Tag: FDA

  • FDA Warns 9 More for Illegal Vape Sales

    FDA Warns 9 More for Illegal Vape Sales

    The U.S. Food and Drug Administration issued warning letters to eight online retailers and one manufacturer for selling and/or distributing unauthorized flavored, disposable e-cigarettes.

    Some of the unauthorized products cited in the warning letters are marketed under brand names for disposable products, including Geek Bar and Lost Mary, according to the FDA. Other unauthorized products cited feature the names and/or images of celebrities.

    The firms receiving these warning letters sold and/or distributed e-cigarettes in the United States that lack authorization from FDA to be legally marketed in the U.S., which is in violation of the Federal Food, Drug, and Cosmetic Act.

    In addition to the violations mentioned in the warning letters, the firms were warned to address any violations that are the same as, or similar to, those stated in the warning letter and to promptly take necessary actions to comply with the law.

    Failure to promptly correct the violations can result in additional actions such as an injunction, seizure, and/or civil money penalty.

  • FDA Sends Nicotine Limits Proposal to White House

    FDA Sends Nicotine Limits Proposal to White House

    VV Archives

    The Biden administration has proposed a rule that would significantly lower the amount of nicotine in tobacco products. The U.S. Food and Drug Administration’s efforts to counter the dangers of the chemical in stretch back to 2018, when it first proposed the idea.

    Then, FDA Commissioner Robert Califf went even further in 2022 and announced that the agency was developing a rule requiring tobacco companies to reduce the amount of nicotine in cigarettes.

    The next step in that effort occurred Tuesday when the FDA finally submitted its refined proposal to the Office of Management and Budget. There won’t be any immediate changes to tobacco products. The approval process for the Office of Management and Budget can take months. There will also be a public comment period, and the nicotine industry often sues the government to stop new regulations.

    “A proposed product standard to establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain combusted tobacco products, when finalized, would be among the most impactful population-level actions in the history of U.S. tobacco product regulation,” the FDA said in a statement reported by CNN on Wednesday.

    When the FDA announced its initial plans to reduce nicotine in 2022, it estimated that reducing nicotine levels could keep more than 33 million people from becoming regular smokers, that about 5 million additional smokers would quit within a year, and that 134 million years of life would be gained.

    In the draft proposal from 2018, which the FDA has since refined, it cited a 2013 survey that found that reducing the total nicotine content of cigarettes to 0.5 milligrams per rod would minimize addictiveness. Still, it also said that questions remain with respect to the precise level of nicotine in cigarettes.

    The agency’s proposal was met with high praise Wednesday.

    “Once finalized, this rule could be a game-changer in our nation’s efforts to eliminate tobacco use,” said Harold Wimmer, president and CEO of the American Lung Association. “Making tobacco products non-addictive would dramatically reduce the number of young people who become hooked when they are experimenting. To fully address the toll of tobacco on our nation’s health and across all communities, it is critical to reduce nicotine levels to non-addictive levels in all commercial tobacco products, including e-cigarettes.”

    Not all smokers would quit if nicotine levels were limited, experts say, nor would all smoking-related diseases disappear since tobacco products contain other chemicals that can be harmful to health.

  • FDA Seeks Fines for 18 Sellers of Illegal Vapes

    FDA Seeks Fines for 18 Sellers of Illegal Vapes

    Credit: Adobe Stock

    The U.S. Food and Drug Administration announced it is seeking fines against two brick-and-mortar retailers and 16 online retailers who have continued to sell unauthorized vaping products.

    The regulatory agency previously issued warning letters to these retailers for their sale of unauthorized tobacco products; however, follow-up inspections revealed that the retailers had failed to correct the violations, according to an agency press release.

    “Many recipients of warning letters correct the violative conduct, the release states. “However, failure to promptly correct the violations can result in additional enforcement actions such as civil money penalties, as is the case for these companies.”

    The FDA has filed civil money penalty complaints against 79 manufacturers and 175 retailers for distribution and/or sale of unauthorized tobacco products. Additionally, the FDA works closely with federal enforcement partners, including through a newly announced federal interagency task force.

    For example, FDA and U.S. Customs and Border Protection recently announced the seizure of $76 million in illegal e-cigarettes.

    A bipartisan group of influential House lawmakers recently stated their doubts about the Food and Drug Administration’s proposal to begin collecting fees from e-cigarette companies, akin to how the agency charges fees to tobacco firms.

    FDA officials say that the fees would give regulators resources to tackle the thousands of illegal vapes lining store shelves.

