Tobacco Firms Advertising Natural Cigarettes Draws FDA Warning

Cigarette - Tobacco Firms Advertising
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August 27, 2015

Today, the U.S. Food and Drug Administration (FDA) delivered warning letters to three tobacco manufacturers for using banned language to describe its products.

ITG Brands LLC, Santa Fe Natural Tobacco Company Inc., and Sherman's 1400 Broadway N.Y.C. Ltd attracted the attention of the FDA with the use of "additive-free" and/or "all-natural" to characterize their cigarettes. These terms constitute violations section 911 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

"The FDA's 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," Mitch Zeller, director of the FDA's Center for Tobacco Products, said in a press release. "This 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."

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 regulatory action regarding the use of these terms in regards to tobacco product labeling.

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. If the application is accepted, the manufacturer would be free to use "natural" and "additive-free" on any labeling introduced into interstate commerce. To date, the FDA has not issued any of these orders.

The manufacturers are requested to respond to the warning letters within 15 working days and explain what actions they plan to take to remedy the violation and come into compliance with the law or, if they do not believe that they are in violation, to provide reasoning and supporting information to the FDA. Failure to obey federal tobacco law may result in the FDA initiating further action, including, but not limited to, civil money penalties, criminal prosecution, seizure, and/or injunction.