On July 11, the Iowa Attorney General Thomas J. Miller sent a letter to the U.S. Food and Drug Administration (FDA) demanding a more evidence-based approach to vaping regulations. The commentary comes just days before the ending of a 120-day FDA probe seeking public input regarding a possible nationwide ban of the sales of flavored e-liquids. It also closely follows the passage of similar legislation at the municipal level passed in San Francisco last June, which many regulatory experts believe could be used as a supportive argument in favor of the proposed FDA ban.
This is not the first time that the Iowa AG has been openly critical of the FDA, its deeming regulations, and the associated Pre-Market Tobacco Application (PMTA) process. In December 2017, Miller blasted the FDA for employing “overly simplistic” reasoning when creating and implementing the controversial FDA deeming regulations that now lump e-cigs and combustibles into the same category labeled “tobacco products.” In June 2017, Miller rebuked the FDA for failing to issue regulatory actions based on “established evidence-based prevention and cessation tools of tobacco control.”
Miller’s latest letter to the FDA focusses on a multitude of very specific issues related to vaping regulations. He demands that the FDA revisit the protocols surrounding the PMTA process which has an estimated price tag of between $300,000 to $1 million per product. Since the vaping industry is largely comprised of small businesses which cannot afford such high costs – as compared to the deep pockets of Big Tobacco, for example - the Iowa Attorney General calls for a revised set of PMTA guidelines that are more “proportionate” to the associated health risks of individual products under review.
“In line with these principles, the PMTA process should be redesigned to make its costs and burdens more proportionate to risk while recognising the significant benefits that alternative nicotine delivery systems can provide when used as an alternative to smoking. It should not be a route to market that only works for a small number of products marketed by the largest companies. Excessive regulation of much safer alternatives should not be allowed to create de facto regulatory protection for the most harmful products.”
Miller also suggests that the FDA deeming regulations in their current form stifle innovation, rely on post-market surveillance versus scientific modeling, and mislead or under-inform the public into mistakenly believing that vaping is just as hazardous to one’s health as smoking.
“Information on risk provided by trusted agencies must change. The emphasis on there being ‘no safe’ or ‘harmless’ tobacco product, when given in isolation, under-informs consumers and can mislead them to think that non-combustible products are just as dangerous as cigarettes. FDA’s modelling (see Apelberg et al11) assumes a substantial risk reduction when smokers switch to e-cigarettes, and it is important to share this insight with the public. This will prepare the ground for a nicotine standard by encouraging switching to non-combustibles both before and after the rule coming into effect.”
Other expressed concerns include the need for transparency regarding the approval of PMTA applications and a stronger emphasis on thermal, electrical, and mechanical standards for enhanced consumer safety. Miller’s July 11 letter to the FDA was signed and endorsed by a long list of highly regarded members of the scientific and public health communities, including Clive Bates (Former Director of the Action on Smoking and Health, UK London), David Sweanor (Chairperson of the Advisory Board of the Center for Health Law, Policy and Ethics at the University of Ottawa), and David Levy (Professor of Oncology Georgetown’s School of Medicine).