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Tag: FDA

  • FDA COO Says Balance is the ‘Gold Standard’

    FDA COO Says Balance is the ‘Gold Standard’

    In an open letter today (Feb. 26), FDA Deputy Commissioner for Operations and Chief Operating Officer Dr. Barclay Butler underscored the FDA’s dual mandate to promote regulatory transparency while rigorously safeguarding sensitive commercial and personal data submitted by regulated industries. Titled, “Why Protecting Confidential Information is Key to the FDA’s ‘Gold Standard,’” his remarks highlighted the agency’s role as both public health watchdog and custodian of proprietary information, emphasizing that while the Freedom of Information Act supports disclosure, statutes such as the Trade Secrets Act and Privacy Act require strict confidentiality around trade secrets, confidential commercial information (CCI), personal health data, and law enforcement materials.

    Barclay reiterated that manufacturing processes, product formulas, financial data, and other proprietary submissions remain legally protected, a subject of particular importance tobacco and nicotine product companies navigating the FDA’s premarket review pathways. He also stressed the importance of shielding adverse event reports, inspection records, and internal deliberative documents to preserve investigative integrity and candid scientific review. Barclay said that improper disclosure can carry criminal liability and undermine market fairness, particularly given the market-moving potential of regulatory decisions. He said the FDA’s strict ethics and insider trading safeguards are central to maintaining trust, institutional integrity, and a level playing field across regulated sectors.

  • Atlas IoT Gets USPTO Grant for Age-Restricted Vape Technology

    Atlas IoT Gets USPTO Grant for Age-Restricted Vape Technology

    Atlas IoT announced that it secured a patent grant from the United States Patent and Trademark Office for an age-restricted device and system designed for electronic nicotine delivery systems, positioning the technology as a potential pathway to strengthen regulatory compliance and support broader adult-focused flavor approvals. The company’s standalone system uses AI-powered age verification to confirm users are 21 or older without requiring app downloads or storing personal data, followed by a one-time thumbprint enrollment that serves as the device’s unlocking mechanism. A secondary bioimpedance sensor embedded in the mouthpiece is designed to prevent use by minors, creating a dual-verification process intended to block unauthorized access.

    Atlas IoT said it has requested a Q-Submission meeting with the U.S. Food and Drug Administration to discuss a Component Premarket Tobacco Product Application covering the device’s core technology, with plans to partner with e-liquid manufacturers that would file their own PMTAs for compliant flavored pods. The company also emphasized domestic manufacturing and FDA-registered filling operations for its replaceable pods, contrasting its compliance-focused model with the illicit disposable vape market. Atlas IoT said that, if authorized, its platform could establish a new standard for age-restricted ENDS products in the regulated U.S. market.

  • 22nd Century Reports Momentum for VLN Products

    22nd Century Reports Momentum for VLN Products

    22nd Century Group touted early sales momentum for its VLN low-nicotine cigarettes, distributing approximately 8,800 cartons to about 1,700 new retail outlets nationwide in the fourth quarter of 2025, with initial sell-through data indicating growing adoption across its 22nd Century VLN, Pinnacle VLN, and Smoker Friendly VLN brands. The company said expanding retail placement across convenience stores, wholesalers, and independent chains supports its plan to exceed 5,000 points of distribution in 2026.

    22nd Century positioned its progress alongside regulatory developments, including a January 2025 proposed rule by the U.S. Food and Drug Administration to cap nicotine levels in cigarettes at 0.7 mg per gram of tobacco, and broader global support for nicotine reduction under the World Health Organization Framework Convention on Tobacco Control.

  • K&H Announces Agenda for Industry Law Symposium

    K&H Announces Agenda for Industry Law Symposium

    Keller and Heckman LLP announced the agenda for its 10th Annual E-Vapor, Nicotine, and Tobacco Law Symposium, scheduled for May 4–5, 2026, in Las Vegas, Nevada, ahead of the CHAMPS Trade Show. The two-day seminar will feature the firm’s attorneys alongside industry and scientific guest speakers, offering in-depth insights into legal, regulatory and scientific developments affecting tobacco, nicotine and CBD/hemp product manufacturers, suppliers, distributors and retailers. Organizers also reminded prospective attendees that the super early-bird registration rate expires February 20.

