The US Food and Drug Administration has been warned that a proposed local ban on the sale of flavored tobacco products, including flavored e-liquids, could undermine the agency’s comprehensive regulatory plan to fight tobacco smoking.
Today, voters in San Francisco will vote on whether to approve a Board of Supervisors’ ordinance, Proposition E, that includes a ban on the sale of flavored e-cigarettes.
According to a press note from the Consumer Choice Center, proponents of the ban claim the measure is necessary to protect ‘kids’.
“Yet,” according to the Center’s senior fellow Jeff Stier (pictured), “California law already prohibits the sale of all e-cigarettes to anyone under 21. As such, the ordinance would change the legal status of the sale of flavored e-cigarettes to adults exclusively.”
Stier is calling on the FDA to “speak out about how a local ban on the sale of flavored e-cigarettes to adults could undermine the FDA’s comprehensive regulatory plan to fight smoking, given the role flavors in e-cigarettes play in helping adult smokers quit”.
The press note said that the FDA, which was studying whether to regulate e-cigarette flavors, had already noted the potential life-saving nature of e-cigarette flavors, saying that, ‘certain flavors may help currently addicted adult smokers switch to potentially less harmful forms of nicotine-containing tobacco products’.
Stier said that “because the San Francisco Ordinance would do nothing to prevent sales to kids, and everything to ban sales to adults who use flavored e-cigarettes to quit smoking, the FDA should alert the public to how the ordinance would undermine federal anti-smoking efforts”.
Category: Flavors
Ban would impair FDA plan
Flavors vote tomorrow
A proposed ban on the sale of flavored tobacco products in the city of San Francisco, US, has been portrayed as a fight between pro-ban David and anti-ban Goliath, but the allegory doesn’t work because David isn’t the good, little guy he’s made out to be.
In a piece for the Competitive Enterprise Institute, Michelle Minton wrote on Friday that ‘big tobacco’ was pouring millions into a campaign to maintain its ability to keep selling harmful products that target children. ‘At least, that’s the narrative most news outlets have sold about Proposition E, a measure on the city’s June 5th ballot, which would ban the sale of flavors, including menthol, for tobacco products, including e-cigarettes,’ she added as clarification.
‘The David and Goliath story is compelling, but don’t be fooled. The other side, comprised of hundreds of anti-tobacco activists, is just – if not more – powerful than big tobacco companies. These groups have an advantage by cloaking their support of Prop E under the guise of “public health” and the support of factions in government and the university system, along with the industries that compete with e-cigarettes (e.g. big pharma). They also have vast financial resources, including taxpayer money, which they can spend without reporting it as “lobbying”.’
Minton goes on to describe the amounts and types of funding behind this lobbying and ‘non-lobbying’.
And she looks at the situation as it is currently, concluding, in part, that ‘kids, it seems, are neither targeted nor very interested in vaping, despite what anti-vaping activists claim’.
‘However, adult smokers increasingly rely on these devices as a safer means of consuming nicotine.
‘While likely not risk-free, recent analyses estimate that vaping has just one percent of the cancer risk that traditional combustible cigarettes carry.
‘And flavor seems to be an essential element in keeping people from returning to cigarettes. As a 2013 study found, the number of flavors a vaper used was independently associated with smoking cessation.’Flavors defended
The introduction to the city council of Chicago, US, of a measure aimed at banning flavored nicotine cartridges used with electronic cigarettes has been condemned by experts at the free-market think tank, The Heartland Institute.
The measure has been put forward by Alderman Ed Burke.
‘Alderman Ed Burke’s proposed ordinance is nothing more than preening for moralizing anti-fun busybodies,’ said Jesse Hathaway, research fellow, budget and tax policy at the institute.
‘Selling e-cigarettes to individuals under the age of 18 is already illegal in Illinois, so the ordinance’s aims are already addressed by existing laws.
‘Prohibiting the sale of flavored vaping products won’t save any lives, but it may stop people currently addicted to cigarettes from switching to less-harmful alternatives or even kicking the nicotine habit.
‘If Burke’s goal is to promote public health, restricting access to flavoring in e-cigarettes advances the ball in the wrong direction.
‘If Burke’s goal is to look like he’s doing something to gain accolades from the puritan anti-e-cig crowd without actually doing anything useful, then this is perfect.’
