A second woman has filed a lawsuit in the US against the UC San Francisco professor and prominent tobacco control activist Dr. Stanton Glantz, who last year was accused of sexual harassment by a former female researcher at the school, according to a story by Laura Waxmann for the San Francisco Examiner.
Former research associate Juliette Jackson is seeking unspecified damages for claims that Glantz, who heads UCSF’s Center for Tobacco Research and Education, created a ‘sexually-charged’ and hostile work environment in which he allegedly ‘repeatedly leered at Jackson’s and other females’ breasts,’ according to the complaint.
The lawsuit, filed in Alameda County Superior Court, comes after a sexual harassment lawsuit filed in December by Eunice Neeley, a former doctoral researcher whom Glantz mentored for about two years.
A spokesperson for UCSF said the school “cannot comment on litigation”.
In an email to the San Francisco Examiner, Glantz pointed to a blog post he authored in December, in which he denied both Neeley and Jackson’s claims. He also alleged that Neeley and Jackson had been ‘collaborating in their efforts’ against him ‘for over a year’.
Tag: United States
Harassment alleged
Prohibition Lite on the way
In a piece on the Reason website, J.D. Tuccille posits that there’s no particular reason to think that smokers will be happier with denatured tobacco than drinkers have been with weak beer.
In examining the US Food and Drug Administration’s proposal to lower nicotine in cigarettes to minimally or non-addictive levels, Tuccille says that low-nicotine cigarettes sound a lot like the 3.2 percent beer that plagued much of the country after Prohibition. ‘Nobody was happy with the diluted swill, and they tolerated it only if they couldn’t smuggle in something better,’ he writes. ‘Most places have since dumped it, indicating that a taste for the unadulterated product remained strong even after years of restrictions.’
Tuccille’s piece ends by saying that FDA Commissioner Scott Gottlieb’s proposal to mandate low-nicotine cigarettes looks a lot like other well-intentioned but presumptuous efforts to substitute the will of regulators for the desires of the public – Prohibition Lite. And like all such efforts, he says, it’s likely to get people turning up their noses and looking for something better.
Tuccille’s piece is at: https://reason.com/archives/2018/03/26/fdas-low-nicotine-cigarette-scheme-is-an.FDA 'messing' with cigars
The US Food and Drug Administration has issued an advance notice of proposed rulemaking (ANPRM) seeking comments and scientific data related to the patterns of use and resulting public health impacts of ‘premium’ cigars.
In a note issued through its Center for Tobacco Products (CTP), the agency said it was specifically requesting comments and information not previously submitted in response to its proposed deeming rule.
Submissions, it is said, will be used to inform the agency’s regulatory policies.
The note said that, in 2016, the FDA had finalized the deeming rule extending its authority under the Family Smoking Prevention and Tobacco Control Act to tobacco products not already under its authority, including e-cigarettes, cigars, pipe tobacco and hookah tobacco, among others. The rule included provisions making the sale of these products subject to a range of requirements, such as mandatory age and photo-ID checks to prevent illegal sales to minors; warning statements; submission of health documents; and the prohibition on marketing modified risk products without an FDA order in effect.
‘When proposed, the deeming rule put forth two, alternative regulatory options, one of which would have excluded so-called “premium” cigars from FDA regulation,’ the note said. ‘After carefully considering the public comments on the rule, FDA concluded all cigars pose serious negative health risks, and the evidence did not provide a public health basis for FDA to exclude any type of cigars from regulation.’
Mitch Zeller, director of the FDA’s CTP, said all tobacco products, including ‘premium’ cigars, remained subject to manufacturing, distribution and marketing oversight by FDA.
“However, given the ongoing interest from many parties on this issue ‒ as well as the potential for new data on the topic since the deeming rule published ‒ we’re providing stakeholders an opportunity to submit relevant new information that could inform FDA’s regulation of ‘premium’ cigars.”
Through the premium cigars ANPRM, the agency is requesting comments, data, research results, or other information not submitted in response to the proposed deeming rule on topics including, but not limited to:- ‘The definition of ‘premium’ cigars;
- Use patterns of ‘premium’ cigars generally and among youth and young adults specifically;
- Public health considerations associated with ‘premium’ cigars, including the health effects;
- Studies or information regarding consumer perceptions of the health risks of ‘premium’ cigars; and
- Studies or information on whether any applicable manufacturing, marketing, sale, distribution, advertising, labeling, and/or packaging requirements and restrictions should be applied differently to ‘premium’ cigars compared to other tobacco products, including other cigars.’
