A trade group representing small vape businesses is asking the investigative arm of the federal Department of Health and Human Services (HHS) to scrutinize possible improper political influences on the FDA’s vaping product review process.
In a July 7 letter to HHS Inspector General Christi Grimm, American Vapor Manufacturers Association (AVM) President Amanda Wheeler asked the watchdog agency to “open an inquiry into improper political pressure that appears to have influenced senior leadership at the [FDA] and the extent to which such interference has corrupted FDA’s statutory obligation to properly implement its premarket tobacco product application (PMTA) review process based solely on scientific, empirically-based judgment.”
The HHS Office of the Inspector General (OIG) is an independent unit within the department, dedicated to investigating waste, fraud and abuse. The HHS OIG is the largest in the federal government, with more than 1,600 auditors, investigators and evaluators. The office reports to both the HHS secretary and Congress. Inspector General Grimm has worked at OIG since 1999. She served as Acting IG from January 2020 until she was nominated to fill the post permanently in February 2022 by President Biden.
In the letter, Wheeler details how pressure on FDA Commissioner Robert Califf from anti-harm reduction members of Congress appears to have pushed the agency to issue a rushed Marketing Denial Order (MDO) to Juul Labs. The FDA was forced to stay the order and agree to re-review Juul’s PMTA after Juul court filings showed that evidence the FDA said was missing had been in the company’s application all along. Juul itself believes the FDA denial order was the result of “immense political pressure from Congress.”
“The PMTA process is rigged,” Wheeler said in a press release. “Arbitrary standards rewritten behind closed doors corrupt any effective review. It’s embarrassing for the [FDA] commissioner, but one U.S. Senator’s call for his resignation was enough for Dr. Califf to override the standards set for the PMTA process. We are confident that OIG intervention will reveal what we have feared all along, ideology, not science, is driving decisions at the FDA.”
According to Wheeler, who owns Arizona-based Jvapes and is a leader in two state trade associations (in addition to AVM), the FDA actively thwarts inquiries into its review and authorization processes, claiming to have a two-year backlog of Freedom of Information Act requests. At this point, Wheeler says, an investigation by the OIG is “the only way” to find out if the agency is fulfilling its duties or bowing to political pressure from anti-vaping extremists.
Wheeler is asking the OIG to “determine if Commissioner Califf was aware that his agency’s JUUL decision was based on incomplete information as implied by the FDA’s justification for its administrative stay,” and to make public FDA officials’ communications with members of Congress, a Wall Street Journal reporter who first reported the leaked story of the Juul Labs MDO, the Campaign for Tobacco-Free Kids and Parents Against Vaping; and internal correspondence between the commissioner’s office and the Center for Tobacco Products.
“The OIG should open the door and hold the FDA accountable to its standards,” Wheeler says.
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