A U.S. trade group representing small vaping companies has asked the investigative arm of the federal Department of Health and Human Services (HHS) to examine possible undue political influence on the FDA's vaping product review process.

In a July 7 letter to HHS Inspector General Christie Green, Amanda Wheeler, president of the American Association of Vapor Manufacturers (AVM), asked regulators to address the extent and extent of undue political pressure that appears to have affected senior FDA leadership. investigation.

This intervention has undermined FDA's statutory obligation to properly conduct its Premarket Tobacco Product Application (PMTA) review process based solely on scientific, empirical judgment.

The HHS Office of Inspector General (OIG) is an independent unit within the department dedicated to investigating waste, fraud and abuse.

HHS OIG is the largest in the federal government, with more than 1,600 auditors, investigators and assessors. The office reports to the HHS secretary and Congress.

Inspector General Green has been with the Office of Inspector General since 1999. She served as acting inspector general from January 2020 until she was nominated by President Biden permanently in February 2022.

In the letter, Wheeler detailed that pressure from congressional anti-harm reduction members on FDA Commissioner Robert Califf appeared to have prompted the agency to issue a hasty marketing denial order (MDO) to Juul Labs.

The FDA was forced to withhold the order and agreed to re-examine Juul's PMTA after Juul court filings showed what the FDA said was missing evidence had been in the company's filing.

Juul itself sees the FDA's refusal order as the result of intense political pressure from Congress.

"The PMTA process is rigged," Wheeler said in the release. "Arbitrary standards rewritten privately would undermine any effective review. It was embarrassing for the FDA Commissioner, but a US senator's call for his resignation was enough for Dr. Califf to overturn the standards set for the PMTA process. We believe , OIG's intervention will reveal what we've always feared is that ideology, not science, is driving FDA decision-making."

Wheeler, who owns Arizona-based Jvapes and is the leader of two state trade associations (other than AVM), said the FDA actively blocked investigations into its review and authorization process, alleging a two-year freedom of information backlog ask.

At this point, Wheeler said, the OIG investigation is the only way to know whether the agency is doing its job or bowing to political pressure from anti-vaping extremists.

Wheeler asked the OIG to determine if Commissioner Califf knew his agency's JUUL decision was based on incomplete information implied by the FDA's justification for his executive stay, and to have FDA officials communicate with members of Congress, WSJ reporter first reported on Juul Labs MDO Leaked story of The Campaign for Tobacco-Free Kids and Parents Against Vaping; Internal Communication Between the Office of the Commissioner and the Tobacco Products Centre.

"The OIG should open the door and hold the FDA accountable for its standards," Wheeler said.

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