National Consumer Watchdog Praises Court for FDA Ruling 

For Immediate Release

Contact: Kara Zupkus, (224)-456-0257

After over two years of legal maneuverings, the United States Court of Appeals for the Fifth Circuit has found that the U.S. Food and Drug Administration (FDA) acted in an “arbitrary and capricious” manner when issuing marketing denial orders (MDOs) for nicotine e-liquid products. Specifically, the majority opinion found that the FDA “did not give manufacturers fair notice of the rules; the agency did not acknowledge or explain its change in position; the agency ignored reasonable and serious reliance interests that manufacturers had in the pre-MDO guidance; and the agency tried to cover up its mistakes with post hoc justifications at oral argument.” With the ruling, the MDO issued for the company’s e-liquid products are “set aside.”

TPA Senior Fellow on Harm Reduction Lindsey Stroud noted that, “This is the first-of-its-kind court decision, and the latest example of FDA’s failure to properly regulate a growing market that could save hundreds of millions of lives.  In 2020, all e-cigarette manufacturers were required to submit premarket tobacco product applications (PMTAs) to the agency. The FDA gave companies who had submitted PMTAs one year to continue marketing their product and then in 2021, the agency began issuing denial orders to the majority of applications.”

Stroud continued, “To date, the FDA has issued only 23 marketing granted orders (MGOs), none of which include any non-tobacco flavored e-cigarette. Meanwhile, the FDA has issued millions of MDOs for a wide variety of flavored e-cigarette products.

More than a dozen e-liquid manufacturers have also appealed their own MDOs in various circuit courts across the country.

It is now up to FDA to counter the latest court ruling – and at most inopportune time. Despite issuing massive rounds of denials, FDA still cannot contain the growing vapor market place in the United States. In fact, the agency is bogged down by the millions of illicit e-cigarette products by outside manufacturers who did not even submit PMTAs to the agency in 2020. “

Stroud concluded, “Ultimately it is the million American adults who continue to smoke who are most harmed by FDA’s inaction in regulating a robust marketplace of alternatives to cigarettes. And it doesn’t take a court deciding FDA acted arbitrarily and capriciously to see how the agency hinders adult access. It’s time for the nation’s federal public health agency to start improving the lives of adults who smoke and lessen arbitrary rules and regulations regarding the manufacturing of safer alternatives to cigarettes.”