Category: Regulation

Malaysia’s Generational Tobacco Ban Clears Cabinet

Photo: PX Media
Malaysia’s Cabinet has approved the Tobacco and Smoking Control Bill, reports The Star.
“I will be sending [the Bill] to Parliament for this session,” Health Minister Khairy Jamaluddin told reporters during the presentation of a new drug perception study report on July 14.
Among other provisions, the bill calls for a ban on sales of cigarettes, tobacco and vapor products to those born after 2005.
The proposed law is modeled on legislation in New Zealand, which in December 2021 revealed a plan to phase out smoking by gradually raising the smoking age until it covers the entire population.
Presently, some 40.5 percent of men and 20 percent of women smoke in Malaysia.
July 17, 2022
Cambodia Police Campaign Against E-Cigarette Use

Credit: Luzitanija
Authorities in Cambodia are stepping up their campaign against vaping throughout the country with students and youths as the main targets.
Cambodian law bans the sale, consumption and import of e-cigarettes. However, there is no information that could be found on any consequences for using or selling vaping products.
According to Khmer Times, no legal action can be taken against users or sellers but authorities hope to reverse the trend of vaping, if not stop it, by creating awareness of the ill effects of smoking an e-cigarette and educating users about “the folly of their ways.”
General Meas Vyrith, secretary-general of the National Authority for Combating Drugs (NACD) said, “most e-cigarettes contain nicotine. Nicotine is highly addictive and can harm adolescent brain development, which continues into the early to mid-20s. E-cigarettes contain harmful substances besides nicotine.”
Cambodian authorities cannot arrest anyone for e-cigarette use. Police can only advise underage users.
“We can however take action against people who sell e-cigarette devices on the sly. We are also studying ways we can use existing laws and regulations to stop this threat to public health,” he said yesterday.
July 15, 2022
AVM Wants HHS to Probe Congressional Pressure on FDA

Credit: Kristina Blokhin
American Vapor Manufacturers (AVM) president Amanda Wheeler is asking the U.S. Department of Health and Human Services Inspector General (OIG) to launch an inquiry into whether “political pressure” is driving U.S. Food and Drug Administration Commissioner Robert Califf’s marketing denials for vaping products.
AVM wants the OIG to help the public learn about the commissioner’s coordination with elected officials, allied activists, and reporters as his agency continues its review of premarket tobacco product applications (PMTA), according to a press note.
“I am asking the Inspector General to intervene,” said Wheeler. “The PMTA process is rigged. Arbitrary standards rewritten behind closed doors corrupt any effective review. It’s embarrassing for the commissioner, but one U.S. senator’s call for his resignation was enough for Dr. Califf to override the standards set for the PMTA process. We are confident that OIG intervention will reveal what we have feared all along, ideology, not science, is driving decisions at the FDA.”
In a letter sent to HHS Inspector General Christi A. Grimm requesting an inquiry into “improper political pressure,” Wheeler contends that “interference has corrupted FDA’s statutory obligation to properly implement its premarket tobacco product application (PMTA) review process based solely on scientific, empirically-based judgment.”
Amanda Wheeler
A timeline of suspect events shows Califf’s decision to deny a marketing order for Juul Labs, Inc. came within hours of a U.S. senator calling for the commissioner’s resignation. Within days, a federal judge blocked the FDA from implementing its order, forcing the agency to re-open its review of the JUUL application.
The FDA backtracked on its decision, claiming there were “scientific issues unique to the Juul application that warrant additional review.” An OIG inquiry can show the public how the commissioner and his staff were forced into their decision by political pressure while ignoring salient facts.
“Manufacturers are routinely meeting the PMTA requirements to scientifically demonstrate how their products are appropriate for the protection of public health,” Wheeler said. “Despite compliance, the agency isn’t approving the vape products sought by adults who want to quit smoking. The OIG should open the door and hold the FDA accountable to its standards.”
Wheeler is requesting a full review to affirm the FDA’s assertion that the administrative stay was based on incomplete information. The agency is also thwarting Freedom of Information Act requests, so the OIG has an opportunity to create a new level of transparency.
Wheeler is requesting the OIG make public communication between the commissioner and members of Congress, the media, and ideologically aligned advocacy organizations.
July 13, 2022
U.S. FDA Updates Safety Reporting Portal for Tobacco
The U.S. Food and Drug Administration has made several updates to the desktop Safety Reporting Portal (SRP) tobacco questionnaire to improve the clarity, internal consistency and utility of the information being collected, according to the regulatory agency. The move will enhance the agency’s Center for Tobacco Products’ (CTP) public health surveillance for new and existing safety signals.
Some of the updates include:
Questions have been edited for inclusiveness and clarity that FDA is interested in health and product problems arising both from direct use of (by users) or exposure to (in nonusers) tobacco products
Questions about a tobacco product’s manufacturer are now designed with a search/select response list that provides submitters who know the manufacturer’s name with the full contact information for many of the manufacturers
The optional health questions now include questions about use of alcohol and other substances of abuse, and ask more details about diagnostic testing, treatment settings, and final health outcomes
Additionally, when manufacturers register an account in the SRP, they are asked to specify the type of manufacturer.
“FDA encourages anyone who has had a reaction to, or was hurt by, a tobacco product – or knows someone who experienced such effects – to visit the SRP and provide as much information as possible,” according to an FDA statement. “Reports from consumers/concerned citizens and healthcare professionals may be submitted anonymously, but including contact information allows FDA the option to find out more about the adverse experience. FDA reviews all tobacco-related SRP reports to identify new or concerning trends.”
July 11, 2022
Brazil Maintains Ban on E-Cigarette Sales, Imports