The ANPRM will be available for comment from March 26 through June 25.
The ANPRM is one of three previously announced in July 2017 as part of FDA’s comprehensive plan on nicotine and tobacco regulation,’ the note said. ‘Earlier this month, FDA published the other two ANPRMs, “Tobacco Product Standard for Nicotine Level of Combusted Cigarettes” and “Regulation of Flavors in Tobacco Products”.
‘The comprehensive plan serves as a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease and death.’A 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
Modified risk application
Altria said on Tuesday that its smokeless tobacco business, US Smokeless Tobacco Company, had submitted to the US Food and Drug Administration a Modified Risk Tobacco Product application for its Copenhagen® Snuff Fine Cut moist smokeless tobacco product.
‘Altria aspires to be the US leader in authorized, non-combustible, reduced-risk products,’ the company said in a note posted on its website.
‘This action furthers Altria’s plan for submitting reduced-harm product applications with the FDA on a range of non-combustible tobacco products.
‘FDA will now undertake an administrative review to determine whether to accept the application for substantive review.’Legislating against nuisance
A bill due to be introduced in New York City Council today would ban smoking a cigarette while walking along a city sidewalk, according to a story in the New York Daily News.
Under the bill, smokers standing on one spot on the sidewalk would be allowed to light up.
Councilman Peter Koo said he wanted to spare fellow pedestrians the nuisance of being caught behind a smoker and breathing in second-hand smoke.
“It has happened to me many times – I’m walking behind someone who’s smoking, and I’m suffering for five or 10 minutes,” Koo said.
“I see mothers with their strollers walking behind people who smoke, and they’re exposing the baby to second-hand smoke.”
The Daily News story said it was already illegal to smoke in city parks, as well as inside bars, restaurants, stores and other indoor public places.
If the new legislation passed, pedestrians caught blowing smoke could be hit with a $50 fine, the same penalty that applies in parks.
The smoking-while-walking ban would also apply to street medians and Parks Department parking lots.
The Councilman said he was moving to legislate what should be common courtesy.
“In a perfect world, every smoker would have the self-awareness to realize smoking while walking subjects everyone behind you to the fumes,” he said.
There was no mention in the story of the vehicle fumes that are mostly exhausted at stroller height.Imperial drops US OTP
Imperial Brands announced today the ‘disposal’ in the US of a range of other tobacco products, including roll-your-own brands, tubes, tips, cigarette papers and other accessories.
In a note posted on its website, Imperial said the disposal simplified its portfolio in the US, ‘enabling us to further sharpen our focus on driving revenue growth in the USA from our core US tobacco brands and next generation products’.
“We are clear on our strategic priorities and focus for growth and are proactively actioning capital reallocation opportunities to generate additional shareholder value,” said chief executive, Alison Cooper (pictured). “The disposal of our US OTP business is an example arising from the ongoing review of our assets.
“In next generation products, we are focused on delivering an exceptional consumer experience and we are investing behind an exciting innovation pipeline. Our product and market launch programs are on track with the recent launches of myblu in the USA and the UK, with additional markets coming on stream in the next few months. In tobacco, our investment focus continues to deliver share gains in our Growth Brands and priority markets.”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.Strung out on nicotine
The US Food and Drug Administration says that its release of an advance notice of proposed rulemaking (ANPRM) in respect of nicotine is a major step on the path to changing ‘dramatically’ the future of smoking in the US and saving millions of lives.
The ANPRM, Tobacco Product Standard for Nicotine Level of Combusted Cigarettes, is seeking public comment for consideration in developing a potential nicotine product standard.
The FDA believes that lowering nicotine to a minimally- or non-addictive level ‘could potentially save millions of lives, both in the near and long-terms’.
‘The ANPRM includes newly published estimates of one possible policy scenario for a nicotine product standard, including that approximately five million additional adult smokers could quit smoking within one year of implementation, compared to the baseline scenario,’ the FDA said in a note issued through its Center for Tobacco Products.
‘However, an even greater impact could be felt over time: by the year 2100, its estimated more than 33 million people – mostly youth and young adults – would have avoided becoming regular smokers. This could result in more than eight million fewer tobacco-caused deaths through the end of the century.
‘In July 2017, FDA Commissioner Scott Gottlieb, M.D., announced a new comprehensive plan that places nicotine – and the issue of addiction – at the center of the agency’s tobacco regulation efforts. As the cornerstone of the plan, the release of today’s [March 15] ANPRM is a major step on the path to dramatically changing the future of smoking in the United States and saving millions of lives.’
