Tag: United States

  • Lawsuit being retired

    Lawsuit being retired

    The Altria Group and Philip Morris USA said yesterday that they and other US companies had agreed on the timing of court-ordered communications about cigarettes and smoking on television and in newspapers.

    ‘The communications, which will begin on November 26, 2017, stem from a 1999 lawsuit the federal government brought against the major domestic cigarette companies that focused on industry conduct dating back to the 1950s,’ according to a note posted on the Altria website.

    ‘The court’s order requires the companies to publish five statements related to cigarette smoking across several communication channels, including newspaper and television ads, on the companies’ websites and on cigarette packs for a year or more.’

    In describing the background to the federal government’s action, Altria said that, in 1999, the US government had filed a lawsuit in the US District Court for the District of Columbia against various cigarette manufacturers and their parent companies asserting claims under various federal statutes. ‘The lawsuit sought to recover billions of dollars in health care costs for tobacco-related illnesses,’ Altria said. ‘The government also sought disgorgement of company profits and an injunction prohibiting certain actions by defendants.

    ‘The court eventually dismissed all of the government’s claims but one, and rejected the monetary penalties the government sought.

    ‘In August 2006, the court entered judgment in favor of the government on its remaining claim. The court issued findings related to the companies’ conduct and a permanent injunction that is in place today.’

    Altria said that, as part of the injunction, the court had ordered the defendants to make certain ‘corrective statements’ related to issues raised in the litigation. And since 2006, the parties had vigorously litigated aspects of the injunction, including the content of the corrective statements.

    “This industry has changed dramatically over the last 20 years, including becoming regulated by the FDA, which we supported,” said Murray Garnick, Altria’s executive vice president and general counsel. “We’re focused on the future and, with FDA in place, working to develop less risky tobacco products.”

    Altria said that today, tobacco was one of the most regulated industries in the country. The way in which cigarettes were manufactured, marketed and sold had changed markedly since the lawsuit was filed. And, according to government data, underage cigarette smoking had declined to historical lows – from 28.3 percent in 1997 to 5.9 percent in 2016.

    ‘The 1998 tobacco settlement agreements with the state attorneys general led to significant industry changes,’ it said. ‘For example, the settlement agreements banned cigarette billboards, stadium advertisements and brand-name merchandise.

    ‘Restrictions became more extensive in 2009 when Congress gave the US Food and Drug Administration broad regulatory authority over nearly every aspect of tobacco product manufacturing and marketing.’

    “We remain committed to aligning our business practices with society’s expectations of a responsible company, said Garnick. “This includes communicating openly about the health effects of our products, continuing to support cessation efforts, helping reduce underage tobacco use and developing potentially reduced-risk products.”

  • Children miss out

    Children miss out

    The US Congress failed to extend funding for the Children’s Health Insurance Program (CHIP) by the October 1 deadline, a program that is supported by tobacco taxes, according to a halfwheel.com story relayed by the TMA.

    CHIP is a Federal program that was expanded in 2009 with funding coming from federal excise tax increases on tobacco products.

    The tax increases remain in effect.

    The 2009 expansion levied a federal excise tax of 52.75 percent on cigars, capped at 40.26 cents per piece, on every cigar imported to the US, and increased the federal tax on cigarettes from 39 cents to $1 per pack.

    “Tax itself is statute,” said Daniel Trope, director of federal government affairs for the International Premium Cigar and Pipe Retailers Association.

    “If anything, (the money will) just go to general treasury but the tax remains in perpetuity.”

  • Recruiting for nicotine study

    Recruiting for nicotine study

    Participants are being sought for a US study to assess nicotine uptake from electronic- and combustible-cigarettes, according to a note on the clinicaltrials.gov website.

    The stated purpose of the study, which is being sponsored by RAI Services Company, a subsidiary of Reynolds American, is: ‘To determine the rate and amount of nicotine uptake with 10-minute ad libitum use of five different marketed electronic cigarettes, or one combustible cigarette (CC). Furthermore, to measure overall product liking by subjects to assess potential willingness to seek out the Electronic Cigarette (EC) again in the future.’

    The website described the study as ‘a single-center, randomized, open-label, parallel study during which up to 210 healthy adult subjects [21-60 years of age], consisting of 35 subjects per product group, will be enrolled’.

    ‘Subjects will be evaluated for plasma nicotine uptake, as well as overall product liking,’ according to the description.

