Tag: United States

A difficult question
A US public health expert has made the point that people – young people in this case – who vape are not tobacco users. They are vapers.
Dr. Michael Siegel, a professor in the Department of Community Health Sciences, Boston University School of Public Health, was responding to a press release issued by city attorney Dennis Herrera and supervisor Shamann Walton announcing the introduction of legislation to ban the sale of all electronic cigarettes in the city of San Francisco.
In part, Siegel’s point-by-point response to the press release focuses on the seemingly strange disconnect between the way that e-cigarettes and combustible cigarettes are viewed by legislators.
This is the second point of the press release that Siegel addressed:
“San Francisco has never been afraid to lead,” Herrera said, “and we’re certainly not afraid to do so when the health and lives of our children are at stake.”
And this is what Siegel had to say:
‘San Francisco is apparently afraid to lead because they are willing to take the politically expedient step of requiring safety testing for e-cigarettes, but they are not willing to place the same requirement on real cigarettes. In fact, tobacco cigarettes have already had their safety testing and they failed miserably. If San Francisco wants to lead, then why isn’t it taking cigarettes off the shelves?’
Siegel’s The Rest of the Story blog is here.
March 26, 2019
Hyperbole epidemic
US Health and Human Services (HHS) Secretary Alex Azar and departing Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, penned an op-ed in The Washington Post last week warning of a regulatory crackdown on the electronic cigarette industry if teen use didn’t decline, according to a story by Tal Axelrod published at thehill.com.
Gottlieb, who announced his resignation earlier this month, has repeatedly raised concerns about teenage use of e-cigarettes. And the FDA threatened earlier this year to take these products off the market if vaping rates didn’t drop in the coming months.
‘The e-cigarette craze among teenagers has become an epidemic,’ the two wrote in the joint op-ed.
‘We agree with those who believe that e-cigarettes may offer a lower-risk alternative for adult smokers who still want access to nicotine. But the continued availability of this opportunity to adults is being endangered by the e-cigarette industry’s slowness to address the dangers its products pose to teens.
‘While we pursue changes to regulatory policy, we call on the industry – manufacturers and retailers – to step up with meaningful measures to reduce the access and appeal of e-cigarettes to young people.’
March 26, 2019
FDA final guidance
US vape shops that modify a product so that it is deemed by the US Food and Drug Administration to be a ‘new tobacco product’ are required to comply with the agency’s premarket authorization requirements, according to a final FDA guidance.
In a note issued through its Center for Tobacco Products, the FDA said it had posted a notice in the Federal Register announcing the publication of the final guidance, Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops. This guidance was said to finalize the draft guidance of the same title, which was available for public comment on January 17, 2017.
‘Under section 903(a)(2)(C) of the Food, Drug, and Cosmetic Act [FD&C], a tobacco product in package form is misbranded if its label does not include an accurate statement of the percentage of tobacco used in the product that is foreign-grown and domestic-grown,’ the note said. ‘This guidance clarifies FDA’s interpretation of this as applying only to tobacco products that are made or derived from tobacco. Tobacco products (such as components, parts, and accessories) that are not made or derived from tobacco would not be required to bear the statement.
‘Additionally, at this time, FDA does not intend to enforce this requirement for certain products, including tobacco-derived liquid nicotine, e-liquid made or derived from tobacco, cigars, smokeless tobacco, and waterpipe tobacco. FDA is providing this compliance policy as the agency recognizes the current scientific and technical difficulties of quantifying the percentage of foreign and domestic tobacco used in these products.
‘The guidance also clarifies [that] vape shops that are tobacco product manufacturers are subject to the requirements in section 904(a) and (c) of the FD&C Act, including the requirements to provide ingredient listings, report harmful and potentially harmful constituents, and submit health documents. Those vape shops that modify a product so that it is a new tobacco product are required to comply with the premarket authorization requirements. Vape shops that are engaged in the manufacture, preparation, compounding, or processing of tobacco products are required to comply with the establishment registration and product listing requirements in section 905 of the FD&C Act.
‘The final guidance explains certain activities which modify a product, and which would subject the vape shop to the requirements of the Act that apply to manufacturers and includes a compliance policy for limited circumstances for which FDA does not intend to enforce these requirements…’
March 25, 2019
E-cig epidemic explodes
The US Food and Drug Administration Commissioner Scott Gottlieb, MD, has said that his agency might need to pull pod-based nicotine products off the market to fight teen vaping, according to a story by Anna Edney published by the LA Times.
