Bidi Vapor Submits Comments to Group Evaluating FDA

MELBOURNE, Fla. – Bidi Vapor, LLC, the maker of the premium electronic nicotine delivery system (ENDS) called the BIDI^® Stick, announced that it has submitted comments ranging from a plea to review science to a call for increased enforcement actions to the Regan Udall Foundation, an independent partner organization conducting an evaluation of the U.S. Food and Drug Administration’s (FDA’s) tobacco procedures.

The review comes as the FDA has met challenges during its review of premarket tobacco product applications (PMTAs) in the vaping category. Over the past year, the agency has been battling litigation over its decisions to issue marketing denial orders (MDOs) for millions of non-tobacco flavored ENDS devices.

On July 19, 2022, Robert Califf, commissioner of FDA announced the independent review, which will also encompass the agency’s food program following shortages of baby formula that occurred earlier this year. This past fall, the FDA set a comment period, opening an electronic portal for stakeholders to submit feedback.

In their response, officials with Bidi Vapor emphasized how the FDA should adhere to guidance documents it produced during the PMTA process, describing the current situation as “chaotic.” An example was Bidi Vapor’s need to write a Freedom of Information Act or FOIA request to understand why the FDA denied a competitor’s PMTA. Bidi officials called the FDA’s criteria a “rapidly evolving interpretation of the Congressionally mandated ‘appropriate for the protection of the public health’ or APPH standard.”

Another point was the need to avoid “arbitrary and capricious” decisions that failed to review all elements of a PMTA, as well as the larger market landscape and consumer demands. This past August, Bidi Vapor won a 2-1 decision in the 11th Circuit Court of Appeals that set aside an MDO against its non-tobacco flavored ENDS. Judges based their ruling on “shortcuts” made in the agency’s decision-making process.

“We have always prioritized compliance to federal, state and local regulation,” said Niraj Patel, president and CEO of Bidi Vapor, Melbourne, Fla. “But it’s a two-way street. The FDA has to stick to what it said were the requirements in its PMTA guidance.”

The feedback also touched on concerns over enforcement, inclusive of not only counterfeit products but ENDS devices with newly banned synthetic nicotine. “These counterfeit products pose a potential risk to public health, serve to undermine the reputation of compliant U.S. small businesses manufacturing ENDS devices like Bidi Vapor, deprive state authorities of needed tax revenue, and in many instances, are sold on the market without proper age verification,” the company said in its comment.