    ‘The study will involve the use of five different marketed ECs or one CC in tobacco consumers who are exclusive smokers (i.e., naïve EC users) or dual users of cigarettes and ECs (i.e., intermittent EC users).’

  • ‘Cruel’ research suspended

    ‘Cruel’ research suspended

    The US Food and Drug Administration has announced that it has suspended experiments on the effects of nicotine on squirrel monkeys, according to a story by Laurie McGinley for the Washington Post.

    The British primatologist Jane Goodall had written to the FDA Commissioner Scott Gottlieb urging an end to what she called ‘cruel and unnecessary’ and ‘shameful’ research.

    He responded by saying that he had put a hold on the study this month ‘after learning of concerns related to the study you referenced’. He said also that he had sent a medical team of primate experts to the FDA facility – the National Center for Toxicological Research in Arkansas – ‘to evaluate the safety and well-being of the monkeys and to understand whether there are additional precautions needed’.

    Goodall was enlisted in the fight against the monkey tests by the White Coat Waste Project (WCWP), an organization ‘fighting an epidemic of government secrecy about taxpayer-funded animal experiments’.

    Justin Goodman, vice president of advocacy and public policy at WCWP, told Tobacco Reporter in an email exchange earlier this year that, in December 2016, the WCWP had filed with the FDA a request under the Freedom of Information Act (FOIA) for information relating to the agency’s squirrel monkey experiments.

    In response, in January this year, the FDA apparently provided 64 pages of documents. However, the agency had redacted cost information and failed to produce some of the requested items, including veterinary records, adverse animal welfare event reports, and photographs and videos.

    In March 2017, the WCWP filed various appeals regarding improper redactions and the missing items, and the FDA acknowledged receiving them, but by the end of July it had not responded or provided the outstanding documents and information requested.

    The WCWP said that all the FDA’s redactions and document withholdings constituted violations of federal FOIA laws, and that, consequently, its legal team on August 8 had filed a lawsuit challenging the FDA’s open records failure.

    McGinley wrote that both the Jane Goodall Institute and the WCWP had praised the commissioner’s suspension of the experiments.

    But Goodman, in an email to Tobacco Reporter on Tuesday, said that the WCWP’s lawsuit was proceeding, as of now.

  • 22nd Century set free

    22nd Century set free

    The 22nd Century Group says that a 2013 Research License and Commercial Option Agreement between it and British American Tobacco (Investments) Limited is now at an end.

    ‘BAT no longer has rights to any intellectual property or other assets of 22nd Century; 22nd Century is now again in sole control of the company’s highly disruptive intellectual property portfolio relating to the ability to grow patent-protected Very Low Nicotine tobacco plants,’ 22nd said in a press note issued through Business Wire.

    ‘Accordingly, the company has recommenced discussions with global tobacco companies and international pharmaceutical companies that have expressed strong interest in a business relationship with 22nd Century but were, until now, unable to enter into a licensing agreement with 22nd Century due to restrictive covenants contained in the BAT agreement.’

  • Growing organically

    Growing organically

    Last year, the US state of Virginia’s organic farms certified by the US Department of Agriculture (USDA) produced certified-organic tobacco valued at $18.5 million, according to a story by Jeff Clabaugh for WTOP Radio and citing the USDA’s National Agricultural Statistics Service.

    Tobacco accounted for 33 percent of the state’s organically-produced commodities.

    The number of certified-organic farms increased by 26 or 19 percent in 2015.

  • Final warning given

    Final warning given

    The US Food and Drug Administration has issued its final guidance on small-cigar-pack health-warnings, Compliance Policy for Required Warning Statements on Small-Packaged Cigars.

    From August 10, 2018, it will be unlawful for anyone to manufacture, package, sell, offer to sell, distribute, or import for sale or distribution within the US any cigar unless its product packaging bears one of the following warning statements:

    • WARNING: This product contains nicotine. Nicotine is an addictive chemical.
    • WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale.
    • WARNING: Cigar smoking can cause lung cancer and heart disease.
    • WARNING: Cigars are not a safe alternative to cigarettes.
    • WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in non-smokers.
    • WARNING: Cigar use while pregnant can harm you and your baby; or SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth and Low Birth Weight.

    The FDA does not intend to take enforcement action with respect to cigars sold in packaging that is too small or otherwise unable to accommodate a label with the required warning statement once the compliance policy takes effect, if the warning statements appear either:

    • On the carton or other outer container or wrapper if the carton, outer container, or wrapper has sufficient space to bear the information; or
    • On a tag otherwise firmly and permanently affixed to the tobacco product package.

