Tag: U.S. Food and Drug Administration

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.
December 13, 2024
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.
December 8, 2024
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.
November 7, 2024
U.S. Urged to Bolster Post-Employment Rules

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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.
October 31, 2024
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.
October 30, 2024
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.”
October 22, 2024
Taxpayer Group Files Amicus Brief

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The Taxpayers Protection Alliance (TPA) submitted an amicus curiae brief to the U.S. Supreme Court in support of the Wages and White Lion Investments case, challenging the Food and Drug Administration’s regulation of e-cigarettes under the Family Smoking Prevention and Tobacco Control Act (TCA). The TPA argues that the FDA’s actions have been arbitrary, capricious and detrimental to public health.
The brief contends that the TCA’s standard for determining what is “appropriate for the protection of the public health” is unconstitutionally vague, providing insufficient guidance to regulated entities and delegating excessive authority to the FDA. This vagueness has led to unpredictable enforcement, adversely affecting both taxpayers and adults who smoke and are seeking safer alternatives to conventional cigarettes.
Furthermore, the TPA criticizes the FDA for failing to recognize the significant benefits of e-cigarettes as a smoking cessation tool, as acknowledged by leading health organizations such as Public Health England. According to the TPA, the TCA is clear on the need for the FDA to consider the impact of e-cigarettes on smoking cessation, yet the agency has abjectly failed to undertake this analysis. The TPA highlights the FDA’s stringent regulatory approach and high denial rates for new e-cigarette products, which the group says stifle market diversity and limit consumer choice, particularly harming adults who smoke and who might benefit from less harmful alternatives.
The TPA also notes the FDA’s disregard for market realities and consumer preferences, particularly the benefits of open-system e-cigarettes that allow for customization and have been shown to be more effective for quitting smoking.
The TPA urges the Supreme Court to uphold the 5th Circuit’s decision, affirming that the FDA’s regulatory approach under the TCA is arbitrary and capricious and violates due process. The TPA calls for a regulatory framework that adequately considers the benefits of e-cigarettes and gives regulated parties fair notice of how their products will be evaluated.
October 17, 2024
Frustration Voiced at FDA Hearing

Photo courtesy of Plus PR
U.S. lawmakers and advocacy groups expressed concern about the Food and Drug Administration’s regulation of smoke-free products during a Sept. 10 House of Representatives’ Energy and Commerce Subcommittee hearing.
Health Subcommittee Chair Brett Guthrie criticized FDA delays and what he viewed as a lack of transparency. “Manufacturers filing premarket tobacco product applications [PMTAs] with the goal of meeting the standard of an ‘appropriate [for the] protection of public health’ still have no clear guidance and are waiting for hundreds of days for outreach on their applications,” he said.
“More importantly, these products pending at FDA could present an opportunity to improve public health by providing less harmful alternatives to traditional cigarettes. This lack of transparency has consequences.”
Full Committee Chair Cathy McMorris Rodgers highlighted the massive backlog of product applications at the FDA’s Center for Tobacco Products (CTP). “Out of the over 26 million applications for electronic nicotine-delivery systems, or ENDS products, the center has authorized fewer than 50 products,” he said.
“However, according to recent market data, those products only account for about 10 percent of sales, showing how behind the FDA is in keeping up with demand.”
Representative Richard Hudson blamed the CTP for the increase in illegal products on the U.S. market from abroad. “Millions of illegal products are on the market targeting our youth while some legitimate companies have been waiting for years for review or [to] even hear a word from FDA about their application,” he said.
“The illicit market has been enabled by the Center for Tobacco Products’ lack of action … the fact is, the inefficiency of CTP has driven an illicit market that has been filled by China.”
In a separate statement, Philip Morris said the hearing put a bright bipartisan spotlight on the fact that the agency is neglecting millions of adult smokers by failing to authorize scientifically substantiated, smoke-free nicotine products that are better alternatives to combustible cigarettes.
“More than 26 million premarket tobacco product applications have been submitted to the FDA for review, but the agency has authorized only several dozens of those applications, and none within the 180-day deadline set by Congress,” said PMI Director for Regulatory Communications Matthew Sheaff.
“FDA’s goal to strike ‘an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes’ is far from the reality of its actions. It is our hope the FDA will fully embrace the tobacco harm reduction principles enshrined in the Tobacco Control Act and more importantly provide the millions of adult smokers in the United States access to better alternatives to combustible cigarettes.”
The Taxpayers Protection Alliance (TPA) criticized the FDA’s authorization process and noted the low rate of youth e-cigarette use. “The PMTA costs to manufacturers are astronomical while the regulatory requirements are obscure at best,” Lindsey Stroud wrote on the TPA’s website.
“To date, the FDA has only authorized 56 products under the PMTA pathway. Given the current low rate of youth e-cigarette use and the high number of adults using novel tobacco products, there is a pressing need for the FDA to adapt its authorization strategies to better serve adults seeking to quit smoking through these alternatives. Lawmakers are urged to advocate for this necessary shift in FDA policy.”
Americans For Tax Reform (ATR) called on the FDA to educate the public about the continuum of risk for nicotine products. “The agency’s failures to educate the public about the continuum of risk in nicotine products—despite their own internal documents demanding the need to do so—has meant that 75 percent of Americans inaccurately believe vaping is equal to or worse than smoking,” Tim Andrews wrote on ATR’s website.
“The fact that the agency’s leadership continues to ignore its own comprehensive plan for tobacco and nicotine, where harm reduction is supposed to play a central role in the FDA’s tobacco control plan, is a downright scandal.”
September 13, 2024
FDA Halts Packaging Enforcement for 15 Months

