DARIEN, Conn. — The U.S. Food and Drug Administration (FDA) moved E-Alternative Solutions’ (EAS) Leap and Leap Go vapor products to the substantive review phase of the premarket tobacco applications (PMTAs) process.
This follows the reviews of EAS’s filings to ensure the submissions met the baseline criteria for review. Next, the FDA will review whether the Leap and Leap Go products are appropriate for the protection of public health, according to the Darien, Conn.-based company.
"This milestone represents an important step forward for EAS as we support our mission of producing high-quality vapor products that serve as an alternative to combustible cigarettes with our Leap and Leap Go vapor products," said Jacopo D'Alessandris, president and CEO of EAS. "FDA acceptance and filing letters are a testament to the strength and thoroughness of our applications, which we believe will meet FDA's requirements.”
Leap Vapor was designed for adult smokers and vapers and features e-liquid, batteries and multiple nicotine levels. Leap Go is a line of disposable e-cigarettes.
"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 FDA in the weeks and months to come and remain optimistic that the PMTA process will result in marketing orders."
EAS has developed, marketed and distributed retail products for adults seeking alternative e-cigarette brands since 2014. It is a member of the Vapor Technology Association (VTA) and the National Association of Tobacco Outlets (NATO).