Willie McKinney
Chief Executive OfficerMcKinney Specialty LabsDr. Willie McKinney is an established regulatory and inhalation toxicology expert with over two decades of research, product development, and regulatory strategy experience in the Consumer-Packaged Goods industry. As the founder and CEO of McKinney Regulatory Science Advisors, LLC, he leverages his extensive background, including his previous role on the FDA’s Tobacco Product Scientific Advisory Committee and his past position as Vice President of Regulatory Sciences at Altria, to guide clients through multiple constantly evolving regulatory landscapes.
Dr. McKinney’s knowledge and experience are widely respected. He holds a Ph.D. in Environmental Toxicology from the University of North Carolina School of Public Health and is certified by the American Board of Toxicology. He launched McKinney Specialty Labs, LLC in January 2024 to offer specialized aerosol testing services as well as chemical and GLP toxicology analysis.
Together, McKinney Regulatory Science Advisors, LLC, and the newly established lab provide over 25 years of combined expertise in regulatory strategy, application filing, and product testing. This suite of services is customized to meet the unique needs of each client, guaranteeing integrity and quality at every step. Dr. McKinney’s leadership remains instrumental in driving scientific research and regulatory compliance forward.
Building a Safety Standard for Cannabis Vape Products: A Science-Based Risk Assessment Framework for Manufacturers and Regulators
The cannabis industry operates without a harmonized product safety standard for products intended for vaporization and inhalation. Manufacturers face
…The cannabis industry operates without a harmonized product safety standard for products intended for vaporization and inhalation. Manufacturers face a patchwork of state testing requirements with no consistent methodology for evaluating whether a pr
…The cannabis industry operates without a harmonized product safety standard for products intended for vaporization and inhalation. Manufacturers face a patchwork of state testing requirements with no consistent methodology for evaluating whether a product is actually safe to inhale, and regulators lack a shared framework to assess the submissions they receive.
This session introduces a peer-reviewed, iterative risk assessment framework developed
The cannabis industry operates without a harmonized product safety standard for products intended for vaporization and inhalation. Manufacturers face a patchwork of state testing requirements with no consistent methodology for evaluating whether a product is actually safe to inhale, and regulators lack a shared framework to assess the submissions they receive.
This session introduces a peer-reviewed, iterative risk assessment framework developed specifically for cannabis inhalation products, built on decades of toxicological evaluation science from adjacent regulated industries. Drawing on real formulation and nonclinical data from an 8% terpene blend in THC distillate evaluated through targeted and nontargeted chemical analysis, aerosol characterization, stability testing, and in vitro toxicology, the panel will walk through what a credible product safety program actually looks like, where current standardized methods fall short when applied to cannabis matrices, and how manufacturers can begin implementing evidence-based risk evaluation today without waiting for federal guidance that may not come soon.
Learning Objectives:
1. Understand the structure of an integrated, iterative cannabis product evaluation framework from ingredient-level hazard identification through formulation assessment, nonclinical testing, and aerosol characterization.
2. Learn why standard ENDS testing methods developed for nicotine products require adaptation when applied to high-viscosity THC distillates and terpene-rich cannabis formulations.
3. Identify which chemical constituents in cannabis vape products (including carbonyls, metals, VOCs, and thermal degradation products) require targeted analysis and why nontargeted screening is essential for a complete safety picture.
4. Understand the role of stability testing in product evaluation and what chemical changes in cannabis vape formulations over a 12-month period reveal about formulation risk.
5. Learn how in vitro toxicology assays (cytotoxicity, genotoxicity, mutagenicity) can be practically applied to cannabis subcomponents and finished formulations, and what their limitations are in this context.
6. Recognize how lessons from tobacco and nicotine product regulation (including FDA's PMTA framework) offer a practical blueprint for cannabis manufacturers seeking to demonstrate product responsibility ahead of formal federal oversight.
7. Leave with a practical roadmap for implementing a tiered product safety evaluation program at your organization, regardless of scale or regulatory jurisdiction.