Credit: Bilitster
The U.S. Food and Drug Administration has provided guidance on the “Tobacco Products; Required Warnings for Cigarette Packages and Advertisements” final rule that established new required health warnings for cigarette packages and advertisements.
Specifically, the FDA has issued guidance to the tobacco industry that describes the agency’s enforcement policy for the final rule. The final rule was issued in March 2020 and was challenged in the U.S. District Court for the Eastern District of Texas. In December 2022, the District Court struck down the rule.
The government appealed the decision and in May of 2024, the U.S. Court of Appeals for the 5th Circuit reversed the District Court’s decision. This reinstated the final rule, causing the rule to now be in effect. The plaintiffs’ petition for a review by the Supreme Court review is pending.
“The new guidance for the agency’s enforcement policy states that the FDA intends to exercise enforcement discretion and generally not enforce requirements of the final rule for 15 months, or until December 12, 2025,” an FDA release states. “With respect to products manufactured before December 12, 2025, the FDA also intends to exercise enforcement discretion and generally not enforce the rule’s requirements for these products for an additional 30-day period, or until January 12, 2026.”
The pause aligns with the 15-month compliance period originally contemplated by the Family Smoking Prevention and Tobacco Control Act.
The FDA chose 15 months to provide an orderly transition period; this aligns with the 15-month compliance period originally contemplated by the Family Smoking Prevention and Tobacco Control Act, before that timing was disrupted by litigation.
The final rule also requires the industry to submit a plan and obtain FDA approval for the random and equal display and distribution of required warnings on cigarette packages and the quarterly rotation of required warnings in cigarette advertisements.
The agency’s guidance recommends that entities that do not already have approved cigarette health warning plans submit such plans as soon as possible, but in any event, within five months or by February 10, 2025. Entities that previously submitted cigarette plans to the FDA do not need to resubmit their plans unless they wish to make changes.
The public can provide comment on the guidance in the docket at regulations.gov.
September 12, 2024
Mixed Feelings at PMTA Anniversary

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Representatives of the U.S. vapor industry expressed mixed feelings at the four-year anniversary of the filing of the first premarket tobacco product applications (PMTAs).
Since the Sept. 9, 2020, deadline, the Food and Drug Administration’s Center for Tobacco Products (CTP) has received applications for 26 million novel tobacco products, mostly electronic cigarettes or e-cigarettes.
However, despite its acknowledgement that e-cigarettes overall are less harmful and less toxic than combustible cigarettes, the agency has rejected more than 99 percent of PMTAs for these products.
At the same time, the FDA has authorized 6,670 new combustible tobacco products to be sold in the U.S., including 3,232 new cigars, 1,291 new pipe tobacco products,1,073 new hookah tobacco products and 973 new cigarettes.
According to the Vapor Technology Association (VTA), current CTP Director Brian King has authorized only four vaping devices for as alternatives to cigarettes, compared with 1,270 combustible products.
Director King has justified his refusal to authorize flavored e-cigarettes that are widely used by American adults with the need to protect youth. Yet the most recent National Youth Tobacco Survey revealed that the youth vaping rate—the share of users who say they’ve used an e-cigarettes at least once in the past 30 days—has declined to 5.9 percent, the lowest level in more than a decade.
“Since Sep. 9, 2020, 1.93 million Americans have died from smoking cigarettes (480,000 each year), and approximately 64 million Americans suffered from smoking-related disease (16 million each year), according to the CDC, at a cost of hundreds of billions of dollars to the U.S. health care system and gross domestic product,” the VTA wrote in a statement.
“In this time, the FDA has only allowed the purveyors of these deadly combustible products to strengthen their grip on the market. Meanwhile, more and more Americans die from smoking, making this anything but a happy anniversary.”
September 10, 2024