FDA questions whether Juul withheld documents from the agency in ongoing probe

By | September 10, 2019

JUUL advertising outside a vape shot in New York.

Melissa Fares | Reuters

The Food and Drug Administration is questioning whether Juul withheld documents from the agency in an ongoing probe into the company’s marketing practices that began about 18 months ago, an FDA official said in a letter sent to the company Monday.

The House panel that oversees consumer product investigations launched its own probe in June, holding two days of hearings on Juul in July.

Despite the two requests being “substantially similar,” it appears Juul submitted “a substantially greater number of documents” to Congress than the FDA, Mitch Zeller, head of the agency’s Center for Tobacco Products, said in a letter to Juul on Monday.

“Given the similarity in the scope of the requests, and the substantially greater number of documents apparently provided to Congress, we are concerned that JUUL has not provided the agency relevant documents and information, and we are investigating the extent to which JUUL might not have provided the agency documents responsive to its request,” Zeller wrote.

The FDA asked Juul to turn over everything the company gave the House subcommittee and a group of senators who sent a letter to the company in April. Juul didn’t respond to CNBC’s request for comment.

Zeller’s letter was one of two the FDA sent to Juul on Monday. He also requested more information from the company, including its promotional activities, such as sending Juul representatives into schools and pitching its e-cigarettes to health insurers and employers.

In a separate letter, the FDA ordered Juul to stop illegally promoting its vapes as less harmful than cigarettes without the agency’s permission to do so.

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