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09/21/2022

FDA's Refusal to Disclose Marketing Denial Documents Sparks Juul Labs' Lawsuit

The e-cigarette company said the agency missed a Sept. 13 deadline to resolve an administrative appeal.
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WASHINGTON, D.C. — Juul Labs Inc. filed a lawsuit against the Food and Drug Administration (FDA) on Sept. 20 after the agency did not disclose documents supporting its marketing denial orders (MDOs) that would ban the company from selling e-cigarettes in the United States.

In the complaint filed with a federal court in Washington, D.C., Juul accused the FDA of invoking the deliberative process privilege to improperly withhold scientific materials that are "central" to understanding the basis for the sales ban, according to a Reuters report.

Juul stated that these documents would show whether the FDA conducted a legally requiring balancing of the public health benefits and risks of its products, such as claims that they help smokers to quit cigarettes. They would also indicate whether the FDA's reasoning was scientifically sound, according to the lawsuit.

"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," Juul stated.

The case is Juul Labs Inc v Food & Drug Administration, U.S. District Court, District of Columbia, No. 22-02853.

The FDA ordered JUUL products off the U.S. market on June 23. It later administratively stayed the MDOs in early July pending additional review. The stay followed a decision by the U.S. Court of Appeal for the District of Columbia Circuit to grant Juul Labs an emergency administrative stay while the company fights the FDA's denial of its premarket tobacco product applications.

In its recent complaint, Juul said the FDA violated the federal Freedom of Information Act by withholding a majority of the "scientific disciplinary reviews" on which it based the sales ban. The company added that it previously filed an administrative appeal through the agency, but the FDA did not meet a Sept. 13 deadline to resolve it.

Juul recently reached a $438.5 million agreement with 34 states and territories to settle a two-year investigation into the vapor company's marketing and sales practices, as Convenience Store News reported. In addition to the financial terms, Juul agreed to comply with a series of injunctive terms limiting its marketing and sales practices.

A spokesperson for the FDA declined to comment on the lawsuit, noting that the agency does not discuss pending litigation.