FDA goes along with court order allowing Juul e-cigarettes to stay on the market while it conducts 'additional review' of products-HEALTHYLIVE

Photo from The Hill

By Melissa Patrick
Kentucky Health News

The Food and Drug Administration has decided to stop, temporarily, its fight to ban Juul Labs' electronic cigarettes, saying there are "scientific issues unique to the Juul application that warrant additional review." 

"This administrative stay temporarily suspends the marketing denial order during the additional review but does not rescind it," a July 5 FDA news release says.

This decision follows an FDA order issued June 23 for Juul to stop selling and distributing its products in the U.S., on grounds the company did not provide enough data for the FDA to determine relevant health risks. The next day, a federal appeals court temporarily blocked the ban, allowing the products to continue selling while the decision was challenged in court. 

In its initial ban of the Juul products, the FDA said the company's marketing applications “lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.” Juul said the information it provided was sufficient and met the standard of being "appropriate for the protection of the public health."

Anti-smoking advocates praised the FDA's initial ruling, largely because of the role Juul has played in the rise of youth vaping, but supporters of the products maintain that they are safer than combustible tobacco products and are an important tool to help people stop smoking.

from KENTUCKY HEALTH NEWS https://ift.tt/6JcpYXr

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