Tag: United States

  • Corrective statements online

    Corrective statements online

    The US’ major cigarette companies will have to post court-ordered ‘corrective statements’ on their websites from next month.
    A note posted on the Website of the US Department of Justice said that on Tuesday the District Court for the District of Columbia had entered a consent order requiring the country’s major cigarette companies to begin posting ‘corrective statements’ on their websites starting on June 18.
    ‘The order, part of a long-running lawsuit against the cigarette companies, also requires them to attach the same statements to cigarette packages for two weeks at a time, for a total of twelve weeks over two years,’ the note said. ‘The order will also apply to any social media campaigns by the companies to promote cigarettes.
    ‘The statements address the effects of cigarette smoking and the fact that cigarettes are deliberately designed to create and sustain addiction. As a result of a previous court order, the statements are currently running on television five times per week, and previously ran as full-page ads in about fifty newspapers across the country.
    ‘The statements specifically state, among other things:

    • ‘That smoking cigarettes causes numerous diseases and on average 1,200 American deaths every day;
    • ‘That the nicotine in cigarettes is highly addictive and that cigarettes have been designed to create and sustain addiction;
    • ‘That so-called light, low-tar, and natural cigarettes are just as harmful as regular cigarettes; and
    • ‘That second-hand smoke causes disease and death in people who do not smoke.

    ‘The corrective statements were ordered as part of a 2006 permanent injunction against cigarette companies, including Altria, its Philip Morris USA subsidiary, and R.J. Reynolds Tobacco, to “prevent and restrain” further deception of the American people regarding tobacco use. The order also applies to ITG Brands, which purchased Winston, Kool, and other cigarettes brands from companies in the case.’

  • PMI to webcast meeting

    PMI to webcast meeting

    Philip Morris International is due to host at www.pmi.com/2018annualmeeting a live audio webcast of its 2018 Annual Meeting of Shareholders, which is scheduled to start at 09.00 Eastern Time on May 9.
    During the meeting, Louis C. Camilleri, chairman of the Board, will address shareholders and answer questions, while CEO André Calantzopoulos will give the business presentation.
    The audio webcast, which will be in listen-only mode, 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 will be available until 17.00 on June 7 at www.pmi.com/2018annualmeeting.
    Presentation slides and script will be available, also at www.pmi.com/2018annualmeeting.

  • Youngsters targeted

    Youngsters targeted

    The US Food and Drug Administration and the Federal Trade Commission (FTC) have issued 13 warning letters to manufacturers, distributors and retailers about selling e-liquids in packaging likely to appeal to young people.
    In a note issued through the FDA’s Center for Tobacco Products, the agencies said that they were targeting those involved in e-liquids used in e-cigarettes with labeling and/or advertising that caused them to resemble ‘kid-friendly food products, such as juice boxes, candy or cookies, some of them with cartoon-like imagery’.
    Several of the companies that received warning letters were also cited for selling such products to minors.
    “No child should be using any tobacco product, and no tobacco products should be marketed in a way that endangers kids – especially by using imagery that misleads them into thinking the products are things they’d eat or drink,” said FDA Commissioner Scott Gottlieb, M.D, as part of the note.
    “Looking at these side-to-side comparisons is alarming. It is easy to see how a child could confuse these e-liquid products for something they believe they’ve consumed before – like a juice box.
    “These are preventable accidents that have the potential to result in serious harm or even death. “Companies selling these products have a responsibility to ensure they aren’t putting children in harm’s way or enticing youth use, and we’ll continue to take action against those who sell tobacco products to youth and market products in this egregious fashion.”

  • Secretive science deposed

    Secretive science deposed

    The US Environmental Protection Agency (EPA) administrator, Scott Pruitt, has signed a proposed rule to strengthen the science used in regulations issued by the EPA.
    According to an EPA press note, the rule will ensure that the ‘regulatory science underlying Agency actions’ is fully transparent, and that underlying scientific information is publicly available in a manner sufficient for independent validation.
    “The era of secret science at EPA is coming to an end,” said Pruitt. “The ability to test, authenticate, and reproduce scientific findings is vital for the integrity of rulemaking process. Americans deserve to assess the legitimacy of the science underpinning EPA decisions that may impact their lives.”
    ‘This proposed rule is in line with the scientific community’s moves toward increased data sharing to address the “replication crisis” – a growing recognition that a significant proportion of published research may not be reproducible,’ the note said.
    ‘The proposal is consistent with data access requirements for major scientific journals like Science, Nature, and Proceedings of the National Academy of Sciences as well as recommendations from the Bipartisan Policy Center’s Science for Policy Project and the Administrative Conference of the United States’ Science in the Administrative Process Project.’
    The proposed rule is said to build upon President Donald Trump’s executive orders on regulatory reform and energy independence.
    Meanwhile, the House Science, Space, and Technology Committee chairman, Lamar Smith, said that Pruitt’s announcement ensured that data would be secret no more.
    “For too long, the EPA has issued rules and regulations based on data that has been withheld from the American people,” he said. “It’s likely that in the past, the data did not justify all regulations. Today, Administrator Pruitt rightfully is changing business as usual and putting a stop to hidden agendas.”

