Category: Regulation

France Unveils Plans to Curb Smoking

Photo: Richard-Villalon
France will increase tobacco taxes, ban disposable vapes and further restrict outdoor smoking as part of an ambitious plan to reduce the health impact of tobacco consumption and create a “tobacco-free” generation by 2032, a term that is usually defined as a situation in which less than 5 percent of the population smokes.
Smoking rates in France have remained roughly unchanged since 2019 after decades of regularly declining, according to French public health authorities. Nearly a quarter of French adults, or about 12 million people, still smoke daily. Smoking is the leading cause of avoidable mortality in France, causing about 75,000 deaths per year.
Some 15 percent of teenagers have vaped, and 47 percent of them started their nicotine consumption through e-cigarettes, according to an ACT Alliance Contre Le Tabac survey published in November.
The government plan bans smoking on beaches, near public buildings like schools and in public parks and forests next year. Previously, local authorities had already barred people from smoking at more than 7,000 outdoor locations, including at beaches, forests and parks across the country, but there was no nationwide ban.
The government also wants to extend the plain packaging requirement for cigarette packs to vaping products and set a minimum tobacco price of €13 ($14) per pack.
Health Minister Aurelien Rousseau said the government will enact most measures by degree early next year. The ban on disposable vapes, however, will require legislation that is expected to go to Parliament in December.
While welcoming France’s ambition to end smoking, tobacco harm reduction activists expressed concern about the planned ban on single-use vapes, which they described as a step backward in the fight against smoking.
“Such prohibitions only serve to drive consumers either back to smoking or to black markets,” said Michael Landl, director of the World Vapers Alliance, in a statement.
“We’ve seen time and again that prohibition doesn’t work. France should look to countries like Sweden, where a balanced approach to harm reduction has led to significant public health gains. The French government must recognize the importance of offering a variety of less harmful alternatives to smokers.”
November 30, 2023
Malaysia Passes Watered-Down Bill

Image: PX Media
Malaysia’s lower house of Parliament has passed the Control of Smoking Products and Public Health Bill without the controversial generational endgame (GEG) clause, reports the New Straits Times.
The legislation regulates advertisements, packaging and smoke-free places but excludes a provision that would have made it illegal for Malaysians born after 2007 to buy or consume nicotine products.
Health Minister Zaliha Mustafa said the GEG was dropped due to constitutional concerns. The Attorneys General Chambers had warned that the proposal contravenes Article 8 of Malaysia’s constitution, as it creates unequal treatment before the law between persons born before Jan. 1, 2007, and individuals born after the date.
Critics blamed Malaysia’s U-turn on tobacco lobbying.
Zaliha insisted that any shortcomings in the bill could be improved over time.
November 30, 2023
MRTP Renewal Filed for General Snus
On Nov. 30, 2023, the U.S. Food and Drug Administration filed for scientific review modified-risk tobacco product (MRTP) renewal applications submitted by Swedish Match USA for General Snus smokeless tobacco products, including:
General Loose;
General Dry Mint Portion Original Mini;
General Portion Original Large;
General Classic Blend Portion White Large, 12 count;
General Mint Portion White Large;
General Nordic Mint Portion White Large, 12 count;
General Portion White Large; and
General Wintergreen Portion White Large.
In 2019, the FDA issued modified-risk granted orders for eight smokeless tobacco products made by Swedish Match USA. These orders expire in 2024. To continue marketing the MRTPs after the authorized five-year term, the company submitted an MRTP renewal application to the FDA.
Starting Dec. 1, the public may submit comments on these applications on regulations.gov.
November 30, 2023
Malawi Approves Tobacco Law

Photo: Taco Tuinstra
Lawmakers in Malawi approved the Tobacco Industry Bill, which stipulates how stakeholders are supposed to operate, reports the Nyasa Times.
In addition to provisions on child labor and tenancy, the legislation includes clauses on traceability and the use of agrochemicals. Lawmakers hope the new rules will improve compliance and make it easier for Malawi to market its leaf around the world.
The Tobacco Industry Bill will also regulate contract and noncontract farming, tobacco production and delivery quota, and prices, along with disposal of tobacco stalks.
November 30, 2023
Accorto and Inter Scientific Team Up

