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Two electronic vape pens on a table beside two vials of murky liquid
Chaffin Luhana LLP
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Many e-cigarette manufacturers are facing an important deadline that could determine whether their products remain on the market.

In August 2016, the U.S. Food and Drug Administration (FDA) stepped in to regulate products that had previously been unregulated on the market: e-cigarettes. This required companies manufacturing electronic nicotine delivery systems (ENDS) to follow the same regulatory and legal requirements that had been in place for manufacturers of traditional cigarettes.

Specifically, manufacturers had to obtain premarket authorization from the FDA to continue to market their products to U.S. consumers. The deadlines for getting those authorizations were changed a few times. Then in the summer of 2019, District Judge Paul Grimm of the U.S. District Court for the District of Maryland granted the FDA’s request to extend the premarket review submission deadline to May 12, 2020. In April 2020, the judge extended the deadline once more to September 9, 2020, due to the COVID-19 pandemic. This is likely to be the final extension.

Manufacturers must file applications to keep their products on the market by this date. Meanwhile, several health groups have called on the FDA to carefully review these applications to protect public health.

There Is No FDA-Authorized E-Cigarettes on the Market

According to the FDA, as of December 2019, no ENDS  product in the U.S. was on the market legally. “To be legally marketed as a tobacco product, the product would need to obtain premarket authorization from the Agency.”

To obtain that authorization, the product has to undergo scientific review by the FDA, and the FDA must determine that it is appropriate to grant permission to the manufacturer to market the product. Those products intended for therapeutic purposes—such as helping people stop smoking—would have to be reviewed and approved under the FDA’s drug authorities to be legally marketed as a drug.

“Currently, there is no FDA-authorized or FDA-approved ENDS product on the market,” the FDA stated.

As manufacturers work to change that and get their products approved, six leading public health and medical organizations recently urged the FDA to be extra cautious in their approach to approvals.

Health Groups Push FDA to Use Extra Caution in Approving E-Cigarettes

With the regulatory deadline looming, on August 10, 2020, six health groups called on the FDA to deny the applications for any flavored products that appeal to kids, and to require manufacturers to provide “rigorous scientific evidence demonstrating that a product will benefit public health before authorizing its sale….”

Flavored e-cigarettes have been shown in studies to attract young users, as they prefer the sweeter and fruitier flavors, and are believed to have contributed to the current vaping epidemic among young people.

The groups call for the need for “rigorous scientific evidence”, including U.S. studies that show the product will not lead youth and adults who do not currently use nicotine to initiate use, and data that shows the product will not deliver nicotine at levels that increase the risk of abuse or addiction among youth.

The groups also requested that the FDA “promptly remove” those products that miss the filing deadline, and to make its decisions regarding the applications in a “timely, transparent manner…”

The six health groups hoping to sway the FDA include:

  1. American Academy of Pediatrics (AAP)
  2. American Cancer Society Cancer Action Network
  3. American Heart Association (AHA)
  4. American Lung Association (ALA)
  5. Campaign for Tobacco-Free Kids
  6. Truth Initiative

This same group sued the FDA after the FDA previously extended the application deadline for manufacturers to 2022. That action resulted in the FDA imposing the updated September 9, 2020 deadline.

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