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Tag: FDA

  • CAA Seeks New Definition of “Premium Cigar”

    CAA Seeks New Definition of “Premium Cigar”

    The Cigar Association of America (CAA) has submitted a revised definition of “premium cigar” in its ongoing legal battle with the U.S. Food and Drug Administration. Filed June 6 as part of Cigar Association of America et al. v. United States Food and Drug Administration et al., the brief marks a shift from the working definition previously agreed upon by Judge Amit P. Mehta, the Premium Cigar Association (PCA), and Cigar Rights of America (CRA).

    Mehta, CRA, and PCA have been satisfied with an eight-point working definition, however earlier this year the CAA said it was opposed. Last week in its brief, the CAA said it “does not agree that the definition suggested by the agency and adopted in the Court’s previous rulings is the proper definition of a premium cigar, or that it was properly adopted. That organization’s proposed definition is reflected in the comments it submitted in response to the Proposed Rule.”

    The CAA proposed modifying the definition to a five-point standard: that is wrapped in whole tobacco leaf; contains a 100% leaf tobacco binder; made by manually combining the wrapper, filler, and binder; has no filter, tip, or non-tobacco mouthpiece, and is capped by hand; and weighs more than six pounds per 1,000 units.

    CAA’s proposed five-point standard omits language prohibiting characterizing flavors and allows for machine-assisted production. It also lowers technical requirements for filler content. The FDA, CRA, and PCA must respond to the proposed changes by July 7.

  • FDA Updates Tobacco Application Forms; Effective Immediately

    FDA Updates Tobacco Application Forms; Effective Immediately

    Today (June 6), the FDA posted six updated or new forms that are required for submitting new tobacco product applications under the premarket tobacco product application (PMTA) and Substantial Equivalence (SE) pathways. Starting July 6, 2025, applicants must use these forms in their PMTA and SE Report submissions. If applicants do not use the latest version of the forms or do not complete them properly, FDA generally intends to refuse to accept the application.

    The updated forms reflect public comments and are part of FDA’s work to promote efficiency, effectiveness, and transparency to improve its tobacco product application review process. The latest versions of the forms offer new instructions and additional details on the information applicants are required to include. Ultimately, these forms can help applicants submit higher-quality applications to facilitate FDA’s review.

    A list of the updated forms is below. Use of old versions of the forms will no longer be accepted after the 30-day notice period.

    Updated PMTA forms:

    • Form FDA 4057 – Premarket Tobacco Product Application (PMTA) Submission
    • Form FDA 4057a – Premarket Tobacco Product Application Amendment and General Correspondence Submission
    • Form FDA 4057b – PMTA Unique Identifying Information for New Tobacco Products (formerly referred to as a grouping spreadsheet)

    Updated or new SE forms: 

    • Form FDA 3965 – Tobacco Substantial Equivalence Report Submission
    • Form FDA 3965a – Tobacco Substantial Equivalence Report Amendment and General Correspondence Submission (formerly Form FDA 3964)
    • Form FDA 3965b (NEW) – SE Unique Identifying Information for New Tobacco Products

    To assist applicants’ proper use of Form FDA 4057b and Form FDA 3965b, FDA is releasing version 2.0 of its Product Form Validator Tool. Applicants may use the tool for both forms to validate the data and confirm if a completed form is consistent with FDA ingestion requirements before submission.

    If applicants have questions about the forms, they can email AskCTP@fda.hhs.gov or call 1-877-287-1373 between 9 a.m. and 4 p.m. EST. Additionally, applicants can explore FDA’s PMTA tips. 

  • House Working with Trump’s $6.8B FDA Budget

    House Working with Trump’s $6.8B FDA Budget

    House appropriators advanced a bill to fund the FDA for fiscal 2026 on a party-line vote out of a subcommittee yesterday (June 5)— but, according to Politico, the bill has a long path ahead before it potentially becomes law. The topline number from the House bill aligns with President Donald Trump’s budget proposal, which sought $6.8 billion for the FDA.

