Author: Timothy Donahue

  • FDA Officially Issues Notice of Better Web Portal

    FDA Officially Issues Notice of Better Web Portal

    Credit: Postmodern Studio

    According to a release, today, FDA’s Center for Tobacco Products (CTP) issued two notices in the Federal Register regarding its intention to launch CTP Portal Next Generation—an improved web portal for the submission of applications for certain new tobacco products—next year.

    The improvements are intended to:

    • Streamline electronic submission into one system for substantial equivalence (SE) reports and premarket tobacco product applications (PMTAs), amendments to previous submissions, and submission of general correspondence;
    • Introduce a more efficient submission process by eliminating the need for multiple tools, including combining PDF-editing software, FDA’s eSubmitter Desktop Tool, and FDA’s CTP Portal Web application in one place;
    • Provide tools to expedite data entry, guide applicants to relevant sections, and verify that the applicant has provided all required data.

    No action is needed from current users of any CTP systems regarding these planned improvements. Existing CTP Portal accounts, along with any pending or in-process applications, will be automatically migrated to the new CTP Portal Next Generation.

    CTP is committed to ensuring a smooth transition to CTP Portal Next Generation and will provide additional communication and support, including resources on how to use the new system, leading up to the change. 

  • Australia’s New Vape Rules Boosts Black Market

    Australia’s New Vape Rules Boosts Black Market

    The Australian government’s plan to make pharmacies the gatekeepers of vaping will push more young people onto the black market, experts on the illicit trade say, as new data shows nicotine use is rising.

    Nicotine levels found in wastewater in December were almost the highest since authorities started recording them in 2016, a worrying trend that the health department attributes to the rise of vaping among young people.

    An Australian Criminal Intelligence Commission report last week found that nicotine consumption was highest in regional areas, and had risen from August in capital cities to be the second highest since 2016. The peak use of nicotine was in December 2022, according to media reports.

    Federal Health Minister Mark Butler announced in May last year that the government would increase tobacco excise by five percent a year for three years to deter smoking.

    “Studies have confirmed that the rise in vaping over the last decade has driven more young Australians to nicotine consumption,” a federal health department spokesman said, adding the nicotine data also captured people using nicotine patches and gum to quit smoking.

    But former Australian Federal Police officer Rohan Pike, who created and led the Australian Border Force’s tobacco strike force, warns that many of the country’s 1.7 million vape users could actually be pushed into smoking.

    Pike, who is speaking at a Victorian parliamentary inquiry into vaping and tobacco controls on Monday, says this would represent a “public health disaster.”

    Since July 1, vape sales require a doctor’s prescription, nicotine levels are regulated, and flavors are limited to tobacco, menthol, and mint. Another requirement restricts products to plain packaging.

  • Federal Judge Provides Hope to Iowa Hemp Sellers

    Federal Judge Provides Hope to Iowa Hemp Sellers

    Credit: Zorbor

    A federal judge has given hope to 10 companies looking to block the enforcement of a new Iowa law, which they argue unfairly prevents them from selling products containing hemp-derived THC.

    During a hearing about their request for an injunction against the law, U.S. District Judge Stephanie Rose stated that their argument that the law is unconstitutional is unlikely to succeed. However, she acknowledged that there may be merit to their claim that the state is applying the law in a discriminatory manner.

    The Hemp Amendments, a law passed by the Iowa Legislature during this year’s session, became effective on July 1. Under this law, the sale of hemp products to individuals under the age of 21 is prohibited. It also mandates compliance with new regulations that restrict the amount of tetrahydrocannabinol (THC) allowed in a serving and requires specific labeling, according to media sources.

    Rose already turned down an injunction request by two of them: Field Day, a Johnson County maker of THC sparkling water, and Climbing Kites, a Des Moines-based joint venture of the Lua and Big Grove breweries, maker of a THC-containing seltzer. She rejected their argument that the law was unconstitutional because it failed to define a serving size but said at the time that she had “serious concerns” about how the law would be enforced.