More information is at: https://www.fda.gov/TobaccoProducts/NewsEvents/ucm600955.htm?utm_source=Eloqua&utm_medium=email&utm_term=StratComms&utm_content=webemail&utm_campaign=CTPConnect%26News%26SOS%3A%20Special%20Announcement%20Nicotine%20ANPRM%20-%2031518.
Meanwhile, Gottlieb said in a statement that the ANPRM provided a wide-ranging review of the current scientific understanding about the role nicotine played in creating or sustaining addiction to cigarettes. It sought comments on key areas, as well as additional research and data for public review, as the FDA continued its consideration of developing a nicotine product standard.
‘We’re interested in public input on critical questions such as: what potential maximum nicotine level would be appropriate for the protection of public health?,’ the statement said. ‘Should a product standard be implemented all at once or gradually? What unintended consequences – such as the potential for illicit trade or for addicted smokers to compensate for lower nicotine by smoking more – might occur as a result? As we explore this novel approach to reducing the death and disease from combustible cigarettes, it’s critical that our policies reflect the latest science and is informed by the input we receive from our meetings with stakeholders, comments to the open public docket and future opportunities for comment.’
Gottlieb said also that the FDA’s plan demonstrated a greater awareness that nicotine, while highly addictive, was delivered through products on a continuum of risk, and that in order to address cigarette addiction successfully, it had to make it possible for current adult smokers who still sought nicotine to get it from alternative and less harmful sources.
‘To that end, the agency’s regulation of both novel nicotine delivery products such as e-cigarettes and traditional tobacco products will encourage the innovation of less harmful products while still ensuring that all tobacco products are put through an appropriate series of regulatory gates to maximize any public health benefits and minimize their harms,’ Gottlieb said. ‘This will be achieved through our ongoing regulatory work to develop several foundational rules, guidances, product standards and other regulations.’
Gottlieb said also that the FDA planned shortly to issue two additional ANPRMs: one to seek comment on the role that flavors – including menthol – played in initiation, use and cessation of tobacco products. ‘A second ANPRM will solicit additional comments and data related to the regulation of premium cigars.
‘At the same time we’re also jump-starting new work to re-evaluate and modernize our approach to the development and regulation of safe and effective medicinal nicotine replacement products such as nicotine gums, patches and lozenges that help smokers quit. This is a pivotal part of our overall public health approach.’
Gottlieb’s statement is at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm601039.htm.Evidence is full of holes
Scientists from multiple institutions are gathering evidence to assist the US Food and Drug Administration in making a decision about whether to recommend design changes to filtered cigarettes, according to a Virginia Tech story published on medicalxpress.com.
The scientists, who include a group of addiction neuroscience researchers from the Virginia Tech Carilion Research Institute (VTCRI), are being funded by the National Institutes of Health’s National Cancer Institute.
Warren Bickel, the Virginia Tech Carilion behavioral health research professor and director of the VTCRI Addiction Recovery Research Center, along with VTCRI co-investigators and research assistant professors Mikhail Koffarnus and Jeff Stein, are said to be spearheading one of three integrated projects involving teams of multidisciplinary investigators who are charged with determining whether ventilated filters on cigarettes have been a boon or bane to public health.
VTCRI scientists will focus on how ventilated filters on cigarettes, product packaging and messaging have affected cigarette use, and how alternative nicotine delivery systems – such as electronic cigarettes – can be used to modify smoking behavior.
“My piece of the puzzle is to understand the role of filter ventilation on the likability and addictive potential of cigarettes,” said Bickel, who is also a professor in the Department of Psychology in Virginia Tech’s College of Science. “We are going to see how smokers respond to the same tobacco product, with and without filter ventilation. We want to understand the impact of the ventilated and unventilated products on how likely people will want to smoke. We also want to determine if filter ventilation reinforces smoking activity and thereby increases the likelihood of addiction.”
When they were introduced in the 1960s, ‘light cigarettes,’ which had tiny ventilation holes in the filters, were thought to be a safer, cleaner way to smoke because they purportedly lowered the amounts of tar and nicotine exposure.
However, a 2014 Surgeon General’s Report named ventilation in cigarette filters as a potential contributor to lung cancer.
And in 2017, an influential study in the Journal of the National Cancer Institute recommended that the FDA consider regulating filter ventilation.
The story is at: https://medicalxpress.com/news/2018-03-scientists-unfiltered-truth-cigarettes.html.
