Author: Staff Writer

A Common Language

MedDRA helps evaluators describe the health effects of tobacco products in consistent terms.

By Samina Qureshi

From the time the U.S. Congress passed the landmark Family Smoking Prevention and Tobacco Control Act (FSPTCA) granting the Food and Drug Administration authority over select tobacco products in 2009, the tobacco industry has had to expend vast financial and human resources in efforts to effectively comply.

The FSPTCA in an unprecedented way allows the FDA to implement standards for tobacco products to protect public health. In addition, various statutory pathway applications for new tobacco products must fulfill requirements to record health effects. The applications must have full reports of all investigations to address the health risks of the product. There must also be an established system for maintaining records of health effects. The requirements around recording health effects have to be continued in post-market use of the relevant products.

These requirements have a framework that somewhat resembles FDA requirements for other regulated product industries, such as pharmaceuticals and devices. Although the adverse event recording, reporting and signal detection requirements are much more stringent in these products, the main objective is similar.

The FDA’s usual “safe and effective” standard for evaluating medical products does not apply in the same way to tobacco products. Tobacco products are evaluated based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole. This “whole” includes users and nonusers. For developing future regulations, the law requires the FDA to apply a public health approach with a focus on the population overall, not just the individual user.

It would be pragmatic to utilize the same standardized international medical terminology that is already being used globally for medicinal products for regulatory communication and evaluation of data pertaining to tobacco products as well.

The terminology used to capture adverse events throughout the drug development lifecycle from clinical trials to investigational new drug applications (IND), new drug applications (NDA) and post-market surveillance is the Medical Dictionary for Regulatory Activities (MedDRA). MedDRA is a clinically validated international medical terminology dictionary. It contains terms that may be used for capturing and recording adverse events experienced by clinical trial subjects as well as in the general population in post-marketing scenarios associated with the regulated product.

The terminology consists of a five-level hierarchy in which the concepts are organized from the most granular lowest level term (LLT) to the broadest system organ class (SOC). The most granular level (LLT) contains multiple terms (over 84,000), which are synonyms or lexical variants of one another but are grouped under a preferred term level (PT) at which level each term is a unique medical concept. Each PT term is further organized under a high level term (HLT) based upon anatomy, pathology, physiology, etiology or function. The HLT are in turn linked to high level group terms (HLGTs). Finally, HLGTs are grouped into System Organ Classes (SOCs). The SOC level is the broadest level and are grouped by etiology, manifestation site or purpose (see Figure 1). There are 27 SOCs in total.

The structure and organization of a concept is very logical in MedDRA and thus supports sophisticated analyses. MedDRA can be used to analyze individual medical events of interest in a database of compiled events or issues involving a system, organ or etiology using its hierarchical structure. MedDRA is a global terminology and is currently mandatory for use in the EU (European Medicines Agency and EU member states) and Japan (MHLW) and encouraged by other global regulators for drug development lifecycle activities including the FDA. MedDRA is listed in the FDA data standards catalog as a terminology to use. Global MedDRA use is facilitated by the fact that it is a multilingual terminology allowing most users to utilize it in their native languages. MedDRA is currently available in 14 languages (Brazilian Portuguese, Chinese, Czech, Dutch, English, French, German, Hungarian, Italian, Japanese, Korean, Portuguese, Russian and Spanish). MedDRA is also a part of the International Council on Harmonization (ICH) e-submission standards.

The functions of maintenance, evolving development and distribution of the terminology to users was tasked to the Maintenance and Support Services Organization (MSSO) by the ICH, who owns the terminology.

MedDRA continuously evolves, and additional concept terms are added with user community input as well as the maintenance organization’s development and proactivity initiatives.

MedDRA is amenable for adaptation and has added terms that address an increasing number of device and product issue terms over the years. There is an opportunity for users to request concept terms with the twice-yearly version releases of the terminology.

