FDA Rejects Reynolds Petition to Change Smokeless Warning

Congress in 1986 legislated that smokeless tobacco products carry a warning label, “This product is not a safe alternative to cigarettes.”  In 2011, Reynolds American petitioned the FDA to replace that deceptive language. As I have noted (here), Reynolds’ request was straightforward: “…the Government should, in suitably brief form, tell the whole truth, not mislead by telling only part of the truth” about the health risks of smokeless tobacco use.

On May 11 the FDA denied Reynolds’ petition.  Center for Tobacco Products Director Mitch Zeller defended the action on the grounds that (1) the current not-safe-alternative warning is factual, (2) there is no evidence that the current warning is responsible for the fact that a vast majority of Americans incorrectly believe smokeless tobacco is just as hazardous or more hazardous than smoking, and (3) there is no evidence that the proposed replacement warning would “promote greater understanding of the risks associated with the use of smokeless tobacco products.”  The "greater understanding" phrase is repeated throughout the FDA’s 12-page decision letter. 

The agency’s rejection rests on distorted logic.  First, as I have pointed out for 20 years, the not-safe-alternative warning sets up a straw man; a perfectly safe alternative to cigarettes – or to any consumer product – doesn’t exist.  Extending the FDA’s logic, every consumer product should carry a warning that it is not “safe.” 

I do agree with the FDA’s assertion that the not-safe warning is not responsible for Americans’ misperceptions about smokeless tobacco; major medical organizations (here, here and here),  federal agencies (here and here) and state governments share the blame.  However, the FDA shifts the burden of proof.  Reynolds clearly demonstrated that the warning is inaccurate and misleading, but the agency wants the company to prove that the warning causes the misperceptions.  In effect, the FDA acknowledges that the warnings accomplish the government’s purpose – to portray all tobacco products as equally dangerous.

Most importantly, the FDA says that there is no evidence that Reynolds’ proposed replacement warning – No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes – would “promote greater understanding of the risks associated with the use of smokeless tobacco products.”  Mr. Zeller then repeats a list of diseases vaguely “known” and “shown” to be linked to smokeless tobacco.  But he doesn’t concede that the risks are so low that the government has never produced or cited specific estimates of deaths from smokeless tobacco use.

The Swedish Match MRTP application, discussed previously in this blog, would delete the cancer, gum disease/tooth loss and not-safe-alternative warnings and add a relative risk warning virtually identical to the one Reynolds proposed.  It remains under FDA review.