    The budget calls for $3.2 billion in direct appropriations, with the rest coming from user fee revenue. It also represents a $300 million cut in taxpayer funding compared to what the House Appropriations subcommittee sought last year for fiscal 2025.

    According to Politico, the Senate is likely to fund the agency at a higher level than the House. Sen. John Hoeven, the Republican senator in charge of FDA appropriations, said Trump’s proposal is a starting point.

    “We now have the president’s budget proposal,” Hoeven said. “But we’re going through our process now, and it will be different. … I think that you’ll see when we bring it out that we adequately fund FDA.”

  • U.S. Faces Vape Shortage as Tariffs Hit, Seizures Increase

    U.S. Faces Vape Shortage as Tariffs Hit, Seizures Increase

    Popular vape brands like Geek Bar may get more expensive in the U.S.—if you can find them at all, Reuters reports. Shipments of vapes from China to the U.S. ground to a near halt in May from a year ago, official data shows, hit by U.S. President Donald Trump’s tariffs and a crackdown on unauthorized e-cigarettes in the world’s biggest market for smoking alternatives.

    That includes Geek Bar, which is not authorized to sell in the U.S. but has been widely available due to porous import controls. Geek Bar was by far the most popular unauthorized vape brand in the U.S. last year, accounting for around a quarter of sales tracked by market research company Circana in 2024 despite lacking a license to sell from the FDA.

    One retailer, who asked not to be named because their business sells unauthorized vapes, told Reuters that one of the store’s vape suppliers normally receives 100 boxes of Geek Bar vapes per week, but is now getting just 10. Another supplier imposed unprecedented purchase limits of five boxes.

    “There were a lot of supply chain issues” during COVID-19, the person said. “But I’ve never seen this.”

    Trump’s decision to impose steep tariffs on China, now at 30% after peaking at 145% in April, as well as blockbuster seizures of unauthorized vapes, have constrained the supply of Chinese-owned vape brands and Geek Bar in particular, according to five industry sources and notices from U.S. Geek Bar wholesalers reviewed by Reuters. In May 2025, the FDA recorded just 71 shipments of products labelled as e-cigarettes or vapes from China, compared with nearly 1,200 over the same period last year.

    To mitigate tariffs, illicit vape producers can mislabel or undervalue their shipments or spoof their origin entirely to make it look like they came from a lower-tariff country like Indonesia, Vietnam or Mexico, said Luis Pinto, a spokesperson for British American Tobacco. Vapes from China are often smuggled into the U.S. disguised as other items entirely, such as shoes or toys, to evade officials hunting for unauthorized vapes at the border, according to public statements from the FDA and Customs and Border Protection.

    The growth of Geek Bar and other unregulated vape brands has eaten into the market share of cigarette companies like Altria and BAT, which estimates unauthorized e-cigarettes accounted for some 70% of all U.S. vape sales last year.

  • Advocacy Groups Tell RFK Jr. Federal Tobacco Oversight Already Too Thin

    Advocacy Groups Tell RFK Jr. Federal Tobacco Oversight Already Too Thin

    Bloomberg is reporting that more than 80 public health organizations and advocacy groups sent a letter to Robert F. Kennedy Jr. this week voicing concern that recent cutbacks at the Department of Health and Human Services will hurt, or even reverse, decades of progress in reducing the use of tobacco products. Groups including the American Lung Association and Campaign for Tobacco-Free Kids, said the Office on Smoking and Health at the Centers for Disease Control and Prevention, as well as the Food and Drug Administration’s Center for Tobacco Products, were already stretched thin, and further layoffs would derail efforts to remove unauthorized products and hold tobacco companies accountable. The letter further argues that the FDA’s tobacco regulation is entirely funded by fees levied on the companies selling the products, so personnel cuts do not save any taxpayer money.

    The FDA is also grappling with a booming market for illegal flavored vapes, many of them imported from China. Despite lacking FDA authorization, these products have flooded US shelves, with some estimates suggesting unauthorized vapes now make up as much as 70% of the market.