Almost all of the ICH regulatory members have implemented MedDRA, including the EU, FDA, MHLW, MHRA, and Health Canada. As global regulators expand their scope of products they regulate, other industries, such as tobacco and cosmetics, have correspondingly started to use MedDRA for capturing adverse health events. It is advantageous for industry users to utilize a terminology in their regulatory applications that is familiar to the regulators who are reviewing the product applications. In addition, it is prudent to leverage the hierarchical nature of MedDRA that is amenable for easy analysis.

MedDRA may be used in all of the statutory pathways for new products in which provisions of the FSPTCA mention recording or reporting adverse health effects related to tobacco products.

An example of potential use of MedDRA in each of the regulatory pathways for tobacco products is shown in the table below, with the regulatory aspect addressed as mentioned in the FSPTCA section.

Statutory Pathways for New Products	Regulatory Aspect	Relevant FSPTCA Section
Substantial Equivalence Reports	Does not raise different questions of public health	905
Premarket Tobacco Product Application	Appropriate for the protection of public health	910
Modified-Risk Tobacco Product Application	Benefits the health of the population as a whole	911

In addition, the FSPTCA section 909 “Records and Reports on Tobacco Products” states, “to report … information that reasonably suggests that one of its marketed tobacco products may have caused or contributed to a serious unexpected adverse experience associated with the use of the product or any significant increase in the frequency of a serious, expected adverse product experience.”

This particular aspect is best addressed by maintaining a database of adverse health effects reported by consumers on marketed products and may be used to quantify the required events. Pharmaceutical organizations maintain internal safety databases to compile reports of post market adverse events. Many tobacco organizations have adopted this approach and are currently utilizing MedDRA for capturing adverse health effects in their post-market databases. The MedDRA hierarchy is leveraged to perform regular and ad hoc analysis. MedDRA has evolved with the addition of concept terms related specifically to tobacco-related events from the user community.

The hierarchical structure, adaptability to evolve and availability in multiple global languages positions MedDRA as the best terminology for the tobacco industry to increasingly adopt for regulatory applications and for internal systems. MedDRA is also suited for internal assessment of developing consumer products. The product issues SOC is dedicated with concept terms addressing manufacturing, supply, distribution and quality system issues, thus enabling analysis for issues within this realm. It is very useful for analyzing reports of counterfeit products, a common concern. Currently, over 125 countries utilize MedDRA for their regulatory and product development lifecycle activities.

Samina Qureshi serves as international medical officer at MSSO in McLean, Virginia, USA.

December 1, 2021

Uniquely Deadly

A street vendor offers smokeless tobacco in Kolkata. (Photo: Taco Tuinstra)
India’s crackdown on its dangerous smokeless tobaccos in the wake of Covid-19 should be complemented by a more coherent harm reduction strategy.
By Stefanie Rossel
The Covid-19 pandemic presented an opportunity for India to intensify its fight against the consumption of local smokeless tobaccos. On April 15, 2020, the government banned the sale of tobacco products, including chewing tobacco, the most widely used form of tobacco in India, as a measure to slow the spread of the coronavirus. Chewing smokeless tobacco products, which in India typically contain areca (betel) nut, increase the production of saliva and create a strong urge to spit—an undesirable habit during a pandemic.
As in Sweden, smokeless tobacco is significantly more popular than combustible tobacco in India. According to a 2020 analysis, nearly 199.4 million Indian adults consume smokeless tobacco regularly, which is more than twice the number of smokers. This makes it the country with the largest number of smokeless tobacco users. However, unlike Sweden’s snus, which ranks at the bottom of the continuum of risk, Indian smokeless tobaccos are quite risky. Public health experts describe them as “uniquely deadly.”
There is a wide variety of chewing tobacco available in India. The most commonly used products are khaini, a mixture of tobacco and lime used by 11.2 percent of adults, and gutkha, which consists of tobacco, slaked lime, paraffin wax, catechu (an extract of acacia trees) and crushed areca (betel) nut, and is consumed by 6.8 percent adults. Other smokeless tobaccos use mixtures of betel quid and paan masala.
What all these types of tobacco have in common is that they are highly addictive and full of carcinogens. In addition to the typical ingredients, these products can be laced with thousands of chemicals. The products are said to have both stimulant and relaxing effects; some are sold as mouth fresheners. Available for a few rupees, they are also affordable for poor people.
The consumption of smokeless tobacco was above the national average of 21.4 percent in 13 Indian states, with prevalence ranging from 23.5 percent in Bihar to 48.5 percent in the Tripura, according to the 2016–2017 Global Adult Tobacco Survey (GATS).
Smokeless tobacco consumption is responsible for India’s high rate of oral cancer. With 141.2 million male users compared to 58.2 million female users, consumption of smokeless tobacco is predominantly a male habit. However, three-fifths of the deaths attributable to smokeless tobacco use occur among women. In contrast to smoking, which is generally considered a taboo for women, smokeless tobacco consumption is more socially acceptable. As smokeless tobacco is deeply entrenched in the region’s culture, it tends to pass from one generation to the next. Children as young as 10 years old have been found to regularly use smokeless tobacco.
Samrat Chowdhery, who leads consumer advocacy for tobacco harm reduction in India and is the past president of the International Network of Nicotine Consumer Organizations, estimates that smokeless tobacco is responsible for 350,000 premature deaths annually in India. “Though this mortality rate is lower than from combustible tobacco, it is still quite high,” he says. “The main reason for this is that Indian/southeastern smokeless tobacco products are handmade or made in poor hygienic conditions, which allows for impurities to creep in. There is no attempt to control or reduce tobacco-specific nitrosamines; the use of slaked lime adds another cancerous component; there is no licensing, standards or quality control; and finally toxic additives, such as nicotine sulphate and flavoring agents, are added to tobacco products.”