  • Italy Again Labels CBD as Narcotic, Defies EU Law

    Italy Again Labels CBD as Narcotic, Defies EU Law

    Credit: Cloudy Design

    The Italian government has placed CBD on the country’s list of narcotic drugs in defiance of a regional administrative court ruling and in contravention of European Union law.

    The Ministry of Health said the designation is in line with Italian Presidential Decree 309/1990, the cornerstone of drug legislation in Italy. However, that contradicts a ruling by a regional court last year, which was based on a legally binding ruling applicable across the European Union.

    The attack on CBD is only the latest move by the Italian government. The Ministry of Health first classified CBD as a narcotic and banned the compound from the market in October 2020 – only to rescind the order shortly thereafter, according to media reports.

    Later, in a separate attempt in early 2022, the State-Regions Conference – a platform for dialogue and cooperation between the central and regional governments – updated language in a 2018 decree to classify hemp as strictly a medicinal plant.

    In that case, four cannabis associations filed suit, and one year later, the decree was annulled by the Regional Administrative Tribunal of Lazio, which ruled it violated European law.

  • Malaysia: Vending Machine Sales Ban Extends to Vapes

    Malaysia: Vending Machine Sales Ban Extends to Vapes

    Photo: evannovostro

    E-cigarettes may not be sold in vending machines, Malaysia’s health ministry confirmed, according to a New Straits Times report.

    According to the ministry, Section 10 of the Control of Tobacco Product Regulations for Public Health Act prohibits selling and displaying all “tobacco” products, including e-cigarettes. “Regulations regarding sales, including through vending machines, are under review and will be enforced alongside the act once approved,” the law states.

    Earlier this week, the Malaysia Crime Prevention Foundation criticized the sale of vapes through vending machines at a Kuala Lumper mall, describing the practice as “irresponsible.”

    The vending machine has been removed from the premises after an inspection by health ministry officials.

    The ministry has begun briefing authorities nationwide on the prohibitions under the Control of Tobacco Product Regulations for Public Health Act.

  • Risk of Secondhand Exposure Lower for Vaping: Study

    Risk of Secondhand Exposure Lower for Vaping: Study

    Photo: pavelkant

    Children exposed to vaping indoors absorb less than one-seventh the amount of nicotine as children who are exposed to indoor smoking but more than those exposed to neither, according to a new study led by UCL researchers.

    The study, published in JAMA Network Open and funded by Cancer Research U.K., looked at blood tests and survey data for 1,777 children aged three to 11 in the United States.

    The researchers said that secondhand exposure to harmful substances in e-cigarettes would likely be much lower still, as e-cigarettes deliver similar levels of nicotine to tobacco but contain only a fraction of the toxicants and carcinogens.

    The researchers looked at nicotine absorption in children, but they said the findings were likely to be similar for adults.

    “Our study shows, using data from the real world rather than an artificial lab setting, that nicotine absorption is much lower from secondhand vapor than from secondhand smoking,” said lead author Harry Tattan-Birch of the UCL Institute of Epidemiology and Health Care in a statement.

    “Nicotine itself is of limited risk, but it shows what the highest possible exposure might be from secondhand vaping. Exposure to harmful non-nicotine substances present in vapor will likely be substantially lower still.”

    “This paper suggests that concerns about secondhand vaping may be somewhat overstated, with secondhand exposure to toxic substances likely to be very low,” said senior author Lion Shahab of the UCL Institute of Epidemiology and Health Care.

    “The findings confirm the risks of smoking indoors around children, which should be avoided at all costs. However, as secondhand vaping still exposes children to more harmful substances than no vaping or smoking exposure at all, it is best to avoid indoor vaping around children too.”

    The study used data from a nationally representative sample of children in the U.S. collected between 2017 and 2020 as part of the annual U.S. National Health and Nutrition Examination Survey.

    Blood tests that detected the concentration of cotinine were used to assess how much nicotine the children had absorbed. Cotinine is a chemical the body produces after exposure to nicotine. Survey responses indicated if the children had been exposed to smoking or vaping indoors in the past week.