    RFK Jr., who has supported shrinking the federal workforce and cutting “wasteful” public health spending, has not addressed how the layoffs will affect tobacco regulation. HHS did not immediately respond to a request for comment from Bloomberg.

  • FDA and CBP Seize $34M in Illegal E-Cigarettes in Chicago

    FDA and CBP Seize $34M in Illegal E-Cigarettes in Chicago

    The U.S. Food and Drug Administration (FDA) today (May 22) announced the seizure of nearly 2 million units of unauthorized e-cigarette products in Chicago, with an estimated retail value of $33.8 million. The seizures, which occurred in February of this year in collaboration with U.S. Customs and Border Protection (CBP), were part of a joint federal operation to examine incoming shipments and prevent illegal e-cigarettes from entering the country.

    During this operation, the team uncovered shipments of various illegal e-cigarette products, almost all of which originated in China and were intended for shipment to various U.S. states. FDA and CBP personnel determined that, in an apparent attempt to evade duties and the review of products for import safety concerns, many of these unauthorized e-cigarette shipments contained vague product descriptions with incorrect values. Upon examining shipments, the team found several brands of unauthorized e-cigarettes, including Snoopy Smoke, Raz, and others.

    “The FDA, working with our federal partners, can and will do more to stop the illegal importation and distribution of e-cigarette products in the United States,” said FDA commissioner Marty Makary. “Seizures of illegal e-cigarettes keep products that haven’t been authorized by the FDA out of the United States and out of the hands of our nation’s youth.”

    In the lead up to this operation, the joint FDA and CBP team identified potentially violative incoming shipments and completed other investigative work. The team was also able to successfully implement several new internal efficiencies and procedures, building off previous operations.

    “We continue to see an increased number of shipments of vaping-related products packaged and mislabeled to avoid detection,” said Bret Koplow, acting director of the FDA’s Center for Tobacco Products. “However, we have been successful at preventing these shipments from entering the U.S. supply chain – despite efforts to conceal the true identity of these unauthorized e-cigarette products.”

    Most shipments violated the FDA’s Federal Food, Drug, and Cosmetic Act, while some products were also seized for Intellectual Property Rights violations for unauthorized use of protected trademarks. All of the e-cigarette products seized in this operation lacked the mandatory premarket authorization orders from the FDA and therefore cannot be legally marketed or distributed in the United States.

    Standard practice for products forfeited to the government include disposing of the products in accordance with the law. In the case of unauthorized new tobacco products, including e-cigarettes, that generally means they will be destroyed.

    FDA also sent, for the first time, import informational letters to 24 tobacco importers and entry filers responsible for importing these illegal e-cigarettes. The letters advise the recipients that it is a federal crime to make false statements or entries to the U.S. government, and the FDA seeks information on the steps they have taken to ensure compliance with applicable federal tobacco laws and regulations. Specifically, the letters advise the firms to ensure their import entries contain complete and accurate information moving forward. Failure to do so may also be viewed as an intentional attempt to circumvent the FDA’s review of the shipment. Firms are requested to respond to the letters within 30 days with the requested information.

  • Thoughts on FDA Reform

    Thoughts on FDA Reform

    Prioritizing Education on Smoke-Free Alternatives

    By Dr. Tom Price

    The recent marketing authorization by the U.S. Food and Drug Administration (FDA) of 20 Zyn nicotine pouch products is a good step forward in building a more robust market for smoke-free nicotine and tobacco products. This critical decision, coupled with the Trump administration, U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. and expected FDA Commissioner Marty Makary’s stated priority to “Make America Healthy Again,” foretells an emerging regulatory landscape in the U.S. that presents a meaningful opportunity to expand access to smoke-free products that can help adults who smoke make the switch away from cigarettes.

    This paradigm shift has been a long time coming, and I am thrilled to see it happening in real time. Now, it is time for the FDA to step up its education efforts—with both consumers as well as the medical community—to raise awareness of these products and how, although not risk free, they are a better choice than continuing to smoke or using other traditional tobacco products.

