Global Regulation - Tobacco Reporter

EU Bill: Firms Liable for Supply Chain Violations

The European Commission has proposed a law that would hold large companies operating in the European Union for environmental violations or human rights abuses committed by businesses in their supply chains, reports The New York Times.

“This proposal is a real game-changer in the way companies operate their business activities throughout their global supply chain,” said Didier Reynders, Commissioner for Justice, in a statement. “With these rules, we want to stand up for human rights and lead the green transition. We can no longer turn a blind eye on what happens down our value chains.”

Under the legislation, businesses would need to establish mechanisms to detect, prevent and mitigate breaches of human rights, such as child labor, as well as environmental hazards in their supply chains. National governments would define the financial penalties for violators.

Victims could sue for compensation in domestic courts of EU member nations, even if the harm occurred outside the bloc.

According to the European Commission, the new rules will bring legal certainty and a level playing field. “For consumers and investors they will provide more transparency,” the Commission wrote on its website. “The new EU rules will advance the green transition and protect human rights in Europe and beyond.”

The proposal would initially apply to companies with more than 500 employees and annual revenue over €150 million ($170 million). Around 2,000 companies based outside the bloc but doing business in the European Union, amounting to an annual revenue of more than €150 million, would also be covered.

After two years, the range would be expanded to include smaller businesses in so-called high-impact sectors, such as textiles, food products and mining.

The legislation will now be discussed by the European Parliament and the 27 national governments, with all parties able to modify the language. The final draft will require passage by the EU lawmakers and member nations. The whole process could take a year or more.

February 23, 2022

First FDA Warning for Vapor Hardware

The U.S. Food and Drug Administration posted its first warning letter for vaping hardware products on Tuesday. The letter was issued on Feb. 14.

“Our review of the website http://sigelei.com revealed that you manufacture and offer for sale or distribution to customers in the United States ENDS [electronic nicotine-delivery system] products without a marketing authorization order including: Sigelei Humvee 80 and Sigelei 213 Fog Coil,” the agency wrote in its letter.

On Feb. 5, 2021, the FDA sent Sigelei a “refuse to accept” letter regarding its premarket tobacco product application (PMTA) for six products. “New tobacco products that do not have the required FDA marketing authorization order in effect, including your ENDS products covered by PMTA STN PM0001221 that resulted in a refuse to accept determination, are adulterated and misbranded,” the agency warned.

The move signals a shift in the FDA’s typical regulatory action against companies selling illegal vaping products. Thus far, the agency has issued letters for e-liquids, but now hardware manufacturers have been put on notice. One manufacturer, who asked to remain anonymous to avoid FDA scrutiny, said the recent action is worrisome.

“The hardware segment has been operating almost at a near-normal, the same as before PMTAs were due,” the manufacturer said. “It hasn’t really hit home yet that FDA has the full intention to start enforcing hardware regulations too. This is going to hurt several companies, and we are going to start to see smaller businesses end their marketing in the U.S.”

The letter also suggests that the warning is for all Sigelei products and not just the rejected PMTA products. “The violations discussed in this letter do not necessarily constitute an exhaustive list,” the letter states.

February 23, 2022

New Tobacco Restrictions in Mexico

Mexican President Andrés Manuel López Obrador has published a new tobacco control law that includes bans on tobacco advertising, promotion and sponsorship, alongside restrictions on public smoking.

Under the new law, the use of e-cigarettes and heated tobacco products will also be prohibited in indoor public places.

According to the Campaign for Tobacco-Free Kids (CTFK), about 30 percent of youth are exposed to secondhand smoke in hospitality venues in Mexico.

“Mexico’s comprehensive law is a victory not only for public health, but for the government champions and advocates in Mexico who worked tirelessly to ensure this life-saving measure was enacted,” wrote CFTK Director of Latin American Programs Patricia Sosa in a statement. “It is critical that the Mexican government ensure swift implementation of the new law so that all Mexicans can truly be protected from the deadly tactics of Big Tobacco companies.

February 21, 2022

Swiss Support Tighter Limits on Tobacco Ads

A majority of Swiss voters want to limit tobacco advertising seen by minors, reports SWI.

During a ballot on Feb. 13, 56.6 percent of voters and most of the country’s 26 cantons backed a proposal to ban all tobacco and e-cigarette advertising that may reach young people in Switzerland. About 5.3 million people took part in the vote.

Gregoire Vittoz, director of Addiction Switzerland, described the outcome as a “big step forward.”

“The people have understood that health is more important than economic interests,” said Stefanie de Borba of the League Against Cancer.

Home to some of the world’s largest tobacco companies, including Philip Morris International and Japan Tobacco International, Switzerland currently has some of the weakest laws against tobacco advertising in Europe.

While cigarette ads in general on television and radio are prohibited at the federal level, each region has different rules for tobacco promotions in cinemas and public places, such as festivals or public transport. Only a few cantons ban cigarette ads in the written press or on the internet.

Around one in four people in Switzerland smokes—a share that has remained stable over the past decade. The figure is slightly higher among 15-year-olds to 24-year-olds. Research shows that most adult smokers began when they were minors.

