Bidi Vapor PMTA Moves to Substantive Review Phase

Kaival Brands Innovations Group, the global distributor of all Bidi Vapor products, announced its premarket tobacco product application (PMTA) has moved the substantive review phase of the regulatory process. Bidi’s disposable e-cigarettes, Bidi Stick, comes in 11 flavor varieties, according to a press release.

Substantive Review is where the scientific review of the U.S. FDA’s regulatory process is undertaken. The company received its acceptance letter, the first step, on Feb. 9. The FDA will determine if Bidi products meet the criteria for “appropriate for the protection of the public health” established in the Tobacco Control Act. The agency issues marketing orders that authorize the continued marketing and sale of products meeting the criteria.

“Seeking an order for the continued marketing of Bidi Sticks in the United States is a long process. But it was always our goal to provide a premium vaping experience and an option to traditional, combustible tobacco that meets the needs of every adult smoker,” said Niraj Patel, the president and CEO of Kaival Brands. “This substantive review phase is where months of extensive information collection and hard work gathering together 285,000 pages of science-based evidence will pay off, as we continually put consumer health and the environment first.”

Bidi Vapor also announced they have discontinued their online direct-to-consumer (DTC) sales through its website as of February 22, 2021. The company will allow sales through gopuff.com. “With a long history of distribution of alcoholic beverages, goPuff has pioneered a very stringent and dynamic compliance program and age-gating process,” the release states.

“We are extremely excited to partner with one of the fastest growing and most secure online delivery services in the country,” stated Kaival Brands’ Chief Executive Officer, Niraj Patel. “More importantly, goPuff’s commitment to protecting minors and stringent procedural implementations will allow Kaival Brands to focus on our rapidly developing additional wholesaler distribution agreements.”

While Kaival Brands will continue its business-to-business (B2B) online sales to retailers, it believes its decision to halt online DTC sales specifically through www.bidivapor.com will set an example for the industry and help reduce the larger problem of underage access to vaping devices. “The decision also bolsters its commitment to brick-and-mortar retail, which Kaival Brands believes to be a stronger age-verification distribution model than online sales,” the release states.