A ruling by the International Trade Commission blocks the importation of FDA-approved e-cigarettes while ignoring the flood of illicit products from China.
N ot so long ago, United States policy on e-cigarettes seemed to represent a success story in the nation’s efforts to protect public health. This light-touch regulatory approach aimed to reduce youth access to vaping products while still allowing adult smokers to use e-cigarettes as a less harmful alternative to traditional cigarettes. This approach sought to balance harm reduction with preventing a new generation from developing nicotine addiction.
But this success story is now under threat. China’s tobacco monopoly is flooding the U.S. market with illicit e-cigarette products, ignoring U.S. federal safety standards.
A recent ruling by the U.S. International Trade Commission, a federal agency, may inadvertently help the Chinese Communist Party sell even more of these illegal e-cigarettes in the U.S.
The ruling was in response to a complaint, filed with the ITC by American vape manufacturer JUUL Labs, that another U.S. company, NJOY (which is owned by the U.S. company Altria), infringed on several of its patents with its Ace device and the pods that go into it. NJOY challenged the allegations and argued that JUUL violated its patents, but an ITC administrative law judge found for JUUL. It has yet to weigh in on whether JUUL violated NJOY’s patents.
At the end of January, the full ITC confirmed the judge’s ruling. The effect will be to ban NJOY from selling its NJOY Ace vapes and Ace pods in the U.S. These have been authorized by the Food and Drug Administration (FDA) and include the only menthol (and only non-tobacco-flavored) e-cigarette products approved by the agency. While NJOY is an American company, some of its vapes and pod components are manufactured in China, so the ITC’s import ban would wholly eliminate these products from the American marketplace.
Currently, the U.S. has imposed bans on domestic sales of fruity and candy-flavored e-cigarettes to minimize the prospect of kids using them. Despite the prohibition, the FDA’s enforcement has been slow and inconsistent, and its marketing denial orders have been ignored. As a result, state-controlled Chinese manufacturers have flooded U.S. stores with illicit flavored vapes, hoping to pick up more of the American market as domestic suppliers comply with the ban. As of June 2024, more than 80 percent of U.S. e-cigarette sales were flavors other than tobacco, suggesting that the Chinese efforts to gain market share and evade U.S. restrictions have been successful. Restricting FDA-authorized menthol and tobacco-flavored products would only expand the dominance of unregulated Chinese manufacturers, exacerbating the very issues policymakers seek to address.
Chinese vapes pack a wallop of nicotine. The average strength of the nicotine contained in Chinese e-liquids has increased almost 300 percent in recent years — over 225 percent more than those made in the U.S. One expert has estimated that a single vape containing 5,000 puffs of 5 percent nicotine e-liquid equals 25 packs of cigarettes but at a fraction of the cost. At least partly as a result of the boom in Chinese flavored vapes in U.S. stores, e-cigarette sales have increased by about 35 percent in the U.S. between early 2020 and mid-2024. ITC action against FDA-approved vapes would not help this situation. If the federal government wants to shield Americans from nicotine, it is not going about it very effectively.
But the government does have another aim in its policy on vaping — to use e-cigarettes to help smokers quit — but that presumes they will be vaping products authorized by the FDA.
As of June 2024, almost 6,300 different e-cigarette products were available for purchase in the U.S., according to the government’s own statistics. But only 34 e-cigarette products had been authorized by the Food and Drug Administration for sale in the U.S. as of July.
Most public health leaders would take FDA-approved vaping products over strengthening a Chinese-supplied black market any day.
Notably, the ITC is acting against the first and only company authorized to produce an e-cigarette in menthol (or non-tobacco) flavor. “Banning” it could do disproportionate harm to African Americans. According to the CDC, in 2020, approximately 81 percent of non-Hispanic black adults who smoked cigarettes used menthol cigarettes, compared with 34 percent of non-Hispanic white adults. Denying these smokers menthol-flavored vapes would almost assuredly drive them back to using much more harmful menthol cigarettes.
“Excluding one of the relatively few FDA approved e-cigarette products exposes Americans to health risks and diminishes public health,” Elinore McCance-Katz, a former assistant secretary of the Department of Health and Human Services, wrote in a recent comment on the ITC case. “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.”
The government would do well to devote more resources to enforcing its existing vaping rules to better police the marketplace. That effort has been half-hearted and ineffective so far.
The patent dispute between NJOY and JUUL will ultimately be resolved in the courts, and the remedies will be what they will be. Meanwhile, the Office of the U.S. Trade Representative in President Donald Trump’s new administration has 60 days to overturn the ITC’s decision for public policy reasons.
The president has the authority to do so for economic impact, national security considerations, and foreign relations/trade policy reasons. This issue checks all three boxes.
In 2013, President Barack Obama overruled the ITC on a similar patent dispute that Apple had with Samsung. President Trump should do the same here. A ruling that effectively assists the market for unauthorized Chinese e-cigarettes is not in the public interest.