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Latest on Vape: Battle for Enforcement

Greater federal, state measures needed to remove counterfeit, synthetic ENDS devices from market, vaping manufacturer says

MELBOURNE, Fla. – As the U.S. Food and Drug Administration (FDA) and other state and local regulatory agencies create new rules for vaping devices, the next step is to increase efforts at enforcement and compliance, said officials with Bidi Vapor, LLC, the maker of the premium electronic nicotine delivery system (ENDS) called the BIDI® Stick.

“Counterfeit ENDS coming into the U.S. illegally arrive in unmarked pallets and are then distributed through informal distribution networks to consumers, primarily landing in independent tobacco retailers and convenience stores,” said Niraj Patel, president and CEO of Bidi Vapor, LLC, Melbourne, Fla. “We urge the FDA to address the lack of enforcement regarding counterfeit ENDS devices entering the U.S. market. These counterfeit devices often copy the design and packaging of existing devices that are compliant with the FDA’s guidance and for which premarket tobacco product applications or PMTAs have been submitted.”

The BIDI® Stick is currently the No. 1-selling disposable in the United States, according to numbers from New York-based Nielsen. ECigIntelligence, which surveys hundreds of vaping and tobacco shops each year, predicted the U.S. vape market, counting web sales, would be nearly $6 billion in 2022.

Included in the problem of counterfeit and illegal vape products are devices containing synthetic nicotine. In March of this year, the FDA received authority over vape devices containing lab-produced or synthetic nicotine. The FDA created deadlines for a PMTA process for these devices, which set a July 13, 2022 deadline for all ENDS with synthetic nicotine to come off the market.

“Despite that deadline, products containing synthetic nicotine are still on the market and part of the larger problem of illegitimate sales,” Patel said.

Sales of ENDS with synthetic nicotine went from almost nothing in 2020 to taking up shelf space in two-thirds of U.S. vape shops in 2021, according to ECigIntelligence. Those stores said such products accounted for nearly 20% of sales.

The reasons to avoid noncompliant and counterfeit product are numerous. “An emerging concern across the country, black-market vapor products present many issues impacting our local

communities,” said Ann M. Harkins, president and CEO of the National Crime Prevention Council, Washington, D.C. “First and foremost, they undermine tobacco-control measures to address underage use of tobacco and nicotine products. Because these illicit products often are sold online with little to no age-verification or through social sourcing outside of traditional retail channels, they are easier for youth to access.”

Harkins continued, saying these products “may present additional health and safety risks for adult consumers, given the unknown chemicals and substances they may contain, the poor manner in which they are manufactured, and the ability for users to add illicit substances like tetrahydrocannabinol (THC).”

Other reasons to avoid counterfeit and black-market product were the contribution to and facilitation of other criminal activity that “threatens our economy, public health and community safety, as well as violate the intellectual property rights of U.S. companies,” Hawkins said.

The FDA, in conjunction with the Department of Justice, has begun taking enforcement action against a number of smaller vape manufacturers and sent warning letters to over 100 retailers, but Patel of Bidi Vapor believes more can be done. “It’s difficult and costly to keep up with the regulations on the federal, state and local level,” he said. “When bad actors are allowed to participate in the marketplace without any consequences, it’s not good for the industry as a whole.”

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