The FDA will be implementing new regulations with the objective of reducing the overall health effects of tobacco on the public. Approximately two and a half years ago, the deeming rule came into effect on August 8, 2016, which was the start of the FDA regulation of what is known as “All Other Tobacco Products.” This list of newly regulated products includes cigars, e-cigarettes, hookah tobacco, pipe tobacco, nicotine gels, and dissolvables.

As part of this new FDA initiative, the deadlines for applications to market newly-regulated combustible products, such as cigars, hookah tobacco, and pipe tobacco, will be extended to August 8, 2021. Also, applications to market newly-regulated non-combustible products, such as electronic nicotine delivery systems (ENDS) or e-cigarettes, will be extended to August 8, 2022. All other deadlines for newly implemented FDA tobacco regulations will remain the same.

FDA stated that further details and specific regulations will be announced in the near future. It seems that the FDA’s Center for Tobacco is still figuring out the proper guidance they need to issue for who they call small-scale tobacco product manufacturers or small tobacco product manufacturers to overcome the compliance hurdles plaguing these newly regulated businesses in the tobacco industry. It is a difficult process for smaller businesses to comply with new regulations that were never part of the overall business models and products costs initially. However, the FDA does offer specific guidance for “small entity” manufactures and distributors for new products, grandfathered products, and substantially equivalent products to curb the financial burden of the new FDA regulations.

A finished tobacco product refers to a tobacco product, including all components and parts, sealed in final packaging intended for consumer use (e.g., filters or filter tubes sold separately to consumers or as part of kits).

Gerald “Jerry” Donnini II is a shareholder of the Law Offices of Moffa, Sutton, & Donnini, P.A. Mr. Donnini concentrates in the area of state and Federal tax matters, with a heavy emphasis on the tobacco, alcohol, motor fuel and related industries. He also handles a myriad of multi-state state and local tax issues. Mr. Donnini is a co-author for CCH’s Expert Treatise Library: State Sales and Use Tax and writes extensively on multi-state tax issues for SalesTaxSupport.com.  For more information please call us at 888-966-8216.

Posted in Regulated Substances, Tobacco