  • SCOTUS to Hear Triton Vaping Case Next Week

    SCOTUS to Hear Triton Vaping Case Next Week

    Credit: Renas Child

    In one week, the U.S. Supreme Court will hear the U.S. Food and Drug Administration’s defense of the agency’s rejection of two companies’ premarket tobacco product applications (PMTAs) to sell flavored vape products that it has determined pose health risks for young consumers.

    The live audio of the hearing can be found here.

    The justices took up the FDA’s appeal filed after a lower court ruled that the agency had failed to follow proper legal procedures under federal law when it denied the applications to bring their nicotine-containing products to market.

    The Supreme Court is due to hear the case in its next term, which begins in October, according to Reuters.

    Two e-cigarette liquid makers, Triton Distribution and Vapetasia LLC, filed FDA applications in 2020 for products with flavors such as sour grape, pink lemonade, and crème brulee and names such as “Jimmy The Juice Man Strawberry Astronaut” and “Suicide Bunny Bunny Season.”

    An FDA rule that took effect in 2016 deemed e-cigarettes to be tobacco products, like traditional cigarettes, subject to agency review under a 2009 federal law called the Tobacco Control Act. The rule said manufacturers of the products would need to apply for approval to continue selling them.

    The FDA rejected the applications by the two companies, along with more than one million other products, according to court records. The FDA has approved only 27 e-cigarette products, all tobacco or menthol flavored.

    Triton and Vapetasia in 2021 asked the New Orleans-based 5th U.S. Circuit Court of Appeals to review the FDA’s denial of their applications.

    In January, the full slate of 5th Circuit judges ruled 10-6 that the FDA had been arbitrary and capricious, in violation of a federal law called the Administrative Procedure Act, by denying the applications without considering plans by the companies to prevent underage access and use.

  • Surgeon General Releases Report on Tobacco Use

    Surgeon General Releases Report on Tobacco Use

    Vivek Murthy

    The Surgeon General of the United States released a new report on health disparities related to tobacco use. The report finds that despite the nation’s substantial progress in reducing cigarette smoking and secondhand smoke exposure in the overall U.S. population, that progress has not been equal for all population groups.

    Disparities in tobacco use persist by race and ethnicity, income, education, sexual orientation and gender identity, occupation, geography, behavioral health status, and other factors. Additionally, cigarette smoking and secondhand smoke exposure continue to cause nearly half a million deaths a year in the United States—nearly one in five of all deaths.

    “Tobacco use continues to decline. Americans increasingly understand tobacco products are dangerous and addictive and many are taking advantage of available tools to help them quit. That’s great news,” said Xavier Becerra, HHS Secretary for Health. “Smoking is still the leading cause of preventable death in the United States. That’s unacceptable. We will keep working until tobacco is no longer a menace to individuals and families across the nation. We will continue our efforts to improve health equity and support communities that remain the most vulnerable.”

    This report expands upon the 1998 Surgeon General’s report on tobacco use among U.S. racial and ethnic groups to include data and trends by additional demographic factors and their intersection. This report also summarizes research on factors that influence tobacco-related disparities, and outlines actions everyone can take to eliminate these disparities and advance health equity in the United States.

    “Tobacco use imposes a heavy toll on families across generations. Now is the time to accelerate our efforts to create a world in which zero lives are harmed by or lost to tobacco,” said Surgeon General Dr. Vivek Murthy. “This report offers a vision for a tobacco-free future, focused on those who bear the greatest burden, and serves as a call to action for all people to play a role in realizing that vision.”

    Tobacco-Related Disparities Today

    Smoking has declined more than 70% in the United States since 1965. However, progress achieved through improvements in tobacco-related policies, regulations, programs, research, clinical care, and other areas, has not resulted in the same outcomes across all U.S. population groups.

    Cigarette smoking is higher among American Indian and Alaska Native people than other racial and ethnic groups, and smoking among men and women living in poverty is more than twice as common compared to those not living in poverty. Smoking is also higher among adults with lower levels of education; people who identify as gay, lesbian, or bisexual; adults who work in manual labor and service jobs; people who reside in rural areas; adults who reside in the Midwest or South; and people living with a mental health condition or substance use disorder.

    Despite the good news that deaths due to secondhand tobacco smoke exposure have declined by more than 50% since 2006, among people who don’t smoke, secondhand smoke exposure remains disproportionately high among children, Black people, people with lower incomes, and adults with lower levels of education. The magnitude of these disparities has increased since 2000.