    In clearing the FDA’s extensive premarket tobacco product application (PMTA) process, which includes years of scientific review, ZYN became the first and only FDA-authorized nicotine pouch in the U.S. In the FDA’s announcement, the Director of the Office of Science at the FDA’s Center for Tobacco Products (CTP), Matthew Farrelly, Ph.D., noted that these “products offer greater benefits to population health than they do risks,” and the data shows that ZYN nicotine pouches “meet that bar by benefitting adults who use cigarettes and/or smokeless tobacco products and completely switch to these products.”

    While this should be good news for the 45 million American nicotine consumers, there is still more work for the FDA to do to clearly illustrate the potential benefits of nicotine pouches and other smoke-free products to consumers and medical experts alike. However, that will require clearing up a long history of misinformation.

    According to the FDA, it is not nicotine but a toxic mix of chemicals contained in tobacco and tobacco smoke that drives the serious health threats facing tobacco users. Despite the science proving that smoke-free products represent a better option compared to smoking, various groups, such as the American Lung Association (ALA), continue to spread misinformation about the potential benefits of Zyn nicotine pouches for smokers and other tobacco users, directly contradicting the FDA and scientific evidence.

    Even America’s medical community seems flummoxed by what should be a clear distinction between nicotine consumption and the serious side effects tied to cigarette smoking. According to one study, 60 percent of nurses mistakenly believe that nicotine causes cancer. Another one found that more than 80 percent of physicians “strongly agreed” that nicotine “directly contributes to the development of cardiovascular disease (83.2 percent), chronic obstructive pulmonary disease (COPD) (80.9 percent), and cancer (80.5 percent).”

    Of course, none of this is true, underscoring the dire need for the FDA and CTP to prioritize educating the public and medical community with accurate information about the vital role smoke-free products could play in helping Americans who smoke to reduce their exposure to harm.

    CTP Director Brian King, Ph.D., M.P.H., recently acknowledged as much, saying that “misperceptions among physicians and other healthcare professionals” may result in advising patients in a manner that is “not consistent with existing scientific evidence.” Moreover, he continued, these “misperceptions are associated with lower odds of completely transitioning from cigarettes” to a noncombustible product.

    While misinformation abounds, there is still some hope. Even passionate anti-smoking groups, such as the Truth Initiative, have—to some degree—begun to acknowledge the benefits of nicotine pouches, noting that the FDA’s authorization of ZYN nicotine pouch products “addresses an ongoing need to provide adults who smoke with access to less harmful alternatives to combustible cigarettes.”

    The FDA and CTP may be well aware of the misperceptions behind smoke-free products. Still, neither has taken meaningful action to counter the spread of misinformation with proper, accurate education for healthcare providers and adults who smoke. That must change, and it must change soon.

    The FDA has a responsibility to not only help provide adults who smoke with more smoke-free options, but also to ensure the medical community and public at large understand the benefits and risk these products provide—both in terms of personal and public health. Recent events have made me hopeful that, together, we can build a healthier country, but the FDA and CTP must lead the way there.

    Tom Price, M.D., was the 23rd Secretary of the U.S. Department of Health and Human Services and is a former member of Congress (GA06), and an advisor to PMI U.S. Corporate Services Inc.

  • Koplow Tabbed New CTP Chief

    Koplow Tabbed New CTP Chief

    U.S. Food and Drug Administration Commissioner Marty Makary announced that Bret Koplow will be acting director of the Center for Tobacco Products, according to emailed announcements reported by Bloomberg.

    Koplow has worked for the agency in various roles since 2011, serving as senior counselor to the commissioner in the Immediate Office of the Commissioner since early 2020, where he focused principally on regulatory, policy, and operational matters involving CTP, including work on e-cigarettes, cigars, and other tobacco products. Before joining the Commissioner’s Immediate Office, he served as senior counsel in the FDA’s Office of the Chief Counsel, and before that served in the FDA’s Office of Legislation as the Senior Advisor for Oversight.

