A recent report by Nicotine & Tobacco Research urges lawmakers not to treat electronic cigarettes and vaping devices in the same way as combustible cigarettes are treated, according to a story by Lindsey Stroud at heartland.org.
The report said that such a distinction was important because the more research treated e-cigarettes as equivalent to cigarettes, the more likely the research was to err in its conclusions about ‘these unique devices’.
The lead author, Matthew Olonoff, a PhD student at Northwestern University’s Feinberg School of Medicine, was quoted as saying that before ‘making policy changes, such as controlling nicotine or flavor options in e-cigarettes, [there is a] need to better understand what role these unique characteristics have’.
Stroud reported that the authors had used articles and studies to compare the differences between combustible cigarettes and vaping devices and noted key differences between the two, as well as differences between electronic cigarette devices.
‘These differences include the variety of nicotine levels in electronic cigarettes, vaping versus combustion, variability in nicotine dosing, the role of marketing and technology in attracting users to e-cigarettes, and the ability to use vaping devices in places where combustible cigarettes are banned,’ she said.
‘Increasingly, research indicates that the smoke in cigarettes causes the most harm, and tobacco harm reduction products, including e-cigarettes as well as smokeless tobacco, have proven to effectively deliver nicotine in a manner much less harmful than combustible cigarettes.’
Tag: United States
Vive la différence
FDA holds public meeting
The US Food and Drug Administration commissioner, Scott Gottlieb, M.D., yesterday issued a statement on what he said was the agency’s commitment to improving the efficiency and transparency of the tobacco-product application-review process.
The statement coincided with the FDA’s two-day (October 22 and 23) public meeting to discuss the policies and processes for such reviews.
‘When we first unveiled our comprehensive plan on tobacco and nicotine regulation, we set out to tackle the leading cause of preventable death in the US by focusing on two key areas: reducing the nicotine levels in combustible cigarettes to render them minimally or nonaddictive; and harnessing new forms of nicotine delivery that could allow currently addicted adult smokers to get access to nicotine without all the risks associated with lighting tobacco on fire,’ the statement said.
‘As we continue to advance these policies to significantly reduce tobacco-related disease and death, including a particular emphasis on protecting kids from the dangers of nicotine, it’s critical that we have an efficient regulatory process that puts novel products like e-cigarettes through an appropriate series of regulatory gates to fully evaluate their risks and their potential benefits. Such products still pose health risks, including possibly releasing some chemicals at higher levels than conventional cigarettes. And those risks require closer scrutiny. We must also take a closer look at how these products impact youth use of nicotine and tobacco, and how they may promote adult cessation of combustible cigarettes.
‘As part of this ongoing work, this week we’re holding a two-day public meeting to discuss the policies and processes for tobacco product application review. The discussion on the tobacco product review process is important because the regulatory review of individual products gives the FDA the ability to evaluate important factors such as ingredients, product design and health risks, as well as their appeal to youth and non-users. ‘For e-cigarettes, for example, under the most likely path for marketing authorization, manufacturers of these products must show that marketing the product is appropriate for protecting the public health, taking into account their risks and benefits to the population as a whole. This includes evaluating whether these products get kids addicted to nicotine – a grave concern that we’re addressing through a variety of tools such as cracking down on the sale and marketing of e-cigarettes to kids and educating youth about the dangers of using these products.’
The full statement is here.They had a plan but …
The US Food and Drug Administration is considering prohibiting the sales of some vapes in convenience stores, according to a story by Jim McDonald for Vaping360 quoting the agency’s Commissioner Scott Gottlieb.
The agency might also restrict online sales, as Gottlieb has already threatened, to try to stem what Gottlieb regularly calls an “epidemic” of teenage vaping.
“We have a sense of where we’re going to be heading from a policy standpoint,” Gottlieb told CNBC’s Squawk Box program.
“We have a problem with access. These products are too accessible to kids. And we have a problem with appeal. These products are too appealing to kids right now. And it’s mostly the cartridge-based e-cigarette products. The open-tank products that you might find in a vaping store aren’t generally used by kids.”
McDonald pointed out that that position was a reversal from the concerns expressed by the agency in its 2016 Deeming Rule. In creating that document, the FDA had carefully plotted a course to cripple and then destroy the open-system vaping market, while encouraging manufacturers to pursue products like pod vapes or cartridge-based systems.
The new plan, meanwhile, would restrict sales in the places smokers are most likely to see and buy vaping products: stores that also sell cigarettes.
Gottlieb said that vape shops seemed to be doing a better job than c-stores and other tobacco sales channels at verifying ID.
Gottlieb seemed to indicate that flavored products might be allowed in vape shops if they were “adult-only.” Such a requirement would require rulemaking by the agency, or legislation in Congress.
The FDA would have to have an objective standard for which flavors – or flavor descriptors – would be allowed in traditional retail channels.
But they would likely face lawsuits from retailers, who would object to an arbitrary rule that prevented only certain stores from selling legal products.FDA issues reminder
The US Food and Drug Administration has issued a reminder that the ingredient-listing compliance deadline for small-scale manufacturers of ‘deemed’ products on the market as of August 8, 2016, is November 8, 2018.
