Category: Regulation

Malaysia Proposes Vaping Ban for People Born After 2005
Malaysia’s Ministry of Health (MOH) clarified that its proposed smoking ban for everyone born after 2005 does not only cover cigarettes and tobacco products, but also vape, e-cigarettes, and heated tobacco products.
Credit: Peter Nguyen
Health Minister Khairy Jamaluddin announced at the World Health Organization’s (WHO) executive board meeting in Geneva about Malaysia’s plans to prohibit the sale of cigarettes and tobacco products to people born after 2005 in a bid to outlaw smoking for the next generation.
This means that Malaysians who are 17 years old today will not be able to legally buy tobacco, vape, or e-cigarettes next year when they turn 18, the current legal age for smoking in Malaysia, or ever, in their lifetime. Neither will subsequent generations be ever permitted to purchase cigarettes and other smoking products.
An MOH official said the prohibition covered all tobacco products, including cigarettes, cigars, tobacco leaves, and smokeless tobacco, as well as electronic devices like vape or e-cigarettes and heated tobacco products.
“Tobacco products, smoking substances, substitute tobacco products, and smoking devices,” the MOH official told CodeBlue.
Disposable e-cigarettes or vape pens are also sold in Malaysia. Some e-liquids and disposable vapes do not contain nicotine.
“Wait for RUU,” the MOH official said when asked if the proposed generational ban on the sale of tobacco and smoking products covered zero-nicotine vape liquids. He was referring to the new Tobacco and Smoking Control Act that the government plans to table in the upcoming Parliament meeting, according to the story.
The government previously announced during the tabling of Budget 2022 plans to tax vape and e-cigarette liquids containing nicotine, essentially legalising vape products that are presently under a grey area of regulation.
Current tobacco control legislations under the Food Act 1983 do not cover vape or e-cigarettes. However, under the Poisons Act 1952, nicotine can only be supplied by pharmacists or medical practitioners.
January 31, 2022
Philippine Vaping Bill Heads to President Duterte’s Desk

Photo: Oleksii
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 non-smokers,” she told CNN Philippines.
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 30, 2022
Thailand Continues to Explore Legalizing E-Cigarettes

Credit: Tuayai
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 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
Vape Bill Survives Philippine Bicameral Conference
Credit: Vitalii Vodolazskyi
The bicameral conference committee of the Congress of the Philippines on Wednesday approved a measure that would regulate the importation, manufacture, sale, packaging, distribution, use, and communication of e-cigarettes and heated tobacco products (HTPs).
The panel, composed of the House of Representatives and the Senate contingents led by Deputy Speaker Wes Gatchalian and Senate President Pro Tempore Senator Ralph Recto, respectively, approved the report reconciling the disagreeing provisions of House Bill 9007 and Senate Bill 2239.
During the conference meeting, House Deputy Speaker Rufus Rodriguez said the measure aims to offer an alternative for Filipinos who want to quit smoking, according to a press release. Recto, however, noted that while congress intends to push for the shift from smoking to vaping, the bill does not back its promotion “as a lifestyle.”
With the enactment of the bill into law, posts, messages, or images by manufacturers, importers, distributors, and retailers that encourage the purchase and use of vape products would be prohibited. The bill mandates the Department of Health to prescribe guidelines on the implementation of smoking and vaping restriction awareness campaigns.
The Department of Trade and Industry (DTI), meanwhile, would consult with the Food and Drug Administration in setting technical standards for the safety, consistency, and quality of vape products. Manufacturers, distributors, importers, and sellers would then be given an 18-month transitory period from the issuance of the implementing rules and regulations to comply with the requirements of the measure.
This would include the registration of the vape products with the DTI. The report is up for ratification by both the House and the Senate. If successful, it would then head to President Rodrigo Duterte’s desk for a signature.
January 21, 2022
FDA Urged to Act on Remaining PMTA Submissions

Photo: New Africa
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 non-tobacco 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 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 and high school students reported currently using e-cigarettes in 2021.”
January 20, 2022
Broughton: New China Vapor Laws Present Opportunity

Photo: Smoore
Recent amendments to China’s Tobacco Monopoly Law present an opportunity for responsible companies to demonstrate how alternative high-quality products are an important and appropriate element of tobacco harm reduction, according to Broughton.
Writing on the website of the contract research organization, Broughton’s head of regulatory affairs, Lloyd Smart, and regulatory consultant Xiangyin Wei summarize China’s tobacco monopoly law changes and explain what they means for electronic nicotine delivery systems (ENDS).
On Nov. 26, 2021, China’s State Council amended the country’s tobacco law, giving the State Tobacco Monopoly Administration jurisdiction over e-cigarettes. Next-generation products will now be managed in the same way as combustible cigarettes.
Among other things, this means that ENDS companies, including exporters, will need to apply for a license. A single transaction platform will be implemented for product distribution and all products must comply with a new national standard. Regulation of products likely to be introduced following an initial transition period of between three and five months, during which no new products may be brought to market. Products with synthetic nicotine will be banned in China.
According to Broughton, the recently announced changes to e-cigarette regulation in China offer an excellent business opportunity for companies that want to build consumer trust by showcasing their product’s high quality and safety standards.
“As with all regulatory requirements, the most important initial step is to understand fully what’s needed—to provide reassurance or identify gaps that need to be addressed. And to act quickly; seizing the opportunity while making sure you don’t get left behind as the market changes,” write Smart and Xiangyin.
January 18, 2022
Philippine Sin Tax Coalition Urges Duterte to Veto Vape Bill
A group of 60 civil society organizations calling themselves the Sin Tax Coalition in the Philippines have called on President Rodrigo Duterte to veto an “anti-youth” and “anti-health” legislation legalizing the sale of electronic vaporizers and heated tobacco products.
Credit: Craitza
The measure, which merges Senate Bill 2239 and House Bill 9007, would lower the age limit of access to e-cigarettes and vapes from 21 years old to 18, transfer regulatory jurisdiction from the Food and Drug Administration (FDA) to the Department of Trade and Industry (DTI), and allow multiple flavors to vape products, according to the Manilla Times.
The coalition said that the bill “contradicts the supposed intention of protecting the Filipino youth from addiction [to cigarettes].” Citing a 2019 Global Youth Tobacco Survey that showed that one in seven Filipino students aged 13-15 are electronic cigarette users, the expansion of access to these devices will endanger young Filipinos, thus stricter regulation is needed to prevent the epidemic of vaping-related lung injuries in the country, according to the group.
The group called on Duterte to fulfill his campaign promise and leave a legacy of protecting public health by vetoing the bill, noting that he issued an executive order banning the manufacture, distribution, sale and marketing of unregistered e-cigarette products and expanding the smoking ban in enclosed public areas. “Passing this bill is an utter disservice to the health, welfare and well-being of your constituents. It is anti-youth, anti-health, and pro-addiction,” the group stated.

