FDA Announces New Plan for Tobacco and Nicotine Regulation

The FDA will be implementing new regulations with the objective of reducing the overall health effects of tobacco on the public. Approximately one year 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. See below for a list of a few upcoming deadlines.

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.

1. Submit tobacco health documents – February 8, 2017 for non-“small tobacco product manufacturers” & November 8, 2017, for “small tobacco product manufacturers”

2. Submit cigar warning plans by August 10, 2017

3. Submit ingredient listing by May 8, 2018 for small and November 8, 2017, for non-small

4. Submit a premarket application for “new” tobacco products to stay on the market

Exemption from Substantial Equivalence due by November 8, 2017

Substantial Equivalence by May 8, 2018

Premarket Tobacco Applications by November 8, 2018

5. Stop manufacturing products with modified risk claims by November 8, 2017

Stop distributing these products by December 8, 2017

6. Include required warning statements on packages and advertisements by August 10, 2018

7. Submit quantities of harmful and potentially harmful constituents by November 9, 2019

8. Report user fee information for cigars & pipe tobacco by August 20, 2016 and monthly thereafter

9. Pay user fees for cigars and pipe tobacco by December 31, 2016, and quarterly thereafter

10. Register your establishment and submit list of products, including labeling and advertisements by September 30, 2017; for products introduced after August 8, 2016 you must register and submit product listing immediately upon manufacturing.

11. Submit a modified risk tobacco product application

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).

About the author: Mr. Donnini is the president and founder of Tobacco Tax Refunds, Inc. He is also multi-state sales and use tax attorney and an associate in the law firm Moffa, Sutton & Donnini, PA, based in Fort Lauderdale, Florida. Mr. Donnini has extensive knowledge handling wholesale tax controversy and refunds.

In his law practice Mr. Donnini's primary practice is multi-state sales and use tax as well as state corporate income tax controversy. Mr. Donnini also practices in the areas of federal tax controversy, federal estate planning, Florida probate, and all other state taxes including communication service tax, cigarette & tobacco tax, motor fuel tax, and Native American taxation. Mr. Donnini obtained his LL.M. in Taxation at NYU. Mr. Donnini is licensed to practice law in Florida. If you have any questions please do not hesitate to contact him via email [email protected] or phone at 954-639-4496.