  • Enorama Sues FDA for Disparate Pouch PMTAs

    Enorama Sues FDA for Disparate Pouch PMTAs

    Enorama Pharma Inc. filed a lawsuit against the U.S. Food and Drug Administration in federal court in Washington, D.C., alleging the agency unlawfully imposed costly premarket tobacco application (PMTA) requirements on its nicotine oral pouches. In a complaint filed Feb. 17, the company argues the FDA violated the Regulatory Flexibility Act and Administrative Procedure Act by subjecting pouches to the same regulatory framework as combustible tobacco without properly assessing the impact on small businesses. Enorama contends that although the FDA previously suggested publicly available data could support applications, it now requires product-specific scientific studies, dramatically increasing costs.

    According to the filing, the FDA estimated bundled application costs between $181,686 and $2 million, but Enorama claims actual expenses range from $3 million to more than $15 million — forcing some manufacturers to exit the market. The company also alleges unequal treatment, asserting that larger competitors such as Philip Morris International and Altria Group have been allowed to market similar nicotine pouch products despite pending applications, while Enorama received a refusal-to-file letter. Attorney Eric N. Heyer of Thompson Hine LLP said the company plans to seek a preliminary injunction to halt the FDA’s action.

  • VTA ‘Disappointed’ by Lack of Progress from FDA Roundtable

    VTA ‘Disappointed’ by Lack of Progress from FDA Roundtable

    The Vapor Technology Association said it welcomed the chance to participate in a recent roundtable hosted by the U.S. Food and Drug Administration focused on premarket tobacco product application (PMTA) submissions for electronic nicotine delivery systems (ENDS), calling the meeting an opportunity for small businesses to engage directly with regulators. In a statement, VTA Executive Director Tony Abboud said industry representatives advocated for a more transparent, standards-based regulatory framework that would allow companies to invest in vapor technology and navigate product reviews with clearer scientific expectations.

    Abboud said VTA was encouraged by comments from FDA Commissioner Marty Makary acknowledging the need for predictability in regulatory standards but expressed frustration that some agency officials supported maintaining flexible or undefined scientific benchmarks.

    “Small businesses made it completely clear that they wanted and needed transparent and objective scientific standards governing how vape products should be made and how they should perform,” Abboud said. “Unfortunately, we were disappointed by so many FDA representatives throughout the meeting who either argued for continued scientific ambiguity or completely rejected standards. Their comments signaled a lack of alignment among FDA leadership on providing clear and predictable scientific standards or guidance for our industry – or even benchmarks that would ensure product and consumer safety. We received no guarantee of additional clarity on the broken and opaque PMTA rule and process, which has been used to prevent access to the products that Americans who smoke want and need to quit smoking deadly cigarettes.” 

    The association argued that clearer regulatory guidance would align with broader free-market principles supported by Donald Trump’s policy agenda.

  • U.S. Vape Block on Imports Could Cut Illicits by a Third: BAT

    U.S. Vape Block on Imports Could Cut Illicits by a Third: BAT

    A potential U.S. ban on imports of certain disposable e-cigarettes could reduce illegal vape sales by as much as one-third, according to British American Tobacco CEO Tadeu Marroco. BAT estimates unauthorized products, largely manufactured in China, account for roughly 70% of U.S. e-cigarette sales, undermining both regulated vape brands and traditional cigarette businesses. The company is pursuing two cases before the U.S. International Trade Commission (ITC) seeking to block imports of products that infringe its patents. An ITC judge previously recommended an exclusion order, with a final decision expected in March, followed by a 60-day presidential review.

    “What we want to see in the US is a level playing field because in a level playing field, we know that we can win,” Marroco said.

