Wednesday, May 20, 2015

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.


Larry Waters said...

I don't sympathize with Reynolds on this one. Unlike Swedish Match, they did not put forth the effort through the MRTP process to prove Camel SNUS is indeed less harmful than cigarettes overall.

We don't know what is in Camel SNUS, how it is made, or by what process. Admittedly by virtue of Camel SNUS being a smokeless tobacco, it does not carry the known risks cigarette smoking.

Camel SNUS could, however, turn out to be just as dangerous as cigarettes for different reasons. Without knowing exactly what Camel SNUS is, we have no way of knowing.

Congress and FDA has an established process to reclassify a smokeless tobacco product as a MRTP. It's expensive and time consuming for the manufacturers to follow, but it makes sense to have such a process before declaring any tobacco product to be safer than cigarettes.

Painting all smokeless tobacco products made by anyone anywhere by simple Petition is painting with much too broad a brush. I agree with Zeller's decision although not some of his rationalizations.

The 123K+ page MRTP application SM submitted does justify and quantify the label changes they are requesting for General Snus.

If FDA denies this application, then no smokeless tobacco has any hope of declaring its product less harmful than cigarettes.

Either way, we'll know in August.

Anonymous said...

Well this is once again solid proof that tobacco control is based on an ideology not science. The empirical evidence was ignored because it contradicted dogma.

Brad Rodu said...

The research community has gathered a lot of information about Camel snus. Numerous laboratory studies, some of which have been discussed in this blog, generally show that there are only small traces of contaminants present, in similar concentrations as in Swedish snus. The differences in contaminant levels among all moist snuff and snus products sold in the U.S. are so small that there is no measurable differential impact on health.

For more information about Camel snus, plug the term into my blog’s search function. These published studies also provide information.

Smokers interested in going smokeless have many options from Sweden and the U.S., and they should use the product that is satisfying and enjoyable.