Photo: Brenda Blossom
Brazil’s national health surveillance agency, Anvisa, decided on July 6 to maintain its ban on the import, advertising and sale of electronic cigarettes in Brazil, according to News Bulletin 24/7. The restriction began in 2009, but marketing continues illegally in the country, so Anvisa also called for increased inspections and educational campaigns to curb the illicit trade in e-cigarettes.
The decision was taken unanimously during a meeting of the body’s collegiate board. According to Anvisa Director Cristiane Rose Jourdan, scientific studies show that the use of electronic smoking devices increases the risk of smoking in young people, the potential for dependence and the likelihood of lung, cardiovascular and neurological health problems.
The Brazilian Medical Association (AMB) applauded Anvisa’s position. ”This is a wise decision, as there is increasing scientific evidence that the use of electronic smoking devices, the DEFs, is not harmless, does not support smoking cessation or is a form of harm reduction, but a product that causes dependence and can cause several diseases, especially cardiovascular, respiratory and cancer,” said Ricardo Meirelles, coordinator of the Commission to Combat Tobacco at AMB.
A survey carried out in the first quarter of 2022 by the Vital Strategies organization and the Federal University of Pelotas, revealed that 19.7 percent of Brazilians aged between 18 and 24 have tried electronic cigarettes.
BAT Brasil (formerly Souza Cruz) said it will assess the regulatory impact analysis of Anvisa’s decision when it is published.
“Dozens of countries have already understood the importance of risk reduction as part of their tobacco control policies and, given this reality, have advanced in the regulation of these devices,” the company said in a statement, citing the examples of United States, the European Union and the United Kingdom, among others.
Japan Tobacco International regretted Anvisa’s decision. “The use of electronic devices in the country is current and supplied exclusively by illicit trade. Legalized companies do not sell the product and the growth in consumption that affects the population comes from the illegal acquisition of devices,” the company said.
July 8, 2022
FDA Suspends Juul Market Ban Pending Court Appeal

