Tag: regulation

  • Senator Demands FDA Testify Before Congress

    Senator Demands FDA Testify Before Congress

    Vapor Voice Archive

    After months of pressure from lawmakers to prevent the unauthorized sale of vaping devices, federal regulators may soon have to explain themselves before Congress.

    Senate Majority Whip Dick Durbin, who chairs the Senate Judiciary Committee, has long urged the U.S. Food and Drug Administration to follow through on a court-ordered review of premarket tobacco product applications (PMTAs) from e-cigarette manufacturers.

    The U.S. Court for the District of Maryland mandated the survey, ruling in 2019 that the FDA had run afoul of federal law by allowing unauthorized vape sales. The review was supposed to have been completed in 2021, according to Court House News.

    Durbin, in a January letter, accused the agency of “granting a free pass to scores of vaping products that are harming the health of children in our country.”

    Now, Durbin is angling to haul FDA officials before Congress. He demanded in a letter Tuesday that Brian King, director of the agency’s Center for Tobacco Products, testify before the Senate Judiciary Committee.

    Durbin extended a similar invite to Brian Boynton, principal deputy assistant attorney general for the Justice Department’s civil division. Federal law enforcement is tasked with assisting the FDA in bringing enforcement for violations of the Tobacco Control Act, which includes marketing authorizations for vape manufacturers.

    Durbin met with Boynton and King in April during a private meeting to discuss the enforcement of unauthorized e-cigarettes. If the officials agree to testify publicly, the Judiciary Committee will hold a hearing in June.

    A spokesperson for the FDA did not immediately respond to a request for comment on whether it would comply with the request.

  • Regulators Urged to Distinguish Combustibles and Smoke-Free

    Regulators Urged to Distinguish Combustibles and Smoke-Free

    Photo: Finn Bjurvoll Hansen

    A study released on May 7 adds further evidence that the harm from nicotine use is determined primarily by the consumption method.

    Titled No Smoke, Less Harm, the report details rates of nicotine usage in Sweden and a number of comparable countries, finding that nicotine use was not a factor in tobacco-related disease.

    Karl Fagerstrom

    While nicotine consumption in Sweden mirrors the European average, the country reports a 41 percent lower incidence of lung cancer and fewer than half the tobacco-related deaths of its European peers. This stark contrast is attributed to the widespread adoption of smoke-free nicotine products such as snus, nicotine pouches and electronic cigarettes.

    “This distinction between smoking and the use of smokeless products is crucial,” says Karl Fagerstrom, a public health expert and contributor to the report.

    “While nicotine is addictive, it does not cause the serious diseases associated with smoking. Our findings support a shift in focus from cessation to substitution with less harmful alternatives for those unable to stop completely.”

    According to the authors, Sweden’s proactive measures in public health education and regulatory frameworks have encouraged a transition to these alternatives, significantly impacting public health outcomes. The report points out that embracing similar harm reduction strategies could be pivotal for other nations striving to reduce the health impacts of tobacco.

    “The Swedish experience demonstrates that understanding and addressing public misperceptions about nicotine can lead to health policies that better protect and inform consumers,” said Fagerstrom.

  • Critics Claim Registry Bills Harmfully Limit Options

    Critics Claim Registry Bills Harmfully Limit Options

    Photo: Andrey Popov

    Premarket tobacco product application (PMTA) registry bills in the United States are harmfully limiting options for people seeking to quit cigarettes, according to critics.

    The bills, which restrict sales to products that have either been authorized by the Food and Drug Administration under the PMTA pathway or are undergoing that process, have been spreading rapidly around the nation, according to Filter.

    Alabama, Louisiana and Oklahoma already have PMTA registry bills in force while laws in Kentucky, Utah and Wisconsin are set to take effect in 2025.

    To date, the FDA has authorized only a handful of e-cigarettes, all of which are owned by tobacco companies. The remaining vapes on the market are sold unauthorized and often imported from China. Limited FDA enforcement has prompted many states to step in with registry bills.

    Tobacco harm reduction advocates have long condemned the PMTA process as excessively onerous. They point out that it’s easier to bring new cigarettes to market than it is to gain authorization for safer vapes that can replace them.

    Tobacco companies are supporting PMTA registry bills in what critics say is a bid to dominate the market at the expense of people who smoke.

