The Food and Drug Administration ignored the best available science in making determinations about the safety of certain tobacco products, according to a whistleblower who has since seen his complaints largely substantiated by the agency.
In 2019, FDA’s Center for Tobacco Products issued a new memorandum that changed the process for signing off on new goods under its purview. The whistleblower, a toxicologist at CTP who brought his allegations to the independent Office of Special Counsel, said the new process shifted from a fully quantitative review to a more qualitative one. Different employees could reach different conclusions and it created an approach “more akin to eyeballing it,” the whistleblower said. He added that he and his colleagues who brought these concerns up the chain were subject to reprisal and alleged the process for making scientific complaints was broken.
OSC brought the allegations to FDA, which created a review panel made up of scientific experts. They eventually substantiated most of the claims.
The new memo “lacks sufficient detail and guidance to be enacted as a scientific methodology in its current form,” the panel found. Specifically, the scientists said, the process failed to provide a methodology for assessing cancer risks using a quantitative analysis, comparing risks of different organs or determining the non-cancer chemical hazards.
In issuing the memo, CTP leadership said the review of tobacco products was an “evolving discipline that...
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