Date: Jul 23, 2020
Keller and Heckman Partner Azim Chowdhury was quoted in the Bloomberg article, “Juul Quietly Revamped Its E-Cigarette, Risking the FDA’s Rebuke.” The article discusses a time in 2018 when Juul Labs Inc. (Juul) had an e-cigarette that leaked nicotine solution, which burned the lips and tongues of customers and seeped into the device’s circuitry, causing it to fail. So Juul fixed it. The upgrade was not announced by the company and no customer had a clue the device had been updated. Neither did the Food and Drug Administration (FDA).
In 2016, the FDA formally deemed e-cigarettes tobacco products, known as the deeming rule. The deeming rule has one particularly important provision for e-cigarette manufacturers: they are required to secure the agencies authorization before putting a new product on the market or modifying an existing one. Revelations about this change came to FDA when Juul was already under investigation by multiple federal agencies regarding whether the company illegally marketed its device to children.
In 2018, FDA launched its formal probe into Juul, announcing a nationwide ‘blitz’ designed to crack down on the sale of Juul products both in stores and online. Later that year, federal agents went into Juul’s headquarters in San Francisco to investigate the unannounced change to their product. After four days of looking at Juul’s files, FDA decided to not take action against the company.
The deeming rule often leaves e-cigarette manufacturers in what some experts call a gray zone. According to Mr. Chowdhury, companies are often unsure about what is and is not allowed under the new regime.
“The FDA’s deeming rule is antiquated,” he continued. “It wasn’t structured in a way that made it easy for companies to make changes that resulted in safe products or fixing a product that was otherwise dangerous.” He said if a company is contemplating even a minor change in its product, even if it’s to improve safety, “we’d have to advise clients that FDA may view that as a new product.”
To read the full article, please click here.