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The U.S. Food and Drug Administration has temporarily halted its ban on Juul Labs products while the e-cigarette maker appeals the agency’s decision, the FDA announced on Twitter.
On June 23, the FDA ordered Juul Labs to pull its e-cigarettes from U.S. store shelves, saying the e-cigarette manufacturer had submitted insufficient evidence that they were “appropriate for the protection of the public health.”
A federal appeals court then granted Juul Labs a emergency stay of the order to give the judges time to evaluate the merits of Juul’s appeal. The e-cigarette company separately asked the FDA to stay its own order pending the appeal.
In a series of Twitter messages, the FDA said it had determined that there are scientific issues unique to the Juul application that warrant additional review. The agency stressed that the stay suspends but does not rescind it the marketing denial order (MDO).
The FDA initially rejected Juul’s request for a stay, prompting Juul to seek a stay of the ban in court, according to The Wall Street Journal.
In its court filing challenging the FDA ruling, Juul said the agency had overlooked more than 6,000 pages of data that the company had submitted to the FDA on the aerosols that users inhale. Juul also suggested that the FDA’s decision was influenced by political pressure.
The FDA’s marketing denial order for Juul surprised many in the vaping business, especially in the wake of marketing authorizations for vapor products manufactured by competitors such as Reynolds American Inc. and NJOY Holdings. A pioneer in the vaping segment and backed by Altria Group—a company boasting decades of experience with regulatory compliance—Juul labs appeared in a better position than most to meet the agency’s exacting standards.
Public health advocates criticized the stay of the FDA ruling.
“It is deeply disappointing and harmful to our nation’s kids that the FDA has issued an administrative stay of its marketing denial order for Juul’s e-cigarette products,” wrote Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, in a statement.
“This decision will allow the continued sale, at least for now, of the brand most responsible for creating and fueling the youth e-cigarette epidemic. We are nearly 10 months past a court-ordered deadline for the FDA to complete its review of e-cigarette marketing applications and can’t afford more delays by the FDA in removing kid-friendly products from the market.”
July 6, 2022
Panama Bans Imports and Sales of Vaping Products

Photo: searagen
Panamanian President Laurentino Cortizo has signed legislation banning the sale of vapor products, reports Vaping360. The country had already prohibited e-cigarette sales in 2014 by executive decree.
The new law prohibits not only sales and imports of e-cigarettes, but also bans consumption in any place where smoking is not allowed. The ban includes internet purchases and authorizes customs officials to inspect and seize shipments. Resellers are still allowed to import vapor products intended for export to third countries.
Consumer vaping advocates have warned that restrictions on vaping products will push vapers to illegal products of questionable quality.
Panama joins more than a dozen Latin American and Caribbean countries with vape bans. On May 31, Mexican President Andrés Manuel López Obrador signed a decree outlawing the sale of e-cigarettes.
Panama will host the 1oth Conference of the Parties to the Framework Convention on Tobacco Control in 2023.
July 2, 2022
Juul: FDA ‘Overlooked’ 6,000 Pages of Aerosol Data

The U.S. Food and Drug Administration overlooked a key part of Juul’s premarket tobacco product application (PMTA) when the agency ordered Juul Labs’ products off the U.S. market, according to court documents.
In court filings Tuesday, Juul said the agency overlooked more than 6,000 pages of data that the company had submitted to the FDA on the aerosols that users inhale, according to the Wall Street Journal.
Juul also said the agency failed to consider the totality of Juul’s evidence, which the company said established that the public-health benefits of Juul products significantly outweighed the potential risks.
“FDA’s order acknowledged that ‘exposure to carcinogens and other toxicants present in cigarette smoke were greatly reduced with exclusive use’ of Juul products compared with combustible cigarettes,” Juul Labs stated in court documents.
The company added that the decision was reached “against a backdrop of immense political pressure” from Congressional lawmakers who “tainted the entire agency process” by pushing for a Juul ban. Juul officials say its products are held to a different regulatory standard than those made by rivals.
“If the court does not intervene, [Juul Labs] products will disappear from store shelves and politics will have won over sound science and evidence,” the filing said.
A federal appeals court last week granted Juul Labs a temporary stay of the FDA’s marketing denial order that requires the vaping company to pull its e-cigarettes off the U.S. market.
“The purpose of this administrative stay is to give the court sufficient opportunity to consider petitioner’s forthcoming emergency motion for stay pending court review and should not be construed in any way as a ruling on the merits of that motion,” the court wrote.
The FDA has until July 7 to respond to Juul’s motion and Juul Labs has until July 12 to reply to the FDA response if submitted.
“Having received the emergency temporary stay, we are now seeking the ability to continuously offer our products to adult smokers throughout our appeal with the court and science- and evidence-based engagement with our regulator,” said Joe Murillo, Juul Labs’ chief regulatory officer.
Last week, the Wall Street Journal reported that the company is mulling a potential bankruptcy filing if the FDA ban is upheld.
June 28, 2022
U.S. Appeals Court Delays FDA’s Ban on Juul

