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Tag: U.S. Food and Drug Administration

  • Senate Confirms New FDA Commissioner

    Senate Confirms New FDA Commissioner

    Last week the U.S. Senate confirmed former Johns Hopkins surgeon and professor Dr. Marty Makary to lead the U.S. Food and Drug Administration by a 56-44 vote. During his confirmation hearing, Makary said his goals for the agency were “more cures and meaningful treatments for Americans,” and offered several insights as to how he would achieve those goals throughout the hearing.  

    In the past, Makary has been critical of the FDA, in 2021 calling for “fresh leadership at the FDA to change the culture at the agency and promote scientific advancement, not hinder it.” Reporting to Health and Human Services Secretary Robert F. Kennedy Jr., Makary’s leadership of the FDA also includes its Center for Tobacco Products (CTP). However, it’s not yet clear how he will approach CTP’s looming issues of reviewing premarket tobacco product applications (PMTAs), the illicit vape market, and other tobacco-related issues.

    Much of the confirmation hearing centered around past problems, including those with Covid-19 vaccines, the pharmaceutical industry, and various other issues that have often gained headlines of late, but he did not commit to specifics in that venue.

    “I have no preconceived plans on mifepristone policy except to take a hard look at the data and to meet with the professional career scientists at the FDA who have reviewed the data,” he said at his hearing. “We now have a generational opportunity in American healthcare. President Trump and Secretary Kennedy’s focus on healthy foods has galvanized a grassroots movement in America. Childhood obesity is not a willpower problem, and the rise of early-onset Alzheimer’s is not a genetic cause. We should be, and we will, be addressing food as it impacts our health.”

    When asked about the backlog of cases the FDA has across all departments, Makary did not rule out leveraging artificial intelligence and making other regulatory changes to streamline the drug review process. He suggested FDA reviewers could use AI “to help reviewers in the review process—not to replace human reviews, but to improve efficiency.”

    National Association of Tobacco Outlets (NATO) Executive Director David Spross told CSP on Friday that “NATO looks forward to working with Dr. Makary and the team at FDA on tobacco and nicotine product regulatory issues, including for the FDA is to support tobacco harm reduction policies by authorizing more PMTA vapor and nicotine pouch product applications that provide adult smokers with more choices.”

    Spross added that there is a “need for more transparency from the agency by providing retailers more information on illicit products, specifically in the vapor and nicotine pouch categories.”

    Makary is a surgical oncologist and health policy researcher who has spent more than 20 years at Johns Hopkins.

    “I am pleased to congratulate Dr. Makary on his new role as FDA commissioner,” said Johns Hopkins University President Ron Daniels. “We are fortunate to have one of our senior faculty members at the School of Medicine undertake this critical service to the nation.

    “An accomplished clinician and widely published health policy researcher, Dr. Makary has had a storied career at Johns Hopkins that reflects the research and clinical acumen and openness to different ideas and approaches undergirded by academic freedom that are the hallmark of our great institution,” said Daniels.

    Makary founded the Johns Hopkins Center for Surgical Trials and Outcomes Research and co-developed a surgical safety checklist used in operating rooms worldwide. He is a member of the National Academy of Medicine and has published more than 300 peer-reviewed articles and three New York Times bestselling books on healthcare.

    Senate also confirmed Jay Bhattacharya as the new director of the National Institutes on Health.

  • FDA Rule on Nicotine Content Clears OMB

    FDA Rule on Nicotine Content Clears OMB

    The Biden administration has moved closer to implementing a rule that would limit nicotine levels in cigarettes, with the proposal clearing an Office of Management and Budget review on Friday.

    Public health experts are optimistic about the potential impact. Studies suggest significantly reducing nicotine—by as much as 95%—could render cigarettes non-addictive, prompting many smokers to quit or transition to less harmful alternatives like e-cigarettes or nicotine pouches. Dorothy Hatsukami, a tobacco policy researcher, noted that minimally addictive cigarettes have shown promise in helping people quit smoking.

    However, critics warn of unintended consequences. Guy Bentley of the libertarian Reason Foundation argued that restricting nicotine levels could effectively ban cigarettes, fueling a black market and benefiting foreign entities.  “Biden’s ban is a gift with a bow and balloons to organized crime cartels with it, whether it’s cartels, Chinese organized crime, or Russian mafia. It’s going to keep America smoking, and it’s going to make the streets more violent,” said Rich Marianos, former assistant director of the U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives and the current chair of the Tobacco Law Enforcement Network.