  • Regulations enforced

    Regulations enforced

    The US Bureau of Alcohol, Tobacco and Firearms (ATF) has begun to enforce more aggressively a decades-old law known as the Trafficking in Contraband Cigarettes and Smokeless Tobacco Act, according to a note posted on the California Distributors’ Association (CDA) website.
    The CDA said that this move could affect all distributors, but especially those that had a cash and carry business operated from their warehouses, branches, offices, or stores.
    It gave details of the information that had to be obtained from purchasers in respect of sales of more than 10,000 cigarettes (50 cartons) or more than 500 single-unit consumer-sized cans or packages of smokeless tobacco in a single transaction at a distributor’s place of business.
    ‘This rule does not apply to duly licensed distributors who deliver to the recipient’s place of business stamped cigarettes or smokeless tobacco on which applicable taxes have been paid,’ the CDA said.
    ‘This rule requiring license numbers and driver’s licenses applies when cigarettes or smokeless tobacco is bought at the distributor’s place of business.’
    The CDA said that the ATF had advised that its enforcement of the Cigarette and Smokeless Tobacco Contraband Act was expected to expand throughout the entire US. To date, its activities have been primarily centered around Virginia and North Carolina on criminal-oriented activities.
    The CDA added that the ATF was not advising distributors in advance when it might arrive at their businesses to review their records.
    ‘CDA will continue to monitor the situation and will advocate – at a minimum – that the ATF advise in advance when it may visit a distributor’s place of business,’ it said.

  • Marlboro US share down

    Marlboro US share down

    PM USA’s domestic cigarette shipment volume during the three months to the end of March, at 27,552 million, was down by 4.2 percent on that of the first quarter of 2017, 28,727 million.
    In reporting its first-quarter results, Altria – of which PM USA is its cigarette division – said that the fall in cigarette shipments was driven primarily by the industry’s rate of decline and retail share declines, partially offset by trade inventory movements.
    Within PM USA’s total shipments, Marlboro volume was down by 4.2 percent to 23,653 million, while the volume of the company’s other premium brands fell by 2.8 percent to 1,409 million. Sales of discount brands fell by 4.7 percent to 2,460 million.
    PM USA’s cigarette market share during the three months to the end of March, at 50.3 percent, was down by 0.7 of a percentage point on that of the first quarter of 2017.
    Marlboro’s share fell by 0.5 of a percentage point to 43.2 percent, while the share of the company’s other premium brands fell by 0.1 of a percentage point to 2.6 percent. The share of PM USA’s discount brands fell by 0.1 of a percentage point to 4.5 per cent.
    Altria’s first quarter results, reported yesterday, included also those of Middleton and USSTC.
    Middleton’s domestic cigar shipment volume during the three months to the end of March, at 378 million, was up by 3.0 percent on that of the first quarter of 2017, 367 million. Shipment volume of the company’s Black & Mild brand was increased by 3.3 percent to 375 million, while that of its other brands fell by 25 percent from four million to three million.
    USSTC’s domestic market shipment volume of smokeless products during the three months to the end of March, at 195.7 million cans and packs, was down by 0.1 percent on that of the first quarter of 2017, 198.5 million.
    Copenhagen’s shipment volume fell by 0.1 percent to 124.4 million, and Skoal’s volume was down by 1.1 percent to 55.0 million. The shipment volume of other brands increased by 3.8 percent to 16.3 million.
    USSTC did not provide adjusted shipment volume comparisons because of the unusual effects caused by a 2017 recall. But it said that the smokeless industry volume had declined by an estimated one percent during the past six months.
    USSTC’s retail market share during the three months to the end of March, at 53.8 percent, was up by 0.1 of a percentage point from that of the first quarter of 2017.
    Copenhagen’s market share increased by 1.1 percentage points to 34.3 percent, while Skoal’s share fell by 1.2 percentage points to 16.2 percent. Other brands’ market share increased by 0.2 of a percentage point to 3.3 percent.
    “Altria is off to a fast start to the strong year of EPS growth to which we’ve guided, with adjusted diluted EPS growth of 30.1 percent in the first quarter of 2018,” said Marty Barrington, Altria’s chairman, CEO and president.
    “In addition, Altria continued to reward shareholders by paying out nearly $1.3 billion in dividends, announcing an out-of-cycle dividend increase of 6.1 percent and repurchasing approximately $513 million in shares.
    “Within the reporting segments, income performance reflects the timing of previously announced investments for the long-term strength of the business.
    “We continue to expect full year adjusted diluted EPS growth of 15 percent to 19 percent.”
    Meanwhile, Altria said that in pursuit of its ambition to be the US leader in ‘authorized, non-combustible, reduced-risk products’, USSTC had submitted a modified risk tobacco product application (MRTPA) to the US Food and Drug Administration for Copenhagen Snuff Fine Cut.
    In addition, Altria had grown Nu Mark volume by about 30 percent and expanded the distribution of MarkTen Elite, a pod-based closed system product, to more than 6,000 retail stores.
    And PM USA had participated in Philip Morris International’s presentation to the FDA’s Tobacco Products Scientific Advisory Committee about the IQOS MRTPA. PM USA’s initial lead market plans for IQOS were ready to deploy upon FDA authorization.

