FDA Issues MDO to Bidi Vapor E-Cigarette

The agency issued a marketing denial order on the Bidi Stick – Classic.

January 24, 2024

The U.S. Food and Drug Administration (FDA) issued a marketing denial order (MDO) to Bidi Vapor LLC for its Bidi Stick—Classic e-cigarette, a closed-system, disposable, tobacco-flavored e-cigarette device.

The announcement follows the recent issuing of MDOs to Shenzhen Youme Information Technology Co. Ltd., Fontem US LLC and Shenzhen IVPS Technology Co. Ltd.

The agency stated that it determined that company’s premarket tobacco product applications (PMTAs) lacked sufficient evidence to demonstrate that permitting marketing of the product would be appropriate for the protection of the public health. The FDA said that the company may submit a new application to the agency for review.

Niraj Patel, CEO of Bidi Vapor LLC, issued a statement in response to the MDO:

“Bidi Vapor is disappointed by the FDA's decision and is currently reviewing the opinion based on its merits. In the meantime, the decision only affects our 'Classic' or tobacco-flavored product. Our remaining 10 flavors are still under scientific review and available for sale. At this time, we are investigating legal remedies and expect to have updates in the coming days. For now, we ask that our wholesale and retail partners direct their questions to our sales representatives.”

In August 2022, MDOs issued by the FDA in 2021 regarding Bidi Vapor’s non-tobacco flavored Bidi Sticks were remanded by the 11th Circuit Court of Appeals.

Earlier this month, NACS Daily reported that a federal appeals court ordered the FDA to reconsider its decision barring two makers of flavored liquid for e-cigarettes from marketing their products.