Meanwhile, Lindsey Stroud, state government relations manager at the institute, said the role of flavors in electronic cigarettes and vaping devices was crucial – and a motivating factor that had enabled thousands of smokers to quit combustible cigarettes, according to 72 percent of the respondents to a 2015 Consumer Advocates for Smoke-free Alternatives study of 19,000 observations.
‘While attempting to “protect the children,” Alderman Burke ignores the role of tobacco harm reduction (THR) products for adults and is attempting to limit the choices available to help alleviate these individuals from cigarette addiction,’ said Stroud.
‘Rather than placing restrictions on products that have been proven to aid individuals who desire to quit smoking, policy makers should promote the unencumbered use of THR products.’A plain failure of policy
Campaigners have called for an independent ‘root and branch’ review of the impact of all tobacco regulations introduced in the UK since 2010, including that requiring standardized tobacco packaging and a tobacco-products display ban at retail outlets.
The call came after evidence emerged that smoking levels had gone up since the introduction this time last year of standardized packaging and other measures.
‘According to independent research, recent statistics suggest that smoking rates in England were higher than for the same time last year before plain packaging was fully implemented on 20th May 2017,’ a Forest press note said.
‘The figures, published this week by the Tobacco Manufacturers Association, follows evidence that plain packaging has also failed to reduce smoking rates in Australia and France.’
‘In 2012 Australia became the first country in the world to impose standardized packaging on tobacco products. Five years after its implementation, data published by the Australian government showed that the measure had made no significant difference to the daily smoking rate.
‘Instead low-priced cigarettes doubled their market share between 2011 and 2016 (from 29 percent to 60 percent) at the expense of medium- and high-priced cigarettes (from 19 percent to 10 percent) as people switched to cheaper brands.
‘France introduced plain packaging of tobacco products in January 2017. One year later data published by the public authority OFDT showed that the number of cigarettes shipped to retailers remained largely unchanged, with a decrease of just 0.7 percent in 2017.
‘The failure of plain packaging to reduce smoking prevalence in France was acknowledged by health minister Agnès Buzyn during a parliamentary debate. According to the minister, plain packaging “does not lead smokers to quit smoking”. She added that she didn’t know if the introduction of plain packaging in France “has been effective in preventing youth from starting smoking”.
As well as standardized packaging, May 2017 saw the introduction of other tobacco control measures. The European Commission’s revised Tobacco Products Directive forced all EU member states to adopt larger health warnings and prohibit the sale of smaller packs of cigarettes and rolling tobacco. A ban on menthol cigarettes will follow in 2020.
“The experience of Australia, France and Britain suggests that plain packaging doesn’t lead to a decline in smoking rates,” said Simon Clark (pictured), director of Forest, the consumer group.
“Governments blunder on from one tobacco control measure to another, regardless of their impact.
“It’s time for an independent root and branch review of all the tobacco control measures introduced since 2010, including plain packaging and the behind-the-counter display ban.”
The failure of standardized packaging was said to be an indictment of the haste with which the policy was pushed through parliament before the 2015 general election.
“Plain packaging has nothing to do with health,” Clark said. “The decision to introduce it in the UK was based not on evidence that it would reduce smoking rates but on party politics.
“It wasn’t right then and it isn’t right now.”FDA submissions update
The US Food and Drug Administration’s Center for Tobacco products (CTP) has said that it has updated its electronic document submission system.
According to a note issued by the CTP, the update has been made in response to industry feedback.
The update, which includes that to the eSubmitter, is said to have been made to assist manufacturers of deemed tobacco products with navigating the ingredient listing submission process and other online submissions in a quicker and more efficient way.
‘For example, the updated eSubmitter software now:- Has more memory for better overall performance,
- Permits alphanumeric tobacco product (TP) numbers, and
- Allows manufacturers to choose from several preformatted Microsoft Excel .xlsx spreadsheet files, depending on the tobacco product type and number of products.’
More information is available through the FDA website note: FDA Software Helps Tobacco Product Manufacturers Meet FDA’s Compliance Deadlines.
Ingredient listings are due today for non-small-scale manufacturers.Preconceived flavors
South Korea’s Ministry of Health and Welfare has revealed plans to regulate the flavoring of cigarettes, according to a story in The Korea Bizwire.
The Ministry says it will be working alongside other ministries, such as the Ministry of Strategy and Finance and the Ministry of Food and Drug Safety, to pass three bills that would ban or limit flavored cigarettes.
