FDA says no to harm reduction

The FDA has just issued new guidelines dealing with chemicals in tobacco and how tobacco companies will be able to market potentially less risky products. While spokesmen for the agency, along with a variety of other organizations, are trumpeting these new strictures as a triumph for public health, the sad truth is that it s more of the same meaningless regulations being portrayed as beneficial. And the hurdles placed for reduced risk products bode ill for these products ever gaining access to the tobacco marketplace, which spells bad news for addicted cigarette smokers.

Under the new rules, tobacco companies will need to report, in a consumer-friendly format, the levels of 20 different chemicals in their products. Regulators have targeted these 20 chemicals, which include ammonia, formaldehyde, and carbon monoxide, because of concerns over links to cancer, lung disease, and other adverse health effects.

The guidance as to what companies will need to do before they can market any modified risk tobacco (MRT) products may well put an end to any realistic chance of these potentially beneficial products ever being sold in the U.S. According to these guidelines, a company must conduct extensive scientific studies on the health risks, usage, and consumer comprehension of these MRT products before they can market them as posing a lower risk to health than cigarettes. Currently, tobacco companies are not allowed to market their products with such statements, despite the extensive evidence demonstrating that certain MRT products, such as snus-type smokeless tobacco or dissolvables, are significantly less risky than smoking.

Dr. Lawrence Deyton, director of the FDA s tobacco center, applauded the new guidelines, saying, The law sets a high standard to make sure that tobacco products marketed to reduce risk actually reduce risk.

But ACSH's Dr. Gilbert Ross believes that, rather than benefiting public health, the new regulations will lead to a continued loss of life due to cigarette addiction. The new MRT guidelines create major hurdles to truthfully telling smokers about thebenefits of switching to these products, he notes. As for the chemical list, while it may seem like a great idea to help smokers become aware of the toxins they re inhaling, who is actually going to read this list and decide that they re going to quit? This rule won t do anything to reduce smoking.

ACSH s Dr. Josh Bloom isn t buying any of it. The packages will list a bunch of chemicals, some carcinogenic and some not, and then what? he asks. People will read this incomprehensible list? I don t think so. It s like requiring that the word 'bullet' be etched on all bullets so people know what it s for. Very useful.