The FDA has agreed to allow a popular cigarette brand to continue to include the word "natural" in its name, despite an earlier finding by federal regulators that the product labeling constituted a reduced-harm claim.
R.J. Reynolds-owed Santa Fe Natural Tobacco Company, which markets the Natural American Spirit brand, will be required to remove the terms "natural" from the cigarette packaging, with the exception of the brand name, which will not change.
A joint press release issued Thursday afternoon by the anti-tobacco groups Truth Initiative and Campaign for Tobacco-Free Kids strongly criticized the action, and the fact that the agreement, issued on Jan. 19th, was not disclosed to the public.
The between the FDA's Center for Tobacco Products and Reynolds American Incorporated/Santa Fe Natural Tobacco, Inc. was labeled "Confidential - Not for Public Disclosure."
Truth Initiative CEO and president told 鶹ý that the agreement came to light as part of a public court filing by Santa Fe Tobacco seeking dismissal of several class-action consumer fraud lawsuits.
"It is purely by accident that we know about this," she said.
In response to an email request for comment from 鶹ý, FDA press officer Michael Felberbaum wrote that, "I do not have anything to share as this is an ongoing compliance matter."
In August of 2015, the FDA issued a warning letter to Santa Fe Tobacco notifying the company that their use of the terms "natural" and "additive-free" on their product labeling constituted a reduced-harm claim, which is prohibited without FDA approval by the 2009 Tobacco Control Act.
The new agreement does require the removal of the term "additive-free" from the labeling of the company's various products and the word "natural" from all packaging with the exception of the brand name, but the packaging can still include the word "organic," which the anti-tobacco groups say also misleads the public into thinking the cigarettes are less harmful than other brands.
In a press release, Koval called the agreement, "a gift to the tobacco industry, permitting R.J. Reynolds to continue the highly misleading, and very possibly legally fraudulent, marketing and labeling of American Spirit cigarettes."
The agreement was issued on the last day of the Obama presidency, and Koval said it is not clear why it was not made public.
In the press release, Campaign for Tobacco-Free Kids president Matthew L. Myers said the agreement falls "woefully short of the complete prohibition needed" on the term "natural" and other terms that falsely imply a safer cigarette.
"The marketing for Natural American Spirit is the most deceptive of any major U.S. cigarette brand now on the market and has helped fuel a large increase in the brands's sales even as overall cigarette sales in the U.S. have fallen," he said.
A recent study by researchers from the Truth Initiative found that smokers who preferred the Natural American Spirit cigarette brand were 22 times more likely than smokers of other brands to inaccurately perceive their cigarette choice as being less harmful.
Nearly two out of three (64%) of Natural American Spirit smokers believed their brand to be safer than other cigarette brands, compared to 8.3% of smokers of those other brands, according to the analysis of data from the study.