Juul Sues FDA Over Documents Related to Its MDO

• Facebook
• Twitter
• LinkedIn

WASHINGTON — Juul is suing the U.S. Food and Drug Administration, alleging it withheld documents related to the agency’s decision to issue the electronic-cigarette company a marketing denial order (MDO).

The FDA banned Juul’s products from the market on June 23 after issuing MDOs for the San Francisco-based company’s Juul device and four types of Juulpods—Virginia tobacco-flavored pods at nicotine concentrations of 5% and 3% and menthol-flavored pods at nicotine concentrations of 5% and 3%. A Washington, D.C., appeals court and the FDA later stayed the decision, allowing the products to remain on the market while the review process is ongoing.

Less than a day after the FDA issued the denial, Juul filed two Freedom of Information Act (FOIA) requests for the scientific disciplinary reviews underlying the FDA’s decision, Juul said in a lawsuit, filed on Sept. 20 in the U.S. District Court for the District of Columbia. The act allows the public the right to request access to records from any federal agency.

“The agency invoked one of the most widely abused exemptions—the deliberative process privilege—to withhold the majority of those materials. But the withheld materials are central to understanding the basis for FDA’s [MDO], whether FDA balanced the public health benefits and risks of [Juul Lab Inc.’s] products as the Family Smoking Prevention and Tobacco Control Act requires, and whether FDA’s reasoning is scientifically sound,” Juul said in its lawsuit.

The documents are also relevant to Juul’s pending appeal of the FDA’s decision, Juul said, in which Juul is challenging the agency’s findings and conclusions based on its review and the complete science and evidence in Juul’s applications, Juul said.

“Withholding the disciplinary reviews that would answer these questions impedes [Juul Lab Inc.’s] ability to seek appropriate relief from FDA’s decision and is also completely at odds with the purpose of FOIA and the transparency Congress expects from administrative agencies,” Juul said. “The public deserves a complete picture of the scientific facts behind one of the agency’s most controversial and closely scrutinized decisions in recent years, especially where even FDA recognizes its order is suspect.”

Juul is asking the court to disclose all responsive records and ensure the agency doesn’t continue to withhold responsive agency records, among other demands.

Neither Juul nor the FDA responded to CSP’s request for comment on the lawsuit.

Members help make our journalism possible. Become a CSP member today and unlock exclusive benefits, including unlimited access to all of our content. Sign up here.