FDA In Brief: FDA issues revised final guidance on tobacco manufacturer registration and product listing requirements as part of the agency’s efforts to provide continued, effective oversight of the newly-regulated tobacco products, including e-cigarettes

For Immediate Release: Sept. 15, 2017

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"Requiring tobacco manufacturers to register with the FDA and submit information about the products they sell is vital to effectively implementing our tobacco authorities to protect public health. At the same time, we must also aim to make the regulatory process more transparent, efficient and predictable for industry,” said FDA Commissioner Scott Gottlieb, M.D. “Our aim is to strike a balance between fostering product innovation that could offer consumers lower-risk alternatives to combusting tobacco, while providing a solid regulatory foundation for our oversight of these new products. With our comprehensive approach to the regulation of nicotine, we’re seeking to dramatically reduce tobacco-related disease and death."

Today, the U.S. Food and Drug Administration issued a revised final guidance regarding the requirements for tobacco product manufacturers to register with the FDA and submit a listing of their products, which must be updated annually. The updated guidance includes a compliance policy that aims to reduce the product labeling submissions by a manufacturer, and provides more transparency and predictability to this process. In particular, the guidance outlines how a registrant could provide information and labeling for a selected line of products as a single submission.

Registration and product listing requirements have applied to cigarette, cigarette tobacco, roll-your-own tobacco and smokeless tobacco manufacturers since the Family Smoking Prevention and Tobacco Control Act went into effect in 2009. Following the May 2016 final rule that extended the FDA’s authority to additional tobacco products, this requirement now applies to newly-regulated tobacco products including Electronic Nicotine Delivery Systems such as e-cigarettes, as well as cigars, pipe tobacco and hookah tobacco, among others. For owners and operators of domestic establishments manufacturing newly-regulated tobacco products prior to Aug. 8, 2016 and continuing after that date, the compliance deadline for registration and listing is Sept. 30, 2017. Those first engaged in manufacturing on or after Aug. 8, 2016, must immediately register and list.

In July, the FDA announced a new comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease and death. The approach places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts. The goal is to ensure that the FDA has the proper scientific and regulatory foundation to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act. This includes making certain that the FDA is striking an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less harmful than cigarettes.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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