From left to right: Vince Angelico: chief scientific officer (Accorto), Jason Krull: chief operating officer (Accorto), Tom Beaudet: CEO (Accorto), Mark Dignum: director (Inter Scientific), Russ Rogers: president (Accorto), David Lawson: director (Inter Scientific)
Photo: Inter Scientific
Accorto Regulatory Solutions and Inter Scientific have entered into a strategic alliance agreement to provide single-point regulatory and testing solutions for customers in the nicotine industry and other sectors.
Based in the U.S., Accorto specializes in helping small- to mid-sized companies navigate the regulatory landscape to bring products that are regulated by the Food and Drug Administration to market. Inter Scientific is an ISO 17025/GMP-compliant testing laboratory and compliance firm based in the U.K.
The strategic alliance will offer customers in the U.S., Europe, the Middle East and Asia improved access to a Accorto’s regulatory strategy development expertise, FDA regulatory application development and submission services, and project management solutions combined with Inter Scientific’s testing and regulatory compliance expertise in the U.K., Europe and the Middle East.
The two companies aspire to use this alliance to streamline their clients’ regulatory application development processes, providing a turn-key solution for both regulatory support and associated analytical data development.
“We are thrilled to unveil our strategic alliance with Accorto,” said Inter Scientific co-founder David Lawson in a statement. “This collaboration represents a significant milestone, offering both new and existing clients a competitive advantage. By aligning with another industry-leading regulatory company that shares the same commitments to quality, urgency, and value, we are confident this will further elevate our standards and capacity.”
“We could not be more pleased to be entering into our first strategic alliance with a company like Inter Scientific that has such a fantastic team,” said Tom Beaudet, CEO of Accorto. “This not only provides our clients with the ability to collect data needed to prove the safety and efficacy of their products, but also allows us to shorten their regulatory application timelines, giving them a competitive advantage.”
November 28, 2023
BAT Urges Stricter Vape Rules

Photo: BAT
BAT is urging the U.K. to introduce new regulations that the company believes will help the country achieve its “smoke-free” ambitions.
England wants to reduce smoking prevalence to 5 percent of less by 2030, with Wales targeting a similar timeline and Scotland four years later.
Ahead of the consultation on the Tobacco and Vapes Bill that ends Dec. 6, BAT is now publishing proposals that seek to minimize the underage appeal of, and access to, vapor products, along with the environmental impact of single-use e-cigarettes.
In addition to a ban on dessert and soft drink flavors for vapes, the company is calling for an end to marketing slogans and imagery involving toys, cartoons and sweets.
“Vaping is the key to unlocking the U.K.’s smokefree target,” said Asli Ertonguc, BAT lead for the U.K., in a statement. “As the largest manufacturer of vaping products in the U.K., we are clear on our responsibilities and are urging the government to introduce more stringent vaping regulations. We believe that underage users should never vape, so we want confectionery, dessert and soft drink flavors to be banned and the introduction of a new regime for how and where vapes are sold.”
In practice, this would mean requiring vape sellers to have a retail license, similar to that in place with alcohol and cigarettes, and which would be revoked if they were found to be selling to anyone underage, according to BAT. Retailers would also have to demonstrate to Trading Standards that they observe either Challenge 25 protocols or new technologies at point-of-sale locations which verify age, such as facial recognition cameras.
In addition to tackling underage vaping, BAT also wants vapes to be made more environmentally responsible. BAT wants it to be mandatory for single use vapes to have removable batteries, to make recycling more straightforward.
Five million single use vapes are thrown away each week in the U.K. according to 2023 research from recycling campaign group Material Focus—a fourfold increase since 2022. But only 17 percent of vapers recycle in the correct recycling bins, according to the same data.
Finally, according to BAT, products shipped to the U.K. should be subject to a mandatory testing program to ensure products are compliant with U.K. regulations before they can be sold.
“We recognize that some want single use vapes banned altogether, but we are concerned such a move would lead to unregulated sales, and less options for adult smokers looking to switch,” said Ertonguc. “Governments should wield their enforcement powers to help re-build confidence in vaping by ensuring adult consumers can buy legitimate products, and suitably penalizing those who fail to comply.”
November 27, 2023
U.S. Crackdown on Youth Appealing Vapes Continues

