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  • U.S. FDA May Publish Draft Guidance for CBD

    U.S. FDA May Publish Draft Guidance for CBD

    The U.S. Food and Drug Administration is planning to make recommendations on how to regulate the use of the popular cannabis compound cannabidiol (CBD) in food and supplements, the Wall Street Journal reported, citing agency officials.

    After weighing the evidence on the compound’s safety, the FDA will decide within months how to regulate legal cannabis and whether that will require new agency rules or new legislation from Congress, according to the report.

    In an interview, Janet Woodcock, the FDA’s deputy commissioner and leader of the agency’s cannabis regulation efforts, expressed concern about the safety of CBD and whether current regulatory pathways for food and dietary supplements are suitable for this substance.

    However, the agency is interested in determining whether it is safe to consume CBD on a daily basis for extended periods of time or during pregnancy.

    Woodcock mentioned concerns about potential effects on fertility in the future, but, at the same time, her comment signaled that the agency is working to establish regulatory frameworks for the legal sale of appropriate cannabis and cannabis-derived products.

    CBD is a chemical compound found in cannabis plants. It is one of the main ingredients in cannabis, but unlike THC, it does not cause a high or have psychoactive effects.

    The 2018 Farm Bill legalized hemp cultivation in the U.S., which led to significant growth in the market for CBD products. These products, sold as dietary supplements, are believed to have health benefits. As a result, many businesses in the cannabis industry are now selling CBD products across the country.

    Over the last few years, the FDA posted several warning letters to companies for illegally selling products containing CBD. The companies are accused of selling products containing CBD that the FDA states some people may confuse for traditional foods or beverages that do not contain CBD or were making medical claims about their CBD products.

    In 2021, The FDA told Charlotte’s Web Holdings, one of the world’s largest CBD companies, that its cannabidiol product cannot be sold as a dietary supplement, signaling that CBD reform may have to wait for congressional action.

  • Cohiba Trademark Canceled in U.S.

    Cohiba Trademark Canceled in U.S.

    Image: Tobacco Reporter archive

    After more than 25 years of court battles, General Cigar Co.’s trademark for Cohiba cigars was canceled by the United States Trademark Trial and Appeal Board (TTAB).

    Scandinavian Tobacco Group, General’s parent company, and Empresa Cubana del Tabaco (Cubatabaco) have fought over the U.S. rights to the Cohiba trademark since 1997. In a ruling earlier this month, the TTAB sided in favor of the Cuban cigar conglomerate in its claim on the name, saying that General Cigar Co.’s registrations on the Cohiba trademark are to be canceled due to a violation of an international agreement that dates back to 1929.

    In the U.S., the Cohiba brand is made by General Cigar Co. and is known for a Cohiba logo with a red dot that fills the O in the word. In the rest of the world, the Cohibas found on store shelves come from Cuba and are known for a gold and black color scheme as well as the profile image of a Taino Indian, writes Patrick Lagreid from Halfwheel.

    While the TTAB’s ruling indicated that General’s registrations on the Cohiba marks are to be canceled “in due course,” it does not mean that the General-made Cohibas have to immediately be pulled from store shelves. First, the TTAB did not award the Cohiba mark to Cubatabaco; second, General Cigar Co. has vowed to appeal, saying that it will continue to manufacture and sell Cohiba cigars during that process.

    Cohiba is a particularly unique case due to both its prominence on the global stage and its creation by the state-run tobacco company after the Cuban Revolution, whereas other brands with Cuban roots that General Cigar Co. owns, such as Partagas, Hoyo de Monterrey and La Gloria Cubana, were assumed by the Cuban government in 1959.

    Similarly, General’s largest competitor in the cigar industry, Altadis USA, owns several brands with pre-Revolution roots, including Montecristo, Romeo y Julieta and H. Upmann. Prior to Imperial Brands selling its premium cigar business in April 2020, Altadis USA was owned by Imperial, which also owned a 50 percent stake in Habanos S.A., a joint venture with the Cuban tobacco monopoly for the sales and marketing of Cuban cigars. Imperial also owned stakes in distributors of Habanos S.A. products around the world and stakes in companies that make and distribute Cuban machine-made cigars.

    The U.S. Court of Appeals for the Federal Circuit in 2015 ruled in favor of Cubatabaco. After the Supreme Court’s denial to hear the case, it went to the TTAB.

  • Registration Open for Menthol Ban Seminar

    Registration Open for Menthol Ban Seminar

    Interested parties can now register for the Jan. 12 U.S. Food and Drug Administration seminar covering the ban of menthol flavors in tobacco products. “The Scientific Basis of Proposed Tobacco Product Standards to Prohibit Menthol as a Characterizing Flavor in Cigarettes and Flavors in Cigars” is the first FDA tobacco-related seminar of the year.