    Marroco cautioned that any market impact would likely be delayed due to existing supply chains and inventory levels, suggesting significant effects may not occur until 2027. He also indicated that the U.S. Food and Drug Administration could consider alternative regulatory approaches for e-cigarettes, potentially including flavored products, as the agency evaluates ways to streamline product authorization processes.

  • Manufacturers Tell FDA They Need Benchmarks, Communication

    Manufacturers Tell FDA They Need Benchmarks, Communication

    During yesterday’s (Feb. 10) afternoon session of the U.S. Food and Drug Administration’s “Roundtable on Premarket Tobacco Application Submissions for Electronic Nicotine Delivery Systems Products,” Dr. Lynn Hull, acting senior science advisor in the Office of Science at FDA’s Center for Tobacco Products (CTP), moderated the Pharmacological Panel along with the FDA’s supervisory pharmacologist in CTP’s Division of Individual Health Science, Dr. Carolina Ramôa.

    Manufacturers warned that conducting studies has been prohibitively expensive and unpredictable without clear performance benchmarks. They also urged the FDA to allow greater use of modeling and data-bridging approaches, though regulators signaled that such alternatives would face strict validation requirements and may not replace product-specific clinical testing.

    “How can we simplify and have more communication and lean more toward product characteristics to model and understand abuse liability?” Dr. Willie McKinney, founder and CEO of Mckinney Regulatory Sciences asked. “How do we have more meetings regardless of where our application is in the process to understand what you are currently thinking?”

    The agency maintained that measuring nicotine delivery and addiction potential is essential when determining whether products meet public health standards, highlighting clinical pharmacokinetic (PK) data as the most reliable evidence.

    “I absolutely understand where you’re coming from,” said Dr. Ramôa, “where you want to make it as efficient as possible, but understand where I’m coming from, where I have a duty to the American public to make sure I make the correct decision that does not impact them negatively.”

  • FDA PMTA Roundtable Being Held

    FDA PMTA Roundtable Being Held

    Today (February 10), the U.S. Food and Drug Administration is hosting its much-anticipated “Roundtable on Premarket Tobacco Application Submissions for Electronic Nicotine Delivery Systems Products.”  Center for Tobacco Products (CTP) director Dr. Matthew Farrelly offered his opening remarks, which led into the “product characterization” panel moderated by deputy director Dr.  Todd Cecil.

    Dr.  Matthew Walters, Dr. Karen Coyne, Dr. Lynn Hull, and Dr. Carolina Ramôa rounded out the early sessions for FDA. Industry representatives said that unclear product characterization standards are limiting the long-term viability for smaller ENDS manufacturers, argued that the absence of objective, measurable benchmarks create uncertainty around PMTA compliance, and raised questions about defining testing ranges for open-system products and the ability to update long-pending PMTAs. FDA said it wants to create a dialogue with manufacturers, but statutory requirements constrain its regulatory flexibility.

    The afternoon panels were led by Cecil, Dr. Benjamin Apelberg, Dr. Mollie Miller, Dr. Amy Gross, Dr. Mary Irwin, and Dr.  Hans Rosenfeldt, and were still being held at the writing of this article. Tobacco Reporter will update the proceedings as the information becomes available.

  • FDA to Host Discussion on PMTAs Feb. 10

    FDA to Host Discussion on PMTAs Feb. 10

    FDA issued a reminder today regarding the Federal Register notice (FRN) roundtable discussion it is hosting tomorrow (February 10) for small tobacco product manufacturers (fewer than 350 employees). The discussion aims to solicit input on premarket tobacco product application (PMTA) submissions for electronic nicotine delivery systems (ENDS) products and will be held from 9 a.m.–5 p.m. ET.

    The topics to be discussed will include certain components of ENDS PMTAs, such as product characterization, manufacturing controls, pharmacological profile (e.g., pharmacokinetic studies), studies of adult benefit (e.g., longitudinal cohort/randomized controlled trial (RCT) studies), and toxicological profile (e.g., estimated lifetime cancer risk).

    FDA has also established a docket for public comment on this roundtable discussion. All electronic comments must be submitted on or before March 12. The regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of March 12.