Speaking at the Brookings Institution on Tuesday, Gottlieb said he had had a contentious meeting last week with executives of Altria and Juul Labs.
“The e-cigarette industry has been overly dismissive” of the risk that young people could become addicted to nicotine through e-cigarette use, Gottlieb said. “We’re capturing an exploding epidemic right now.”
Gottlieb said the FDA was working on defining what constituted a pod-based product in case it needed to ban them temporarily.
Sales of vaping pods could resume if manufacturers showed that their devices were geared toward adult cigarette smokers trying to quit, and not toward young people.
“It was a difficult meeting,” the commissioner said, noting that there was a “disconnect” between the companies’ priorities and those of health officials.
He added that it appeared Altria’s decision to purchase a stake in Juul was purely a business decision and not driven by public health concerns.
Edney said that Altria and Juul hadn’t responded to Gottlieb’s characterization of the meeting.
But she added that both companies said they remained committed to combating underage use of e-cigarettes.
March 21, 2019
E-cig ban proposed
Two San Francisco officials on Tuesday introduced bills that would ban the sale of electronic cigarettes in the city until the US Food and Drug Administration had evaluated their effect on public health, according to a story at cbsnews.com.
Supporters say that if the ban is approved, it will be the first in the country.
City Attorney Dennis Herrera and Supervisor Shamann Walton also proposed a bill at a Board of Supervisors meeting that would prohibit companies that make, sell and distribute tobacco products, including e-cigarettes, from occupying city-owned property.
The San Francisco Chronicle was quoted as saying that tobacco companies were already barred from doing business on city property, but that the proposed legislation would embrace e-cigarettes.
It wouldn’t apply retroactively, so Juul Labs would be allowed to stay in space it rents for its headquarters at Port of San Francisco property on Pier 70. But, says the Chronicle, e-cigarette companies wouldn’t be able to lease city property in the future.
Juul said in a statement to CBS News that the proposed legislation would limit adult smokers’ access to e-cigarettes that could help them kick regular smoking habits.
‘We encourage the City of San Francisco to severely restrict youth access but do so in a way that preserves the opportunity to eliminate combustible cigarettes,’ Juul said.
“This proposed legislation begs the question – why would the City be comfortable with combustible cigarettes being on shelves when we know they kill more than 480,000 Americans per year?”
Herrera said San Francisco, Chicago and New York had sent a joint letter demanding that the FDA begin its review. He said the review should have been done before e-cigarettes ever hit the market.
March 21, 2019
That’s some ‘problem’
A public health expert in the US has set out to answer a question that has probably popped into many heads in recent times: why does vaping seem so threatening to the tobacco control movement?
Writing on his blog, The Rest of the Story, Dr. Michael Siegel (pictured), a Professor in the Department of Community Health Sciences, Boston University School of Public Health, starts off by saying that he and his colleagues in the tobacco control movement had based their entire careers on the principle that it was wrong to lie to the public.
On the other hand, much of their campaign against Big Tobacco had been based on the contention that cigarette companies lied to the public about the health risks of smoking.
However, Siegel said he believed that during the past few years the tobacco control movement had largely abandoned truth as a central value in so far as its campaigns against vaping were concerned.
Why is vaping so threatening to the tobacco control movement? he asks. Is it threatening because it is extremely dangerous – basically as harmful as smoking – and is therefore harming the health of the nation’s 11 million adult vapers?
No, he replies to his own question; it’s precisely the opposite…
‘The problem with vaping is that it is not killing anyone, so there is no punishment for the vice of being addicted to nicotine,’ he said. ‘And that’s something that the tobacco control movement can simply not tolerate.’
March 19, 2019
Of mice and smokers
Philip Morris International has said that the results of a new study add to the existing evidence that switching smokers to smoke-free products can be part of a successful tobacco-harm-reduction strategy for adult smokers worldwide.
The study was conducted on mice, which were exposed to air, cigarette smoke, or three formulations of e-cigarette vapors for three hours/day, five days/week for six months via a ‘whole-body inhalation system’ [a whole-body inhalation system, though not necessarily the one used in the study, is described here].
In a note posted on its website yesterday, PMI said that it had presented ‘today’ the results from a new study on electronic cigarettes at the 58th Annual Society of Toxicology Meeting in Baltimore.
‘The study demonstrates that after six months, e-cigarette vapors with and without nicotine induced a significantly lower biological responses associated with cardiovascular and pulmonary diseases than cigarette smoke,’ the note said.