Critics of the people’s initiative, which included the Swiss government, argued unsuccessfully that the proposal represented an intrusion on economic freedoms and would be hard to implement in the digital age. They submitted a counterproposal that would have still allowed tobacco advertising at points of sale.

Federal authorities must now adjust Switzerland’s Tobacco Product Law to incorporate the proposal. A law must be drafted and put forward for consultation and discussion in Parliament. Once adopted, the law must be subjected to a facultative referendum. Health Minister Alain Berset said the new rules are unlikely to take force in 2022.

February 14, 2022

Activists Welcome Thai Plan to Legalize E-Cigs

Tobacco harm reduction advocates have welcomed Thailand’s plans to legalize and regulate vapor products.

“Countries which have chosen to legalize and regulate e-cigarettes have seen a fall in overall smoking rates and have much better control over youth vaping. It’s exciting for Thailand, and in fact the world, that the government is now set to overturn its ban on the sale of vape products,” says Asa Saligupta, director of ENDS Cigarette Smoke Thailand (ECST).

According to Saligupta, Thailand’s harsh ban and penalties on vape sales has meant too many smokers have been stuck with cigarettes, while young people buy e-cigarettes in the underground economy with no control over the purchase age or product safety standards.

“We’ve seen the legalization and regulation of vaping in places like the United States, United Kingdom and New Zealand work very well. I’m delighted the Thai government is now listening to the science with the adoption of effective tobacco harm reduction (THR) policies now increasingly imminent,” he says.

The ECST director says Digital Economy and Society Minister Chaiwut Thanakamanusorn, government officials, public health experts and advocates have all been key to finally addressing Thailand’s failed tobacco control policies.

He says that, despite the minister adopting an evidence-based approach, local conservative health groups continue to unfairly target him and publicly scaremonger.

“It was a big breakthrough last year when the minister told local media that vaping is safer for people trying to quit smoking. Since then, he has walked the talk—looking at ways vaping can be legalized. He fully understands it offers smokers a less harmful alternative to deadly cigarettes and protects non-smokers from the dangers of second-hand smoke.

“Consumer groups like ours have worked hard to encourage our politicians and officials to follow the significant international public health evidence. It has been a long journey, but we’re pleased with the progress the government’s working group continues to make on legalizing e-cigarette sales,” says Saligupta.

International research also shows countries which have adopted progressive policies around vaping have seen their smoking rates fall twice as fast as those countries that haven’t.

Nancy Loucas, executive coordinator of The Coalition of Asia Pacific Tobacco Harm Advocates (CAPHRA), says that by lifting its long ban on vape sales, Thailand will join about 70 countries that have legalized vaping.

“Around the world, vaping is saving millions of ex-smokers’ lives and can save many more if safer nicotine products are embraced, not demonized,” says Loucas. “Thailand’s 10 million smokers have long deserved a readily and legally available alternative to cigarettes. The country’s sky-high smoking rate is totally unacceptable but thanks to the work of ECST and others, it’s about to be seriously addressed.”

According to Loucas, Thailand has become increasingly isolated internationally with its harsh policies. Vapers currently risk arrests, sanctions and even imprisonment.

“By legalizing that sale of vapes, Thailand will join countries like the Philippines and Malaysia which are also waking up to the fact that vaping bans inevitably fail, leading to unnecessary smoking-related illnesses and deaths,” says Loucas.

February 14, 2022

Malaysians Skeptical About Generational Tobacco Ban

Malaysians are skeptical about the effectiveness of a plan to prohibit the sale of tobacco and vapor products to those born after 2005, according to a survey by the Retail and Trade Brand Advocacy (RTBA) Malaysia Chapter that was relayed the New Straits Times.

In January, Malaysia’s health minister, Khairy Jamaluddin, said he wanted to ban smoking for the next generation of Malaysians, following the example of New Zealand, which announced a similar policy in December.

Eighty-five percent of respondents to the RTBA survey said the ban would not work and would create a black market for cigarettes and vape products. They also said that the ban would be difficult to enforce and ultimately impact Malaysia’s legal and local businesses.

“Banning is not a solution,” said RTBA Malaysia managing director Fazli Nordin. “For example, vape products containing nicotine are currently prohibited from being sold in the market. Yet there is consumer demand for vape products containing nicotine. Worst still is the tobacco black market, where Malaysia has the highest level of illegal cigarettes in the world, driven by the huge price gap between legal and illegal products.”

Nearly 1,200 Malaysians participated in the survey by RTBA Malaysia, which is a non-governmental organization that safeguards businesses from criminal conduct.

While Malaysia’s plans were inspired by New Zealand’s, they differ in that New Zealand does not plan a ban on vapor products, according to Fazli.

“Instead, the country promotes vape as a less harmful alternative and encourages New Zealanders to make the switch from traditional cigarettes,” he said.

A recent study revealed that encouraging smokers to switch to vape as a less harmful alternative would help Malaysia reduce the smoking population to 4 million by 2025.

The report estimated that such a strategy would help the country to reduce its spending on treating smoking-related diseases by MYR1.3 billion ($310.21 million) in 2025.

