Representative Matters:
- Representing E-Vapor Industry trade associations in a lawsuit challenging FDA’s Deeming Regulation and aspects of the Tobacco Control Act in the U.S. District Court for the District of Columbia.
- Defending major e-liquid company and manufacturer in false advertising class action lawsuit in California’s Orange County Superior Court, Complex Division
- Advised e-liquid companies on EU Tobacco Products Directive and Member State laws and labeling requirements
- Representing a Coalition of e-vapor companies challenging the constitutionality of Indiana’s new e-liquid law (HEA 1432/SEA 463) in federal district court
- Advised e-vapor companies on the development of product standards in the U.S., EU, and China
- Established a Working Group of Chinese e-cigarette stakeholders dedicated to working with the government authorities to develop appropriate, product-specific regulations and standards for e-cigarettes and e-liquids in China
- Advised e-liquid producer on safety of e-liquid ingredients, including diacetyl and related compounds
- Advised manufacturers of filter components of the impact of product changes on customer compliance issues
- Advised paper manufacturers of the impact on compliance obligations arising from changes in processing aids
- Presented at Tobacco Merchant Association conference on Deeming Regulation issues
- Presented at FDLI Introduction to Tobacco Law and Regulation Seminar on Product Standards, Menthol, and FDA’s Deeming Regulation
- Presented at an FDA workshop on risk reduction and the utility of risk assessment techniques for evaluating non-combustion sources of inhaled nicotine
- Presented at the American Chamber of Commerce in Shanghai, China on the Evolution of FDA and Global Regulation of Electronic Cigarettes
- Conducted numerous webinars for FDLI and other organizations on tobacco and nicotine product regulation by FDA
- Acting as General Counsel to trade association of e-liquid companies and 501(c)(3) research foundation
- Attended with FDA to familiarize staff with the variety of advanced, non-combustion delivery vehicles for vaping nicotine and aromatics (with or without nicotine)
- Prepared trade association comments to OMB regarding FDA’s efforts to justify its proposed Deeming Regulation with regard to the objectives of the Paperwork Reduction Act
- Prepared comments to FDA proposals regarding Modified Risk Tobacco Product Applications, Harmful and Potentially Harmful Constituent disclosure requirements, regulation of menthol, and the Deeming Regulation
- Attended meetings at FDA’s Center for Tobacco Products on behalf of clients
- Advised clients regarding compliance with California law to e-liquid company
- Authored numerous articles in FDLI Update magazine and the Tobacco Reporter on FDA regulation of tobacco products and e-cigarettes
- Advised concerning labeling of e-cigarettes in the European Union
- Advised concerning permitted ingredients in tobacco products under National legislation in Europe and around the world
- Advised concerning novel technologies for harm reduction in tobacco products
- Advised concerning regulation of tobacco additives under the EU REACH Regulation
- Advised concerning import and export of tobacco products under U.S. law