    The researchers focused on data from children as, unlike adults, children were unlikely to have vaped or smoked themselves, meaning higher nicotine absorption was a result of secondhand vapor or smoke only. However, two children were excluded from the analysis for having a cotinine concentration that suggested they had vaped or smoked directly. Children exposed to both indoor smoking and vaping were also excluded from the analysis.

    The team found that children exposed to indoor vaping absorbed 84 percent less nicotine than children exposed to indoor smoking while children exposed to neither absorbed 97 percent less.

    The lower levels of nicotine among those exposed to secondhand vaping were consistent with previous laboratory studies finding that people retained 99 percent of the nicotine they produced during vaping. With tobacco cigarettes, smoke is generated both by smokers breathing out as well as by the lighted end of the cigarette. E-cigarettes, however, do not generate aerosol aside from when vapers exhale.

    The researchers said their findings had implications for whether vaping should be allowed indoors, providing further evidence that the impact of vaping on bystanders’ health will be much less than smoking.

    However, the researchers said there were other factors to consider when assessing whether indoor spaces should be made vape-free. In particular, if vaping commonly occurs indoors, this may normalize the behavior, encouraging people to start vaping and making it harder for them to stop.

    Previous research from the same team showed that adults in England were much more likely to vape than smoke indoors, with nine in 10 vapers found to vape inside while only half of smokers smoked inside.

  • Malaysia Health Policy Group Decries Vape Tax Usage

    Malaysia Health Policy Group Decries Vape Tax Usage

    Credit: Kenary820

    A public health advocate was shocked by the Malaysian government’s decision to retain the tax revenue from vape products collected over the last four years in the Federal Consolidated Fund despite a previous pledge to utilize it for health-related initiatives.

    “Government and non-governmental organizations working in public health are going to need all the additional resources that they can get to deal with the consequences of unrestricted and unprohibited marketing and sales of disposable nicotine vape devices, including through vending machines,” a release from the Galen Centre for Health and Social Policy states.

    The group has opposed the move to de-classify nicotine in vape products as a poison so that the government could tax its sale. According to media reports, Galen Centre CEO Azrul Mohd Khalib said, “The vape tax revenue would have been used for this purpose.”

    Prime Minister Anwar Ibrahim, who is also the finance minister, recently said the government collected RM141.1 million ($30 million) in vape tax revenue, including RM58.55 million from nicotine-containing vape liquid products, from 2021 to 2024.

    He had previously stated that half of the vape tax revenue would be earmarked for the health ministry, which was seen as appeasing criticism that the government was trying to stop stricter anti-tobacco laws in the face of protests from the powerful tobacco lobby.

    “The government supports the spirit of the generational end game (GEG) and has agreed to earmark half of the revenue from this excise duty for the Ministry of Health for efforts to improve the quality of health services and for effective anti-smoking and anti-drinking campaigns,” Anwar had said during his budget speech on Feb 24 last year.

    Galen Centre said the government made the promise to justify its argument that nicotine vaping should not be banned.

    “Half of RM141.1 million is RM70 million more funds, which could help repair the damage of having nicotine vape completely deregulated for more than a year,” said Azrul. “This money is intended to complement existing allocations given to the Ministry of Health, especially in the area of health education and promotion, which is severely underfunded.”

  • Poll: Voters Want ‘Reasonable’ Vaping Regulation

    Poll: Voters Want ‘Reasonable’ Vaping Regulation

    Photo: Victor Moussa

    Equipped with evidence showing that e-cigarettes are a proven smoking cessation tool, a majority of American voters become opposed to efforts to eliminate flavored e-cigarettes, according to a poll carried out by Kellyanne Conway, who previously served as a counselor to former President Donald Trump.

    Conducted in Michigan, Wisconsin and Pennsylvania, the survey showed that a majority of registered voters support fair and reasonable regulations that would preserve flavored e-cigarettes as a smoking cessation tool for adults while also safeguarding youth through marketing and advertising restrictions.

