Tag: United States

  • Dettelbach Confirmed as ATF Director

    Dettelbach Confirmed as ATF Director

    Credit: ATF

    The U.S. Senate on Tuesday voted to confirm Steve Dettelbach to serve as director of the Bureau of Alcohol, Tobacco, Firearms and Explosives.

    Dettelbach, 56, was confirmed by a 48-46 vote that went largely along party lines.

    “Following the passage of the Bipartisan Safer Communities Act, today’s vote is another important sign that both parties can come together to support law enforcement and stand up against the horrific scourge of gun violence,” President Joe Biden said in a statement following the vote.

    Prior to landing the job as the head of the ATF, Dettelbach worked as a federal prosecutor for the Justice Department – the ATF’s parent agency.

    “Steve understands the importance and urgency of ATF’s mission and I am confident he will lead ATF with integrity, dedication and skill,” U.S. Attorney General Merrick Garland said in a statement.

    Tuesday’s vote marked the first time the Senate has confirmed an ATF director since 2013.

  • U.S. House votes to decriminalize marijuana

    U.S. House votes to decriminalize marijuana

    Photo: p_gangler

    The U.S. House of Representatives voted on April 1 to decriminalize marijuana at the federal level, reports The New York Times.

    While the Marijuana Opportunity Reinvestment and Expungement Act is unlikely to get the required majority in the Senate, supporters said the vote was a necessary step toward building consensus on something that can become law.

    The bill would remove marijuana from the federal government’s list of controlled substances, impose an 8 percent tax on cannabis products, allow some convictions on cannabis charges to be expunged and press for sentencing reviews at the federal and state levels. It would also make Small Business Administration loans and services available to cannabis businesses while setting standards for them.

    By lowering law enforcement and incarceration costs and imposing new taxation, the bill would save the government hundreds of millions of dollars. The Congressional Budget Office estimated that the act would reduce the federal deficit by nearly $3 billion over the next decade.

    Thirty-seven states have legalized cannabis for medical use, and 15 have granted adults legal access for purely recreational purposes. Because cannabis remains a federally controlled substance, however, banks insured by the federal government have been loath to make their services available to the burgeoning marijuana industry.

    Faced with declining demand for cigarettes, some tobacco companies have been eying marijuana as a new business area.

    Sales in that industry totaled $20 billion in 2020 and are projected to more than double by 2025.

  • U.S.: Record Premium Cigars Imports

    U.S.: Record Premium Cigars Imports

    Photo: laboko

    The United States imported a record-setting 456.3 million premium cigars in 2021, according to the Cigar Association of America (CAA).

    The CAA estimates that 364.4 million premium cigars were imported in 2020, showing a 25.2 percent increase in 2021.

    December, however, showed a 23.7 percent drop in imports, marking the only month that did not exceed 2020 figures. The fourth quarter as a whole represented a 6.8 percent decrease compared to 2020.

    According to Halfwheel, the CAA calculates its numbers based on the import numbers provided by the U.S. Census Bureau, U.S. Customs Services and information from cigar companies. The trade group’s numbers are not exact because of reporting differences; it estimates how many “large cigars” were actually “premium cigars.” There are some machine-made cigars that meet the U.S. definition of a “large cigar,” though those cigars would not be considered premium cigars by most people.

  • FDA Gets Authority Over Synthetic Nicotine

    FDA Gets Authority Over Synthetic Nicotine

    Photo: The White House

    U.S. President Joe Biden on Tuesday signed into law a spending bill that gives the Food and Drug Administration authority over synthetic nicotine.

    The language of the Tobacco Control Act will now change to define a tobacco product as “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption.”

    The amendment comes into effect 30 days after the bill’s enactment. Manufacturers of products made with synthetic nicotine will then have an additional 30 days to submit a premarket tobacco product application (PMTA) to the FDA. If FDA has not authorized the product within 90 days after the effective date, the product must be removed from the market.

    According to Bryan Haynes, a partner with Troutman Pepper, the measure could amount to an effective ban on synthetic nicotine products. “FDA is highly unlikely to authorize a PMTA in 90 days when other PMTAs for electronic nicotine delivery systems have been pending for more than two years,” he wrote on the law firm’s blog.

    April Meyers, board president for the Smoke-Free Alternatives Trade Association (SFATA) suspects the bill will have little effect on youth vaping, which is already down significantly since highs in 2015. “Although the sponsors of the bill claim the intent was to close the loophole on synthetic nicotine-derived products from large companies now popular among youth, the reality is that this bill—and others like it—aren’t likely to have the intended effect,” she said. “Instead, consumers using these products as a harm reduction option will suffer, as will licensed small businesses in full compliance with federal, state, and local laws.

    “The FDA created a problem by overregulating a product used by millions of adults who find vaping a safer alternative to smoking. When a market in high demand is overregulated, grey and black markets emerge where there are no regulations requiring safe products or ID checks.”

    The FDA appears keen to crack down on synthetic nicotine. During his Senate confirmation hearing, FDA Commissioner Robert Califf vowed to close what he described as the synthetic nicotine “loophole.”

