Global Regulation - Tobacco Reporter

FDA Asked to Clarify PMTA Process

U.S. senators Ted Budd, Rand Paul and Joe Manchin, sent a letter to Food and Drug Administration Commissioner Robert Califf requesting he explain and clarify the FDA’s approach to nicotine product regulation and urging him to reform the tobacco product application process, according to Vaping360.

“Since 2009, more than 26 million premarket tobacco product applications (PMTAs) have been submitted for new tobacco products in the U.S.,” the senators wrote.

“Of those 26 million applications, the CTP [Center for Tobacco Products] has authorized fewer than 50. Remarkably, it has also authorized a total of only 16 modified-risk tobacco products (MRTPs) for only four unique products and their accessories.

“This miniscule authorization rate is not in keeping with the CTP policy acknowledging that tobacco products fall on a continuum of risk. The availability of scientifically substantiated, authorized PMTAs or MRTPs could potentially improve health outcomes for smokers currently using riskier products.”

The Tobacco Control Act requires that the CTP review and decide on PMTAs and MRTPs within 180 days, however, the FDA has not delivered on this timeline.

The senators cited the Reagan-Udall Foundation’s report on the CTP and posed a series of questions to Califf.

The senators are asking Califf to respond to their questions within 30 days.

December 15, 2023

Malaysia Tobacco Law Passes Upper House

Malaysia’s upper house of Parliament has passed the Control of Smoking Products for Public Health Bill 2023, reports The Star. Earlier, the legislation had been approved by the country’s lower house.

The legislation prohibits the sale and purchase of tobacco products, smoking materials of smoking substitute products and providing any smoking-services to minors.

A provision banning the sale of tobacco products to individuals born from Jan. 1, 2007, onwards in an earlier version of the legislation was dropped.

The so-called generational tobacco ban (GEG) was abandoned after the Attorney General’s Chambers suggested it might violate the constitution by creating different rules for different age groups. Critics however blamed tobacco industry pressure for Malasia’s U-turn.

A day earlier, Malaysia’s newly appointed health minister, Dzulkefly Ahmad, expressed his regrets for the GEG exclusion.

He noted that 18 engagement sessions with stakeholders and three roundtable discussions had taken place before the bill was finalized.

“However, human plans, and Allah decides, and fate has placed us here today, where you cannot see or read the GEG provisions in this bill,” said Ahmad. “I apologize sincerely.”

In related news, new figures suggested that vaping has overtaken smoking as the main method of nicotine consumption among young Malaysians. According to the Southeast Asian Tobacco Control (SEATCO) Alliance, e-cigarette use among this age group is about 30 percent, compared with 12.5 percent for smoking.

“Claims of harm reduction are unproven and deceptive,” said SEATCO. “It is more accurate to say this is harm initiation for youths that have never smoked and harm substitution for smokers trying to quit,” it added.

The organization called on Malaysia to follow the example of neighboring countries that have banned e-cigarettes. Vapor products are prohibited in Brunei, Cambodia, Laos, Singapore and Thailand.

December 15, 2023

Argentina Asked to Repeal E-cigarette Ban

The Argentinean vapers’ association, Asovape Argentina, and the World Vapers’ Alliance have sent an open letter Argentina’s recently elected president, Javier Milei, calling for the repeal of the National Administration of Medicines, Food and Medical Technology Provision 3226/2011 banning the commercialization of e-cigarettes.

The provision banned the import, distribution, marketing, advertising and promotion of e-cigarettes. It went into effect May 6, 2011.

The letter explains that numerous studies conducted since the ban took effect have demonstrated the significantly lower risk profile and the usefulness of e-cigarettes for smoking cessation as well as the low health risk of nicotine. The signatories also argue that the ban is incompatible with respect for the individual freedom of Argentinian adults and the rights to free development of personality, information and health of users and smokers.

“The ban violates the rights and freedoms of Argentine adults and should be repealed,” said Juan Facundo Teme, president of Asovape Argentina, in a statement. “The state is not the one to tell Argentines how to consume nicotine and should respect the decisions of individuals who choose to vape in order to consume it in a less harmful way. Moreover, all the arguments on which the ban was based have been disproved.”

