The Food and Drug Administration’s Center for Tobacco Products (CTP) has come under scrutiny for its ineffective handling of nicotine product applications and questionable allocation of resources, creating opportunities for illegal Chinese manufacturers while hindering legitimate U.S. businesses.
As of mid-2024, the CTP’s track record during the Biden-Harris administration showed a striking lack of progress, with zero authorizations for e-cigarettes or vaping systems. The agency has approved merely 0.001% of submitted applications, leaving a staggering 557,000 applications pending review.
This regulatory gridlock has had serious consequences. While legitimate U.S. manufacturers wait for approvals, illicit Chinese-made vapes have flooded the American market, generating approximately $3.5 billion annually. These unauthorized products often feature
youth-oriented flavors and packaging, raising significant safety concerns.
The FDA’s stance on flavored vapes became so problematic that it led to a legal defeat in the U.S. Fifth Circuit Court in January 2024. The court’s ruling highlighted how the FDA had misled manufacturers through an elaborate process of detailed instructions and guidance documents, only to later disregard these requirements and reject applications without proper review.
Recent investigations through Freedom of Information Act requests by Protect the Public’s Trust (PPT) have revealed concerning patterns in the CTP’s use of industry-provided user fees. Instead of directing these funds toward efficient product regulation, the agency has been channeling money to anti-tobacco advocacy groups. Notable recipients include The Truth Initiative ($472,756), the Campaign for Tobacco-Free Kids ($195,600), and the Bloomberg-affiliated Bureau of National Affairs ($145,068).
The agency’s relationship with these organizations extends beyond financial support. For instance, CTP official Cathy Crosby faced allegations of improper conduct regarding gala tickets from the Center for Tobacco-Free Kids, and subsequently became CEO of The Truth Initiative after networking with its board member.
Perhaps most striking is the CTP’s allocation of user fees over the past four fiscal years, totaling $1.235 billion. A remarkable 41% of this sum went to a single communications company, essentially funding public relations while application backlogs grew and illegal products proliferated.
This misalignment of resources has created a perfect storm: legitimate manufacturers invest heavily in compliance while facing indefinite delays, Chinese black market products circulate freely, and
substantial funds are diverted to advocacy groups rather than addressing these pressing issues.
The situation has caught the attention of potential incoming Health and Human Services Secretary Robert F. Kennedy Jr., who has pledged to reform HHS. The FDA’s apparent transformation from a regulatory body into what critics describe as another anti-nicotine special interest group represents a significant departure from its statutory
obligations.
The agency’s prohibition-focused approach has effectively created a vacuum in the legal market, which illegal operators have readily filled. Rather than pursuing its mandated role of efficient, objective industry regulation, the FDA has aligned itself with groups advocating for complete nicotine product bans, while maintaining close ties through both funding and personnel exchanges.
This regulatory dysfunction has created a paradoxical situation where efforts to protect public health may actually be undermining it by pushing consumers toward unregulated, potentially more dangerous alternatives while legitimate manufacturers remain in regulatory limbo despite their compliance efforts and significant investments in safety research.