Image: iCheer
The U.S. Food and Drug Administration issued warning letters to seven online retailers for selling and/or distributing unauthorized e-cigarettes packaged to look like youth-appealing toys and drink containers, including milk cartons, soft drink bottles and slushies, according to the FDA. The agency stated that the products’ designs may also help youth conceal the e-cigarettes from adults or be confused with an everyday object and the contents accidentally ingested by young children.
“As we continue into the school year, it’s critical that parents, teachers and other adults are aware of illegal e-cigarettes deceptively packaged to look like everyday items,” said Brian King, director of the FDA’s Center for Tobacco Products. “These types of products can be easily concealed and contain nicotine, which is highly addictive and can harm the developing adolescent brain.”
The seven retailers that were issued warning letters were given 15 working days to respond with the steps they will take to correct any violations and to prevent future violations. Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure and/or civil money penalties.
November 17, 2023
Ghana’s Tobacco Control Strategy

Image: Asada
Ghana’s government has developed a five-year National Tobacco Control Strategy (NTCS) with a goal of decreasing the consumption rate of tobacco in the country, reports The Ghanaian Times. The end goal of the NTCS is to eradicate all tobacco usage.
The Ministry of Health, the Food and Drugs Authority (FDA), the World Health Organization and the United Nations Development Program put the strategy plan together along with advocate policymakers on tobacco control.
According to Baffour Awuah, acting director of the Technical Coordination Directorate of the Ministry of Health, cardiovascular disease rates due to increased smoking are rising.
“The strategy we are launching today is the climax of extensive collaboration, research and commitment by various stakeholders, experts and civil society,” Awuah said. “Its purpose is to guide us in combatting the devastating effects of tobacco use, both in terms of health and the economy.
“It aims to ensure effective coordination among agencies involved in tobacco control, setting clear goals and adopting strategic timelines.”
Awuah encouraged stakeholders to actively engage in discussions to help transform the document into tangible action.
Olivia Boateng, director in charge of tobacco and substance abuse at the FDA, stated that illicit trade in tobacco products has made them more accessible at lower prices. The country has made progress in tobacco control policies, but the illicit trade has “amplified the tobacco epidemic,” according to Boateng.
Stakeholders will be trained on the protocol to eliminate illicit trade in tobacco products in the country once the NTCS is implemented, according to Boateng.
November 16, 2023
Malaysia Scraps Endgame Clause

Image: Zimmytws
The government of Malaysia has eliminated the generational endgame (GEG) clause from its Control of Smoking Products for Public Health Bill 2023, reports CodeBlue.
The move follows an opinion issued by Attorney-General Ahmad Terrirudin Mohd Salleh’s that the proposed age-based prohibition—which seeks to ban tobacco and vape products for anyone born from Jan. 1, 2007—is unconstitutional because it would create two sets of laws for two different groups of citizens based on age.
Enacting the GEG would require a change to Malaysia’s constitution, according to the attorney general, and the government was reportedly not confident it would be able to secure the required two-thirds majority in Parliament.
Anti-smoking activists were outraged, saying that the cabinet’s decision to drop the generational provision from the bill violates the Convention of the Rights of the Child, which Malaysia ratified in 1995.
“We believe that this is a backward step that will lead the people of Malaysia, especially children and adolescents, into the realms of nicotine addiction and drug dependence,” said Family Medicine Specialists’ Association (FMSA) President Nor Hazlin Talib.
The FMSA urged the government to reinsert the GEG clause into the bill. “The government needs to prioritize public health over political and economic interests,” Talib said.
In addition to the now removed GEG clause, the bill includes provisions on registration of tobacco products, advertisement, packaging and smoke-free places, among other items.
November 14, 2023
Slovenia Bans Flavors and Smoking Rooms

Photo: Taco Tuinstra
The government of Slovenia has banned most flavorings in electronic nicotine delivery systems such as e-cigarettes and tobacco-heating products, reports Euractiv. The only flavors still permitted are tobacco and mint.
“There is mounting research showing that among adolescents who otherwise do not smoke, the use of electronic cigarettes raises the likelihood of them starting to smoke regular cigarettes by up to four times,” Health Minister spokesperson Valentina Prevolnik Rupel was quoted as saying.
The government has also prohibited smoking rooms in public places such as bars and airports, as ventilation, filtration and other technologies have proven ineffective against exposure to tobacco smoke, according to Rupel.
To discourage black market sales of flavored products, the government intends to introduce new rules prohibiting individuals from selling or importing tobacco products in bulk.
Every year, 3,100 people die from smoking in Slovenia, according to Health Ministry data.
November 13, 2023