Tag: Willie McKinney

  • ATNF Panel Highlights Innovation Barriers and Regulatory Challenges

    ATNF Panel Highlights Innovation Barriers and Regulatory Challenges

    At the American Tobacco and Nicotine Forum (ATNF) preconference, an innovation-focused panel examined the challenges of bringing reduced-risk nicotine products to market, with moderator Ryan Selby, managing Director for Emerald Innovations Ltd., emphasizing the difficulty of changing consumer behavior despite decades of public health messaging. He noted that while the risks of smoking are well understood, millions continue to smoke, raising questions about whether innovation must be “perfect” or simply “better” to make an impact. Selby also highlighted the stigma surrounding nicotine products, the cost pressures facing innovators, and the difficulty smaller companies face in gaining shelf space and competing with low-cost combustible cigarettes.

    Tadas Lisauskas, president and co-founder of Greenbutts, said U.S. regulations are effectively pushing innovation abroad, with smaller companies unable to navigate the regulatory burden or secure funding without clearer rules. He argued that “capital follows clarity,” and warned that the current system favors large legacy players while limiting new entrants, even as demand for alternative products exists. Dr. Willie McKinney, founder and CEO of McKinney Specialty Labs, focused on the importance of responsible innovation, stressing the role of scientific oversight and toxicology in product development, while noting that inconsistent public messaging and regulatory communication create confusion for consumers.

    Dr. Anna Franzén, clinical and regulatory business development officer at Emplicure Consumer AB, said regulation can support innovation if it is clear and structured, but current frameworks—particularly in the U.S.—are better suited to large companies and hinder smaller innovators. She called for more guidance, pilot programs and engagement with regulators, while pointing to international markets such as Sweden as examples of successful product adoption. Amber Sandrock, Chief of Staff at Shelf Partners, compared nicotine regulation to the food industry, noting that the rigid PMTA process limits the ability to refine products after submission and slows innovation. She also highlighted the need for more flexibility, cost efficiency and support for sustainable product development within the regulatory system.

  • 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.”