A Message From SFMMS Past-President John Maa, MD: Prioritizing Health: Five Recommendations to the FDA About E-Cigarettes September 7, 2021 Advocacy, FDA 0 John Maa is Past-President of the San Francisco Marin Medical Society (SFMMS), and Jeff Wigand was featured in the film "The Insider". The SFMMS has long advocated for strong, health-oriented regulation of electronic cigarettes and all tobacco/nicotine products and marketing. By September 9, 2021, the FDA is required to issue a final decision regarding Premarket Tobacco Product Applications (PMTA) from every e-cigarette brand that wishes to remain on the US market. Those companies not receiving approval will join the 3 e-cigarette companies who were already issued marketing denial orders by the FDA on August 26 and will be blocked from sales in the US. In anticipation of the September 9 decision, vaping proponents have made significant efforts to sway the FDA to grant approval. The New York Times highlighted Juul’s payment of $51,000 to publish several articles co-authored by their own employees in an issue of the American Journal of Health Behavior. Similar concerns relate to another article in the American Journal of Public Health (AJPH), which included several, but not all Past-Presidents of the Society for Research in Nicotine and Tobacco (SRNT). This article has been amplified by the vaping industry to imply SRNT’s endorsement of vaping, but at least 7 Past-Presidents of SRNT declined to join as co-authors. (Perhaps it would be helpful if those Past-Presidents issued a counterpoint?). Another confusion arising from the AJPH article is the mixture of UK and US authors, as there are important differences in perspectives between the two nations about the safety and efficacy of e-cigarettes, with a much lower concentration of nicotine in UK Juul pods. A number of civil lawsuits across America against Juul continue forward, citing marketing and advertising tactics targeting middle and high school students. Our first recommendation is that the FDA await resolution of those lawsuits before taking action on Juul’s PMTA application to sell tobacco and menthol flavors. We must prioritize children’s health: from birth through the early twenties, brains are being built and behaviors becoming wired. To keep young people out of harm’s way, we must stop tobacco companies from marketing addictive products to youth – with Juul’s menthol pods being popular among kids. Our second recommendation is for the FDA to require independent clinical safety and efficacy evaluation of e-cigarettes before issuing a decision, to balance widespread biased information such as the industry-sponsored articles that appeared in the American Journal of Health Behavior. As of June 2021, e-cigarettes are only available with a doctor’s prescription in Australia, and our third recommendation is that the FDA require Juul’s e-cigarettes only be sold here with a physician prescription, perhaps in pharmacies. This established pathway was required for all other nicotine replacement products (NRT) intended for smoking cessation in the US, but not undertaken with e-cigarettes as they eluded FDA regulation. NRT’s were sold for years by prescription before becoming available over the counter. A prescription requirement could facilitate independent studies of any role in smoking cessation, while limiting youth access to devices and pods as they would no longer be sold in convenience stores and vaping shops. Our fourth recommendation is that the Juul application to sell menthol flavored vaping pods should be denied, given the recent announcement by the Biden White House to ban menthol cigarettes and flavored cigars. Big Tobacco has for decades targeted communities of color with menthol sweeteners, to mask the irritating nature of tobacco smoke on the airway. Eliminating menthol results in smokers quitting sooner by reducing the addictiveness of cigarettes, and is consistent with the larger goal of a comprehensive flavor ban across all categories of tobacco products to reduce their appeal and addictive nature. If the FDA chooses to approve the Juul PMTA for tobacco flavored pods only, our final recommendation would be to only allow the lower nicotine concentration of 3.0%, which is the closer to the maximum limit in the UK. The financial conflicts of interest from vaping stores and business that profit directly from e-cigarette sales have greatly hampered the discussion over the years about the true risks and benefits of e-cigarette use. Missing from the debate about e-cigarettes has been the concept of “vaping cessation”. While vaping may play a role as a temporary bridge to smoking cessation for some current smokers, lifelong vaping is not the desired final outcome for adults, or youth who would never have smoked otherwise. A lifetime of health problems resulting from nicotine addiction likely predisposed many patients to develop more severe COVID-19 disease and die sooner than expected, and preventing another generation of youth from a lifetime of nicotine addiction that begins with vaping is essential. Ultimately, success in tobacco control through the Tobacco Endgame would be achieved in a nicotine-free world where the products of electronic cigarette manufacturers no longer need to be produced. Comments are closed.