    “While there is much to celebrate, the progress has not been equal across all populations or communities. Progress, in the form of improvements in tobacco-related policies, regulations, programs, research, clinical care, and other areas, has not resulted in the same outcomes for everyone,” said Adm. Rachel L. Levine, HHS Assistant Secretary for Health. “We have not made progress unless we have all made progress.”

    While cigarette smoking remains the leading preventable cause of disease and death in the United States, disparities exist in smoking-related health outcomes. For example, American Indian and Alaska Native adults have the highest prevalence of COPD, and Black men have the highest incidence and death rate due to lung cancer of any racial and ethnic group of men or women. 

    Factors that Influence Tobacco-Related Disparities

    Multiple factors influence tobacco-related health disparities, including:

    • Poverty, racism, discrimination, and other social determinants of health—such as where people live, how much money they make, access to health care – and exposure to tobacco product advertising and marketing.
    • The tobacco industry, whose tactics include concentrated marketing of tobacco products in neighborhoods with greater percentages of Black and Hispanic people, and residents with lower incomes; and marketing flavored products, including menthol, to specific groups. Menthol can make it easier to start smoking and harder to quit.
    • Financial and other obstacles to accessing treatments proven to help people quit using tobacco.
    • Social and environmental influences, such as whether family and friends smoke, smokefree air policies at home and work, and stress and exposure to dangers in the workplace.
    • Gaps in tobacco prevention and control protections, such as smokefree air policies.
    • Preemptive laws that block communities from protecting their members’ health.

    What Can be Done to Eliminate Tobacco-Related Disparities

    Everyone has a role to play in eliminating tobacco-related disparities, according to a press release.

    “To do this, we must:

    • Address the factors that influence tobacco-related disparities, such as inequitable access to health care; high-quality education; and safe, smokefree housing and workplaces.
    • Drive down the appeal, addictiveness, and availability of commercial tobacco products, such as by placing restrictions on the sale of flavored tobacco products, establishing a maximum nicotine yield to reduce the addictiveness of cigarettes and other combusted tobacco products, and regulating the number of stores that sell tobacco.
    • Equitably implement strategies proven to reduce commercial tobacco use and exposure to secondhand smoke. These strategies include tobacco product price increases, comprehensive smokefree air policies, effective counter-marketing and media campaigns, and evidence-based quitting resources.
    • Encourage friends, family members, and coworkers—including youth—to quit the use of tobacco products and support them in getting help to quit through resources, such as 1-800-QUIT-NOW and smokefree.gov.”

    For Surgeon General’s report information and resources, including the full report, a report executive summary, a consumer guide, and fact sheets, visit www.SurgeonGeneral.gov or www.CDC.gov/EndTobaccoDisparities

  • IKE Tech, Ispire to File Age Gating Technology PMTA

    IKE Tech, Ispire to File Age Gating Technology PMTA

    Credit: Thapana Studio

    Ispire Technology and IKE Tech announced a successful pre-premarket tobacco product application (PMTA) meeting with the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) for their age verification technology for electronic nicotine delivery systems (ENDS).

    According to an e-mailed release, the technology aims to prevent youth access while expanding adult market access to flavored PMTA-authorized products. IKE Tech is a joint venture among three leading technology and research companies Ispire and Touch Point Worldwide d/b/a Berify and Chemular Inc.

    IKE Tech will submit a component PMTA, which would allow ENDS manufacturers to incorporate their blockchain-based age-gating solution if authorized. The FDA indicated potential priority review consideration and acceptance of a component PMTA. The company plans to complete the required studies in Q1 2025.

    This critical regulatory milestone marks an essential step in the journey to provide an innovative, secure universal solution aimed at preventing youth access to ENDS and expanding the market for adults who choose to use flavored PMTA-authorized products, according to the release.

    “The IKE Tech identity and age verification technology unlocks opportunities for adults who choose to use flavored vapor products while introducing a pioneering approach to reducing youth access and usage,” the release states.

    Due to its innovative design, reliance on blockchain technology, and partnership with leading identity and age verification providers, the IKE Tech system is an advanced component that could be used — in any ENDS device — to ensure only authorized adult users can access vaping products.