    The future of the rule remains uncertain given the upcoming change of administration and the likelihood of litigation by industry.

  • FDA Issues Final Guidance on Testing Methods

    FDA Issues Final Guidance on Testing Methods

    The FDA has published final guidance for the tobacco industry on the “Validation and Verification of Analytical Testing Methods Used for Tobacco Products.” This guidance provides recommendations for tobacco manufacturers on how to generate validation and verification data for analytical methods supporting regulatory submissions, including Substantial Equivalence (SE) reports, Premarket Tobacco Product Applications (PMTA), and Modified Risk Tobacco Product Applications (MRTPA). It also applies to testing and reporting harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke.

    The updated guidance finalizes the draft issued in December 2021, incorporating comments received from stakeholders. Key changes include updates reflecting recent statutory revisions, such as the inclusion of synthetic nicotine under the definition of tobacco products, and clarifications on alternative validation procedures. The guidance also supports the use of national and international standard test methods and provides detailed recommendations on laboratory accreditation, statistical methods, and analytical test method validation, helping the industry produce more reliable and consistent data for regulatory purposes.

  • FDA Tightens Oversight on Vape, Pouch Imports

    FDA Tightens Oversight on Vape, Pouch Imports

    The FDA has updated import alerts 98-07 and 98-06 to strengthen the regulation of unauthorized e-cigarettes and other tobacco products entering the country. The changes clarify that all new vapor products must have FDA authorization to be marketed legally in the U.S. Under Import Alert 98-07, unauthorized vapor imports may face detention or refusal of entry without physical examination. The update also provides clearer guidance for importers, customs brokers, and federal partners, including links to the FDA’s searchable database of authorized tobacco products.

    Import Alert 98-06 focuses on non-e-cigarette tobacco products, including smokeless tobacco and nicotine pouches such as NOIS, LYFT, and SKRUF. These products, like vapor products, may also be detained if unauthorized. The FDA emphasized that mis-declared products remain a key focus, citing the seizure of three million units of unauthorized vapor products worth $76 million in collaboration with U.S. Customs and Border Protection. To date, the FDA has authorized only 34 vapor products and devices, underscoring its commitment to enforcing compliance and preventing illegal products from entering the market.

  • FDA Submits Proposal to Limit Nicotine

    FDA Submits Proposal to Limit Nicotine

    The U.S. Food and Drug Administration has submitted a proposal to limit the amount of nicotine in tobacco products, reports CNN.

    The FDA has been discussing limiting nicotine levels since 2018, and this week, the FDA submitted the proposal to the Office of Management and Budget (OMB). This move comes as the Biden administration enters into its last weeks and President-elect Donald Trump prepares to take office in January 2025.

    “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.

    “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 nonaddictive 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 nonaddictive levels in all commercial tobacco products, including e-cigarettes.”

    “Certainly, there would be individuals who would benefit from substantially lower nicotine levels and find it easier to quit,” said Rose Marie Robertson, a cardiologist and chief science officer at the American Heart Association. “It’s really hard to quit. I’ve seen patients over many years who have gotten the wake-up call with a heart attack or a stroke and really want to improve their health and reduce their risk, but it’s just very, very hard to do.”

    The submitted proposal does not mean that there will be any immediate changes. The OMB’s approval process can take months, and there must be a public comment period. It is likely that the tobacco industry will sue the government as well, as has been seen with other proposed regulations.

    It is unclear what will happen with the proposal following the change in presidency. In Trump’s first term, the Trump administration signaled that it wanted to limit nicotine, but during this year’s election season, the tobacco industry donated heavily to Republicans, and Trump’s pick for chief of staff was previously a tobacco lobbyist.

  • FDA Warns Retailers for Illegal Sales

    FDA Warns Retailers for Illegal Sales

    The U.S. Food and Drug Administration issued warning letters to 115 brick-and-mortar retailers for selling unauthorized vaping products. The warning letters cite the sale of disposable e-cigarette products owned by Chinese manufacturers and marketed under popular brand names, including Geek Bar Pulse, Geek Bar Skyview, Geek Bar Platinum, and Elf Bar. 

