In what might have been an attempted end run around efforts by President Trump and Congress to limit the number of last-minute regulations that were rushed through at the end of the previous administration, the FDA announced new regulations for smokeless tobacco on the last day of the Obama administration and published the proposed rule on the first business day of the new Trump administration.
The proposed rule, issued pursuant to the Family Smoking Prevention and Tobacco Control Act, would limit the levels of a naturally occurring constituent in smokeless tobacco — N-Nitrosonornicotine (NNN), which has been shown to be a carcinogen in rodent tests.
The proposed regulation would limit NNN levels to a standard of one part per million (dry weight) at any time through the product expiration date. Reason Foundation has filed a public comment with the FDA on the proposed rule and encourages the agency to abandon it.
In its proposal, FDA asserts that the rule is “appropriate for the protection of public health” but relies upon a fatally flawed risk analysis for the arbitrary standard it creates. The agency fails to demonstrate that the standard would improve product safety or save even one life. Manufacturer compliance with the standard may be technically impossible and to the extent standards could be met, it would fundamentally change the product to something consumers wouldn’t recognize.
Congress specifically mandates in the underlying Family Smoking Prevention and Tobacco Control Act that FDA must consider the technical achievability of compliance and the potential for creating demand for black market products. But the proposed rule would potentially ban an entire category of tobacco products, create a black market to satisfy existing demand for products, and shutter over a thousand centuries-old farms in Kentucky and Tennessee that produce crops with a cash value approaching $200 million per year. If the rule results in the closure of numerous manufacturing facilities (and ancillary businesses) in Kentucky and Tennessee, thousands of people would lose their jobs.
Rather than improving public health, this proposed regulation is more likely to damage it. Somewhere between four and eight million Americans consume smokeless tobacco. Government surveys reveal that over 33 percent of them have never smoked and over 25 percent are former smokers who now use smokeless products exclusively. If the proposal bans or materially changes the products these consumers enjoy, there is little doubt that many of them will instead begin, or return to, smoking.
On top of that, anywhere from 20 to 40 percent of smokeless tobacco consumers are also smokers. If this regulatory overreach causes these “dual users” to lose the smokeless products they enjoy, they too could turn to greater cigarette use. The greatest health consequences related to tobacco don’t come from nicotine or even the tobacco itself, but from smoking – burning tobacco leaves and breathing in tobacco smoke.The end result for perhaps millions of these Americans would be increased exposure to the thousands of chemicals in cigarette smoke, many of which can contribute to cancer, heart
The greatest health consequences related to tobacco don’t come from nicotine or even the tobacco itself, but from smoking – burning tobacco leaves and breathing in tobacco smoke. If this regulation ultimately shifts millions of Americans from smokeless tobacco to cigarettes, the outcome would be increased exposure to the thousands of chemicals in cigarette smoke, many of which can contribute to cancer, heart disease and other adverse health effects. Such an outcome would hardly serve to “protect the public health.”
This proposal represents the first time that the FDA has attempted to establish product standards for tobacco products since the underlying law was signed by President Obama in 2009. When the FDA has pursued new rules in the past, the agency announced its intention to do so and then solicited and received input from scientists, public health professionals, relevant industries, employees and others who would be impacted by the law before drafting and publishing new rules. The feedback from knowledgeable and interested parties can dramatically improve the rules and outcomes.
This time, however, the agency provided no warning and solicited no input. The FDA should abandon this rule. If, or when, it wants to revisit the proposal the FDA should first seek out and listen to doctors about the negative health implications of pushing smokeless tobacco users toward cigarettes, from scientists and manufacturers describing whether or not it is even possible to comply with the proposal, and from workers who could lose their jobs as a result of the rule.