    FDA alignment on key points:

    • Component PMTA: IKE Tech will submit a PMTA for a component, as opposed to a finished tobacco product to be sold to consumers, and the FDA indicated it will accept such a component PMTA if all statutory requirements are met. Additionally, due to the fact this component employs novel point-of-use technology, the FDA indicated it will consider a request to grant the IKE Tech system priority review. If authorized, the component PMTA would allow ENDS manufacturers to use the IKE Tech system in their finished tobacco product PMTAs, as a plug-and-play age-gating solution, which may allow for the approval of a variety of flavored ENDS products.
    • Creation of Tobacco Product Master File (TPMF): IKE will create and file a TPMF for the IKE component. Once authorized, the component and TPMF can, subject to agreement, be available to ENDS device manufacturers for incorporation into products.

    IKE Tech anticipates completing the required studies for the component PMTA for the IKE Tech system, including the Identity and Age Verification component in Q1 2025.

    “Our commitment to harm reduction through innovation and our collaborative efforts with regulators are central to Ispire’s mission,” said Michael Wang, Co-CEO of Ispire. “We are proud to introduce technologies that are designed to responsibly support adult consumer choice while significantly reducing youth access. This technology represents our dedication to aligning with regulatory guidance and setting new standards for safer

     

  • Robert Kennedy, Jr. Tapped to Lead Trump’s HHS

    Robert Kennedy, Jr. Tapped to Lead Trump’s HHS

    Robert Kennedy Jr. (Credit: Cage Skidmore)

    President-elect Donald Trump has nominated Robert F. Kennedy, Jr. to serve as the new secretary of the Department of Health and Human Services (HHS). The effects Kennedy will have on the nicotine market remain unclear. Kennedy must still be confirmed by Congress.

    “For too long, Americans have been crushed by the industrial food complex and drug companies who have engaged in deception, misinformation, and disinformation when it comes to Public Health,” Trump posted. “The Safety and Health of all Americans is the most important role of any Administration, and HHS will play a big role in helping ensure that everybody will be protected from harmful chemicals, pollutants, pesticides, pharmaceutical products, and food additives that have contributed to the overwhelming Health Crisis in this Country.”

    As the leader of HHS, Kennedy will oversee the FDA, which regulates vaping, nicotine pouches, and all other nicotine and tobacco products through its Center for Tobacco Products.

    Kennedy’s position on vaping, nicotine, and tobacco harm reduction (THR) remains an unknown. During the presidential campaign, Trump promised that, if elected, he would “save vaping” after meeting with Tony Abboud of the Vapor Technology Association.

    “I saved Flavored Vaping in 2019, and it greatly helped people get off smoking,” Trump said on his Truth Social platform in September. “I raised the age to 21, keeping it away from the ‘kids.’ Kamala and Joe want everything banned, killing small businesses all over the country. I’ll save Vaping again!”

  • U.S. Urged to Bolster Post-Employment Rules

    U.S. Urged to Bolster Post-Employment Rules

    Image: bluraz

    Public policy experts are calling for stronger federal post-employment regulations as U.S. regulators, including those overseeing the tobacco business, are increasingly losing talent to the private sector.   

    A recent article in The Examination details how, over the past 15 years, nearly two dozen lawyers have left the U.S. Food and Drug Administration and its Center for Tobacco Products to advise, litigate for or work with the tobacco and vaping industry.

    “It seems like every time we get sued in the tobacco industry, a former FDA lawyer is leading the lawsuit,” Commissioner Robert Califf told an FDA oversight organization last year.

    After gaining  FDA experience, lawyers can significantly increase their salaries by moving to a major law firm or corporation. While a lawyer’s salary in the FDA’s chief counsel’s office, for example, starts at around $83,000, a first-year lawyer at a firm made on average $200,000 a year in 2023, according to the National Association for Law Placement.

    Daniel Aaron, a former FDA attorney, says lawyers who’ve left the agency to work on behalf of the tobacco industry not only increase their renumeration but can also have a powerful impact on what lands on store shelves.

    “It’s a huge advantage to getting your product to market.” said Aaron, now a University of Utah law professor. “Ex-FDA lawyers know what the agency is worried about, and how a client can maximize its options. They know not just what the law is, but they know how the FDA will enforce the law.”

    Federal post-employment rules also bar former employees from communicating with or lobbying a federal employee for two years on behalf of a client or employer under certain circumstances. That said, employees are allowed to work “behind the scenes” advising clients, according to the FDA’s post-employment guidelines. 

    Genevieve Kanter, a professor at the University of Southern California who co-published a study in 2023 on the revolving door in health care regulation, believes the rules should be strengthened if society is truly interested in preserving independent government.

    Kanter’s study focused specifically on conflicts of interest of employees at the highest level of the U.S. Department of Health and Human Services; It found that 38 percent percent of the political appointees from the FDA went into private industry, the fourth highest out of roughly two dozen offices and divisions.