  • The cost of success

    The cost of success

    JUUL Labs has said that it will take additional decisive action to build on its existing ‘youth prevention and education programs.
    The Commissioner of the US Food and Drug Administration, Dr. Scott Gottlieb, said on April 24 that the agency was introducing several enforcement actions as part of a new Youth Tobacco Prevention Plan to stop young people from using and gaining access to JUUL and other electronic cigarettes.
    In a note issued through PRNewswire on April 25, JUUL said it would support state and federal initiatives to raise the minimum age for buying tobacco products to 21+.
    Such support would be funded by an investment of $30 million during the next three years that would be dedicated to ‘independent research, youth and parent education, and community engagement efforts’.
    ‘JUUL Labs has seen significant success in its efforts to enable adult smokers to transition from cigarettes and also recognizes that young people have become aware of and gained access to its products,’ the company said.
    ‘The company is committed to combatting underage use of its products and engaging with the US Food and Drug Administration (FDA), members of Congress, local and state officials and members of the public health community on this important issue.
    ‘JUUL Labs will work with Tom Miller, the Iowa Attorney General, and a group of public officials and tobacco control individuals he will assemble to continue strengthening existing initiatives and new efforts to keep JUUL out of the hands of young people.
    ‘In addition, Attorney General Miller and the same group will work with JUUL Labs to develop a transparent and effective framework for independent research focused on the scientific and societal implications of vapor products.’
    “Our company’s mission is to eliminate cigarettes and help the more than one billion smokers worldwide switch to a better alternative,” said JUUL Labs CEO Kevin Burns.
    “We are already seeing success in our efforts to enable adult smokers to transition away from cigarettes and believe our products have the potential over the long-term to contribute meaningfully to public health in the US and around the world.
    “At the same time, we are committed to deterring young people, as well as adults who do not currently smoke, from using our products. We cannot be more emphatic on this point: No young person or non-nicotine user should ever try JUUL.”
    The company said its support for state and federal efforts to raise the minimum age of purchase for JUUL and other vapor products to 21+ followed its announcement in August 2017 that it had raised the minimum age of purchase on its own e-commerce site to 21+, even though the legal age of purchase in many states remained at 18.
    As part of its note, JUUL said that additional programs to be launched or expanded in 2018 included:

    • Investing in research and development to evaluate potential technologies to help prevent youth from gaining access to, and/or using JUUL;
    • Building on the company’s efforts to enforce appropriate age verification at retail through its ‘secret shopper’ program;
    • Calling on social media platforms to remove content showing, and/or encouraging, youth use of JUUL;
    • Calling on online marketplaces to remove content that violates JUUL resale agreements by offering JUUL products for sale without age verification;
    • Providing educational material at retail locations where JUUL products are sold and on the JUUL website to help increase parents’ awareness of JUUL and provide information on the negative impacts of nicotine on youth.
  • FDA’s aptitude questioned

