The US Food and Drug Administration (FDA) has extended its authority to regulate all tobacco products, including e-cigarettes, cigars, pipe tobacco, hookah and their accessories. On May 2016, the FDA finalized the “Deeming Rule” that allows the agency to regulate all tobacco products under the Family Smoking Prevention and Tobacco Control Act.
The Deeming Rule requires all tobacco products to be subject to premarket approval, reporting, inspection and other requirements imposed by the Act. While the final rule goes into effect August 8, 2016, applications for “tobacco” products need to be submitted now to avoid delays on shipments and not being able to market or sale your tobacco products in the United States.
Section 901 of the Food, Drug, and Cosmetic Act (FD&C) Act grants the FDA authority to deem “any… tobacco products that the Secretary by regulation deems to be subject to Chapter IX of the FD&C Act.” Further, 21 U.S.C. §321(rr) defines the term “tobacco product” as “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product…”
Under this new regulation, to legally sell the new FDA-regulated tobacco product in the United States, your business must receive a written order from the FDA permitting the sale of a new tobacco product under one of three pathways:
- Substantial Equivalence
- Exemption form Substantial Equivalence
- Premarket Tobacco Products
Under the Substantially Equivalence Report, a tobacco product must have similar or different characteristics to a product that was commercially marketed in the United States as of February 15, 2007. In addition, the tobacco product must not raise different questions of public health since if it does, the product will not be considered under the Substantially Equivalence Report.
If your tobacco product has only been modified by adding or deleting a tobacco additive, your tobacco product may be considered for an exemption from demonstrating substantial equivalence. If your business has a tobacco product that may be legally marketed under the FD&C Act, and your business has a new tobacco product that is only a modification to that legally marketed product the exemption from substantial equivalence may be an avenue available to your business.
In cases where no other similar tobacco products were commercially marketed in the United States prior to February 15, 2007, then, your business will have to apply under the Premarket Tobacco pathway. Under this pathway, investigation reports and other documents showing the health risks of such tobacco product must be submitted to the FDA for review.
Furthermore, the scope of the Deeming Rule’s “tobacco products” definition includes accessories items such as “batteries,” “digital displays,” and others.
The FDA has provided guidelines as to how to submit an application for each of these three pathways and while no application form is provided, the FDA has clearly listed all items required on these applications. If your business needs assistance with receiving FDA permission to sell your tobacco products, we can help your business with these new-changing regulations.
About the Author: 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.