    The agency is facing pressure to crack down on illicit products, improve new product submission procedures, and change how it approaches foreign inspections.

    “Bret Koplow—an attorney and longtime FDA bureaucrat,” Gregory Conley, a harm-reduction advocate posted on X. “This would seem to signal the Biden era status quo will continue for now.”

    Makary also announced Elizabeth Miller will serve as the acting associate commissioner for the Office of Inspections and Investigations, filling two high-profile vacancies. The former top tobacco regulator, Brian King, was pushed out during agency-wide layoffs in April.

  • Don’t Gamble Your PMTA: Bet on Your Quality System

    Don’t Gamble Your PMTA: Bet on Your Quality System

    By: Gabriel Muñiz

    The recent leadership changes and staffing reductions at the FDA’s Center for Tobacco Products (CTP) have created a moment of uncertainty, but also opportunity, for the tobacco and nicotine industry. With shifting priorities and new leadership on the horizon, some manufacturers see a chance to reset the regulatory conversation. While some companies are using this moment to tighten up operations and reinforce compliance in order to have a better chance at a favorable premarket tobacco product application (PMTA) outcome, others are taking a gamble, scaling back on quality systems and asking themselves, “Do we really have to keep doing all of this?”

    The question often centers around the expectations outlined in 21 CFR Part 1114 and the commitments companies made in their PMTAs. In a push to save costs, some manufacturers are reportedly reducing quality oversight, cutting corners in documentation, and stepping away from key controls they originally described in their PMTAs. The rationale? If enforcement is slowing down, maybe the FDA won’t notice or maybe it won’t matter.

    That’s a risky assumption.

    A PMTA is more than a regulatory formality. It’s a company’s game plan. A commitment to how the product will be manufactured, tested, controlled, and distributed. If your application included a robust quality management system (QMS), specific product testing protocols, or detailed supplier qualification processes, you’re expected to follow through. Along with the science, those commitments were the basis on which the FDA evaluated whether your product was “appropriate for the protection of public health.”

    Under Section 910 of the Federal Food, Drug, and Cosmetic Act (FDCA), the FDA has the authority to withdraw or suspend a marketing granted order (MGO) if it determines that a tobacco product is no longer “appropriate for the protection of public health,” the standard upon which PMTAs are evaluated and approved. If an inspection or oversight activity reveals that a company has significantly deviated from the manufacturing methods, testing protocols, or quality systems described in its PMTA, the FDA may conclude that the product no longer meets the criteria for market authorization. While there hasn’t yet been a public case of an MGO being rescinded solely for failure to follow internal PMTA commitments, the legal basis for such action is clear. An MGO is conditional—it depends on a company continuing to manufacture its product as promised. Deviating from that blueprint introduces real regulatory risk.

    While some in the industry viewed the Fifth Circuit’s ruling in Bidi Vapor v. FDA as a signal that the tide was turning in manufacturers’ favor, the outcome in FDA v. Wages and White Lion Investments LLC made it clear: Companies are still expected to meet regulatory requirements and support their products with quality data and compliance. The courts may question FDA procedures, but they won’t eliminate the work required to maintain market authorization.

    Even in a more industry-friendly political environment, the responsibility to protect public health isn’t going away. The current administration may support regulatory efficiency and streamlined processes, but not at the expense of consumer safety. Companies that ignore or scale back their quality systems risk finding themselves unprepared when FDA inspections or compliance reviews resume in full force.

    Now is the time for manufacturers to take stock of their internal systems and ensure alignment with their PMTAs. This includes verifying that quality controls, personnel training, document management, complaint handling, and supplier oversight are functioning as described. A comprehensive, well-maintained QMS doesn’t just satisfy regulatory requirements; it builds trust and stability, especially in a time of change.

    This transition at CTP represents a golden opportunity, but only if companies take the right approach. Cutting corners today to save money may end up costing you far more if it puts your MGO at risk. Regulatory clarity, product stability, and long-term market access depend on more than a favorable headline—they depend on daily operational integrity.