    The presentation will provide an overview of the scientific evidence that informed the development of these proposed rules, with an explanation of the external peer review process the FDA utilized for review of the highly influential scientific assessments for these proposed rules.

    Bridget Ambrose, director of the Division of Population Health Science in the Office of Science at the FDA’s Center for Tobacco Products, will be the speaker. Ambrose has over 20 years of experience in tobacco control and regulatory science, with specialized experience in longitudinal analyses of tobacco use.

  • FDA Fails in Enforcement: Report

    FDA Fails in Enforcement: Report

    Photo: Postmodern Studio

    The U.S. Food and Drug Administration has failed to follow through after issuing warning letters to online tobacco products and vapor product sellers, according to a report by the Health and Human Services Office of the Inspector General (OIG).

    Between 2010 and 2020, the FDA issued warning letters to 899 online retailers but “took no enforcement actions,” according to the report.

    The FDA enforcement schedule, as of March 2022, calls for the following actions: first violation—warning letter; second violation within a 12-month period—fine of up to $320; third violation within a 24-month period—fine of up to $638; fourth violation within a 24-month period—fine of up to $2,559; fifth violation within a 36-month period—fine of up to $6,398; sixth violation within a 48-month period—fine of up to $12,794; and five or more repeated violations within 36 months—no-tobacco-sale order of 30 calendar days or six months or permanent.

    The OIG report criticizes the FDA’s lack of transparency, which it says makes it hard to track the FDA’s performance. The report suggests that the FDA collaborate with the Bureau of Alcohol, Tobacco, Firearms and Explosives on oversight of online tobacco retailers; complete its rulemaking on non-face-to-face sales of tobacco products as required by the Tobacco Control Act; collect data to support process and outcome measures for its oversight of online tobacco retailers; and publish information and performance data on its oversight of online tobacco retailers.

    In a response, the FDA did not dispute a lack of enforcement actions and agreed with the first and fourth suggestions, stating it is in the process of making those changes. The organization was noncommittal regarding the other two suggestions.

    The OIG report is separate from the Reagan-Udall Foundation review of the FDA’s Center for Tobacco Products.

  • Inflation Boosts Discount Cigarette Sales

    Inflation Boosts Discount Cigarette Sales

    Photo: pkstock

    U.S. smokers are switching to lower priced cigarettes in the wake of inflation, reports The Wall Street Journal. Cheaper tobacco brands increased their share of the U.S. cigarette market to 27.1 percent in the third quarter of 2022, up 1.8 percentage points from a year ago.

    While the tobacco industry tends to weather economic downturns better than other sectors, smokers are sensitive to inflation because they have lower incomes than the average consumer. In the U.S., smoking prevalence among people earning less than $35,000 a year is about 21 percent compared with 7 percent for those earning more than $100,000.

    The trend toward lower priced cigarettes favors smaller players like Vector Group, which reported record tobacco revenues in the third quarter of 2022. The company sold 30 percent more cigarettes during the quarter than it did the same time last year. Driven by the significant growth of its price-fighting Montego brand, Vector’s wholesale market share reached 5.7 percent in the quarter—its highest market share since 1984.

    The Wall Street Journal notes that Vector’s position is strengthened by the fact that, due to the company’s relatively small market share, about one-third of its volumes are exempt from payments under the 1998 Master Settlement Agreement.

    Imperial Brands, which has a big portfolio of discount cigarette brands in the U.S., has also been gaining market share as smokers look for bargains.

  • Court Blocks FDA Graphic Health Warnings

    Court Blocks FDA Graphic Health Warnings

    Image: FDA

    A federal judge has blocked the U.S. Food and Drug Administration from enforcing a rule requiring tobacco manufacturers to print graphic warning labels on their products, citing the companies’ First Amendment rights, reports Law360.

    The Family Smoking Prevention and Tobacco Control Act of 2009 instructs the FDA to create visual health warnings, but the D.C. Circuit in 2012 blocked the agency’s first attempt, saying that regulators had not convincingly demonstrated that the warnings would actually reduce smoking.

    In March 2020, the FDA released the final rule requiring new graphic warnings for cigarettes that feature some of the lesser known but still serious health risks of smoking, such as diabetes, on the top half of the front and back of cigarette packages and at least 20 percent of the area on the top of cigarette advertisements.

    R.J. Reynolds Tobacco Co., ITG Brands and Liggett Group filed a First Amendment challenge in April 2020. The rule was set to take effect in November 2023 after it was repeatedly pushed back by court.

    In a lengthy opinion issued Dec. 7, U.S. District Judge J. Campbell Barker of the U.S. District Court for the Eastern District of Texas vacated the FDA’s rule after finding that the required label statements and graphic images are not narrowly tailored to the agency’s interest in promoting public awareness of the health risks of smoking.

    “The government has not shown that compelling these large graphic warnings is necessary in light of other options,” the judge said, noting that the government could put more effort into public awareness campaigns.