    “Most legislators do not understand that PMTA registries aim to ban the sale of the vast majority of vaping products used by adults in their state,” said Greg Conley, director of legislative and external affairs for the American Vapor Manufacturers trade organization. “They think they are fighting Chinese scofflaws, but really they are making life worse for their own voters.”

  • FDA Updates Authorized Products Database

    FDA Updates Authorized Products Database

    Photo: Andrey Kuzmin

    The U.S. Food and Drug Administration has uploaded the first update to its recently created Searchable Tobacco Products Database, which provides an overview of tobacco products and vapor products that may be legally marketed in the United States.

    Due to timing factors associated with the initial launch, the products included in this update cover a longer time period (January through mid-April 2024) than will typically be included in the future. The agency intends to update the database every month.

    The current database updates include the addition of several tobacco products that were issued a substantial equivalence or exempt order, a number of tobacco products that were determined to be preexisting tobacco products through voluntary submissions, and links to redacted and 508-compliant order letters, decision summaries and other documents for various authorized products that were already in the database.

    The database is available here.

  • Cook Islands Lawmakers to Table Bill Banning Vapes

    Cook Islands Lawmakers to Table Bill Banning Vapes

    Credit: Oleksii

    Lawmakers in the Cook Islands have proposed a ban on all next-generation tobacco products, including e-cigarettes.

    The proposal is included in the Tobacco Products Control Amendment Bill 2024, which will be tabled in Parliament this month.

    Cook Islands residents, permanent residents and work permit holders are not allowed to bring in any vaping or heated tobacco products for personal use, sale or distribution if they leave and return to the Cook Islands, according to the Bill.

    Tourists over the age of 21 are allowed to bring only one “imitation tobacco device” and up to 30 milliliters of e-liquid, according to media reports.

    The Bill says any breach of the regulations by individuals will result in a fine of $100,000 or up to three months in prison.

    Businesses caught importing imitation tobacco products face a $1 million fine. Additionally, non-compliant businesses will incur a daily penalty of $100,000 for each day the violation continues.

  • Development of Vaping Rules a Priority in Samoa

    Development of Vaping Rules a Priority in Samoa

    Credit: SC Stock

    Development of regulations to support the enforcement of e-cigarettes in Samoa, including their sale and usage, is in the pipeline.

    Parliament’s discussion on the topic last year and young people seen smoking e-cigarettes has prompted calls for the Ministry of Health (MOH) to take action.

    Vaping products were not readily available when the MOH developed Somoa’s Tobacco Control policy and legislation, but its availability in neighboring countries and the product being sold locally without control meant the Government had to reconsider whether tobacco rules applied to vaping, according to media reports.

    In those efforts, the Samoa Australia Tautua program funded by Australia has put out a vacancy for Technical Assistance assigned to develop a comprehensive set of regulations for e-cigarettes in Samoa as a means to support its enforcement and prevention of the harmful effects of its use.

    The term of reference for the Technical Assistance is to draft regulations to “prohibit the importation, distribution, sale, and usage” of e-cigarettes in Samoa.

  • Vaping Group Praises Reclassification of Marijuana

    Vaping Group Praises Reclassification of Marijuana

    Credit: Good Man Photo

    Representatives of the U.S. vapor industry have welcomed a decision by the Biden Administration to reclassify marijuana.

    “The decision clearly underscores this administration’s commitment to listening to constituents and demonstrates a willingness to recognize and accept real-world, category-wide scientific evidence, said Tony Abboud, executive director of the Vapor Technology Association (VTA) in an e-mailed statement.

    “In light of today’s decision, VTA is encouraging other agencies within the Biden Administration, specifically, the U.S. Food and Drug Administration, to follow the similarly overwhelming body of evidence on the use of vaping products as effective harm reduction and smoking cessation tools for adult smokers.

    “In just the past year, FDA’s selective pattern of prioritizing politics over science has led to the approval of more than 650 new cigarettes. VTA reiterates its call for the FDA to follow suit with other agencies in the Administration to stop turning a blind eye to the overwhelming body of science proving the benefits of flavored nicotine options to Americans looking to quit smoking.”

  • U.S. DEA Asks White House to Reclassify Marijuana

    U.S. DEA Asks White House to Reclassify Marijuana

    Vapor Voice Archives

    The U.S. Drug Enforcement Administration plans to reclassify marijuana as a less dangerous drug, which could have far-reaching implications for American drug policy.

