Hand Holding FDA Paperwork

The Food and Drug Administration (FDA) is requiring e-cigarette makers like JUUL Labs to submit applications to the FDA if they want to sell their products in the United States. Originally, e-cigarette manufacturers had until May 2020 to provide complete applications to the FDA. The coronavirus pandemic extended that deadline until at least September 9, 2020, but the FDA requirements remain the same.

What’s Expected of JUUL Labs and Other E-Cig Makers

E-cigarette makers, such as JUUL Labs, must provide the FDA with studies that show:

  • The health effects of their products
  • How their products may help smokers quit smoking
  • Whether their products may appeal to kids and people who don’t currently smoke

JUUL expects to provide the results of more than 100 toxicological, scientific and behavioral studies to the FDA.

According to news reports, FDA regulators are seeking this information to protect a new generation of children and teens from the health effects of nicotine addiction. Before e-cigarettes became popular, smoking rates had decreased for decades in the United States.

E-cigarette makers who cannot meet the FDA requirements will be forced to stop selling their products in the U.S.

Public Health and Medical Organizations Want More

In August 2020, the American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, American Academy of Pediatrics, Campaign for Tobacco-Free Kids, and Truth Initiative requested that the FDA:

  • Not authorize the sale of any flavored e-cigarette products because flavors appeal to kids and there is no evidence that flavors help adults stop smoking
  • Require rigorous scientific evidence to demonstrate that a vaping product will benefit public health before allowing it to be sold
  • Quickly remove vaping products from the market if a company fails to file the required application before the September 2020 deadline
  • Make decisions on product applications promptly and transparently

Our JUUL injury lawyers hope that the FDA, public health groups, and medical organizations successfully protect teens and children from vaping injuries. However, we know that some kids are already hurt.

If your child suffers from a JUULing illness, then we encourage you to contact us today for a free, confidential, no-obligation consultation. We will do everything that we can to help you help your child.

Jason F. Abraham
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Managing Partner, Hupy and Abraham