FDA Commissioner Sounds Alarm on Illegal Chinese Nicotine Vapes

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Dr. Robert Califf says the FDA is concerned about the 480,000 Americans who die every year from tobacco related illnesses.

Dr. Robert Califf, the Food and Drug Administration (FDA) commissioner, testified about the ongoing proliferation of illegal Chinese nicotine vaporizers, or “vapes,” and potential upcoming regulations on menthol cigarettes at a congressional budget hearing on April 18.

The commissioner fielded questions on drug and food testing, prescription drug shortages, plans by the Drug Enforcement Administration (DEA) to reschedule marijuana, domestic drug manufacturing, infant formula contamination, FDA budget constraints, and the drug overdose epidemic.

However, most of the discussion focused on illicit tobacco products, such as illegally imported Chinese nicotine vaporizers, and on the societal impacts of menthol cigarettes, particularly within the black community.

Reps Barbara Lee (D-Calif.) and Lauren Underwood (D-Ill) asked about the FDA’s intention to prohibit menthol cigarettes, noting how the cooling effects of menthol make it easier to hook users on tobacco and how companies have used these products to disproportionately target the black community.

The commissioner, citing his decades of work as a cardiologist, said tobacco is one of the FDA’s biggest health concerns as it kills more than 480,000 Americans every year.

Dr. Califf said it is a struggle to adequately address the large volume of Chinese nicotine vaporizers that are illegally imported into the United States every year, sometimes skirting customs laws by labeling the vapes as other products, such as lanterns. He asked for more resources to combat the problem.

Illegal Chinese Vapes

Rep. Ben Cline (R-Va.) asked Dr. Califf about a February tobacco expo in Las Vegas, which he called an “open-air market for Chinese manufacturers to sell illicit vapor products.”

Mr. Cline asked why the FDA didn’t do more to prevent the sales of these illegal Chinese nicotine vapes at this expo, as several senators signed a letter to Dr. Califf informing him of the situation beforehand.

The commissioner disagreed with Mr. Cline, saying the FDA does everything it can to “intercede” and seize these products when they enter the country, but that “by law, we have to treat offshore and internal people with the same rights in terms of their products.“ This creates a lot of regulatory ”red tape,” he said, and he asked Congress to find ways to overcome those obstacles.

“So it’s a huge expenditure of resources,” Dr. Califf added while reemphasizing the need for more agency funding.

Ms. Underwood underscored the importance of keeping nicotine vapes, also called e-cigarettes, out of the hands of children. She cited a 2023 Centers for Disease Control and Prevention (CDC) study that found 2.8 million middle and high school students use tobacco nationwide, including nicotine vapes. Nicotine is the highly addictive, active component of tobacco.

Dr. Califf said the agency is addressing this concern and that tobacco companies “will have to get approval” to put a product on the market.

Rep. Dan Newhouse (R-Wa.) said part of the problem is the FDA’s delay in authorizing new vapor products made in the United States to meet market demand, leaving Chinese companies to fill the void. He asked Dr. Califf why the FDA wasn’t approaching the problem “with guns blazing” to address the surge of illicit vapes.

Rep. Dan Newhouse during a hearing in the Rayburn House Office Building on Capitol Hill, on July 25, 2019. (Chip Somodevilla/Getty Images)

Dr. Califf said the FDA is taking the issue seriously, having sent 40,000 warning letters to companies selling to underage customers. He added that companies selling illegal tobacco products could also face civil monetary penalties.

Menthol Cigarette Ban?

The commissioner also signaled the FDA’s intention to move forward with a ban on menthol cigarettes after the agency announced an initial proposal in 2022.

Menthol cigarettes are considered more addictive than traditional cigarettes because the menthol produces a cooling effect, making it easier for the user to inhale the smoke. While white and black people use tobacco at similar rates, a CDC study found that 81 percent of black smokers use menthol cigarettes. Black smokers are also more likely to die from tobacco-related illnesses, according to another CDC study.

Ms. Lee, who is black, said she was disappointed that the FDA had not yet finalized its rules on menthol, although Dr. Califf said it is a “top priority” for the agency.

The congresswoman charged tobacco companies with engaging in “predatory behavior” by specifically marketing menthol cigarettes to “the black community, specifically black youth.”

“I’m with you all the way,” Dr. Califf said in agreement but claimed he could not give a specific timeline on the FDA’s plans for menthol cigarettes. However, he said a ban could potentially prevent 600,000 deaths over the next 30 years.

Ms. Underwood, also black, agreed that menthol cigarettes disproportionately harm the black community in the United States.

“We know our opponents and big tobacco are powerful, well funded, and well armed,” the congresswoman said.

She cited a poll from the Campaign for Tobacco-Free Kids that found 58 percent of voters support a ban on menthol cigarettes. Additionally, 62 percent of black voters also support the proposed ban.

Unless there are court cases or “delay tactics” from tobacco companies, the FDA should have its menthol proposal submitted by the middle of the year, Dr. Califf said.

“We’re 94 percent done,” he added.