According to the Korea Centers for Disease Control and Prevention, a study of cigarettes carried out by Professor Shin Hosang of Kongju National University in 2016 and 2017 had shown that they contained between two and 28 flavorings.
Meanwhile, professor Kim Huijin, of Yonsei University, reportedly said that 65 percent of 9,063 people between the ages of 13 to 39 who participated in an online survey consumed flavored cigarettes.
Those whose first cigarettes were flavored were said to be 1.4 times more likely to become regular smokers than those who started with cigarettes with no added flavors.
And more than 70 percent of smokers were said to have indicated that the flavor of their cigarettes of choice was an influential factor in trying them for the first time.
The story said that menthol, one of the ingredients used to produce a minty flavor, was known to numb the nerves and minimize the stimulation that users felt when inhaling smoke.
‘As smokers inhale other dangerous substances in cigarettes such as nicotine, the chances of becoming addicted and being exposed to cancer escalates,’ the story said. ‘Theobromine, an ingredient found in cocoa, expands the bronchus allowing nicotine to be absorbed in the lungs.’Listing ingredients
The US Food and Drug Administration has published its revised guidance on the Listing of Ingredients in Tobacco Products.
In a note issued through the FDA’s Center for Tobacco Products, the agency said the guidance was intended to assist manufacturers and importers making tobacco product ingredient submissions to the FDA, as required by the Tobacco Control Act.
The guidance announces that the FDA 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 note said.
‘For example, ingredients of cigarette paper should be submitted to FDA as it is burned during the use of a cigarette and produces constituents that are inhaled by the smoker.’
The note added that, for example, the FDA did not intend to enforce the ingredient listing submission requirement in respect of coils, wicks and mouthpieces.
Information of what components and parts require an ingredient listing submission is at: https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm191982.htm?utm_source=Eloqua&utm_medium=email&utm_term=stratcomms&utm_content=guidance&utm_campaign=CTP%20News%3A%20Listing%20Guidance%20Update%20-%2041318.
The guidance is said to streamline the 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 submits ingredient information, what information is included in the submissions, how and when to submit the information, FDA’s compliance policies, and definitions,’ the note said.
The note issued a reminder to manufacturers and importers of ‘deemed tobacco products’ that were on the market as of August 8, 2016, that the deadline to submit ingredient listings is May 8, 2018. For small-scale manufacturers, the deadline was said to be November 8, 2018.US suffering flavor blur
The findings of two recently-published studies on the emergence of hookah use in the US indicate that public health officials might need to consider broadening their tobacco prevention efforts beyond traditional cigarettes, according to a story by David J. Hill of the University of Buffalo, US, published on medicalxpress.com.
“Taken together, the results from these two studies underscore the important role hookah has played in the tobacco product landscape,” Jessica Kulak, the lead author on both papers, was quoted as saying. Kulak, PhD, is a postdoctoral fellow in the Primary Care Research Institute of the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo.
Kulak published both papers as part of her dissertation through collaborations with colleagues at the Rutgers University School of Public Health and Roswell Park Comprehensive Cancer Center.
The first study, published in March in the American Journal of Health Behavior, examined patterns and trends of hookah use among public high school students in New Jersey.
The findings were said to have shown significant increases in hookah use across three indicators – those who had ever used hookah, those who were currently using hookah and those who smoked hookah frequently.
Overall, 23.6 percent of New Jersey high school students were found to have ever used hookah in 2014, significantly higher than the nearly 18 percent who reported ever using it in 2008, Kulak and her colleagues reported.
In 2014, past 30-day hookah use (11.8 percent) was said to be as high as e-cigarette use (12.1 percent) and higher than other-tobacco-product use. Among all high school students, frequent hookah use increased from 1.6 percent in 2008 to 2.9 percent six years later.
Kulak and her colleagues cited a variety of factors that might be contributing to the popularity of hookah among teens. For example, hookah tobacco was taxed at a lower rate than were cigarettes, and it was sold in a variety of flavors, many of which had been banned in cigarettes.
Many hookah users believed also that it was not as harmful as other tobacco products.
Kulak’s second dissertation-based paper, also published in March in Substance Use & Misuse, looked at hookah’s role in nicotine product initiation among college students.
For this study, Kulak surveyed 832 college students in Western and Central New York. Among study participants who reported having used a nicotine product at some point, 25 percent said hookah was the first product they had tried. Only combustible cigarettes (39.5 percent) were reported more frequently.
