Tag: United States

  • Still counting the cost

    Still counting the cost

    Hurricane Florence is testing the resolve of farmers in the US states of North and South Carolina, who could face billions of dollars in agricultural damage while still feeling the sting from Hurricane Matthew almost two years ago, according to a story by Gary D. Robertson and Emery P. Dalesio for Associated Press.
    Writing on Friday, the AP reporters said that after ‘last weekend’s’ high winds and rain that was followed by ‘this week’s’ rising rivers and standing water in fields, early farm reports were confirming pre-storm worries about losses to tobacco, cotton and corn crops.
    Matthew hurt eastern North Carolina farmers in 2016, but that storm arrived in October, after most field crops had been harvested.
    With Florence, most major crop harvests were still underway or just getting started. “This hurricane couldn’t have come at a worse time,” North Carolina Farm Bureau president, Larry Wooten, was quoted as saying.
    North Carolina is unlikely to have preliminary crop damage estimates until the end of the next week, said state agriculture commissioner Steve Troxler. Floodwaters and blocked country roads were making it difficult for agency agronomists to check out farms.
    Five of North Carolina’s top six farming counties are within the hardest-hit areas in the eastern part of the state.
    “I think it’s easily going to be in the billions of dollars,” Troxler said in an interview, calling the damage “catastrophic” and “unbelievable”.

  • FDA invites comments

    FDA invites comments

    The public is being invited to comment on a modified risk tobacco product (MRTP) application submitted by U.S. Smokeless Tobacco Co. for Copenhagen Snuff Fine Cut.
    In a notice issued by the Food and Drug Administration’s Center for Tobacco Products (CTP), the CTP said ‘[t]he Federal Register has issued a notice establishing a docket on regulations.gov to receive public comments on one modified risk tobacco product (MRTP) application submitted by U.S. Smokeless Tobacco Co. LLC for Copenhagen Snuff Fine Cut.
    ‘The FDA filed this application on September 14, 2018, for scientific review and will continue to make application materials publicly available, in accordance with applicable laws, on a rolling basis via the CTP website,’ the notice said.
    ‘Starting … September 21, anyone may submit research, data, or other public comments related to these MRTP applications to docket FDA-2018-N-3261 on regulations.gov.
    ‘The FDA encourages interested parties to submit public comments earlier in the comment period, as the agency may be less able to review later comments before the MRTP applications are referred to the Tobacco Products Scientific Advisory Committee.’

  • Sensing a whiff of marijuana

    Sensing a whiff of marijuana

    Writing at fool.com, Leo Sun recently asked whether Altria will start selling marijuana and forget about electronic cigarettes.
    Sun noted that Altria shares had risen nearly seven percent on September 12 after executive vice president and general counsel Murray Garnick had discussed the cannabis market at the Barclays 2018 Consumer Staples Conference. Garnick was reported to have said that Altria was “exploring options” and “evaluating market opportunities,” though only after Barclays analyst Gaurav Jain had prodded Altria on the issue.
    But that suggestion seemed to offset a negative development regarding Altria’s e-cigarette business, which appeared under threat after the US Food and Drug Administration issued a warning to tobacco companies that it would pull their e-cigarettes from retail shelves if they didn’t make more changes to curb the use of these products by young people.
    In a long piece that ranges over Altria’s traditional tobacco business, its vapor business and the possibility of its entering the marijuana business, Sun admitted that it seemed like a big leap for a major tobacco seller to start selling cannabis, though he noted that at least one tobacco dealer and one manufacturer had already dipped their toes in the market.
    However, he said these investments didn’t mean that tobacco makers would start rolling joints at their factories.
    ‘For now, investors should realize that neither the cannabis nor e-cig headlines will have much of an impact on Altria’s growth,’ Sun said. ‘Instead, they should focus on the FDA’s proposals for lower-nicotine cigarettes – which could deal serious damage to its core business.’

