Jack Mitchell, National Center for Health Research: September 14, 2018.
Thank you for permitting me to address the meeting. I’m Jack Mitchell, director of health policy for the National Center for Health Research. NCHR performs research to better inform public policymakers, monitors drug and medical device safety, and advocates for patients. We accept no funding from any manufacturer or sponsor of medical products, so we have no conflicts of interest to report.
On Wednesday, Commissioner Scott Gottlieb made an important public announcement which for which the agency should be commended. He revealed that FDA now considered the proliferation of e-cigarettes and vaping among youthful consumers to be what he termed an “epidemic”. Dr. Gottlieb also stated that the agency recently had issued more than 1,000 warning letters and 131 fines to manufacturers and retailers, some penalties of which are now going to increase dramatically in cost.
Significantly, Dr. Gottlieb has given manufacturers, including one vaping firm owned by RJRT, sixty days to come up with a credible plan to keep increasingly popular e-cigarette and vaping products from under-aged consumers. Otherwise, Dr. Gottlieb intimated, the agency may consider rescinding the years-long regulatory delay earlier given to this segment of the nicotine distribution industry. That warning included the continuing use of flavors in e-cigarette and vaping products.
While you’re not considering e-cigarette products today, the bar has now been raised concerning all aspects of tobacco and nicotine use among young people. Any industry advertisements that suggest their wording is adequate to warn smokers or non-smokers concerning the dangers of addictive nicotine should be viewed with skepticism, and these claims vetted by non-conflicted scientific experts with extreme caution.
All the Camel products under consideration by this panel contain the flavors which are meant to attract young consumers to tobacco use. That was the intent of the flavors utilized by cigarette manufacturers until the flavors were banned from combustible cigarettes in 2009. I know this because I was part of the FDA’s landmark investigation into the tobacco industry 20 years ago.
Now these flavors are being utilized in an attempt to create another generation of addicted smokers. Any claim to the contrary defies common sense and the industry’s own decades-long trail of internal documents.
Credible research suggests that the compounds that give e-cigarettes their flavor are toxic, with some ingredients being worse than others. The effects of these flavors in tobacco is not well known or yet adequately studied.
The FDA review of the RJRT data stated that these flavors in smokeless tobacco may act as “permeation enhancers”, thus increasing the overall health risks associated with these products, when compared to other smokeless tobacco products that do not have the same flavor ingredients.
The FDA’s review also noted that their products may contain two-and-a-half to seven times the amount of nicotine than mainstream cigarette smoke. The American Heart Association concluded that nicotine may contribute to smoking’s negative effect on cardiovascular health.
There is also more arsenic, cadmium, and NNN in the Camel smokeless products. The higher levels of these ingredients compared to other tobacco products may result in increased user exposure to carcinogens and other toxicants that may subsequently increase the risk for cancer, heart diseases, and other negative developmental effects.
In fact, FDA concluded, evidence of cigarette smokers switching to Camel Snus use is limited, and dual use of smokeless tobacco and combustible cigarettes was common in the studies produced for FDA’s consideration.
Moreover, the sponsor did not provide evidence from population-level studies to assess the likelihood that U.S. cigarette smokers would switch to smokeless tobacco products at all — or, to Camel snus products specifically. Some data show that the incidence of switching from cigarettes to smokeless tobacco is only slightly more than one percent. The evidence that combustible cigarette smokers would switch to Camel or other smokeless tobacco products is limited.
NCHR urges you to consider your advisory decision in the light of the newly-expressed public concern by FDA about the wide-ranging impact of tobacco and nicotine use on our young people, and what we must do to reduce it. Thank you.