After more than two years in review, the Food and Drug Administration (FDA) finally approved the sale of Phillip Morris International’s (PMI) tobacco heating system known as IQOS.
IQOS uses a heating blade to warm leaf tobacco producing a tobacco flavored aerosol, but due to the lack of combustion the levels of harmful and potentially harmful chemicals are dramatically reduced.
Available in 47 countries IQOS has enjoyed spectacular success in Japan and South Korea. Despite widespread opposition from anti-tobacco campaigners, the FDA deemed IQOS “appropriate for the protection of public health,” and is the first tobacco product ever to clear the pre-market tobacco application process.
“We believe PMTA approval confers an immense competitive advantage to iQOS (MO/PM) as the first FDA approved heat-not-burn product to launch in the U.S,” wrote Wells Fargo’s Bonnie Herzog. Reason’s Guy Bentley covered the approval for the Washington Examiner.
A federal judge sided with public health groups suing the FDA over its delay in reviewing e-cigarette product applications. The judge lambasted the FDA, claiming the delay was “so extreme as to amount to an abdication of its statutory responsibilities.” President of the American Vaping Association (AVA) Gregory Conley said the FDA “must appeal this ruling” to “protect adult access to less harmful alternatives to cigarettes.” The ruling poses a major threat to e-cigarette manufacturers who have so far been unable to navigate and comply with the PMTA process.
North Carolina Attorney General Joshua Stein is suing Juul Labs alleging the company is “deceptively downplaying the potency and danger of the nicotine.” Stein claims Juul used advertising campaigns to target minors. North Carolina is also demanding the prohibition of non-tobacco or menthol e-cigarette flavors and the extension of the advertising restrictions that apply to traditional cigarettes to e-cigarettes.
On May 29, Sen. Dick Durbin (D-Ill.) sent a letter to FDA Commissioner Ned Sharpless excoriating him for failing to take a more draconian approach to e-cigarettes. Durbin demanded immediate action to ban e-cigarette flavors and enforcement of the Deeming Rule.
California vapers are breathing a sigh of relief after a bill to ban all flavored tobacco products was withdrawn. Sen. Jerry Hill (D-San Mateo), who introduced Bill 38, abandoned the effort for this year following amendments that would’ve exempted tobacco products with a patent pre-dating January 1, 2000.
On the other side of the country, Massachusetts State Senator John Keenan (D-Quincy) is pushing a bill to ban the sale of all flavored tobacco products, including mint and menthol. In January, the bill was referred to the Senate’s Committee on Public Health but Keenan vowed to propose the ban as an amendment to the state budget.
Nevada Senator Julia Ratti (D-S013) is proposing a 30 percent wholesale tax on vapor products to discourage youth vaping and is proposing an amendment to add vaping to the state’s indoor clean air law.
Science and Harm Reduction
A study published in the American Journal of Health Behavior estimating the prevalence and awareness of Juul among adolescents found that around 45.5 percent of those aged 15-17 and 29.1 percent of aged 13-14 had ever seen or heard of Juul. 7.6 percent of those aged 15-17 had ever used Juul, while four percent had used Juul in the past 30 days, and 0.3 percent had used a Juul on 20-30 of the past 30 days. Among those aged 13-14 years, 1.5 percent had ever used Juul, 0.8 percent had used a Juul in the past 30 days, and 0.0 percent had used a Juul on 20-30 of the past 30 days.
According to a study published in Tobacco Control, one of the best ways to communicate the comparative risks of e-cigarettes relative to combustible cigarettes may be to show direct comparisons of the number of toxic chemicals in each product, citing a credible source, while emphasizing the risks of smoking.
A study published in Addiction estimating the effectiveness of smoking cessation aids found e‐cigarettes and varenicline were associated with higher abstinence rates following a quit attempt in England. Nicotine replacement therapy was also associated with higher abstinence but only in older smokers.
A Question of Taste: The Public Health Case for E-Cigarette Flavors
The World Health Organization’s Opposition to Tobacco Harm Reduction: A Threat to Public Health?
The Vapor Revolution: How Bottom-Up Innovation Is Saving Lives
Reason’s Research and Analysis of Nicotine and Vapor Issues