  • Fake education

    Fake education

    The US Food and Drug Administration yesterday launched its The Real Cost Youth E-Cigarette Prevention Campaign, describing it as a ‘new, comprehensive effort aimed at educating kids about the dangers of e-cigarettes’.
    The campaign is said to target nearly 10.7 million people aged 12-17 who have used electronic cigarettes or are open to trying them.
    It features ‘hard-hitting’, public notices on digital and social media sites popular with teenagers, and includes posters with e-cigarette prevention messages posted in high schools across the nation.
    During the past several years, e-cigarettes were the tobacco product [the FDA ‘deems’ e-cigarettes to be tobacco products] most commonly used by young people, the FDA said in a statement issued through its Center for Tobacco Products.
    ‘In fact, more than two million middle- and high-school students were current users of e-cigarettes in 2017, and the FDA now believes that youth use of e-cigarettes is reaching epidemic proportions,’ according to the statement.
    ‘With its tagline, “Know the Real Cost of Vaping,” the campaign aims to educate youth that using e-cigarettes, just like cigarettes, puts them at risk for addiction and other health consequences. The messages highlight that nicotine can rewire the brain to crave more nicotine, particularly because adolescent brains are still developing. Other messages highlight that e-cigarettes, among other things, can contain dangerous chemicals such as: acrolein, a chemical that can cause irreversible lung damage; formaldehyde, a cancer-causing chemical; and toxic metal particles, like [such as] chromium, lead and nickel, which can be inhaled into the lungs.
    ‘This new campaign is part of the FDA’s ongoing efforts to prevent disease and death caused by tobacco use and will complement the agency’s other youth tobacco prevention campaigns.’
    More details, including the statement that e-cigarettes have become an ‘almost ubiquitous’ trend among young people, are here.

  • Florence hits tobacco

    Florence hits tobacco

    It will be some time before North Carolina will be able fully to assess the damage caused to tobacco and other crops by Hurricane Florence, but it is likely to be considerable.
    Some of the counties harder hit by Florence are located on the southern end of North Carolina’s largest tobacco-growing region, according to a Bloomberg News story yesterday quoting Matthew Vann, assistant professor and tobacco extension specialist at North Carolina State University.
    Other large tobacco-growing counties also suffered damage, but not the amount of flooding that was being reported further south, he said.
    “There is a fairly wide range in terms of severity when you look specifically at the tobacco-growing regions,” said Vann, who added that it was too early to estimate total losses.
    Lynda Loveland, spokeswoman for the North Carolina Farm Bureau agreed. No one was certain how many tobacco, corn, soybean, cotton, peanut and sweet potato fields were still under water or experiencing flooding, she said in an email to Bloomberg.
    It would take several days properly to assess crop damage because the water still needed to recede.
    Meanwhile, Kim K. LeQuire, co-owner of Kornegay Family Farms and Produce, was quoted as saying that her operation at Princeton, North Carolina, had seen at least 14 inches (36 cm) of rain as of Sunday, and was still experiencing showers.
    Some tobacco leaves on tobacco plants had been blown off their stalks by the strong winds and were lying in puddle-filled fields.
    Although about 70 percent of her farm’s tobacco crop had been harvested before the hurricane, the damage had affected some of its best-quality leaf.

  • Alarmism overused

    ‘FDA [the US Food and Drug Administration] seems to just be going around in circles,’ according to Lindsey Stroud, state government relations manager at The Heartland Institute.
    Stroud was commenting on a recent FDA demand that five electronic-cigarette manufacturers address within 60 days what the agency describes as an “epidemic” of teenage vaping or face possible market restrictions on their products: blu, Juul, Logic, MarkTen, and Vuse.
    ‘Despite the alarmism, youth vaping dropped in 2016 and remained flat in 2017,’ said Stroud.
    ‘And youth cigarette smoking – it’s at an all-time low.
    ‘As tobacco companies have been doing for decades, electronic cigarette manufacturers are investing millions into anti-youth initiatives, and some states like Massachusetts have publicly refused to take their money.
    ‘Retailers in vape shops practice strict and responsible policies to ensure underage consumers are not purchasing vaping products.’
    At the same time, Stroud said, the FDA had yet to approve a premarket tobacco product application. ‘Delaying such products limits companies’ ability to modify their current products to be even more child-resistant, including locks on these products,’ she said.
    ‘Although “protecting the children” is a laudable goal, this rhetoric is overused and threatens the millions of smokers who have quit smoking combustible cigarettes by using these products.’

  • Sharpen your pen nibs

    Sharpen your pen nibs

    The US Food and Drug Administration says that by participating in its comment process the public can help shape the agency’s decisions. Such participation is, it says, an important part of the ‘notice-and-comment rulemaking and guidance development processes’.
    The FDA was spotlighting public comments as part of its series of notices about Understanding Tobacco Regulation and Guidance.
    ‘Public participation in the rulemaking process is an essential function of good governance,’ the agency said in a statement. ‘By providing input, individuals and other stakeholders offer FDA a chance to actively listen to a wide-range of concerns, values, and perspectives, which in turn can inform regulatory decisions.
    ‘FDA accepts comments on documents within a defined timeframe, known as the open comment period.
    ‘FDA invites public comments on Advance Notices of Proposed Rulemaking (ANPRMs), proposed rules (Notices of Proposed Rulemaking or NPRMs) and draft guidances, and announces the length of the public comment period in the Federal Register.
    ‘FDA reviews and considers the submitted comments in preparing the final documents.
    ‘When FDA publishes a final rule, the agency describes and responds to comments received.’
    The FDA suggested ways of submitting effective comments that included providing a clear statement of whether the participant supported or oppose the proposed rule or guidance, and any comments or data that supported her position. Other tips for submitting effective comments are here.
    The FDA said that it solicited information and comments, announced in the Federal Register and posted in dockets on regulations.gov, from the general public, industry, and organizations on a wide range of issues related to implementation of the Tobacco Control Act.
    It said it would consider all comments, data, research, and other relevant information submitted to the docket to determine what regulatory next steps may be appropriate for a given issue. Comments may be submitted:

