The Food and Drug Administration is determined to crack down on businesses that sell vaping products without its approval since e-cigarettes and e-liquids that contain nicotine have been considered a prescription-only medicine since 2021, reported STAT. However, many businesses are still making and selling illicit goods, thus ignoring FDA orders.
Moreover, defining the FDA’s demands seems to be a trend, with smoke shops and online retailers leading the way, despite facing seven-figure fines and removal of its products from shelves. Still, the FDA continues to refrain from taking action.
“FDA has been a toothless tiger that the industry isn’t afraid to ignore,” said Matt Myers, president of the Campaign for Tobacco-Free Kids.
To that end, there are signals that the agency may change the approach to the issue.
“The agency is currently working on further enforcement in situations where companies that have [been banned from the market] continue to sell illegal products,” the spokesperson wrote in an email to STAT. “The FDA is currently engaged in discussions with the Department of Justice (DOJ) regarding specific potential enforcement actions.”
FDA’s Rules Are Not Clear
On the other hand, vape shops justify their actions by arguing that the agency’s rules are not clear enough.
“There’s a complete lack of clarity or transparency from the agency to piece together what products are still legally able to be sold,” Amanda Wheeler, the president of the American Vapor Manufacturers said. “It would be legally and morally irresponsible for us to recommend that companies should voluntarily close down their businesses because FDA cannot sort out their filing systems.”
Meanwhile, the deadline for the companies to apply for FDA’s permission to sell vaping products was September 2020. In the years leading to that date, the vaping industry has grown into a $6 billion industry selling products without the agency’s approval.
For example, Juul Labs Inc., a producer of e-cigarettes, is a $15 billion enterprise with a 1,500-person workforce that started as a small, 200-person company. However, in June, the agency announced that it has banned the sale of Juul e-cigarettes in the U.S., reported CNBC. Even though the company has asked for the FDA’s approval for its vaping device and tobacco earlier, the agency said that the data provided by Juul are insufficient or conflicting in regards to the products’ use.
“Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders,” Michele Mital, acting director of the FDA’s Center for Tobacco Products said in a statement.
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