FDA Dysfunction Rewards Chinese Black Marketeers at the Expense of Kids
- February 3, 2025
Michael Chamberlain, RealClearHealth
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.