    The proposed measure, which is yet to be reviewed by the White House Office of Management and Budget, aims to acknowledge the medical benefits of using cannabis and recognize the fact that it is less prone to abuse in comparison to some of the most dangerous drugs in the country and reclassify cannabis as a Schedule III drug.

    However, it does not seek to legalize marijuana for recreational purposes.

    Five people familiar with the matter who spoke on the condition of anonymity to discuss the sensitive regulatory review confirmed the agency’s move to the AP on Tuesday. The move clears the last significant regulatory hurdle before the agency’s biggest policy change in more than 50 years can take effect.

    According to the DEA, the following are examples of Schedule I drugs: 

    • Heroin 
    • Lysergic acid diethylamide (LSD) 
    • Cannabis 
    • Methamphetamine 
    • Methaqualone (Quaalude) 
    • Peyote 

    According to the National Institute for Health, California became the first State to make it illegal to possess cannabis. In the 1930s, the then U.S. Federal Bureau of Narcotics warned of the increasing abuse of cannabis, and by 1937, 23 States had criminalized possession.

    By 1970, the Controlled Substances Act passed, and the Federal government categorized marijuana as a Schedule I substance.

    The planned DEA rule change followed an August 2023 recommendation from the Department of Health and Human Services (HHS) that DEA reschedule marijuana from Schedule I to Schedule III. Any change to the status of marijuana via the DEA rulemaking process would not take effect immediately.

  • FDA: 14 More Warning Letters for Flavored Vape Sales

    FDA: 14 More Warning Letters for Flavored Vape Sales

    The U.S. Food and Drug Administration announced on May 1 that it had sent warning letters to 14 online retailers. The reason for the warning letters was that these retailers were selling unauthorized e-cigarette products.

    The warning letters specifically mentioned the sale of disposable e-cigarette products marketed under various brand names such as Elf Bar/EB Design, Esco Bars, Funky Republic, Hyde, Kang, Cali Bars, and Lost Mary, according to press release.

    The retailers receiving these warning letters sold or distributed e-cigarette products in the United States that lack authorization from FDA, in violation of the Federal Food, Drug, and Cosmetic Act.

    Warning letter recipients are given 15 working days to respond with the steps they will take to address the violation(s) cited in the warning letter and to prevent future violations. Failure to promptly address the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalties.

    The agency announced on April 30 that the U.S. Marshals Service seized more than 45,000 unauthorized e-cigarette products valued at more than $700,000 in California.

    The seized products were mostly flavored, disposable e-cigarette products, including brands such as Puff Bar/Puff, Elf Bar/EB Design, Esco Bar, Kuz, Smok and Pixi.

  • U.S. Marshals Seize $700,000 in Unauthorized Vapes

    U.S. Marshals Seize $700,000 in Unauthorized Vapes

    Photo: APchanel

    The U.S. Marshals Service seized more than 45,000 unauthorized e-cigarette products valued at more than $700,000 in California. The seized products were mostly flavored, disposable e-cigarette products, including brands such as Puff Bar/Puff, Elf Bar/EB Design, Esco Bar, Kuz, Smok and Pixi.

    “FDA has been unequivocally clear that we are committed to using the full scope of our enforcement tools—including seizures—to hold those who peddle unauthorized e-cigarettes accountable,” said Brian King, director of the FDA’s Center for Tobacco Products, in a statement. “The writing is on the wall for those in the tobacco product supply chain who fail to heed the law.”

    This action represents the first time the U.S. Food and Drug Administration and the Department of Justice (DOJ) have seized tobacco products in coordination with the U.S. Marshals Service.

    The seizure initially targeted products being held and sold by MDM Group, a distributor doing business as Eliquidstop.com. FDA issued a warning letter to MDM Group in May 2023, for offering unauthorized, flavored e-cigarette products for sale or distribution. In January 2024, FDA conducted a follow-up inspection of the firm and determined that it continued to commercially market its illegal products. While conducting the seizure at MDM’s facility, the agencies were informed that several firms may have an ownership interest in the unauthorized e-cigarettes seized.

    As of April 2024, the FDA had issued approximately 670 warning letters to firms for manufacturing and/or distributing illegal e-cigarette products and issued more than 550 warning letters to retailers for the sale of unauthorized e-cigarettes. The agency has also filed civil money penalty complaints against more than 50 e-cigarette manufacturers and more than 100 retailers for manufacture and/or sale of unauthorized new tobacco products, as well as complaints for permanent injunction against seven e-cigarette manufacturers.