    FDA’s aptitude questioned

    An opinion piece published in The Hill poses and answers the question: How much does the US Food and Drug Administration do to promote public health?
    Lindsey Stroud, a state government relations manager at The Heartland Institute, a non-profit group aimed at promoting limited government, describes how, in recent years, the FDA has become increasingly more involved in ‘protecting the public health by ensuring the safety, efficacy, and security’ of numerous products, including prescription medications, tobacco, and food and cosmetic products.
    ‘In many cases, the agency has proven itself to be exceptionally biased against harm reduction devices and services, while at other times, FDA has failed to protect the public from potentially dangerous substances,’ Stroud writes.
    ‘Such is the case with OxyContin, one of the most important contributors to America’s current opioid epidemic.
    ‘In countless instances, FDA has been too stringent and inflexible. In others, it has seemingly been ignorant of the dangers of particular drugs, leading many (this writer included) to wonder: Does FDA have any clue what it’s doing?’
    Later in her piece, Stroud says that it is important to note that, while the FDA has shown it is willing to allow powerful prescription painkillers to become one of the few relief methods available for chronic pain, it has at the same time applied a narrow standard to other products that could save lives.
    ‘For instance, FDA has yet to allow many e-cigarette, heat-not-burn, and snus products to be marketed as less harmful alternatives to combustible cigarettes – even though ample evidence shows they are,’ she writes.
    Stroud’s piece is at: http://thehill.com/opinion/healthcare/384407-how-much-does-the-fda-really-do-to-promote-public-health.

  • FDA comes down on JUUL

    FDA comes down on JUUL

    The Commissioner of the US Food and Drug Administration, Dr. Scott Gottlieb, said yesterday that the agency was introducing several enforcement actions as part of a new Youth Tobacco Prevention Plan to stop young people from using and gaining access to JUUL and other electronic cigarettes.
    In a note issued through its Center for Tobacco Products, the FDA said it understood that many kids were using e-cigarettes with a particular set of characteristics: an appearance that closely resembled a USB flash drive, high levels of nicotine, and emissions that were hard to see. It said that these characteristics might facilitate youth use by making the products more attractive to children and teens.
    Several of these products fell under the JUUL brand, but other brands with similar characteristics were emerging, it said.
    As part of the Youth Tobacco Prevention Plan to stop youth use of tobacco products – particularly e-cigarettes – the FDA said it was announcing several new actions and efforts, including:

    • Issuing warning letters to 40 retailers for violations related to youth sales of JUUL e-cigarettes;
    • Conducting a large-scale, undercover nationwide blitz of retail establishments;
    • Sending an official request for information to JUUL Labs requiring the company to submit important documents to better understand the reportedly high rates of youth use and the particular youth appeal of these products; and
    • Taking steps to foreclose online sales of JUUL to minors.

    Finally, the FDA said that as part of the FDA’s responsibility to protect kids and significantly reduce tobacco-related disease and death, these were the first steps in a new effort aimed at stopping youth use of e-cigarettes.

  • E-cig crackdown coming

    E-cig crackdown coming

    The US Food and Drug Administration will step up its crackdown on electronic cigarette sales to teens, according to a story by Robert King for the Washington Examiner quoting the head of the agency.
    Lawmakers on a House Appropriations subcommittee were said to have grilled FDA Commissioner Scott Gottlieb about ‘excessive’ use of e-cigarettes among young people.
    The FDA has the authority ‘to go after’ e-cigarette makers and retailers if they violate a ban on sales to people under 18, but lawmakers questioned if the agency was doing enough.
    “I am concerned that FDA’s silence on e-cigarettes could open the door to the next public health emergency,” said Rep. Nita Lowey, D-N.Y.
    Gottlieb replied that the FDA would crack down on young people’s use of e-cigarettes in the coming weeks.
    The agency has several avenues for targeting retailers that are selling to minors. Those include a warning letter, massive fines, or banning the retailer from selling any tobacco or e-cigarettes.
    Gottlieb said e-cigarettes could offer fewer health risks than traditional cigarettes, but the soaring use among minors was worrisome. A recent study had found that e-cigarette use grew by 900 percent among high school students from 2011 to 2015 [there was no mention of the level of use in 2011].
    “We can’t just addict a whole generation of young people onto nicotine,” Gottlieb reportedly said.