• April 21, 2024

FDA Accepts Premarket Applications for Leap

 FDA Accepts Premarket Applications for Leap

E-Alternative Solutions (EAS) has received acceptance and filing letters from the U.S. Food and Drug Administration (FDA) for its Leap and Leap Go products.

EAS is now in the substantive review phase of the premarket tobacco product application (PMTA) process. If successful, this phase will result in marketing orders from the FDA authorizing the continued marketing and sale of these products.

“The substantive review is where our months of hard work assembling more than 100,000 pages of evidence will pay off in supporting our proposition that the Leap and Leap Go products are appropriate for the protection of public health,” said Chris Howard, vice president, general counsel and chief compliance officer at EAS.

“We are looking forward to continued collaboration with [the] FDA in the weeks and months to come and remain optimistic that the PMTA process will result in marketing orders.”