Samrat Chowhery
Ineffective Ban
India has been targeting smokeless tobacco as it aims to reduce the number of tobacco users by 30 percent by 2025. In 2012, states started banning the manufacture, sale and distribution—but not consumption—of pre-packaged gutkha under laws governing food, which may not contain tobacco. Some states extended this ban to other tobacco-containing oral products, such as paan masala.
Enforcement, however, has been patchy. A 2014 World Health Organization study found that 15 percent of respondents continued to purchase prepackaged gutkha. According to a 2018 YouTube feature by The Print, many street vendors in Delhi were unaware of the ban, and police were not taking action.
A large-scale household survey in Delhi in 2016 revealed that a mere 18.84 percent of gutkha users attempted to quit after the ban, although 97.5 percent of respondents believed tobacco to be harmful or very harmful. Only 2.4 percent successfully quit, the report found. Gutkha, a white-to-brownish granular flavored product, turns saliva bright red, and is usually spat onto a wall or on the ground, causing red stains that are hard to remove. It typically comes in colorful sachets. Following the ban, manufacturers started selling gutkha and tobacco in separate packs. In Delhi, 84.1 percent of pre-ban gutkha users switched to these twin sachets, the household survey found. Many switched from single-dose to multi-dose sachets or to khaini.
In March 2015, legislators prohibited all smokeless tobacco products including twin packs. Violators risk prison sentences or fines of up to INR25,000 ($336.39).
“The reporting of the so-called bans is usually skewed by the need to showcase them to their peers from the global tobacco control community,” says R. N. Sharan, retired professor of biochemistry, molecular biology and genetics at North-Eastern Hill University in Shillong, India. “Thus, at global and national forums on tobacco control, India’s attempts to ban risky smokeless tobacco products are often given a high profile and kudos showered on the involved public health advocates as well as policymakers. However, the proof is in the pudding. The bans have been cleverly, and sadly, circumvented by manufacturers, retailers and common ones. On the ground, prohibition seems to have, once again, failed.”

