FDA Denies R.J. Reynolds Request to Weaken Smokeless Tobacco Warning

AAFP Among Groups That Advocated Against the Change

May 20, 2015 01:10 pm News Staff

The AAFP and other anti-tobacco stakeholders scored a big win last week when the FDA denied an industry request(www.fda.gov) to weaken the language in one of the agency's four smokeless tobacco warning statements.

[Box of smokeless tobacco]

More than 2 1/2 years ago, the AAFP joined about 30 other health care and tobacco reform advocacy groups in submitting comments(15 page PDF) to the FDA that opposed a so-called citizen petition submitted by the R.J. Reynolds Tobacco Co. and its smokeless tobacco subsidiary the American Snuff Co. that asked the agency to revise warning labels on smokeless tobacco products.

A more comprehensive follow-up letter(4 page PDF) the AAFP and others sent five months later responded to the FDA's open-ended request for comments on "what changes to the current statutory warnings on smokeless tobacco products, if any, would promote greater public understanding of the risks associated with the use of smokeless tobacco products."

R.J. Reynolds' initial petition asked the FDA to change the current warning statement from "WARNING: This product is not a safe alternative to cigarettes" to the less definitive risk statement "WARNING: No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes."

Story highlights
  • On May 11, the FDA denied a petition from tobacco giant R.J. Reynolds that had asked for a change in smokeless tobacco warnings; the AAFP had advocated against the change.
  • On two occasions, the AAFP joined with dozens of other health care and tobacco reform advocates to submit comments to the FDA opposing the petition.
  • The FDA concluded, among other things, that given the strong scientific evidence of risk from smokeless tobacco, the current statutory smokeless tobacco warning is factual and not misleading.

Then, in a supplement dated March 28, 2013, the petitioners asked that, if FDA officials determined that the originally proposed warning lacked specificity or that it might promote dual use of smokeless tobacco and cigarettes, the agency change the challenged warning to "WARNING: No tobacco product is safe; however, exclusive use of smokeless tobacco products presents substantially less risk to health than cigarettes."

On May 11, the AAFP and other opponents of the petition saw their efforts pay off when the FDA posted a letter(www.regulations.gov) from Mitchell Zeller, director of the FDA Center for Tobacco Products, to R.J. Reynolds. In the letter, Zeller denied the petition, saying that the agency found that no revision of the smokeless warnings was warranted.

Among the key conclusions the FDA reached were

  • given the strong scientific evidence of the risk of disease from smokeless tobacco, the current statutory smokeless tobacco warning is factual and not misleading;
  • specifically, the current warning accurately states that smokeless tobacco is not safe and does not imply, contrary to R.J. Reynolds' assertion, that cigarettes and smokeless tobacco present equal risks;
  • the current warning doesn't violate Reynolds' First Amendment rights; and
  • granting the R.J. Reynolds petition would give all smokeless tobacco products the status of modified-risk tobacco products without meeting the requirements of Section 911 of the Family Smoking Prevention and Tobacco Control Act, which governs claims of modified risk for specific products.

These points also were among the key arguments made in the letters to the FDA that the Academy signed on to in opposition to R.J. Reynolds' petition.

The FDA letter to R.J. Reynolds concluded by saying, "After careful consideration of the
scientific and legal evidence, the FDA has determined that there is insufficient evidence to show that the current warning is not factual or is misleading, or that either of the proposed warnings is effective in promoting greater public understanding of the risks associated with smokeless tobacco products."