February 13, 2022

FDA Webinar on Pending Product Standards

The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) will hold a live webinar, titled “FDA’s Rulemaking Process and Upcoming Tobacco Product Standards,” on Feb. 10 from 2 p.m. to 3 p.m. Eastern Time.

The webinar will address the FDA’s planned tobacco product standards to prohibit menthol as a characterizing flavor in cigarettes and to prohibit characterizing nontobacco flavors in cigars; the FDA’s rulemaking process and how stakeholders can submit comments on proposed rules; and available cessation resources and tools.

The webinar will feature a presentation from the FDA’s Office of Minority Health and Health Equity, the CTP’s Office of Health Communication and Education, and the CTP’s Office of Regulations. There will also be a question-and-answer session.

The FDA will respond only to questions submitted by Feb. 4. To submit a question, please register for the webinar and complete the appropriate field on the registration form.

The FDA stresses this webinar is not intended to communicate contents of the proposed rules or details about the timeline for their release.

The webinar is live and free of charge, but prior registration is required by Feb. 9.

February 1, 2022

Philippine Vaping Bill Heads to President’s Desk

The Philippine House of Representatives and Senate have ratified a vaping bill that critics describe as too industry-friendly. The legislation will now be forwarded to President Rodrigo Duterte for his signature.

Among other provisions, the bill transfers regulatory powers from the Food and Drug Administration to the Department of Trade and Industry (DTI) and lowers the legal purchase and consumption age for vapor products from 21 to 18. The DTI is also in charge of setting technical standards for the safety, consistency and quality of these smoking alternatives.

Philippine College of Physicians (COP) President Maricar Blanco-Limpin said he was particularly concerned about the lower vaping age. “We have been telling all the legislators that making these more available at a younger age is making these e-cigarettes and heated-tobacco products more available to all, including the nonsmokers,” she told CNN Philippines.

Blanco-Limpin said vape products could lead to health concerns and the “mandate to protect the health of the country falls under the FDA, not the DTI.”

If the president signs the measure, Blanco-Limpin said the COP would consider all actions, including bringing the issue to the Supreme Court.

January 31, 2022

Thailand Explores E-Cigarette Legalization

The Digital Economy and Society (DES) Ministry set up a working group to see if electronic cigarettes can be legalized as an alternative for smokers, reports The Nation.

Asa Salikupt, from the End Cigarette Smoke Thailand (ECST) network, said the network supports DES Minister Chaiwut Thanakamanusorn’s plan to legalize e-cigarettes and hopes the working group will be transparent, listen to public opinions and allow e-cigarette users to provide information.

“We believe the legalization of e-cigarettes will help Thailand achieve the goal of reducing cigarette smokers and protecting nonsmokers from the danger of secondhand smoke,” Salikupt said.

The Excise Department can introduce an e-cigarette tax once e-cigarettes are legalized.

Maris Karanyawat, also from the ECST, said Britain, New Zealand and the Philippines are likely to promote the use of e-cigarettes to help reduce the consumption of harmful substances and help those who cannot quit smoking cold turkey.

“More than 70 countries have legalized e-cigarettes as it can reduce the number of smokers,” Karanyawat added.

By banning e-cigarettes, the government is losing tax revenue, people are losing access to safer alternatives and the Tobacco Authority of Thailand is losing a chance to make money, according to Taopiphop Limjittrakorn, Move Forward’s Bangkok MP.

January 24, 2022

FDA Urged to Act on Remaining Applications

Several anti-tobacco groups have sent a letter to the U.S. Food and Drug Administration urging the agency to act on the outstanding premarket tobacco product applications (PMTAs) and pushing for the denial of all flavored e-cigarette products.

It’s been more than four months since the FDA was supposed to decide which e-cigarette products can remain on the market, but the agency still hasn’t completed some of the reviews, including some of the bestselling e-cigarettes.

“We write to urge the U.S. Food and Drug Administration (FDA) to expedite decisions on the premarket tobacco product applications (PMTAs) still pending before the agency involving the flavored e-cigarette products, including those with menthol flavoring and, based on the best available scientific evidence, deny the pending applications for all nontobacco flavored e-cigarettes in order to protect the nation’s young people from the health harms of these products,” the letter said.

The letter was signed by the American Academy of Pediatrics, the American Heart Association and the Campaign for Tobacco-Free Kids, among others.

“Every day that FDA delays action, more of our kids remain at risk,” said Matthew Myers, president of the Campaign for Tobacco-Free Kids. “While the FDA has ruled on applications from a lot of small companies, it hasn’t ruled on the applications from the large companies whose products are being used by a majority of kids.”

American Vaping Association President Gregory Conley pointed to data showing that youth vaping has been declining. According to the Centers for Disease Control and Prevention (CDC), use of e-cigarettes went down among middle school and high school students from 2019 to 2020.

But even with the drop, the CDC said it “estimated that more than 2 million U.S. middle [school] and high school students reported currently using e-cigarettes in 2021.”

January 20, 2022

Category: Global Regulation