RAI's Santa Fe & FDA Reach Product Labeling Agreement

WINSTON-SALEM, N.C. — Santa Fe Natural Tobacco Co. will no longer user "additive-free" in all Natural American Spirit cigarette product labels, labeling, advertising and promotional material.

The change is part of the Winston-Salem-based Reynolds American Inc. subsidiary's agreement with the Food and Drug Administration (FDA) to resolve a 2015 warning letter.

In August 2015, the FDA issued warning letters to three tobacco manufacturers — including Santa Fe — that described their cigarettes on product labeling as "additive-free" and/or "natural." ITG Brands LLC and Sherman's 1400 Broadway NYC Ltd. also received the letters, as CSNews Online previously reported.

It was the first time the agency used its authority under the Family Smoking Prevention and Tobacco Control Act of 2009 to pursue regulatory action regarding the use of "additive-free" or "natural" claims on tobacco product labeling. 

Santa Fe and the FDA reached an agreement in mid-January; the pact was recently made public by the Campaign for Tobacco-Free Kids.

Under the terms of the pact, Santa Fe will also remove the term "natural" from all Natural American Spirit cigarette product labels, labeling, advertising and promotional material. However, it will retain the term in the Natural American Spirit brand name and trademarks.

Santa Fe can use the statement "Tobacco Ingredients: Tobacco & Water" or "Tobacco Filler Ingredients: Tobacco & Water." The phrases are not required, however, the tobacco company wanted to have the option of using the statements, according to the agreement.

The FDA's Center for Tobacco Products has given Santa Fe seven months to implement changes to its materials and will not take any enforcement action against the tobacco company during that timeframe.

By accepting the terms of the agreement, Santa Fe does not admit any liability or wrongdoing.

According to the Campaign for Tobacco-Free Kids, the Jan. 19 agreement, which is labeled "confidential – not for public disclosure," came to light as part of a public court filing by Santa Fe seeking dismissal of a number of class-action consumer fraud cases which have been consolidated and are pending in the U.S. District Court in Santa Fe, N.M.