    • Online through the Federal eRulemaking Portal at https://www.regulations.gov.
    • By mail, hand delivery, or courier to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.
  • FDA to review risk claim

    FDA to review risk claim

    U.S. Smokeless Tobacco Company said on Friday that the Food and Drug Administration had accepted and filed for substantive scientific review a Modified Risk Tobacco Product application for its moist smokeless tobacco product Copenhagen® Snuff Fine Cut.
    The application requests FDA authorization to make one claim: ‘IF YOU SMOKE CONSIDER THIS: Switching completely to this product from cigarettes reduces risk of lung cancer’.
    “It’s critical that smokers have accurate, non-misleading health information about different tobacco products,” said Joe Murillo, senior vice president, regulatory affairs at Altria Client Services.
    “We filed this application because we think adult smokers looking for potential reduced risk alternatives to cigarettes should have accurate information about the relative risks of Copenhagen Snuff.”
    The Agency is due to begin a substantive scientific review process, which includes opportunities for public comment.

  • We'll ‘work with FDA’

    We'll ‘work with FDA’

    The Imperial Brands subsidiary, Fontem Ventures, has said that it is ready to work with the FDA to further strengthen its ‘youth access prevention policies and procedures’.
    The company was responding to a statement from the US Food and Drug Administration issued on Wednesday in which it gave electronic-cigarette manufacturers accounting for 97 percent of the US market 60 days to submit plans describing how they intend to address what the FDA sees as the widespread use of their products by young people.
    Fontem Ventures said it strongly believed that e-vapor products such as blu and myblu™ were to be used only by adult smokers. ‘Minors should not use any tobacco or nicotine products, and we fully support and advocate for both legislation prohibiting sales of vaping products to minors and the ongoing FDA enforcement action against retailers selling e-vapor and other tobacco products to minors,’ the company said in a statement posted on its website on September 13.
    ‘We are evaluating today’s [Wednesday’s] request and statement from the FDA. On youth access, we have common aims. We welcome the opportunity to demonstrate, and work with the FDA to further strengthen, our youth access prevention policies and procedures. We will continue to work with regulators in the US and elsewhere to implement best practices in all our commercial activities.
    ‘Since 2009, blu has marketed e-vapor products to adult smokers in the US and around the world in a responsible manner. While youth smoking rates and use of combustible tobacco products have declined in the US, in line with trends in adult use, we fully understand and share current public concern about youth use of e-vapor products.’
    Fontem Ventures said that marketing and advertising standards for blu ensured all communications were intended for, and presented to, adult audiences only. ‘We also take proactive measures to ensure responsible sales practices, both on our own online storefront and through third-party online and brick-and-mortar retail locations:

    1. ‘We conduct a thorough online age verification process via third party vendors Veratad and Experian, in addition to mandatory manual ID checks for anyone with a date of birth that shows them to be under 27.
    2. ‘We monitor all transactions for evidence of fraudulent activity, unauthorized wholesaling, or sales by proxy where products could potentially reach non-adult users.
    3. ‘We require a commitment from vape store partners to prohibit underage access.
    4. ‘We require retail partners’ compliance with all applicable local, state, and federal laws.
    5. ‘We conduct post-market surveillance to flag any concerning demographic trends.’

    Fontem Ventures said it looked forward to working with FDA to address this critical issue.

  • AOI investor day

    AOI investor day

    Alliance One International is due to host a webcast of its Investor and Analyst Day from 09.15 Eastern Daylight Time on September 12.
    During the webcast, Pieter Sikkel (pictured), president, CEO and chairman, and other members of the company’s leadership team, will provide an in-depth look into the progress of the company’s ‘One Tomorrow’ transformation initiative, its corporate name change to Pyxus International, and other aspects of its brand, strategy and structure.
    The live webcast and slide presentation for the event can be accessed at www.pyxusintl.com.
    An archived copy of the webcast will be available following the event.
    Audio for the event can be accessed live over the telephone by dialing (877) 809-7264, or (857) 244-8352 (international calls), and entering the passcode 59388299.
    Listeners need to dial in 10 minutes before the call start time to be placed into the conference.