The Tobacco Control Act requires specific health warnings for smokeless tobacco products. The packaging and advertising of smokeless tobacco products must contain one of the following four specified warning statements:
- WARNING: This product can cause mouth cancer.
- WARNING: This product can cause gum disease and tooth loss.
- WARNING: This product is not a safe alternative to cigarettes.
- WARNING: Smokeless tobacco is addictive.
Although tobacco companies may select which warning statement to affix to their packages, the smokeless tobacco warning statement must cover at least 30 percent of each of the two primary display panels. Additionally, the Tobacco Control Act mandates the size, color, type and placement of the warning statement on the packaging and advertisements.
In December 2012, R.J. Reynolds filed a citizen petition with FDA challenging the warning statements for smokeless tobacco products. R.J. Reynolds’ petition was a request to allow tobacco companies to market smokeless tobacco products as a less harmful alternative to cigarettes. Specifically, R.J. Reynolds’ petition requests FDA to amend one of the warning statements from “WARNING: This product is not a safe alternative to cigarettes” to read “WARNING: No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.” In order to market a tobacco product as a lower-risk tobacco product, the company must provide FDA with scientific proof that product will reduce harm to users and provide overall health benefits to the population. FDA held a hearing where it heard R.J. Reynolds’ arguments supporting its petition and comments on the petition.
On January 29, 2013, FDA published a notice that the agency established a docket to obtain comments regarding possible changes to the warning statements on the packaging and advertising of smokeless tobacco products. FDA’s notice provided that comments must be supported by scientific evidence and submitted to within 60 days of the publication of the notice.