- General
- July 15, 2019
- 5 minutes read
E-Cigarette Makers Get 10 Months FDA Review Window
Acting FDA Commissioner Ned Sharpless image: U.S. Food and Drug Administration (FDA) A recent ruling from a federal District Court judge…
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| Acting FDA Commissioner Ned Sharpless
image: U.S. Food and Drug Administration (FDA)
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A recent ruling from a federal District Court judge in Maryland has given e-cigarette makers like Juul, Vuse, Blu, Njoy and more a 10 months deadline to submit applications to U.S. regulators to continue selling their products. The U.S. Food and Drug Administration (FDA) had previously provided a guideline to help e-cigarette makers form their applications. As per the recent ruling, a company’s e-cigarettes can be sold for up to one year while the FDA reviews its application.
The ruling from a U.S. federal judge was in response to a legal case brought by public-health and anti-tobacco groups after the FDA delayed an earlier application deadline.The groups argued that the FDA had avoided its obligation to regulate e-cigarette products. E-cigarette products have been blamed for an increase in youth vaping.
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| A Vuse e-cigarette
image: R.J. Reynolds Vapor Company
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The groups behind the legal case had requested a four-month deadline, while the FDA had told the federal judge 10 months was the earliest it would suggest for applications to be turned in. One of the plaintiffs, Matthew Myers, who serves as president of the Campaign for Tobacco-Free Kids, termed the new deadline as “a dramatic improvement”.
In a statement to Bloomberg, Juul — which commands 76% of the e-cigarette market — said it was supportive of the application process. “We’re confident in the content and quality of the materials we will submit with our application,” a company spokeswoman said in a statement.
The FDA as of late has taken some action against e-cigarette makers and sellers. From April 2018 through April 2019, more than 3,950 warning letters and 665 civil fines were issued to online and brick-and-mortar retailers for illegal sales of e-cigarettes to minors. The FDA also took action against more than 15 firms for selling e-liquids used in cigarettes that bear resemblance to kid-friendly foods, like cereal, candy and juice boxes.
