Category: Regulation

Glover: Kiwi Tobacco Rules Hurt Minorities
Marewa Glover
New Zealand’s new tobacco rules will likely have harsh consequences for indigenous Māori and other minority groups, according to Marewa Glover, founder and director of the Centre of Research Excellence: Indigenous Sovereignty & Smoking.
On Dec. 9, New Zealand announced a raft of new measures to help achieve its Smokefree 2025 goal. The legislation includes a plan to gradually raise the age at which people can purchase tobacco until it covers all age groups. Children now aged 13 and below face a lifetime ban on legally buying tobacco.
The new law will introduce a licensing system for tobacco retailers, reducing the number approved to 5-10 percent of the current estimated outlets. It bans filters and flavors, and seeks to cap cigarette nicotine to levels that are unsatisfying for smokers dependent on the substance.
Writing in Filter, Glover says Māori will be disproportionally affected because they have significantly higher rates of daily smoking (22.3 percent) than New Zealanders of European ancestry (8 percent).
“Illicit markets will scale up to fill the void where there should be a regulated market,” says Glover. “Competition over such markets can bring violence, and Māori, heavily overrepresented among lower-income groups with the highest smoking rates, will bear the brunt. The government response to illicit sales will mean criminalization and arrests, further swelling the grossly disproportionate numbers of Māori who are incarcerated.”
Meanwhile, New Zealand’s sizable Indian and Asian communities will be hurt economically by the new rules, as they own the majority of the small retail businesses that sell tobacco, according to Glover. “When raised tobacco taxes made cigarettes unaffordable for a large proportion of people who smoked, we saw a surge in aggravated robberies of such stores, in an illustration of ignored unintended consequences.”
Glover argues that, in pursuing smoke-free objectives, a legal reduced-risk product market is more effective than prohibition and punishment.
December 17, 2021
Mexico Senate OKs New Tobacco Restrictions

Photo: JustLife
The Senate of Mexico on Dec. 14 approved amendments to the General Law on Tobacco Control that include a complete ban on tobacco advertising, promotion and sponsorship. They also prohibit smoking and vaping—including the use of heated tobacco products—in any indoor public spaces, as specified by the World Health Organization Framework Convention on Tobacco Control, which Mexico ratified in 2004.
Once the law is referred to the President and published, Mexico will become 100 percent smoke-free and join a community of 23 countries in the Americas that entirely ban indoor smoking.
Anti-smoking activists welcomed the development. “We applaud President Andrés Manuel López Obrador and the head of the Undersecretariat of Prevention and Health Promotion at the Mexican Secretariat of Health, Dr. Hugo López-Gatell, for playing a pivotal role in the approval of the reform, and all the deputies, senators and government officials for protecting the health of their people and standing up to the tobacco industry’s persistent interference,” the Campaign for Tobacco-Free Kids wrote on its website.
December 16, 2021
Vapor Companies Brace for Radical Change