And it is informing those that need additional time to comply with the November 8 deadline because they were directly impacted by recent natural disasters to contact it by email at CTPRegistrationandListing@fda.hhs.gov. The Agency said it would ‘assess each situation on a case-by-case basis’.
‘Deemed tobacco products entering the market after August 8, 2016, must submit the ingredient information at least 90 days before the product is introduced to interstate commerce,’ the FDA said in a note issued yesterday through its Center for Tobacco Products. ‘FDA encourages manufacturers to start the process as early as possible.
‘In April 2018, FDA published a revised Listing of Ingredients in Tobacco Products guidance to assist manufacturers and importers preparing tobacco product ingredient submissions. The guidance announced that FDA currently intends to enforce the ingredient listing submission requirements of section 904(a)(1) only with respect to finished tobacco products and their components or parts that are made or derived from tobacco, or containing ingredients that are burned, aerosolized or ingested during tobacco product use.
‘The guidance also streamlines requirements for manufacturers by clarifying ways in which tobacco product manufacturers or importers can satisfy the ingredient listing requirements by providing one listing that corresponds to multiple products. It explains the statutory requirement to submit a list of all ingredients in tobacco products; who is required to submit ingredient information; what information must be included in the submissions; how and when to submit the information; FDA’s compliance policies; and definitions.
‘In response to industry feedback, FDA has developed three webinars to assist manufacturers with the submission of tobacco product ingredient listings:- Using FDA Tools to Submit Ingredient Listings Electronically;
- Using a Tobacco Product Master File (TPMF) for Ingredient Listing Submissions;
- Examples of Ingredient Listing Spreadsheets by Product Category.’
More information is available at the FDA’s Submit Ingredient Listing for Tobacco Products page.
PATH-study data available
The US National Institutes of Health (NIH) and the Food and Drug Administration (FDA) said yesterday that new data files from the Population Assessment of Tobacco and Health (PATH) Study had been released.
In a note issued through its Center for Tobacco Products, the FDA said the PATH Study was a household-based, nationally-representative, longitudinal cohort study of youth (12-17 years old) and adults in the US. The study was launched in 2011 to inform FDA’s regulatory activities under the Family Smoking Prevention and Tobacco Control Act.
The latest release includes:
* New Wave 3 Questionnaire Public-Use Files (PUF).
‘Data in the third wave were collected from October 2015 to October 2016,’ the FDA said. ‘Public-use questionnaire data files (PUFs) from the third wave of the PATH Study may be downloaded from the National Addiction & HIV Data Archive Program (NAHDAP) of the Inter-university Consortium for Political and Social Research (ICPSR).’
* Updates to Wave 1 Biomarker Restricted-Use Files (BRUF).
‘Data and documentation for five Wave 1 Biomarkers of Potential Harm assay panels were added to the PATH Study Biomarker Restricted-Use Files (BRUF),’ the note said. ‘Data in the first wave were collected from September 2013 to December 2014. The updated files were added to the existing biomarkers of tobacco exposure data in the BRUF, which include measurements of arsenic, creatinine, metals, polycyclic aromatic hydrocarbons, tobacco-specific nitrosamines, nicotine metabolites, and volatile organic compounds in urine and measurements of cotinine and hydroxycotinine in serum. Qualified researchers may apply for access to the PATH BRUF.’
The FDA said it encouraged researchers interested in the PATH Study to join the PATH Study Data User Forum. ‘The forum enables researchers using PATH Study data to submit and answer questions,’ it said. ‘Announcements, data releases and updates, new publications, upcoming events, and other information for PATH Study data users are also posted to the forum.’
There is more information here.Selling CMPs and NTSOs
The US Food and Drug Administration has published five webinars designed to assist retailers and small businesses that have received a civil money penalty (CMP) or a no-tobacco-sale order (NTSO) complaint.
These webinars are:- Introduction to CMP and NTSO Complaints.
- How to Pay a CMP Using the Online Payment Portal.
- How to File an Answer and Consequences for Not Filing an Answer.
- The Settlement Process.
- The Hearing Process.
All five webinars are posted as separate videos so that all five can be watched in order or an individual video watched on its own.
Additionally, the FDA said it had complied a glossary of common terms used with CMPs and NTSOs. The glossary and copies of the webinar slides can be downloaded from the Tobacco Compliance Webinars page.
More information is available here.Setting standards
UL, a global safety science company, said yesterday that Joyetech, a global manufacturer of electronic cigarettes and vaporizers, had become the first organization to certify to UL 8139, a safety standard that evaluates the electrical and battery systems of ‘vaping devices and electronic cigarettes’. The certification was issued to Joyetech’s vapor pen, eGO AIO.
In a press note issued through PR Newswire, UL said it had recently published ANSI/CAN/UL 8139, Electrical Systems of Electronic Cigarettes and Vaping Devices, which had been recognized by the American National Standards Institute (ANSI) and the Standards Council of Canada (SCC), covering the electrical, heating, battery and charging systems of these products. The development of UL 8139 addressed also specific fire safety concerns raised by North American fire officials.