Credit: Tanasin
A federal appeals court today granted Juul Labs Inc. a temporary stay of the U.S. Food and Drug Administration’s order for the vaping company to pull its e-cigarettes off the U.S. market.
“The purpose of this administrative stay is to give the court sufficient opportunity to consider petitioner’s forthcoming emergency motion for stay pending court review and should not be construed in any way as a ruling on the merits of that motion,” the court wrote.
The e-cigarette maker had earlier asked the court to pause what it calls an “extraordinary and unlawful action by the regulatory agency that would require it to immediately halt its business.
The company filed an emergency motion with the U.S. Court of Appeals in Washington as it prepares to appeal the FDA´s decision.
Juul said that the FDA cannot argue that there was a “critical and urgent public interest” in immediately removing its products from the market when the agency allowed them to be sold during its review.
The company noted that the FDA denied its application while authorizing those submitted by competitors with similar products.
The order sets a briefing schedule of June 27 for the petitioner’s emergency motion; July 7 for the respondent’s response, and July 12 for the reply.
The request for an emergency stay while waiting to file an appeal was expected.
“We respectfully disagree with the FDA’s findings … intend to seek a stay and are exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator,” said Joe Murillo, chief regulatory officer at Juul Labs, said in a statement. “We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide.”
The marketing denial order, which concerns the FDA’s analysis of Juul products has not been released to the public. “Any portion of the record that was placed under seal . . . before an agency remains under seal in this court unless otherwise ordered,” the emergency motion states.
June 24, 2022
It’s Official: FDA Denies Juul U.S. Market Access

Today, the U.S. Food and Drug Administration confirmed what many had already been anticipating: Juul Labs must remove all currently marketed Juul products from the U.S. market.
“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” said FDA Commissioner Robert M. Califf. “The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.”
These marketing denial orders (MDO) pertain only to the commercial distribution, importation and retail sales of these products, and do not restrict individual consumer possession or use—the FDA cannot and will not enforce against individual consumer possession or use of Juul products or any other tobacco products.
“We respectfully disagree with the FDA’s findings … intend to seek a stay and are exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator,” said Joe Murillo, chief regulatory officer at Juul Labs, said in a statement. “We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide.”
After reviewing the company’s premarket tobacco product applications, the FDA determined that the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.
In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data—including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods—that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications.
Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, called the FDA decision “the most significant action the FDA has taken to reverse the youth e-cigarette epidemic. Juul, more than any other product or company, has been responsible for creating and fueling the youth e-cigarette epidemic.”
The FDA says that, to date, it has not received clinical information to suggest an immediate hazard associated with the use of the Juul device or Juul pods. However, the MDOs issued today reflect FDA’s determination that there is insufficient evidence to assess the potential toxicological risks of using the Juul products.
“There is also no way to know the potential harms from using other authorized or unauthorized third-party e-liquid pods with the Juul device or using Juul pods with a non-Juul device,” the agency wrote in a statement.
“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products. “As with all manufacturers, Juul had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”
Gregory Conley, president of the American Vaping Association, asserted on Twitter that the Juul decisions were “manufactured” and “complete nonsense.”
Andrew Bagley is the owner of the Illuminati Smoke Shop in Columbia, South Carolina, and says even with the popularity of Juul, he doesn’t have concerns about the ban’s effect on sales, reports News19.
“I’m not concerned,” he said. “We have quite a few other vape products that are PMTA approved, which just means at this point we are legally allowed to sell them and Juuls were a very small percent of our sales, it’s not that big of a deal.”
June 23, 2022