Photo: Taco Tuinstra
China’s domestic e-cigarette market is going to look very different next year. On Nov. 27, the State Council gave the State Tobacco Monopoly Administration (STMA) jurisdiction over vapor products. Shortly after, the STMA issued draft rules for the sector.
While much remains unclear, the draft does offer some insights, according to an industry source who spoke to Tobacco Reporter’s sister publication, Vapor Voice, on the condition of anonymity because he didn’t have permission to speak on the matter.
For starters, China will allow only closed pod systems with tobacco-derived nicotine and tobacco-derived nicotine salts. Flavors will be permitted, and cartridges can’t leak, according to a translated copy of the proposed rules.
Unlike some other countries, China will allow only tobacco-derived nicotine. The rules do not allow for a synthetic nicotine. “Nicotine extracted from tobacco should be used, and the purity should not be less than 9 percent,” the standards state. “Benzoate, tartrate, lactate, levulinate, malate and citrate of nicotine are allowed, and nicotine for preparing the above nicotine salts shall meet the requirements of [the previous statement].”
However, synthetic nicotine will still be allowed in products for export. What isn’t clear is if that synthetic nicotine must be shipped into China premixed in PG and/or VG and held in bond or if a pure synthetic can be imported.
“There’s no legal imports of nicotine as far as we can tell,” the Vapor Voice source said. “There’s seems to be no leeway for legal imports of a pure synthetic nicotine. However, we think if people import e-liquids with nicotine as a certain percent of that, that’s okay.”
“We don’t know if it’s 10 percent or 20 percent and it can only be brought into the country to be manufactured for re-export—that appears to be okay. That is just how we are interpreting the rule though, maybe someone else is seeing it differently.”
It also seems that the proposed rules also do not allow for a company to import finished vaping products into China and then sell them domestically without having a license and being registered with STMA. However, the country will continue to encourage exports, and wants domestic manufacturers to develop markets overseas.
“What they’ve really done is they’re clamping down on anything that is destined for the domestic market,” the source said. “They’ve also tapped into the tax department. Any time a manufacturer wants to manufacturer an e-cigarette or parts for an e-cigarette, they have to have a local representative from the taxation bureau there. And each day’s production that they run, they have to pay tax on those products at the end of that day. They’re clamping down in terms of what people can do as well as trying to ensure that they collect relevant taxes from all the manufacturers.”
Chinese vapor manufacturers are still waiting to understand what needs to be done officially for a company to produce vaping products for either the international or domestic market. “We’re still waiting on that,” the source told Vapor Voice.
“The important piece isn’t the product standards. What I’m really interested in is the registration process, who’s allowed to do what, who has to issue licenses, because now there’s an emergency management bureau involved, not just STMA, so it’s a lot of people. We’re also trying to figure that piece out.”
China’s product standards do clarify what types of products China will allow domestically. The country will only allow closed-pod systems to be sold, stating that “devices and cartridges using e-liquid should have a closed structure to prevent artificial filling.”
Additionally, while flavors are approved only under a “temporary permit for additive in e-vapor matter” and any substance or flavor not listed “shall be used only after being proved to be safe and reliable by risk assessment,” the standards state. The listed additives include flavoring extracts such as coffee, cocoa, prune and vanilla bean.
The standards allow for a maximum of 20 mg nicotine per milliliter (mL).
The outlook for China’s domestic manufacturers the outlook is grim, according to the Vapor Voice source. While international players will likely survive, they are confused about what will expected when the rules are finalized.
In Shenzhen, the capital of global vapor manufacturing, the industry is said to be in a state of shock. “Everybody, from big to small, is scrambling to try and find out how this relates to them,” the source said. “They all have to register immediately with State Tobacco Monopoly to continue doing business. They have to register what they’re going to be manufacturing, what their exports are, where they are going. It’s a complete disaster.”
December 10, 2021
Spain to Update 2006 Tobacco Law

The health ministry in Madrid (Photo: Photo: Stoyan Haytov)
Spain’s ministry of health has finalized a draft of new tobacco regulations that call for plain packaging, a higher prices and restrictions on the sales and distribution of e-cigarettes, reports Euro Weekly. The proposal also includes smoking bans in certain private spaces, such as personal motor vehicles.
Spain’s current anti-smoking legislation dates from 2006 and makes no provisions for newer nicotine products such as e-cigarettes.
The government is concerned that e-cigarettes could “encourage experimentation in young people and non-smokers”, who may be lured by the “colors of the vaporizers or the flavors used.” The ministry of health noted that many websites selling vapor products had insufficient age-verification measures in place.
Spain’s proposed regulations dovetail with the EU’s goal to create a tobacco-free generation and the World’ Health Organization’s ambition to achieve a relative reduction in tobacco consumption of 30 percent by 2025.
The draft regulations are now with Spain’s scientific and medical societies for comment.
December 10, 2021
Chinese Regulations to Reverberate Globally