January 17, 2022
Thai Minister Reaffirms Goal to Legalize Vaping
Thailand’s digital economy and society minister, Chaiwut Thanakamanusorn on Jan. 14 stated he would continue efforts to legalize e-cigarettes, according to the Bangkok Post.
Thanakamanusorn believes vapor products are safer than combustible cigarettes. He said legalization of e-cigarettes would enable the country to tax sales and would provide people who found themselves unable to quit smoking with a safer option.
The minister intends to create a working group to study legalization and invite people to sign in support of a request next month that the Constitutional Court rule if the ban on imports of e-cigarettes violates people’s rights, especially the right to have access to less dangerous products.
The minister insisted he had no vested interest in legalizing vaping. Tobacco harm reduction advocates have been pushing for legalization in Thailand.
January 14, 2022
Harm Reduction Advocates File Fourth MDO Amicus Brief
Several court cases challenging the U.S. Food and Drug Administration’s issuing of marketing denial orders (MDOs) in response to its review of premarket tobacco product applications are still pending. Last week, three high profile tobacco harm reduction advocates filed their fourth amicus brief in support of companies that are challenging the FDA.
Credit: Sang Hyun Cho
Clive Bates, director of Counterfactual Consulting, David Abrams, a professor of social and behavioral sciences at the NYU College of Global Public Health, and David Sweanor, adjunct professor of law at the University of Ottawa, filed the latest brief in support of Chicago-based Gripum LLC, which has had its MDO temporarily stayed by the court while the FDA’s actions are reviewed.
“The PMTA process and [appropriate for the protection of public health] APPH test do not apply to combustible cigarettes, which have a much less onerous path to market; accordingly, the most dangerous products are easily accessible throughout the United States, and their manufacturers do not face the threat of financial ruin from FDA’s regulatory burdens and determinations,” the brief states. “FDA’s regime for evaluating ENDS amounts to a major barrier to entry for less harmful products than cigarettes and unjustified regulatory protection of the incumbent combustible cigarette trade. The harms arising from adult and adolescent cigarette smoking far outweigh the harms arising from youth use of ENDS.”
The group also addressed the FDA’s having established an onerous new standard of evidence in PMTAs. The FDA has admitted to using a “fatal flaw” checklist to deny over one million PMTAs without further consideration because they do not provide randomized controlled trials, cohort studies, or other types of (unspecified) evidence that FDA had retrospectively deemed necessary. They also state that the APPH test doesn’t differentiate between adults and youth.
“The APPH test applies to the ‘population as a whole.’ There is no distinction drawn between adolescents and adults in the Act. In some circumstances, ENDS use can be beneficial to adolescents who would otherwise smoke,” the brief states. “As a matter of policy, FDA chooses to take no account of such benefits to youth, but that approach is incompatible with the APPH test in either the PMTA pre-market review process TCA §910(c)(4) or in rulemaking for setting product standards §907(a)(3).”
The group filed similar briefs in three other cases: Triton v FDA – Fifth Circuit (17 Nov 2021), My Vape Order v FDA – Ninth Circuit (24 Nov) and Bidi Vapor v FDA – Eleventh Circuit (24 Nov).
January 3, 2022
Redwood City, Calif. Prohibits Sale of Vaping Products
At its most recent meeting, the Redwood City City Council in California unanimously passed a ban on the sale of flavored vaping and other tobacco products.
Credit: Valeriya Zankovych
The ordinance also prohibits the sale of all electronic cigarettes and electronic smoking devices, and bans all pharmacies from selling tobacco products by way of making them ineligible to obtain a tobacco retailer’s permit.
The ordinance does create an exemption for businesses holding a tobacco retailer’s permit that sell flavored tobacco for on-site hookah consumption, provided the business was operational and licensed as of Nov. 22, 2021. The rules do not allow for the exemption to be transferable or assignable to a subsequent owner of the business.
The city joins eight cities in San Mateo County and many more across the state and nation to ban flavored tobacco products over their health impacts, particularly to young consumers. Burlingame, East Palo Alto, Half Moon Bay, Menlo Park, Portola Valley, San Carlos, San Mateo, and South San Francisco have all passed similar ordinances.
On October 28, 2019, the City Council directed staff to research and draft an ordinance for consideration to ban flavored tobacco and electronic cigarettes (e-cigarettes), modeled after the County of San Mateo’s ordinance.
There is no exception for premium cigars in the ordinance. The ban will go into effect on April 1, 2022. Meanwhile, statewide legislation (SB 793) to ban the sale and distribution of flavored tobacco products is currently on hold pending the result of a ballot measure in the Nov. 8, 2022 election.
December 30, 2021