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Healio
August 27, 2015
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FDA issues warning letter against tobacco manufacturers for ‘additive-free’ and ‘natural’ claims

The FDA has issued warning letters to three tobacco manufacturers that list cigarettes as “additive-free” and “natural” on the products’ labeling, according to a press release.

The companies that received the letters include:

  • ITG Brands LLC — for Winston cigarettes with the modified risk tobacco product claim of “additive-free”;
  • Santa Fe Natural Tobacco Company — for Natural American Spirit cigarettes with the modified tobacco risk product (MTRP) claim of “natural” and “additive-free”;
  • Sherman’s 1400 Broadway N.Y.C. — for Nat Sherman cigarettes with the MTRP claim of “natural”.

“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, JD, director of the FDA’s Center for Tobacco Products, said in the release.

Mitch Zeller

Mitch Zeller

The warning letters are in response to violations of section 911 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

A manufacturer that attempts to claim that a product poses fewer risks than other tobacco products can submit a modified MTRP application to the agency with scientific evidence that supports that claim. However, the FDA has yet to issue any orders that allow the introduction of MRTPs into interstate commerce.

The FDA requests the manufacturers respond to the warning letters within 15 business days and explain how the manufacturers plan to remedy the violation and come into compliance with the law — or if they believe they are not in violation — to provide reasoning and supporting information to the agency. Failure to comply may result in further action including civil money penalties and an injunction.

“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,” Zeller said in the release.