The FDA has faced scrutiny for various reasons related to its handling of safer alternatives to nicotine products. This is no secret. Last month, the agency was heavily criticized by Senators Dick Durbin (D-Ill.) and Susan Collins (R-Maine). In a letter referencing a report by STAT, the Senators stated that the FDA "seems to be failing again in protecting our nation's children" for not taking action on the ban of synthetic nicotine announced earlier this year.
Similarly, Matt Myers, the chairman of the Smoke-Free Kids movement, emphasized that the FDA should exercise its power to withdraw products from the market. "All unauthorized synthetic nicotine products are currently illegal and must be immediately removed from the market in accordance with the law, rather than on some unspecified date in the future.
Moreover, the organization has continuously faced condemnation for failing to comply with the deadline and timely completion of the PMTA process. To make matters worse, the FDA has been forced to temporarily suspend the newly released Juul Marketing Denial Order (MDO).
To ensure that the mistakes are being taken seriously, Commissioner Califf has announced an evaluation of the Center for Tobacco Products (CTP). In a press release, he stated that he has discussed the assessment with the leaders of the relevant centers and offices, who welcome the opportunity to work towards improvement. "Each field is filled with diligent and talented individuals who devote their careers to various scientific, policy, legal, and administrative activities. FDA employees should receive the best possible support so that they can fulfill their steadfast commitment to public health and the American public we serve," he added.
The review will be conducted by the non-profit organization, Reagan-Udall Foundation along with undisclosed experts. The aim is to assess the "processes and procedures, resources, and organizational structure" of the Food Plan and CTP.
I don't think this will bring about a huge change," said a former CTP employee quoted by Filter. "It's unclear at this point whether the Reagan-Udall Foundation is an anti-vaping collaborator or if it will become a true partner for millions of adult users of e-cigarette products trying to quit smoking.
The FDA has failed to fulfill its regulatory mandate without remorse, by not approving electronic cigarette products that could benefit public health. This is not a matter of the system being overwhelmed or underfunded - the agency collects nearly $1 billion in user fees annually.
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