    “Americans continue to reject outright bans on popular, legal everyday consumables. Whether it’s social media apps, gas-powered cars, gas stoves, nicotine pouches, menthol cigarettes or flavored vaping products,” said Conway. “In this survey, we find voters favor common-sense reform over outright bans that put science over politics to reduce harm and protect vulnerable communities like youth.”

    The polling also shows an “information underload” among the American public as only 12 percent believe that vaping is better than smoking cigarettes while 75 percent believe vaping is as bad as or worse than smoking.

    In addition, the polling shows that voters question why their elected officials at the state and federal levels prioritize flavored e-cigarette bans and restrictions over more obvious and urgent concerns. Importantly, survey participants suggested that they are poised to reward those elected officials who reassess outright bans on flavored e-cigarettes and work toward science-based solutions that are less extreme and do not erode basic freedoms.

    The Vapor Technology Association (VTA) welcomed the poll results.

    “The latest polling conducted across Pennsylvania, Michigan and Wisconsin further reinforces what VTA has long maintained: When presented with factual information, American voters accept the importance of vaping as a harm reduction and smoking cessation tool and then question regulators’ constant derogation of flavored e-cigarettes,” said VTA Executive Director Tony Abboud in a statement.

    “Voters are not stupid; they have just been negligently misinformed by FDA leaders for years. Today’s poll reveals not only the importance of changing public perceptions about vaping but also highlights the political dangers of continuing down the path the FDA is on. It’s clear that voters across party lines are receptive to evidence-based approaches that balance adult access to smoking cessation tools with youth protection measures.”

  • ‘Vaping Innovation Just Getting Started’: Hon Lik

    ‘Vaping Innovation Just Getting Started’: Hon Lik

    Hon Lik (Photo: Imperial Tobacco)

    Hon Lik, the inventor of the modern e-cigarette, spoke with Imperial Brands about the vaping category, the challenges it faces and his hopes for the future of tobacco harm reduction.

    Lik said that he’s “satisfied and gratified to witness this revolution [vaping] that’s changing the lifestyle of millions of adult smokers around the world.”

    “I truly believe the innovation has only just started,” he said.

    “In the coming decades, with the help of long-term epidemiological data, I think it will be revealed that NGP [next-generation products] like vapes are clearly harm reduced compared to combustible tobacco—hopefully creating a pathway for tens of millions more smokers to leave cigarettes behind.”

    The full interview is available on Imperial Brands’ website.

  • Regulatory Testing Firm Inter Scientific Joins UKVIA

    Regulatory Testing Firm Inter Scientific Joins UKVIA

    Credit: Adobe Stock

    Inter Scientific, an independent global analytical testing and regulatory compliance firm, announced its membership in the UK Vaping Industry Association (UKVIA), the largest trade body representing the UK vaping industry.

    The commitment underscores Inter Scientific’s focus on promoting high safety, quality, and compliance standards within the vaping industry, according to a press release.

    Inter Scientific and UKVIA are committed to fostering a robust and responsible vaping industry. By collaborating, Inter Scientific aims to support UKVIA’s initiatives, leveraging its extensive expertise in regulatory affairs to help shape a sustainable future for vaping in the UK, according to the release.

    David Lawson, CEO of Inter Scientific, stated, “We are thrilled to join UKVIA as a full board member and contribute to the advancement of the vaping industry in the UK. At Inter Scientific, we believe in the potential benefits to [the] public that the vape industry holds.

    “Our collaboration with UKVIA will enable us to work closely with industry leaders to ensure the highest standards of safety, quality, and compliance are met, to benefit consumers and public health.”

    Inter Scientific plans to actively participate in UKVIA’s working groups and committees, contributing knowledge and experience to address key industry challenges. The collaboration will focus on areas such as regulatory compliance, product safety standards, and public education.

    “By working collaboratively, Inter Scientific and UKVIA aim to enhance the credibility and trustworthiness of the vaping industry, ensuring that consumers have access to safe and reliable products,” the release states.