  • U.S. Youth Smoking at Historical Low

    U.S. Youth Smoking at Historical Low

    Youth cigarette smoking rates in the United States are at historically low levels with just 1.9 percent of high school students reporting current use of cigarettes, according to the National Youth Tobacco Survey 2021.

    In 2021, an estimated 34 percent of high school students (5.22 million) and 11.3 percent of middle school students (1.34 million) reported ever using a tobacco product, a definition that includes e-cigarettes, cigarettes, cigars, smokeless tobacco, hookahs, pipe tobacco, heated-tobacco products, nicotine pouches and bidis.

    Current (past 30-day) use of a tobacco product was 13.4 percent for high school students (2.06 million) and 4 percent for middle school students (470,000). E-cigarettes were the most commonly currently used tobacco product cited by 11.3 percent of high school students (1.72 million) and 2.8 percent of middle school students (320,000) followed by cigarettes, cigars, smokeless tobacco, hookahs, nicotine pouches, heated-tobacco products (HTPs) and pipe tobacco.

    The report also shows that 170,000 middle school students and high school students used HTPs in 2021, which appears odd given that the only HTP sold in the United States last year—Philip Morris International’s IQOS—was available only in a handful of test markets. Jim McDonald of Vaping360 suspects that this group of survey participants confused HTPs with another product, possibly cannabis vaporizers.

    Interestingly, while 85 percent of youth vapers reported using flavored products, the availability of flavors was not listed as a top consideration by survey participants. When asked about their reasons for using e-cigarettes, they ranked friends and family, curiosity, anxiety and “I can use them to do tricks” as more important factors in their decisions.

    Administered from January to May 2021, this NYTS was the first to be fully conducted amid the Covid-19 pandemic, with about half the students completing the online survey in schools and half completing it at home or at other locations. The Centers for Disease Control and Prevention and the Food and Drug Administration cautioned that the 2021 results cannot be compared to previous years because of pandemic-related changes in methodology.

  • Synthetic Nicotine Regulation Clears House

    Synthetic Nicotine Regulation Clears House

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    The House of Representatives approved a $1.5 trillion spending package that would give the U.S. Food and Drug Administration authority to regulate synthetic nicotine. The bill now goes to the Senate.

    Synthetic nicotine—nicotine that is made in a lab rather than derived from tobacco—has long existed in a legal gray area, and many companies started using it after their natural nicotine products were denied market access by the FDA. Public health groups have been warning that synthetic nicotine e-cigarettes, such as Puff Bar, have grown in popularity among teens while skirting FDA oversight.

    The Food, Drug and Cosmetic Act, which includes the 2009 Tobacco Control Act, defines a tobacco product as “any product made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part or accessory of a tobacco product).”

    If the spending bill currently under consideration passes, the language of the Tobacco Control Act would change to define a tobacco product as “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption.”

    The synthetic nicotine provisions are set to take effect 30 days after the bill’s passage. Synthetic nicotine producers then have 60 days from its enactment—or 30 days after it becomes effective—to file premarket tobacco product applications with the FDA to legally stay on the market. Ninety days after the effective date, or 120 days after the bill’s passing, these manufacturers will have to stop selling their products if the FDA has not authorized them. At that point, the FDA can exercise its enforcement discretion.

    Anti-smoking activists welcomed the legislation. “By using synthetic nicotine, e-cig companies are avoiding public health protections for flavored tobacco products and still hooking teens,” tweeted billionaire philanthropist Michael Bloomberg. “With millions of kids still using e-cigs, we must get synthetic nicotine products off the market.”

    Consumer advocates, by contrast, warned the move would deny adult smokers access to lower risk alternatives. “Only the largest and most powerful vaping and tobacco companies can afford the lawyers and the time necessary to complete the paperwork necessary to pass the FDA’s process, meaning thousands of hard-working American business owners will now be forced to close, depriving millions of adult consumers of harm reducing options,” said Yael Ossowski, deputy director of the Consumer Choice Center.

    The FDA appears keen to crack down on synthetic nicotine. During his Senate confirmation hearing, FDA Commissioner Robert Califf vowed to close what he described as the synthetic nicotine “loophole.”

    Earlier, FDA Center for Tobacco Products Director Mitch Zeller indicated that the synthetic nicotine could be considered a component of e-cigarettes, which would have allowed the agency to assert authority over the substance under existing legislation.

  • PMI to Make IQOS in the U.S. After Import Ban

    PMI to Make IQOS in the U.S. After Import Ban

    Photo: Mariakray

    Philip Morris International plans to manufacture IQOS in the United States to get its tobacco-heating device back on that country’s store shelves, reports Bloomberg.

    The move follows an adverse ruling against the company and its U.S. partner, Altria Group, in a patent dispute with British American Tobacco.

    In September 2021, the International Trade Commission (ITC) upheld an initial determination from May 2021 that IQOS infringes on two patents owned by BAT subsidiary Reynolds American Inc. (RAI).

