The Family Smoking Prevention Tobacco Control Act (the Tobacco Control Act) amended the Food, Drug and Cosmetic Act to give the U.S. Food and Drug Administration (FDA) authority to regulate tobacco products. Keller and Heckman has followed FDA’s implementation of the Tobacco Control Act since it became law in 2009, and has commented directly and assisted clients in commenting on FDA Guidance Documents and implementing regulations, including the proposed “Deeming Regulation,” which proposes to give FDA authority over currently unregulated tobacco products such as electronic cigarettes and advanced personal vaporizers, dissolvable tobacco, cigars, pipe tobacco and hookah (water pipes).
We carefully track U.S. and European Union (EU) legislative and regulatory developments, including the possible regulation of novel tobacco products, such as e-cigarettes, as well as the impact of current laws on suppliers of materials that become components of tobacco products. In the U.S., the Tobacco Control Act established numerous new pre-market review, ingredient disclosure, labeling, manufacture, distribution, advertising, modified risk and safety data requirements, among others, for manufacturers and importers of regulated tobacco products. Our attorneys and scientists work with clients to assist them with developing plans for meeting these FDA requirements. We are also closely monitoring parallel developments in the EU with respect to the revision of the Tobacco Products Directive, as well as Member State initiatives.
Keller and Heckman's comprehensive and extensive experience dealing with the regulation of food, drugs, medical devices and dietary supplements before the FDA uniquely positions us to guide tobacco product companies through the myriad of new FDA requirements for tobacco products. We provide legal and scientific support to tobacco product companies and their suppliers with respect to the statutory and regulatory requirements specifically imposed by the Tobacco Control Act, including:
- Ingredient, additive, and harmful and potentially harmful constituent disclosure requirements;
- Health document submissions;
- Manufacturing facility registration;
- Good Manufacturing Practice guidance;
- Substantial equivalency determinations and exemptions;
- Premarket Tobacco Product Applications;
- Modified Risk Tobacco Product Applications;
- Retailer compliance issues; and
- Tobacco product testing requirements.
Our attorneys and scientists also participate in tobacco industry meetings; FDA-sponsored workshops; and actively contribute to the Food, Drug Law Institute (FDLI) Tobacco Law, Regulation & Policy Resource Center. In particular, several of our attorneys contributed to FDLI's publication, Tobacco Regulation and Compliance: An Essential Resource¸ and FDA Regulation of Tobacco: A Comprehensive Guide – An FDLI Primer.
Representative Matters:
- 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 others 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
