Kaival Brands Group Announces Appeal Over FDA Rejection of Bidi Vapor Product Marketing

Kaival Brands Innovation Group, based in Florida, USA, said it will appeal a decision by the U.S. Food and Drug Administration (FDA) after the agency rejected the premarket tobacco product application (PMTA) for Bidi Vapor’s “Classic” tobacco-flavored BIDI Stick device.

According to a January 29 report from GlobeNewswire, Kaival Brands Innovation Group, based in Florida, USA, said it will appeal the U.S. Food and Drug Administration’s rejection of the PMTA for Bidi Vapor’s “Classic” tobacco-flavored BIDI Stick. Kaival Brands reportedly holds the global distribution license for Bidi Vapor products.

The FDA’s decision did not involve Bidi Vapor’s other ten non-tobacco-flavored products, which remain under FDA scientific review and may continue to be sold by Kaival Brands. Bidi Vapor has challenged the MDO and asked the U.S. Court of Appeals for the 11th Circuit to review the FDA’s decision, while also requesting that enforcement of the MDO be stayed during the litigation period.

Bidi Vapor founder and CEO Niraj Patel, who also serves as Kaival Brands’ chief science officer and founder, made it clear that Bidi Vapor does not agree with the FDA’s decision and is taking immediate action in response.

Kaival Brands Executive Chairman Barry M. Hopkins said:

“We are disappointed by the FDA’s decision, but we have remained in close contact with Bidi Vapor and are committed to selling those Bidi Vapor products that are permitted.”