Among students who ever smoked cigarettes, most reported these as their introductory product. Nearly half of the students who had never smoked cigarettes reported that hookah was the first tobacco product they smoked.
This study suggested also that hookah users were less likely than were combustible-cigarette smokers to use multiple tobacco products – such as combustible cigarettes, cigars and chewing tobacco.
Based on the findings of the two studies, Kulak said public health agencies might need to consider revising the surveys and other data collection instruments they used to account more accurately for hookah use.
In addition, she said, there were opportunities for further regulation by the US Food and Drug Administration, especially banning flavors in hookah tobacco.
The full story is at: https://medicalxpress.com/news/2018-04-hookah-critical-role-tobacco-product.htmlA flavor of things to come
The US’ Food and Drug Administration has issued an advance notice of proposed rulemaking (ANPRM) in respect of tobacco-product flavors.
In a ‘Special Announcement’ issued through its Center for Tobacco Products, the FDA said it was seeking ‘comments, data, research results, or other information related to the role that flavors, including menthol, play in tobacco product use and potential regulatory options the agency could take, such as tobacco product standards and measures related to the sale and distribution of flavored tobacco products’.
‘This notice, along with another ANPRM issued last week related to reducing nicotine in cigarettes to minimally addictive or non-addictive levels, is part of the FDA’s comprehensive plan on tobacco and nicotine regulation, as announced in July 2017.
‘FDA values the public’s input through the comment process and will consider all submissions as it considers possible regulatory actions on these topics. If FDA decides to issue a rule, the first step would be to issue a notice of proposed rulemaking in the Federal Register, which would give the public another opportunity to comment on the proposal.’
The ANPRM on the role of flavors in tobacco products was made available for comment for 90 days from yesterday.
Meanwhile, the FDA Commissioner Scott Gottlieb, MD, issued a 1,400-word statement on the flavors ANPRM in which he said, in part, that, ultimately, the FDA was working to ensure its policies achieved the greatest public health benefit.
‘As such, we’re proceeding with the utmost caution by securing more information about both the potential positives and negatives of flavors in youth initiation and getting adult smokers to quit or transition to potentially less harmful products. ‘Through this lens, the ANPRM we’re issuing today seeks comments, data, research results or other information on topics, including, but not limited to:- The role that flavors play in initiation and patterns of tobacco use, particularly among youth and young adults;
- The role that flavors may play in helping some adult cigarette smokers reduce cigarette use and/or switch to potentially less harmful tobacco products;
- The role that flavors in non-combusted tobacco products may play in quitting combusted tobacco products use, quitting all tobacco use or starting to use more than one type of tobacco product;
- Consumer perceptions of health risks and addictiveness of flavored tobacco products;
- Whether certain flavors used in tobacco products present potential adverse health effects to users or others; and
- The impact of local, state and international efforts to restrict the sale or marketing of flavored tobacco products.
Gottlieb’s piece is at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm601690.htm
Into the Cosmic Fog
The Netherlands-based Fontem Ventures said today that it had acquired an equity stake in Cosmic Fog Vapors, which it described as ‘an iconic innovator in high quality e-vapor liquids’.
‘Founded in 2013 [in California, US] by Brant Peto and Rob Crossley, Cosmic Fog has an excellent reputation for developing unique flavours with significant appeal to adult vapers,’ Fontem said in a press note. ‘Their products are sold in more than 5,000 vape stores in the USA and in more than 60 countries around the world.’
Liquids are the largest contributor to the value of the global e-vapor sector.
“[W]e’re excited about this partnership with Cosmic Fog,” said Fontem’s CEO, Titus Wouda Kuipers (pictured). “Working alongside them shows our commitment to seeing the vaping category grow and prosper.
“Becoming a partner in Cosmic Fog demonstrates that we love their passion and entrepreneurship. We see a great opportunity to learn from their expertise, particularly in the vape shop sales channel.
“Cosmic Fog will continue to do what it does best – develop unique, high quality liquids with huge appeal to adult vapers.”
Meanwhile, Peto said the partnership allowed Cosmic Fog to leverage Fontem’s experience in e-vapor, including in regulatory compliance, ensuring that Cosmic Fog’s customers enjoyed continued access to its products as international e-vapor markets matured.
And Crossley was quoted as saying the partnership was hugely beneficial, not only to Cosmic Fog but to the category as a whole, because it demonstrated Fontem’s support for a variety of vaping formats, including open systems.