    The FDA may be shifting, but its core mandate remains. This is the moment for responsible manufacturers to lead by example, double down on quality, and show that this industry can thrive without sacrificing quality or consumer trust. For those willing to roll the dice, just remember, being the first company to lose an MGO over PMTA noncompliance isn’t the kind of milestone you want your brand remembered for.

    Gabriel Muñiz, an independent consultant with EAS Consulting Group, is a regulatory compliance expert with extensive experience in the tobacco industry. Muñiz’s tenure at the FDA, particularly as a director within the Office of Regulatory Affairs (ORA), involved leading compliance and enforcement activities for the agency’s tobacco program. His work in building the tobacco operations program and shaping tobacco regulatory policy was instrumental in the development of key compliance strategies and regulatory frameworks, including the proposed tobacco product manufacturing practices. After his FDA career, Muñiz further honed his skills at Juul Labs, where he played a key role in developing premarket tobacco product applications and ensuring alignment with evolving federal regulations. His deep expertise in tobacco regulation will be invaluable to EAS’ clients seeking strategic compliance advice and navigating tobacco-related regulatory challenges.

    About EAS Consulting Group

    EAS Consulting Group, a member of the Certified family of companies, is a global leader in regulatory solutions for industries regulated by the FDA, USDA, and other federal and state agencies. As part of Certified Group, EAS Consulting Group delivers expert regulatory solutions our customers can feel confident in—so the world can trust in what it consumes. Our network of over 200 independent consultants enables EAS to provide comprehensive consulting, training, and auditing services, ensuring proactive regulatory compliance for food, dietary supplements, pharmaceuticals, medical devices, cosmetics, tobacco, hemp, and CBD.

  • FDA Completes AI-Assisted Review Pilot, Ready for Agency-Wide Rollout

    FDA Completes AI-Assisted Review Pilot, Ready for Agency-Wide Rollout

    FDA Commissioner Dr. Martin A. Makary today (May 8) announced an aggressive timeline to scale the use of artificial intelligence (AI) internally across all FDA centers by June 30, 2025, following the completion of a new generative AI pilot for scientific reviewers.

    “I was blown away by the success of our first AI-assisted scientific review pilot,” Makary said. “We need to value our scientists’ time and reduce the amount of non-productive busywork that has historically consumed much of the review process. The agency-wide deployment of these capabilities holds tremendous promise in accelerating the review time for new therapies.”

    The generative AI tools allow FDA scientists and subject-matter experts to spend less time on tedious, repetitive tasks that often slow down the review process.

    “This is a game-changer technology that has enabled me to perform scientific review tasks in minutes that used to take three days,” said Jinzhong (Jin) Liu, Deputy Director, Office of Drug Evaluation Sciences, Office of New Drugs in FDA’s Center for Drug Evaluation and Research (CDER).

    To reflect the urgency of this effort, Makary directed all FDA centers to begin deployment immediately, with the goal of full integration by the end of June. Work will continue to expand use cases, improve functionality, and adapt to the evolving needs of each center after June 30. By that date, all centers will be operating on a common, secure generative AI system integrated with FDA’s internal data platforms.

    “There have been years of talk about AI capabilities in frameworks, conferences, and panels, but we cannot afford to keep talking,” Makary said. “It is time to take action. The opportunity to reduce tasks that once took days to just minutes is too important to delay.”

    Looking ahead, the FDA plans to expand generative AI capabilities across all centers using a secure, unified platform. Future enhancements will focus on improving usability, expanding document integration, and tailoring outputs to center-specific needs, while maintaining strict information security and compliance with FDA policy.

    The agency-wide rollout is being coordinated by Jeremy Walsh, the FDA’s newly appointed Chief AI Officer and Sridhar Mantha. Walsh previously led enterprise-scale technology deployments across federal health and intelligence agencies and Mantha recently led the Office of Business Informatics in CDER.

    The agency will continue to assess performance, gather user feedback, and refine features to support the evolving needs of FDA staff and advance its public health mission. Additional details and updates on the initiative will be shared publicly in June.