Inaccurate warnings forever

A US public health expert has described the warnings that are required to appear on snus products sold in the United States as ‘egregiously inaccurate’.

University of Louisville professor Brad Rodu was reacting to the rejection by the Food and Drug Administration’s Center for Tobacco Products (CTP) of Swedish Match’s request to eliminate or revise the 30-year-old, egregiously inaccurate warnings.

Writing on his blog rodutobaccotruth, Rodu explained that, in 2014, Swedish Match had sought to:

• Remove the warning, ‘This product can cause gum disease and tooth loss’;
• Remove the warning, ‘This product can cause mouth cancer’; and
• Replace the warning, ‘This product is not a safe alternative to cigarettes’ with this text: ‘No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes’.

Rodu said that the FDA had justified its rejections in a six-page letter to the company, in a 115-page supporting document, and subsequently in an announcement proclaiming, ‘FDA Issues Science-Based Decisions on First MRTP Applications’.

Rodu raised a question mark over the claim that the decision was ‘science based’ and went on to review ‘the FDA’s tortured interpretation of the scientific evidence in its decisions on the gum disease/tooth loss and mouth cancer warnings’.

He said also that while the FDA had closed the door on the gum disease tooth loss warning, it had given Swedish Match the option of submitting a revised application for the other warnings.

But he didn’t appear to be holding out much hope. He said it appeared that the agency’s revision/amendment pathway was designed to defeat all but the wealthiest and most determined applicants, leaving millions of smokers and future smokers with demonstrably false warnings against the use of safer smoke-free products.

Rodu’s blog is at: http://rodutobaccotruth.blogspot.co.uk/