R. N. Sharan
Expanded Authorities
With the advent of the pandemic in India, the government cracked down on tobacco. After the first reports that smoking might increase the risk of severe Covid-19, many Indians attempted to switch from cigarettes to smokeless tobacco. According to Statista, about 77 percent of smokers aged between 25 years old and 39 years old tried to transition to smokeless tobacco.
In addition to the government’s national directive on Covid-19 management, states and union territories received new powers under the Epidemic Disease Act, the Disaster Management Act and the Indian Penal Code to prohibit use of smokeless tobacco and spitting in public places.
By May 2020, up to 28 states and union territories had implemented various restrictions linked to smokeless tobacco, according to the Observer Research Foundation. The study’s authors concluded that the jurisdictions were right to act. Despite the country being a signatory to the WHO Framework Convention on Tobacco Control (FCTC), many of the treaty’s recommended policies, such as graphic health warnings on packs and advertising bans, tend to be circumvented by smokeless tobacco products.
The bans, all of which are outside FCTC policy, strengthened during the pandemic and appeared to have been more uniformly rolled out across the country, giving additional powers to states, the authors stated, but the amendment of some policies within a short span of time was likely to have caused confusion. At the time of writing, several states had extended the bans on smokeless tobacco manufacture, sale and distribution for another year.
Sharan says there are a number of reasons why the ban on chewing tobacco hasn’t shown the desired results so far. “India’s capabilities for technical analysis of smokeless products are not yet fully up and running, despite significant investment over the years,” he says. “Enforcement on the ground is also a big issue, further complicated by (a) the governance structure where primarily the central government legislates while the responsibility of their implementations remains essentially vested in the state or provincial governments, and (b) a complex web of vested interests.”
In fact, says Sharan, the Covid-19 pandemic may have made the situation worse. The regulatory apparatus in India has been and continues to be under severe stress from the pandemic, and they can only focus on so many things at one time. This is in sharp contrast to the Food and Drug Administration in the U.S. and the Trading Standards Authority in the U.K., which are well funded, adequately resourced to police the regulated products in the market and empowered to identify prohibited products or pull out noncompliant products from the market and suitably punish the erring vendors/manufacturers if required.
“It is to be noted that the FDA’s Center for Tobacco Products is funded from fees paid by the industry they regulate, thus ensuring a fair and level marketplace. I am not aware of the existence of any such mechanism in India. In this context, India could be a winner if it chose to learn some lessons from the rest of the world.”

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Desperately Needed: Harm Reduction
India closely adheres to the WHO’s abolitionist stance, as evidenced by the country’s 2019 ban on vape products. “My understanding is there is a general denial of harm reduction approaches among governmental stakeholders,” Chowdhery says. “I am not sure, though, how the bans are evaluated or if there is a mechanism for that, though I do keep hearing about smuggling of these goods going up through everyday reports of seizures.
“My view is that such bans, if not accompanied by meaningful cessation support in the form of in-person counselling centers and affordable, subsidized nicotine-replacement products or substitution products, such as nicotine pouches and snus, for those who can’t or don’t want to quit, along with strong enforcement, will lead to creation of black markets, which end up increasing population-level harm through proliferation of unregulated, substandard products.”
Sudhanshu Patwardhan, U.K.-based medical doctor and tobacco cessation expert, looked exactly at these issues in a paper, “New Nicotine Pouch Category: A Tobacco Harm Reduction Tool?” which he published with Swedish Scientist Karl Fagerstrom in October 2021.
“India’s latest GATS [Global Adult Tobacco Survey] data shows that nearly 200 million people continue to use risky forms of oral tobacco,” he says. “With no meaningful cessation support available, nor any affordable and appealing safer nicotine alternatives, consumers are struggling to give up their risky tobacco habit. Frankly, it is naive to expect governments to embrace tobacco harm reduction at face value.
“The ban on e-cigarettes was partly fueled by irresponsible behavior from multinational companies and international experts’ lack of understanding of the Indian policymaking milieu and worsened by nicotine illiteracy among Indian policymakers and their influencers, such as healthcare professionals. A lot of work needs to be done in India and globally to enable and empower healthcare professionals by disentangling in their minds nicotine’s addictive properties from smoked as well as smokeless tobacco products’ carcinogenic and other harmful properties.
“Nicotine-replacement therapy is on the WHO’s model essential medicines list and also on India’s essential medicines list. As I and globally renowned nicotine dependence expert Dr. Fagerstrom argue in our paper in the Nicotine and Tobacco Research Journal, ‘there is a great challenge and opportunity in India to bring affordable nicotine pouches that are responsibly manufactured and marketed only to adult tobacco users. It would be important to ensure that adult users’ access and affordability are not compromised by the regulatory regime and the behaviors of profit-maximizing manufacturers.’”
Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.