    The compliance policy does not apply to other labeling provisions, such as the random display and distribution of cigar warning statements on packaging in accordance with an FDA-approved warning plan.

  • Another day, another study

    Another day, another study

    The nicotine in electronic-cigarette vapor may cause adrenaline levels to spike in the heart, potentially increasing the risk of heart attack and sudden cardiac death, according to a story by Dennis Thompson for HealthDay, citing the results of a new study.

    E-cigarettes have been promoted as a healthier alternative to traditional tobacco cigarettes because, researchers have said, they deliver vastly lower levels of carcinogens.

    But laboratory studies showed that e-cigarettes could pose a threat to health because of the nicotine that they typically deliver, said lead researcher Dr. Holly Middlekauff, who is a cardiologist with the David Geffen School of Medicine at the University of California, Los Angeles.

    Nicotine-containing e-cigarettes seemed to promote a fight-or-flight response, causing a release of adrenaline that increased heart rate and reduced the amount of time between heart beats, researchers found.

    “The concern is that extended use of nicotine is going to expose you to long-term high adrenaline levels in the heart,” Middlekauff said. “That has been shown to be a risk factor for heart attack.”

    Based on the results, Middlekauff said, current tobacco cigarette smokers still would be better off switching to e-cigarettes. They would avoid the carcinogens produced by burning tobacco, even though they could face heart health effects from nicotine.

    Meanwhile, Gregory Conley, president of the American Vaping Association, said that the researchers had overstated their findings.

    “Past studies have shown that eating meals high in carbohydrates induces heart rate variability,” he said. “Are we going to be warning people away from corn flakes?”

  • Mice given third degree

    Mice given third degree

    Mice exposed to household fabrics contaminated with ‘third-hand’ tobacco smoke showed changes in biological markers of health after only one month, according to a story in The Conversation (Australia) citing a recent study. After six months, the mice showed evidence of liver damage and insulin resistance, symptoms that usually precede the development of type 2 diabetes.

    The story described third-hand smoke as the residue left behind after cigarettes are smoked. ‘Once the smoke clears, after a cigarette has been extinguished, nicotine and other harmful chemicals left behind can stick to surfaces and fabrics,’ the story said. ‘This residue is known as third-hand smoke.’

    The Conversation said that the idea of third-hand smoke had been around for a few decades, but that it had come to prominence in 2009 after a study by Jonathan Winickoff, an assistant professor of paediatrics at Harvard Medical School, had identified a link between parents’ belief that third-hand smoke might cause harm and the likelihood they would prohibit smoking within their homes.

    ‘The new mouse model study investigated the effects of third-hand smoke exposure over time on animal health (the first study to do so),’ the story said. ‘The researchers, from the University of California, Riverside, used a smoking machine to create third-hand-smoke-contaminated household fabrics in mice cages, including curtain material, upholstery and carpet. Once the fabrics showed levels likely to be found in smokers’ homes, the mice were placed in the cage and monitored over a period of six months.

    ‘After just one month, the mice showed changes in markers of health in the blood serum, liver and brain tissues. The range and severity of the changes on the health of mice got progressively worse the longer they were exposed.

    ‘After four months, the mice showed increases in factors related to oxidative stress and liver damage. Fasting glucose and insulin levels increased with third-hand smoke exposure and, after four months, the mice already had a[n] increased risk of type 2 diabetes.

    ‘The speed at which third-hand smoke residues cause measurable health effects in the mice is surprising. How the health effects observed in mice translate to humans, though, remains an open question.’

  • FDA seeks industry flavour

    FDA seeks industry flavour

    The US Food and Drug Administration is inviting companies that develop or manufacture tobacco product flavors to participate in a voluntary Flavor Developer and Manufacturer Site Tours Program, according to an announcement by the agency’s Center for Tobacco Products (CTP).

    The program is intended to help the FDA understand how flavors used in tobacco products are developed, tested, and produced.

    The CTP said the tours were solely for educational purposes and were not regulatory inspections.

    Starting today, interested companies will have 60 days to submit a response online at regulations.gov docket FDA-2017-N-3998, or by mail to FDA’s Dockets Management Staff.

    Further information is at:

    https://www.federalregister.gov/documents/2017/09/19/2017-19900/flavor-developer-and-manufacturer-site-tours-program