{"id":17751,"date":"2015-08-27T00:00:00","date_gmt":"2015-08-27T00:00:00","guid":{"rendered":"https:\/\/cadca1stg.wpengine.com\/resource\/government-takes-proactive-approach-to-cigarette-labeling\/"},"modified":"2023-05-01T14:44:42","modified_gmt":"2023-05-01T14:44:42","slug":"government-takes-proactive-approach-to-cigarette-labeling","status":"publish","type":"resource","link":"https:\/\/www.cadca.org\/es\/resource\/government-takes-proactive-approach-to-cigarette-labeling\/","title":{"rendered":"Government Takes Proactive Approach to Cigarette Labeling"},"content":{"rendered":"

The Food and Drug Administration (FDA) has taken action against three tobacco manufacturers for making \u201cadditive-free\u201d and\/or \u201cnatural\u201d claims on cigarette labeling.<\/p>\n

Today, the FDA issued warning letters<\/a>\u00a0to three tobacco manufacturers \u2014 ITG Brands LLC, Santa Fe Natural Tobacco Company Inc., and Sherman\u2019s 1400 Broadway N.Y.C. Ltd. \u2014 who\u00a0describe their cigarettes on product labeling as \u201cadditive-free\u201d and\/or \u201cnatural.\u201d The warning letters are for violations of section 911 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).<\/p>\n

The action marks the first time the FDA has used its authority under the Family Smoking Prevention and Tobacco Control Act of 2009 to pursue\u00a0regulatory action regarding the use of \u201cadditive-free\u201d or \u201cnatural\u201d claims on tobacco product labeling.<\/p>\n

\u201cThe\u00a0FDA\u2019s job is to ensure tobacco products are not marketed in a way that leads consumers to believe cigarettes with descriptors like ‘additive-free’ and ‘natural’ pose fewer health risks than other cigarettes, unless the claims have been scientifically supported,\u201d said Mitch Zeller, J.D., director of the FDA\u2019s Center for Tobacco Products, in a news release. \u201cThis action is a milestone, and a reminder of how we use the tools of science-based regulation to protect the U.S. public from the harmful effects of tobacco use.\u201d<\/p>\n

The FD&C Act, amended by the Tobacco Control Act, gives the FDA the authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. It also created a process for the FDA to evaluate requests from companies seeking to market their products as\u00a0modified risk.<\/p>\n

Under section 911(b)(1) of the FD&C Act, a \u201cmodified risk tobacco product\u201d is \u201cany tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.\u201d This includes products, the label, labeling, or advertising of which represents implicitly or explicitly that the product or its smoke does not contain or is free of a substance and\/or that the product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products.<\/p>\n

A manufacturer who seeks to claim that a product poses fewer risks than other tobacco products may submit a modified risk tobacco product (MRTP) application to the FDA with scientific evidence to support that claim.\u00a0To date, the FDA has not issued any orders permitting the introduction of modified risk tobacco products into interstate commerce.<\/p>\n

The companies received warning letters for the following products and their related modified risk claims:<\/p>\n