December 1, 2021
Back in Business

After a year of making do with virtual gatherings, industry representatives were delighted to meet each other face to face again during the World Tobacco Middle East exhibition in October. Thousands of tobacco professionals gathered in Dubai to reconnect with one another and learn about the latest product and services. Above are some impressions from the exhibition floor.
Photos: Elise Rasmussen and Mohamed Ahmed

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December 1, 2021
Altria Banned From Importing IQOS Into U.S.

Photo: Kuznietsov Dmitriy
The U.S. Trade Representative has upheld the International Trade Commission’s (ITC) finding that Philip Morris International’s IQOS tobacco heating device infringes on patents held by British American Tobacco, reports The Winston-Salem Journal.
As a result of the ITC ruling, Philip Morris USA is barred from importing PMI’s IQOS 2.4, IQOS 3, IQOS 3 Duo heat-not-burn traditional cigarette products. It also was ordered to halt future sales of those products—marketed as Marlboro HeatSticks—already in the U.S.
Some retailers of the Marlboro HeatSticks, including convenience stores, already had displayed notifications to customers that those products could no longer be sold as of Monday.
“Today’s announcement provides a measure of success for our enforcement of intellectual property rights to ensure we can continue to innovate, as is common practice among innovation-based industries,” Gareth Cooper, BAT’s assistant general counsel, said in a statement. “As we have strenuously noted, there was no reason to overturn the policy.”
Altria said expressed disappointment with the decision. “We continue to believe that the plaintiff’s patents are invalid and that IQOS does not infringe on those patents,” the company said in a statement.
“The ITC’s importation ban makes the product unavailable for all consumers who have switched to IQOS, reduces the options for the over 20 million smokers looking for alternatives to cigarettes, and ultimately is detrimental to the public health.”
This sentiment was echoed by Gregory Conley, president of American Vaping Association, at the time of the ITC’s Sept. 30 decision.
“By potentially denying them the opportunity to switch to a harm reduction production IQOS, the real losers of this protracted court battle could end up being American adult smokers,” Conley said.
“While some may use vaping, snus, or pouches in the absence of IQOS, far too many American adults will choose to just smoke cigarettes instead.”
The U.S. Food and Drug Administration authorized IQOS for sale in April 2019. The products debuted in test markets in Atlanta in October 2019 and Richmond, Virginia, in November 2019. During the second quarter, PM USA expanded retail distribution of Marlboro HeatSticks into the Triad and other metro areas of North Carolina, as well as northern Virginia and Georgia.
Altria will likely appeal to the U.S. Court of Appeals for the Federal Circuit, which handles patent lawsuits. That process could take up to a year to reach a decision, with the likelihood of a successful appeal not favorable, according to industry analysts.
In the worst-case scenario for Altria and Philip Morris, the two companies would have to go back to the drawing board, moving production to the U.S. or changing up the design enough to avoid patent infringement claims.
PMI has successfully defended similar cases in the U.K. and elsewhere. BAT has already pursued litigation over IQOS in Poland, the Czech Republic, Bulgaria, Romania and Greece and through the European Patent Office.
November 30, 2021
Researchers Call for End to ‘War on Nicotine’
Photo: kues1
A new research paper attempts to clarify the confusion surrounding nicotine consumption and the role it plays in the diseases caused by smoking. The paper, released by the Consumer Choice Center, outlines six main reasons why the “war on nicotine is pointless” and should end.
“Instead of celebrating declining numbers of smokers and far fewer deaths, many governments, public health agencies and anti-smoking activists have been on the hunt for new enemies,” the researchers wrote. “They decided to scapegoat nicotine, and as a result, the fight against smoking gradually transformed into a fight against nicotine. Such an approach has dire consequences: fewer people switching to less harmful alternatives.”
The paper was co-authored by Michael Landl, director of the World Vapers’ Alliance, and Maria Chaplia, research manager at the Consumer Choice Center
The authors list six reasons to stop the war against nicotine:
People consume nicotine, but they die from smoking
Nicotine in patches and gums is not a problem — it is neither (a problem) when vaped nor in a pouch
Addiction is complex and not solved by a war on nicotine
Nicotine makes some people smarter, stronger and more attractive
Misconceptions about nicotine are hindering progress
Prohibition never works
The researchers advise policymakers to prioritize practical solution. “Public health needs to make use of all available possibilities,” they write. “People who cannot quit smoking should be encouraged to switch to less harmful alternatives. Nicotine is not the main problem when it comes to smoking, the toxins are.
The authors also say regulation should be risk proportionate. “Regulation must be drafted according to the actual risk of a product,” they write. “Vaping or snus are less harmful than smoking, hence must be treated differently. Nicotine doesn’t become a poison when delivered through vaping. When nicotine isn’t a problem in gums and patches, it can’t be a bigger problem in vaping. The moral panic when it comes to nicotine must end.
“Addiction is complex and is not solved with a war on nicotine. When it comes to addiction, public health policies should not single out a single substance. Potential benefits of nicotine must be explored and unbiased scientific endeavors must be ensured. Public policy must accept that many people use nicotine recreationally. A war on nicotine will fail like the war on drugs or alcohol prohibition failed. Public misconceptions about nicotine must be fought. They discourage people from switching to less harmful alternatives and therefore hurt public health.”
November 29, 2021
JT Amends Articles of Incorporation