    The warning letters result from the FDA’s ongoing enforcement efforts, in coordination with state partners, to identify and crack down on the sale of unauthorized e-cigarettes, according to the agency. FDA has contracts with states, territories, or third-party entities to assist with compliance check inspections of retail establishments.  

    Findings from the 2024 National Youth Tobacco Survey indicated that 5.8 percent of current youth e-cigarette users reported using products under the Geek Bar brand. FDA’s review of additional rapid surveillance data and preliminary data from the Population Assessment of Tobacco and Health Study has also identified the brand as popular or youth-appealing. 

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

    A new tobacco product must have FDA authorization before it can be legally marketed, and generally, products without authorization are at risk of enforcement action. To date, the FDA has authorized 34 e-cigarette products and devices.

  • FDA Renews MRTPs for General Snus

    FDA Renews MRTPs for General Snus

    After a scientific review, the U.S. Food and Drug Administration issued a renewal of modified risk granted orders to Swedish Match USA, Inc., for eight General Snus products.

    With the renewal, the products may continue to be marketed – as they have been authorized to do so since 2019 – with the following modified risk claim: “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” 

    The products receiving modified risk granted orders are: General Loose, General Dry Mint Portion Original Mini, General Portion Original Large, General Classic Blend Portion White Large-12ct, General Mint Portion White Large, General Nordic Mint Portion White Large-12ct, General Portion White Large, and General Wintergreen Portion White Large.

    The modified risk granted orders issued by FDA are specific to the products as mentioned above and expire Nov. 7, 2032. If the agency determines that, among other things, the continued marketing of the products no longer benefits the health of the population as a whole, the agency may withdraw the orders.

    “The FDA’s review determined that this modified risk claim is supported by scientific evidence, that consumers understand the claim, and that consumers appropriately perceive the relative risk of these products compared to cigarettes,” the FDA stated in a release. “FDA found that these modified risk products, as actually used by consumers, will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole.

    “In particular, the available scientific evidence, including long-term epidemiological studies, shows that relative to cigarette smoking, exclusive use of these products poses lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis. The available evidence does not indicate significant youth initiation of these products.”

    The modified risk granted order does not permit the company to market the product with any other modified risk claim that conveys or could mislead consumers into believing that the products are endorsed or approved by FDA, or that the agency deems the products to be safe for use by consumers.

  • 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.

  • FDA to Review 2ONE Marketing Application

    FDA to Review 2ONE Marketing Application

    The U.S. Food and Drug Administration has accepted for review 2ONE Labs’ premarket tobacco product application (PMTA) for 2ONE brand nicotine pouches.

    According to 2ONE Labs CEO Vincent Schuman, this means that the company’s application will now enter the next critical phase of the FDA review process. “Our company will continue to fully fund this application through to its successful completion, and our wholesale, retail and sponsorship partners should view this ‘acceptance’ as a sign of our ability to navigate this complex PMTA process and our unwavering commitment to support the long-term availability of the 2ONE brand in the U.S. market,” Schuman said in a German-language statement.

    “We have developed 2ONE nicotine pouches for adult consumers—21 and older—who find it difficult to switch from combustible or traditional oral tobacco products. The availability of the 2ONE brand in the market over the past five years and the interest and growth our brand has achieved through strong retail partnerships, such as with Circle K, have shown that it is possible even for innovative companies to identify and introduce unique brands that truly offer adults the perfect transition product.”

    Earlier this month, 2ONE Labs filed a trademark infringement lawsuit and a preliminary injunction against Imperial Brands subsidiaries’ Zone nicotine pouch trademark. The suit alleges that Imperial’s Zone products willfully infringe the 2ONE nicotine pouch brand.

  • U.S. Authorities Seize $76 Million in Illegal Vapes

    U.S. Authorities Seize $76 Million in Illegal Vapes

    Image: FDA

    The U.S. Food and Drug Administration and U.S. Customs and Border Protection (CBP) announced they seized approximately 3 million units of unauthorized e-cigarette products, with an estimated retail value of $76 million. The seizures were part of a joint operation to examine incoming shipments and prevent illegal e-cigarettes from entering the United States.

    “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 M. Califf in a statement. “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.

    “CBP’s trade enforcement mission places a significant emphasis on intercepting illicit products that could harm American consumers,” said Troy A. Miller, a 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. 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.”