Argentina has a smoking rate of 24.5 percent, the second highest in Latin America and one of the highest in the world.

“Smoking is a huge problem for Argentina, and the ban has only exacerbated it,” said Teme. “It spreads the misconception that vaping is the same or worse than smoking, makes it difficult for millions of smokers to switch to a safer alternative and has pushed thousands of vapers back to tobacco. With clear information and proper regulation of vaping, we could reduce smoking rates quickly and significantly.”

Argentina should respect smokers who choose to consume nicotine in a less harmful way.

Alberto Gomez Hernandez, policy manager, WVA

“Argentina is one of the most restrictive countries on vaping in the whole region and consequently has one of the highest smoking rates,” said Alberto Gomez Hernandez, policy manager of the World Vapers’ Alliance. “It is second only to Chile, which has just passed a law regulating vaping to allow adults to use it to quit smoking, as Brazil is also working to do. Argentina should not lag behind and should respect smokers who choose to consume nicotine in a less harmful way.”

Michael Landl, director of the World Vapers’ Alliance, added, “Argentina’s approach to vaping is outdated and irreconcilable with upholding the individual freedom of consumers. Argentina now has a great opportunity to take the lead and adopt the approach of countries like Sweden or the U.K., which respect users’ right to choose while improving public health. Sweden is on the verge of becoming the first smoke-free country thanks to this approach, and the U.K. is reducing its smoking rate rapidly. We encourage President Milei and his government to follow these examples. Vaping is not a crime and should be legalized immediately.”

December 13, 2023

Mexico Vape Ban Ruled Unconstitutional

Mexico’s ban on the sale of e-cigarettes is unconstitutional, the nation’s top arbiter ruled, according to Reuters. The Second Chamber of the Supreme Court found that the presidential decree that established the prohibition contravenes freedom of commerce.

The ruling permits only retailers who were parties to the case to sell e-cigarettes, however. If other retailers want to sell e-cigarettes, they must file their own court cases to declare the unconstitutionality of the ban in their specific instances.

Alberto Gomez Hernandez, policy manager of the World Vapers’ Alliance, welcomed the decision of Mexico’s high court, saying that the decree violates not only the freedom of trade of the companies but also the right to health of Mexican adults. “Mexicans should be free to decide how they consume nicotine,” Gomez said in a statement.

Although the ruling does not establish jurisprudence, we hope that the government or the judiciary will reverse the ban soon.

Alberto Gomez Hernandez, policy manager, WVA

The declaration of unconstitutionality was carried out in an amparo lawsuit—a type of lawsuit in Mexico through which a company can seek legal protection or permission not to abide by regulation that violates its rights.

The general ban will stay in place since the ruling applies only to that specific case and business.

“Although the ruling does not establish jurisprudence, we hope that the government or the judiciary will reverse the ban soon,” said Gomez. “The ban has failed; it has aggravated the public health problem of smoking in Mexico and has created a huge black market controlled by mafias.

“Mexico needs to abandon the ban and adopt a strategy that includes the use of less harmful nicotine products as a smoking cessation tool. It should follow the example of Sweden, which is about to become the first smoke-free country, and the U.K., which promotes the use of vapes to quit smoking.”

December 12, 2023

Kathmandu to Ban Plastic-Pack Products

Kathmandu will ban the sale of tobacco products in all its 32 wards from Dec. 13, 2023, reports myRepublica.

Ram Prasad Poudel, chief of the Kathmandu Metropolitan City’s (KMC) health department, said the measure would apply to the sale, storage and use of all tobacco products packaged in plastic. This includes not only cigarettes and bidis, but also tamakhu, sulfa, kakkad, gutkha and paan parag, among other regional products.

“We are on a campaign of making Kathmandu a healthy city,” said Poudel.

The KMC reportedly plans to apply similar measures to water pipe tobacco at a later stage.

December 1, 2023

France Unveils Plans to Curb Smoking

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

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

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

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

Category: Global Regulation