FDA’s Final Tobacco Product Deeming Regulation – Impact, Potential Challenges & Opportunities

The Federal Drug Administration (FDA) currently regulates cigarettes and cigarette tobacco, and it is looking to expand its authority to products that are alike, like pipes and cigars. This change was precipitated by the confusion around electronic cigarettes – a product that contains no tobacco, but is a substitute for it. This had raised several questions about the regulation of electronic cigarettes, because it did not fall neatly into any pre-conceived categories. It was not identifiably a food, drug, or cosmetic. In recognizing the need to bring this set of products under the Food, Drug and Cosmetic Act, the FDA has released a final tobacco product deeming rule (yet to come into force) to include the following products –

1. Electronic cigarettes
2. Cigars
3. Pipe Tobacco
4. Dissolving products that are not ‘smokeless tobacco’
5. Gels
6. Waterpipe Tobacco

This would mean substantial changes in the way these products are marketed and sold. The FDA would be able to exercise its substantial authority to verify health claims, ensure reasonable age restrictions, and lay down labeling and packaging norms for these products. These restrictions on tobacco sale and use come from the recognition that tobacco use continues to be the leading cause of preventable death and disease in this country.

This is an incredibly positive move, especially because there has been some major controversy over whether or not electronic cigarettes are without side effects. The impending expansion of the FDA mandate to deal with them at a regulatory level will hopefully resolve this impasse, especially since electronic cigarettes might be the future of cigarettes, with the promise of reduced side effects.

If you deal in any of these products or use any of them, it is important for you to be aware – either as a producer/retailer or as a consumer – what this means for you. FDA’s Final Tobacco Product Deeming Regulation, when passed, will have a strong impact on all stakeholders. Get an overview of the FDA’s final tobacco product deeming regulation and understand the authority under which FDA will regulate such products. You’ll receive a breakdown of the various compliance periods for newly applicable requirements as well as a review of potential challenges and opportunities for affected industry members. This webinar by expert speaker Will Woodlee is a must-attend for all industry professionals.