    The ITC instituted an import ban and issued a cease-and-desist order, barring Altria Group from importing PMI’s IQOS 2.4, IQOS 3, IQOS 3 Duo products into the U.S. By declining to intervene, the U.S. Trade Representative upheld the ITC finding in November, leaving PMI with the options to produce IQOS domestically or tweak the design.

    A design change, however, would require authorization from the U.S. Food and Drug Administration again.

    In an interview with Bloomberg, PMI CEO Jacek Olczak, said the company had planned to manufacture IQOS in the U.S. all along. “From the very beginning of us going to the FDA, we had in mind that IQOS would one day not only be sold in the U.S., but manufactured there, if you take into consideration the size of the market and the opportunity for IQOS,” he said. “It’s just happening sooner because of the ITC decision.”

    In July 2020, the FDA authorized PMI and Altria to market IQOS with certain modified-exposure claims, giving the company a leg up over its rivals.

    PMI has not specified where it will be manufacturing IQOS but said it plans to sell IQOS in the U.S. again in the first half of 2023.

  • KT&G Suspends U.S. Operations

    KT&G Suspends U.S. Operations

    KT&G Corp. is suspending its tobacco business in the United States for an unspecified period, reports The Korea Herald, citing a regulatory filing by the firm.

    “We need to conduct a review of our business in the U.S. amid intensifying regulations over tobacco and growing competition,” the company said.

    Among other challenges, KT&G cited the Food and Drug Administration’s intention to mandate lower nicotine limits for cigarettes sold in the U.S.

    Such a move would cost the company an estimated KRW205.8 billion ($174 million) in lost sales, amounting to around 3.9 percent of the company’s overall sales revenue for last year, according to KT&G.

    KT&G also pointed to mandatory tobacco escrow accounts for smoking-related legal settlements as reason for its decision.

    “We will reconsider our business strategy in the U.S. after reviewing the business environment and regulations,” a company official said.

  • Vaping Tax Dropped From U.S Bill

    Vaping Tax Dropped From U.S Bill

    Photo: cn0ra

    A proposal to impose U.S. federal taxes on vaping has been removed from the Democrats’ healthcare, education and climate change bill, reports The Wall Street Journal, citing people familiar with the matter.

    Nevada Senator Catherine Cortez Masto, a Finance Committee member in a tough re-election race, reportedly pushed to remove the tax and helped force its deletion.

    The removed provision would have levied a tax on vaping products designed to parallel the existing federal cigarette tax rate of $1.01 per pack.

    The tax had draw considerable criticism from vapor industry representatives and tobacco harm reduction advocates, who said it would in some cases make e-cigarettes more expensive than combustible cigarettes—a perverse outcome, given that vaping is widely believed to be less harmful than smoking.

    Critics also noted the tax would be regressive. According to a recent Gallup poll, Americans with an annual household income of less than $40,000 are significantly more likely to vape than higher-income groups.

    Vaping advocates welcomed the decision. “The evidence is clear that imposing a new excise tax on vaping products will discourage adults from quitting smoking and shut down small businesses already dealing with industry-crushing federal regulations,” Gregory Conley, president of the American Vaping Association, was quoted as saying by The Wall Street Journal.

  • U.S. Pictorial Health Warnings Postponed Again

    U.S. Pictorial Health Warnings Postponed Again

    Image: FDA

    The new effective date for the FDA’s final rule on health warnings is Jan. 9, 2023, after the U.S. District Court for the Eastern District of Texas ruled to extend the date in R.J. Reynolds Tobacco Co. et al. v. United States Food and Drug Administration et al.

    Deadlines tied to the effective date have also shifted. For instance, while the FDA strongly encourages entities to submit cigarette plans as soon as possible, the deadline for submission is now March 12, 2022.

    The Family Smoking Prevention and Tobacco Control Act (TCA) of 2009 directed the FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany new textual warning statements.

    In March 2020, the FDA finalized the “Required Warnings for Cigarette Packages and Advertisements” rule, establishing 11 new cigarette health warnings consisting of textual warning statements accompanied by color graphics, in the form of photorealistic images, depicting the negative health consequences of cigarette smoking.

    The new graphic warnings, which depict some of the lesser known health risks of smoking, such as diabetes, must cover at least the top 50 percent of the front and rear panels of packages as well as at least 20 percent of the top of advertisements.

    In April and May 2020, cigarette manufacturers and retailers sued the FDA, arguing that the graphic warning requirements amount to governmental anti-smoking advocacy because the government has never forced makers of a legal product to use their own advertising to spread an emotionally charged message urging adults not to use their products.

    In a more recent challenge, tobacco companies argued that the deadline was too onerous due to the impact of the Covid-19 pandemic. They also pointed to the risk that they would lose their investments in new packaging if the graphic health warning requirement were ultimately thrown out in court.

    The industry won several postponements of the new health warnings’ effective date in court.

    This is the FDA’s second attempt to enact graphic health warnings under the TCA. The first rule was struck down by the federal court in the District of Columbia as a violation of the First Amendment.