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American Vapor Manufacturers Association calls for investigation into e-cigarette marketing denial orders

American Vapor Manufacturers Association calls for investigation into e-cigarette marketing denial orders

2022-07-15

The American Vapor Manufacturers Association (AVMA) has asked the U.S. Department of Health and Human Services (HHS) Inspector General to investigate whether the U.S. Food and Drug Administration's marketing denial of vaping products was motivated by political pressure.


The AVMA said it wants the inspector general to help the public understand FDA Commissioner Robert Califf's coordination with elected officials, relevant activists and journalists as his agency continues to review premarket tobacco product applications (PMTAs).


In a letter to HHS Inspector General Christi A. Grimm, AVMA President Amanda Wheeler argued that the intervention undermined the FDA's statutory obligation to properly conduct its PMTA review process based solely on scientific, empirically-based judgment.


"Manufacturers typically meet PMTA requirements to scientifically demonstrate how their products are suitable for protecting public health," Wheeler wrote. “Despite compliance, the agency does not approve vaping products sought by adults who want to quit smoking. The Office of the Inspector General should leave the door open and hold FDA accountable for its standards.”


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