The “continuum of risk” is the scientific concept that not all tobacco and nicotine-delivering products are equally harmful. Indeed, while no tobacco product may be completely “safe” it is important for businesses, researchers, and consumers to understand the idea of relative harm when it comes to tobacco and nicotine.

The global legal landscape for vapor and other “next generation” reduced-harm tobacco products is rapidly changing. In the United States, the Tobacco Control Act became law in 2009, amending the existing Food, Drug and Cosmetic Act (FDCA) to give the Food and Drug Administration (FDA) authority to regulate “tobacco products” for the first time. On August 8, 2016, that regulatory authority was extended beyond traditional cigarettes, cigarette tobacco, smokeless and roll-your-own tobacco, to include vapor, e-liquid, and other products that contain tobacco-derived materials (e.g., cigars, pipe tobacco, hookah/shisha, dissolvable tobacco, and heat-not-burn products). In addition, many states are passing their own laws (including online sales restrictions, licensing requirements, and taxes) that are greatly impacting businesses in these industries, as well as consumers.

Similarly, in the European Union (EU), the new Tobacco Products Directive (TPD) has now been implemented into the national legislation of most Member States and captures e-cigarettes and other novel tobacco products. The laws in Canada, the Middle East, China and Asia, and other countries around the world are also quickly evolving.

The Continuum of Risk is not intended to serve as legal advice but provides legal and regulatory updates for manufacturers, distributors, retailers, and suppliers of vapor, tobacco, and reduced-harm companies selling products around the world. Subscribe now and stay tuned for the latest updates that impact your business.

About Keller and Heckman LLP

For over 60 years, Keller and Heckman LLP has provided global legal counseling in the areas of regulatory law, public policy, and litigation. With offices in Washington, DC, San Francisco, Brussels, Shanghai, and Boulder, Keller and Heckman is well positioned to offer truly global support to our clients. Working together with our in-house scientific staff – including toxicologists, chemists, and microbiologists – we offer comprehensive legal, regulatory, and scientific support to clients in highly regulated areas. Chambers & Partners – a leading legal ranking publication – has ranked Keller and Heckman’s Food and Beverages practice in the highest tier, “Band 1,” which includes the top three practices nationwide. Further details regarding our services and personnel can be found at With respect to vapor and tobacco products, our comprehensive and extensive experience dealing with the Food and Drug Administration (FDA) and international regulation of food, food, packaging, drugs, medical devices, and dietary supplements uniquely positions us to guide companies in these industries through the myriad of regulatory requirements for these novel products that are effective now that FDA’s “Deeming Rule” as well as the EU’s Tobacco Product Directive, for example, are final. You can learn more about our Tobacco and Vapor Practice on our website at



Senior Regulatory Counselor