    Public health campaigners were aghast. “Today’s decision by a federal judge to block implementation of graphic cigarette warnings ordered by the Food and Drug Administration is wrong on the law, inconsistent with decades of precedent and harms public health,” read a joint statement issued by the American Academy of Pediatrics, American Cancer Society, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids and Truth Initiative.

    “We urge the justice department to appeal this decision, and we are confident that the FDA’s warnings will ultimately be upheld by a higher court.”

    The health groups also noted that the U.S. had fallen behind other countries with its tobacco control policies. Prior to 2009, when Congress passed the Tobacco Control Act, only 18 countries required graphic warnings for tobacco products, they pointed out. Today, more than 120 countries require them.

  • Stabilization Settlement Funds Available

    Stabilization Settlement Funds Available

    Photo: Taco Tuinstra

    Current and former tobacco growers who wish to claim funds from the U.S. Tobacco Stabilization lawsuit settlement should complete a proof of claim form by Dec. 12, 2022.

    The settlement stems from a lawsuit against the Flue-Cured Tobacco Cooperative over withheld funds, which are now being returned to qualifying grower members.

    Tobacco growers who were a member of the cooperative at some point between 1946 and 2004 are eligible for payment considerations.

    Growers claiming funds must supply their FC Number. Alternatively, they must provide sufficient identifying information, including all names and addresses used during the period that they marketed flue-cured tobacco.

    A copy of the qualified settlement fund procedures, the proof of claim form and additional relevant information is available at https://omniagentsolutions.com/lewissettlementclasstrust.

  • New Guidance on Perception/Intention Studies

    New Guidance on Perception/Intention Studies

    The U.S. Food and Drug Administration Today issued a final guidance on guidance perception and intention studies.

    The guidance, “Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies,” is intended to help applicants design and conduct tobacco product perception and intention (TPPI) studies that may be submitted as part of a modified risk tobacco product (MRTP) application, a premarket tobacco product application (PMTA), or a substantial equivalence report (SE Report).

    TPPI studies can be used to assess, among other things, individuals’ perceptions of tobacco products, understanding of tobacco product information (e.g., labeling, modified risk information), and intentions to use tobacco products, according to the FDA.

    These studies provide critical information during the review of product applications and this guidance provides recommendations on how to perform these studies.

    The final guidance addresses several scientific issues for applicants to consider when designing and conducting TPPI studies to support tobacco product applications:

    • Developing study aims and hypotheses
    • Designing quantitative and qualitative studies
    • Selecting and adapting measures of study constructs
    • Determining study outcomes
    • Selecting and justifying study samples
    • Analyzing study results

    The guidance document is intended to provide clarity to applicants regarding existing requirements under the law, according to FDA.

    “FDA guidance documents, including this guidance, should be viewed as recommendations for consideration, unless specific regulatory or statutory requirements are cited,” the release states.

  • Former FDA Boss to lead CTP Review

    Former FDA Boss to lead CTP Review

    The Reagan-Udall Foundation has picked Clinton-era U.S. Food and Drug Administration commissioner Jane Henney to spearhead its 60-day review of operations in the agency’s food safety and tobacco divisions, according to Politico.

    Henney, the first woman to lead the agency, has not formally been announced yet.

    The FDA Commissioner Robert Califf made the move in an attempt to push past several controversies that have dominated his second stint running the agency, including his issuing of a marketing denial order (MDO) to e-cigarette maker Juul Labs and later having to rescind that order.

  • Study: Major Drop in Vaping by Under-20s

    Study: Major Drop in Vaping by Under-20s

    Use of e-cigarettes vaping devices dropped during the first year of the Covid-19 pandemic, according to a new study.

    Researchers from Johns Hopkins University in Baltimore, Maryland, found that usage of vaping products dropped seven percent overall from 2018 to 2020 – including a 17 percent drop among people aged 18 to 20.

    Researchers published their findings Friday on the JAMA Network Open after gathering data from the U.S. Centers for Disease Control (CDC) and Prevention’s Behavioral Risk Factor Surveillance System for the study, according to media reports.

    The survey included a total of 994,307 respondents. In 2017, the CDC reported 4.4 percent of U.S. adults reported use of an e-cigarette. The figure climbed 25 percent to 5.5 percent in 2018.

    ‘This increase, primarily observed in younger age groups, was associated with the concurrent rise in the availability of flavored products and high nicotine–concentration pod mod devices (modular vaping devices with refillable or replaceable nicotine cartridges, or pods, such as JUUL brand devices),’ the researcher’s wrote in the study.

    Data from 2019 was not gathered. In 2020, overall usage of e-cigarettes fell to 5.1 percent, a seven percent drop from two years earlier. The most dramatic shift was seen among people aged 18 to 20 years old – the youngest group included in the study.