The proposed rule expands FDA regulatory authority over tobacco products to include regulation of cigars, pipe tobacco, hookah tobacco, electronic cigarettes, and other novel tobacco products, such as dissolvable products and gels. Cigars are the most commonly used among this group, though use of electronic cigarettes, or e-cigarettes, is rapidly expanding. Under the proposed rule, Federal Food, Drug, and Cosmetic Act (FD&C Act) requirements would apply to these products that include establishment registration and product listing, ingredient listing, submissions prior to the introduction of new products, labeling requirements, and prohibition of free samples.1 Additional provisions include minimum age and identification requirements, vending machine restrictions, and required warning statements for packages and advertisements.
The proposed rule consists of two co-proposals. Option 1 deems all products meeting the statutory definition of “tobacco product” except accessories of a proposed deemed tobacco product to be subject to chapter IX of the FD&C Act. Option 2 is the same as option 1 except it exempts premium cigars.2
The proposed rule is an enabling regulation that allows the FDA to issue in the future public health regulations related to newly deemed products. The FDA is also authorized to collect ingredient and health information on these products. The FDA does not estimate benefits but anticipates that the largest benefit of the proposed provisions would be improvements in health and life expectancy resulting from reductions in the use of combustible tobacco products deemed under this proposed rule. The FDA also states that public health will improve when it is granted authority to take action against new products that pose greater health risks than those already on the market.
This public interest comment argues that the FDA has failed to develop an appropriate benefit-cost analysis of the proposed rule. The FDA claims its failure to quantify benefits is justified by the uncertainty surrounding them, even as the FDA “anticipates” substantial benefits from reducing harm by regulating newly deemed products. However, promises of anticipated benefits require quite a “leap of faith” given the FDA’s acknowledgment that they have no reasonable means of quantifying how much harm the proposed rule will reduce in the future.
The FDA has also failed to adequately assess costs that appear likely from the proposed rule’s suppression of the e-cigarette market. The FDA has mostly ignored the evolving literature on e-cigarettes that strongly suggests they help smokers quit smoking. The proposed rule pushes e-cigarette manufacturers to focus efforts toward developing new flavors, packaging, and other attributes unrelated to improved public health. The proposed rule might also promote combustible tobacco use because manufacturers will be unable to market e-cigarettes as safer alternatives or even state that they don’t contain tobacco. It is likely that fewer smokers will quit or reduce cigarette consumption. Public health will worsen to the extent that e-cigarettes are a safer alternative to tobacco cigarettes.
This public interest comment estimates the range of annual benefits (costs avoided) associated with e-cigarette use as $15.6 billion to $49.2 billion and that 2.4 million to 6.4 million smokers may potentially become ex-smokers by using e-cigarettes. Estimates are based on a range of quit rates from the current literature and assume all smokers interested in quitting use e-cigarettes. Even a fraction of estimated benefits (costs saved) are substantial. These estimates indicate the FDA is jeopardizing public health by not estimating benefits associated with e-cigarettes using data from readily available studies on their efficacy as harm-reduction tools.