JUUL Receives FDA Approval to Resume Product Sales

Regulations by 2FIRSTS.ai
Jun.07.2024
JUUL Receives FDA Approval to Resume Product Sales
Juul, US e-cigarette brand, welcomed FDA's decision to revoke sales refusal order and initiate scientific review process on June 6.

On June 6th, the American e-cigarette brand JUUL issued a statement announcing that the U.S. FDA has rescinded its Marketing Denial Orders (MDOs) for JUUL products scheduled for June 2022, and will reevaluate JUUL's application through the scientific review process. (See news article: American FDA revokes 2022 Marketing Denial Orders for JUUL products, restarts review process)

JUUL Receives FDA Approval to Resume Product Sales
Translation: JUUL Statement | Image source: JUUL Official Website

 

JUUL expressed the following viewpoints in their statement:

 

JUUL appreciates the FDA's decision and looks forward to re-establishing contact with the agency to seek market approval for JUUL products through a scientific and evidence-based process. 

JUUL is confident in the quality and substance of their application, believing that a comprehensive review of the science and evidence will demonstrate that JUUL products meet the safety standards required to protect public health. 

During this review period, JUUL devices and Virginia Tobacco and Mint JUULpods with 5.0% and 3.0% nicotine concentration will continue to be sold on the market.

 

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2.  The use of nicotine-containing products — including, but not limited to, cigarettes, e-cigarettes, nicotine pouchand heated tobacco products — carries significant health risks. Users are responsible for complying with all applicable laws and regulations in their respective jurisdictions.

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