    Eric Lindblom, director of the Center for Tobacco Products’ Office of Policy from 2011 to 2016, proposed blocking former staff from working for the tobacco industry for at least one or two years, in all cases, after leaving the policy office. “I thought it was really important that we had that independence,” said Lindblom, now a senior scholar at Georgetown University’s O’Neill Institute.

    The proposal went nowhere.

    The Examination is a publication supported by Bloomberg Philanthropies.

  • Joint Operation Nets $76 Million in Illicit Vapes

    Joint Operation Nets $76 Million in Illicit Vapes

    Credit: Eduardo Barraza

    The U.S. Food and Drug Administration, in collaboration with U.S. Customs and Border Protection (CBP), announced the administrative seizure of approximately three million units of illegal vaping products.

    The products have an estimated retail value of $76 million. The seizures were part of a July joint operation to examine incoming shipments and prevent illegal e-cigarettes from entering the country. 

    “The FDA is on high alert and, in coordination with our federal partners, remains committed to stopping unauthorized e-cigarettes at our nation’s borders,” said FDA Commissioner Robert Califf. “These products too often end up in kids’ hands, and the newly formed federal task force is well positioned to collectively combat this unscrupulous activity.”

    In June, the FDA and the Department of Justice announced a joint federal task force to curb the distribution and sale of illegal e-cigarettes. Operations like these are an example of ongoing law enforcement work across federal agencies, which are now increasing in frequency with the creation of the task force. 

    “CBP’s trade enforcement mission places a significant emphasis on intercepting illicit products that could harm American consumers,” said Troy A. Miller, Senior Official Performing the Duties of the Commissioner for CBP. “We will continue to work with our enforcement partners to identify and seize unsafe and unlawful goods.” 

    In preparation for the operation, the joint team worked for several months to review shipping invoices, identify potentially violative incoming shipments, and complete other investigative work that led to this successful operation, according to a press release.

    Upon examining shipments, all of which originated in China, the team found various brands of illegal e-cigarettes, including Geek Bar and others. In an attempt to evade duties and detection, most of these unauthorized e-cigarettes were intentionally mis-declared as items with no connection to vaping products and with incorrect values.

    Products that are seized and forfeited to the government will be disposed of in accordance with CBP authorities. 

    “This isn’t the first joint seizure operation, and it won’t be the last – we will continue to relentlessly pursue those attempting to smuggle illegal e-cigarettes,” said Brian King, director of the FDA’s Center for Tobacco Products. “The $76 million these bad actors just put in the dumpster should be a sobering reminder that their time and money would be better spent complying with the law.”

  • NYTS Survey: U.S. Vaping Rates Hit Record Lows

    NYTS Survey: U.S. Vaping Rates Hit Record Lows

    Credit: TADA Images

    The latest tally of federal data finds that vaping rates fell from 10 percent of high school students in 2023 to 7.8 percent this year, “reaching the lowest level ever measured,” reported a team of researchers from the U.S. Centers for Disease Control and Prevention.

    According to newly released data from the 2024 National Youth Tobacco Survey (NYTS), current tobacco product use among U.S. middle and high school students has dropped to the lowest recorded level in 25 years,

    “Reaching a 25-year low for youth tobacco product use is an extraordinary milestone for public health. However, with more than 2 million youth using tobacco products and certain groups not experiencing declines in use, our mission is far from complete,” Deirdre Lawrence Kittner, director of CDC’s Office on Smoking and Health, said in a news release announcing the new data.

    Rates of use of traditional cigarettes are also meager: Only 1.4 percent of middle- and high-school kids now smoke, the report found.

    “We’re headed in the right direction when it comes to reducing tobacco product use among our nation’s youth,” said Brian King, director of the US Food and Drug Administration’s Center for Tobacco Products. “But we can’t take our foot off the gas. Continued vigilance is needed to continue to reduce all forms of tobacco product use among youth. Addressing disparities remains an essential part of these efforts to ensure that we don’t leave anyone behind.”

    Modern oral nicotine pouches now rank as the second most popular tobacco product, with 2.4 percent of high school students using them regularly, an FDA release states.

    “Nicotine pouch sales have substantially increased nationwide since 2016,” noted the team led by CDC investigator Ahmed Jamal, and “nearly one million (890,000) students reported ever using nicotine pouches in 2024.”

    Still, the overall trends are positive, and by 2024 only 1 in every 10 middle-and high-school students was using any form of tobacco product.