FDA should get out of the smokeless tobacco industry
Just days after President Donald Trump’s inauguration, the Food and Drug Administration proposed new rule mandating major reductions in the trace amounts of a cancer-causing chemical found in smokeless tobacco products. The agency claims the effect will be to reduce the number of U.S. mouth-cancer deaths caused by smokeless tobacco from about 300 per year to about 190 per year.
While it may appear at first glance to have merit, if implemented as proposed, this regulation will likely do more harm than good in terms of tobacco-related addiction, illness, death and health-care costs. It also threatens to remove almost all smokeless products from the market, including the most popular brands.
The FDA readily admits that meeting the new standard likely would require manufacturers to use different types of tobacco and change how that tobacco is processed. Under provisions of the Tobacco Control Act of 2009, new or modified tobacco products cannot be brought to market without explicit FDA approval. The law makes no exception for modifications that are mandated by FDA and the FDA’s proposed rule doesn’t mention any waivers from the law. Complying with the pre-market application process likely will take more than two years to prepare and cost manufacturers more than $1 million, with separate applications required for each version of the revised product, as defined by flavor, nicotine level and labeling.
While the FDA argues these products pose a theoretical risk of cancers and other potentially fatal diseases, the lack of statistical clarity in this narrative suggests the numbers are too small to be estimated. This stands in sharp contrast to cigarettes, which cause about 500,000 deaths per year from cancer, heart and lung diseases. There are about 36 million U.S. smokers and about half of long-term smokers will die of a smoking-related disease. With this vast difference in risk, if even a few users of smokeless products switch to cigarettes, it easily would eliminate any presumed public-health benefit from the FDA’s proposed regulation.
Federal agency misrepresentation of smokeless tobacco risks is not new. We knew in the 1980s that the risks of mouth and throat cancer posed by the kinds of chewing tobacco and moist snuff that were available on the American market were far below the risks posed by cigarettes. Despite this, Congress imposed warnings about mouth cancer and that smokeless products are not safe alternatives to cigarettes. These warnings, and the public-health communications surrounding them, have led most physicians and other Americans to believe, incorrectly, that switching from cigarettes to smokeless tobacco simply swaps lung-cancer risk for mouth-cancer risk, with no overall reduction.
The U.S. Defense Department runs an annual anti-smokeless-tobacco program known as the “Great American Spit Out.” The event inaccurately portrays all smokeless tobacco as extremely hazardous. The Great American Spit-Out webpage on the DOD website offers a prompt for a visitor to “chat” with an “expert” who will detail lists of poisons that may or may not be in American smokeless products. The obvious intent is to scare people to abstain. If specifically asked, the so-called expert will incorrectly refuse to acknowledge that smokeless tobacco products are less hazardous than cigarettes.
Misrepresentation of this risk long has been based on international data that reflect mouth- and throat-cancer mortality in India and elsewhere, stemming from complex product mixtures available there that may or may not even contain tobacco. Another part of the misrepresentation relates to the known long-term risk of a similar cancer from a powdered dry snuff product used almost exclusively by older women in the U.S. Southeast.
As Dr. Rodu, who has explored the risks posed by smokeless tobacco products since the 1990s, pointed out in a Jan. 24 blog post, epidemiologic research conducted by the federal government has shown that American chewing tobacco (also known as “chew”) and moist snuff (also known as “dip”) pose zero increased risk of mouth cancer. This contrasts with the FDA estimate, which is based on a paper that statistically manipulated the data to imply equal risk of disparate products.
The FDA should withdraw its newly proposed smokeless tobacco regulation and limit any future rule, if applicable, to powdered dry-snuff products. Congress should also amend the underlying Tobacco Control Act of 2009 to promote switching from cigarettes to lower-risk alternatives. Federal regulation of any consumer product should focus on predatory marketing and eliminating shoddy products from the market. It should not be used to eliminate entire classes of products without explicit congressional authorization and convincing evidence of harm.
No nicotine or tobacco product is perfectly safe. The best bet, especially for teens or pregnant women, is never to start. For the millions of inveterate smokers who are unable or unwilling to quit, truthful discussion by health professionals and government agencies of the differences in risk between combustible and smoke-free nicotine and tobacco products could be a lifesaver.
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