Photo: Taco Tuinstra
Japan Tobacco has released a document outlining all of the company’s new executive appointments, including changes to the board as well as a new chief financial officer and senior vice president of people and culture, among others.
The document also details partial amendments to the articles of incorporation. It states that “the company will amend an article regarding the term of the board of directors to one year from the current stipulated two-year term in order to build a management foundation to address the changes in the business environment in a timely manner and to strengthen its corporate governance by clearly defining the responsibilities of the directors and enhance the trust with shareholders.”
In related news, JT has resolved to adopt the concept of skills necessary for the members of the board and developed a skills matrix that lists the areas in which the knowledge and experience of each director and member of the audit and supervisory board is expected to be particularly effective.

JT has also developed the skills matrix of the candidates for proposed directors and members of the audit and supervisory board who will assume new responsibilities from March 23, 2022.
November 29, 2021
Lexaria Demonstrates Rapid Nicotine Delivery

Image: Zerbor
Lexaria Bioscience Corp.’s DehydraTECH nicotine pouch delivered nicotine up to 20 times faster than a generic nicotine benzoate pouch during a study conducted on dogs, the company reported.
The analysis, conducted in collaboration with an independent testing laboratory, evaluated nicotine benzoate and polacrilex plasma levels in 40 anesthetized male beagle dogs, comparing Lexaria’s recently developed, advanced DehydraTECH 2.0 nicotine formulation to concentration-matched controls. The dogs’ blood samples were taken every few minutes over the course of two hours.
“The results from the study showed that the generic nicotine benzoate pouch required about 45 minutes to reach its peak delivery rate. In comparison, the DehydraTECH-nicotine benzoate pouch reached peak delivery rates at both eight minutes and again at 30 minutes. It was further noted that in just four minutes after the pouch was placed in the mouth, the DehydraTECH-nicotine had reached a higher delivery level than the generic achieved at any point during the study,” reads a recent article.
“Our technology was ten to twenty times faster in delivering comparable levels of nicotine into [the] bloodstream than the peak of the concentration-matched controls and went on to far exceed their total delivery, which should provide much greater consumer satisfaction,” said Chris Bunka, Lexaria CEO, in a statement.
November 29, 2021
SCOPE Launches THR Online Library

