA said it had revised also the following guidance documents to reflect the compliance policy outlined above:- Submission of Warning Plans for Cigars
- FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements
- Compliance Policy for Required Warning Statement on Small-Packaged Cigars
- Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule
- Tobacco Retailer Training Programs
The note drew attention also to a new tobacco compliance webinar, Retailer Requirements: New Warning Statement Requirements for Certain Tobacco Products. The webinar is said to address the addictiveness warning statement requirement and which tobacco products it applies to, and to answer some frequently asked questions from tobacco retailers about the warning statement requirements.
The FDA said it had created too several visual examples of the required addictiveness warning statement on different tobacco product packaging, and that it had developed a side-by-side product and warning statement chart.Shisha alliance formed
Alliance One International said yesterday that its German subsidiary, Alliance One Rotag, and France Tabac Union de Sociétés Coopératives Agricoles had ‘entered into an agreement for the sourcing, processing and marketing of high-quality flue-cured Virginia shisha-style tobacco’.
‘Together, the two organizations will provide customers with the high-quality flue-cured Virginia shisha-style tobacco that the European region is recognized for producing,’ AOI said in a note posted on its website.
‘Alliance One Rotag intends to continue sourcing high-quality German and Polish flue-cured Virginia tobaccos, which will be processed with the French-origin tobaccos sourced from France Tabac in its processing facility located in Sarlat, France.’
“Our new agreement with Alliance One Rotag is a great opportunity to expand the footprint of European shisha-style tobacco,” said Remy Losser, chairman of the Board of France Tabac.
“Alliance One’s global presence and experience in agronomy, processing and marketing will bring tremendous added value to the French tobacco industry, and we are excited for the future of the market.”
Meanwhile, Scott Burmeister, Alliance One’s regional director for Europe, said French, German and Polish flue-cured Virginia tobaccos were recognized worldwide for their quality and unique natures, and that the agreement would position the company to meet the needs of a growing shisha market, while continuing to serve the needs of its traditional customers. “Our agreement with France Tabac will enable us to deliver enhanced value for shisha and traditional customers as we combine France Tabac’s experience and capabilities in producing high-quality French shisha-style tobaccos with Alliance One’s international footprint.”Spain to host THR summit
What is being billed as Spain’s first tobacco harm reduction scientific congress is due to be held in Barcelona, on September 19.
The congress, which already has 13 expert speakers lined up, is being organized by
ANESVAP (the Spanish Association of Users of Personal Vaporisers) and MOVE (the Medical Organization Supporting Vaping and Electronic Cigarettes).
In a press note, these organizations said they had been fighting hard during the past years to present the latest scientific evidence on the use of personal vaporisers to health and medical professionals in Spain, and to the wider society.
Some had listened, they said, and a few had accepted that tobacco harm reduction (THR) policies could be helpful in respect of public health.
Nevertheless, those supporting THR in Spain were still very few.
ANESVAP and MOVE said that they were therefore organising the first ever conference on THR in Spain.
Presentations from leading international experts in the field, would provide evidence about the place of THR in reducing smoking and its consequences, they added.
Registration for the Tobacco Harm Reduction Summit Spain is available at: http://thrsummitspain.org/.
