The Food and Drug Administration has, for the first time, fined four electronic cigarette manufacturers over allegedly selling unapproved products, marking the latest escalation in the agency's efforts to clamp down on tobacco industry.
The agency is seeking a maximum penalty of $19,192 against BAM Group, Great American Vapes, the Vape Corner, and 13 Vapor Co. for producing and selling certain e-liquids without authorization. The FDA has previously issued fines to businesses caught selling tobacco products to underage consumers, but until now hasn't sought a civil money penalty for selling illegal products.
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“Holding manufacturers accountable for making or selling illegal tobacco products is a top priority for the FDA,” said Brian King, director of the FDA’s Center for Tobacco Products. “We are prepared to use the full scope of our authorities to enforce the law — especially against those who have continued to violate the law after being warned by the agency.”
The FDA said the tobacco manufacturers had received and neglected notices of their violations. Tobacco manufacturers are required to submit a marketing application with the agency and receive authorization prior to selling products, such as e-cigarettes that are battery-powered devices that work by heating up liquid that usually contains nicotine.
"These actions should be a wakeup call that all tobacco product manufacturers — big or small — are required to obey the law," King said.
The manufacturers will be able to pay the fine, enter into a settlement agreement, request an extension to respond to the FDA's complaint, or ask for a hearing. If they do not respond in 30 days, they will be forced to pay the full penalty as a default.
On Friday, FDA Commissioner Robert Califf announced steps that the agency will take to improve regulating tobacco products after an outside panel said in December that the Center for Tobacco Products had wide-ranging issues that hindered its ability to regulate the tobacco industry.
It comes as the agency faces increased pressure from Congress to expedite its review of popular e-cigarette products on the market. Senate Majority Whip Dick Durbin (D-IL) criticized the agency last week for failing to meet the one-year court-ordered deadline to review such products and ensure they meet the agency's requirements, arguing that prolonging the process leaves products appealing to underage teenagers on store shelves.
In 2022, the Centers for Disease Control and Prevention found that more than 2.5 million middle and high school students reported current use of an e-cigarette.
A 2019 court ruling determined the agency had failed to adhere to premarket review requirements under the Family Smoking Prevention and Tobacco Control Act, establishing a Sept. 9, 2021, deadline to review premarket applications for e-cigarette products that the FDA has long since passed. The agency indicated in recent filings that it could take until the end of this year to finish the process.
“Your lack of urgency to address this situation is creating serious public health harm,” said Durbin in a statement. "For too long, FDA has turned a blind eye to its tobacco enforcement duties. "
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The FDA said it has issued more than 550 warning letters to businesses for manufacturing, selling, and/or distributing new tobacco products without approval between January 2021 to Feb. 17, 2023. The majority have complied and taken the products off the market.