If Robert F. Kennedy Jr. is confirmed as Secretary of Health and Human Services (HHS), he has vowed to reform the agency. His work is cut out for him: HHS’s size and scope are matched only by its dysfunction.
Mr. Kennedy has singled out the Food and Drug Administration for attention. Let’s hope he doesn’t overlook the FDA’s Center for Tobacco Products (CTP). CTP is responsible for licensing the sale of all nicotine products in the U.S., a job it doesn’t want to do and is quite successful at avoiding. As of June 2024, the CTP hadn’t authorized the sale of an e-cigarette or vaping system during the entire Biden-Harris administration. It had authorized just 1/1,000th of one percent of the applications it’s received and had a backlog of 557,000 pending applications for new products. That’s impressive inaction. Meanwhile, the U.S. market is flooded with illicit Chinese-made vapes.
The FDA has been so resolute in refusing to approve flavored vapes in particular that the U.S. Fifth Circuit Court in January 2024 decided against it in a case brought by a manufacturer. The judge writing the opinion for the court pulled no punches:
[FDA] sent manufacturers … on a wild goose chase. First [giving] manufacturers detailed instructions for what information [it] needed to approve e-cigarette products … [and saying] manufacturers’ marketing plans would be “critical” to the success of their applications. [It] promulgated hundreds of pages of guidance documents, hosted public meetings, and posted formal presentations … all with the (false) promise that a flavored-product manufacturer could, at least in theory, satisfy FDA’s instructions. The regulated manufacturers dutifully spent untold millions conforming …. Then, months after receiving hundreds of thousands of applications predicated on its instructions, FDA … pretended it never gave anyone any instructions about anything, imposed new testing requirements without any notice, and denied all one million flavored e-cigarette applications for failing to predict the agency’s volte face. Worse … FDA candidly admitted that it did not read a single word of the one million [marketing] plans … [and] denied that its voluminous guidance documents and years-long instructional processes meant anything.
But while the agency was playing “switcheroo” with regulated companies, black-market manufacturers weren’t inactive. Chinese companies rake in $3.5 billion a year here with illegal and potentially more harmful products while regulated U.S. manufacturers’ scientifically researched products sit in CTP limbo. What’s more, those black-market manufacturers don’t scruple at selling flavored e-cigarettes with kid-attractive names and packaging.
That’s the public price of the FDA preference for prohibition of all nicotine products. The other price – the one tobacco companies pay in “user fees” to submit products for FDA approval – it would rather you didn’t know about.
Protect the Public’s Trust (PPT) submitted FOIA requests in early 2023 for documentation on how the agency spends those user fees but was forced to sue later that year to access the documents. Even after we sued, FDA dragged its feet and acted as if it didn’t understand what we wanted. Now we know why. The CTP’s statutory mandate is to regulate the tobacco industry in an efficient, lawful, and objective manner. But it turns out the CTP is taking user fees from tobacco companies and handing them over to anti-tobacco special interests who want to ban all nicotine products.
FDA gave $472,756 to The Truth Initiative. It gave $195,600 to the Campaign for Tobacco-Free Kids and it gave $145,068 to the Michael Bloomberg-affiliated Bureau of National Affairs for tobacco prohibition activism. And its ties to these groups go deeper than money. As reported last June, CTP official Cathy Crosby allegedly improperly solicited gifts in the form of tickets to a gala hosted by the Center for Tobacco-Free Kids. Shortly after chatting at that event with a board member of The Truth Initiative, she left CTP to become its CEO.
Of the $1.235 billion in user fees the FDA has expended during the previous four fiscal years the agency awarded a whopping 41 percent to a single entity – a communications company. So, while a million applications were languishing in FDA purgatory, while “regulated manufacturers dutifully spent untold millions conforming,” and while Chinese black-market manufacturers were raking in nearly $15 billion off the illegal U.S. market, FDA spent over a half-billion dollars trying to tell the American public what a great job it’s doing.
Every dollar sent to prohibitionist activists or spent on self-promotion is a dollar that could be used to get potentially dangerous illegal Chinese products off the shelves and out of the reach of kids. But FDA acts like just another of the anti-nicotine special interest groups uninterested in harm-reduction. It shares money and an active revolving door with activist groups, at the expense of its statutory responsibilities and ultimately of kids
The FDA’s prohibitionist zealotry is more than just wrong-headed. Mr. Kennedy should take note.
Michael Chamberlain is the Director of Protect the Public’s Trust.