SCOPE has launched a comprehensive library of online panel discussions and presentations relating to tobacco harm reduction (THR).
A global collaboration of THR consumer groups, SCOPE includes Consumer Advocates for Smoke-Free Alternatives Association (CASAA) in the United States, Iberoamerica (ARDT) in Latin America and the Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA).
SCOPE recently broadcast around the clock during the nineth Conference of Parties for the World Health Organization’s Framework Convention on Tobacco Control (FCTC).
Alex Clark
“SCOPE’s five-day global livestream was a huge success, countering and shining much-needed sunlight on COP9. It shows just what can be achieved when international consumer organizations come together in their tireless work to humanize and promote the life-changing tobacco harm reduction movement,” says Alex Clark, CEO of CASAA.
Hours of SCOPE’s presentations by international THR experts and panel discussions featuring consumer advocates have now been uploaded into one online library, available at https://bit.ly/319zzkx
Nancy Loucas, executive coordinator of CAPHRA, says if more smokers’ lives are to be saved then the World Health Organization must not be allowed to continue to demonize safer nicotine alternatives like vaping. Instead, it must be mandated to follow the scientific evidence.
It’s critical, she says, over the next two years that the world’s THR organizations work more closely and effectively together.
“SCOPE provides consumers, the public and the media with an invaluable resource and platform going forward. Our focus now shifts to COP10 in 2023 where risk reduced products will be a key discussion topic for delegates. With over one billion smokers’ lives at stake, consumers need one clear voice and SCOPE now provides that,” says Loucas.
Ignacio Leiva Benitez
Chilean consumer advocate Ignacio Leiva Benitez, general secretary of ARDT Iberoamerica, says Latin America is delighted to be part of SCOPE. His organization, he says, is now working more closely with allies from all around the world.
“SCOPE is all about showing the world’s decisionmakers what has worked for us individuals and changed our lives for the better,” says Benitez. “I started vaping 12 years ago, after smoking two packets of cigarettes a day. For years I tried different ways to quit but was unsuccessful until I discovered nicotine vaping. SCOPE will enable us to fight more successfully on behalf of adult smokers, in every country, to gain better access to safer alternatives.”
November 29, 2021
Russia to Crack Down on Counterfeit Goods

Photo: Oleg
Russian Prime Minister Mikhail Mishustin has approved new measures to prevent the illicit trafficking of counterfeit goods, which will be effective until 2025, reports Lexology.
The new anti-counterfeiting strategy will include legislation aimed at raising penalties for the manufacture, storage, transport and sale of counterfeit and fake goods, including alcohol and tobacco. Rules are being drafted that require mandatory certification for nicotine-containing products.
Lawmakers are also developing a new mechanism to hold property owners accountable for goods being sold in the commercial spaces they manage.
Meanwhile, the Russian government is amending procedural and criminal codes governing the storage and destruction of seized counterfeit goods. It will also address what is to be done with the equipment used to produce the fake goods and transport them.
Additionally, the government may develop a database of unlawful manufacturers, importers, suppliers and sellers.
There is also talk of developing a labeling-and-tracking system. Beginning this year, random inspections of accredited businesses may take place in order to confirm that they are complying with requirements directed at preventing the sale of counterfeit goods.
November 29, 2021
China Orders Arrest of Former STMA Inspector

Photo: Oleg
Chinese provincial authorities have ordered the arrest of Pan Jiahua, a former senior disciplinary inspector at China’s State Tobacco Monopoly Administration, for suspected bribe-taking, reports Xinhua.
Pan’s case was transferred to the Anhui Provincial People’s Procuratorate following an investigation by the National Supervisory Commission and the Communist Party’s Central Commission for Discipline Inspection (CCDI).
The joint probe found that “Pan has lost his ideals and convictions, betrayed the responsibilities and duties he was entrusted with, and desecrated his position as a disciplinary inspector by engaging in discipline-violating activities.”
According to the investigators, Pan abused his position to seek benefits for owners of private tobacco businesses, took overseas trips sponsored by private business owners, arranged jobs for relatives and friends in the tobacco system, and allowed his relatives to use his influence to profiteer from the tobacco business. Pan accepted large amounts of money and valuables in return for securing interests for others in business operations, according to the CCDI.
Pan has also been expelled from the Communist Party of China for his actions.
November 29, 2021