UNITED STATES
FDA accused of non-compliance

Center for Regulatory Effectiveness (CRE) states that the FDA Tobacco Advisory Committee is in violation of the Federal Advisory Committee Act (FACA).

The CRE, a regulatory watchdog managed by former White House office of management and budget regulatory officials, has issued a scathing report on FDA non-compliance with the Federal Advisory Committee Act.
In a press release available on its website, the CRE argues that FDA is dominating the advisory committee by controlling the production of key studies.
“CRE has called these illegal actions to the attention of FDA a number of times but FDA continues to act outside the law because they conclude that since the product in question is tobacco that the normal rules of fair play do not apply,” so CRE.
The CRE expressed the concern that FDA will continue to work outside the law regarding the operation of the menthol subcommittee, which will be announced by the FDA on 27 September and which will review scientific studies dealing with menthol.
“More specifically”, continues the press release, “FDA will write the report and submit it to the menthol subcommittee for an up or down vote as it did for the constituents subcommittee —clearly using a group of outside scientists as a ruse for its preconceived views on the science." (pi)

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