Three Tobacco Manufacturers Receive Warning Letters for Labeling Claims

The U.S Food and Drug Administration issued warning letters today to three tobacco manufacturers, ITG Brands LLC, Santa Fe Natural Tobacco Company Inc. and Sherman’s 1400 Broadway N.Y.C. Ltd. These companies claim their cigarettes are “additive-fee” and/or “natural,” and have this information on their labeling. The warning letters are for violations of section 911 of the Federal Food, Drug, and Cosmetic Act (FD&C ACT), said a press release from the U.S. Food and Drug Administration.

According to the press release, this 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 against such claims.

“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,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. Zeller also said this action is “a milestone” and reminder of how the FDA uses the tools of science-based regulation to protect the U.S. public from the harmful effects of tobacco use.

Per the FD&C Act, amended by the Tobacco Control Act, the FDA has the authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco. It also established a process for the FDA to evaluate requests from companies wanting to market their products as “modified risk,” the FDA noted.

Under the FD&C Act, a “modified risk tobacco product” is any tobacco product sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products. This includes products, labeling or advertising.

A manufacturer who claims 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 the claim. As of today, the FDA said it has not issued any orders permitting the introduction of modified risk tobacco products into interstate commerce.

Therefore, all three companies that received the warning letters must respond within 15 working days and explain what actions they plan to take to remedy the violation and come into compliance with the law, or they have to provide reasoning and supporting information to the FDA to support their claims. Failure to do so may result in, but not limited to, civil money penalties, criminal prosecution, seizure and/or injunction, the FDA said.

For those consumers or interested parties who want to report a potential tobacco-related violation of the FD&C Act, they can do so by using the FDA’s Potential Tobacco Product Violation Reporting Form.