Photo: Cultura Allies
China’s recently announced intention to regulate e-cigarettes as tobacco products will reverberate around the world, according to an analyses published on Keller And Heckman’s The Continuum of Risk blog.
On Nov. 26, 2021, China’s State Council announced it would amend the country’s tobacco monopoly law to subject e-cigarettes to the same requirements as traditional cigarettes. On Dec. 2, the State Tobacco Monopoly Administration (STMA) published on its website the draft management rules for e-cigarettes for public comment.
The draft rules define “e-cigarette” as an electronic delivery product that produces nicotine-containing aerosol for human inhalation. The definition does not include heat-not-burn tobacco products, which are already regulated as combustible cigarettes in China, according to Keller and Heckman. The draft rules make clear that e-cigarettes should be regulated like tobacco products by STMA and its local agencies and provide that e-cigarettes must comply with the e-cigarette national standard.
Among other things, e-cigarettes will be subject to premarket registration upon a safety review by the STMA under the draft rules. Producers and sellers of e-cigarettes in China must obtain the same tobacco monopoly licenses as traditional cigarette manufacturers. In addition, all vapor product companies will be required to trade on a national e-cigarette platform to be set up by the SMTA. The draft rules also contain requirements to protect minors such as age-restrictions and warning labels.
Because the draft rules’ registration and production licensing requirements apply to all e-cigarette manufacturers operating in China, they will also impact products sold abroad. China manufactures more than 95 percent of the world’s e-cigarette hardware.
In 2019, China notified the World Trade Organization about its first national standard on e-cigarettes, which covers raw materials, technical requirements, testing methods and labeling, among other topics. On Nov .30, 3021, China published updated draft of the standard for comment.
According to Keller and Heckman, the STMA plans to implement the standard “three to five months after its publication.”
During the transition period, existing enterprises can continue manufacturing and operational activities. However, investors are banned from investing in new e-cigarette enterprises; existing e-cigarette production and operation entities must refrain from constructing or expanding production capacity, and they may not establish new e-cigarette retail outlets and market new products. “New import of e-cigarettes” will also be suspended during this period.
The public comment period for the draft management rules closes on Dec. 17, 2021, 15 days after its publication, and the public comment period for the draft standard closes on Jan. 29, 2022.
December 6, 2021
E-Cig Leaders Welcome China Tobacco Rules

Photo: Timothy S. Donahue
China’s recently announced regulatory framework for e-cigarettes should secure the vapor industry’s future in that country, according to leading players in the business.
On Nov. 26, China’s state council amended the tobacco monopoly law to include vapor products, meaning that, going forward, e-cigarettes will be managed like combustible cigarettes.
With more than 300 million smokers—27 percent of adults—China is the world’s largest tobacco market. It also produces about 90 percent of the world’s e-cigarettes, primarily in the technology manufacturing hub Shenzhen.
The government and the tobacco industry are, essentially, one entity in China, with the State Tobacco Monopoly Administration regulating the industry and China National Tobacco manufacturing tobacco products.
To date, the vapor industry in China has operated in a legal grey area. Regulation had been widely anticipated, but many feared that it would wipe out the sector. The Nov. 26 announcement, however, was welcomed by leading players in the business. Industry representatives say it removes uncertainty and will weed out bad actors.
In background article on the recent news from China, Filter cited Smoore global PR manager Frankie Chen, who expects national mandatory standards to significantly improve product safety and provide global vapers with better products.
“Since the standards set higher requirements for vaping manufacturing, it is expected that only the responsible manufacturer with comprehensive safety management can be compliant,” Chen was quoted as saying.
RLX Technology, too, welcomed the new regulatory framework. “We believe the sector will enter a new era of development—an era marked by enhanced product safety and quality, augmented social responsibilities, and improved intellectual property protection,” said RLX Technology chairperson and CEO Ying Wang at the presentation of the company’s third quarter results.
RLX Technology Chief Financial Officer Chao Lu said the company is well prepared for the new operating environment. “The investments we made in products, talents, research, and compliance in the third quarter and beyond will place us in advantageous positions under the new regulatory paradigm,” he said.
December 3, 2021
China Rules to Require Industry Licensing