“UL strives to help manufacturers bring safer products to market and empower consumer trust,” said Ghislain Devouge, vice president and general manager for UL’s Consumer Technology division. “UL 8139 is a collaborative effort with government agencies and industry stakeholders to further enhance consumer safety.”
The testing requirements for UL 8139 evaluate the safety of the electrical, heating, battery and charging systems, but the standard does not address devices that have removable battery cells, e-cigarette consumables or the long-term or physiological effects of the consumables.
Joshua Church, chief compliance officer for the Joyetech Group, said Joyetech strived to be a leader in the ENDS [electronic nicotine-delivery system] industry and was constantly looking for ways to ensure the safety of its high-end technology. “For us, this UL 8139 certification is a validation of our commitment to using scientific and expert methods to test our products,” he said. “For our customers, it illustrates our dedication to providing greater peace of mind.”
Meanwhile, Maggie Gowen, executive director of the Global Vaping Standards Association, a non-profit trade group, said the Association had been working toward the introduction of safety standards such as UL 8139 that helped manufacturers bring the best products to the consumer. “Our membership base is dedicated to pursuing higher quality standards, especially those that cover hardware and battery design, she said”E-cig epidemic crackdown
The US Food and Drug Administration says it has sent letters to electronic-cigarette companies seeking to discover if 40 such products are being marketed illegally.
In a note issued through its Center for Tobacco Products, the FDA said the 21 letters that had been sent included those to the manufacturers and importers of the brands Vuse Alto, myblu, Myle, Rubi and STIG.
It said it was ‘seeking information about whether more than 40 products – including some flavored e-cigarette products – are being illegally marketed and outside the agency’s current compliance policy’.
‘These new actions build on those taken by the FDA in recent weeks as part of its Youth Tobacco Prevention Plan to address the epidemic of youth e-cigarette use, including cracking down on the sale and marketing of e-cigarettes to kids and educating youth about the dangers of using these products,’ the note said.
“Companies are on notice – the FDA will not allow the proliferation of e-cigarettes or other tobacco products potentially being marketed illegally and outside of the agency’s compliance policy, and we will take swift action when companies are skirting the law,” FDA Commissioner Scott Gottlieb, M.D, was quoted as saying. “Given the explosive growth of e-cigarette use by kids, we’re committed to taking whatever measures are appropriate to stem these troubling use trends. We’re going to address issues related to the access kids have to e-cigarettes, as well as the youth appeal of these products. If products are being unlawfully marketed and outside the FDA’s compliance policy, we’ll act to remove them.”
‘The FDA has received complaints that some companies may be marketing new products that do not meet the Food Drug and Cosmetic Act’s (FD&C Act) premarket requirements and that were introduced or modified after the deeming rule’s Aug. 8, 2016, effective date,’ the note said. ‘Such modifications could include the introduction of new product features, formulations or flavors. These letters ask companies to provide information about the products in question, including evidence that the product is a deemed product that was on the market as of Aug. 8, 2016 and has not been modified since that date.
‘Any product that does not comply with the premarket requirements of the FD&C Act is adulterated and misbranded and may not be marketed without authorization from the FDA. The agency has several tools to enforce these requirements and its regulations, including pursuing administrative actions such as civil money penalty complaints (fines) or judicial actions such as seizures or injunctions.’
There is more information here.Fontem products compliant
All the vaping products sold by Fontem Ventures in the US were available prior to the effective date of the Food and Drug Administration’s deeming rule, August 8, 2016, according to a note posted on the Imperial Brands website.
‘On 12 October 2018 the US Food and Drug Administration (FDA) stated that it had requested information from 21 manufacturers, including our Fontem Ventures subsidiary in the US, to support their compliance with certain FDA rules on the marketing, sale and distribution of vaping products in the US,’ the note said.
‘All Fontem Ventures products in the US were available prior to 8 August 2016. We will be providing the required supporting information to the FDA in line with its 30-day deadline.
‘We fully recognise the challenge faced by the FDA in balancing the positive public health potential of vapor products with legitimate concerns regarding youth access and responsible marketing.
‘Imperial Brands and Fontem are committed to creating something better for the world’s smokers. Vaping provides a unique opportunity to switch smokers to a healthier alternative but this can only be achieved by responsible businesses operating in appropriately regulated markets.
‘We will continue to engage with the FDA and other regulators around the world to shape the regulation that will encourage smokers to switch, focusing on issues including youth access prevention, product standards, harm reduction and responsible marketing.PMI to webcast results
Philip Morris International is due to host a live audio webcast at www.pmi.com/2018Q3earnings from 09.00 Eastern Time on October 18 to discuss its 2018 third-quarter results, which will be issued about 07.00 the same day.
During the webcast, which will be in listen-only mode, CFO Martin King will discuss the results and answer questions from the investment community and news media.
The audio webcast may be accessed also on iOS or Android devices by downloading PMI’s free Investor Relations Mobile Application at www.pmi.com/irapp.
An archived copy of the webcast and the slides and script will be available until 17.00 on November 16 at www.pmi.com/2018Q3earnings.
