A California company planning to pursue drug approval for an inhaled nicotine replacement therapy product appears to also run a website containing false allegations that a scientist commissioned by Public Health England had financial ties to the tobacco industry.
The company, Respira Technologies, Inc., has also engaged in a smear campaign suggesting Juul Labs and other vaping product manufacturers may be responsible for causing some of the “EVALI” lung injury cases, and has encouraged the U.S. Food and Drug Administration (FDA) to adopt standards that would prevent most consumer vapor products from being authorized for sale.
Respira Technologies says it intends to submit an FDA application next year for its nicotine replacement therapy device called RespiRx. The company met with FDA officials in November to discuss its plan to seek approval from the agency’s Center for Drug Evaluation and Research (CDER) through the Investigative New Drug Application pathway.
“We are very pleased with the productive and collaborative discussion with FDA and have confidence that FDA’s guidance will help us achieve our goal to end the death and disease caused by smoking,” said Respira founder and CEO Mario Danek.
Despite a 2020 Respira press release describing its RespiRx device as the “first ‘vapor style’ Nicotine Replacement Therapy,” the device isn’t a true vaping product that uses heat to evaporate flavored e-liquid. While it superficially resembles a pod-style vape, the RespiRx is a...
Why it Matters Federal research agencies face mounting pressure to prevent fraud in grant-making, and Congress is moving to hold them accountable. A House subcommittee grant fraud hearing schedule...