A former Food and Drug Administration (FDA) senior staffer is speaking out about problems at the agency under the Biden administration, including diversity, equity and inclusion (DEI), and failures to combat China flooding the U.S. market with illicit vapes after the FDA’s top tobacco official was removed from his position.
I think many of us had been anticipating it for quite some time, we knew that change was drastically needed at FDA when it came to tobacco control, because tobacco control had really gotten out of control,’ David Oliveira, who recently left the FDA after six years, said in response to FDA chief tobacco regulator Brian King being removed from his post earlier this month.
‘There were many, many failures in the key core missions for the center that needed dramatic change in new leadership. Many of us, whether it be from public health, consumers, small business owners, industry, including even Senator Dick Durbin, who last year at a hearing said to Brian King, ‘It looks to me like you have fallen down on the job.’ So really it runs the spectrum with the people that are unhappy with what’s gone on recently with the FDA in terms of tobacco regulation.’
One of the most prominent missteps at the FDA over the past few years, according to Oliveira, was the influx of illicit Chinese vapes into the U.S. market, which he says made him feel like a ‘canary in a coal mine’ as he warned about the potential dangers and little was done.
Although the rate of youths smoking cigarettes is now at an all-time low, according to the CDC, youth use of Chinese vapes has increased dramatically since 2020, as China has become the world’s leading producer of e-cigarettes, often promoting illicit vapes with flavors appealing to children.
Sales of unauthorized, flavored disposable vapes in the United States amounted to around $2.4 billion in 2024, or 35% of the e-cigarettes from outlets such as convenience stores and supermarkets, Reuters reported.
That compares to sales worth $3.2 billion in 2023 and $2.8 billion in 2022, the data, which comes from market research firm Circana, shows.
We have set up a regulated system, which most of the American players have said, okay, these are the rules of the road, we will obey them, we will comply, and we expect, we hope that our products will be authorized,’ Oliveira explained. ‘The Chinese have said, well, forget that. There’s huge consumer demand for these products for billions of dollars, and we will shamelessly, recklessly, irresponsibly market these products, dump them on our shores because they know there’s billions of dollars to be had. And then, unfortunately, the FDA was ill-equipped, ill-prepared. Didn’t have the skill to go after and shut that down. And now we have an industry that’s absolutely out of control with these products.’
Oliveira told Fox News Digital that the agency has been delegating too much power to other departments like Border Patrol and Department of Justice rather than using the authority it has to crack down with boots on the ground against China’s market flooding, adding that a ‘lack of focus’ and ‘cavalier attitude’ has left the U.S. behind the 8-ball.
Oliveira says that the FDA approves or authorizes only about two products a year, which has allowed China to dominate the market.
Under King, the FDA rejected applications for millions of flavored e-cigarettes, citing insufficient data that the products would help adult smokers. Those rejections have resulted in multiple lawsuits against the FDA from vape makers, including one that was argued before the Supreme Court in December.
Another issue under King, Oliveira explained, was that DEI became a prominent focus that ultimately led to less focus on getting the job in front of them done correctly.
I think we saw a lot more of that once Brian King came in and the fact of the matter is his version of DEI was some of the things that many people don’t find appealing,’ Oliveira said. ‘The idea of virtue signaling or doing it just to be able to wear it on your sleeve and talk about it. So you just do things around the edges like, oh, let’s change and stop using the word grandfathered because of the historical overtones and origins of that term. And then let’s have everyone put their pronouns in their email.’
The FDA recently removed DEI materials from its website amid President Donald Trump signing executive orders to rid the practice from the federal government and instead focus on meritocracy. Oliveira told Fox News Digital that DEI was a distraction from the mission at the FDA.
‘I think it made some people uncomfortable just because of the focus on it when we knew that our work was so critical to helping people live healthier lives, that there was so much work to be done, that we were behind the 8-ball because of all the mistakes and because of this very fast-moving industry that government will always struggle to keep up with the technology. There was much work to be done. There was so more that we could have been doing that we weren’t doing. So anytime you have anything that you feel like takes your eye off the ball a little bit, that can be frustrating in the workplace for sure.’
Oliveira also told Fox News Digital that the FDA under King in the Biden years was beholden to the ‘crusade’ against menthol cigarettes, led by prominent voices like billionaire Michael Bloomberg, which he says was based more on a ‘paternalistic’ attitude toward the Black community than it was about making a positive difference.
In recent years, the FDA’s tobacco center has been besieged by criticism from all sides.
Politicians, parents and anti-tobacco groups want the FDA to do more to stamp out unauthorized vaping products that can appeal to teens, many of which are imported from China. Tobacco and vaping companies say the FDA has been too slow to approve newer products for adult smokers — including e-cigarettes — that generally carry much lower risks than traditional cigarettes.
‘King’s crusade against vaping was public health sabotage, fueled by half-truths and a vendetta against flavors that saved lives,’ Jim McCarthy, spokesman for American Vapor Manufacturers, the leading trade association for the independent vape industry which penned a recent scathing op-ed against King, told Fox News Digital in a statement.
‘He crushed small American businesses, sparked black markets, and ushered in hundreds of new combustible cigarette products. It was a masterclass in hypocrisy: he preached health equity while his policies ravaged marginalized communities by stripping them of safer alternatives to smoking. And while tobacco companies thrived, he sneered at the powerless and never found the simple integrity to tell Americans the truth that vaping is the most effective way to quit smoking and is vastly safer than cigarettes.’
Fox News Digital reached out to the FDA and King for comment.
The Associated Press and Reuters contributed to this report.