Juul Labs has filed a lawsuit in federal court to force the FDA to give it access to documents that would explain the agency’s marketing denial order (MDO) of all current Juul products. The complaint was filed Tuesday in the U.S. District Court for the District of Columbia.
Juul has asked the court to order the FDA to disclose the requested documents, enjoin the agency from continuing to withhold responsive records, and to assume and maintain jurisdiction until the FDA complies with Juul’s FOIA requests and other orders of the court.
FDA’s bizarre actions surrounding Juul’s PMTA
After first leaking its impending action to the Wall Street Journal on June 22, the FDA issued an MDO for current Juul products the next day, based on patently flimsy claims that Juul’s $100 million premarket tobacco applications (PMTAs) had left out important toxicological evidence. The FDA had spent nearly two years reviewing the company’s PMTAs, and could have issued a deficiency letter at any time during that period if vital information was actually missing.
On June 24, a day after the FDA issued the MDO, Juul sought and received a temporary stay of the order from the D.C. Circuit Court of Appeals. Then, on July 5—two weeks after the court temporarily prevented the FDA from enforcing its MDO—the agency backed down and issued its own stay to Juul, claiming it had “determined that there are scientific issues unique to the JUUL application that warrant additional review.” But despite issuing a stay and promising additional PMTA review, the FDA did not rescind its MDO, as it has for other companies like Turning Point Brands.
Jim McDonald – Vaping360 – 2022-09-22.
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