‘The study, conducted in collaboration with Altria Group, Inc., assessed the biological response of mice exposed to e-cigarette vapors compared with that of exposure to cigarette smoke.
‘According to the World Health Organization, there are more than one billion people worldwide who smoke cigarettes and will continue to smoke in the foreseeable future. ‘Tobacco harm reduction can play an important role by supplementing existing tobacco control strategies to help reduce the risk of smoking-related diseases.
‘For harm reduction to be successful, current adult smokers need access to smoke-free products that deliver nicotine but with significantly lower levels of toxicants than cigarettes.’
Dr. Julia Hoeng, PMI’s director of systems toxicology was quoted as saying that the results of the study comprised “a powerful addition to the evidence showing that switching to e-cigarettes is a much better choice than continuing to smoke”.
“This study truly is a landmark study, not just demonstrating the reduced toxicity and disease risk between e-cigarettes and cigarettes but also evaluating the role of nicotine and flavors.”
March 15, 2019
Focus on young people
British American Tobacco has said that it will continue to work with the US Food and Drug Administration as the agency advances new policies aimed at preventing youth access to flavored tobacco products.
The FDA Commissioner Scott Gottlieb, MD, yesterday made a statement on preventing young people from obtaining such products; as described on this website yesterday under the heading Haste urged.
“We welcome the FDA … shining a spotlight on the important issue of youth access to vapor products,” a BAT spokesperson was quoted as saying in a note posted on the company’s website. “We have always been clear that youth should not use vapor products and have had stringent measures in place to address this for some time.
“In relation to today’s announcement, we share the FDA’s concerns that some flavors, such as those resembling ‘kid-friendly’ food products, may play a role in increasing youth appeal and that marketing activities should not be directed to youth. We have never marketed such vapor flavors; we have supported measures to remove vapor products intended to mimic children’s food products or otherwise designed to target youth and have procedures in place to ensure our products are only marketed to adult tobacco consumers.
“We believe flavors are important in helping adult smokers migrate away from cigarettes, and the flavors we market are directed at helping adult smokers who are looking for a potentially less harmful alternatives to cigarettes.
“We already have third-party age verification processes for online sales. We will work with our many convenience retailers to ensure that tobacco, mint and menthol, which are our top selling flavours, remain available for consumers who are looking for potentially less harmful alternatives to cigarettes. We also have plans to make our flavored products available in other age restricted locations, including in specialist vape stores. As with all our retail partners, we will work with any new partners who stock our products to ensure they have appropriate age verification mechanisms.
“In respect of the proposals on bringing forward the PMTA [FDA pre-market tobacco applications] date for flavored products, given our years of product development and scientific assessment of our vapor products, we are well-positioned to file PMTAs for our VUSE products and plan to do so ahead of the 2021 deadline.
“We will continue working with the FDA as the agency moves this proposed compliance change forward over the coming weeks. We will be submitting comments for the FDA to review and consider as the agency works to finalise the guidance document.”
March 14, 2019
FDA acting chief named
Ned Sharpless, the director of the US’ National Cancer Institute, is expected to be named as the temporary chief of the Food and Drug Administration, according to a story by Anna Edney for Bloomberg News.
Sharpless is due to serve as acting head of the agency when commissioner Scott Gottlieb leaves later this year, the Health and Human Services Secretary Alex Azar was quoted as saying at an appearance on Capitol Hill on Tuesday.
Edney said that the appointment of Sharpless could allay the concerns of health advocates that Gottlieb’s departure would signal a let-up in the FDA’s crackdown on flavored electronic cigarettes and teen smoking. Sharpless has apparently supported Gottlieb’s efforts to stem what the commissioner has called an “epidemic” of smoking among young people.
In addition, Edney said, the National Cancer Institute had worked closely with the FDA to fund research related to e-cigarette use, including the device’s impact on smoking cessation.
March 14, 2019
Appointment at LLFlex
LLFlex has hired Curtis Conley as director of global supply chain.
In this role, Conley will be responsible for all aspects of the company’s supply chain operations, including inventory control, supplier management, logistics and customer service.
Prior to joining LLFlex, Conley served as a global commodity manager at Woodward, Inc, and for Amcor Flexible Packaging.
LLFlex is said to be North America’s largest supplier of cigarette inner bundling material, as well as custom-printed laminations for cigar, pipe and smokeless tobacco.
March 12, 2019