Public health and national security scholars are pushing the International Trade Commission to deny a request to remove the only Food and Drug Administration-authorized, pod-based — and the first non-tobacco flavored — vaping product from the marketplace.
In June, the FDA issued marketing orders to NJOY Ace for four menthol-flavored e-cigarette products, marking the first non-tobacco flavored e-cigarette products to receive FDA authorization.
Vape manufacturer JUUL Labs filed an ITC complaint arguing that NJOY Ace infringed on some of its patents, which an administrative law judge looked upon favorably. NJOY Ace has disputed the charges, insinuating that they were made in retaliation for actions that NJOY has taken against JUUL in the past.
In comments to the Commission, numerous healthcare experts sided with NJOY.
Elinore F. McCance-Katz MD, PhD., who served as the Assistant Secretary of Health and Human Services under the Trump administration, argued that the ITC ruling against NJOY would undermine public health by making it more difficult for smokers to quit nicotine.
“Excluding one of the relatively few FDA approved e-cigarette products exposes Americans to health risks and diminishes public health,” she wrote. “Americans should not be denied products that have met FDA standards and have been declared by FDA to be a tool in the arsenal of smoking cessation devices when used with healthcare provider assistance.”
Jeff Stier, a senior fellow at the Consumer Choice Center who specializes in health policy and tobacco control, concurred. He argued that it is extremely difficult for any e-cigarette to receive authorization and that the government should not dispose of ones that have received approval so carelessly.
“In order for the FDA to authorize an e-cigarette, as required by the Tobacco Control Act, it conducts an exhaustive scientific review for each product under consideration. The Act establishes a public health standard, a very high bar for authorization, which requires the FDA to find that a particular product is ‘Appropriate for the Protection of Public Health,’ he wrote. “In this instance, the harm would be particularly great because, by some estimates, NJOY Ace comprises nearly a third of the authorized e-cigarette market.”
Dr. McCance-Katz added that minorities would especially feel the impact from an NJOY Ace ban because NJOY has the only approved menthol e-cigarette product on the market, which are used by 85% of non-Hispanic, African American adult smokers.
At the same time, national security experts emphasized that the Chinese Communist Party oversees most of NJOY’s competition and that an exclusion order against the company would only embolden this authoritarian regime.
“With the Chinese Communist Party’s State Tobacco Monopoly Law of China stipulating that the state-owned Chinese State Monopoly Association (STMA) license and control this market, it’s clear that the money for these illegal Chinese vape products is benefiting this authoritarian regime,” Dr. Richard Weitz, Senior Fellow and Director of the Center for Political-Military Analysis, wrote. “The STMA is already responsible for 10% of all the CCP’s revenue. Banning U.S. marketplace alternatives would only serve to inflate this number. Nothing would run more counter to accomplishing the mission of this Commission.”
Jeremy C. Hunt, Esq., a national security scholar and former U.S. Army Intelligence Captain, similarly took umbrage with the financial windfall that he argued the CCP would enjoy should an exclusion order against NJOY go into effect.
“In my years of research into the threat of the Chinese Communist Party, I have observed numerous instances where China has flooded the U.S. market with products to gain economic leverage over American manufacturers or secure other strategic advantages,” he wrote. “The vaping industry is no exception.”
A decision from the ITC is expected soon.
