Mark Vaders provides cost-effective scientific and legal solutions to clients whose branded products are regulated by the FDA and state agencies. He has assisted in drafting many submissions to FDA’s Center for Tobacco Products, and serves as an in-house resource on vapor product science. His practice also focuses on developing legal- and science-based defenses to product liability lawsuits. Mark has provided counsel to RJ Reynolds Tobacco Company, RJ Reynolds Vapor Company, a leading national supplier of scientific and medical equipment, a global reinsurance provider, and other clients.
Before his law practice, Mark worked in the genomics services industry supporting global clinical trials. Years of working in a GLP and GMP environment give him a client’s perspective on sitting across the table from regulatory auditors.
Mark is passionate about serving his community, maintaining an active pro-bono practice and a strong commitment to the arts. He serves on the board of the Piedmont Wind Symphony, assists local non-profit organizations, and is accredited by the US Department of Veterans Affairs to prosecute veterans’ benefits claims.
Publications and Presentations
- "Seed to Sale: The Buzz on Understanding the FDA Regulatory Landscape for Cannabis,” National Law Review, October 21, 2021
- Moderator, “Assessing the Modified Risk Tobacco Products (MRTPs) Pathway,” Tobacco and Nicotine Products Regulation and Policy Conference organized by the Food and Drug Law Institute (FDLI), October 28, 2021
- Jilted, Biosethikos (Spring 2013).
- Cranial suture complexity in white-tailed deer (Odocoileus virginianus). J Morphol 267(7):841-9 (July 2006). Co-authored with CW Nicolay
- Discussion on Counterfeit and Compatible E-Cigarettes, the Annual Enforcement, Litigation, and Compliance Conference, Dec 2019
- “The Future of Nicotine Products and FDA’s Nicotine Steering Committee”, the Annual Food and Drug Law Institute (FDLI) Tobacco and Nicotine Products Regulation and Policy Conference, Nov 2018
Professional and Civic Activities
- Food and Drug Law Institute – Planning Committee, 2020 Tobacco and Nicotine Products Regulation and Policy Conference
- President, Piedmont Wind Symphony Board of Directors, 2020 – Present
Representative Experience
Any result the lawyer or law firm may have achieved on behalf of clients in other matters does not necessarily indicate similar results can be obtained for other clients.
- Ongoing practice drafting and providing scientific and legal counsel for successfully filed PMTA submissions encompassing more than 80 vapor and oral products.
- Providing subject matter expertise related to vapor and oral nicotine products.
- Crafting science-based arguments around epidemiology, clinical research, toxicology, chemistry, and product design to support regulatory submissions.
- Identifying and working with toxicology experts to conduct risk assessments of inhaled products.
- Conducting gap analyses for EPA-regulated products.
- Crafting science-based public comments on proposed regulations to support industry goals.
- Providing scientific and legal counsel related to California’s Proposition 65 including defense of alleged violations, testing, labeling, and settlement.
- Advised clients on compliance with Medical Device Reporting (MDR) requirements.