Photo: chokniti
China’s State Tobacco Monopoly Administration issued new draft rules governing e-cigarettes on Dec 1, reports Reuters. The move follows a decision by China’s cabinet last week to give the country’s tobacco monopoly oversight over the e-cigarette business.
According to the draft rules, companies selling e-cigarettes in China must meet national standards in order to register with the tobacco authority and do business legally. Companies engaged in the production of e-cigarettes must also receive a special license from the tobacco authority, provided they can prove that they have the funds for production and a facility with equipment that meets standards.
The tobacco authority said that it will establish a “unified national electronic cigarette transaction management platform” that all licensed e-cigarette wholesalers and retailers “must sell products through.” Tax collection and payment of e-cigarettes, meanwhile, “shall be implemented in accordance with national taxation laws and regulations,” the regulator wrote.
China’s e-cigarette sector has been growing rapidly following the international success of vapor products. Market leader RELX Technology went public in New York in January.
The vapor business in China operated in a legal grey zone thus far. Analyst had been expecting the government to assert control over the sector for some time now, and the recent announcements end months of speculation over what regulations might look like.
China’s cigarette industry works under a state-run monopoly directly controlled by the tobacco regulator, which dictates pricing and distribution for brands and generates tax income for the government.
December 2, 2021
Health Groups Demand Regular PMTA Updates

Photo: Ulf
The health groups that brought forward the submission deadline for U.S. premarket tobacco product applications (PMTAs) through litigation have asked the federal judge in that case to require the Food and Drug Administration to regularly report on its PMTA review process, reports Vaping360.
On Nov. 15, an attorney representing the plaintiffs sent a letter to U.S. District Court Judge Paul Grimm. The groups want Judge Grimm to force the FDA to explain its progress on PMTAs submitted by mass-market vaping brands.
“Plaintiffs will seek a modification that would require FDA to provide regular status reports to the Court giving FDA’s estimate of the date(s) by which it expects to complete its review of the Premarket Tobacco Product Applications (PMTAs) for all products for which PMTAs were filed by Juul, Vuse, NJOY, Blu, SMOK, Suorin, and any other brands that rank among the top 10 brands in market share, according to FDA,” wrote attorney Jeffrey Dubner on behalf of his clients.
Earlier in the review process, the FDA announced it would prioritize its resources to complete assessments of the most popular products first. But when the agency’s self-imposed one-year review deadline rolled around, the FDA had made no decisions on the products with the greatest market share.
To date, the FDA has ruled on only one mass-market vaping product—Vuse Solo, a dated product with limited market share.
In addition to asking Judge Grimm to monitor the FDA’s PMTA review progress on popular vape brands, the plaintiffs complain that the agency has not taken any enforcement actions against companies still waiting for a PMTA decision.
The plaintiffs in the lawsuit against the FDA are the American Academy of Pediatrics and its Maryland chapter, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, and Truth Initiative.
December 1, 2021

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

China Places ENDS Under Monopoly

Photo: watman
China’s State Council on Nov. 26 amended the country’s tobacco monopoly law to include vapor products, reports The Global Times. According to the amendment, new types of tobacco products, such as e-cigarettes, will be managed like combustible cigarettes.
Among other things, this means that manufacturers of new tobacco products will be required to reveal ingredients, warn consumers about the health risks presented by their products and pay higher tax rates. They will also be banned from opening stores near schools, analysts said.
To date, the vapor business in China has operated in a legal grey area.
China’s vapor business was valued at CNY8.38 billion ($1.31 billion) in 2020, according to the data from iimedia. China’s e-cigarette market experienced a compound annual growth rate of 72.5 percent between 2013 and 2020, the report said.
China is also the world’s leading manufacturer of vapor product hardware. In 2021, China’s e-cigarette exports will hit CNY100 billion, according to China’s Electronic Cigarette Industry Committee (ECIC).
While government regulation may hurt some e-cigarette businesses in the short term, some expect greater regulatory clarity to benefit the industry in the long run.
The State Council statement may speed up the introduction of a detailed e-cigarette national standard to raise the industry entry thresholds, which benefits leading companies with compliance advantages, TF Securities told Shine.
And it may bring more tax income in China, TF Securities said.
The growing e-cigarette market will usher in a healthy development under standardized supervision, said Shi Fanke, an analyst of Zheshang Securities.
Vapor market leader RELX said that it “firmly supports” amendment of the law and will actively implement regulation requirements later, according to media reports.
China’s tobacco industry is controlled entirely by a government monopoly, and strict controls determine which companies and retailers can produce and sell cigarettes.
The government outlawed the sale of e-cigarettes to minors in 2018 and banned online sales the following year, while Chinese state media have warned of the health and safety risks of using the products.
November 27, 2021