Kaival Brand Files Complaint Against FDA Over Bidi Vapor's PMTA

Regulations by 2FIRSTS.ai

Jan.30.2024

Kaival Brands, the global distributor for Bidi Vapor, plans to sue the FDA over the rejection of their tobacco product application.

According to a report by Global News Wire on January 29th, the innovative group Kaival Brands in Florida, United States, has announced its plan to file a complaint against the Food and Drug Administration (FDA) over the rejection of Bidi Vapor's pre-market tobacco product application (PMTA) for their "Classic" tobacco-flavored BIDI® Stick device. It is worth noting that Kaival Brands holds the global distribution license for Bidi Vapor's manufacturing products.

This decision does not affect Bidi Vapor's other ten non-tobacco flavored products, which are still undergoing FDA scientific review and can be sold under the Kaival brand. Bidi Vapor filed a response to the MDO on January 26, 2024, requesting the United States Court of Appeals for the 11th Circuit to review the FDA's decision and also asking for an extension of the MDO's enforcement period during the litigation.

Niraj Patel, the founder and CEO of Bidi Vapor, as well as Kaival's chief scientist and founder, has made it clear that Bidi Vapor does not agree with the FDA's decision and is taking immediate action in response.

Barry M. Hopkins, the executive director of the Kaival brand, stated:

We are disappointed by the FDA's decision, but we have been in close communication with Bidi Vapor and are committed to selling the approved Bidi Vapor products.

References:

[1] Kaival Brands Partner Bidi Vapor to Contest FDA Denial of ‘Classic' Tobacco-Flavored ENDS

Also Read:

[1] FDA Rejects Bidi Vapor's Bidi Stick Classic Market Application, Again

[2] Bidi Proposes Scan Data to Identify Non-compliant E-cigarette Companies

#North America #United States #Traditional tobacco #Legislation #FDA

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