JUUL E-Cigarette Will Receive FDA Review to Continue in U.S. Market

JUUL also files trademark infringement actions in several states.

August 20, 2020

WASHINGTON—The Food and Drug Administration will soon start reviewing JUUL Labs’ applications for its e-cigarette device and nicotine cartridges, Bloomberg reports.

Late last month, JUUL filed its FDA applications seeking the regulator’s permission to keep selling its device, as well as Virginia-tobacco- and menthol-flavored pods with 3% and 5% concentrations, in the U.S. The FDA will determine whether the products are appropriate for the protection of public health.

The company will “look forward to this next step as the FDA commences substantive review of the application,” said Joe Murillo, chief regulatory officer, JUUL. All e-cigarette makers must submit applications to the FDA by Sept. 9. The review process could reshape the U.S. market.

In addition, JUUL Labs has filed six trademark infringement actions in several states in order to disrupt the illicit trade of black-market vapor products. Over the coming weeks, as part of a nationwide campaign, JUUL will file trademark infringement lawsuits against approximately 20 retailers that have refused to stop selling counterfeit JUUL products even after JUUL verified their illicit activities, demanded they stop and served them with cease and desist notices.

Such products circumvent federal and state laws, can present health and safety risks to adult consumers and undercut underage-prevention measures. According to the company, counterfeit JUUL products are designed and marketed to mimic authentic JUUL merchandise and are largely imported from China-based suppliers. In conjunction with law enforcement, JUUL has identified and shut down numerous illicit manufacturing operations in China, each capable of producing thousands of counterfeited products a month. But others remain active.

The counterfeit products are not manufactured in accordance with JUUL’s stringent requirements and contain unknown ingredients and materials. They are often sold through nontraditional retail channels, such as social sourcing and online, with inadequate age-verification requirements, undermining established underage-prevention measures.

JUUL’s Mystery Shop program has shown that where retailers are willing to sell illicit vaping products, they are often willing to ignore other legal requirements, such as completing proper age verification and complying with the company’s internal product-quantity limits.

“It is our hope that these actions will help remove counterfeit JUUL products from the market and also yield additional information on upstream suppliers that will help JUUL Labs and others further disrupt the illicit black market for vapor products,” the company said in a statement.